Evelyn P Whitlock

Current Processes of the U.S. Preventive Services Task Force: Refining Evidence-Based Recommendation Development

The U.S. Preventive Services Task Force (USPSTF) is an internationally recognized, independent panel of nonfederal experts in primary care, prevention, and research methods that makes evidence-based recommendations to guide the delivery of clinical preventive services. Convened and supported by the Agency for Healthcare Research and Quality (AHRQ), the USPSTF is charged by the U.S. Congress to review the scientific evidence for clinical preventive services and to develop evidence-based recommendations for their delivery to the health care community. The disciplines of USPSTF members include family medicine, internal medicine, geriatrics, preventive medicine, pediatric and adolescent medicine, obstetrics and gynecology, nursing, psychology and behavioral medicine, public health, and health policy. Since its inception more than 20 years ago, the USPSTF has worked to fulfill its mission by 1) evaluating the benefits and harms of preventive services in apparently healthy persons on the basis of age, sex, and known risk factors for disease and 2) making recommendations about which preventive services should be provided routinely in primary care practice and which should not. The USPSTF recommendations are intended to improve both clinical practice and the health of patients. The scope of the Task Force is specific: Its recommendations address primary or secondary preventive services targeting conditions of substantial burden in the United States and are provided in primary care settings (or are available through primary care referral). Although the main audience for USPSTF recommendations is the primary care clinician, these recommendations also have relevance for and are widely used by policymakers, managed care organizations, public and private payers, quality improvement organizations, research institutions, professional medical organizations, specialist physicians, and patients. The USPSTF is distinct from other groups that provide recommendations for preventive services. It does not create guidelines based on expert opinion, as do many nonprofit advocacy organizations and professional groups. The Task Force does not advocate for prevention, perform decision analysis to routinely standardize the personal preferences and values of patients, consider medicolegal issues or the cost or coverage of services in making recommendations, or set clinical standards or health policy. Instead, the Task Force follows a unique and explicit methodology to develop recommendations that pass a rigorous evidence-based standard (1). Table 1 shows the Task Forces current procedures for developing recommendations. The USPSTF stands as an independent arbiter of the evidence and, as such, has set the standard for evidence-based recommendations for the delivery of clinical preventive services. Table 1. Procedures for Developing a Recommendation Statement* The process of making evidence-based recommendations occurs in an environment in which many stakeholders, often with competing interests, have their own preferences for or ideas about the delivery of preventive services. In such an environment, in which outside organizations maintain a keen interest in what the Task Force recommends, it is especially important for the USPSTF to maintain transparency, accountability, and consistency to ensure the independence and the integrity of their process and recommendations. This paper is 1 in a series presenting the refinements that the USPSTF has undergone since its methodology was last published in 2001. The Task Force processes of selecting topics, synthesizing evidence, deliberating and voting on recommendations, soliciting peer review, and finalizing recommendations have evolved over time. The purpose of this refinement is to continually improve the methods of evidence-based review, to maintain transparency and objectivity, and to increase USPSTF efficiency. Table 2 summarizes the ways in which the USPSTF has refined its processes to meet these and other aims. Table 2. Aims and Processes of the U.S. Preventive Services Task Force to Ensure Integrity* Types of Recommendations New Topics The Task Force solicits new topics for consideration from the field through a periodic notice in the Federal Register and solicitation of professional liaison organizations. Task Force members may also generate new topics for consideration. The USPSTF first considers whether newly nominated topics are within the scope of the USPSTF (that is, a primary or secondary preventive service that is relevant to primary care and addresses a disease with a substantial health burden) and then prioritizes the topics by using specific criteria: 1) the public health importance of the condition to be prevented (burden of suffering and expected effectiveness of preventive services to reduce that burden) and 2) the potential for the USPSTF to affect clinical practice (based on existing controversy or the belief