A randomised controlled study of an audiovisual patient information intervention on informed consent and recruitment to cancer clinical trials

Abstract

Recruitment to cancer clinical trials needs to be improved, as does patient knowledge and understanding about clinical trials, in order for patients to make an informed choice about whether or not to take part. Audiovisual patient information (AVPI) has been shown to improve knowledge and understanding in various areas of practice, but there is limited information about its effect in the cancer clinical trial setting, particularly in relation to consent rates. In this study, 173 patients were randomised to receive either the AVPI, in addition to the standard trial-specific written information, or the written information alone. There was no difference in clinical trial recruitment rates between the two groups with similar study entry rates: 72.1% in the AVPI group and 75.9% in the standard information group. The estimated odds ratio for refusal (intervention/no intervention) was 1.19 (95% CI 0.55 -2.58, P ¼ 0.661). Knowledge scores increased more in the AVPI group compared to the standard group (P ¼ 0.0072). The change in anxiety score between the arms was also statistically significant (P ¼ 0.011) with anxiety improving in the intervention arm more than in the no intervention arm. Audiovisual patient information was shown to be a useful tool in improving patient knowledge and anxiety, but further work is necessary in relation to its effect on clinical trial recruitment rates.

A Comparison of Patient Knowledge of Clinical Trials and Trialist Priorities

“…Although tests and scoring systems differ, studies of general patient populations have shown similar results 11,17,18 . By comparison, a study involving participants in clinical trials showed higher knowledge scores 22 , consistent with a similar subset in our data.…”

“…Education can improve apparent willingness to join a clinical trial 2,18,20,21 , but it is not clear that such willingness translates into improved trial recruitment 2,17,20 .…”

“…Education interventions have sometimes translated into a greater declared willingness to join clinical trials in oncology 2,18 , but the resulting recruitment has often failed to improve 17,19,23 . That failure may have several causes.…”

“…Patient knowledge about clinical trials is poor, including knowledge of several concepts ranked important specific clinical trial or of clinical trial methods 11,[16][17][18][19] . Education can improve apparent willingness to join a clinical trial 2,18,20,21 , but it is not clear that such willingness translates into improved trial recruitment 2,17,20 .…”

Audiovisual Multimedia Combined with Standard, Verbal, Informed Consent; Enhancing the Satisfaction and Comprehension of Surgical Patients: A Comparative Trial in Patients Undergoing Laparoscopic Cholecystectomies at the HRH Princess Maha Chakri Sirindhorn Medical Center, Thailand

“…The results correlate with research performed in other countries. Some previous studies revealed that providing the patient with audiovisual information is effective in giving the patient knowledge and understanding before signing the statement of informed consent [4,5] in many different kinds of surgeries such as; laparoscopic cholecystectomies [6,7], gastric banding, knee arthroscopies, and central venous catheterizations. These studies found that the use of multimedia help the patient to gain a better understanding of the disease process and the surgical proce-dure, without experiencing any more anxiety that those not receiving the information materials [8][9][10].…”