Research Priorities

U.S. Preventive Services Task Force (USPSTF) Insufficient Evidence (I) Statements

The U.S. Preventive Services Task Force (USPSTF) insufficient evidence statements, or I statements, report areas of clinical preventive services for which evidence is lacking, of poor quality, or conflicting, and the balance of benefits and harms for a clinical preventive service cannot be determined.

The list below can serve as a useful resource for prevention researchers. However, the I Statements do not necessarily reflect the research priorities of NIH Institutes and Centers.

 

Abdominal Aortic Aneurysm: Screening

The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of screening for AAA with ultrasonography in women aged 65 to 75 years who have ever smoked or have a family history of AAA.

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. Well-conducted cohort studies examining rescreening benefits (including growth rates and health outcomes) for persons who initially screen negative for AAA to determine the benefit and timing of additional screening ultrasonography.
  3. Epidemiologic studies on the current prevalence of AAA in the United States, including in subpopulations.
  4. 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.
  5. Well-designed studies, RCTs, or registry data on the thresholds for repair of AAA in women to inform the benefits and harms of screening in women, as evidence suggests that AAAs in women may rupture at a smaller size than in men.
  6. Studies examining systems approaches to improving implementation of evidence-based AAA screening in the United States
  7. Studies examining the efficacy of screening and treatment in diverse populations (e.g., older adults, women, and racial/ethnic groups) to inform the need for specific recommendations in subpopulations.

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Adolescent Idiopathic Scoliosis: Screening

The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of screening for adolescent idiopathic scoliosis in children and adolescents aged 10 to 18 years.

Research Needs/Gaps Summary

  1. Prospective, controlled screening studies that compare screened vs. unscreened populations, and different screening settings, personnel, and procedures.
  2. Good-quality studies with prospective identification of cohorts at the time of diagnosis or treatment for long-term follow-up.
  3. High-quality studies on the potential harms of screening and treatment.
  4. Studies to help determine whether individual characteristics (ie, BMI) influence response to bracing treatment.
  5. Studies on long-term outcomes, with results stratified by degree of spinal curvature at diagnosis and at skeletal maturity.
  6. Data on long-term outcomes: pulmonary disorders, disability, back pain, psychological effects, cosmetic issues, quality of life.
  7. Good-quality studies on treatment with bracing, exercise, and surgery among screen-detected individuals.
  8. Studies conducted in primary care settings

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Alcohol Use in Adolescents and Adults, Unhealthy: Screening and Behavioral Counseling Interventions

The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of screening and brief behavioral counseling interventions for alcohol use in primary care settings in adolescents aged 12 to 17 years.

Research Needs/Gaps Summary

  1. A trial with an unscreened comparison group to understand the population-level effects of screening in primary care settings.
  2. More direct evidence on the harms associated with screening and behavioral interventions.
  3. Further test performance studies on the USAUDIT and USAIDIT-C to confirm their accuracy in identifying unhealthy alcohol use in various populations.
  4. Evidence on important clinical outcomes, such as longer-term morbidity, mortality, health care utilization, and social and legal outcomes.
  5. Trials designed a priori to report subgroup effects in diverse populations (e.g., by age, sex, race/ethnicity, or baseline severity)
  6. High-quality studies to assess the effects of screening and behavioral counseling in adolescents
  7. In addition, studies in adolescents are often conducted in school settings, which may not translate to primary care settings. More studies of adolescents in primary care settings are needed.

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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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Atrial Fibrillation: Screening with Electrocardiography (ECG)

The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of screening for atrial fibrillation with ECG.

Research Needs/Gaps Summary

  1. Randomized trials enrolling asymptomatic persons and directly comparing screening with usual care as well as assessing both health outcomes and harms.
  2. Understanding how to optimize the accuracy of ECG interpretation.
  3. Effectiveness (benefits and harms) of newer screening technologies that are capable of assessing pulse and heart rhythm.
  4. Understanding the stroke risk associated with brief episodes of subclinical atrial fibrillation and the potential benefit of anticoagulation therapy if risk is significant.

