Draft Recommendation Statement on Interpersonal Violence by the US Preventive Services Task Force

June 2012

Note: This draft Recommendation Statement is not the final recommendation of the U.S. Preventive Services Task Force. This draft is distributed solely for the purpose of pre-release review. It has not been disseminated otherwise by AHRQ. It does not represent and should not be interpreted to represent an AHRQ determination or policy.

This draft Recommendation Statement is based on an evidence review that was published on May 8, 2012 (available at http://www.uspreventiveservicestaskforce.org/uspstf12/ipvelder/ipvelderart.htm).

The USPSTF makes recommendations about the effectiveness of specific clinical preventive services for patients without related signs or symptoms.

It bases its recommendations on the evidence of both the benefits and harms of the service, and an assessment of the balance. The USPSTF does not consider the costs of providing a service in this assessment.

The USPSTF recognizes that clinical decisions involve more considerations than evidence alone. Clinicians should understand the evidence but individualize decisionmaking to the specific patient or situation. Similarly, the USPSTF notes that policy and coverage decisions involve considerations in addition to the evidence of clinical benefits and harms.

This draft Recommendation Statement is available for comment from June 12 until July 10, 2012, at 5:00 PM ET. You may wish to read the entire Recommendation Statement before you comment. A fact sheet that explains the draft recommendations in plain language is available here.


Screening for Intimate Partner Violence and Abuse of Elderly and Vulnerable Adults: U.S. Preventive Services Task Force Recommendation Statement
Summary of Recommendations and Evidence
The U.S. Preventive Services Task Force (USPSTF) recommends that clinicians screen women of childbearing age for intimate partner violence (IPV), such as domestic violence, and provide or refer women who screen positive to intervention services.

This is a B recommendation. This recommendation applies to women who do not have signs or symptoms of abuse. Go to the Clinical Considerations section for more information on effective interventions.

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

This is an I statement. Go to the Clinical Considerations section for suggestions for practice regarding the I statement.

Table 1 describes the USPSTF grades, and Table 2 describes the USPSTF classification of levels of certainty about net benefit.

IPV and abuse of elderly and vulnerable adults is common in the United States, but often remains undetected. Between 1.3 and 5.3 million women are estimated to experience IPV each year in the United States, with a lifetime prevalence rate of approximately 25 percent (1-3). These estimates likely underrepresent actual rates because of underreporting. In addition to the immediate effects of IPV, such as injury and death (4, 5), there are other health consequences, many with long-term effects, including sexually transmitted diseases (6), pelvic inflammatory disease (7), and unintended pregnancy (8). Rates of chronic pain, neurological disorders, gastrointestinal disorders, migraine headaches, and other disabilities (9-11) are also increased. IPV is also associated with preterm birth, low birth weight, and decreased gestational age (12-14). Women experiencing IPV often develop chronic mental health conditions, such as depression, posttraumatic stress disorder, anxiety disorders, substance abuse, and suicidal behavior (9, 15-18). For adolescent and young adult women, the effects of physical and sexual assault are associated with poor self-esteem, alcohol and drug abuse, eating disorders, obesity, risky sexual behaviors, teen pregnancy, depression, anxiety, suicidality, and other conditions (19, 20).

Little information is available on the prevalence of abuse among noninstitutionalized elderly or vulnerable adults, although reported rates range from 2 to 25 percent (21, 22).

For IPV, there is adequate evidence that available screening instruments can identify current and past abuse or increased risk for abuse. Several instruments used in more than one study were highly sensitive and specific.

The USPSTF found inadequate evidence on the accuracy of screening instruments for elderly or vulnerable adults.

Benefits of Detection and Early Intervention
The USPSTF found adequate evidence that effective interventions can reduce violence, abuse, and physical or mental harms for adult women of reproductive age.

The USPSTF found inadequate evidence that screening or early detection reduces exposure to abuse or reduces physical or mental harms or mortality for elderly and vulnerable adults.

