U.S. Preventive Services Task Force Insufficient Evidence 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.

USPSTF announces the “Evidence Gaps Research Taxonomy” table

This standardized template for communicating research gaps will accompany each new recommendation and I statement.


 

Abdominal Aortic Aneurysm: Screening

5982

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

9196

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: Screening and Behavioral Counseling Interventions

5983

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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Anxiety Disorders in Older Adults: Screening

38756

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

Research Needs/Gaps Summary

  1. Accuracy of screening tools in older adults.
  2. Effectiveness of anxiety disorder screening and treatment in older adults.
  3. Screening and treatment in populations defined by sex, race and ethnicity, sexual orientation, and gender identity.
  4. Direct benefits and harms of screening for anxiety disorders in primary care settings (or similar settings) compared with no screening or usual care. RCTs are needed for this topic.
  5. Diagnostic accuracy of screening tools that are feasible for use in primary care settings, tested among primary care patients or similar populations, using valid reference standards, and determining (and replicating) optimal cutoffs for various anxiety disorders; research is needed to identify optimal screening interval in all populations.
  6. Accuracy of screening tools in pregnant and postpartum persons.
  7. Effectiveness of anxiety disorder treatment in in pregnant and postpartum persons.
  8. Barriers to establishing adequate systems of care related to anxiety disorders and how these barriers can be addressed.
  9. Prevalence of anxiety disorders. For this topic, large epidemiologic studies are needed.
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Anxiety in Children: Screening

34001

The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of screening for anxiety in children 7 years or younger.

Research Needs/Gaps Summary

  1. RCTs on direct benefits and harms of screening for anxiety among children and adolescents in primary care settings (or similar settings) compared with no screening or usual care.
  2. Multiple types of anxiety disorders exist, so future research could clarify trade-offs between screening instruments designed to identify any anxiety disorder and instruments designed for specific anxiety disorders.
  3. Accuracy of screening tools in children and adolescents and the effectiveness of anxiety treatment in younger children.
  4. Feasibility of using screening tools in the primary care setting.
  5. More evidence is needed in populations defined by sex, race and ethnicity, sexual orientation, and gender identity.
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Atrial Fibrillation: Screening

9326

The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of screening for atrial fibrillation among asymptomatic adults 50 years or older.

Research Needs/Gaps Summary

  1. Randomized trials enrolling asymptomatic persons that directly compare screening with usual care and that assess both health outcomes and harms. It is important that screening trials enroll sufficient participants of both sexes and diverse racial and ethnic groups to enable assessment of whether the detection of atrial fibrillation (AF), or the benefits or harms of screening, vary in different population groups.
  2. How to best optimize the accuracy of screening tests or strategies for AF.
  3. Understanding the risk of stroke associated with subclinical AF, or AF detected with use of consumer devices, how that risk varies with duration or burden of AF, and the potential benefit of anticoagulation therapy among persons with subclinical AF.
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Autism Spectrum Disorder in Young Children: Screening

5986

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

5987

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

5988

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 (High) in Children and Adolescents: Screening

5989

The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of screening for high blood pressure in children and adolescents.

Research Needs/Gaps Summary

  1. Test accuracy of blood pressure measurements with sphygmomanometers or oscillometric automated devices and establishing thresholds for hypertension for 24-hour ambulatory monitoring.
  2. Application of new thresholds for determining abnormal blood pressure to existing data sets and testing the validity of these thresholds.
  3. Benefits and harms of long-term pharmacologic treatment. Studies should have long-term follow-up of several months or years across various age groups because benefits and harms of treatments may be age dependent and hypertension in children may be self-limiting.
  4. Benefits and harms of screening and treatment should also include children at increased risk, such as Black and Hispanic/Latino populations.
  5. Long-term natural history of hypertension in children and the spontaneous resolution of hypertension.
  6. Associations among childhood hypertension, adulthood hypertension, and surrogate measures of cardiovascular disease in childhood and adulthood, as well as adulthood clinical cardiovascular disease.
  7. Effect of individual components of multifactorial interventions.
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Breast Cancer in Women: Screening (≥75 years)

5990

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

The USPSTF summarizes the gaps in the evidence for screening for breast cancer and emphasizes health equity gaps that need to be addressed to advance the health of the nation. Although the health equity gaps focus on Black women because they have the poorest health outcomes from breast cancer, it is important to note that all studies should actively recruit enough women of all racial and ethnic groups, including Asian, Black, Hispanic, Native American/Alaska Native, and Native Hawaiian/Pacific Islander participants, to investigate whether the effectiveness of screening, diagnosis, and treatment vary by group. 