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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 Pregnant Persons 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 BV in pregnant persons who are at increased risk for preterm delivery.

Research Needs/Gaps Summary

  1. Benefits of treatment for bacterial vaginosis in asymptomatic pregnant persons at increased risk for preterm delivery.
  2. Benefit of screening and treating asymptomatic bacterial vaginosis in pregnant persons at increased risk for preterm delivery.
  3. Methods to better identify persons at increased risk for preterm delivery.
  4. Accuracy of screening tests for pregnant persons at increased risk for preterm delivery.
  5. Adequately powered studies to detect a reduction of all-cause preterm delivery prior to 37 weeks’ gestation.

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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 (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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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 (≥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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Cardiovascular Disease Risk: 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 to prevent CVD events in asymptomatic adults at intermediate or high risk for CVD events.

Research Needs/Gaps Summary

  1. Studies that assess the incremental value of adding ECG to current CVD risk assessment tools or instruments to directly inform decision making and that examine patient outcomes.
  2. Studies that assess the added value of ECG for risk reclassification across clinically relevant risk thresholds.
  3. Studies of CVD risk assessment that evaluate the harms associated with assessment as well as those related to additional testing and treatment.
  4. Studies measuring risk reclassification that report total, event, and nonevent Net Reclassification Indices, with corresponding confidence intervals and measures of calibration and discrimination.

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Cardiovascular Disease: Risk Assessment With Nontraditional 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 CVD to prevent CVD events.

Research Needs/Gaps Summary

  1. Good-quality studies comparing traditional risk assessment with traditional risk assessment plus the ABI, hsCRP level, or CAC scores to measure the effect of adding nontraditional risk factors on clinical decision thresholds and patient outcomes (CVD events; mortality).
  2. Studies are needed in more diverse populations (women, racial/ethnic minorities, persons of lower socioeconomic status) in whom assessment of nontraditional risk factors may help address the shortcomings of traditional risk models.
  3. Well-designed prospective studies reflective of real-world practice to identify the downstream effects of CAC score on additional testing and procedures.

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Celiac Disease: Screening

The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of screening for celiac disease in asymptomatic persons.

Research Needs/Gaps Summary

  1. Studies that randomly assign participants at increased risk for celiac disease to screening vs. non screening and evaluate clinical outcomes.
  2. Accuracy of serologic testing in asymptomatic persons, especially those with disease risk factors.
  3. Natural history of positive serology in patients without histologic changes or with histologic confirmation but no symptoms.
  4. Treatment studies in screen-detected, asymptomatic persons to understand the effects of adherence to a gluten-free diet, as well as the effects of immediate vs. delayed dietary changes.
  5. Treatment studies should report results stratified according to baseline histologic findings, given current uncertainty about the natural history of celiac disease in persons with mild histologic abnormalities.

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Child Maltreatment: 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.

Research Needs/Gaps Summary

  1. Further research to determine effective methods for clinicians to identify children at increased risk of maltreatment (i.e., risk assessment instruments).
  2. For studies that include home visitation, there is need for standardization of outcome measurement across trials to strengthen the evidence base and improve the ability to pool data. Additionally, research on home visitation should base interventions on proven and well-designed theoretical models.  
  3. Inclusion of diverse populations and settings in studies of interventions and outcomes to improve the applicability of study findings. This should include families with known risk factors for child maltreatment (e.g., history of substance abuse in the home) and settings with limited access to social services.
  4. Further research on the unintended harms of risk assessment and preventive interventions.

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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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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 for cognitive impairment in older adults.

