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U.S. Preventive Services Task Force (I) Statements

The USPSTF External Website Policy utilizes systematic reviews to make recommendations for primary care clinicians and health systems regarding a broad range of clinical preventive services. Often, the evidence base summarized in these systematic reviews is insufficient to enable the USPSTF to make a recommendation for or against a preventive service because the evidence is lacking, of poor quality, or conflicting, and the balance of benefits and harms for a clinical preventive service cannot be determined. When this occurs, the USPSTF issues an insufficient evidence, or I statement, along with a description of research needs and gaps.

The list below details 47 I statements, each with a brief summary of research needs and gaps. The list can serve as a resource for prevention researchers and does not necessarily reflect the research priorities of NIH Institutes and Centers.

Abdominal Aortic Aneurysm (AAA): Screening

The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of screening for AAA in women ages 65 to 75 years who have ever smoked.

Research Needs/Gaps Summary
  1. Randomized controlled or modeling studies assessing the effectiveness of screening for AAA in women who smoke and in men and women with a family history of AAA.
  2. Studies, especially those using genetic markers, to assess the validation of risk-scoring tools to identify patients most likely to benefit from screening for AAA.
  3. Effectiveness of antibiotics, statins, or other pharmaceutical agents to reduce AAA growth.
  4. Interventions that address modifiable risk factors and strategies for smoking cessation.
  5. Appropriately powered studies that assess efficacy of treatments on health outcomes.

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Alcohol Misuse: Screening and Behavioral Counseling Interventions in Primary Care

The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of screening and behavioral counseling interventions in primary care settings to reduce alcohol misuse in adolescents.

Research Needs/Gaps Summary
  1. Effects of screening and behavioral counseling in adolescents.
  2. Effect of brief behavioral counseling interventions on longer-term morbidity, mortality, or quality of life.
  3. Whether persons engaging in harmful drinking or alcohol abuse might benefit from behavioral counseling interventions in the primary care setting.
  4. Comparative effectiveness of behavioral counseling components or approaches.
  5. Effectiveness of individualized treatment decisions for a given subpopulation.

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Aspirin Use to Prevent Cardiovascular Disease and Colorectal Cancer (< 50 years): Preventive Medication

The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of initiating aspirin use for the primary prevention of cardiovascular disease and colorectal cancer in adults younger than 50 years.

Research Needs/Gaps Summary
  1. Data on the role of aspirin therapy in preventing CVD in racial/ethnic groups.
  2. Benefits and harms of aspirin therapy in preventing CVD in persons younger than 50 years.
  3. Updated individual-patient data meta-analysis from the Antithrombotic Trialists’ Collaboration
  4. How statins and aspirin interact.
  5. How the use of proton-pump inhibitors with aspirin changes the balance of benefits and harms.
  6. Studies that differentiate between aspirin’s effect in reducing ischemic stroke risk and increasing hemorrhagic stroke risk.
  7. Differential effects of aspirin in preventing CRC by sex, race/ethnicity, age, genetic factors, and/or CRC screening status.
  8. Dosing strategies and long-term effects of aspirin in persons with previous adenomas and on adenoma prevention.
  9. Longer-term follow-up of CVD prevention trials that report CRC incidence and mortality outcomes.
  10. Harms of aspirin-induced GI bleeding.
  11. Validated risk assessment tools for GI bleeding that can be used at the point of care.
  12. Risk assessment tools that consider both CVD risk and GI bleeding risk.

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Aspirin Use to Prevent Cardiovascular Disease and Colorectal Cancer (≥ 70 years): Preventive Medication

The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of initiating aspirin use for the primary prevention of cardiovascular disease and colorectal cancer in adults aged 70 years or older.

Research Needs/Gaps Summary
  1. Data on the role of aspirin therapy in racial/ethnic groups.
  2. Benefits and harms of aspirin therapy in persons 70 years or older.
  3. Updated individual-patient data meta-analysis from the Antithrombotic Trialists’ Collaboration
  4. How statins and aspirin interact.
  5. How the use of proton-pump inhibitors with aspirin changes the balance of benefits and harms.
  6. Studies that differentiate between aspirin’s effect in reducing ischemic stroke risk and increasing hemorrhagic stroke risk.
  7. Differential effects of aspirin in preventing CRC by sex, race/ethnicity, age, genetic factors, and/or CRC screening status.
  8. Dosing strategies and long-term effects of aspirin in persons with previous adenomas and on adenoma prevention.
  9. Longer-term follow-up of CVD prevention trials that report CRC incidence and mortality outcomes.
  10. Harms of aspirin-induced GI bleeding.
  11. Validated risk assessment tools for GI bleeding that can be used at the point of care.
  12. Risk assessment tools that consider both CVD risk and GI bleeding risk.

