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Closing Evidence Gaps in Clinical Prevention (2022)

Chapter:Appendix F: U.S. Preventive Service Task Force Research Needs Statements from I Statements Issued Between 2017 and 2021

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Suggested Citation:"Appendix F: U.S. Preventive Service Task Force Research Needs Statements from I Statements Issued Between 2017 and 2021." National Academies of Sciences, Engineering, and Medicine. 2022. Closing Evidence Gaps in Clinical Prevention. Washington, DC: The National Academies Press. doi: 10.17226/26351.
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F

U.S. Preventive Service Task Force Research Needs Statements from I Statements Issued Between 2017 and 2021

Gestational Diabetes: Screening (USPSTF, 2021a)
August 10, 2021

The U.S. Preventive Services Task Force (USPSTF) identified several gaps in the evidence where more research is needed. These include

  • Studies (specifically randomized controlled trials [RCTs]) on the effect of screening for gestational diabetes and health outcomes.
  • Studies examining the benefits and harms of screening for and treatment of gestational diabetes in pregnant persons before 24 weeks of gestation.
  • Studies reporting on the effects of screening for gestational diabetes on populations defined by race/ethnicity, age, and other relevant socioeconomic factors.
  • Studies examining how health outcomes differ by screening strategy (1- versus 2-step testing and various thresholds for gestational diabetes, fasting plasma glucose level, and HbA1c concentration).
  • Greater consistency in both the diagnostic criteria and outcome definitions used in studies.
  • More studies that report on maternal health outcomes, especially hypertension and preeclampsia.
  • Studies focusing on longer-term outcomes (i.e., obesity, impaired fasting glucose) for both pregnant persons and children.
  • Studies on potential harms of screening and treatment (i.e., anxiety, hospital experience, and cesarean delivery).
Suggested Citation:"Appendix F: U.S. Preventive Service Task Force Research Needs Statements from I Statements Issued Between 2017 and 2021." National Academies of Sciences, Engineering, and Medicine. 2022. Closing Evidence Gaps in Clinical Prevention. Washington, DC: The National Academies Press. doi: 10.17226/26351.
×

Vitamin D Deficiency in Adults: Screening (USPSTF, 2021d)
April 13, 2021

More studies are needed that address the following areas:

  • More research is needed to determine whether total serum 25(OH)D levels are the best measure of vitamin D deficiency and whether the best measure of vitamin D deficiency varies by subgroups defined by race, ethnicity, or sex.
  • More research is needed to determine the cutoff that defines vitamin D deficiency and whether that cutoff varies by specific clinical outcome or by subgroups defined by race, ethnicity, or sex.
  • When vitamin D deficiency is better defined, studies on the benefits and harms of screening for vitamin D deficiency will be helpful.

Hearing Loss in Older Adults: Screening (USPSTF, 2021c)
March 23, 2021

More studies are needed that address the following areas:

  • The benefit of screening for and treatment of hearing loss in asymptomatic adults on health outcomes, such as quality of life and function, not just on hearing aid use or quality of hearing.
  • The potential harms of screening and treatment, such as false-positive results and overtreatment.
  • Consistent use of definitions of hearing loss to improve certainty about the accuracy of screening tests.
  • The general adult population, as well as diverse subpopulations.
  • The role of over-the-counter assistive hearing devices compared with prescription amplification devices.
  • Screening tools that identify not just adults with hearing loss by audiometry definition criteria, but adults with unrecognized hearing loss that would benefit (the most) from amplification.

Tobacco Smoking Cessation in Adults,
Including Pregnant Persons: Interventions (USPSTF, 2021b)

January 19, 2021

The greatest research needs are to gain a better understanding of the effectiveness of e-cigarettes for smoking cessation, as well as potential short- and long-term harms of e-cigarette use, and to understand whether there are effective pharmacotherapy options for pregnant persons.

  • E-cigarettes: Given the potential negative effect that increasing e-cigarette use in youth is having on overall tobacco control efforts, there is an urgent need for research that provides both a clearer understanding of
Suggested Citation:"Appendix F: U.S. Preventive Service Task Force Research Needs Statements from I Statements Issued Between 2017 and 2021." National Academies of Sciences, Engineering, and Medicine. 2022. Closing Evidence Gaps in Clinical Prevention. Washington, DC: The National Academies Press. doi: 10.17226/26351.
×
  • whether e-cigarettes may increase adult tobacco smoking cessation, as well as the potential harms of e-cigarette use as a tobacco product. Future research on e-cigarettes for smoking cessation in adults should address the following:
    • Studies must be well-designed RCTs that compare e-cigarette interventions with placebo, as well as established, effective combinations of pharmacotherapy and behavioral support.
    • Studies should be adequately powered to detect differences in continued smoking abstinence rates at 6 months or more.
    • 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. More research is needed on 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.
    • Given the rapidly evolving landscape of e-cigarettes, 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.
    • More research is needed to understand the patterns of e-cigarette use in youth and the risk factors for their transition from e-cigarette use to conventional cigarette smoking.
    • More research is also needed to better understand patterns of e-cigarette use in pregnant persons and potential harms of e-cigarette use to both pregnant persons and their offspring.
    • More research is needed on understanding how to help adults quit e-cigarettes.
  • Pharmacotherapy in pregnant persons: Although behavioral counseling interventions have been found to be effective in improving smoking cessation during pregnancy, additional research is needed on pharmacotherapy options, in particular NRT, for pregnant persons for whom behavioral counseling interventions alone are not effective.
    • 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.
    • A better understanding of why adherence rates to NRT during pregnancy is so low would also be helpful.

