[Quality of information transfer for informed consent: an experimental study in 21 patients]

Delivering information to the patient, an ethical obligation recognized for years, has recently become a legal obligation. Proof of information delivery has become the legal responsibility of the surgeon. We conducted a prospective study to evaluate the quality of information transfer by assessing patient comprehension of information delivered in an orthopedic surgery unit.

All patients attending consultations before undergoing arthroscopic treatment for rotator cuff tendinopathy were enrolled in this study when the consultation was conducted in the presence of an observer. Two questionnaires, one for the patient and one for the surgeon, were used to collect given information about the pathological condition, the modalities of treatment, and the expected results of the treatment and its complications.

All 21 patients included in the study considered they had been well informed and that they had understood their pathological condition as well as the complications of the proposed treatment. However, agreement between their stated comprehension and the information delivered was poor, varying from 15 to 50%. Furthermore, 90% of the patients stated they had understood the potential complications of the surgical procedure, despite the fact that the consulting surgeons had not (generally) provided information on such complications.

There is a gap between what the surgeon says (or thinks he/she says) and what the patient understands. Potential biases in this study (non-unbiased observer) might explain this discordance which was probably related to the unequal relationship between the patient and the physician for any consultation. Therefore, the basis of informed consent cannot be found in the details concerning complications actually delivered to the patient. Surgeons must become aware that the patients understand very little of their explanations. This does not mean that the information should not be delivered but on the contrary that it must be. The important point is not necessarily the information content but rather the quality of the human relationship enabling information transfer.