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Autism Spectrum Disorder in Young Children: Screening*

The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of screening for autism spectrum disorder (ASD) in children for whom no concerns of ASD have been raised by their parents or clinical provider.

Research Needs/Gaps Summary
  1. Intermediate and long-term health outcomes of screening for ASD in children
  2. Whether earlier identification through screening is associated with clinically important improvements in health outcomes.
  3. Studies following large samples of screen-negative children to provide information about screening specificity.
  4. Treatment studies that enroll younger children, especially those with screen-detected ASD, to elucidate the potential benefits of screening.

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Bacterial Vaginosis in Pregnancy to Prevent Preterm Delivery: Screening

The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of screening for bacterial vaginosis in asymptomatic pregnant women at high risk for preterm delivery.

Research Needs/Gaps Summary
  1. Benefits of treatment for bacterial vaginosis in asymptomatic pregnant women at increased risk for preterm delivery
  2. Benefit of screening and treating asymptomatic bacterial vaginosis in women at highest risk for preterm delivery
  3. Which screening tests providers use to diagnose bacterial vaginosis in clinical practice and the accuracy of these tests
  4. Optimal treatment regimens for bacterial vaginosis

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Bladder Cancer in Adults: Screening

The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of screening for bladder cancer in asymptomatic adults.

Research Needs/Gaps Summary
  1. Randomized, controlled trials or well-designed case-control studies to evaluate clinical outcomes in screened versus unscreened populations.
  2. Harms of screening and treatment.
  3. Cohort studies of the natural history of early-stage, untreated bladder cancer to elucidate potential overdiagnosis and overtreatment associated with screen-detected bladder cancer.
  4. Diagnostic accuracy of urine screening tests in representative populations.
  5. Effect of screening on bladder cancer incidence, tumor characteristics, and subsequent treatments.
  6. Comparisons of the effects of using less-toxic treatments earlier and more frequently to prevent progression, versus using treatments with greater toxicity.

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Blood Pressure in Children and Adolescents (Hypertension): Screening

The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of screening for primary hypertension in asymptomatic children and adolescents to prevent subsequent cardiovascular disease in childhood or adulthood.

Research Needs/Gaps Summary
  1. Effectiveness and comparative effectiveness of pharmacologic and lifestyle interventions to achieve sustained reductions in blood pressure and longer-term modification of adult hypertension and cardiovascular risk in children with primary hypertension.
  2. Accuracy and reliability of blood pressure screening tools and protocols in primary care among children and adolescents of varying ages and characteristics.
  3. Adverse effects of screening.
  4. Comparative accuracy studies of different types of devices to measure blood pressure.
  5. Screening strategies that reduce the rate of false-positive diagnoses of hypertension.
  6. Cohort studies that include blood pressure measures and other cardiovascular risk factors in children and adolescents with long-term follow-up.
  7. Studies that elucidate the association among childhood hypertension, adult hypertension, and surrogate measures of cardiovascular disease in childhood and adulthood, as well as adult clinical cardiovascular disease.
  8. Treatment trials examining surrogate or subclinical cardiovascular outcomes during adolescence or young adulthood.
  9. Trials in high-risk adolescent populations (such as those with obesity) that include longer-term follow-up with future hypertension and subclinical cardiovascular outcomes.
  10. Treatment studies that assess medication harms, measures of long-term compliance, and individual components of multifactorial interventions.

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Breast Cancer: Screening (≥ 75 years)

The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of screening mammography in women aged 75 years or older.

Research Needs/Gaps Summary
  1. Measurement and monitoring of overdiagnosis and overtreatment in breast cancer screening programs, applying uniform definitions and standards.
  2. Ways to reduce overdiagnosis and overtreatment of breast cancer identified through screening.
  3. Development of prognostic indicators to distinguish non-progressive or slowly-progressive breast lesions from tumors that are likely to affect quality or length of life.
  4. Comparisons of the long-term benefits and harms of immediate treatment versus observation or surveillance in women with screen-detected DCIS.
  5. Direct evidence of the effectiveness of breast cancer screening for African American women and older women.

