Literature DB >> 15651501

[A modified informed-consent procedure in which the complete information is given retrospectively: no objection from participating patients].

H Boter1, J J M van Delden, R J de Haan, G J E Rinkel.   

Abstract

OBJECTIVE: 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.

Entities:  

Mesh:

Year:  2005        PMID: 15651501

Source DB:  PubMed          Journal:  Ned Tijdschr Geneeskd        ISSN: 0028-2162


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