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The complex agenda for comparative-effectiveness research outlined by the Institute of Medicine and the Federal Coordinating Council will require sustained, mission-focused leadership. Jordan VanLare and colleagues propose a five-step process.

In this issue of the Journal, a study by Heijnsdijk et al.1 shows the way to a resolution of the long-standing controversy about screening for prostate cancer. This is welcome news, since the 2009 reports of the long-awaited European and North American randomized trials of prostate-specific antigen (PSA) screening did not settle the matter.2,3 In the American trial, screening did not reduce prostate-cancer mortality, but the results were confounded by frequent PSA screening in the control group (e.g., 52% in the sixth year).3 In the European Randomized Study of Screening for Prostate Cancer, the screening of men between the . . .

In October 2010, the National Cancer Institute (NCI) announced that patients who were randomly assigned to screening with low-dose computed tomography (CT) had fewer deaths from lung cancer than did patients randomly assigned to screening with chest radiography. The first report of the NCI-sponsored National Lung Screening Trial (NLST) in a peer-reviewed medical journal appears in this issue of the Journal.1 Eligible participants were between 55 and 74 years of age and had a history of heavy smoking. They were screened once a year for 3 years and were then followed for 3.5 additional years with no screening. At . . .

Stage An 80-year-old man with degenerative arthritis of the hip and spine began to have midthoracic back pain and worsening pain in his left hip. The pain began suddenly, was not preceded by trauma, did not radiate, and was not relieved in any position. The back pain persisted for two weeks despite rest and treatment with ibuprofen. The patient took no other medications. Response In an 80-year-old with back pain, I would worry about osteoporosis, either primary or secondary. The midthoracic area is a common site of compression fractures. Although osteoporosis is more common in women than men, at this . . .

Stage A 48-year-old man who had received three cadaveric renal transplants had a 10-day history of painless edema of the legs. He was not short of breath at rest but had had moderate dyspnea on exertion for a week. Response The edema may be hydrostatic in origin, from either heart failure or other causes, or oncotic in origin, from hypoalbuminemia; bilateral deep venous thromboses would be unusual. The patient's shortness of breath may be caused by heart failure or fluid overload, but it could indicate lung infection. He is immunocompromised, so we need a broad differential diagnosis that includes opportunistic . . .

Stage A 22-year-old, non–English-speaking Laotian woman came to the clinic because she had abdominal pain. The history was obtained with her husband acting as interpreter. The pain was epigastric, described as a heartburn, and was somewhat relieved by eating and episodic use of antacids. She had had the pain intermittently for weeks or months during the previous two years. She reported no tobacco or alcohol use. She used antacids and occasionally used ibuprofen for headaches. She had immigrated to the United States five months earlier and had presented to a gynecology clinic requesting oral contraceptives. She was not taking any . . .

The principal aims of health system reform are to provide access to care for uninsured Americans and to control health care costs. Accomplishing these goals will require a lean package of health benefits that will be provided to all Americans. We must begin to think about the criteria for inclusion in a benefits package. Screening for lipid disorders, a widely recommended preventive service, is an illustrative case. To be considered effective, screening tests must meet three conditions: the clinical problem must be important, the test must be accurate, and early detection must improve prognosis. Screening for lipid disorders generally meets . . .

Despite many high-quality randomized trials, the balance of harm and benefit attributable to breast-cancer screening is not known for women 40 to 49 years of age. In this issue of the Journal, Elmore et al.1 describe a high rate of false positive results of such screening. Over a period of 10 years, nearly one third of the women screened had at least one false positive mammogram or clinical breast examination. Physicians must integrate this information into their approach to helping women decide about breast-cancer screening. Periodic screening invites repeated exposure to the possibility of a false positive result, as occurs . . .

The objective of clinical prediction rules is to reduce the uncertainty inherent in medical practice by defining how to use clinical findings to make predictions. Clinical prediction rules are derived from systematic clinical observations. They can help physicians identify patients who require diagnostic tests, treatment, or hospitalization. Before adopting a prediction rule, clinicians must evaluate its applicability to their patients. We describe methodological standards that can be used to decide whether a prediction rule is suitable for adoption in a clinician's practice. We applied these standards to 33 reports of prediction rules; 42 per cent of the reports contained an adequate description of the prediction rules, the patients, and the clinical setting. The misclassification rate of the rule was measured in only 34 per cent of reports, and the effects of the rule on patient care were described in only 6 per cent of reports. If the objectives of clinical prediction rules are to be fully achieved, authors and readers need to pay close attention to basic principles of study design.

The Medical Progress article by Pauker and Kassirer in this issue describes advances in applying the principles of decision analysis to patient care.1 Some problems remain and deserve comment. Decision analysis is a logically consistent approach to a common clinical problem: a decision whose consequences cannot be foretold with certainty. The uncertainties in medical practice stem from biologic variation and the inadequacies of clinical data. Uncertainty is intrinsic to the practice of medicine and cannot be eliminated by any analytical technique, however powerful. Decision analysis claims to identify the best decision, given the constraints imposed by uncertainty. This claim, valid . . .