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Breast Cancer: Screening (Digital Breast Tomosynthesis (DBT))

The USPSTF concludes that the current evidence is insufficient to assess the benefits and harms of digital breast tomosynthesis (DBT) as a primary screening method for breast cancer.

Research Needs/Gaps Summary
  1. Effectiveness of DBT in improving important health outcomes.

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Breast Cancer: Screening (Adjunctive Screening)

The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of adjunctive screening for breast cancer using breast ultrasonography, magnetic resonance imaging, DBT, or other methods in women identified to have dense breasts on an otherwise negative screening mammogram.

Research Needs/Gaps Summary
  1. Effectiveness of DBT, ultrasonography, and/or MRI in improving important health outcomes for women with dense breasts.
  2. Research to improve the validity and reproducibility of serial BIRADS assessments in women with dense breasts.
  3. Long-term randomized trials or longitudinal cohort studies comparing screening outcomes (stage at diagnosis, breast cancer recurrence rates, rates of overdiagnosis, breast cancer mortality) in women with dense breasts who receive adjunctive screening vs. those who do not.

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Child Maltreatment: Primary Care Interventions

The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of primary care interventions to prevent child maltreatment. This recommendation applies to children who do not have signs or symptoms of maltreatment.

Research Needs/Gaps Summary
  1. Relationship between harsh punishment and abuse.
  2. Relationship between intimate partner violence and child maltreatment.
  3. Methods for health care professionals to identify children at risk for or currently experiencing maltreatment.
  4. Prevention of maltreatment in older children.
  5. Research to confirm or refute the efficacy and expand the applicability of benefits reported in some of the intervention studies.
  6. Studies that lead to standardization of interventions and outcomes.
  7. Whether there are unintended harms from screening, risk assessment, and interventions.
  8. How to measure outcomes related to child abuse and neglect.

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Chlamydia and Gonorrhea: Screening

The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of screening for chlamydia and gonorrhea in men.

Research Needs/Gaps Summary
  1. Effectiveness of: different screening strategies for identifying persons who are at increased risk for infection, co-testing for concurrent STIs, and different screening intervals.
  2. Effectiveness of screening asymptomatic men to reduce the consequences of infection and transmission to sexual partners.
  3. Studies to identify subgroups (e.g., men who have sex with men, sexually active males younger than 24 years, men residing in high-prevalence communities) for whom screening may be effective.
  4. Adverse effects of screening in any population.

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Chronic Kidney Disease (CKD): Screening

The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of routine screening for chronic kidney disease in asymptomatic adults.

Research Needs/Gaps Summary
  1. Sensitivity and specificity of one-time testing for chronic kidney disease.
  2. Reasons for and interventions to prevent progression to end-stage kidney disease among African Americans.
  3. Benefits and harms of screening and early treatment of CKD in persons without diabetes or hypertension
  4. Effect of screening for CKD in patients with hypertension but not diabetes.

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Cognitive Impairment in Older Adults: Screening

The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of screening older adults for cognitive impairment.

Research Needs/Gaps Summary
  1. Screening for and treatment of mild cognitive impairment.
  2. Effect of screening and early detection of mild to moderate dementia on decision-making, planning, or other important patient outcomes.
  3. Effect of treatment for mild to moderate dementia on long-term cognitive outcomes.
  4. Harms of screening.
  5. New interventions that address the changing needs of patients and families and interventions that affect the long-term clinical course of mild to moderate dementia.

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Coronary Heart Disease: Screening Using Non – Traditional Risk Factors

The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of using the nontraditional risk factors studied to screen asymptomatic men and women with no history of CHD to prevent CHD events.

Research Needs/Gaps Summary
  1. Benefits and harms of aggressive treatment of persons reclassified from intermediate to high risk on the basis of additional information obtained from hs-CRP, ABI, and EBCT tests.
  2. Health effect of reclassifying those at high and intermediate risk for CHD events into lower-risk categories on the basis of hs-CRP, ABI, and EBCT tests.
  3. Predictive value and prevalence of periodontal disease, carotid IMT, and lipoprotein(a), in conjunction with traditional Framingham risk factors, for predicting CHD events and death.
  4. Predictive value and prevalence of nontraditional risk factors for predicting CHD events and death in diabetic populations.

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Coronary Heart Disease: Screening with Electrocardiography

The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of screening with resting or exercise ECG for the prediction of CHD events in asymptomatic adults at intermediate or high risk for CHD events.