that a gap exists between evidence and practice). The USPSTF secondarily considers the need to balance the portfolio of topics to address diverse groups, types of conditions, and types of preventive services (for example, screening, counseling, and preventive medication). The USPSTF recommendation statement on routine use of aspirin or nonsteroidal anti-inflammatory drugs for the primary prevention of colorectal cancer, which appeared in the 6 March 2007 issue of Annals of Internal Medicine, represents a new topic nominated by the Centers for Disease Control and Prevention (CDC) (2). Updated Recommendations To efficiently utilize available resources, the Task Force has implemented new procedures to review previous topics and update recommendations for continued inclusion in the current Task Force library. To be consistent with the standards of the National Guidelines Clearinghouse (www.ngc.gov), the process of revisiting and updating a previous USPSTF recommendation begins approximately 3.5 years after that recommendation was released, or earlier if a landmark study is published that could change a current recommendation. The USPSTF screens topics under consideration to identify emerging scientific issues and current clinical relevance, and then prioritizes them by using the criteria described above, in addition to considering the potential for new, recent evidence to change a previous recommendation. The USPSTF then recommends a targeted evidence update or a full evidence update. A full evidence update systematically examines a complete analytic framework of key questions by using recent evidence, taking into account any need to reframe the topic or focus of the recommendation since it was last considered, whereas a targeted evidence update systematically examines a subset of the key questions from the original analytic framework. Reaffirmation Recommendations Some clinical preventive services, such as screening for hypertension, have a strong, well-established evidence base and are a routine part of clinical practice. Because it is unlikely that new evidence will change USPSTF recommendations for such services, the USPSTF reviews the evidence for them in an expedited manner by conducting literature searches that address benefits and harms and consulting experts. Some recommendations for clinical preventive services fall within the scope of not only the USPSTF but also other federal agencies. For example, adult and childhood immunizations are addressed by the CDC Advisory Committee on Immunization Practices (ACIP). In a few select cases, the Task Force chooses to refer to such recommendations. Although the USPSTF considers these recommendations part of its portfolio of recommended clinical preventive services, it refers clinicians to the ACIP active evidence review process and recommendations for 2 reasons: The USPSTF does not have adequate resources to keep such recommendations current, and it does not wish to duplicate the efforts of the ACIP. Inactive Recommendations The USPSTF considers some recommendations made in previous years (for example, those for electronic fetal monitoring, home uterine monitoring, and counseling for dental disease) to be no longer current or priority topics. These topics are regarded as inactive for various reasons. First, the USPSTF may consider such recommendations now to be outside its scope of work. Second, such recommendations may be judged to be no longer clinically relevant, because of changes in technology or clinical practice or because of new understanding of disease etiology or natural history. Finally, the topic of a recommendation may be judged to have low priority because it has limited potential to influence public health burden or clinical practice. Currently inactive recommendations are identified on the USPSTF Web site (www.preventiveservices.ahrq.gov). Types of Evidence Reviews The USPSTF bases its recommendations on systematic evidence reviews, which form the critical underpinnings of its deliberations and decision making. The USPSTF members are intensively involved in the conceptualization, content, and interpretation of these reviews. The reviews are products of a partnership between members of the USPSTF and Evidence-based Practice Center (EPC), which conducts, synthesizes, and produces them. The process is facilitated and coordinated by the staff of the AHRQ, and in some cases, the AHRQ staff conducts targeted evidence updates. The USPSTF now uses 4 types of reviews to support its recommendations: full evidence reviews, staged evidence reviews, targeted evidence updates, and reaffirmation updates. Recommendations for new topics are informed by full evidence reviews (which may be, in rare instances, staged evidence reviews). Updates of previous recommendations are informed by 1 of 3 types of reviews: full evidence updates, targeted evidence updates, or reaffirmation updates. These 3 updated reviews represent a new methodology for the USPSTF process. Table 3 provides descriptions and examples of the types of reviews.

