Patients' evaluation of informed consent to postponed information: cohort study
BMJ 2004; 329 doi: https://doi.org/10.1136/bmj.38041.636250.EE (Published 08 July 2004) Cite this as: BMJ 2004;329:86
- Han Boter (h.boter@azu.nl), junior researcher1,
- Johannes J M van Delden, professor of medical ethics2,
- Rob J de Haan, professor of clinical epidemiology3,
- 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
- Accepted 18 February 2004
Introduction
Fundamental bias can be introduced in randomised trials if patients cannot be masked for the allocated strategy and assess subjective outcomes. In such a trial, on the effectiveness of outreach stroke care in addition to standard care, we masked patients by modifying the informed consent procedure. Before discharge home we informed patients that we were studying their needs six months after discharge; we could not inform about an additional research question because that would affect the results; this question entailed no risk and would be clarified after follow up; and the ethics committee approved this study.1 After we got consent we randomised patients.
We informed patients in the intervention group about the outreach care programme and asked them to participate, but we kept them ignorant that we were studying the programme for effectiveness. Controls received no further information. After follow up, we sent all participants a …