Research Needs/Gaps Summary
  1. Studies that use a conventional risk stratification algorithm and evaluate the changes in risk classification, treatment, and CHD outcomes that occur as a result of adding resting or exercise ECG.
  2. Evidence to help understand restratification of persons at intermediate risk.
  3. Harms associated with screening and with additional testing and therapies.

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Dental Caries in Children from Birth Through Age 5 Years: Screening

The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of routine screening examinations for dental caries performed by primary care clinicians in children from birth to age 5 years.

Research Needs/Gaps Summary
  1. Multivariate risk assessment tools that can identify high-risk populations most likely to benefit from caries preventive interventions, such as fluoride varnish.
  2. Benefits of fluoride varnish among lower-risk and younger children.
  3. Risk assessment and preventive interventions that enroll sufficient numbers of racial and ethnic minority children to understand the benefits and harms of interventions in these populations.
  4. Effectiveness of interventions by clinicians to educate parents and caregivers about optimum health practices for oral hygiene at home.

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Depression in Children and Adolescents: Screening

The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of screening for major depressive disorder (MDD) in children ages 11 years or younger.

Research Needs/Gaps Summary
  1. Studies of screening for and treatment of MDD in children younger than 11 years of age.
  2. Large randomized controlled trials to better understand the effects of screening for MDD on intermediate and long-term health outcomes.
  3. Estimates of the proportion of persons with screen-detected MDD who are treated or referred and their willingness and ability to be assessed and treated.
  4. Studies in child and adolescent populations of the effects of comorbid conditions on screening accuracy, type of treatment selected for MDD, and benefits and harms of screening.
  5. Studies of psychotherapy and combined treatments for MDD.
  6. Studies of the benefits and harms of treatments other than psychotherapy, such as non-SSRI medications and complementary or alternative approaches.
  7. Treatment studies with long-term follow-up.
  8. For rare events, meta-analyses that include only children and adolescents with MDD and focus on current FDA-approved medications.

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Developmental Hip Dysplasia: Screening

The USPSTF concludes that the current evidence is insufficient to recommend routine screening for developmental dysplasia of the hip in infants as a means to prevent adverse outcomes.

Research Needs/Gaps Summary
  1. Natural history of spontaneous resolution of hip instability and dysplasia.
  2. Multicenter studies of interventions that measure functional outcomes (including long-term outcomes) in a standardized fashion.
  3. Valid and reliable radiological outcomes of DDH as proxy measures of functional outcomes.
  4. Controlled studies that assess the effects of delaying treatment on outcomes.

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Drug Use, Illicit: Primary Care Interventions for Children and Adolescents

The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of primary care–based behavioral interventions to prevent or reduce illicit drug or nonmedical pharmaceutical use in children and adolescents. This recommendation applies to children and adolescents who have not already been diagnosed with a substance use disorder.

Research Needs/Gaps Summary
  1. Brief interventions.
  2. Interventions that link screening with tailored interventions.
  3. Social media, cell phone, and Internet-based interventions to identify novel, effective risk-reduction strategies.
  4. Studies on diverse populations and the effects of interventions on children and adolescents with different risks, as well as which interventions work best in these subpopulations.
  5. Effectiveness of behavioral interventions with and without parental involvement.
  6. Studies that evaluate interventions and address drug use in the context of other substances, including tobacco and alcohol.
  7. Tools to measure current and past substance use.

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Drug Use, Illicit: Screening

The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of screening adolescents, adults, and pregnant women for illicit drug use.

Research Needs/Gaps Summary
  1. Whether interventions found effective for treatment-seeking individuals with symptoms of drug misuse are equally effective when applied to asymptomatic individuals identified through screening.
  2. Observational studies to establish the effect of treatment on social/legal problems and longer-term health outcomes, including morbidity/mortality.
  3. Trials that assess treatment outcomes for adolescents and pregnant women.
  4. Clinical utility of validated standardized questionnaires to screen for illicit drug use/misuse when they are applied in busy primary care practice settings.

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Gestational Diabetes Mellitus (GDM): Screening

The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of screening for GDM in asymptomatic pregnant women before 24 weeks of gestation.

Research Needs/Gaps Summary
  1. Research to directly evaluate screening for GDM and maternal and infant health outcomes.
  2. The most beneficial glucose thresholds for a positive screen and treatment targets.
  3. Alternative screening methods, such as glycosylated hemoglobin (HbA1c) measurement and risk factor‒based assessment.
  4. Effect of different treatments for GDM on longer-term metabolic maternal and infant outcomes (persistent maternal glucose intolerance after delivery; type 2 diabetes and obesity in mother and infant).
  5. Whether identifying and treating glucose intolerance before 24 weeks of gestation reduces maternal and fetal complications at delivery or leads to improved long-term health outcomes.