Harms of Detection and Early Intervention
For IPV, the USPSTF found adequate evidence that the risk for harm to the individual from screening or interventions is no greater than small.

For elderly and vulnerable adults, the USPSTF found inadequate evidence on the harms of screening or interventions.

USPSTF Assessment
The USPSTF concludes with moderate certainty that screening women of childbearing age for IPV has a moderate net benefit.

The USPSTF concludes that the benefits and harms of screening elderly or vulnerable adults for abuse are uncertain, and that the balance of benefits and harms cannot be determined.

Clinical Considerations
Patient Population Under Consideration
These recommendations apply to asymptomatic adult women of reproductive age and elderly and vulnerable adults. Reproductive age is defined across studies as ranging from 14 to 46 years, with the majority of research focusing on women age 18 years or older. A vulnerable adult is a person age 18 years or older whose ability to perform the normal activities of daily living or to provide for his or her own care or protection is impaired due to a mental, emotional, long-term physical, or developmental disability or dysfunction, or brain damage. Definitions vary by state, and sometimes include the receipt of personal care services from others. Types of abuse that apply to elderly and vulnerable adults include physical abuse, sexual abuse, emotional or psychological abuse, neglect, abandonment, financial or material exploitation, and self-neglect.

Child abuse and neglect is addressed in a separate recommendation.

Assessment of Risk
While all women are at risk for abuse and should be screened, there are a number of risk factors that have been reported, such as young age, substance abuse, marital difficulties, and economic hardships.

Screening Tests
A number of screening instruments can be used to screen women for IPV. Those with the highest levels of sensitivity and specificity for identifying IPV are:

•HITS (Hurt, Insult, Threaten, Scream) (English and Spanish versions)
•OAS/OVAT (Ongoing Abuse Screen/Ongoing Violence Assessment Tool)
•STaT (Slapped, Threatened, and Throw)
•HARK (Humiliation, Afraid, Rape, Kick)
•CTQ-SF (Modified Childhood Trauma Questionnaire–Short Form)
•WAST (Woman Abuse Screen Tool)
The HITS instrument includes four questions, can be used in a primary care setting, and is available in both English and Spanish. It can be self- or clinician administered. HARK is a self-administered four-item instrument. STaT is a three-item self-report instrument that was tested in an emergency department setting.

The USPSTF found no valid, reliable screening tools to identify abuse of elderly or vulnerable adults in the primary care setting.

Screening Interval
The USPSTF found no evidence on appropriate intervals for screening.

Evidence from randomized trials support a variety of interventions, including counseling, home visits, referrals to community services, and mentoring support for women of childbearing age. Depending on the type of intervention, these services may be provided by clinicians, nurses, social workers, nonclinician mentors, or community workers. Counseling generally includes information on safety behaviors and community resources. In addition to counseling, home visits may include emotional support, education on problem solving strategies, and parenting support. One study used a 20-minute nurse case management protocol focusing on a safety plan, supportive care, and guided referrals. No intervention studies were identified for elderly or vulnerable adults. See below for suggestions for practice in this population.

Suggestions for Practice Regarding the I Statement for Elderly or Vulnerable Adults
Potential benefits. The estimated prevalence of elder abuse ranges from 2 to 10 percent based on a variety of different definitions, methods, and sampling strategies (21). One study indicated that one in 10 elderly adults may experience abuse, but only one in five or fewer cases are actually reported (22).

Potential harms. While there is no direct evidence, the existing evidence about the lack of harms resulting from IPV screening suggests that the harms of screening elderly and vulnerable adults are no greater than small. Some potential harms of screening include shame, guilt, self-blame, fear of retaliation or abandonment by perpetrators, and the repercussions of false-positive results.

Costs. There is no evidence about the costs of screening for or interventions to reduce elder abuse.