  1. Research is needed to determine the benefits and harms of screening for breast cancer in women age 75 years or older.
  2. Research is needed to understand and address the higher breast cancer mortality among Black women.
    • Research is needed to understand why Black women are more likely to be diagnosed with breast cancers that have biomarker patterns that confer greater risk for poor health outcomes.
    • Research is needed to understand how variations in care (including diagnosis and treatment) leads to increased risk of breast cancer morbidity and mortality in Black women, across the spectrum of stages and biomarker patterns, and on effective strategies to reduce this disparity.
    • Research is needed to determine whether the benefits differ for annual vs biennial breast cancer screening among women overall and whether there is a different balance of benefits and harms among Black women compared with all women.
  3. Research is needed to identify approaches to reduce the risk of overdiagnosis leading to overtreatment of breast lesions identified through screening that may not be destined to cause morbidity and mortality, including DCIS.
    • Research is needed on the natural history of DCIS and to identify prognostic indicators to distinguish DCIS that is unlikely to progress to invasive breast cancer.

Research Taxonomy: For additional information on research needed to address these evidence gaps, see the Research Gaps Taxonomy table on the USPSTF website.

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Breast Cancer in Women: Screening (Supplemental Screening)

5991

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

Research Needs/Gaps Summary

The USPSTF summarizes the gaps in the evidence for screening for breast cancer and emphasizes health equity gaps that need to be addressed to advance the health of the nation. Although the health equity gaps focus on Black women because they have the poorest health outcomes from breast cancer, it is important to note that all studies should actively recruit enough women of all racial and ethnic groups, including Asian, Black, Hispanic, Native American/Alaska Native, and Native Hawaiian/Pacific Islander participants, to investigate whether the effectiveness of screening, diagnosis, and treatment vary by group. 

  1. Research is needed to help clinicians and patients understand the best strategy for breast cancer screening in women found to have dense breasts on a screening mammogram, which occurs in more than 40% of women screened.
    • Research is needed to determine the benefits and harms of supplemental screening (e.g., ultrasonography, MRI, or contrast-enhanced mammography) compared with usual care (DBT or digital mammography alone) for women with dense breasts. Studies are needed that report outcomes such as the rates of advanced breast cancers diagnosed across consecutive screening rounds in addition to the rates of diagnosis of breast cancer, and health outcomes such as quality of life and breast cancer–associated morbidity and mortality.
  2. Research is needed to understand why Black women are more likely to be diagnosed with breast cancers that have biomarker patterns that confer greater risk for poor health outcomes.
    • Research is needed to understand and address the higher breast cancer mortality among Black women.
    • Research is needed to understand how variations in care (including diagnosis and treatment) leads to increased risk of breast cancer morbidity and mortality in Black women, across the spectrum of stages and biomarker patterns, and on effective strategies to reduce this disparity.
    • Research is needed to determine whether the benefits differ for annual vs biennial breast cancer screening among women overall and whether there is a different balance of benefits and harms among Black women compared with all women.
  3. Research is needed to identify approaches to reduce the risk of overdiagnosis leading to overtreatment of breast lesions identified through screening that may not be destined to cause morbidity and mortality, including DCIS.
    • Research is needed on the natural history of DCIS and to identify prognostic indicators to distinguish DCIS that is unlikely to progress to invasive breast cancer.

Research Taxonomy: For additional information on research needed to address these evidence gaps, see the Research Gaps Taxonomy table on the USPSTF website.

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Cardiovascular Disease Risk: Screening With Electrocardiography

5999

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

5998

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

5993

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 Prevention: Primary Care Interventions

5994

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

Evidence is needed linking validated risk assessment and primary care–feasible or referrable interventions to direct or intermediate measures of abuse and neglect. Notably, measures of abuse and neglect are prone to underreporting, disproportionality (e.g., overrepresentation of Black children and underrepresentation of White children), and bias (e.g., recall bias in patient-reported outcomes and surveillance bias in intervention group exposure to opportunities for reporting or diagnosing abuse). Reconceptualizing the linkages between primary care–relevant risk assessment, prevention-based interventions, and standardized, accurate, and unbiased maltreatment outcomes measures is needed.

