Background and objective:
Patients' knowledge and attitudes regarding clinical research may affect study recruitment and adherence. Efforts to enhance patients' understanding and to learn about their concerns around involvement in clinical research are necessary.
We recruited patients with diabetes from six tertiary hospitals in Beijing and Jinan, and randomised them into education or no intervention groups. Trained researchers educated the patients on clinical research including definitions, methods, ethical issues, benefits and risks, and patients' rights for 90 minutes, and conducted a semi-structured interview with patients post-education. We compared patients' knowledge and attitudes between groups.
We randomised 258 inpatients. There was no significant difference between the education and control group in age, sex, education, and job type at baseline (Table 1). For 19 items that assessed the concepts of understanding and attitudes towards participation, the proportion of patients with sound knowledge and concerns was significantly higher in the education group (Table 2) (P < 0.05). After education, almost all patients recognized the value of clinical research and would participate for the benefits of health improvement and scientific contribution. There were some concerns about safety, psychological pressure, amount of time needed and privacy disclosure. Patients expected more information on the benefits and risks, to have staff to answer relevant questions from patients and to receive financial subsidy. Fifty-seven per cent of the patients preferred hospital-based research where well-equipped medical facilities were guaranteed and communication and encouragement between patients was better; 23% wanted to participate in clinical research at home to save time and interfere less with daily treatment and life.
Education significantly increased patients' understanding of clinical research concepts and they were more willing to participate with a positive attitude. There are, however, concerns about risks, time, privacy and psychological pressure. We recommend additional education efforts around clinical research concepts in the future to increase informed consent and adherence in clinical studies.
This research is about education efforts to promote patients' understanding of clinical research and we examined patients' views about participating in research.