Thomas G. DeWitt

Screening for colorectal cancer: U.S. Preventive Services Task Force recommendation statement.

DESCRIPTION Update of the 2002 U.S. Preventive Services Task Force (USPSTF) recommendation statement on screening for colorectal cancer. METHODS To update its recommendation, the USPSTF commissioned 2 studies: 1) a targeted systematic evidence review on 4 selected questions relating to test characteristics and benefits and harms of screening technologies, and 2) a decision analytic modeling analysis using population modeling techniques to compare the expected health outcomes and resource requirements of available screening modalities when used in a programmatic way over time. RECOMMENDATIONS The USPSTF recommends screening for colorectal cancer using fecal occult blood testing, sigmoidoscopy, or colonoscopy in adults, beginning at age 50 years and continuing until age 75 years. The risks and benefits of these screening methods vary. (A recommendation). The USPSTF recommends against routine screening for colorectal cancer in adults 76 to 85 years of age. There may be considerations that support colorectal cancer screening in an individual patient. (C recommendation). The USPSTF recommends against screening for colorectal cancer in adults older than age 85 years. (D recommendation). The USPSTF concludes that the evidence is insufficient to assess the benefits and harms of computed tomographic colonography and fecal DNA testing as screening modalities for colorectal cancer. (I statement).

Aspirin for the Prevention of Cardiovascular Disease: U.S. Preventive Services Task Force Recommendation Statement

DESCRIPTION Update of the 2002 U.S. Preventive Services Task Force (USPSTF) recommendation about the use of aspirin for the prevention of coronary heart disease. METHODS Review of the literature since 2002, focusing on new evidence on the benefits and harms of aspirin for the primary prevention of cardiovascular disease, including myocardial infarction and stroke. The new evidence was reviewed and synthesized according to sex. RECOMMENDATIONS Encourage men age 45 to 79 years to use aspirin when the potential benefit of a reduction in myocardial infarctions outweighs the potential harm of an increase in gastrointestinal hemorrhage. (A recommendation) Encourage women age 55 to 79 years to use aspirin when the potential benefit of a reduction in ischemic strokes outweighs the potential harm of an increase in gastrointestinal hemorrhage. (A recommendation) Evidence is insufficient to assess the balance of benefits and harms of aspirin for cardiovascular disease prevention in men and women 80 years or older. (I statement) Do not encourage aspirin use for cardiovascular disease prevention in women younger than 55 years and in men younger than 45 years. (D recommendation).

Screening for chlamydial infection: U.S. Preventive Services Task Force recommendation statement

