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Users' Guides to the Medical Literature
XIX. Applying Clinical Trial Results A. How to Use an Article Measuring the Effect of an Intervention on Surrogate End Points
Heiner C. Bucher, MD, MPH;
Gordon H. Guyatt, MD, MSc;
Deborah J. Cook, MD, MSc;
Anne Holbrook, MD, MSc;
Finlay A. McAlister, MD;
for the Evidence-Based Medicine Working Group
JAMA. 1999;282:771-778.
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CLINICAL SCENARIO
You are a physician seeing a 62-year-old woman with postmenopausal osteoporosis. Her bone mineral density, as measured by dual-energy x-ray absorptiometry, is 2.5 SDs below the mean value in premenopausal women. Although she does not have back pain, a spinal radiograph shows an old vertebral fracture. The patient has not yet experienced problems as a result of her vertebral fracture, but she is disturbed by the prospect that she may end up like her mother whose osteoporotic fractures have resulted in severe, long-term back pain.
The patient has reflux esophagitis and a past endoscopy revealed nonspecific gastritis. A specialist had prescribed alendronate, which the patient had to stop taking after several weeks because of dyspepsia. She searched the Web and discovered . . . [Full Text of this Article]
THE SEARCH
INTRODUCTION
THE GUIDES
Are the Results Valid? Is There a Strong, Independent, Consistent Association Between the Surrogate End Point and the Clinical End Point? Is There Evidence From Randomized Trials in Other Drug Classes That Improvement in the Surrogate End Point Has Consistently Led to Improvement in the Target Outcome? Is There Evidence From Randomized Trials in the Same Drug Class That Improvement in the Surrogate End Point Has Consistently Led to Improvement in the Target Outcome? What Were the Results? How Large, Precise, and Lasting Was the Treatment Effect? Will the Results Help in Caring for My Patients? Are the Likely Treatment Benefits Worth the Potential Harms and Costs?
RESOLUTION OF THE SCENARIO
Author Affiliations: Medizinische Universitäts-Poliklinik, Kantonsspital Basel, Basel, Switzerland (Dr Bucher); Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Ontario (Drs Guyatt, Cook, and Holbrook); and Division of General Internal Medicine, University of Alberta Hospital, Edmonton (Dr McAlister).
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