Although the benefits of behavioral counseling interventions and pharmacotherapy in nonpregnant adults and the benefits of behavioral counseling interventions in pregnant adults are well established, additional research on effective components of behavioral counseling and who to target specific interventions to would be informative. More research on newer modalities and remotely delivered interventions (mobile phone apps, Internet-based interventions) would also be helpful. Additionally, the effectiveness of interventions for cessation of other

Suggested Citation:"Appendix F: U.S. Preventive Service Task Force Research Needs Statements from I Statements Issued Between 2017 and 2021." National Academies of Sciences, Engineering, and Medicine. 2022. Closing Evidence Gaps in Clinical Prevention. Washington, DC: The National Academies Press. doi: 10.17226/26351.
×

forms of tobacco and whether interventions need to be tailored to individual tobacco product types are also needed. Last, more research is needed on interventions to prevent relapse of tobacco use.

High Blood Pressure in Children and Adolescents:
Screening (USPSTF, 2020c)

November 10, 2020

There are several critical evidence gaps in understanding the potential net benefit of screening for high blood pressure in childhood and adolescence. Studies are needed that provide more information on

  • The test accuracy of blood pressure measurements with sphygmomanometers or oscillometric automated devices and establishing thresholds for hypertension for 24-hour ambulatory monitoring.
  • The application of new thresholds for determining abnormal blood pressure to existing data sets and testing the validity of these thresholds.
  • The benefits and harms of long-term pharmacologic treatment. These 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.
  • The benefits and harms of screening and treatment should also include children at increased risk, such as Black and Hispanic/Latino populations.
  • The long-term natural history of hypertension in children and the spontaneous resolution of hypertension.
  • The associations among childhood hypertension, adulthood hypertension, and surrogate measures of cardiovascular disease in childhood and adulthood, as well as adulthood clinical cardiovascular disease.
  • The harms of medications, long-term adherence with treatment, and the effect of individual components of multifactorial interventions.

Unhealthy Drug Use: Screening (USPSTF, 2020f)
June 9, 2020

The USPSTF identified important gaps related to screening for unhealthy drug use. To fill these gaps, the USPSTF needs more evidence from well-designed studies that further evaluate the following:

  • The effectiveness of screening and interventions for drug use in adolescents.
  • The optimal screening interval for detecting unhealthy drug use.
  • The accuracy of screening tools for detecting nonmedical use of prescription drugs, including opioids.
  • Strategies to improve access to pharmacotherapy and psychosocial interventions for persons with various types of drug use disorders.
Suggested Citation:"Appendix F: U.S. Preventive Service Task Force Research Needs Statements from I Statements Issued Between 2017 and 2021." National Academies of Sciences, Engineering, and Medicine. 2022. Closing Evidence Gaps in Clinical Prevention. Washington, DC: The National Academies Press. doi: 10.17226/26351.
×
  • The harms that occur when the result of screening is punitive.
  • 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.

Illicit Drug Use in Children, Adolescents, and Young Adults:
Primary Care–Based Interventions (USPSTF, 2020d)

May 26, 2020

The USPSTF identified several gaps in the evidence where more research is needed:

  • There was promising evidence that interventions could be effective in preventing cannabis use specifically; however, the benefit to harm ratio could not be determined because of a lack of studies reporting harms. Future research on cannabis prevention that deliberately addresses both benefits and harms is needed.
  • There was minimal reporting on health, social, or legal outcomes and significant heterogeneity in reporting on drug use outcomes. Standardization of outcome measurement across trials would greatly strengthen the evidence base and improve the ability to pool data.
  • Several interventions such as the Familias Unidas program (a family-based intervention program focusing on Hispanic youth) and interventions that included clinician training, education, personal coaching, and continuous quality improvement components showed promise in reducing illicit drug use. More studies are needed that replicate and further refine these interventions.
  • There was no evidence on preventing or reducing illicit drug use in children younger than 10 years and limited evidence in young adults (aged 18–25 years). More data are needed on the benefits and harms of interventions in these age groups.
  • Technology-based interventions such as text-based messaging, smart-phone apps, games, web-based interventions, and social media have the potential for wide reach, although there are limited data about their effectiveness. More studies of implementation of these types of interventions is needed, specifically among families referred from primary care, to determine their uptake and effectiveness.

Tobacco Use in Children and Adolescents:
Primary Care Interventions (USPSTF, 2020e)

April 28, 2020

More studies are needed to identify effective interventions to help children and adolescents who use tobacco products to quit.

Suggested Citation:"Appendix F: U.S. Preventive Service Task Force Research Needs Statements from I Statements Issued Between 2017 and 2021." National Academies of Sciences, Engineering, and Medicine. 2022. Closing Evidence Gaps in Clinical Prevention. Washington, DC: The National Academies Press. doi: 10.17226/26351.
×
  • Larger, adequately powered studies and studies of new behavioral counseling interventions for cessation are needed.
    • 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).
  • More studies are needed that evaluate the benefits and harms of medications to help youth with tobacco cessation.
  • More research is needed on interventions tailored specifically to prevent initiation of use and promote cessation of e-cigarette use in youth. The landscape of e-cigarette devices is rapidly evolving, so research in this area is challenged by the need to be timely, flexible, and comprehensive.
  • More research is also needed on 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) and 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).

