Russell Harris

Current methods of the U.S. Preventive Services Task Force: A review of the process

The U.S. Preventive Services Task Force (USPSTF/Task Force) represents one of several efforts to take a more evidence-based approach to the development of clinical practice guidelines. As methods have matured for assembling and reviewing evidence and for translating evidence into guidelines, so too have the methods of the USPSTF. This paper summarizes the current methods of the third USPSTF, supported by the Agency for Healthcare Research and Quality (AHRQ) and two of the AHRQ Evidence-based Practice Centers (EPCs). The Task Force limits the topics it reviews to those conditions that cause a large burden of suffering to society and that also have available a potentially effective preventive service. It focuses its reviews on the questions and evidence most critical to making a recommendation. It uses analytic frameworks to specify the linkages and key questions connecting the preventive service with health outcomes. These linkages, together with explicit inclusion criteria, guide the literature searches for admissible evidence. Once assembled, admissible evidence is reviewed at three strata: (1) the individual study, (2) the body of evidence concerning a single linkage in the analytic framework, and (3) the body of evidence concerning the entire preventive service. For each stratum, the Task Force uses explicit criteria as general guidelines to assign one of three grades of evidence: good, fair, or poor. Good or fair quality evidence for the entire preventive service must include studies of sufficient design and quality to provide an unbroken chain of evidence-supported linkages, generalizable to the general primary care population, that connect the preventive service with health outcomes. Poor evidence contains a formidable break in the evidence chain such that the connection between the preventive service and health outcomes is uncertain. For services supported by overall good or fair evidence, the Task Force uses outcomes tables to help categorize the magnitude of benefits, harms, and net benefit from implementation of the preventive service into one of four categories: substantial, moderate, small, or zero/negative. The Task Force uses its assessment of the evidence and magnitude of net benefit to make a recommendation, coded as a letter: from A (strongly recommended) to D (recommend against). It gives an I recommendation in situations in which the evidence is insufficient to determine net benefit. The third Task Force and the EPCs will continue to examine a variety of methodologic issues and document work group progress in future communications.Abstract Abstract: The U.S. Preventive Services Task Force (USPSTF/Task Force) represents one of several efforts to take a more evidence-based approach to the development of clinical practice guidelines. As methods have matured for assembling and reviewing evidence and for translating evidence into guidelines, so too have the methods of the USPSTF. This paper summarizes the current methods of the third USPSTF, supported by the Agency for Healthcare Research and Quality (AHRQ) and two of the AHRQ Evidence-based Practice Centers (EPCs). mThe Task Force limits the topics it reviews to those conditions that cause a large burden of suffering to society and that also have available a potentially effective preventive service. It focuses its reviews on the questions and evidence most critical to making a recommendation. It uses analytic frameworks to specify the linkages and key questions connecting the preventive service with health outcomes. These linkages, together with explicit inclusion criteria, guide the literature searches for admissible evidence. mOnce assembled, admissible evidence is reviewed at three strata: (1) the individual study, (2) the body of evidence concerning a single linkage in the analytic framework, and (3) the body of evidence concerning the entire preventive service. For each stratum, the Task Force uses explicit criteria as general guidelines to assign one of three grades of evidence: good, fair, or poor. Good or fair quality evidence for the entire preventive service must include studies of sufficient design and quality to provide an unbroken chain of evidence-supported linkages, generalizable to the general primary care population, that connect the preventive service with health outcomes. Poor evidence contains a formidable break in the evidence chain such that the connection between the preventive service and health outcomes is uncertain. For services supported by overall good or fair evidence, the Task Force uses outcomes tables to help categorize the magnitude of benefits, harms, and net benefit from implementation of the preventive service into one of four categories: substantial, moderate, small, or zero/negative. mThe Task Force uses its assessment of the evidence and magnitude of net benefit to make a recommendation, coded as a letter: from A (strongly recommended) to D (recommend against). It gives an I recommendation in situations in which the evidence is insufficient to determine net benefit. mThe third Task Force and the EPCs will continue to examine a variety of methodologic issues and document work group progress in future communications.

