http://bmj.com/cgi/content/full/323/7311/488
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Papers
Getting informed consent from patients to take part in the clinical
training of students: randomised trial of two strategies
Katarina Westberg
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 niels.lynoe@socmed.umu.se
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Methods
and results |
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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).
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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 (
2 test, P=0.002).
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Comments |
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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.
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Acknowledgments |
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.
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Footnotes |
Funding: This study received support through a grant from the Swedish
Council for Social Research (grant No 97-0074).
Competing interests: None declared.
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References |
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1. |
Lynoe N, Sandlund M, Westberg K, Duchek M. Informed
consent in clinical training |
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2. |
Lynoe N, Sandlund M. Ethical and educational aspects of
clinical training |
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3. |
O'Flynn N, Spencer J, Jones R. Consent and confidentiality
in teaching in general practice: survey of patients' views on presence of
students. BMJ 1997; 315: 1142 |
patients' experiences and
attitudes. Med Educ 1998; 32: 465-471(Accepted 25 June 2001)
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