Bacterial Vaginosis in Pregnant Persons to Prevent
Preterm Delivery: Screening (USPSTF, 2020a)

April 7, 2020

More studies are needed to evaluate screening for and treatment of asymptomatic bacterial vaginosis in pregnant persons at increased risk for preterm delivery. These studies should

  • Include pregnant persons with a history of prior preterm delivery, as well as other risk factors for preterm delivery, such as cervical insufficiency, multifetal gestation, young or advanced maternal age, low maternal body mass index (<20), and African American, Native Hawaiian/Other Pacific Islander, or American Indian/Alaska Native race/ethnicity.
  • Be adequately powered to detect a reduction of all-cause preterm delivery prior to 37 weeks’ gestation.

If a reduction in preterm delivery is found with treatment of asymptomatic bacterial vaginosis in pregnant persons at increased risk for preterm delivery, then additional research is needed on ways to better identify persons at increased risk for preterm delivery. Additionally, given the biochemical and hormonal changes that occur during pregnancy, further studies of bacterial vaginosis screening tests in pregnant persons are needed to confirm test accuracy in this population.

Suggested Citation:"Appendix F: U.S. Preventive Service Task Force Research Needs Statements from I Statements Issued Between 2017 and 2021." National Academies of Sciences, Engineering, and Medicine. 2022. Closing Evidence Gaps in Clinical Prevention. Washington, DC: The National Academies Press. doi: 10.17226/26351.
×

Cognitive Impairment in Older Adults: Screening (USPSTF, 2020b)
February 25, 2020

  • More research is needed on the 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.
  • The body of evidence on screening and interventions for cognitive impairment would benefit from more consistent definitions and reporting of outcomes to allow comparisons across trials, especially from trials with longer-term follow-up.
  • Studies are needed of the effects of caregiver or patient–caregiver dyad interventions on delay or prevention of institutionalization, and the effects of delay in institutionalization on caregivers.
  • Research is needed on treatments that clearly affect the long-term clinical course of cognitive impairment. It is also important that studies on screening and interventions for cognitive impairment report harms and reasons for attrition of trial participants.

Abdominal Aortic Aneurysm: Screening (USPSTF, 2019a)
December 10, 2019

Addressing several key research gaps could help inform the benefit of screening for AAA in U.S.-based populations1:

  • Although evidence shows that women who smoke or have a family history are at increased risk for AAA compared with nonsmoking women without a family history, evidence is insufficient that screening this population confers a net benefit. Ideally, appropriately powered RCTs among women with risk factors could answer these critical gaps in the evidence on screening for AAA. In the absence of new trial data, high-quality, well-calibrated modeling studies based on reliable data on the harms and benefits of screening in women who smoke or in men and women with a family history of AAA may be informative.
  • Well-conducted cohort studies examining rescreening benefits (including growth rates and health outcomes) are needed for persons who initially screen negative for AAA to determine the benefit and timing of additional screening ultrasonography.
  • External validation of risk prediction models that have already been developed will allow policy makers to assess their value for making more individualized screening recommendations.
  • Epidemiologic studies on the current prevalence of AAA in the United States, including in subpopulations, would help inform the applicability of older population-based screening trials to the current U.S. population.
  • Well-designed studies, RCTs, or registry data on the thresholds for repair of AAA in women may inform the benefits and harms of screening in
Suggested Citation:"Appendix F: U.S. Preventive Service Task Force Research Needs Statements from I Statements Issued Between 2017 and 2021." National Academies of Sciences, Engineering, and Medicine. 2022. Closing Evidence Gaps in Clinical Prevention. Washington, DC: The National Academies Press. doi: 10.17226/26351.
×
  • women, as evidence suggests that AAAs in women may rupture at a smaller size than in men.
  • Studies examining systems approaches to improving implementation of evidence-based AAA screening in the United States are needed.
  • Studies examining the efficacy of screening and treatment in diverse populations (e.g., older adults, women, and racial/ethnic groups) are needed to inform the need for specific recommendations in subpopulations of Americans.

Elevated Blood Lead Levels in Children
and Pregnant Women: Screening (USPSTF, 2019b)

April 16, 2019

Research is needed to better inform decisions about screening for elevated blood lead levels in children and pregnant women, such as the development of validated questionnaires to identify at-risk populations most likely to benefit from screening. Studies reporting intermediate and health outcomes, outcomes in newborns, and harms in women and infants are needed, as well as studies evaluating effective interventions for reducing blood lead levels in pregnant women. Research is also needed to evaluate the effectiveness of treatments for elevated blood lead levels in trials with adequate sample sizes to inform treatment strategies. However, randomized trials may not always be appropriate for screening and environmental interventions because of ethical issues. Well-designed research studies are needed on the benefits of nutritional supplementation in reducing blood lead levels in children. Research on newer approaches to detecting elevated blood lead levels, such as point-of-care testing, that include intraindividual and interlaboratory reliability would be useful for assessing screening strategies in children and pregnant women. Different sources of lead exposure that are now emerging in at-risk communities are not well incorporated into current screening questionnaires. Research on screening and prevention in these populations remains limited. Additional research is needed to validate these potential risk factors in specific geographic locations and among at-risk populations.