Research Needs/Gaps Summary

  1. Effect of screening and early detection of cognitive impairment (MCI and mild to moderate dementia) on important patient, caregiver, and societal outcomes, including decision-making, advance planning, and caregiver outcomes.
  2. Effects of caregiver or patient-caregiver dyad interventions on delay or prevention of institutionalization, and the effects of delay in institutionalization on caregivers.
  3. More consistent definitions and reporting of outcomes to allow comparisons across trials, especially from trials with longer-term follow-up.
  4. Treatments that affect the long-term clinical course of cognitive impairment.
  5. Harms and reasons for attrition of trial participants in screening and intervention studies

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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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Drug Use, Illicit: Primary Care-Based Interventions for Children, Adolescents, and Young Adults

The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of primary care-based behavioral counseling interventions to prevent illicit drug use, including nonmedical use of prescription drugs, in children, adolescents, and young adults.

Research Needs/Gaps Summary

  1. Research on cannabis prevention that deliberately addresses both benefits and harms.
  2. Standardization of outcome measurement across trials (e.g., health, social, or legal outcomes) to strengthen the evidence base and improve the ability to pool data.
  3. More studies that replicate and further refine interventions that include family-based, clinician training, education, personal coaching, and continuous quality improvement components.
  4. There was no evidence on preventing or reducing illicit drug use More data are needed on the benefits and harms of interventions in children younger than 10 years and in young adults (aged 18-25 years).
  5. Implementation of technology-based interventions (e.g., text-based messaging, smartphone apps, games, web-based interventions, and social media) among families referred from primary care, to determine their uptake and effectiveness.

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Drug Use, Unhealthy: Screening

The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of screening for unhealthy drug use in adolescents.

Research Needs/Gaps Summary

  1. The effectiveness of screening and interventions for drug use in adolescents
  2. The optimal screening interval for detecting unhealthy drug use
  3. The accuracy of screening tools for detecting nonmedical use of prescription drugs, including opioids
  4. Strategies to improve access to pharmacotherapy and psychosocial interventions for persons with various types of drug use disorders
  5. The harms that occur when the result of screening is punitive
  6. The benefits and harms of providing prophylactic prescriptions for naloxone “rescue therapy” to patients in whom opioid misuse or opioid use disorders are detected after primary care screening

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Gestational Diabetes Mellitus: 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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Gynecological Conditions: Periodic Screening with the Pelvic Exam

The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of performing screening pelvic examinations in asymptomatic women for the early detection and treatment of a range of gynecologic conditions.

Research Needs/Gaps Summary

  1. Accuracy and effectiveness of screening pelvic examination to detect conditions other than ovarian cancer, bacterial vaginosis, genital herpes, and trichomoniasis.
  2. Harms of screening with pelvic examination (including quantified psychological harms) in asymptomatic women in primary care.
  3. Effects of performing routing screening pelvic examinations on health outcomes (all-cause mortality, disease-specific morbidity and mortality, quality of life, psychological benefits and harms).
  4. Effectiveness of risk assessment tools to determine which women might benefit from a pelvic exam.
  5. For which indications are primary care clinicians currently using the pelvic exam in asymptomatic patients, and which components of the pelvic exam are performed most frequently.
  6. Women’s attitudes toward pelvic exams, the outcomes women value from these exams, and how pelvic exams affect women’s decisions to seek and obtain care.

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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, Elder Abuse, and Abuse of Vulnerable Adults: Screening

The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of screening for abuse and neglect in all older or vulnerable adults.

Research Needs/Gaps Summary

  1. Accuracy of screening tools in the primary care setting for elder abuse and abuse of vulnerable adults when there are no recognized signs or symptoms of abuse.
  2. High-quality RCTs on the benefits and harms of screening and interventions in the primary care setting to prevent elder abuse and abuse of vulnerable adults.
  3. Effectiveness of interventions for women of all ages, including nonpregnant women and women who are past childbearing age.
  4. Research on the most effective characteristics of ongoing support services (i.e., home visits, cognitive behavioral therapy, services that address multiple risk factors) for reducing intimate partner violence.
  5. Research on screening and interventions in other populations, especially men.

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

The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of routine iron supplementation for pregnant women to prevent adverse maternal health and birth outcomes.