Current practice. Screening practices for elder abuse are limited for many reasons. Currently, there are no standards about how clinicians should ask elderly patients about possible abuse. In addition, there are varying definitions of abuse, wide variety of mechanisms of elder abuse, lack of universal screening tools, wide-ranging risk factors, unclear guidance about who to screen and what to do if abuse is identified, physician discomfort with screening, and time constraints. Screening is not done routinely and varies by locality.

Useful Resources
Other USPSTF recommendations may be useful in responding to a patient who has been victimized. In particular, the recommendation on screening for depression in adults can be used to determine if a woman is depressed, a common condition found in situations where there is abuse (23). The USPSTF recommendation on screening for alcohol misuse (update in progress) might also be of use (24).

Other Considerations
Research Needs and Gaps
Evidence on the use of newer screening approaches would be useful. Computerized screening and intervention have been found to increase rates of domestic violence discussion, disclosure, and service provision (25-27). Furthermore, computerized screening has been found to be more acceptable for patients (28, 29). Use of an audio questionnaire has been perceived by patients as more private and less likely to increase risk for abuse (25-27). Further evaluation of the accuracy, efficiency, and acceptability of these methods is needed.

Studies of the diagnostic accuracy of screening instruments are limited by the lack of accepted reference standards. Further development or validation of an accepted standard would allow more accurate assessment of performance measures and allow instruments to be more readily compared with each other. The broad and inconsistent definitions of abuse pose challenges for creating screening instruments, especially for detecting abuse and neglect in elderly and vulnerable populations.

Although there are significant challenges in this research field, additional studies are needed to determine the effectiveness of different postscreening interventions. For the elderly and vulnerable adult populations, good-quality randomized, controlled trials focusing on both screening and interventions are needed. Because many elderly and vulnerable adults may not have sufficient physical, mental, or financial abilities to engage in screening functions, instruments need to be framed around third-party responses (30, 31). Other challenges to research in this population include legal requirements related to disclosure, underlying medical conditions, and dependence on the perpetrators.

Another significant gap recognized by the USPSTF is the absence of evidence of effective interventions for middle-aged women who are past childbearing age but not yet elderly. Similar to the research needs for elderly and vulnerable adult populations, research is also needed to inform practice for this group of women.

Burden of Disease
IPV is considered to be a significant and largely unaddressed public health problem. The U.S. Department of Justice estimates that approximately 5.3 million IPV assaults of U.S. women age 18 years or older occur each year (1). Based on data from the Centers for Disease Control and Prevention’s (CDC’s) Behavioral Risk Factor Surveillance System, 23.6 percent of women reported a lifetime history of suffering abuse in 2005 (2).

In one study, abuse occurred in 11 percent of postmenopausal women (3). In another study, a range of 1.3 to 4.6 percent of pregnant women reported abuse during the pregnancy. In a large study in one health care system, the prevalence of abuse in the preceding year was 7.9 percent, and 14.7 percent in the preceding 5 years (4). Many factors make it difficult to obtain true estimates of abuse. Because of the stigma of abuse, including fear, shame, and reprisal, many cases go unreported (5, 6). Only a minority of women (35.6 percent) injured during their most recent rape or during their most recent physical assault (30.2 percent) actually received medical treatment of any kind (7).

Among older and vulnerable adults, a recent study estimated that 14 percent of noninstitutionalized older adults had experienced physical, psychological, or sexual abuse; neglect; or financial exploitation during the past year (32). Women with disabilities are four times more likely to experience sexual assault in the past year than women without disabilities (33).

Risk Factors
The CDC has developed a comprehensive list of risk factors for IPV, which are organized into four categories (34): individual (e.g., low self-esteem), relationship (e.g., marital conflict and instability), community (e.g., poverty and associated factors), and societal (e.g., traditional gender roles).

Scope of Review
In updating its 2004 recommendation, the USPSTF commissioned a systematic evidence review on screening women for IPV and elderly and vulnerable adults for abuse and neglect. This review examined the accuracy of 14 screening tools for identifying IPV. Published literature on randomized, controlled trials and other systematic reviews were searched for evidence on the benefits and harms of screening adult women of childbearing age and elderly and vulnerable adults.