Child Maltreatment: Interventions (USPSTF, 2018e)
November 27, 2018

The USPSTF recognizes the importance of this serious health problem and calls for the prioritization of research to address gaps in numerous areas related to child maltreatment. There is limited evidence supporting the use of risk-assessment instruments to identify children at risk of maltreatment. Further research to determine effective methods for clinicians to identify children at increased risk should be a priority.

Although most studies included home visitation, there was significant heterogeneity in study design and outcome measurements. Standardization of outcome measurement across trials would greatly strengthen the evidence base and

Suggested Citation:"Appendix F: U.S. Preventive Service Task Force Research Needs Statements from I Statements Issued Between 2017 and 2021." National Academies of Sciences, Engineering, and Medicine. 2022. Closing Evidence Gaps in Clinical Prevention. Washington, DC: The National Academies Press. doi: 10.17226/26351.
×

improve the ability to pool data. Additionally, research on home visitation should base interventions on proven and well-designed theoretical models. Without this type of contextual information, it will be difficult to interpret whether inventions are successful and, if so, how those interventions worked. When investigating interventions and outcomes, the inclusion of diverse populations and settings would help improve the applicability of study findings. These would 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. In addition, future research is needed to determine whether there are unintended harms from risk assessment and preventive interventions.

Unhealthy Alcohol Use in Adolescents and Adults: Screening and
Behavioral Counseling Interventions (USPSTF, 2018j)

November 13, 2018

The USPSTF has identified several research gaps. Although difficult, conducting a trial with an unscreened comparison group to understand the population-level effects of screening in primary care settings would be valuable. More direct evidence is needed on the harms associated with screening and behavioral interventions. The USPSTF found a preliminary study that evaluated the USAUDIT and USAUDIT-C, recent U.S. adaptations of the AUDIT and AUDIT-C. Further test performance studies are needed to confirm their accuracy in identifying unhealthy alcohol use in various populations. More evidence on important clinical outcomes is needed, such as longer-term morbidity, mortality, health care utilization, and social and legal outcomes. Trials designed a priori to report subgroup effects in diverse populations (e.g., by age, sex, race/ethnicity, or baseline severity) would be useful. Limited evidence is available to assess the effects of screening and behavioral counseling in adolescents, and high-quality studies specifically addressing this population are needed. 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.

Intimate Partner Violence, Elder Abuse, and Abuse
of Vulnerable Adults: Screening (USPSTF, 2018f)

October 23, 2018

There are several key research gaps related to IPV. The USPSTF recognizes that a significant body of evidence is lacking for men. The CDC has conducted studies demonstrating the prevalence and importance of IPV in men; however, there is a lack of research on screening and interventions to prevent IPV in men. Research is needed in all areas related to the accuracy of screening tools for men, and trials are needed that examine the effectiveness (benefits and harms) of screening and interventions for IPV in the primary care setting in men without recognized signs and symptoms of abuse.

More research is also needed on the most effective characteristics of ongoing support services for reducing IPV. In particular, more RCTs that compare the ben-

Suggested Citation:"Appendix F: U.S. Preventive Service Task Force Research Needs Statements from I Statements Issued Between 2017 and 2021." National Academies of Sciences, Engineering, and Medicine. 2022. Closing Evidence Gaps in Clinical Prevention. Washington, DC: The National Academies Press. doi: 10.17226/26351.
×

efits and harms of screening (plus ongoing support services or referral for women who screen positive) versus no screening are needed, where support services may include more frequent and intensive interventions such as home visits, cognitive behavioral therapy, or other forms that address multiple risk factors. These studies should evaluate the optimal duration, format, and method of delivery.

Trials of ongoing support services should enroll women of all ages, including nonpregnant women and women beyond reproductive age. These trials will help with understanding the types of postscreening, ongoing support services that can be most effective, and the patients for whom they are most effective.

More research is also needed in all areas related to the accuracy of screening tools in the primary care setting for elder abuse and abuse of vulnerable adults when there are no recognized signs and symptoms of abuse. High-quality RCTs are also needed on the effectiveness (benefits and harms) of screening and interventions in the primary care setting to prevent such abuse.

Atrial Fibrillation: Screening with
Electrocardiography (USPSTF, 2018b)

August 7, 2018

The connection between atrial fibrillation and stroke is well established, as is the existence of undiagnosed atrial fibrillation, especially among older adults. Randomized trials enrolling asymptomatic persons that directly compare screening with usual care and that assess both health outcomes and harms are needed to understand the balance of benefits and harms of screening for atrial fibrillation. Other research needs include understanding how to best optimize the accuracy of ECG interpretation. Although the evidence review for this recommendation statement focused on screening with ECG, the effectiveness of newer technologies capable of assessing pulse and heart rhythm as potential screening strategies should be evaluated. In addition, as ECG and other technologies (e.g., AliveCOR Kardia system [AliveCor Inc.], discussed in the context of the REHEARSE-AF trial below) are used to record heart activity for longer periods and thus are able to detect shorter episodes of arrhythmia, understanding the stroke risk associated with brief episodes of subclinical atrial fibrillation, and the potential benefit of anticoagulation therapy if risk is significant, is another important research need.