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 Prostate Cancer: An Update of the Evidence for the U.S. Preventive Services Task Force

The American Cancer Society estimates that 189 000 men will receive a diagnosis of prostate cancer in 2002 and that 30 200 men will die of the disease (1). Many more men receive a diagnosis of prostate cancer than die of it (lifetime risk, about 1 in 6 vs. about 1 in 29). Among types of cancer, only lung cancer kills more men each year. The cause of prostate cancer is unknown, and the best-documented risk factors (age, ethnicity, and family history) are not modifiable. The burden of prostate cancer falls disproportionately on men who are older or black. The median age at diagnosis is approximately 71 years, and the median age at death is 78 years (2). More than 75% of all cases of prostate cancer are diagnosed in men older than 65 years of age, and 90% of deaths occur in this age group (2, 3). Incidence is approximately 60% higher and mortality rate is twofold higher in black men than in white men (2). Asian-American men and Hispanic men have lower incidence rates than non-Hispanic white persons (3). Although approaches to primary prevention of prostate cancer are being tested, to date none are known to be effective. The most common strategy for reducing the burden of prostate cancer is screening, but screening remains controversial. Many studies on this topic have been published since 1996, when the U.S. Preventive Services Task Force (USPSTF) last examined prostate screening (4). To assist the USPSTF in updating its recommendation, the Research Triangle InstituteUniversity of North Carolina Evidence-based Practice Center performed a systematic review of the evidence on screening for prostate cancer. Methods Using USPSTF methods (5), we developed an analytic framework and eight key questions to guide our literature search. Because we found no direct evidence connecting screening and reduced mortality, we searched for indirect evidence on the yield of screening, the efficacy and harms of various forms of treatment for early prostate cancer, and the costs and cost-effectiveness of screening. We developed eligibility criteria for selecting relevant evidence to answer the key questions (Table 1). We examined the critical literature from the 1996 USPSTF review and used search terms consistent with the eligibility criteria to search the MEDLINE database and Cochrane Library for English-language reviews and relevant studies published between 1 January 1994 and 15 September 2002. Table 1. Key Questions, Inclusion Criteria, and Articles Meeting Criteria The first author and at least one trained assistant reviewed abstracts and articles to find those that met the eligibility criteria. For these studies, the two reviewers abstracted relevant information using standardized abstraction forms. We graded the quality of all included articles according to USPSTF criteria (5). The authors worked closely with two members of the USPSTF throughout the review and periodically presented reports to the full USPSTF. We distributed a draft of the systematic evidence review to experts in the field and relevant professional organizations and federal agencies for broad-based external peer review and made revisions based on the feedback. We then revised the full systematic evidence review into this manuscript. A more complete account of the methods of this review can be found in the Appendix. The complete systematic evidence review is available on the Web site of the Agency for Healthcare Research and Quality (www.ahrq.gov) (6). This evidence report was funded through a contract to the Research Triangle InstituteUniversity of North Carolina Evidence-based Practice Center from the Agency for Healthcare Research and Quality. Staff of the funding agency and members of the USPSTF contributed to the study design, reviewed draft and final manuscripts, and made editing suggestions. Results Direct Evidence That Screening Reduces Mortality Randomized, Controlled Trials Labrie and colleagues (7) completed the first randomized, controlled trial (RCT) of prostate cancer screening with more than 46 000 men. At the end of 8 years of follow-up, approximately 23% of the invited group and 6.5% of the not-invited group had been screened with prostate-specific antigen (PSA) testing and digital rectal examination (DRE). Prostate cancer death rates did not differ between groups (4.6 vs. 4.8 deaths per 1000 persons, respectively). Two other RCTs of prostate cancer screening, both initiated in 1994, are ongoing: the U.S. National Cancer Institute Prostate, Lung, Colorectal, and Ovary Trial and the European Randomized Study of Screening for Prostate Cancer. Neither study will have data on mortality for several more years. CaseControl Studies Three well-conducted, nested casecontrol studies (two since 1994) examined the relationship between chart review documentation of DRE and advanced prostate cancer or death from prostate cancer. Two studies found no relationship (8, 9). The third study found that men who died of prostate cancer had fewer DREs in the years before diagnosis (odds ratio indicating a protective effect of DRE, 0.51 [95% CI, 0.31 to 0.84]) (10). Why results from these otherwise similar studies differ is not clear. The three studies depended on large databases and on individual medical records. They defined cases slightly differently and used different approaches to differentiate screening DRE from diagnostic DRE. Because such studies are complex in design, we were not able to determine whether one method was more accurate than another (11). All three studies were small, and all were consistent with a reduction in prostate cancer mortality of up to 50% with DRE. We found no casecontrol studies of PSA screening. This can be explained, at least in part, by the fact that insufficient time has elapsed since the introduction of PSA as a screening test in the late 1980s. Such studies are under way (12). Ecologic Studies Around 1987, use of PSA screening began to increase rapidly in the United States. Important trends in prostate cancer incidence and mortality also occurred at that time. Although incidence rates had been slowly increasing for some years before 1987, data from the U.S. Surveillance, Epidemiology, and End Results program showed a dramatic increase in age-adjusted prostate cancer incidence20% per yearfrom 1989 to 1992. The rates then decreased at 10.8% per year (13), stabilizing after 1994 (14). Most of the increase in incidence was seen in localized or regional disease. Incidence of distant-stage disease at diagnosis showed little initial increase and then began to decline; annual decline for white men was 17.9% after 1991 (15). Disease-specific mortality rates paralleled trends in prostate cancer incidence (15, 16). In the late 1980s, the average annual percentage increase rose from 0.7% to 3.1% for white men and from 1.6% to 3.2% for black men. In 1991, prostate cancer mortality rates for white men began to decline (21.6% decrease from 1991 to 1999); in 1993, rates for black men followed suit (16.0% decrease from 1993 to 1999) (14). Mortality rates decreased in all age groups at about the same time. Analyses of trends in prostate cancer incidence and mortality in Olmsted County, Minnesota (17), and in Canada (18, 19) have shown similar results. Ecologic evidence is difficult to interpret. Although screening probably explains trends in incidence of prostate cancer (20), trends in mortality are more difficult to understand. Some aspects of the trends (for example, a decline in distant-stage disease) are consistent with screening, but other aspects (for example, the short time between increased screening and decreased mortality) (21) are not as consistent with our current view of the natural history of prostate cancer. The argument that the decline in mortality can be attributed to PSA screening would be stronger if it could be shown that the decline was largest in areas with more screening. To date, data on this issue are conflicting (19, 22-27). Other possible explanations for decreased mortality include attribution bias and improved treatment. Attribution bias suggests that some deaths are mistakenly attributed to prostate cancer. If the percentage of deaths so attributed is stable, then the prostate cancer mortality rate would be expected to increase and decrease in close approximation with the incidence of prostate cancer in the population (16). Changes in prostate cancer treatment during the late 1980s and early 1990s included higher rates of radical prostatectomy, development of luteinizing hormonereleasing hormone (LHRH) agonists (allowing improved androgen deprivation therapy without castration), and refinements in radiation therapy. Such changes may explain the reduction in prostate cancer mortality. A recent study by Bartsch and coworkers (27), for example, documented a greater reduction in prostate cancer mortality in the Austrian state of Tyrol, which had instituted a free PSA screening program, compared with the rest of Austria. This finding could be a consequence of the screening program, changes in treatment that accompanied the screening program, misattribution of cause of death, or some combination of the three. Accuracy of Screening Three problems complicate any attempt to determine the accuracy of screening tests for prostate cancer. First, research has yet to clarify which tumors screening should target. Second, the reference standard (prostate biopsy) for diagnosing prostate cancer after positive results on a screening test is imperfect. Third, few studies perform biopsy on men with negative results on screening tests. Prostate cancer is a heterogeneous tumor. Different cases of prostate cancer have widely varying growth rates and potential for causing death. Ideally, prostate cancer screening would target only tumors that would cause clinically important disease. Currently available prognostic markers can distinguish a small number of men with excellent prognosis for long-term survival and a small number of men with po