Accuracy of Screening Tests
A total of 15 studies of 13 screening instruments to identify IPV in women were included in this review, and three met criteria for good quality (35-39). Most of the tools assessed current or past abuse rather than risk factors for future abuse.

All of the screening instruments include questions for patients and are administered in a variety of ways—self-administered either on paper or by computer, or interviews by various clinicians. Examples of questions from the instruments include “In the past year, have you ever been afraid of a partner?” and “Have you ever been in a relationship where your partner pushed or slapped you?”

The six tools that achieved the highest levels of sensitivity and specificity were HITS (English and Spanish versions), OVAT, STaT, HARK, modified CTQ-SF, and WAST. Limitations of the studies were high attrition rates, enrollment of dissimilar groups at baseline, and unclear application of the reference standard. A major limitation of the evidence is the lack of an established gold standard; all of the studies compared the screening instrument with a second instrument that was usually validated and often more detailed.

One study evaluated the four-item HITS instrument by comparing it with two others—the Index of Spouse Abuse (ISA) and the Spanish-version of WAST. In a sample of women attending a family practice clinic, the sensitivity and specificity of the English version were 86 and 99 percent, and 100 and 86 percent for the Spanish version.

OAS, a five-item instrument measuring current and past abuse, had sensitivity and specificity of 60 and 90 percent when compared with ISA in emergency department patients. This instrument was edited to a four-item version, OVAT, that demonstrated sensitivity and specificity of 93 and 86 percent in the same population. A subsequent study comparing OVAT with ISA among patients presenting to an emergency department also reported high sensitivity and specificity (86 and 83 percent).

The three-item STaT instrument was evaluated among women presenting to primary care clinics in two studies. Compared with a semistructured interview, STaT demonstrated sensitivity ranging from 62 to 96 percent and specificity ranging from 37 to 100 percent depending on the reference standard and number of positive responses.

The four-item HARK instrument was compared with the Composite Abuse Scale (CAS) among women presenting to primary care in London. For a positive response on any question, the sensitivity and specificity were 81 and 95 percent.

Two items from CTQ-SF, an instrument designed to detect a history of physical or sexual abuse in childhood, were compared with the Evaluation of Lifetime Stressors structured interview among women in a health maintenance organization. Using a single item from CTQ-SF, sensitivity and specificity were 70 and 94 percent for physical abuse and 82 and 89 percent for sexual abuse. Using two items to screen for physical or sexual abuse resulted in sensitivity and specificity of 85 and 88 percent.

WAST results were compared with CAS results for 2,461 women presenting to family practices, emergency departments, and women’s health clinics in Canada. Sensitivity and specificity were 47 and 96 percent for WAST. In a subsequent study of a larger sample of women from Canadian clinics, WAST demonstrated higher sensitivity (81 to 88 percent) and specificity (89 percent), using CAS again as the reference standard. WAST identified a 12-month prevalence rate of 22 percent, while CAS found 14 percent.

The ages of the women participating in these studies ranged from 14 to 46 years.

Effectiveness of Early Detection
The USPSTF found that effective interventions to reduce IPV, abuse, and physical or mental harms consist of a number of approaches. Most of the studies were conducted with women of childbearing age in settings providing services for pregnancy or pregnancy prevention. Limitations of the studies were enrollment of dissimilar groups at baseline, high and/or differential loss to followup, recall bias, missing data, and the Hawthorne effect among control participants.

A large cluster randomized, controlled trial of the effectiveness of screening for IPV included 6,743 Canadian women randomly assigned to screening or nonscreening groups. Primary outcomes were exposure to abuse and quality of life in the 18 months after screening. Secondary outcomes included depression, posttraumatic stress disorder, alcohol and drug abuse, mental and physical health, and use of health and social services. These outcomes were not significantly different between women in the screened versus nonscreened groups. Given the limited evidence in screening trials, the USPSTF considered the chain of evidence linking screening and improved outcomes from effective intervention studies.

