ANSWER
The US Preventive Services Task Force (USPSTF) recommends clinical preventive services. The USPSTF examines chains of direct and indirect evidence to demonstrate the effectiveness of clinical preventive service. Missing links in the evidence chains indicate research gaps. Evidence gaps can exist between preventive services that receive a letter grade and those that receive an I statement (insufficient evidence). This article describes the types of evidence gaps encountered by the USPSTF across its various recommendations and how the USPSTF identifies and communicates these gaps to researchers and policymakers who can help generate the necessary evidence. Evidence gaps in primary care settings and populations are standard, as is a lack of appropriate health outcomes, evidence linking behavior change to health outcomes, and evidence for effective preventive services in diverse populations. The USPSTF’s annual report to Congress focuses on the evidence gaps of new recommendations from the previous year and is distributed to leading research funding organizations. The National Institutes of Health’s Office of Disease Prevention uses this report to help direct future funding opportunities that may address these evidence gaps. The USPSTF is critical in highlighting the information required to advance the science of clinical preventive services in primary care.
Introduction
The United States Preventive Services Task Force (USPSTF) is an independent panel of national prevention and evidence-based medicine experts. The USPSTF makes evidence-based recommendations about clinical preventive services for asymptomatic infants, children, adolescents, adults, older adults, and pregnant women, such as screening tests, counseling about healthy behaviors, and preventive medications. 1
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Evidence gaps emerge during the systematic evidence review process. These gaps are described in the evidence reports and the section of the USPSTF recommendation statements titled Research Needs and Gaps. To stimulate research, this section of the recommendation highlights evidence gaps. 2
This article aims to describe common types of evidence gaps encountered by the USPSTF across its recommendations to inform the development of research agendas that will improve the evidence base for prevention recommendations.
The USPSTF employs an analytic framework (Figure 1) to visually present the key questions that guide the systematic literature review, which evaluates the preventive service’s benefits and harms. The USPSTF is looking for direct evidence that a clinical preventive service improves health outcomes. If no evidence of effectiveness is available, the USPSTF examines the chain of indirect evidence, which includes evidence about the accuracy of screening tests, the efficacy and risks of early treatment, and the relationship between changes in intermediate outcomes due to treatment and differences in health outcomes. 1, 3 When there is sufficient evidence, the USPSTF assigns a letter grade (A, B, C, or D) to each of its recommendations based on the certainty of the evidence and the balance of benefits and harms of the preventive service. When the USPSTF does not have enough direct or indirect evidence to recommend a clinical preventive service, it issues an “I” (insufficient evidence) statement. The I statement does not recommend for or against providing a preventive service but instead identifies critical evidence gaps that can be filled by future research, leading to a more definitive recommendation. 1 Evidence gaps can also occur in letter-graded preventive services.
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Figure 1: Generic analytic framework for a preventive screening service.
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Common Evidence Deficits
Populations and Primary Care Settings
The USPSTF develops recommendations for preventive services delivered in primary care settings or accessible through them. Research conducted in primary care settings and on asymptomatic primary care patients is limited for many conditions and preventive interventions. Available clinical preventive services research (e.g., screening or behavioral counseling) is frequently conducted in high-risk patient populations recruited from specialty care settings. The USPSTF often finds that this evidence is inapplicable to primary care patients and practices because the risk factors, epidemiology, and natural history of the condition may differ significantly between primary care patients and patients in a specialty or academic setting. Similarly, available treatment trials are frequently not carried out in primary care settings or with primary care patients. As a result, both data on screening test accuracy and treatment effectiveness could be more extensive in their applicability to primary care and prevention. As a result, USPSTF recommendations frequently request additional primary care evidence.
Health Effects and Harms
Evidence of an effect on health outcomes (conditions that affect how long a patient lives or the quality of a patient’s life) is given more weight by the USPSTF than evidence of an effect on intermediate outcomes (i.e., pathological, physiological, psychological, social, or behavioral measures).