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Glaucoma: Screening

The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of screening for primary open-angle glaucoma (POAG) in adults.

Research Needs/Gaps Summary
  1. The link between the intermediate glaucoma outcomes of optic nerve damage and visual field loss and the final health outcomes of visual disability and patient-reported outcomes.
  2. Screening effectiveness, ideally from a randomized, controlled trial of routine or targeted screening versus standard care with long-term follow-up.
  3. Treatment studies of adequate duration and size to assess important clinical outcomes (such as visual impairment and vision-related quality of life), or greater changes in visual fields.

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Hearing Loss in Older Adults: Screening

The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of screening for hearing loss in asymptomatic adults aged 50 years or older.

Research Needs/Gaps Summary
  1. Studies that focus on patients older than 70 years and examine differential effects of treatment on outcomes at different ages (for example, older than 70 or 80 years).
  2. Effect of screening for hearing loss on health outcomes (emotional and social functioning, communication ability, cognitive function), particularly among adults without self-perceived or established hearing loss at baseline.
  3. Incremental benefits and costs of screening asymptomatic adults compared with only testing and treating those who seek treatment of perceived hearing impairment.
  4. Factors or patient characteristics associated with increased and sustained use of hearing aids.

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Impaired Visual Acuity in Older Adults: Screening

The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of screening for visual acuity for the improvement of outcomes in older adults.

Research Needs/Gaps Summary
  1. Methods of screening in a primary care setting to identify disorders that do not manifest themselves through loss of visual acuity.
  2. Evaluation of the link between vision screening in older adults and improved function, quality of life, and independence.
  3. Association between falls risk and corrective lenses, including associations with changes in lens prescriptions and use of multifocal glasses.

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Intimate Partner Violence and Abuse of Elderly and Vulnerable Adults: Screening

The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of screening all elderly or vulnerable adults (physically or mentally dysfunctional) for abuse and neglect.

Research Needs/Gaps Summary
  1. Utility of newer screening approaches, such as computerized screening and intervention.
  2. Accuracy, efficiency, and acceptability of computerized screening.
  3. Development or validation of an accepted standard to allow accurate assessment of performance measures and comparison of instruments.
  4. Effectiveness of different postscreening interventions.
  5. Studies in vulnerable adult populations (those with financial difficulties, dementia, or living in a care-taking environment).
  6. Effectiveness of interventions for middle-aged women who are past childbearing age, but not yet elderly.
  7. Evidence for screening and treatment in other populations, especially men.

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Iron Deficiency Anemia in Young Children: Screening

The USPSTF concludes that the current evidence is insufficient to recommend for or against routine screening for iron deficiency anemia in asymptomatic children aged 6 to 12 months.

Research Needs/Gaps Summary
  1. Whether screening and early treatment for iron deficiency anemia in infancy improve neurocognitive outcomes.
  2. Efficacy of preventing iron deficiency vs. detecting and treating existing iron deficiency.
  3. Efficacy of screening and early treatment of multiple nutritional deficiencies, rather than iron deficiency anemia alone, in preventing adverse neurocognitive outcomes.

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Iron Deficiency Anemia in Pregnant Women: Screening and Supplementation – Screening

The USPSTF concludes that the current evidence is insufficient to recommend for or against routine screening for iron deficiency anemia in pregnant women to prevent adverse maternal health and birth outcomes.

Research Needs/Gaps Summary
  1. Effects of screening for and early treatment of iron deficiency anemia on maternal and infant health outcomes.

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Iron Deficiency Anemia in Pregnant Women: Screening and Supplementation – Supplementation

The USPSTF concludes that the current evidence is insufficient to recommend for or against routine iron supplementation for non-anemic pregnant women.

Research Needs/Gaps Summary
  1. Clinical significance of iron supplementation in improving maternal hematologic indexes.
  2. Well-designed, adequately powered studies that evaluate the effects of iron supplementation, or change in maternal iron status as a result of intervention, on maternal and infant health outcomes (e.g., postpartum hemorrhage, maternal illness, preterm delivery, low birthweight, and perinatal death), particularly in settings similar to the U.S. with respect to nutrition, hemoparasite burden, and socioeconomic status.