Several ongoing trials may help to fill these evidence gaps. The STROKE-STOP study (NLM, 2012) randomized 28,768 Swedish adults aged 75–76 years to be invited or not invited for screening, first with 12-lead ECG and then intermittently with a single handheld lead over 2 weeks. The primary outcome is stroke incidence. The SCREEN-AF study (NLM, 2015) randomized more than 800 participants to a 2-week ambulatory ECG patch monitor or usual care. The primary outcome is new diagnosis of ECG-confirmed atrial fibrillation or flutter, but clinical events are included as secondary outcomes. The IDEAL-MD study (NLM, 2014) randomized 16,000 adults older than 65 years to screening with a single-lead ECG device or usual care. The primary outcome is new diagnosis of atrial fibrillation over 1 year; secondary outcomes include major cardiovascular events and all-cause mortality. Last, the Detecting and Diagnosing Atrial Fibrillation (D2AF) study (University Medical Center Utrecht, n.d.) is a cluster randomized trial that

Suggested Citation:"Appendix F: U.S. Preventive Service Task Force Research Needs Statements from I Statements Issued Between 2017 and 2021." National Academies of Sciences, Engineering, and Medicine. 2022. Closing Evidence Gaps in Clinical Prevention. Washington, DC: The National Academies Press. doi: 10.17226/26351.
×

compares different approaches to case-finding among adults 65 years and older. The primary outcome is the difference in detection rate of new atrial fibrillation cases over 1 year compared with usual care; however, the study does not include clinical outcomes.

Peripheral Artery Disease and Cardiovascular Disease: Screening and
Risk Assessment with the Ankle-Brachial Index (USPSTF, 2018h)

July 10, 2018

Large, population-based, randomized trials of screening versus no screening are needed to determine whether screening for PAD with the ABI improves clinical outcomes. One ongoing study in Denmark has published preliminary results; however, that study limited enrollment to men aged 65–74 years and included screening for abdominal aortic aneurysm and high blood pressure, making it difficult to evaluate the benefit of screening with the ABI alone.2 Two other ongoing trials that include the ABI as part of a screening bundle may have the same limitation (Betriu et al., 2016; Diederichsen et al., 2015). Future studies, in addition to isolating the effect of individual tests, should address the population of persons at potentially increased risk for PAD who are not already receiving interventions to reduce cardiovascular risk, because this is the population most likely to benefit from an additional screening intervention. 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 a lower socioeconomic status) and populations at high risk (i.e., persons with diabetes) would also be valuable.

Cardiovascular Disease: Risk Assessment with
Nontraditional Risk Factors (USPSTF, 2018d)

July 10, 2018

A substantial number of studies demonstrate an association between the ABI, hsCRP level, and CAC score and cardiovascular outcomes, so additional association studies are unlikely to add more information. Similarly, studies assessing nontraditional risk factors in isolation are of limited value, given that current treatment recommendations are based on risk assessment with the Framingham Risk Score or Pooled Cohort Equations. Good-quality studies comparing traditional risk assessment with traditional risk assessment plus the ABI, hsCRP level, or CAC scores are needed to measure the effect of adding nontraditional risk factors on clinical decision thresholds and patient outcomes (CVD events and mortality). Studies are especially 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. In addition, well-designed prospective studies reflective of real-world practice are needed to identify the downstream effects of CAC score on additional testing and procedures.

Suggested Citation:"Appendix F: U.S. Preventive Service Task Force Research Needs Statements from I Statements Issued Between 2017 and 2021." National Academies of Sciences, Engineering, and Medicine. 2022. Closing Evidence Gaps in Clinical Prevention. Washington, DC: The National Academies Press. doi: 10.17226/26351.
×

Osteoporosis to Prevent Fractures: Screening (USPSTF, 2018g)
June 26, 2018

The majority of reviewed studies focused on women. Treatment trials that focus on or include men and report on fracture outcomes (rather than BMD) as well as harms are needed. More studies are also needed that evaluate the direct effect of screening for osteoporosis (either with BMD or clinical risk assessment tools) on fracture outcomes. Additional research is needed 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. The development of prognostic models incorporating age, baseline BMD, and hormone replacement therapy use27,28 may also help identify optimal screening intervals.

Cardiovascular Disease Risk: Screening
with Electrocardiography (USPSTF, 2018c)

June 12, 2018

A considerable number of studies have reported hazard ratios and other measures of association between ECG changes and cardiovascular outcomes, so additional studies of this nature are unlikely to advance the field. Studies are needed that assess the incremental value of adding ECG to current CVD risk assessment tools or instruments to directly inform decision making; studies that examine patient outcomes would be most useful. Failing that, studies are needed that assess the added value of ECG for risk reclassification across clinically relevant risk thresholds. Any study of CVD risk assessment should also evaluate the harms associated with assessment as well as those related to additional testing and treatment. Studies that measure risk reclassification should report total, event, and nonevent Net Reclassification Indices, with corresponding confidence intervals, as well as measures of calibration and discrimination.

Vitamin D, Calcium, or Combined Supplementation for
the Primary Prevention of Fractures in Community-Dwelling
Adults: Preventive Medication (USPSTF, 2018k)

April 17, 2018

Research is needed to determine whether daily supplementation with doses greater than 400 IU of vitamin D and greater than 1000 mg of calcium reduces fracture incidence in postmenopausal women and in older men. Prospective studies should assess the potential benefits of vitamin D and calcium supplementation in premenopausal women on fracture incidence later in life. Studies need to be adequately powered and should evaluate consistent fracture outcomes. Studies are also needed to evaluate the effects of vitamin D supplementation on diverse populations. Because white women have the highest risk for osteoporotic fractures, most fracture prevention studies have been conducted in this population,

Suggested Citation:"Appendix F: U.S. Preventive Service Task Force Research Needs Statements from I Statements Issued Between 2017 and 2021." National Academies of Sciences, Engineering, and Medicine. 2022. Closing Evidence Gaps in Clinical Prevention. Washington, DC: The National Academies Press. doi: 10.17226/26351.
×

and it is difficult to extrapolate results to nonwhite populations. In addition, more studies evaluating the potential harms of supplementation are needed, particularly studies on calcium and potential adverse cardiovascular outcomes.

