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February 21, 2008  Vol. 358 No. 8

Audio Summary of this Issue

Perspective
765-767
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Can it be ethical to conduct quality-improvement research without informed consent? Franklin Miller and Ezekiel Emanuel discuss a recent investigation by the Office for Human Research Protections that places this issue in bold relief.

768-769
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Peter Pronovost and other Johns Hopkins investigators helped 103 ICUs in 67 Michigan hospitals carry out a highly successful infection-control effort, only to run into major problems with federal regulators. Mary Ann Baily writes that the case ...

Original Articles
771-783
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Aprotinin (Trasylol) is used to control bleeding during coronary-artery bypass grafting (CABG), but in this observational study, there was an increased risk of in-hospital death when this drug was used, as compared with when aminocaproic acid was used. These data concur with those of Shaw et al. in this issue of the Journal and, in conjunction with those from previous studies, call into question the safety of aprotinin use in patients undergoing CABG.

784-793

In this single-center study, the use of aprotinin in coronary-artery bypass grafting (CABG) was associated with an increase in mortality and worsening renal function. The results concur with those of Schneeweiss et al. in this issue of the Journal, and together these studies raise concern about the safety of aprotinin in CABG.

794-810

Lumbar spinal stenosis is the most common reason for spinal surgery in patients over the age of 65 years. This randomized clinical trial compared surgical decompression with nonsurgical therapy for spinal stenosis without spondylolisthesis. Although the trial was limited by frequent crossover between the two randomized groups and therefore was not definitive, the findings favored surgical decompression over nonsurgical care for this common spine disorder.

811-817

Hepatitis E virus (HEV) is considered responsible for acute hepatitis but has not been thought to cause progression to chronic hepatitis. The authors of this paper identified 14 transplant recipients who had acute HEV infection; in 8, the infection evolved to confirmed chronic hepatitis. The numbers of lymphocytes and of CD2, CD3, and CD4 T cells were significantly lower in the patients with chronic hepatitis than in those in whom the infection resolved.

Clinical Practice
818-825
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A 72-year-old woman with hypertension presents with a 4-month history of lower back discomfort that radiates to both buttocks and lateral thighs. Previously, she walked 2 miles (3.2 km) a day; now she has difficulty walking two blocks and standing up for more than 15 minutes at a time. Her physical examination is notable only for a slightly stooped posture and a reduction of vibratory sensibility in both great toes. How should she be evaluated and treated?

Images in Clinical Medicine
826
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A 59-year-old man with a medical history of hypertension, hyperlipidemia, and coronary artery disease presented with transient, painless visual obscuration in the left eye, and he was referred for retinal evaluation. Two months earlier, he had undergone ...

e9
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This 43-year-old woman presented with a 10-month history of an urticarial rash induced by cold, particularly when she was swimming.

Case Records of the Massachusetts General Hospital
827-838

A 46-year-old woman was seen by a rheumatology consultant because of stiffness of the joints and skin. She had been well until 7 years earlier, when an episode of group A streptococcal pneumonia complicated by septic shock left her with chronic kidney disease and a painful peripheral neuropathy. Three years later, gradually progressive stiffness of the skin of her hands and feet developed, with pain and stiffness of the joints; renal failure worsened, and respiratory distress and congestive heart failure developed. A diagnostic procedure was performed.

Editorial
840-842

Aprotinin, a hemostatic agent that inhibits the fibrinolytic enzyme plasmin,1 was approved by the Food and Drug Administration (FDA) in 1993 for reducing blood loss during coronary-artery bypass grafting (CABG). By 2006, aprotinin was prescribed for ...

Health Law, Ethics, and Human Rights
843-849

Many recombinant-protein drugs such as erythropoietin are now off patent, and the availability of generic versions of these drugs would reduce costs. The federal laws that simplify and expedite approval of generic forms of other drugs do not apply to recombinant-protein drugs. Congress is developing legislation to facilitate the approval of follow-on protein drugs.

Correspondence
850-853

To the Editor: Computed tomographic (CT) scans deliver a radiation dose of about 20 mSv. Brenner and Hall (Nov. 29 issue)1 assess the risk associated with CT radiation exposure by using the linear no-threshold extrapolation model, which assumes that ...

853-855

To the Editor: Vernooij et al. (Nov. 1 issue)1 have contributed valuable knowledge about the prevalence of asymptomatic intracranial lesions. However, we disagree with their statement that many incidental lesions do not merit further evaluation or ...

855-856

To the Editor: The single-subject study design used by De Ridder et al. (Nov. 1 issue)1 makes it difficult to conclude whether the changes seen on positron-emission tomography (PET) were due to out-of-body experiences or simply to the differential ...

856-857

To the Editor: In Oberlander's Perspective article on failure in health care reform (Oct. 25 issue),1 the author's assessment of the current prospects for major reform is too bleak. Many changes since the failure of the Clinton plan make health care ...

857
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To the Editor: In their Clinical Problem-Solving article, Cornia et al. (Oct. 4 issue)1 present a case of pertussis in a 73-year-old man with several outpatient visits to health care providers while he was infectious. Although the authors discuss the ...

858

To the Editor: Previously in the Journal, we reported on a 4-year-old boy with the hepatopulmonary syndrome, a condition characterized by intrapulmonary shunting due to dilatation of pulmonary vessels in the setting of liver disease or dysfunction.1 The ...

859-860

The authors report a rapidly progressing case of cirrhosis in a renal-transplant recipient with chronic hepatitis E virus infection.

Book Review
861-862

There were overtones of the Salem witch trials and the convictions of Sacco and Vanzetti when, in 1975, a jury found Dr. Kenneth C. Edelin guilty of manslaughter for having performed an abortion by hysterotomy on an unmarried 17-year-old girl. In 1973, ...

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