  1. Research is needed to help primary care clinicians accurately identify families who might benefit from supportive interventions that may prevent child maltreatment.
    • Research is needed to determine if accuracy of risk assessment tools differs by social factors and race and ethnicity.
    • Research is needed to understand the optimal frequency of risk assessment considering chronicity, duration, intermittency, and severity of maltreatment.
  2. Studies are needed to evaluate the effectiveness of primary care–feasible or referable preventive interventions designed to reduce exposure to maltreatment, including neglect.
    • Research is needed to determine whether intervention effectiveness or child maltreatment reporting differs by social factors and race and ethnicity.
    • Studies evaluating the effectiveness of interventions using more accurate outcome measures that limit bias (e.g., surveillance) are needed. Outcome measures could also include those outside the child welfare system (e.g., composite measures).
    • In addition, consistency in outcome measure definitions, outcome types, and outcome timing across studies is needed.
    • Research is needed on the most effective ways to prevent child maltreatment (using more accurate outcome measures), including interventions that address the social determinants of health that can negatively affect families.
  3. Research is needed to determine whether there are unintended harms from risk assessment (e.g., stigma or legal risks related to Child Protective Services) and to engagement in preventive interventions (e.g., risk of biased reporting for maltreatment)
    • Research is needed to understand whether potential harms differ in children by social factors and race and ethnicity.

Research Taxonomy: For additional information on research needed to address these evidence gaps, see the Research Gaps Taxonomy table on the USPSTF website.

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Chlamydia and Gonorrhea: Screening

5995

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

5997

​​​​​​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 Younger Than 5 Years: Screening

6000

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 younger than 5 years.

Research Needs/Gaps Summary

  1. Multivariate risk assessment and preventive interventions should enroll sufficient numbers from certain racial and ethnic populations (e.g., Black and Hispanic children) to understand the benefits and harms of interventions in these specific groups.
  2. Validate the accuracy and utility of caries risk assessment instruments for use in primary care settings and to determine how referral of young children for dental care by primary care clinicians affects caries outcomes.
    1. Benefits of fluoride varnish among lower-risk and younger children.
    2. Benefits or harms of routine screening by primary care clinicians on caries outcomes in children younger than 5 years.
  3. Effectiveness of preventive measures in economically disadvantaged children.
  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: Screening

33341

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 11 years or younger.

Research Needs/Gaps Summary

  1. More randomized controlled trials (RCTs) are needed on the benefits and harms of screening for and treatment of MDD in children 11 years or younger.
  2. Large, good-quality RCTs are needed to better understand the overarching effects of screening for MDD on long-term health outcomes.
  3. More research is needed in child and adolescent populations that are similar to those found in primary care settings to study the effects of comorbid conditions on screening accuracy, type of MDD treatment selected, and benefits and harms.
  4. More research is needed on collaborative care and integrated behavioral health in children and adolescents.
  5. More research is needed on screening and treatment in populations defined by sex, race and ethnicity, sexual orientation, and gender identity.
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Drug Use, Illicit: Primary Care-Based Interventions for Children, Adolescents, and Young Adults

6003

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

6004

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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Eating Disorders in Adolescents and Adults: Screening

31781

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

Research Needs/Gaps Summary

  1. Screening and early treatment trials that focus on health outcomes and that enroll screen-detected populations from general primary care settings.
  2. Studies on the potential harms of screening such as labeling and false-positive results.
  3. Trials addressing the benefits and harms of screening and treatment in adolescents, men, and across sexual orientation/gender identity and racial and ethnic populations.
  4. Accuracy studies enrolling asymptomatic adults and adolescents from primary care settings that use consistent definitions and reference standards to define eating disorder conditions.
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Elder Abuse, and Abuse of Vulnerable Adults: Screening

6010

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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Gestational Diabetes Mellitus: Screening

6005

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 (Primary Open-Angle): Screening

6006

The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of screening for primary open-angle glaucoma (PAOG) in asymptomatic adults 40 years or older.

