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Age and Ageing 2003; 32: 149-153
© 2003, British Geriatrics Society

Research Paper

Older people included in a venous thrombo-embolism clinical trial: a patients' viewpoint

B. Tardy, P. Lafond2, A. Viallon, A. Buchmuller1, F. Zeni and H. Decousus1

Intensive Care Unit and
1 Department of Internal Medicine, Hôpital Bellevue, CHU Saint Etienne, 42055 Cedex 2, France
2 Emergency and Intensive Care Unit, Hôpital Emile Roux, CHG Le Puy en Velay, 43012 Cedex, France

Abstract

Background and objectives: despite the numerous publications debating ethical rules of clinical research, older patients' opinions are rarely taken into account. We report on the feelings and memories related by older patients included in a randomised controlled trial.

Design and settings: a closed-questionnaire was submitted to patients, aged >65 years, who had been included in the randomised trial ‘PREPIC’. PREPIC was a multicentre open trial performed in France, that included 400 patients over 42 months. The aim of PREPIC was to evaluate the benefits and risks of prophylactic filter placement in patients with proximal deep-vein thrombosis who were considered to be at risk for pulmonary embolism.

Results: 104 patients (mean age: 74 years) were interviewed. At the time the trial was proposed to them, 45% of patients felt surprised or shocked and 30% feared incurring additional risks. While 85% of patients did not remember the trial methods (including the randomisation), most older patients (77%) not only judged that they received clear medical information but also well remembered (95%) the aim of the study and the treatment they received (67%). Finally, most older patients not only did not regret their participation (91%), but would also recommend their close relations to participate in a clinical trial (62%).

Conclusions: this study demonstrates that medical scientific information can be understood and remembered by older people.

Keywords: clinical trial, elderly patients, informed consent, patient autonomy, ethics, questionnaire


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