The U.S. Preventive Services Task Force (USPSTF) makes recommendations about preventive care services for patients without recognized signs or symptoms of the target condition. The USPSTF bases its recommendations on a systematic review of the evidence of the benefits and harms and an assessment of the net benefit of the service. The USPSTF recognizes that clinical or policy decisions involve more considerations than this body of evidence alone. Clinicians and policymakers should understand the evidence but individualize decision making to the specific patient or situation. Summary of Recommendation and Evidence The USPSTF recommends screening for chlamydial infection for all sexually active nonpregnant young women age 24 years or younger and older nonpregnant women who are at increased risk (Figure). This is a grade A recommendation. The USPSTF recommends screening for chlamydial infection for all pregnant women age 24 years or younger and for older pregnant women who are at increased risk (Figure). This is a grade B recommendation. The USPSTF recommends against routinely screening for chlamydial infection for women age 25 years or older, regardless of whether they are pregnant, if they are not at increased risk (Figure). This is a grade C recommendation. The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of screening for chlamydial infection for men (Figure). This is an I statement. See Table 1 for a description of the USPSTF grades and Table 2 for a description of the USPSTF classification of levels of certainty regarding net benefit. Both are also available at www.annals.org. Figure. Screening for chlamydial infection. For a summary of the evidence systematically reviewed in making these recommendations, the full recommendation statement, and supporting documents, please go to www.preventiveservices.ahrq.gov. *Chlamydial infection results in few sequelae in men. Therefore, the major benefit of screening men would be to reduce the likelihood that infected and untreated men would pass the infection to sexual partners. There is no evidence that screening men reduces the long-term consequences of chlamydial infection in women. Because of this lack of evidence, the USPSTF could not assess the balance of benefits and harms and concluded that the evidence is insufficient to recommend for or against routinely screening men. Information from reference 1. Table 1. What the U.S. Preventive Services Task Force Grades Mean and Suggestions for Practice* Table 2. U.S. Preventive Services Task Force Levels of Certainty Regarding Net Benefit See the Clinical Considerations section for discussion of assessing risk for chlamydial infection in women and suggestions for practice regarding screening for men. Rationale Importance Chlamydial infection is the most common sexually transmitted bacterial infection in the United States. In women, genital chlamydial infection may result in urethritis, cervicitis, pelvic inflammatory disease (PID), infertility, ectopic pregnancy, and chronic pelvic pain. Chlamydial infection during pregnancy is related to adverse pregnancy outcomes, including miscarriage, premature rupture of membranes, preterm labor, low birth weight, and infant mortality. Detection The USPSTF found fair evidence that nucleic acid amplification tests (NAATs) can identify chlamydial infection in asymptomatic men and women, including asymptomatic pregnant women, with high test specificity. In low-prevalence populations, however, a positive test result is more likely to be false positive than true positive, even with the most accurate tests available. Benefits of Detection and Early Intervention Nonpregnant Women at Increased Risk There is good evidence that screening for chlamydial infection in nonpregnant women who are at increased risk can reduce the incidence of PID. The USPSTF concluded that the benefits of screening nonpregnant women at increased risk are substantial. Pregnant Women at Increased Risk There are no studies evaluating the effectiveness of screening for chlamydial infection in pregnant women who are at increased risk. The USPSTF, however, found that 1) screening identifies infection in asymptomatic pregnant women, 2) there is a relatively high prevalence of infection among pregnant women who are at increased risk, and 3) there is fair evidence of improved pregnancy and birth outcomes for women who are treated for chlamydial infection. The USPSTF concluded that the benefits of screening pregnant women who are at increased risk are substantial. Women Not at Increased Risk The USPSTF identified no studies documenting the benefits of screening women, including pregnant women, who are not at increased risk for chlamydial infection. While recognizing the potential benefit to women identified through screening, the USPSTF concluded that the overall benefit of screening would be small, given the low prevalence of infection among women not at increased risk. Men While concluding that the direct benefit of screening in men was likely to be small, the USPSTF noted that screening for chlamydial infection in men may be beneficial if it were to lead to a decreased incidence of chlamydial infection in women. The USPSTF did not, however, find evidence to support this outcome and therefore concluded that the benefits of screening men are unknown. The USPSTF identified this as a critical gap in the evidence. Harms of Detection and Early Treatment The USPSTF concluded that the harms of screening for chlamydial infection are small, although few studies have been published on this subject. Potential harms include anxiety and relationship problems arising from false-positive results and overtreatment. The USPSTF identified the lack of evidence related to potential harms of screening as a gap in the evidence.The USPSTF reached the following conclusions: For nonpregnant women at increased risk, the certainty is high that the benefits of screening for chlamydial infection substantially outweigh the harms. This is a grade A recommendation. For pregnant women at increased risk, the certainty is moderate that the benefits substantially outweigh the harms of screening for chlamydial infection. This is a grade B recommendation. For women not at increased risk (including pregnant women not at increased risk), the certainty is moderate that the benefits outweigh the harms of screening to only a small degree. There may be considerations that support screening an individual patient. This is a grade C recommendation. For men, the benefits of screening are not known; thus, the USPSTF could not determine the balance of benefits and harms of screening men for chlamydial infection. This is an I statement. Clinical Considerations Patient Population under Consideration These recommendations target all sexually active individuals, including adolescents and pregnant women. Assessment of Risk All sexually active women 24 years of age or younger, including adolescents, are at increased risk for chlamydial infection. In addition to sexual activity and age, other risk factors for chlamydial infection include a history of chlamydial or other sexually transmitted infection, new or multiple sexual partners, inconsistent condom use, and exchanging sex for money or drugs. Risk factors for pregnant women are the same as for nonpregnant women. Prevalence of chlamydial infection varies widely among patient populations. African-American and Hispanic women have a higher prevalence of infection than the general population in many communities and settings. Among men and women, increased prevalence rates are also found in incarcerated populations, military recruits, and patients at public sexually transmitted infection clinics. Screening Tests Nucleic acid amplification tests have high specificity and sensitivity when used as screening tests for chlamydial infection. Nucleic acid amplification tests can be used with urine and vaginal swabs, enabling screening when a pelvic examination is not performed. Treatment Appropriate treatment of chlamydial infection has been outlined by the Centers for Disease Control and Prevention (CDC) (www.cdc.gov/std/treatment). In its 2006 sexually transmitted disease treatment guidelines, the CDC recommends that chlamydia infection be treated with 1 g of azithromycin in a single oral dose or with oral doxycycline, 100 mg twice daily for 7 days. Pregnant women with chlamydial infection may be treated with 1 g of azithromycin in a single oral dose or amoxicillin, 500 mg orally 3 times daily for 7 days (1). Because the CDC updates these recommendations regularly, clinicians are encouraged to access the CDC Web site (www.cdc.gov/std/treatment) to obtain the most up-to-date information. To prevent recurrent transmission, clinicians should ensure that all sexual partners of infected individuals are tested and treated if infected, or treated presumptively. Screening Intervals Screening pregnant women who are at increased risk for chlamydial infection is recommended at the first prenatal visit. For pregnant women who remain at increased risk and for those who acquire a new risk factor, such as a new sexual partner, a screening should be conducted during the third trimester. The optimal interval for screening for nonpregnant women is unknown. The CDC recommends at least annual screening for women at increased risk (1). Suggestions for Practice with regard to Insufficient Evidence on Screening in Men The USPSTF concluded that the evidence is insufficient to determine the balance of benefits and harms related to screening men for chlamydial infection. Specifically, the USPSTF did not find evidence that screening programs that target men result in a decreased incidence of infection in women. The USPSTF notes that programs that screen men as a means of reducing transmission to women are not common practice, that primary care clinicians can institute screening in men, that the costs of ad