Skin Cancer Prevention: Behavioral Counseling (USPSTF, 2018i)
March 20, 2018

A better understanding of the effectiveness of counseling on the use of sun protection behaviors in adults 25 years and older is needed to address the key evidence gap on counseling for this age group. Research that evaluates the association between UV exposure during adulthood and skin cancer risk would also be valuable.

In addition, studies regarding the effectiveness of counseling persons without a fair skin type are lacking. Ideally, research studies would provide measurements of sun exposure, sunburn, precursor skin lesions, and cancer among large trial populations, with an emphasis on behaviors and health outcomes among persons who receive an intervention focused on sun protection behaviors. Such studies would also assess whether these behaviors continue after trial completion. These cohorts should include populations with diverse skin colors and should include adolescents, young adults, and preschool-aged children and their parents. These studies may be used to further develop technologies and vehicles for administering relevant interventions for behavior change in the primary care setting, especially among nonwhite persons, young adults, and persons who practice indoor or outdoor tanning. Further evidence is needed to assess the balance of benefits and harms of counseling adults about skin self-examination to prevent skin cancer and premature death.

Adolescent Idiopathic Scoliosis: Screening (USPSTF, 2018a)
January 9, 2018

The USPSTF identified several research gaps. Prospective, controlled screening studies that allow for comparison of screened and nonscreened populations and different screening settings, personnel, and procedures are needed. Good-quality studies with prospective identification of cohorts at the time of diagnosis (e.g., from geographical areas with and without routine screening for adolescent idiopathic scoliosis) or treatment (e.g., treated versus observed cohorts) for the purpose of long-term follow-up are important. High-quality studies on the potential harms of screening and treatment are also needed. Additional studies to help determine whether individual characteristics (e.g., body mass index) may influence response to bracing treatment would be helpful. Studies on long-term outcomes are needed and should stratify results by degree of spinal curvature at diagnosis and at skeletal maturity. Better information on long-term outcomes such as pulmonary disorders, disability, back pain, psychological effects, cosmetic issues, and quality of life would be helpful. Good-quality studies on treatment with exercise, bracing, and surgery among screen-detected patients are needed. Studies conducted in primary care settings are also needed.

Suggested Citation:"Appendix F: U.S. Preventive Service Task Force Research Needs Statements from I Statements Issued Between 2017 and 2021." National Academies of Sciences, Engineering, and Medicine. 2022. Closing Evidence Gaps in Clinical Prevention. Washington, DC: The National Academies Press. doi: 10.17226/26351.
×

Vision in Children Ages 6 Months to 5 Years:
Screening (USPSTF, 2017d)

September 5, 2017

The USPSTF identified several gaps in the evidence. Well-designed trials are needed to better understand the effects of screening versus no screening, the optimal age for initiation of screening, and appropriate screening intervals. Additional studies are needed to determine the best screening approach and most favorable combinations of screening tests in primary care. There is also a need for 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.

Celiac Disease: Screening (USPSTF, 2017a)
March 28, 2017

Studies that randomly assign participants to screening versus no screening and evaluate clinical outcomes are lacking. However, screening studies that target populations at increased risk for celiac disease are likely to be more informative than trials that target the general population, because of the higher prevalence of disease, and should be given higher priority. More information is needed about the accuracy of serologic testing in asymptomatic persons, particularly those with disease risk factors.

Treatment studies in screen-detected, asymptomatic persons are also needed to understand the effects of adherence to a gluten-free diet (compared with no dietary intervention), as well as the effects of immediate versus delayed dietary changes (i.e., at the time of screen-detected diagnosis versus when symptoms develop). Ideally, studies would report both short-term effects on symptoms and quality of life and long-term outcomes (e.g., osteoporotic fractures, cancer, and mortality). As for screening, treatment studies focused on asymptomatic persons at high risk for celiac disease who screen positive would be helpful for developing guidance for this population and may be faster and more efficient to complete than other study designs. More research is needed to better understand the natural history of positive serology in patients without histologic changes or with histologic confirmation but no symptoms. Also, 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.

Suggested Citation:"Appendix F: U.S. Preventive Service Task Force Research Needs Statements from I Statements Issued Between 2017 and 2021." National Academies of Sciences, Engineering, and Medicine. 2022. Closing Evidence Gaps in Clinical Prevention. Washington, DC: The National Academies Press. doi: 10.17226/26351.
×

Gynecological Conditions: Periodic Screening
with the Pelvic Examination (USPSTF, 2017b)

March 7, 2017

The USPSTF recognizes that research on the effectiveness of the screening pelvic examination is difficult, given that multiple conditions could potentially be detected with this single preventive service. However, in reviewing the currently available evidence on the benefits and harms of performing screening pelvic examinations in asymptomatic adult women, the USPSTF identified the following critical evidence gaps. Studies evaluating the accuracy and effectiveness of screening pelvic examination to detect conditions other than ovarian cancer, bacterial vaginosis, genital herpes, and trichomoniasis are lacking. Studies reporting on the harms of screening with pelvic examination (including quantified psychological harms) in asymptomatic women in primary care are also lacking.