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Lead Levels in Childhood and Pregnancy: Screening

The USPSTF concludes that the current evidence is insufficient to recommend for or against routine screening for elevated blood lead levels in asymptomatic children aged 1 to 5 who are at increased risk.

Research Needs/Gaps Summary
  1. Effectiveness of community-based interventions and recommendations regarding their use.

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Lipid Disorders in Children: Screening

The USPSTF concludes that the current evidence is insufficient to recommend for or against routine screening for lipid disorders in infants, children, adolescents, or young adults (up to age 20).

Research Needs/Gaps Summary
  1. Effectiveness of treatment interventions (e.g., diet, exercise, lipid lowering agents) in children with dyslipidemia (including multifactorial dyslipidemia) in improving health outcomes.
  2. Population-based screening studies or randomized controlled trials (RCTs) that follow children and adolescents into adulthood after treatment.
  3. Studies that track dyslipidemia in all age groups (up to age 20) are necessary as the epidemiology of obesity evolves.

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Oral Cancer: Screening

The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of screening for oral cancer in asymptomatic adults.

Research Needs/Gaps Summary
  1. Randomized, controlled trials assessing the benefits and harms of oral cancer screening in U.S. persons who are at increased risk (history of tobacco and heavy alcohol use).
  2. Accuracy of primary care providers, dental hygienists, dentists, or other trained persons screening U.S. patients who are at increased risk.
  3. Longitudinal follow-up of screening studies that show the health effect of screening in the U.S.
  4. Risks and benefits of screening African Americans and men.
  5. Benefits of screening for HPV and selection of populations for oral cancer screening based on HPV status.
  6. Determining the most effective screening examination.
  7. Benefits and harms of screening for oropharyngeal cancer.
  8. Research examining the natural history of oral HPV infection.
  9. Efficacy of HPV vaccines in preventing infection at noncervical sites and in decreasing the risk for oropharyngeal cancer.

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Osteoporosis: Screening

The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of screening for osteoporosis in men.

Research Needs/Gaps Summary
  1. Long-term health outcomes of screened and nonscreened population groups.
  2. Randomized trials of bisphosphonates for fracture prevention in men at high risk for fractures.
  3. Outcomes of screening women during periods of rapid bone loss (during menopause).
  4. Parameters for treatment using quantitative ultrasonography as an osteoporosis screening test.
  5. Incidence of major osteoporotic fractures in nonwhite ethnic groups in the United States.
  6. Optimal screening intervals.
  7. Effect of clinical and subclinical vertebral fractures on health-related quality of life.

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Peripheral Arterial Disease (PAD) and CVD in Adults: Risk Assessment with Ankle Brachial Index

The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of screening for peripheral artery disease (PAD) and cardiovascular disease (CVD) risk assessment with the ankle–brachial index (ABI) in adults.

Research Needs/Gaps Summary
  1. Large, population-based, randomized trials to determine whether screening for PAD with the ABI improves clinical outcomes.
  2. Studies in persons potentially at increased risk for PAD and not already receiving cardiovascular risk reduction interventions.
  3. Verification studies with more diverse populations to ascertain whether low ABI is a valid measure of PAD.
  4. Studies estimating the number of persons who will develop clinical signs or symptoms in their lifetime and risk for overdiagnosis.
  5. Whether identifying and treating asymptomatic persons with screen-detected PAD is more effective than targeting identification to those with signs or symptoms of disease.
  6. Intervention studies of persons with screen-detected PAD or those whose risk has been reclassified based on their ABI to determine whether treatment initiation, modification, or intensification improve clinical outcomes in patients with asymptomatic PAD.
  7. Value of ABI screening for risk prediction.
  8. Value of ABI screening within certain subgroups (persons with higher underlying prevalence of low ABI, those in whom traditional risk prediction does not perform well, or those near thresholds of risk categories).
  9. Whether aggressive modification of risk factors in patients with multiple atherosclerotic risk factors reduces the incidence of symptomatic PAD.

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Skin Cancer: Counseling

The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of counseling adults older than age 24 years about minimizing risks to prevent skin cancer.

Research Needs/Gaps Summary
  1. Randomized, controlled trials to develop effective interventions for children.
  2. Effectiveness of counseling on the use of sun-protective behaviors in adults
  3. Effect of UV exposure during adulthood, in terms of risk for skin cancer.
  4. Technologies and vehicles for administering relevant interventions for behavior change.

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Skin Cancer: Screening

The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of visual skin examination by a clinician to screen for skin cancer in adults.

