Patients' evaluation of informed consent to postponed information: cohort study
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《英国医生杂志》
1 Department of Neurology, Rudolf Magnus Institute of Neuroscience, University Medical Centre Utrecht, PO Box 85500, 3508 GA Utrecht, Netherlands, 2 Julius Centre for Health Sciences and Primary Care, University Medical Centre Utrecht, 3 Department of Clinical Epidemiology and Biostatistics, Academic Medical Centre, PO Box 22660, 1100 DD Amsterdam, Netherlands
Correspondence to: H Boter h.boter@azu.nl
Introduction
The data from patients who had declined recruitment in our trial and from those who had participated do not support the critique that the modified informed consent procedure would reduce patient recruitment, or induce a diminishing trust in doctors or less willingness to participate in future studies. However, a substantial group of recruited patients could not be interviewed, and it could still be argued that this modified procedure fails to treat patients with enough respect. The modified procedure with postponed information deserves consideration when patients cannot be masked and assess subjective outcomes, when the additional treatment entails no risk, and when this treatment seems attractive to patients.
We thank all patients who participated in the study. The members of the steering committee of the Home Evaluation of Stroke Induced Aid Study Group are KW Albrecht, A Algra, H Boter, JA Carpay, J van Gijn, RJ de Haan, LJ Kappelle, VIH Kwa, GJE Rinkel, and M Vermeulen.
Contributors: All authors participated in designing the study and developing the questionnaire that was used during the interviews. H Boter collected the data, performed the analyses, and wrote the successive drafts of the paper. JJMvanD, RJdeH, and GJER supervised and commented on all drafts. All authors approved the manuscript. HB is guarantor.
Funding: An established clinical investigator grant from the Netherlands Heart Foundation to GJE Rinkel (grant D98.014), a grant from the Netherlands Heart Foundation and the Netherlands Organisation for Health Research and Development (940-32-014), and a grant from the University Medical Centre Utrecht.
Competing interests: None declared.
Ethical approval: Ethics committees of the participating centres approved the procedures followed.
This article was posted on bmj.com on 21 June 2004: http://bmj.com/cgi/doi/10.1136/bmj.38041.636250.EE
References
Boter H, van Delden JJM, de Haan RJ, Rinkel GJE, for the Home Evaluation of Stroke Induced Aid Study Group. Modified informed consent procedure: consent to postponed information. BMJ 2003;327: 284-5.
Dennis M. An imperfect compromise. BMJ 2003;327: 286.
Doyal L. Informed consent in medical research: journals should not publish research to which patients have not given fully informed consent—with three exceptions. BMJ 1997;314: 1107-11.
Lambert MF, Wood J. Incorporating patient preferences into randomized trials. J Clin Epidemiol 2000;53: 163-6.
McLean S. No consent means not treating the patient with respect. BMJ 1997;314: 1076.(Han Boter, junior researc)
Correspondence to: H Boter h.boter@azu.nl
Introduction
The data from patients who had declined recruitment in our trial and from those who had participated do not support the critique that the modified informed consent procedure would reduce patient recruitment, or induce a diminishing trust in doctors or less willingness to participate in future studies. However, a substantial group of recruited patients could not be interviewed, and it could still be argued that this modified procedure fails to treat patients with enough respect. The modified procedure with postponed information deserves consideration when patients cannot be masked and assess subjective outcomes, when the additional treatment entails no risk, and when this treatment seems attractive to patients.
We thank all patients who participated in the study. The members of the steering committee of the Home Evaluation of Stroke Induced Aid Study Group are KW Albrecht, A Algra, H Boter, JA Carpay, J van Gijn, RJ de Haan, LJ Kappelle, VIH Kwa, GJE Rinkel, and M Vermeulen.
Contributors: All authors participated in designing the study and developing the questionnaire that was used during the interviews. H Boter collected the data, performed the analyses, and wrote the successive drafts of the paper. JJMvanD, RJdeH, and GJER supervised and commented on all drafts. All authors approved the manuscript. HB is guarantor.
Funding: An established clinical investigator grant from the Netherlands Heart Foundation to GJE Rinkel (grant D98.014), a grant from the Netherlands Heart Foundation and the Netherlands Organisation for Health Research and Development (940-32-014), and a grant from the University Medical Centre Utrecht.
Competing interests: None declared.
Ethical approval: Ethics committees of the participating centres approved the procedures followed.
This article was posted on bmj.com on 21 June 2004: http://bmj.com/cgi/doi/10.1136/bmj.38041.636250.EE
References
Boter H, van Delden JJM, de Haan RJ, Rinkel GJE, for the Home Evaluation of Stroke Induced Aid Study Group. Modified informed consent procedure: consent to postponed information. BMJ 2003;327: 284-5.
Dennis M. An imperfect compromise. BMJ 2003;327: 286.
Doyal L. Informed consent in medical research: journals should not publish research to which patients have not given fully informed consent—with three exceptions. BMJ 1997;314: 1107-11.
Lambert MF, Wood J. Incorporating patient preferences into randomized trials. J Clin Epidemiol 2000;53: 163-6.
McLean S. No consent means not treating the patient with respect. BMJ 1997;314: 1076.(Han Boter, junior researc)