Studies reporting the effects of performing routine screening pelvic examinations on health outcomes such as all-cause mortality, disease-specific morbidity and mortality, quality of life, and psychological benefits and harms could help fill the gaps in the existing evidence and inform future USPSTF recommendations. Studies evaluating and quantifying harms are needed, as well as studies evaluating the potential effectiveness of risk assessment tools to determine which women might benefit from a pelvic examination. Research is needed to clarify which indications primary care clinicians are currently using the screening pelvic examination for in asymptomatic patients and which components of the pelvic examination are performed most frequently. Studies exploring women’s attitudes toward pelvic examinations, the outcomes women value from these examinations, and how pelvic examinations affect women’s decisions to seek and obtain care are also needed to clarify the potential benefits and harms of providing this preventive service.

Obstructive Sleep Apnea in Adults: Screening (USPSTF, 2017c)
January 24, 2017

The identification of valid and reliable clinical prediction tools that could accurately determine which asymptomatic persons (or persons with unrecognized symptoms) would benefit from further evaluation and testing for OSA is needed. In addition, studies that evaluate the effect of OSA treatments or interventions on health outcomes (e.g., all-cause and cardiovascular mortality, cardiovascular disease and cerebrovascular events, motor vehicle crashes, and cognitive impairment) that are adequately powered and have an appropriate length of follow-up are needed. Studies are also needed to evaluate whether improvement in AHI (for mild to severe OSA) leads to improvement in health outcomes. These represent critical gaps in the current evidence base. The USPSTF has identified the need for further research on the effect on health outcomes of screening for OSA among asymptomatic persons in the general population, as well as the role of sleepiness in determining health outcomes. More data on the natural history of mild OSA are also needed, in particular the rates of progression from mild to severe OSA, the length of duration before progression, and the magnitude of benefit if OSA is identified and treated earlier.

Suggested Citation:"Appendix F: U.S. Preventive Service Task Force Research Needs Statements from I Statements Issued Between 2017 and 2021." National Academies of Sciences, Engineering, and Medicine. 2022. Closing Evidence Gaps in Clinical Prevention. Washington, DC: The National Academies Press. doi: 10.17226/26351.
×

REFERENCES

USPSTF (U.S. Preventive Services Task Force). 2017a. Celiac disease: Screening. https://www.uspreventiveservicestaskforce.org/uspstf/recommendation/celiac-disease-screening (accessed July 14, 2021).

USPSTF. 2017b. Gynecological conditions: Periodic screening with the pelvic examination. https://www.uspreventiveservicestaskforce.org/uspstf/recommendation/gynecological-conditions-screening-with-the-pelvic-examination (accessed August 17, 2021).

USPSTF. 2017c. Obstructive sleep apnea in adults: Screening. https://uspreventiveservicestaskforce.org/uspstf/recommendation/obstructive-sleep-apnea-in-adults-screening (accessed November 22, 2021).

USPSTF. 2017d. Vision in children ages 6 months to 5 years: Screening. https://www.uspreventiveservices-taskforce.org/uspstf/recommendation/vision-in-children-ages-6-months-to-5-years-screening (accessed August 17, 2021).

USPSTF. 2018a. Adolescent idiopathic scoliosis: Screening. https://www.uspreventiveservicestaskforce.org/uspstf/recommendation/adolescent-idiopathic-scoliosis-screening (accessed August 17, 2021).

USPSTF. 2018b. Atrial fibrillation: Screening with electrocardiography. https://www.uspreventiveservicestaskforce.org/uspstf/recommendation/atrial-fibrillation-screening-with-electrocardiography (accessed August 17, 2021).

USPSTF. 2018c. Cardiovascular disease risk: Screening with electrocardiography. https://www.uspreventiveservicestaskforce.org/uspstf/recommendation/cardiovascular-disease-risk-screening-with-electrocardiography (accessed August 17, 2021).

USPSTF. 2018d. Cardiovascular disease: Risk assessment with nontraditional risk factors. https://www.uspreventiveservicestaskforce.org/uspstf/recommendation/cardiovascular-disease-screening-using-nontraditional-risk-assessment (accessed August 17, 2021).

USPSTF. 2018e. Child maltreatment: Interventions. https://www.uspreventiveservicestaskforce.org/uspstf/recommendation/child-maltreatment-primary-care-interventions (accessed August 17, 2021).

USPSTF. 2018f. Intimate partner violence, elder abuse, and abuse of vulnerable adults: Screening. https://www.uspreventiveservicestaskforce.org/uspstf/recommendation/intimate-partner-violence-and-abuse-of-elderly-and-vulnerable-adults-screening (accessed August 17, 2021).

USPSTF. 2018g. Osteoporosis to prevent fractures: Screening. https://www.uspreventiveservicestaskforce.org/uspstf/recommendation/osteoporosis-screening (accessed August 17, 2021).

USPSTF. 2018h. Peripheral artery disease and cardiovascular disease: Screening and risk assessment with the ankle-brachial index. https://www.uspreventiveservicestaskforce.org/uspstf/recommendation/peripheral-artery-disease-in-adults-screening-with-the-ankle-brachial-index (accessed August 17, 2021).

