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PAPERS: Katie Featherstone and Jenny L Donovan Random allocation or allocation at random? Patients' perspectives of participation in a randomised controlled trial BMJ 1998; 317: 1177-1180 [Abstract] [Full text]

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First observations to clarify our ideas: the understanding of a RCT is correlated to education.

Eugenio Pucci   (10 November 1998)

First observations to clarify our ideas: the understanding of a RCT is correlated to education. 10 November 1998
Eugenio Pucci, neurologist Istituto Malattie del Sistema Nervoso, Ancona University Send response to journal: Re: First observations to clarify our ideas: the understanding of a RCT is correlated to education.	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, Universitą di Ancona. Ospedale Regionale Torrette di Ancona, Via Conca, 16, 60020 Ancona, Italy.