Research Needs/Gaps Summary

  1. Trials that include larger numbers of Black and Hispanic/Latino persons reporting on the effects of screening and treatment of POAG.
  2. Screening trials that assess referral to an eye care specialist and use contemporary screening and diagnostic modalities (e.g., spectral-domain optical coherence tomography [OCT] or swept-source OCT), are of sufficient duration, and include vision-related outcomes (visual impairment, vision-related function, quality of life, and other patient-reported outcomes).
  3. Research on the accuracy of risk assessment tools both for early identification of persons at increased risk of glaucoma and to inform screening strategies.
  4. Research to better understand the long-term effects of treatment on visual impairment, vision-related function, and quality of life and to verify that benefits of treatment are retained in persons diagnosed with POAG using newer imaging methods such as OCT.
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Hearing Loss in Older Adults: Screening

6008

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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Iron Deficiency and Iron Deficiency Anemia During Pregnancy: Screening

6012

The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of screening for iron deficiency and iron deficiency anemia in pregnant persons to prevent adverse maternal and infant health outcomes.

Research Needs/Gaps Summary

The USPSTF routinely highlights the most critical evidence gaps for making actionable preventive services recommendations. For each evidence gap below, research should focus on settings similar to those in the US to assist in generalizability to a US primary care population.

  1. Research is needed in pregnant persons with iron deficiency and iron deficiency anemia to assess whether changes in maternal iron status (e.g., because of supplementation or treatment for screen-detected populations) improves maternal and infant health outcomes in settings relevant to US primary care clinical practice.
  2. Research is needed to assess the benefits and harms of screening (e.g., with hemoglobin, hematocrit, or ferritin values) for iron deficiency and iron deficiency anemia during pregnancy on maternal (e.g., quality of life or need for transfusion) and infant (e.g., low birth weight or preterm birth) health outcomes.

Research Taxonomy: For additional information on research needed to address these evidence gaps, see the Research Gaps Taxonomy table on the USPSTF website.

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Iron Deficiency and Iron Deficiency Anemia During Pregnancy: Supplementation

6011

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

Research Needs/Gaps Summary

The USPSTF the routinely highlights the most critical evidence gaps for making actionable preventive services recommendations. For each evidence gap below, research should focus on settings similar to those in the US to assist in generalizability to a US primary care population.

  1. Research is needed in pregnant persons with iron deficiency and iron deficiency anemia to assess whether changes in maternal iron status (e.g., because of supplementation or treatment for screen-detected populations) improves maternal and infant health outcomes in settings relevant to US primary care clinical practice.
  2. Research is needed to assess the benefits and harms of treatment (e.g., oral or intravenous iron) in asymptomatic, screen-detected populations with iron deficiency and iron deficiency anemia during pregnancy on maternal and infant health outcomes in settings relevant to US primary care clinical practice.
  3. Research is needed to assess the benefits and harms of routine iron supplementation in asymptomatic pregnant persons without known iron deficiency or iron deficiency anemia on maternal and infant health outcomes.

Research Taxonomy: For additional information on research needed to address these evidence gaps, see the Research Gaps Taxonomy table on the USPSTF website.

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Iron Deficiency Anemia in Young Children: Screening

6013

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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Lipid Disorders in Children and Adolescents: Screening

6015

The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of screening for lipid disorders in children and adolescents 20 years or younger.

Research Needs/Gaps Summary

  1. Long-term data on the effectiveness of screening for and treatment of lipid disorders in children and adolescents to prevent premature cardiovascular events or death in adulthood.
  2. Measurement of the diagnostic yield of lipid screening tests through confirmatory lipid and genetic testing to identify children and adolescents with FH and multifactorial dyslipidemia.
  3. Comparative effectiveness data assessing the optimal age at which to start lipid-lowering interventions for maximal benefit in children and adolescents diagnosed with FH or multifactorial dyslipidemia, including benefits and harms of starting pharmacologic treatment as a child (eg, ages 8 to 10 years) vs as a young adult (early 20s).
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Multivitamin Supplementation to Prevent Cardiovascular Disease and Cancer: Preventive Medication

6034

The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of the use of multivitamin supplements for the prevention of cardiovascular disease or cancer among community-dwelling, nonpregnant adults.