Life-sustaining treatments during terminal illness - Who wants what?

Objective: To determine patient characteristics associated with the desire for life-sustaining treatments in the event of terminal illness.Design: In-person survey from October 1986 to June 1988.Setting: 13 internal medicine and family practices in North Carolina.Patients: 2,536 patients (46% of those eligible) aged 65 years and older who were continuing care patients of participating practices, enrolled in Medicare. The patients were slightly older than the 65+ general population, 61% female, and 69% white, and most had one or more chronic illnesses.Measurements and main results: The authors asked the patients whether they would want each of six different treatments (hospitalization, intensive care, cardiopulmonary resuscitation, surgery, artificial ventilation, or tube feeding) if they were to have a terminal illness. The authors combined responses into three categories ranging from the desire for more treatment to the desire for less treatment. After adjustment for other factors, 53% of women chose less treatment compared with 43% of men; 35%ofblacksvs 15% of whites and 23% of the less well educated vs 15% of the better educated expressed the desire for more treatment. High depression scores also were associated with the desire for more treatment (26% for depressed vs 18% for others).Conclusion: Patients’ choices for care in the event of terminal illness relate to an intricate set of demographic, educational, and cultural factors. These results should not be used as a shortcut to determine patient preferences for care, but may provide new insights into the basis for patients’ preferences. In discussing choices for future life-sustaining care, physicians need to explore with each individual the basis for his or her choices.

