FITTING A ROUTINE HEALTH-CARE ACTIVITY INTO A RANDOMIZED TRIAL - AN EXPERIMENT POSSIBLE WITHOUT INFORMED CONSENT

Due to possible methodological and practical problems, many researcher s refrain from using a randomized controlled trial design to evaluate procedures already embedded in routine health care. We performed a ran domized controlled trial on the effects of routine individual feedback on test ordering behavior of family physicians. The trial started aft er 4 years of feedback and lasted for 2.5 years. With some adaptations a randomized trial proved to be possible. In evaluating health-care p rocedures that cannot be blinded in a traditional way, asking full and study specific informed consent may conflict with the validity of the design. In such studies, an alternative procedure is to be considered . Our trial, with doctors as study subjects, was held on an already ac cepted routine procedure (feedback). This made it possible to refrain from obtaining study-specific informed consent. Consequently, a Hawtho rne effect and contamination of the trial arms through information lea kage could be avoided. Justification and general criteria for not obta ining full and study-specific informed consent are worked out. In heal th-care research on the performance of doctors or on interventions int o the quality of care, obtaining a general informed consent in advance is an acceptable alternative approach. (C) 1997 Elsevier Science Inc.