Treatment by Protocol: Assessment of Gains and Losses

Abstract

Treatment as a mutilating and hazardous intervention — an injury in legal terms - requires an explanation. With a perception of the biology of a given disease in mind, based on available evidence accumulated so far, one first of all has to weigh costs, risks, and benefits of all feasible interventions. Diagnostic procedures prior to remedial interventions and subsequent differential treatments should be specified in advance. Finally, an attempt should be made to account for the outcome of an intervention. In a broad sense, it is this three-point statement — background information, strategy for actions, strategy for analyzing results — that constitutes a protocol. Any intervention by protocol may be called a therapy.

To Professor Herbert Immich on his 70th birthday.

I would like to thank John Haybittle, Richard Kay, and Martin Schumacher for their helpful suggestions.