1, 4, 5 In an ideal world, there would be high-quality evidence to demonstrate effects on health outcomes such as death, disease-specific death, disability, or quality of life. Many studies, however, focus on intermediate results, process measures, or surrogates for the outcomes of interest to patients.
To fill this evidence gap, the USPSTF seeks evidence demonstrating a link between changes in intermediate outcomes caused by treatment and differences in health outcomes. A preventive service with a proven effect on an intermediate outcome only sometimes establishes an impact on health outcomes that patients can perceive. 1, 4, 5 Evidence supporting the link between intermediate and health outcomes needs improvement or better quality.
Some of the most critical evidence focuses on adverse effects (e.g., harms from screening or treatment). It is common to find insufficient evidence on the risks of screening and interventions. Many studies may be powered and designed to detect the benefits of a preventive service but not the harms, which may occur less frequently but have serious consequences. The disadvantages of preventive services, such as patient labeling, anxiety, unintended behavior changes, or opportunity costs, are often overlooked in studies. Finally, the USPSTF considers the consequences of overdiagnosis, diagnostic workup, and treatment of a condition that is unlikely to cause symptoms or harm to the patient during their lifetime. 6 There is a need for more research to understand better the impact of false-positive results on patient labeling, anxiety, and behavior changes in patients who receive false-positive results or are diagnosed with less severe forms of the disease.
Interventions in Behavioral Counseling
Many of the areas identified above have research gaps in the evidence on behavioral counseling; frequently, the USPSTF finds evidence of changing behavior but little evidence linking that behavior change to health outcomes. The USPSTF, for example, concluded that there was insufficient direct evidence to assess the balance of benefits and harms of primary care interventions to prevent maltreatment in children who did not exhibit signs or symptoms of suspected maltreatment (I statement). 7 Evidence on the effectiveness of the elements of behavioral counseling interventions or their delivery needs to be improved. 8, 9, 10 The USPSTF recommendation on smoking cessation, for example, identified research gaps related to the efficacy of newer delivery platforms, such as web-based programs, mobile or smartphone applications, and text-messaging programs. 11 The lack of description of behavioral counseling intervention components, such as essential intervention elements, materials used in the intervention, procedures and processes, intervention providers and their level of expertise, and the type of intervention delivery,12 frequently prevents the USPSTF from making recommendations about the specific components of these complex interventions. Furthermore, there needs to be more evidence comparing various behavioral interventions or determining which features are critical. 8, 9, 10 In a previous article, the USPSTF identified several research gaps for behavioral counseling topics. 8, 9, 10
Population Diversity
As the USPSTF evaluates the evidence for a preventive service, it may assign different grades to different populations. These groups are distinguished by gender, age, race, ethnicity, or other characteristics such as behavior or family history. 13 Although several clinical preventive services have been thoroughly researched in the general population, a lack of evidence for specific subpopulations known to be at higher risk for a condition frequently prevents the USPSTF from developing separate recommendations for these groups. A preventive service may have a disproportionate impact on vulnerable populations (e.g., they may experience compromised access, respond differentially, be less likely to receive follow-up and treatment, or share a different set of harms). 13 The USPSTF is unable to make specific, separate recommendations for these populations due to a lack of high-quality evidence. For example, the USPSTF recommends colorectal cancer screening in asymptomatic adults (A grade for adults aged 50–75 years; C for adults aged 76–85). 14 When compared to other racial/ethnic groups, African American adults have the highest incidence and mortality rates for colorectal cancer. Even though the causes of these disparities are unknown, studies have revealed inequalities in screening, diagnostic follow-up, and treatment. According to research, equal treatment for colorectal cancer results in similar outcomes. 13 More diverse populations included in the analysis will help provide the evidence required for the USPSTF to issue specific recommendations that can be used to improve the quality of preventive care for diverse populations.
