Volume 14, Number 3, September 2002

Consent for Enrolment in Randomised Controlled Trials: a Questionnaire Study

Hidemichi Yuasa,1,2 Tetsuya Yoda,3 Toshihiko Kawai,2 Kenji Kakudo,3 Masashi Sugisaki,5 Masahiro Hinoshita,6 Toshikage Jinde,2,7 Yuji Hachiya,8 Masayuki Sugiura,1 Yosuke Jinno,2 Shintarou Suzuki2

1Department of Oral and Maxillofacial Surgery, Nagoya City Jyouhoku Municipal Hospital, Nagoya, Japan
2The Second Department of Oral and Maxillofacial Surgery, School of Dentistry, Aichi-Gakuin University, Aichi, Japan
3Department of Oral-Maxillofacial Surgery, Dentistry and Orthodontics, The University of Tokyo Hospital, Tokyo, Japan
4Second Department of Oral and Maxillofacial Surgery, Osaka Dental University, Osaka, Japan
5Department of Dentistry, Jikei University School of Medicine, Tokyo, Japan
6Department of Dentistry, Oral and Maxillofacial Surgery, Inazawa City Hospital, Inazawa, Japan
7Department of Oral and Maxillofacial Surgery, Handa Municipal Hospital, Handa, Japan
8Department of Oral and Maxillofacial Surgery, Hekinan City Hospital, Hekinan, Japan


Abstract
Objectives: To test the hypothesis that the enrolment rate in a randomised controlled trial involving 'malignant tumours' would be lower than that involving 'common illness'.
Patients and Methods: Outpatients from oral and maxillofacial surgery clinics were requested to select from among the following 3 statements that which most closely reflected their attitude toward randomized controlled trials for a hypothetical common illness and a malignant tumour: "I may take part in a randomized controlled trial" (accept), "I will take part in a clinical study based on study conditions" (conditional), or "I will not take part in a randomised controlled trial" (refuse).
Results: For common illness, 117 of 1083 participants (10.8%) selected 'accept', 664 (61.3%) selected 'conditional', and 302 (27.9%) selected 'refuse'. For malignant tumours, 137 participants (12.7%) selected 'accept', 644 (59.5%) selected 'conditional', and 302 (27.9%) selected 'refuse'. Among those who would refuse to participate in a randomised clinical trial for a common illness, 27.2% of patients selected "I will take part in a clinical study based on study conditions" or "I may take part in a randomised controlled trial" for malignant tumour.
Conclusion: The hypothesis that the enrolment rate in a randomised controlled trial may be lower when patients are thought to suffer from malignant tumours than when they are thought to suffer from common illness is not justifiable.

Key words:
Research, Randomized controlled trials, Informed consent

Asian J Oral Maxillofac Surg. 2002;14:125-131.
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