Research Needs/Gaps Summary

  1. Studies on the effects of multivitamin supplementation on cardiovascular disease and cancer outcomes. Studies need to be of sufficient duration to detect an effect on these outcomes.
  2. Studies that provide more information on heterogeneity across specific populations, or by baseline nutrient level or socioeconomic factors such as food insecurity, in the effects of multivitamin supplementation on cardiovascular disease and cancer outcomes, especially in persons with no known deficiencies and low prevalence of supplement use and in racially and ethnically diverse populations.
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Obstructive Sleep Apnea in Adults: Screening

6016

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 the general adult population.

Research Needs/Gaps Summary

  1. Well-designed studies of OSA screening in asymptomatic populations representative of the US primary care population that evaluate the benefits and harms of screening on health outcomes (e.g., mortality, cardiovascular disease events, motor vehicle crashes, and quality of life) in screened vs unscreened persons.
  2. Accuracy studies of screening tools in a general US adult primary care population, especially in persons with unrecognized or mild symptoms.
  3. Development of accurate risk assessment tools that can identify populations most likely to benefit from OSA screening.
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Oral Cancer: Screening

6017

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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Oral Health in Adults: Preventive Interventions

40356

The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of preventive interventions performed by primary care clinicians for oral health conditions, including dental caries or periodontal-related disease, in asymptomatic adults 18 years or older.

Research Needs/Gaps Summary

For each of the evidence gaps listed below, research must focus on screening and preventive interventions that can be performed in nondental primary care settings and be inclusive of populations with a high prevalence of oral health conditions, including Asian, Black, Hispanic/Latino, Native American/Alaska Native, and Hawaiian Native/Pacific Islander persons and persons with social determinants that contribute to disparities in oral health.

  1. Research is needed to assess the effectiveness and harms of preventive interventions in the primary care setting.
    1. Research is needed to assess the effectiveness and harms of fluoride gel, fluoride varnish, sealants, silver diamine fluoride, and xylitol in the home or primary care setting on oral health conditions, and include the water fluoridation status, oral health behaviors, and education of study participants.
    2. Research is needed to assess the effectiveness and harms of oral health education and behavioral counseling interventions on oral health outcomes.
  2. Research is needed to identify the effectiveness of strategies that can be delivered in primary care settings to prevent periodontitis and their effects on associated adverse health outcomes such as tooth loss or cognitive or cardiovascular conditions.

Research Taxonomy: For additional information on research needed to address these evidence gaps, see the Research Gaps Taxonomy table on the USPSTF website.

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Oral Health in Adults: Screening

40351

The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of routine screening performed by primary care clinicians for oral health conditions, including dental caries or periodontal-related disease, in asymptomatic adults 18 years or older.

Research Needs/Gaps Summary

For each of the evidence gaps listed below, research must focus on screening and preventive interventions that can be performed in nondental primary care settings and be inclusive of populations with a high prevalence of oral health conditions, including Asian, Black, Hispanic/Latino, Native American/Alaska Native, and Hawaiian Native/Pacific Islander persons and persons with social determinants that contribute to disparities in oral health.

  1. Research is needed to assess the effectiveness and harms of primary care–based oral health screening strategies on oral health outcomes.
  2. Research is needed on the diagnostic accuracy of oral health examinations and risk assessment tools in the primary care setting to identify adults with oral health conditions.

Research Taxonomy: For additional information on research needed to address these evidence gaps, see the Research Gaps Taxonomy table on the USPSTF website.

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Oral Health in Children and Adolescents Aged 5 to 17 Years: Preventive Interventions

39826

The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of preventive interventions performed by primary care clinicians for oral health conditions, including dental caries, in asymptomatic children and adolescents aged 5 to 17 years.

Research Needs/Gaps Summary

For each of the evidence gaps listed below, research must focus on preventive interventions that can be performed in nondental primary care settings and be inclusive of populations with a high prevalence of oral health conditions, including Asian, Black, Hispanic/Latino, Native American/Alaska Native, and Hawaiian Native/Pacific Islander persons and persons with social determinants that contribute to disparities in oral health.