Five randomized, controlled trials of fair or good quality were found. Trials assessed interventions to reduce exposure to IPV, physical and mental harms, or mortality in women of childbearing age. One good-quality trial compared usual care with prenatal and postpartum behavioral counseling for 1,044 African American patients who were pregnant or postpartum. The counseling emphasized safety behaviors and information on community resources. IPV was one of several outcomes measured using an anonymous computer interview. Women in the intervention group had significantly fewer episodes of IPV during pregnancy and postpartum, as well as better birth outcomes (i.e., fewer premature neonates). Although the intervention was targeted to African American women, the USPSTF determined that the potential benefit from the intervention could be applicable to other populations as well. Women in the intervention group had less recurrent episodes of IPV during pregnancy and postpartum (adjusted odds ratio [OR], 0.48 [95% CI, 0.29–0.80]) (13).

One fair-quality trial evaluated a 3-year home visitation program with 685 mothers who gave birth to an infant determined to be at risk for maltreatment. The visits were conducted by paraprofessionals from three community agencies, with a focus on promoting child health and decreasing child maltreatment by linking families to community services. The average number of home visits in the first year was 13.6 visits. In addition to receiving emotional support, parents were taught about child development and received role modeling, positive parenting, and problem solving strategies. The intervention group had lower rates of IPV victimization and perpetration and lower rates of physical assault victimization and perpetration. No differences in sexual violence, verbal abuse, and injury were found (40).

In a trial evaluating a mentoring support program versus usual care, outcomes measured were abuse, depression, wellbeing, parenting stress, and social support. The trial enrolled women in primary care clinics who disclosed IPV or had behavioral symptoms suggestive of abuse. Abuse scores were significantly reduced in the intervention versus comparison groups. Differences for the other outcomes were not significant (41).

Pregnancy coercion is defined as a lack of control over a woman’s reproductive health, including compromised decisionmaking or limited ability to use contraception and family planning and fear of condom negotiation (42). One trial compared a counseling intervention to reduce abuse related to pregnancy coercion with usual care. Women in the intervention group who reported IPV at baseline had decreased pregnancy coercion and were more likely to discontinue an unhealthy or unsafe relationship compared with women receiving usual care, regardless of recent IPV status (42).

In another trial,women were randomly assigned to receive either a referral card with a safety plan and resources for IPV services or a 20-minute nurse case management protocol (March of Dimes) that included a brochure with a 15-item safety plan, supportive care, anticipatory guidance, and guided referrals (43). Both study groups reported fewer threats of abuse, assaults, danger risks for homicide, and events of work harassment when compared with baseline.

The estimated cost of implementing the interventions studied varies widely. For example, the counseling intervention (13) achieving the best results would require fewer resources than some of the interventions requiring new technology.

Potential Harms of Screening
There are a number of potential harms of screening for IPV, including stigma, labeling, clinicians’ negative attitudes, psychological distress, escalation of abuse and family tension leading to added physical or psychological harm, loss of personal residence and financial resources, erosion of established family structure, loss of autonomy for the victim, and lost time from work (44).

Fourteen studies evaluated the adverse effects of screening and interventions. Eleven of the studies were descriptive in design and three were randomized, controlled trials. Of the three randomized, controlled trials, one was a large trial of 6,743 women that evaluated screening versus no screening in which no harms were found. Two trials reported no statistically significant harms compared with the nonintervention groups. The other studies were all descriptive in design, but none reported harms from screening.

