Random allocation or allocation at random? Patients' perspectives of participation in a randomised controlled trialBMJ 1998; 317 doi: https://doi.org/10.1136/bmj.317.7167.1177 (Published 31 October 1998) Cite this as: BMJ 1998;317:1177
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EDITOR- We appreciated Featherstone and Donovan's report about
patients' perspectives of participation in a randomised controlled trial
(RCT) (1). We recently investigated the ability of understanding and
retaining information about RCTs in patients with Alzheimer's disease and
middle aged and elderly normal subjects (caregivers; n= 40, 18 M, 22 F;
age: mean±SD= 64±6, range= 50-76 years; schooling: mean±SD= 6±3, range= 5-
17 years; MMSE: mean±SD= 29±1, range= 25-30). Subjects were informed in a
semi-structured manner, including actual information sheets. Twenty-eight
(70%) caregivers were considered as unable to demonstrate the reason why
placebo, randomisation and double-blind procedures were used. Furthermore,
20% of the caregivers were judged as incapable of recalling anything other
than a vague participation in an "experiment" and the possible intake of a
placebo but with no explanation for or idea of the reason. Using a 4-step
scale to rate the competency to participate in a RCT, based on the
evaluation of the understandings of "information", a significantly
positive correlation between poor competency and low education was found.
So, we agree that accurate information is not capable of ensuring
interpretation of RCT features. Our results are similar to those reported
by Featherstone and Donovan, in the sense that only 30% of the subjects
from the ClasP study and the 20% of the normal subjects we studied are
reported as unaware of the involvement of chance. However, the education
in the ClasP subjects was not reported. We wonder whether a correlation
exists between awareness of randomisation and education in these subjects.
We hope that cross-culture studies will contribute further to our idea
that the problem of information based on a scientific standard in
obtaining consent to RCT is strictly linked to social and cultural
background. The large discrepancy between the complexity of RCT methods
and the poverty of cultural background in a considerable number of
potential participants in RCTs should be less hypocritically censored when
discussing issues concerning informed consent.
(1) Featherstone K, Donovan L. Random allocation or allocation at
random? Patients' perspectives of participation in a randomised controlled
trial. BMJ 1998;317:1177-1180.
E. Pucci, Neurologist, N. Belardinelli, Neurologist, M. Signorino,
Neurologist, F. Angeleri, Professor of Neurology.
Istituto Malattie del Sistema Nervoso, Clinica Neurologica, Università di
Ancona. Ospedale Regionale Torrette di Ancona, Via Conca, 16, 60020
Competing interests: No competing interests