Prevention has always been a priority in health care for children and adolescents. It is imperative to develop age-appropriate recommendations for preventive services for children and adolescents because the spectrum of health conditions that affect children differs from that of adults and changes with age. Furthermore, many of the health problems that affect adults begin in childhood, potentially providing an early window for the prevention of many common chronic diseases. Children and adolescents undergo rapid physical and psychological development. Given the heterogeneity of products, this creates unique windows for studying the effects of interventions and makes measuring outcomes in children and adolescents difficult. 15, 16
Because many health conditions in children and adolescents do not result in severe illness or death until later in life, many research studies in children and adolescents only measure intermediate outcomes. As a result, it can take decades to see the effect of interventions in children and adolescents. The critical evidence required to link intermediate to long-term outcomes is frequently unavailable due to the long time horizon. As a result, the challenge for researchers is to identify and quantify intermediate products linked to long-term health outcomes. 15, 16
Another challenge is considering “non-traditional” health-related outcomes, such as educational attainment or quality of life, as appropriate measures of child and adolescent health in addition to illness or death. More research is needed to fully understand the impact of these unconventional outcomes on health and well-being. 15, 16 More evidence is required to link these non-traditional outcomes to health outcomes.
The importance of preventive services in older adults has grown as life expectancy has increased. Life expectancy, vulnerability to harm, patient preferences, and competing risks for illness and death make developing prevention recommendations for older adults difficult. There needs to be more research on how older adults value clinical prevention and shared decision-making about preventive services, and there is a lot of variation. 17 More research is needed to understand the impact of multiple comorbid conditions and identify and measure appropriate outcomes that are consistent with the goals of the older patient. More research is required to determine which elderly patients will (or will not) benefit from preventive services. This evidence may assist clinicians in deciding when and for whom to discontinue preventive services. 17, 18, 19
Women and girls have distinct healthcare needs throughout their lives, which may manifest in the primary care setting with different symptom constellations and clinical findings than men. The USPSTF views women’s health broadly, including preventing diseases or conditions other than pregnancy and reproductive health. Women are generally included in USPSTF recommendations that apply to adults. Women may differ from men in terms of risk, disease expression, disease progression, or treatment response to an intervention for a specific disease or condition. 20 However, if there is insufficient evidence to show a difference in the magnitude of net benefit for a preventive service, these differences may not translate into specific recommendations for women. For example, most of USPSTF’s recommendations on cardiovascular disease prevention are based on studies that frequently exclude or have a small number of women. As long as women are underrepresented in studies, there will be evidence gaps regarding the benefits and harms of preventive services.
Evidence Gaps in Recommendation Implementation
Although the USPSTF’s deliberations do not include the Use of implementation research, it does note that there are critical questions about how best to implement recommended clinical preventive services in primary care practices. Additional implementation and translational research will strengthen the USPSTF’s work and aid in its deliberations. 21
Effective prevention of many major health issues, such as obesity, cardiovascular disease, and drug and alcohol abuse, necessitates long-term, intensive, multimodal care programs that employ interprofessional approaches. A high priority for research is determining how to adapt complex interventions that have shown efficacy in advanced systems and resources to real-world clinical settings. For example, the USPSTF’s recommendation for adult depression screening (B grade) is primarily based on evidence from trials conducted in large, integrated healthcare systems that focused on retraining primary care nursing staff, collaborating with mental health specialists, and using registry technology—all of which may be difficult to implement in a small primary care practice. 22 Counseling interventions face similar evidence gaps.
More research is required to demonstrate how effective interventions can be modified and implemented in primary care settings. Another critical aspect of implementation research is how to assist primary care practices and health systems in developing the capacity to deliver effective interventions. Other critical areas of implementation research include how direct care health professionals can use new evidence to change practice, how to share evidence with patients to empower them to make healthcare decisions, and how to use health information technology to increase the number of patients who receive recommended clinical preventive services (e.g., increasing access to intensive interventions in rural settings).