Estimate of Magnitude of Net Benefit
In 2004, the USPSTF concluded there was insufficient evidence to make a recommendation to routinely screen women for IPV. Since that recommendation, several studies have been published, and the USPSTF has now determined that screening and intervening for IPV in women of childbearing age is associated with moderate health improvements through the reduction of exposure to abuse, as well as physical and mental harms and mortality. The overall associated harms were deemed no greater than small. Therefore, the USPSTF concludes with moderate certainty that the overall net benefit is moderate. The USPSTF determined that the studies were highly consistent and that the interventions appeared to have dose-response effects.

The USPSTF was not able to estimate the magnitude of net benefit for screening all elderly or vulnerable adults (physically or mentally dysfunctional) for abuse and neglect because there were no studies on the accuracy, effectiveness, or harms of screening.

How Does Evidence Fit With Biological Understanding?
The evidence on screening for IPV is based on a biopsychosocial framework, rather than a pure biological model. As described by the CDC, IPV should be considered using a socioecological model, based on four specific elements: individual, relationship, community, and society (34).

There is ample evidence that a women’s response to violence can cause a biological response and have lasting effects on health. In addition to the possible injuries that might occur, chronic conditions frequently associated with long-term exposure to stress are also possible. These include mental health conditions such as posttraumatic stress disorder, depression, anxiety disorders, substance abuse, and suicide. There are also various physical conditions that stem from IPV, such as chronic pain, neurological disorders (from injuries), gastrointestinal disorders such as irritable bowel syndrome, migraine headaches, and other disabilities.

Update of Previous Recommendation
In 2004, the USPSTF issued an I statement for screening women for IPV and older adults or their caregivers for elder abuse. In that review, the USPSTF found no direct evidence that screening for IPV leads to decreased disability or premature death. It also found no existing studies that determined the accuracy of screening tools. The USPSTF found limited evidence as to whether interventions reduce harm to women, and no studies that examined the effectiveness of interventions in older adults. In the current recommendation, the USPSTF recommends screening women of childbearing age based on research showing high diagnostic accuracy in detecting current or past abuse. Research also demonstrated improved outcomes in trials of interventions to reduce exposure to abuse.

The evidence for screening elderly and vulnerable adults remains insufficient; therefore, the USPSTF was unable to make a recommendation in favor of or against screening, and has issued an I statement.

Recommendations of Others
The American Congress of Obstetricians and Gynecologists recommends that physicians screen all patients for IPV (45). For women who are not pregnant, screening should occur at routine obstetric-gynecology visits, family planning visits, and preconception visits. For women who are pregnant, screening should occur over the course of the pregnancy, including at the first prenatal visit, at least once per trimester, and at the postpartum checkup. The American Medical Association states that physicians should routinely inquire about physical, sexual, and psychological abuse as part of the medical history (46). Physicians should also consider abuse as a factor in the presentation of medical complaints, because patients’ experiences with interpersonal violence or abuse may adversely affect their health status or ability to adhere to medical recommendations. Other organizations, such as the American Academy of Family Physicians, American College of Emergency Physicians, American Academy of Pediatrics, and Emergency Nurses Association, all have statements encouraging clinicians to be especially aware of the dynamics of family violence and the risk factors commonly found with women experiencing IPV. Further, clinicians should be prepared to respond appropriately and refer women to available community resources where possible.