  1. Research is needed to develop primary care–based oral health risk assessment tools to accurately identify children aged 5 to 17 years at increased risk of oral health conditions.
  2. Research is needed to assess the effectiveness and harms of preventive interventions in the primary care setting.
    1. Research is needed to assess the effectiveness and harms of fluoride gel, fluoride varnish, sealants, silver diamine fluoride, and xylitol on oral health conditions.
    2. Research is needed to assess the effectiveness and harms of oral health education and behavioral counseling interventions performed by primary care clinicians on oral health outcomes. To assess their impact on study participants, identification of water fluoridation status and oral health behaviors and education is needed.
  3. Research is needed to identify the effectiveness of strategies that can be delivered in primary care settings to improve quality of life, function, or other clinically important oral health outcomes.

Research Taxonomy: For additional information on research needed to address these evidence gaps, see the Research Gaps Taxonomy table on the USPSTF website.

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Oral Health in Children and Adolescents Aged 5 to 17 Years: Screening

40346

The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of routine screening performed by primary care clinicians for oral health conditions, including dental caries, in asymptomatic children and adolescents aged 5 to 17 years.

Research Needs/Gaps Summary

For each of the evidence gaps listed below, research must focus on screening interventions that can be performed in nondental primary care settings and be inclusive of populations with a high prevalence of oral health conditions, including Asian, Black, Hispanic/Latino, Native American/Alaska Native, and Hawaiian Native/Pacific Islander persons and persons with social determinants that contribute to disparities in oral health.

  1. Research is needed to assess the effectiveness and harms of primary care–based oral health screening strategies on oral health outcomes.
  2. Research is needed on the diagnostic accuracy of oral health examinations and risk assessment tools in the primary care setting to identify children aged 5 to 17 years with oral health conditions.

Research Taxonomy: For additional information on research needed to address these evidence gaps, see the Research Gaps Taxonomy table on the USPSTF website.

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Osteoporosis to Prevent Fractures: Screening

6018

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

6019

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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Prediabetes and Type 2 Diabetes in Children and Adolescents: Screening

33346

The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of screening for type 2 diabetes in asymptomatic children and adolescents younger than 18 years.

Research Needs/Gaps Summary

  1. The effects of screening on health outcomes in child and adolescent populations reflective of the prevalence of diabetes in the US, particularly American Indian/Alaska Native, Black, Hispanic/Latino, and Native Hawaiian/Pacific Islander youth, who have a higher prevalence of diabetes than White youth.
  2. The effects of screening on health outcomes in children and adolescents considered to be at higher risk such as those who are overweight, have obesity, or have a family history of diabetes.
  3. The effects of lifestyle interventions, pharmacotherapy, or both for treatment of screen-detected prediabetes and diabetes on health outcomes in children and adolescents, particularly in racial and ethnic groups who have a higher prevalence of diabetes than White youth.
  4. Trials (both screening and intervention) focusing on health outcomes such as mortality, cardiovascular morbidity, chronic kidney disease, amputation, visual impairment, neuropathy, and quality of life that are of sufficient duration and sample size.
  5. The natural history of prediabetes in children and adolescents, including the identification of factors associated with risk of progression to diabetes or reversion to normoglycemia.
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Skin Cancer Prevention: Behavioral Counseling

6020

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

6021

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 adolescents and adults.

Research Needs/Gaps Summary

  1. Consistent data showing the effects of screening on morbidity and mortality or early detection of skin cancer, particularly melanoma.
  2. Clearer descriptions of skin color and inclusion of a full spectrum of skin colors in study participants.
  3. Morbidity and mortality outcomes in participants reflective of a US population with a diversity of skin tones.
  4. The effectiveness of screening in a range of primary care settings that reflect the variation in access to care in the US.
  5. The effectiveness of screening for reducing morbidity and mortality of acral lentiginous melanoma, which is the most frequently diagnosed melanoma in persons with darker skin color.
  6. Validated risk assessment tools to identify persons at highest risk for skin cancer and who might benefit from screening.
  7. The impact of social determinants of health (e.g., outdoor occupational exposure, geographic exposure differences, and access to quality care) on skin cancer risk, prevention, screening, and treatment.
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Speech and Language Delay and Disorders in Children Age 5 and Younger: Screening

6022

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

For each of the evidence gaps listed below, research must focus on screening and preventive interventions that can be performed in, or referred from, the primary care setting.