Identifying and Addressing Evidence Gaps
Task Force on Preventive Services in the United States Congress’s Annual Report
The USPSTF provides an annual report to Congress highlighting new recommendations from the previous year, evidence gaps, and future research needs to help summarize the evidence gaps that the USPSTF identifies when making its recommendations. As part of the process, the USPSTF reviews all of its previous year’s recommendation statements and prioritizes potential areas of focus based on various criteria, including public health importance, disease burden, and the potential for the recommendation to affect clinical practice. The congressional reports also highlight evidence gaps for specific populations and age groups. Some congressional reports focus on specific populations, such as children and adolescents, women, and older adults. Table 1 lists some of the evidence gaps that have recently been highlighted.
Table 1Highlighted Research Needs in USPSTF Annual Reports to Congress Category Research Needs 2014 – Key Evidence Gaps for Clinical Preventive Services in Children and Adolescents
Substance abuse and mental health problems
Major depression syndrome
1. Screening for and treatment of major depressive disorder in 11-year-old children
2. The prevalence of major depression in children
3. Long-term health outcomes of screening for and treating major depressive disorder
Suicide danger
1. Screening test accuracy and effectiveness
2. The impact of treatment on health outcomes in patients identified through screening
3. Screening in high-risk ethnic and population groups
Tobacco consumption
1. Interventions to discourage the Use of other tobacco products, such as smokeless or dissolved tobacco.
2. The efficacy of interventions in various populations of children and adolescents
Use of illegal drugs
1. Primary care providers’ roles in preventing and reducing drug use among children and adolescents
2. The efficacy of primary care-based interventions, such as tailored and behavioral counseling, with and without parental participation.
3. Interventions that make Use of social media, mobile phones, and the Internet
Obesity and cardiovascular health
Obesity
1. \sEffectiveness of specific components of behavioral interventions
2. \sLong-term weight loss maintenance and possible harms of treatment
3. \sWeight management in diverse populations of children and adolescents
4. \sBehavioral interventions in younger children (age five years) and overweight children
Lipid disorders
1. \sEffects of treatment on health outcomes in childhood or adulthood
2. \sLong-term harms of lipid-lowering medications in children and adolescents
High blood pressure
1. \sAccuracy and reliability of blood pressure screening tools among children and adolescents of different ages and characteristics
2. \sRelationship between elevated blood pressure in childhood and hypertension in adulthood
3. \sEffectiveness of drug and lifestyle interventions and effects of treatment on future adult hypertension and cardiovascular disease
4. \sMedication harms
Behavior and development
Speech and language delay and disorders
1. \sPrevalence of speech and language delays and disorders
2. \sEffects of screening on outcomes
Infectious disease
Dental caries
1. \sAccuracy of risk assessment tools to identify children who are most likely to benefit from preventive interventions
2. \sBenefits and harms of preventive interventions in high-risk children
3. \sEffectiveness of family education about best oral health practices
Sexually transmitted infections
1. \sLong-term harms of HIV antiretroviral therapy
2. \sInterventions to prevent sexually transmitted infections in low-risk adolescents and high-risk adolescent males
3. \sEffectiveness of screening strategies to identify high-risk adolescents
Cancer prevention
Skin cancer
1. \sEffective interventions in primary care for young children aged <10 years and their families 2. \sDevelopment of tools to encourage behavior change Cervical cancer 1. \sOverall effect of human papillomavirus vaccination on cervical cancer Injury and child maltreatment Child maltreatment and neglect 1. \sScreening strategies to identify children who are at risk or currently experiencing neglect 2. \sPrevention of abuse in older children Vision disorders Visual impairment 1. \sBenefits and harms of vision screening in children aged <3 years 2015 – Key evidence gaps for clinical preventive services in women's Intimate partner violence 1. \sNewer screening approaches, such as computerized screening and audio questionnaires 2. \sDevelopment and validation of an accepted definition for a standard of abuse 3. \sScreening and intervention trials focused on the prevention of abuse in elderly, vulnerable, and middle-aged women