Family-centered bedside rounds : A new approach to patient care and teaching

The importance of patient-centered care and the role of families in decision-making are becoming more recognized. Starting with a single acute care unit, a multidisciplinary improvement team at Cincinnati Childrens Hospital developed and implemented a new process that allows families to decide if they want to be part of attending-physician rounds. Family involvement seems to improve communication, shares decision-making, and offers new learning for residents and students. Despite initial concerns of staff members, family-centered rounds has been widely accepted and spread throughout the institution. Here we report our experiences as a potential model to improve family-centered care and teaching.

Screening and Treatment for Major Depressive Disorder in Children and Adolescents: US Preventive Services Task Force Recommendation Statement

DESCRIPTION. This is an update of the 2002 US Preventive Services Task Force recommendation on screening for child and adolescent major depressive disorder. METHODS. The US Preventive Services Task Force weighed the benefits and harms of screening and treatment for major depressive disorder in children and adolescents, incorporating new evidence addressing gaps in the 2002 recommendation statement. Evidence examined included the benefits and harms of screening, the accuracy of primary care–feasible screening tests, and the benefits and risks of treating depression by using psychotherapy and/or medications in patients aged 7 to 18 years. RECOMMENDATIONS. Screen adolescents (12–18 years of age) for major depressive disorder when systems are in place to ensure accurate diagnosis, psychotherapy (cognitive-behavioral or interpersonal), and follow-up (B recommendation). Evidence is insufficient to warrant a recommendation to screen children (7–11 years of age) for major depressive disorder (I statement).

Using nontraditional risk factors in coronary heart disease risk assessment: U.S. Preventive Services Task Force recommendation statement.

DESCRIPTION New recommendation from the U.S. Preventive Services Task Force (USPSTF) on the use of nontraditional, or novel, risk factors in assessing the coronary heart disease (CHD) risk of asymptomatic persons. METHODS Systematic reviews were conducted of literature since 1996 on 9 proposed nontraditional markers of CHD risk: high-sensitivity C-reactive protein, ankle-brachial index, leukocyte count, fasting blood glucose, periodontal disease, carotid intima-media thickness, coronary artery calcification score on electron-beam computed tomography, homocysteine, and lipoprotein(a). The reviews followed a hierarchical approach aimed at determining which factors could practically and definitively reassign persons assessed as intermediate-risk according to their Framingham score to either a high-risk or low-risk strata, and thereby improve outcomes by means of aggressive risk-factor modification in those newly assigned to the high-risk stratum. RECOMMENDATION The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of using the nontraditional risk factors studied to screen asymptomatic men and women with no history of CHD to prevent CHD events. (I statement).

Screening for type 2 diabetes mellitus in adults: U.S. preventive services task force recommendation statement

DESCRIPTION Updated U.S. Preventive Services Task Force (USPSTF) recommendation about screening for type 2 diabetes mellitus in adults. METHODS To estimate the balance of benefits and harms of screening, the USPSTF updated its 2003 evidence review, adding evidence from new trials as well as updates on earlier studies. The review for this current recommendation focused on evidence that early treatment prevented long-term adverse outcomes of diabetes, including cardiovascular events, visual impairment, renal failure, and amputation. RECOMMENDATIONS Screen for type 2 diabetes in asymptomatic adults with sustained blood pressure (either treated or untreated) greater than 135/80 mm Hg. (B recommendation) Current evidence is insufficient to assess the balance of benefits and harms of routine screening in asymptomatic adults with blood pressure of 135/80 mm Hg or lower. (I statement).