Appendix: U.S. Preventive Services Task Force
Members of the U.S. Preventive Services Task Force* at the time this recommendation was finalized are Virginia A. Moyer, MD, MPH, Chair (Baylor College of Medicine, Houston, Texas); Michael L. LeFevre, MD, MSPH, Co-Vice Chair (University of Missouri School of Medicine, Columbia, Missouri); Albert L. Siu, MD, MSPH, Co-Vice Chair (Mount Sinai School of Medicine, New York, New York; James J. Peters Veterans Affairs Medical Center, Bronx, New York); Linda Ciofu Baumann, PhD, RN (University of Wisconsin, Madison, Wisconsin); Kirsten Bibbins-Domingo, PhD, MD (University of California, San Francisco, San Francisco, California); Susan J. Curry, PhD (University of Iowa College of Public Health, Iowa City, Iowa); Mark Ebell, MD, MS (University of Georgia, Athens, Georgia); Glenn Flores, MD (University of Texas Southwestern, Dallas, Texas); Adelita Gonzales Cantu, RN, PhD (University of Texas Health Science Center, San Antonio, Texas); David C. Grossman, MD, MPH (Group Health Cooperative, Seattle, Washington); Jessica Herzstein, MD, MPH (Air Products, Allentown, Pennsylvania); Joy Melnikow, MD, MPH (University of California Davis, Sacramento, California); Wanda K. Nicholson, MD, MPH, MBA (University of North Carolina School of Medicine, Chapel Hill, North Carolina); Douglas K. Owens, MD, MS (Veteran Affairs Palo Alto Health Care System, Palo Alto, California; Stanford University, Stanford, California); Carolina Reyes, MD, MPH (Virginia Hospital Center, Arlington, Virginia); and Timothy J. Wilt, MD, MPH (University of Minnesota Department of Medicine and Minneapolis Veterans Affairs Medical Center, Minneapolis, Minnesota). Bernadette Melnyk, PhD, RN, a former USPSTF member, also contributed to the development of this recommendation.

* Members of the Task Force at the time this recommendation was finalized. For a list of current Task Force members, go to http://www.uspreventiveservicestaskforce.org/about.htm.

Table 1: What the Grades Mean and Suggestions for Practice
Grade Definition Suggestions for Practice
A The USPSTF recommends the service. There is high certainty that the net benefit is substantial. Offer or provide this service.
B The USPSTF recommends the service. There is high certainty that the net benefit is moderate or there is moderate certainty that the net benefit is moderate to substantial. Offer or provide this service.
C Note: The following statement is undergoing revision.
Clinicians may provide this service to selected patients depending on individual circumstances. However, for most individuals without signs or symptoms there is likely to be only a small benefit from this service. Offer or provide this service only if other considerations support offering or providing the service in an individual patient.
D The USPSTF recommends against the service. There is moderate or high certainty that the service has no net benefit or that the harms outweigh the benefits. Discourage the use of this service.
I Statement The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of the service. Evidence is lacking, of poor quality, or conflicting, and the balance of benefits and harms cannot be determined. Read the clinical considerations section of USPSTF Recommendation Statement. If the service is offered, patients should understand the uncertainty about the balance of benefits and harms.

Table 2: Levels of Certainty Regarding Net Benefit
Level of Certainty* Description
High The available evidence usually includes consistent results from well-designed, well-conducted studies in representative primary care populations. These studies assess the effects of the preventive service on health outcomes. This conclusion is therefore unlikely to be strongly affected by the results of future studies.
Moderate The available evidence is sufficient to determine the effects of the preventive service on health outcomes, but confidence in the estimate is constrained by factors such as:
•The number, size, or quality of individual studies.
•Inconsistency of findings across individual studies.
•Limited generalizability of findings to routine primary care practice.
•Lack of coherence in the chain of evidence.
As more information becomes available, the magnitude or direction of the observed effect could change, and this change may be large enough to alter the conclusion.

Low The available evidence is insufficient to assess effects on health outcomes. Evidence is insufficient because of:
•The limited number or size of studies.
•Important flaws in study design or methods.
•Inconsistency of findings across individual studies.
•Gaps in the chain of evidence.
•Findings not generalizable to routine primary care practice.
•A lack of information on important health outcomes.
More information may allow an estimation of effects on health outcomes.

*The U.S. Preventive Services Task Force defines certainty as “likelihood that the USPSTF assessment of the net benefit of a preventive service is correct.” The net benefit is defined as benefit minus harm of the preventive service as implemented in a general, primary care population. The USPSTF assigns a certainty level based on the nature of the overall evidence available to assess the net benefit of a preventive service.

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Source: http://www.uspreventiveservicestaskforce.org/draftrec2.htm