  1. Treatment studies are needed of screen-detected populations that follow children over short and longer (>1 y) durations to detect improvement in outcomes such as academic performance, social and emotional health, or child and family well-being. These studies should focus on enrolling children from groups with the greatest burden of speech and language delay and disorders (Black and Hispanic/Latino children and children from households with low incomes). These types of studies would help to understand if changes in speech and language outcomes translate into changes in the broader health and well-being of children and their families, including how children function in school and at home.
  2. Standardization of outcome measurement across studies is needed. There was significant heterogeneity in reporting on speech and language outcomes in the treatment studies. Standardization would greatly strengthen the evidence base and improve the ability to pool data.
  3. Studies are needed on the potential harms of screening and treatment such as labeling, stigma, parent anxiety, other psychosocial harms, and overdiagnosis.

RESEARCH TAXONOMY: For additional information on research needed to address these evidence gaps, see the Research Gaps Taxonomy table on the USPSTF website: https://uspreventiveservicestaskforce.org/home/getfilebytoken/T6auAz-64DpreTqycmvSJr

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Statin Use for the Primary Prevention of Cardiovascular Disease (CVD) in Adults: Preventive Medication

6023

The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of initiating a statin for the primary prevention of CVD events and mortality in adults 76 years or older.

Research Needs/Gaps Summary

  1. Improving the accuracy of CVD risk prediction in all racial and ethnic and socioeconomic groups.
  2. The balance of benefits and harms of initiating statin use for the primary prevention of cardiovascular events in adults 76 years or older.
  3. The efficacy and safety of long-term statin use in adults younger than 40 years, and to determine the effects of earlier vs delayed initiation of statin use, particularly in persons with an estimated high long-term (longer than 10 years [e.g., lifetime]) risk of CVD.
  4. The causes of disparities in statin use and effective methods to reduce disparities.
  5. Trials that directly compare statin therapy titrated to target lipid levels vs fixed-dose therapy to inform optimal dosing strategies. Trials that directly compare higher- vs lower-intensity statin therapy and are powered to assess clinical outcomes are also needed.
  6. Definitively determining whether statin therapy is associated with increased risk of diabetes in primary prevention populations.
  7. The role of patient preferences in decisions to prescribe statins for persons across the spectrum of CVD risk.
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Suicide Risk in Adults and Older Adults: Screening

6024

The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of screening for suicide risk in the adult population, including pregnant and postpartum persons, as well as older adults.

Research Needs/Gaps Summary

  1. Epidemiology and natural history of suicide risk. Persons who attempt suicide and survive and those who die by suicide are overlapping populations. More research is needed to understand these groups and to determine how primary care can improve health outcomes in these groups.
  2. Foundational research is needed in primary care populations and pregnant and postpartum persons, including determining which tools should be used and how screening for suicide risk should be implemented.
  3. Accuracy of single-item suicide screeners within depression screening instruments among patients who have screened positive for depression.
  4. Whether more individuals with screen-detected suicidal ideation could be helped before they act.
  5. Treatment studies in populations with screen-detected suicide risk in all age groups.
  6. Potential harms of suicide risk interventions.
  7. Benefits and potential harms of targeted vs general screening for suicide risk.
  8. Targeting persons at high risk for suicide, such as Hispanic/Latino and Native American/Alaska Native persons or persons with depression, may help determine whether tailored therapies are more effective in these populations.
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Suicide Risk in Children and Adolescents: Screening

33336

The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of screening for suicide risk in children (11 years and younger) and adolescents (aged 12 to 18 years).

Research Needs/Gaps Summary

  1. More randomized controlled trials are needed on the benefits and harms of screening for suicide risk in children and adolescents in primary care settings compared with no screening or usual care.
  2. More information is needed on the performance characteristics of screening tests for suicide risk.
  3. Treatment studies are needed in populations with screen-detected suicide risk, in all age groups.
  4. Evidence on screening and treatment is lacking in populations defined by sex, race and ethnicity, sexual orientation, and gender identity, such as Native American/Alaska Native youth (who are at increased risk for suicide). More research is needed in these populations.
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Thyroid Dysfunction: Screening

6025

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, Including Pregnant Persons: Behavioral and Pharmacotherapy Interventions — (Electronic Cigarettes)

6026

The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of electronic cigarettes (e-cigarettes) for tobacco cessation in adults, including pregnant persons.

