Hepatitis: Baker WL

Pals SL, Murray DM, Alfano CM, Shadish WR, Hannan PJ, Baker WL. · Division of HIV/AIDS Prevention, National Center for HIV, Viral Hepatitis, STD and TB Prevention, MS E-45, Centers for Disease Control and Prevention, 1600 Clifton Rd, Atlanta, GA 30333, USA. · Am J Public Health. · Pubmed #18556603 No free full text.

Abstract: OBJECTIVES: We reviewed published individually randomized group treatment (IRGT) trials to assess researchers' awareness of within-group correlation and determine whether appropriate design and analytic methods were used to test for treatment effectiveness. METHODS: We assessed sample size and analytic methods in IRGT trials published in 6 public health and behavioral health journals between 2002 and 2006. RESULTS: Our review included 34 articles; in 32 (94.1%) of these articles, inappropriate analytic methods were used. In only 1 article did the researchers claim that expected intraclass correlations (ICCs) were taken into account in sample size estimation; in most articles, sample size was not mentioned or ICCs were ignored in the reported calculations. CONCLUSIONS: Trials in which individuals are randomly assigned to study conditions and treatments administered in groups may induce within-group correlation, violating the assumption of independence underlying commonly used statistical methods. Methods that take expected ICCs into account should be used in reexamining past studies and planning future studies to ensure that interventions are not judged effective solely on the basis of statistical artifacts. We strongly encourage investigators to report ICCs from IRGT trials and describe study characteristics clearly to aid these efforts.

Baker EL, Loewenthal T, Salerno E, Baker WL. · Evidence-Based Practice Center, Hartford Hospital, Hartford, CT, USA. · Am J Health Syst Pharm. · Pubmed #19299370 No free full text.

Abstract: PURPOSE: A case of probable enoxaparin-induced hepatotoxicity is described. SUMMARY: A 29-year-old woman sought treatment from a pulmonologist for a dry, hacking, constant cough not relieved by fast-acting inhalers or narcotic cough medications that had lasted for three weeks. Her primary care physician had earlier made a preliminary diagnosis of pertussis and prescribed a short course of azithromycin and corticosteroids, which did not help relieve the symptoms. Computed tomography angiography of her chest revealed multiple bilateral pulmonary emboli with a moderate clot burden, which resulted in her hospitalization. The pulmonary emboli were thought to be associated with her oral contraceptive, which was discontinued at hospital admission. Anticoagulant therapy was initiated with subcutaneous enoxaparin and oral warfarin. Beginning the second day of therapy, the patient complained of nausea and associated vomiting. Diagnostic procedures did not reveal any liver, kidney, splenic, or pancreatic abnormalities. The results of laboratory tests revealed elevated levels of hepatic enzymes, including alanine transaminase (ALT) and aspartate transaminase (AST). Tests for hepatitis A, B, and C were negative. Enoxaparin therapy was discontinued, and the patient was maintained on oral warfarin. Clinical and laboratory signs of liver injury resolved over the next few days, with a return to baseline levels of AST and ALT levels over the subsequent months. According to the Naranjo et al. adverse-reaction probability scale, enoxaparin was the probable cause of hepatotoxicity in this patient. CONCLUSION: A woman receiving enoxaparin every 12 hours developed signs and symptoms of hepatotoxicity after the second dose. The case was unusual in the rapidity and magnitude of hepatic enzyme elevation.