Sunday, November 25, 2007

Lung Transplantation: Exempt from the scrutiny of a randomized controlled trial?

In last week's NEJM, Liou et al in an excellent article analyzed pediatric lung transplant data and found that there is scant evidence for an improvement in survival associated with this procedure:

The authors seem prepared to accept the unavoidable metholodical limitations of their analyses and call for a randomized controlled trial (RCT) for pediatric lung transplantation. The editorialist, however, does not share their enthusiasm for a RCT, and appears to take it on faith that the new organ allocation scheme (whereby the sickest children get organs first) will make everything OK:

True believers die hard. And because of their hardiness, an RCT will be difficult to perform, as many pediatric pulmonologists will be loathe to allow their patients to be randomized to no transplant. They have no individual equipoise, even though there appears to be collective equipoise among folks willing to give serious consideration to the available data.

What we have here may be an example of what I will call "action bias" - which is basically the opposite of omission bias. In omission bias, people fail to act even though outcomes from action are superior to those from omission - often as a result of reluctance to risk or cause direct harm even though direct benefits outweigh them in the net. Action bias, as the enantiomer of omission bias, would refer to causing worse outcomes through action because of the great reluctance to stand by helplessly while a patient is dying, even when the only "therapies" we can offer make patients worse off - save for the hope they offer, reason notwithstanding.

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