Counseling about Proper Use of Motor Vehicle Occupant Restraints and Avoidance of Alcohol Use while Driving: A Systematic Evidence Review for the U.S. Preventive Services Task Force

Motor vehiclerelated injuries are the leading cause of death among individuals between 3 and 33 years of age in the United States (1) and are a large source of morbidity for the nearly 3 million people who sustain nonfatal injuries annually (2). Increasing the correct use of occupant restraint devices and decreasing alcohol-related driving (that is, driving while under the influence of alcohol or riding with drivers who are under the influence of alcohol) are among the most important strategies to effectively reduce motor vehiclerelated fatalities (38). Overall, occupant restraint use has been increasing and is considered a public health success (9). All 50 states currently have laws requiring child safety seats for infants and children, and 49 states and the District of Columbia have adult seat belt laws (10). Although belt-positioning booster seats reduce the risk for injury by nearly 60% for children 4 to 7 years of age (11) compared with seat belts, 22 states do not have any laws pertaining to booster seats. All 50 states, the District of Columbia, and Puerto Rico have laws that make it illegal to drive with a blood alcohol concentration of 0.08 g/dL or higher (9), and rates of alcohol involvement among fatal crashes have decreased during the past 2 decades (12). Despite widespread regulation and overall increases in safer motor vehiclerelated behaviors, recent crash data show that more than 50% of fatalities were among unrestrained occupants and nearly 40% involved alcohol (2). Primary care providers and their staff have many opportunities to intervene with patients about these health behaviors already known to reduce the risk for motor vehicle occupant injuries (MVOIs). Children and adolescents younger than 15 years of age average more than 2 visits per year to office-based physicians, and older adolescents and adults average 2 to 8 visits per year (13). Additional public health strategies, such as closing gaps in current laws (14) and implementing evidence- and population-based approaches (8, 15, 16), will be important to make further improvements in motor vehicle safety behaviors. These strategies could include components delivered by primary health care providers or their staff. Our objective was to systematically assess the evidence on the effectiveness of primary care counseling among people of all ages to increase the correct use of age- and weight-appropriate occupant restraint devices and reduce alcohol-related driving. The Oregon Evidence-based Practice Center (EPC) conducted the review to assist the U.S. Preventive Services Task Force (USPSTF) in updating its 1996 recommendation (17). The full evidence report is available at www.preventiveservices.ahrq.gov. This article summarizes the reviews findings. Methods Key Questions In conjunction with members of USPSTF, we developed an analytic framework (Appendix Figure 1) and 4 key questions to guide our evidence review. Appendix Figure 1. Analytic framework. Key question 1: Do primary care behavioral counseling interventions for children, adolescents, and adults to increase the correct use of age- and weight-appropriate restraints or reduce driving/riding with drivers under the influence of alcohol reduce morbidity and/or mortality from motor vehicle occupant injuries? Key question 2: Do primary care behavioral counseling interventions for children, adolescents, and adults lead to increased correct use of age- and weight-appropriate restraints? Key question 3: Do primary care behavioral counseling interventions for children, adolescents, and adults reduce driving/riding with drivers under the influence of alcohol? Key question 4: What are the adverse effects of counseling children, adolescents, and adults to correctly use age- and weight-appropriate restraints and reduce driving/riding with drivers under the influence of alcohol? Key question 1 addressed the direct effect of counseling interventions on actual health risk reductions, whereas key questions 2 and 3 addressed effects on intermediate behavioral outcomes known to lead to health risk reduction. This report did not examine the evidence for the efficacy of health risk reduction for the targeted MVOI-related safety behaviors, because the USPSTF found strong evidence for those relationships in 1996 (17). Correct use is defined by age, weight, and location as recommended by traffic safety organizations (18). Appendix Table 1 describes recommended occupant restraint devices for children younger than 9 years of age. Children younger than 13 years of age should ride in the rear of the vehicle. Safety belts with straps across both the lap and shoulder are recommended for children who have outgrown booster seats, as well as for adolescents and adults. Appendix Table 1. Recommendations for Child Safety Seats Based on Age and Weight Data Sources We considered