Research Needs/Gaps Summary

  1. Effectiveness of e-cigarettes for smoking cessation.
  2. Well-designed RCTs that compare e-cigarette interventions with placebo, as well as established, effective combinations of pharmacotherapy and behavioral support.
  3. Adequately powered studies to detect differences in continued smoking abstinence rates at 6 months or more.
  4. Smoking relapse rates in adults who have used e-cigarettes for smoking cessation and how to help with cessation of e-cigarette use once smoking abstinence has been achieved.
  5. Given the high rate of continued e-cigarette use after smoking cessation, research on both the short- and long-term harms of e-cigarette use is needed, as well as the harms in dual users of e-cigarettes and conventional cigarettes.
  6. Trials should include current generations of e-cigarettes. Additionally, to successfully conduct these types of studies, standardization of how to quantify e-cigarette use and levels of nicotine exposure from e-cigarettes is needed.
  7. Patterns of e-cigarette use in youth and the risk factors for their transition from e-cigarette use to conventional cigarette smoking.
  8. Patterns of e-cigarette use in pregnant persons and potential harms of e-cigarette use to both pregnant persons and their offspring.
  9. Understanding how to help adults quit e-cigarettes.
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Tobacco Smoking Cessation in Adults, Including Pregnant Persons: Behavioral and Pharmacotherapy Interventions — (Pregnant Persons)

6027

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 persons.

Research Needs/Gaps Summary

  1. Pharmacotherapy options, in particular nicotine replacement therapy (NRT), for pregnant persons for whom behavioral counseling interventions alone are not effective.
  2. Larger studies adequately powered to detect an effect on both smoking cessation rates (during pregnancy and postpartum) and changes in perinatal and child health outcomes are needed.
  3. Understanding of why adherence rates to NRT during pregnancy is so low.
  4. Newer modalities and remotely delivered interventions (mobile phone apps, internet-based interventions).
  5. Effectiveness of interventions for cessation of other forms of tobacco and whether interventions need to be tailored to individual tobacco product types
  6. Interventions to prevent relapse of tobacco use.
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Tobacco Use Cessation in Children and Adolescents: Primary Care Interventions

21276

​​​​​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 Younger Than 3 Years: Screening

6028

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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Visual Acuity (Impaired) in Older Adults: Screening

6009

The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of screening for impaired visual acuity in asymptomatic adults 65 years or older.

Research Needs/Gaps Summary

  1. Studies that evaluate the effect of referrals by primary care professionals to eye care specialists for comprehensive eye examination.
  2. Well-designed studies in primary care settings that evaluate new vision screening interventions, link screen-positive older adults to appropriate follow-up and care, address barriers to linkage to care, and target higher-risk populations to clarify potential benefits of screening.
  3. Evidence on the effectiveness of antioxidant vitamins and minerals for the treatment of dry age-related macular degeneration (AMD) remains mainly dependent on 1 large trial (AREDS). Large, well-designed trials of alternative treatment regimens designed to evaluate benefits and harms would be useful.
  4. Research to understand the effects of treatment of wet and dry AMD on vision-related quality of life and function.
  5. Head-to-head trials of the recently US Food and Drug Administration–approved vascular endothelial growth factor (VEGF) brolucizumab-dbll vs older VEGF inhibitors to verify that benefits and harms are comparable.
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Vitamin and Mineral (Nutrient) Supplementation to Prevent Cardiovascular Disease and Cancer: Preventive Medication

6033

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 (other than beta carotene and vitamin E) for the prevention of cardiovascular disease or cancer among community-dwelling, nonpregnant adults.

Research Needs/Gaps Summary

  1. Studies on the effects of vitamin and mineral supplementation on cardiovascular disease and cancer outcomes. Studies need to be of sufficient duration to detect an effect on these outcomes.
  2. Whether vitamin D supplementation has an effect on cancer mortality. Studies need to be of sufficient duration to detect an effect on this outcome.
  3. Whether there is heterogeneity across specific populations, or by baseline nutrient level or socioeconomic factors such as food insecurity, in the effects of vitamin and mineral supplementation on cardiovascular disease and cancer outcomes, especially in persons with no known deficiencies and low prevalence of supplement use and in racially and ethnically diverse populations.
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Vitamin D Deficiency in Adults: Screening

6032

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)

9886

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)

9881

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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