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

The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of screening for iron deficiency anemia in pregnant women to prevent adverse material 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 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 24 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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Lead Levels in Childhood: 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 5 years and younger.

Research Needs/Gaps Summary

  1. Accuracy of questionnaires and other clinical prediction tools to identify different sources of lead exposure and the at-risk populations most likely to benefit from screening.
  2.  Newer approaches to detecting elevated blood lead levels, such as point-of-care testing, that include intraindividual and interlaboratory reliability for assessing screening strategies in children.
  3. Adequate sample sizes to inform the effectiveness of treatment strategies.
  4. Effectiveness of interventions to reduce blood lead levels and improve intermediate (reduction in blood lead levels) or health outcomes (newborn outcomes, cognitive or behavioral problems or learning disorders in children).
  5. Effectiveness of screening by gestational age.
  6. Effectiveness of treatments for elevated blood lead levels in trials with adequate sample sizes to inform treatment strategies.
  7. Benefits of nutritional supplementation in reducing blood lead levels in children.
  8. Harms of screening for or treatment of elevated blood lead levels.

Note: Randomized trials may not always be appropriate for screening and environmental interventions because of ethical issues

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Lead Levels in Pregnancy: Screening

​​​​​​The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of screening for elevated blood lead levels in asymptomatic pregnant persons.

Research Needs/Gaps Summary

  1. Accuracy of questionnaires and other clinical prediction tools to identify different sources of lead exposure and the at-risk populations most likely to benefit from screening.
  2. Newer approaches to detecting elevated blood lead levels, such as point-of-care testing, that include intraindividual and interlaboratory reliability for assessing screening strategies in pregnant women
  3. Adequate sample sizes to inform the effectiveness of treatment strategies.
  4. Effectiveness of interventions to reduce blood lead levels and improve intermediate (reduction in blood lead levels) or health outcomes (perinatal outcomes or maternal outcomes).
  5. Effectiveness of treatments for elevated blood lead levels in trials with adequate sample sizes to inform treatment strategies.
  6. Harms of screening for or treatment of elevated blood lead levels.

Note: Randomized trials may not always be appropriate for screening and environmental interventions because of ethical issues

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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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Obstructive Sleep Apnea in Adults: Screening

The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of screening for obstructive sleep apnea (OSA) in asymptomatic adults.

Research Needs/Gaps Summary

  1. Valid and reliable clinical prediction tools that accurately determine which asymptomatic persons would benefit from further evaluation and testing for OSA.
  2. Adequately-powered studies (with an appropriate length of follow-up) that evaluate the effect of OSA treatments or interventions on health outcomes (mortality; CVD and cerebrovascular events; motor vehicle crashes; cognitive impairment).
  3. Studies to evaluate whether improvement in AHI (apnea-hypopnea index) leads to improved health outcomes.
  4. Natural history of mild OSA, especially rates of and length of time for progression from mild to severe OSA, and the magnitude of benefit if OSA is identified and treated earlier.

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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 to Prevent Fractures: Screening

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

Research Needs/Gaps Summary

  1. Treatment trials that include men and report on fracture outcomes (rather than BMD) as well as harms.
  2. Studies that evaluate the direct effect of screening for osteoporosis (either with BMD or clinical risk assessment tools) on fracture outcomes.
  3. Additional research to determine whether clinical risk assessment tools alone (without BMD) could help identify patients at risk of fractures and help guide decisions to initiate medications to prevent fractures.
  4. Prognostic models that incorporate age, baseline BMD, and hormone replacement therapy use to help determine optimal screening intervals.

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Peripheral Arterial Disease and Cardiovascular Disease Screening and Risk Assessment with the 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 with the ankle–brachial index (ABI) in asymptomatic 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. Studies of screening with the ABI and interventions to stop disease progression in the lower limbs in more diverse populations (e.g., women, racial/ethnic minorities, or persons with lower socioeconomic status) and populations at high risk (i.e., persons with diabetes).

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Skin Cancer Prevention: Behavioral Counseling

The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of counseling adults about skin self-examination to prevent skin cancer.