all studies that were included in the 1996 USPSTF recommendation, and we conducted 5 additional literature searches that were limited to English-language studies. For the key questions pertaining to occupant restraint use (1 and 2), we searched for relevant studies in MEDLINE, Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, PsycINFO, CINAHL, and Traffic Research Information Service (TRIS) published from 1992 to July 2005. We also searched the bibliographies of 4 systematic evidence reviews that addressed the effectiveness of counseling for occupant restraints in pediatric populations (16, 1921). For the key questions addressing counseling about driving while under the influence of alcohol (1 and 3), we considered trials that were included in 3 recent systematic evidence reviews (2224) and searched MEDLINE, Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, PsycINFO, CINAHL, and TRIS for studies published from 2002 to September 2005 to update the searches conducted for those reports. In 1996, the USPSTF recommendation did not specifically address the effectiveness of counseling patients about riding with someone who was under the influence of alcohol (key question 3) or the harms of counseling (key question 4). To cover these 2 areas, we searched MEDLINE, Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, PsycINFO, CINAHL, and TRIS for studies published from 1966 to July 2005 and MEDLINE and TRIS for studies published from 1966 to September 2005, respectively. Although no key questions were related to cost, we searched the National Health Service Economic Evaluation Database for data published from the databases inception through July 2005. Literature searches are described in detail in Appendix Table 2 and were supplemented with outside source material from experts in the field. Appendix Table 2. Search Strategy Study Selection Two authors reviewed each abstract for potential inclusion by using the inclusion and exclusion criteria described in Appendix Table 3. We conducted 5 searches to cover the separate focus of each key question, and we reviewed all abstracts for potential inclusion for any of the key questions. For all key questions, we included English-language reports of randomized, controlled trials (RCTs) or nonrandomized, controlled clinical trials (CCTs) and comparative observational studies that included patients of any age and were conducted in the United States or other similarly developed countries. Any intervention that included behavioral counseling as 1 of its components was considered. Studies were required to report 1 of the behavioral or health outcomes specified in our key questions and analytic framework or cost-effectiveness outcomes. We excluded studies rated as having poor quality on the basis of the criteria described in the following section. Appendix Table 3. Inclusion and Exclusion Criteria for Motor Vehicle Occupant Injury Prevention To be within the scope of the USPSTF, interventions needed to be feasible for, or conducted in, a primary care setting or be available for primary care referral. Criteria for deciding whether the intervention was feasible for a primary care setting were developed previously by members of the Oregon EPC and the USPSTF. These criteria included 4 domains: 1) how the participant was identified, 2) who delivered the intervention, 3) how the intervention was delivered, and 4) where the intervention was delivered. Appendix Table 4 contains a more detailed description of these domains. For an intervention to be feasible for primary care referral, we required that it be conducted in a health care setting or be widely available in the community at a national level (such as a car seatfitting station within a hospital). We excluded studies that enrolled selected populations (for example, injured or intoxicated patients recruited from an emergency department) that were not representative of patients normally seen in primary care. Appendix Table 4. Criteria for Interventions Judged to Be Relevant or Feasible to Primary Care Our review did not include programs that counseled risky or harmful alcohol users to reduce alcohol consumption, which was reviewed previously for the USPSTF (22). Rather, we required that alcohol-related counseling interventions target general primary care patient populations of any age and specifically advise patients to reduce drinking and driving (not just reduce overall use of alcohol). Data Extraction and Quality Assessment Using the USPSTFs study designspecific criteria (25, 26), 2 authors rated the quality of all included studies and those excluded because of quality issues. For randomized, controlled trials, criteria included 1) the initial assembly of comparable groups (based on adequate randomization, including first concealment and whether potential confounders were distributed equally among groups); 2) maintenance of comparable groups (including attrition, crossover, adherence, and contamination); 3) important differential loss to follow-up or overa