Een aangepaste 'informed consent'-procedure waarbij de volledige informatie pas achteraf wordt gegeven: geen bezwaar bij deelnemende patiënten

To determine whether a modified informed-consent procedure, in which permission is requested to send a questionnaire and to provide all the information about the study only after it is completed, would raise objections from patients who were asked to participate in a study on satisfaction with the follow-up care after a cerebrovascular accident.

Design

Descriptive cohort study.

Method

123 patients were approached for the randomised study. The patients who were included were interviewed by telephone two weeks after they had been sent the postponed information.

Results

During recruitment, 5 patients refused to participate but this was not because of the modified procedure. Of the 112 survivors, 102 (91) could be interviewed and 79 had read the letter. Nobody (0; 95 CI: 0-5) said that their trust in doctors had decreased; one patient (1; 95 CI: 0-7) indicated decreased willingness to participate in future studies; two patients (3; 95 CI: 0-9) were dissatisfied about the procedure followed.

Conclusion

The participants in the trial had no major objections to the modified informed-consent procedure in which full information was given only after their participation had ended. Furthermore, patients did not refuse participation because of the modified procedure.

Ned Tijdschr Geneeskd 2005;149:29-32