Use of illegal drugs 1. \sTreatment outcomes for pregnant women 2. \sAccuracy and clinical usefulness of screening questionnaires designed for primary care practice settings 3. \sEffectiveness of screening in screen-detected patients 4. \sEffectiveness of treatment on social and legal problems, long-term health outcomes, and morbidity Suicide danger 1. \sDevelopment of a risk assessment tool to better identify people at risk for suicide 2. \sEffectiveness of tailored therapies in people at high risk 3. \sLinkages between clinical and community resources to help people at risk for suicide Thyroid dysfunction 1. \sUnderstanding the natural history of untreated, asymptomatic thyroid dysfunction 2. \sEffectiveness and harms of treating thyroid dysfunction in adults without symptoms 3. \sTreatment trials of watchful waiting using health outcomes, such as cardiovascular-related morbidity Vitamin D deficiency 1. \sDetermining the level that defines vitamin D deficiency and the optimal method of measurement in different populations 2. \sBenefits and harms of screening for and treatment of vitamin D deficiency 3. \sBenefits of early treatment in specific vitamin D–deficient populations, such as nonwhite racial groups Vitamin D and calcium supplementation 1. \sBenefits of daily supplementation with higher doses of vitamin D and calcium in reducing the risk of fractures in postmenopausal women 2. \sEffectiveness of different preparations of vitamin D or different calcium formulations 3. \sEffectiveness of vitamin D supplementation in diverse populations Osteoporosis 1. \sEffects of screening on outcomes during menopause 2. \sIncidence of major osteoporosis-related fractures in nonwhite women 3. \sOptimal screening intervals 4. \sAccuracy of risk assessment tools for predicting fractures in younger postmenopausal women Breast cancer 1. \sEffects of new technology (3-D mammography) on improving long-term health outcomes 2. \sLong-term health outcomes in women with dense breasts who receive additional testing beyond mammography 3. \sImproving the accuracy and reliability of breast density assessment Ovarian cancer 1. \sEffectiveness of new screening methods and treatment strategies on improving benefits and reducing harms Cervical cancer 1. \sOptimal approach to screening using new technologies 2. \sHarms of different screening and treatment options, including long-term risks to future pregnancies 3. \sEffect of human papillomavirus vaccination on cervical cancer screening 2016 – Key evidence gaps for clinical preventive services Autism spectrum disorder 1. \sEffectiveness of screening all children without signs or symptoms, including in populations with low SES and racial/ethnic minority populations 2. \sEffect of screening on intermediate and long-term health outcomes 3. \sEffect of treatment on patient outcomes for children whose autism is detected through universal screening programs Chlamydia and gonorrhea 1. \sEffectiveness of different screening strategies for identifying men who are at increased risk for infection 2. \sSubgroups for whom screening may be effective 3. \sEffectiveness of screening in reducing the spread of chlamydia and gonorrhea, as well as testing for other sexually transmitted infections and different screening intervals Tobacco smoking cessation (electronic nicotine delivery systems [ENDS]) in adults 1. \sEffectiveness of ENDS on achieving smoking abstinence 2. \sSide effects of ENDS 3. \sSafety, benefits, and harms of ENDS 4. \sEffect of ENDS use (and co-use with tobacco) on subsequent tobacco use, especially in people trying to quit Vitamin supplementation (nutrients and multivitamins) to prevent cancer and cardiovascular disease 1. \sEffectiveness of vitamin supplementation (single nutrient or nutrient pair) in the general population, including women and minority groups 2. \sBenefit of targeting supplementation toward people who are high-risk for nutrient deficiency rather than the general population 3. \sNew and innovative research methods for examining effects of nutrients that account for the unique complexities of nutritional research \s4. \sStandardized methods to determine blood nutrient levels \s5. \sThresholds for sufficiency and insufficiency Aspirin is use to prevent cardiovascular disease and colorectal cancer 1. \sRole of aspirin therapy in racial/ethnic subpopulations \s2. \sBenefits and harms of aspirin therapy in adults younger than age 50 years or older than age 70 years 3. \sDifferential effects of sex, race/ethnicity, age, and genetic factors on risk for colorectal cancer and the impact of screening 4. \sLonger-term follow-up of cardiovascular disease prevention trials that report cancer incidence and death outcomes Skin cancer 1. \sEffectiveness of the clinical visual skin examination 2. \sPossible harms of skin cancer screening, particularly for overdiagnosis and overtreatment Open the table in a new tab The USPSTF also disseminates the annual report to Congress to leading research funding agencies and makes it publicly available through its website at www.uspreventiveservicestaskforce.org/Page/Name/reports-to-congress. The USPSTF hopes these reports will encourage funders and researchers to address these critical gaps. Collaboration With NIH The USPSTF, the Agency for Healthcare Research and Quality (AHRQ), and NIH work closely together to identify critical evidence gaps that may be addressed through current and future federal research funding opportunities. 