Research Needs/Gaps Summary
  1. Adequately-powered randomized clinical trials on primary screening by clinical visual skin examination, with cause-specific mortality as an end point.
  2. High-quality case control studies of primary screening by clinical visual skin examination.
  3. Harms of screening for skin cancer (i.e., potential for overdiagnosis and overtreatment).

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Speech and Language Delay and Disorders in Children Age 5 and Younger: Screening

The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of screening for speech and language delay and disorders in children aged 5 years or younger.

Research Needs/Gaps Summary
  1. Whether systematic, routine screening for speech and language delay and disorders in young children in primary care settings leads to improved speech, language, or other outcomes.
  2. Feasibility of speech- and language-specific screening as part of routine developmental screening and the most effective screening instruments.
  3. Potential harms of screening and interventions.
  4. Prevalence of speech and language delays and disorders in young children in the U.S.
  5. Factors associated with intervention effectiveness, including the potential effects of age at diagnosis, age at treatment, treatment type, and treatment duration.

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Suicide Risk in Adolescents, Adults and Older Adults: Screening

The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of screening for suicide risk in adolescents, adults, and older adults in primary care.

Research Needs/Gaps Summary
  1. Epidemiology and natural history of suicide risk.
  2. Persons who attempt suicide and survive and those who die by suicide are overlapping populations. Research to understand these subgroups and determine who accesses primary care is needed.
  3. Performance characteristics of screening tests, particularly in average-risk adolescents.
  4. Whether individuals with screen-detected suicidal ideation could be helped before they act.
  5. Benefits and potential harms of targeted versus general screening.
  6. Incorporation of technology into large-scale screening studies.
  7. Treatment studies in populations with screen-detected suicide risk in all age groups.
  8. Benefits and risks of interventions targeting average- and high-risk adolescents, and parents.
  9. Replication of trials in adults that focus on the process of care (including quality of care and patient adherence) instead of the specific content of treatment sessions.
  10. Ways to link clinical and community resources to help patients at risk for suicide.

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Thyroid Dysfunction: Screening

The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of screening for thyroid dysfunction in nonpregnant, asymptomatic adults.

Research Needs/Gaps Summary
  1. Evidence on benefits of screening from long-term randomized, blinded, controlled trials of screening for thyroid dysfunction in asymptomatic persons.
  2. Treatment trials of either subclinical or asymptomatic “overt” thyroid dysfunction versus watchful waiting, using final health outcomes (cardiovascular-related morbidity and mortality) as the end points of interest.
  3. Long-term observational studies of the natural history of untreated, asymptomatic thyroid dysfunction based on different serum TSH and T4 levels, and outcomes in persons with nonspecific symptoms.
  4. Randomized trials of subclinical thyroid dysfunction treatment effect on cardiac outcomes.
  5. Harms of screening for and treating thyroid dysfunction.
  6. How to communicate the clinical complexity of asymptomatic thyroid dysfunction screening and treatment so that patients and their providers can make informed decisions.

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Tobacco Smoking Cessation in Adults and Pregnant Women: Behavioral and Pharmacotherapy Interventions* – Pregnant Women

The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of pharmacotherapy interventions for tobacco cessation in pregnant women.

Research Needs/Gaps Summary
  1. Research to elucidate features of behavioral counseling interventions, benefits of pharmacotherapy in specific subpopulations, and the efficacy of newer technology-based interventions.
  2. Effects of varying levels of intervention intensity (e.g., how the number of sessions and number of minutes per session affect continuous abstinence rates), behavioral counseling intervention settings (e.g., individual vs. group, health vs. community, primary care vs. specialty), and ways to personalize/tailor self-help materials.
  3. Benefits and harms of pharmacotherapy in specific subpopulations, such as pregnant women and adults with mental health conditions.
  4. Research that directly compares different types of pharmacotherapy in different populations; to help inform providers of which interventions to use with which patients.
  5. Effectiveness of newer technology platforms for smoking cessation interventions, such as Internet-based programs, mobile/smart phone applications, and text messaging programs.

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Tobacco Smoking Cessation in Adults and Pregnant Women: Behavioral and Pharmacotherapy Interventions* – ENDS

The USPSTF concludes that the current evidence is insufficient to recommend electronic nicotine delivery systems (ENDS) for tobacco cessation.

Research Needs/Gaps Summary
  1. Safety of electronic nicotine delivery systems (ENDS)
  2. Benefits and harms of using ENDS as a means for quitting conventional smoking.