Research Needs/Gaps Summary

  1. Studies to assess the effectiveness of provider counseling on the use of sun protection behaviors in adults 25 years and older.
  2. Studies, ideally in large trial populations, of the effectiveness of counseling persons without a fair skin type on the use of sun protection behaviors (including whether behaviors continue after trial completion).
  3. Evidence on the benefits and harms of counseling adults about skin self- examination to prevent skin cancer and premature death.

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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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Statin Use for the Primary Prevention of CVD in Adults: Preventive Medication

The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of initiating statin use for the primary prevention of CVD events and mortality in adults 76 years and older without a history of heart attack or stroke.

Research Needs/Gaps Summary

  1. RCT evidence to evaluate the net benefit (benefits and harms) of initiating statin use for the primary prevention of cardiovascular events in adults 76 years and older.
  2. Long-term harms of statin therapy, particularly the association between stain therapy and possible increased incidence of diabetes and cataracts.
  3. Underuse of statins among older adults who might benefit and overuse among frail older adults.

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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 - 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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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 Use Cessation in Children and Adolescents: Primary Care Interventions

​​​​​The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of primary care-feasible interventions for the cessation of tobacco use among school-aged children and adolescents.

Research Needs/Gaps Summary

  1. Larger, adequately powered studies of new behavioral counseling interventions for cessation. These studies should report tobacco cessation outcomes at 6 months or later and should also provide information on components of the behavioral counseling intervention provided in the study (such as intensity of delivery, frequency of contacts, content and type of counseling or materials provided, delivery setting of studies, and training of persons delivering the intervention).
  2. Benefits and harms of medications to help youth with tobacco cessation.
  3. Interventions tailored specifically to prevent initiation of use and promote cessation of e-cigarette use in youth.
  4. Interventions tailored specifically to prevent initiation of use and promote cessation of other types of tobacco (such as, but not limited to, cigars and smokeless tobacco).
  5.  Interventions tailored to subpopulations with elevated tobacco use rates (such as African American youth, Native American/Alaska Native youth, LGBTQ youth, and youth with mental illness).

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Vision in Children Ages 6 Months to 5 Years: Screening

The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of vision screening in children younger than 3 years.

Research Needs/Gaps Summary

  1. Well-designed trials to better understand the effects of screening versus no screening. 
  2. Optimal age for initiation of screening, and appropriate screening intervals.
  3. Additional studies to determine the best screening approach and most favorable combinations of screening tests in primary care.
  4. Studies that examine the benefits and harms of vision screening and treatment in children younger than 3 years and the long-term benefits and harms of preschool vision screening on health outcomes, such as quality of life, school performance, developmental trajectory, and functioning.

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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 D, Calcium, or Combined Supplementation for the Primary Prevention of Fractures in Community-Dwelling Adults: Preventive Medication (Post-Menopausal 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. Prospective studies to assess the potential benefits of vitamin D and calcium supplementation in premenopausal women on fracture incidence later in life.
  3. Effects of vitamin D supplementation on diverse populations, as results from studies of white women cannot be extrapolated to nonwhite populations.
  4. Studies to evaluate the potential harms of supplementation, particularly studies on calcium and potential adverse cardiovascular outcomes.

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Vitamin D, Calcium, or Combined Supplementation to Prevent Fractures in Community-Dwelling Adults: Preventive Medication (Men and Premenopausal Women)

The USPSTF concludes that the current evidence is insufficient to assess the balance of the benefits and harms of vitamin D and calcium supplementation, alone or combined, for the primary prevention of fractures in men and 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. Prospective studies to assess the potential benefits of vitamin D and calcium supplementation in premenopausal women on fracture incidence later in life.
  3. Effects of vitamin D supplementation on diverse populations, as results from studies of white women cannot be extrapolated to nonwhite populations.
  4. Studies to evaluate the potential harms of supplementation, particularly studies on calcium and potential adverse cardiovascular outcomes.

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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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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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