Screening for chronic obstructive pulmonary disease using spirometry: U.S. Preventive Services Task Force recommendation statement.

DESCRIPTION New U.S. Preventive Services Task Force (USPSTF) recommendation about screening for chronic obstructive pulmonary disease (COPD) using spirometry. METHODS The USPSTF weighed the benefits (prevention of > or =1 exacerbation and improvement in respiratory-related health status measures) and harms (time and effort required by both patients and the health care system, false-positive screening tests, and adverse effects of subsequent unnecessary therapy) of COPD screening identified in the accompanying review of the evidence. The USPSTF did not consider the financial costs of spirometry testing or COPD therapies. RECOMMENDATION Do not screen adults for COPD using spirometry. (Grade D recommendation).

Screening for high blood pressure: U.S. preventive services task force reaffirmation recommendation statement

DESCRIPTION Reaffirmation of the 2003 U.S. Preventive Services Task Force statement about screening for high blood pressure. METHODS The U.S. Preventive Services Task Force did a targeted literature search for evidence on the benefits and harms of screening for high blood pressure. RECOMMENDATION Screen for high blood pressure in adults age 18 years or older. (Grade A recommendation).

Update on the Methods of the U.S. Preventive Services Task Force: Insufficient Evidence

The U.S. Preventive Services Task Force (USPSTF) is an independent panel of experts that is convened and supported by the Agency for Healthcare Research and Quality (AHRQ). The U.S. Congress has charged the USPSTF to review the scientific evidence for clinical preventive services and develop evidence-based recommendations about their delivery. In its recommendations, the USPSTF seeks to maximize population health benefits while minimizing harms. The target audience for USPSTF recommendations is primary care clinicians, but the recommendations are widely used by others as well (1). The USPSTF processes and methods are continually examined, and recent updates have been published (13). The USPSTF Procedure Manual is posted on the AHRQ Web site (4). In this issue, the USPSTF reports that it concluded that the evidence to determine whether the benefits of skin cancer screening outweigh the harms was insufficient (5). No recommendation was made, and no letter grade was assigned. Instead, the USPSTF issued an I statement (2). Evidence is often found to be insufficient for topics considered by the USPSTF. Even for screening topics that pertain to all or a large majority of adults, children, or adolescents, evidence is often insufficient (Table 1) (6). Table 1. Insufficient Evidence Statements for Screening of Large Population Subgroups The release of the I statement for skin cancer screening provides an opportunity for the USPSTF to describe its plan to expand the kinds of information it commissions to be collected and reported routinely by Evidence-based Practice Centers, to describe the process that led to selection of this information, and to illustrate the uses of the information with examples. Problem Statement Primary care physicians and their professional societies expressed frustration with the frequency with which the USPSTF concluded that evidence is insufficient to make a recommendation. In the past, the USPSTF coupled this conclusion with a recommendation worded as follows: the USPSTF concludes that the evidence is insufficient to recommend for or against routine provision of xxx service. Clinicians pointed out that this wording is not a recommendation. Anecdotally, the statement was characterized as useless and sometimes as worse than useless. In focus groups of practicing primary care providers, a common request was for USPSTF guidance on a course of action with individual patients in situations in which evidence about net benefit is insufficient. Professional society representatives reinforced the need for guidance. The USPSTF and other bodies have generally held that the strongest argument for providing an intervention is based on scientific evidence from multiple large, well-conducted, randomized clinical trials (RCTs). However, for most clinical preventive services, this standard of evidence is unattainable. Requirements for RCTs of behavioral counseling interventions are especially problematic because the study interventions in gold-standard RCTs may be artificial. Tucker and Roth (7) discuss this problem in the context of behavioral interventions for substance abuse. They point out that requiring fidelity in treatment delivery in a gold-standard RCT may eliminate the contextual aspects of the treatment experience and the adaptation of treatment to individual needs that underlies treatment success. Requiring a no-treatment or usual-treatment control condition may produce insurmountable barriers to recruitment. Requiring a control condition with the same number of contact hours as the treatment condition can compromise retention. For different reasons, the conduct of RCTs for preventive services delivered to infants, children, and adolescents also presents challenges. For some preventive services, the long timeline required to improve health outcomes makes RCTs impractical. Consensus is lacking about the appropriate outcomes for preventive interventions in children, although agreement is universal that decreasing mortality is not the only goal of preventive services provided to this age group. Finally, many valuable preventive interventions will never be evaluated in an RCT because a trial would be too expensive, recruiting enough participants is not feasible, or investigator