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Visual Impairment in Children Ages 1–5: Screening

The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of vision screening for children < 3 years of age.

Research Needs/Gaps Summary
  1. Optimal age for initiation of screening, screening methods, and screening frequency.
  2. Longitudinal studies that link optimal screening tests to the identification of children with visual impairments.
  3. The most-favorable combinations of screening tests, as well as the optimal treatment for amblyopia and the optimal treatment duration.
  4. Long-term benefits and harms of preschool vision screening (quality of life, school performance, labeling or anxiety).

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Vitamin D and Calcium to Prevent Fractures: Preventive Medication – In Men

The USPSTF concludes that the current evidence is insufficient to assess the balance of the benefits and harms of combined vitamin D and calcium supplementation for the primary prevention of fractures in men.

Research Needs/Gaps Summary
  1. Whether daily supplementation with greater than 400 IU of vitamin D3 and greater than 1,000 mg of calcium reduces fracture incidence in postmenopausal women or older men.
  2. Comparative effectiveness of different preparations of vitamin D (for example, D2 versus D3) or different calcium formulations.
  3. Potential benefits of vitamin D and calcium supplementation in early adulthood on fracture incidence later in life.
  4. Effects of vitamin D supplementation on diverse populations.

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Vitamin D and Calcium to Prevent Fractures: Preventive Medication – Postmenopausal Women

The USPSTF concludes that the current evidence is insufficient to assess the balance of the benefits and harms of daily supplementation with greater than 400 IU of vitamin D and greater than 1,000 mg of calcium for the primary prevention of fractures in noninstitutionalized postmenopausal women.

Research Needs/Gaps Summary
  1. Whether daily supplementation with greater than 400 IU of vitamin D3 and greater than 1,000 mg of calcium reduces fracture incidence in postmenopausal women or older men.
  2. Comparative effectiveness of different preparations of vitamin D (for example, D2 versus D3) or different calcium formulations.
  3. Potential benefits of vitamin D and calcium supplementation in early adulthood on fracture incidence later in life.
  4. Effects of vitamin D supplementation on diverse populations.

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Vitamin D and Calcium to Prevent Fractures: Preventive Medication – Premenopausal Women

The USPSTF concludes that the current evidence is insufficient to assess the balance of the benefits and harms of combined vitamin D and calcium supplementation for the primary prevention of fractures in premenopausal women.

Research Needs/Gaps Summary
  1. Whether daily supplementation with greater than 400 IU of vitamin D3 and greater than 1,000 mg of calcium reduces fracture incidence in postmenopausal women or older men.
  2. Comparative effectiveness of different preparations of vitamin D (for example, D2 versus D3) or different calcium formulations.
  3. Potential benefits of vitamin D and calcium supplementation in early adulthood on fracture incidence later in life.
  4. Effects of vitamin D supplementation on diverse populations.

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Vitamin D Deficiency: Screening

The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of screening for vitamin D deficiency in asymptomatic adults.

Research Needs/Gaps Summary
  1. Determining the cut point that defines vitamin D deficiency, the sensitivity and specificity of various assays using an internationally accepted reference standard, and whether total serum 25-(OH)D is the best measure of vitamin D deficiency in all populations.
  2. Effects of acute inflammation on vitamin D levels.
  3. Which treatment regimens may benefit specific vitamin D–deficient populations, such as men and non-Caucasian ethnic groups, who are absent from the evidence base.
  4. Studies (in addition to the VITAL trial) to evaluate the harms of screening for and treating vitamin D deficiency.

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Vitamin Supplementation to Prevent Cancer and CVD: Counseling – Multivitamins

The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of the use of multivitamins for the prevention of cardiovascular disease or cancer.

Research Needs/Gaps Summary
  1. Studies of multivitamin combinations in groups generalizable to the U.S. population.

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Vitamin Supplementation to Prevent Cancer and CVD: Counseling – Nutrient Supplements

The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of the use of single- or paired-nutrient supplements (except β-carotene and vitamin E) for the prevention of cardiovascular disease or cancer.

Research Needs/Gaps Summary
  1. New and innovative research methods for examining effects of nutrients that account for the unique complexities of nutritional research but maintain rigorous designs.
  2. Studies addressing the lack of standardized methods to determine relevant serum nutrient levels, agreement on thresholds for sufficiency and insufficiency, or predictive validity of current mechanistic models to facilitate progress in understanding potential benefits of dietary supplements.

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*Recommendation is still in draft form and not yet finalized.