23 The NIH Office of Disease Prevention works with NIH Institutes, Centers, and Offices to inform them of USPSTF I statements and to facilitate research collaborations that might address these gaps. The Office of Disease Prevention conducts an annual survey to determine how NIH addresses these critical gaps. The survey collects information about grants, contracts, funding announcements, workshops and conferences, and other activities related to USPSTF recommendations. Survey results are summarized and shared with the NIH Institutes, Centers, and Offices to identify opportunities for further investment, expanded effort, and collaborations. Survey results are also shared with AHRQ and the USPSTF to raise awareness of current NIH research and to inform the USPSTF regarding new research findings. These collaborative efforts help the USPSTF decide when to update recommendations when new study results become available. Additional Collaboration Opportunities AHRQ, the agency mandated by Congress to support the work of the USPSTF, coordinates with the Patient-Centered Outcomes Research Institute to make it aware of research gaps identified by the USPSTF. The increasing availability of clinical data through electronic health records and research infrastructure through research networks such as PCORnet and the NIH collaboration can serve as platforms that allow rigorous studies to answer critical questions. Using practice-based research networks can allow the development of evidence from representative primary care practices. These platforms can provide the foundation for pragmatic trials and cohort studies and enable the inclusion of a representative sample of at-risk subpopulations. They can also provide the infrastructure to study the effectiveness of new electronic prevention methods and to build the needed implementation science of what increases the uptake of preventive services to help achieve the goal of improving population health. Conclusions The USPSTF develops its recommendations based on the current state of the science and the best available evidence. By issuing I statements, the USPTF indicates where evidence is insufficient to assess the benefits and harms of a given intervention accurately. Patients and clinicians must often make decisions in the face of inadequate evidence, and understanding the current state of the evidence in the context of other factors that influence choice can inform decision-making. Dissemination of these findings can inform research agendas and the design and conduct of research to close critical evidence gaps. The USPSTF's annual report to Congress draws on I statements to inform essential research priorities. In addition, the USPSTF, along with AHRQ, works with NIH and its Office of Disease Prevention to enhance coordination in identifying critical evidence gaps that may be addressed through future funding opportunities for research. The USPSTF routinely updates its recommendations and, in recent years, has been able to make recommendations in areas that previously received an I statement (e.g., screening for obesity in children, screening for hepatitis C virus infection) (e.g., screening for obesity in children, screening for hepatitis C virus infection). However, there are often methodologic issues in study design and feasibility that present challenges to conducting the research that provides the needed evidence, including the large sample size required for trials, long lead time for outcomes, and inadequate representation of specific at-risk populations. USPSTF I statements play a critical role in highlighting the information needed to advance the science to optimize the Use of clinical preventive services in primary care. QUESTION
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Following the guidelines of the United States Preventive Service Taskforce (USPSTF), discuss and describe the screening recommendations for the following:

Cervical cancer
Breast cancer
Osteoporosis
Colorectal cancer
Lung cancer
Ovarian cancer
Intimate partner violence (IPV).