Systematic Review: Enhancing the Use and Quality of Colorectal Cancer Screening

BACKGROUND National guideline groups recommend screening and discussion of screening options for persons at average risk for colorectal cancer (CRC). However, emerging evidence suggests that CRC screening is simultaneously underused, overused, and misused and that adequate patient-provider discussions about screening are infrequent. PURPOSE To summarize evidence on factors that influence CRC screening and strategies that increase the appropriate use and quality of CRC screening and CRC screening discussions. DATA SOURCES MEDLINE, the Cochrane Library, and the Cochrane Central Register of Controlled Trials were searched for English-language publications describing studies conducted in the United States from January 1998 through September 2009. STUDY SELECTION Two reviewers independently selected studies that addressed the study questions and met eligibility criteria. DATA EXTRACTION Information on study design, setting, intervention, outcomes, and quality were extracted by one reviewer and double-checked by another. Reviewers assigned a strength-of-evidence grade for intervention categories by using criteria plus a consensus process. DATA SYNTHESIS Reviewers found evidence of simultaneous underuse, overuse, and misuse of CRC screening as well as inadequate clinical discussions about CRC screening. Several patient-level factors were independently associated with lower screening rates, including having low income or less education, being uninsured, being Hispanic or Asian, being less acculturated into the United States, or having limited access to care. Evidence that interventions that included patient reminders or one-on-one interactions (that is, between patients and nonphysician clinic staff), eliminated structural barriers (for example, simplifying access to fecal occult blood test cards), or made system-level changes (for example, using systematic screening as opposed to opportunistic screening) were effective in enhancing use of CRC screening was strong. Evidence on how best to enhance discussions about CRC screening options is limited. No studies focused on reducing overuse, and very few focused on misuse. LIMITATIONS Reporting and publication bias may have affected our findings. The independent effect of individual elements of multicomponent interventions was often uncertain. CONCLUSION Although CRC screening is underused overall, important problems of overuse and misuse also exist. System- and policy-level interventions that target vulnerable populations are needed to reduce underuse. Interventions aimed at reducing barriers by making the screening process easier are likely to be effective. Studies aimed at reducing overuse and misuse and at enhancing the quality and frequency of discussions about CRC screening options are needed. PRIMARY FUNDING SOURCE Agency for Healthcare Research and Quality.

Screening for gestational diabetes: a summary of the evidence for the U.S. Preventive Services Task Force

OBJECTIVE To systematically review the evidence for screening for gestational diabetes mellitus (GDM). DATA SOURCES We established eligibility criteria for relevant studies. We systematically searched MEDLINE and the Cochrane Collaboration Library for studies meeting eligibility criteria. We supplemented this search with further studies identified from reference lists of reviews. METHODS OF STUDY SELECTION Two reviewers examined each article for eligibility. A single reviewer abstracted relevant data from the included articles; a second reviewer checked the abstractions. We graded the quality of the articles according to criteria developed by the U.S. Preventive Services Task Force. TABULATION, INTEGRATION, AND RESULTS No well-conducted, randomized, controlled trial provides direct evidence for the health benefits of screening for GDM. The evidence is unclear regarding the optimal screening and reference diagnostic test for GDM. The impact of hyperglycemia on adverse maternal and neonatal health outcomes is probably continuous. Although insulin therapy decreases the incidence of fetal macrosomia for those women with more severe degrees of hyperglycemia, the magnitude of any effect on maternal and neonatal health outcomes is not clear. The evidence is insufficient to determine the magnitude of health benefit for any treatment among the large number of women with GDM at milder degrees of hyperglycemia. We found limited evidence regarding the potential adverse effects of screening for GDM. CONCLUSION Because of the lack of high-quality evidence concerning critical issues, we are unable to determine the extent to which screening has an important impact on maternal and neonatal health outcomes. A randomized, controlled trial of screening is necessary to answer the many remaining questions.

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).

Patient Preferences for Colon Cancer Screening

OBJECTIVE: To measure patient preferences for four different screening strategies: annual fecal occult blood testing (FOBT) alone; flexible sigmoidoscopy (FSIG) every 5 years alone; both annual FOBT and FSIG every 5 years; or no screening. DESIGN: Survey. SETTING: University internal medicine clinic. PATIENTS: Convenience sample of 146 adults (aged 50–75 years) with no previous history of colon cancer. INTERVENTION: Three-part educational program on colon cancer screening administered verbally by trained research assistants. MEASUREMENTS AND MAIN RESULTS: Patient preferences for screening were measured at three points: after descriptive information about colon cancer and screening options (testing procedure information); after information about test performance but with no out-of-pocket costs (test performance information); and finally with hypothetical out-of-pocket costs (cost information). After only descriptive test information, the most popular strategies were FOBT alone (45%) or both tests (38%). Fewer patients preferred FSIG alone (13%). After information about test performance, more subjects preferred both tests (47%), and fewer subjects preferred FOBT alone (36%) (p=.12). With hypothetical out-of-pocket costs, the proportion preferring FOBT alone increased to 53%, while those preferring both tests decreased to 31% (p<.001). Less than 5% of patients preferred no screening. CONCLUSIONS: Patient preferences for colon cancer screening were modestly sensitive to information about test performance and strongly sensitive to out-of-pocket costs. The heterogeneity of patients’ preferences for how to be screened supports informed shared decision making as a possible means of improving colon cancer screening.