USPSTF. 2018i. Skin cancer prevention: Behavioral counseling. https://www.uspreventiveservicestaskforce.org/uspstf/recommendation/skin-cancer-counseling (accessed August 17, 2021).

USPSTF. 2018j. Unhealthy alcohol use in adolescents and adults: Screening and behavioral counseling interventions. https://www.uspreventiveservicestaskforce.org/uspstf/recommendation/unhealthy-alcohol-use-in-adolescents-and-adults-screening-and-behavioral-counseling-interventions (accessed August 17, 2021).

USPSTF. 2018k. Vitamin D, calcium, or combined supplementation for the primary prevention of fractures in community-dwelling adults: Preventive medication. https://www.uspreventiveservicestaskforce.org/uspstf/recommendation/vitamin-d-calcium-or-combined-supplementation-for-the-primary-prevention-of-fractures-in-adults-preventive-medication (accessed August 17, 2021).

Suggested Citation:"Appendix F: U.S. Preventive Service Task Force Research Needs Statements from I Statements Issued Between 2017 and 2021." National Academies of Sciences, Engineering, and Medicine. 2022. Closing Evidence Gaps in Clinical Prevention. Washington, DC: The National Academies Press. doi: 10.17226/26351.
×

USPSTF. 2019a. Abdominal aortic aneurysm: Screening. https://www.uspreventiveservicestaskforce.org/uspstf/recommendation/abdominal-aortic-aneurysm-screening (accessed August 17, 2021).

USPSTF. 2019b. Elevated blood lead levels in children and pregnant women: Screening. https://www.uspreventiveservicestaskforce.org/uspstf/recommendation/elevated-blood-lead-levels-in-childhood-and-pregnancy-screening (accessed August 17, 2021).

USPSTF. 2020a. Bacterial vaginosis in pregnant persons to prevent preterm delivery: Screening. https://www.uspreventiveservicestaskforce.org/uspstf/recommendation/bacterial-vaginosis-in-pregnancy-to-prevent-preterm-delivery-screening (accessed August 17, 2021).

USPSTF. 2020b. Cognitive impairment in older adults: Screening. https://www.uspreventiveservicestaskforce.org/uspstf/recommendation/cognitive-impairment-in-older-adults-screening (accessed August 17, 2021).

USPSTF. 2020c. High blood pressure in children and adolescents: Screening. https://www.uspreventiveservicestaskforce.org/uspstf/recommendation/blood-pressure-in-children-and-adolescents-hypertension-screening (accessed August 17, 2021).

USPSTF. 2020d. Illicit drug use in children, adolescents, and young adults: Primary care-based interventions. https://www.uspreventiveservicestaskforce.org/uspstf/recommendation/drug-use-illicit-primary-care-interventions-for-children-and-adolescents (accessed August 17, 2021).

USPSTF. 2020e. Tobacco use in children and adolescents: Primary care interventions. https://www.uspreventiveservicestaskforce.org/uspstf/recommendation/tobacco-and-nicotine-use-prevention-in-children-and-adolescents-primary-care-interventions (accessed August 17, 2021).

USPSTF. 2020f. Unhealthy drug use: Screening. https://www.uspreventiveservicestaskforce.org/uspstf/recommendation/drug-use-illicit-screening (accessed August 17, 2021).

USPSTF. 2021a. Gestational diabetes: Screening. https://www.uspreventiveservicestaskforce.org/uspstf/recommendation/gestational-diabetes-screening (accessed August 17, 2021).

USPSTF. 2021b. Hearing loss in older adults: Screening. https://www.uspreventiveservicestaskforce.org/uspstf/recommendation/hearing-loss-in-older-adults-screening (accessed August 17, 2021).

USPSTF. 2021c. Tobacco smoking cessation in adults, including pregnant persons: Interventions. https://www.uspreventiveservicestaskforce.org/uspstf/recommendation/tobacco-use-in-adults-and-pregnant-women-counseling-and-interventions (accessed August 17, 2021).

USPSTF. 2021d. Vitamin D deficiency in adults: Screening. https://www.uspreventiveservicestaskforce.org/uspstf/recommendation/vitamin-d-deficiency-screening (accessed August 17, 2021).

Suggested Citation:"Appendix F: U.S. Preventive Service Task Force Research Needs Statements from I Statements Issued Between 2017 and 2021." National Academies of Sciences, Engineering, and Medicine. 2022. Closing Evidence Gaps in Clinical Prevention. Washington, DC: The National Academies Press. doi: 10.17226/26351.
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Closing Evidence Gaps in Clinical Prevention Get This Book
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Closing Evidence Gaps in Clinical Prevention, a new consensus study report from the National Academies of Sciences, Engineering, and Medicine's Board on Population Health and Public Health Practice, evaluates evidence gaps in clinical prevention recommendations described by the United States Preventive Services Task Force and other clinical practice guideline developers and presents a taxonomy of these evidence gaps for future use. This report aims to improve the coordination of efforts to describe and communicate priority evidence gaps among funders and researchers. It also proposes new opportunities for collaboration among researchers, funders, and guideline developers to accelerate research that could close evidence gaps.

The authoring committee has also developed an interactive graphic that can be used as a workflow diagram for implementing the taxonomy. This workflow walks users through reviewing evidence, characterizing evidence gaps using relevant taxonomies, and developing a research agenda. Click here to view and engage with the interactive graphic.

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