Getting informed consent from patients to take part in the clinical training of students: randomised trial of two strategiesBMJ 2001; 323 doi: http://dx.doi.org/10.1136/bmj.323.7311.488 (Published 01 September 2001) Cite this as: BMJ 2001;323:488
- Katarina Westberg, medical studenta,
- Niels Lynøe, associate professor ()a,
- Ann Lalos, professorb,
- Mats Löfgren, associate professorb,
- Mikael Sandlund, consultantb
- a Medical Ethics, Umeå University, S-901 87 Umeå, Sweden
- b Department of Clinical Science, University Hospital of Northern Sweden, S-901 85 Umeå
- Correspondence to: N Lynøe
- Accepted 25 June 2001
A few studies have examined the empirical aspect of the ethics of clinical training,1-3 but no randomised study has compared different strategies for giving information to patients about clinical training. We conducted a randomised, double blind trial to determine whether advance written information leads patients attending gynaecology outpatient clinics to decline to take part in the clinical training of medical students.
Methods and results
We recruited 163 patients between March 1998 and March 1999, giving them a date for a future consultation. The patients were also randomly allocated to receive either advance written information (plus the standard procedure of the individual gynaecologist) or only the standard procedure of the individual gynaecologist when they arrived at the gynaecology clinic. The advance information stated that (a) the clinic was involved in the clinical training of medical students; (b) the training of future doctors depended on the participation of patients; (c) the skill of the gynaecologist whom the patient would meet resulted from previous patients' participation in training; and (d) participation in the training was strictly voluntary. We obtained ethical approval from the regional research ethics committee in Umeå.
Of the 163 patients, 77 received advance information and 86 were allocated to the standard procedure of the individual doctor. Forty patients receiving advance information and 41 patients allocated to current procedure dropped out for various reasons (for example, the appointed time was inconvenient, they wanted to see a female gynaecologist, or they had already recovered by the consultation time). A questionnaire was completed by 71 of the remaining 82 patients immediately after the consultation. Thus 32 patients remained in the group receiving advance information and 39 in the group allocated to standard procedure.
The patients were not told of their participation in the trial until they had completed the questionnaire, which asked for their views on the information they had received about medical students being present and on the way they had been told of the option to decline to take part in the clinical training; it also asked about their motives for permitting a student to attend the consultation. The doctors and students were unaware of whether their patients had received advance information.
None of the 71 patients declined to participate in the clinical training of medical students; therefore whether they had been informed in advance had no effect on their decision to participate. Generally, most patients said they felt positive in principle about having students present during the consultation and the pelvic examination. Nine patients (two in the group who received advance information and seven in the group allocated to standard procedure), however, felt negative about this. One patient in the group who received advance information stated that she wished to be alone with the doctor on this occasion, compared with eight patients in the other group (Fisher's exact test, P=0.035).
Patients who had received advance information perceived the information as good or rather good, whereas nine patients in the group allocated to current procedure stated that they had not been informed at all (table).
Most patients (55/71) said that they “felt free” to decline to participate in the clinical training. Of the 16 patients who did not feel free, four were in the group who had received advance information and 12 in the group allocated to current procedure. Feeling free when asked to participate in the clinical training seems to be significant (χ2 test, P=0.002).
The strategy on giving advance written information did not jeopardise or negatively affect the patients' inclination to participate in the clinical training of medical students. Arguments for not informing patients in advance seem to be based more on prejudice than on empirical evidence. Furthermore, if the training doctor adopted a policy of always giving patients advance written information, this might act as a model for students and thus for future doctors.
Contributors: KW helped to design and monitor the study and collected data. She also presented the first analysis and draft of the paper. NL helped to formulate the research hypothesis and design the study. He was also responsible for the analysis and for writing the paper. AL helped with the design and analysis and contributed to the writing and editing of the paper. ML helped to formulate the research hypothesis and design the study. He also helped with the analysis and contributed to the writing of the paper. MS helped to write and edit the paper.
Funding This study received support through a grant from the Swedish Council for Social Research (grant No 97-0074).
Competing interests None declared.