interest or funding is lacking. Acknowledging the Contribution of Non-RCT Evidence and Persisting Issues Recognizing the paucity of evidence from RCTs, the USPSTF and other groups consider evidence from non-RCT study designs (such as cohort, cross-sectional, casecontrol, or quasi-experimental) as a standard strategy. Use of an analytic framework, which is an organizing principle for all recent or current USPSTF systematic reviews, permits incorporation of evidence from studies with a variety of designs and yields certainty that can in theory approach the certainty of evidence derived from RCTs. In constructing an analytic framework, clinical problems are conceptualized in terms of a sequence of key questions (8). A systematic review is generally done to answer each key question. When considered together, the key question evidence forms a chain of evidence that permits firm conclusions about net benefit. In the case of skin cancer, notwithstanding the use of an analytic framework and consideration of study designs other than RCTs, the USPSTF could not conclude with even moderate certainty that the benefits of skin cancer screening by inspection outweighed the harms or that the harms outweighed the benefits, making the evidence insufficient to make a recommendation (9). Even when non-RCT evidence is considered within a structured causal framework, the problem of insufficient evidence persists. A New Approach: Process and Outcome In response to the concerns about the frequency of I statements, the frustration expressed by clinicians, and the call for guidance, the USPSTF held a workshop in spring 2005 to consider how better to meet the needs of its constituents when evidence is insufficient. The workshop involved members of the USPSTF, AHRQ staff, and scientists from the Evidence-based Practice Center supporting the USPSTF. The charge to workshop participants was to develop a strategy that would reduce confusion created by the wording I recommendation, and to consider whether the USPSTF should nuance the Ithat is, make a suggestion in favor of or against providing the service. At the workshop, attendees heard presentations from AHRQ and Evidence-Based Practice Center staff involved in the efforts of the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) working group (1012). Other publications about approaches to grading recommendations were identified and reviewed (13). The workshop resulted in a decision to transform what was formerly called an I recommendation into an I statement, as described elsewhere (2). The workshop also led to a group decision to reject the proposal to nuance the I. Nuancing would have resulted in recommendations that clinicians act routinely to offer a service even in the absence of at least moderate certainty that the preventive service has net benefits at the population level, thus violating an underlying principle guiding the work of USPSTF: avoidance of overall harm. Before the workshop, attendees were charged with bringing to the meeting suggestions for criteria that might be used to nuance the I, with practice relevance for clinicians, patients, or systems as the basis for these suggestions. During the workshop, further criteria were identified by using a brainstorming technique. The product of these processes was a list of possible factors that could be used to nuance the I. After rejecting the idea of nuancing the I, the USPSTF decided to explore, after the workshop, whether provision of information about the factors identified during this process might be useful to clinicians. This follow-up work was delegated to the Methods Workgroup and members of the Evidence-based Practice Center. The follow-up group noted that almost all of the factors fell into 1 of 4 groups. The 4 information groups came to be described as domains, a term that connotes hierarchical ranking and is apt, even if accidental. That is, these information domains constitute a limited number of broadly applicable collections of factors, considerations, or attributes pertinent to decision making about preventive services when evidence is insufficient to conclude, with certainty, that there is net benefit or net harm. After more deliberation, the Methods Workgroup proposed in 2006 that the Evidence-based Practice Center gather pertinent information in the 4 domains as part of its evidence retrieval process. The full USPSTF accepted the proposal, and members provided further input to the descriptions of the domains. The authors of this article were asked to prepare a manuscript about the process and product on behalf of the USPSTF. Domains and Rationale The first domain is potential preventable burden of suffering from the condition. When evidence is insufficient, provision of an intervention designed to prevent a serious condition (such as dementia) might be viewed more favorably than provision of a service designed to prevent a condition that does not cause as much suffering (such as rash). The USPSTF recognized that burden of suffering is subjective and involves judgment. In clinical settings, it should be informed by patient values and concerns. The second domain is potential harm of the intervention. When evidence is insufficient, an intervention with a large potential for harm (such as major surgery) might be viewed less favorably than an intervention with a small potential for harm (such as advice to watch less television). The USPSTF again acknowledges the subjective nature and the difficulty of assessing potential harms: For example, how bad is a mild stroke? The third domain is costnot just monetary cost, but opportunity cost, in particular the amount of time a provider spends to provide the service