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January 8, 1997

Effectiveness of Right Heart Catheterization: Time for a Randomized Trial

Author Affiliations

Stanford University School of Medicine Stanford, Calif

JAMA. 1997;277(2):113. doi:10.1001/jama.1997.03540260027026

To the Editor.  —Drs Dalen and Bone1 make some valid and important points, but omit a critical aspect of the PA catheter problem. The editorialists propose to continue general use of the catheter if an acceptable prospective trial is organized and implemented.This proposal implicitly violates patient rights and safety. The basis of the proposed clinical trial is the existence of data that use of the catheter results in a large number of excess and unnecessary deaths. Dalen and Bone propose to continue these risks in large numbers of patients not in the trial while the study is being conducted. If the hypothesis is correct, then large numbers of additional excess deaths will continue in the general population of patients not enrolled in the clinical trial. At the very least, all patients (or their surrogates) about to undergo the use of the catheter should be provided with the opportunity of informed consent