Are patients satisfied with the information in an informed consent form? Questionnaire-based study examining patients' viewpoints.

Abstract

11021 Background: Ensuring that patients understand the information in an Informed Consent Form (ICF) is key to shared decision-making and ethical conduct of a trial. Data regarding patients’ views on the ICF are limited. Methods: Descriptive questionnaire-based survey study conducted in patients with malignancy aged 18 years and over who had earlier been enrolled in an interventional clinical trial at the Tata Memorial Center (Mumbai, India) and had filled an ICF for that trial. Patients were asked to provide their basic demographic information and fill in a 14-item questionnaire regarding their views/suggestions about the information in the ICF. Primary end point was patients’ satisfaction with the information provided in the ICF. Satisfaction was scored on a Visual Analog Scale of 0-10; 0 indicated “least satisfied” and 10 meant “most satisfied”. Level of satisfaction was categorized as low (0 – 4), moderate (5 – 7), and high (8 – 10). The study was approved by the ethics committee and registered with CTRI. Results: Between Jan 2023 – Jun 2024, we recruited 426 patients. Median age was 47 (IQR, 39-56) years; 234 (54.9%) were male, and 43 (10%) were illiterate. Malignancies included head and neck (202 [47.4%]), breast (108 [25.4%]), gastrointestinal (45 [10.6%]), thoracic (44 [10.3%]), and hematolymphoid (27 [6.3%]). Intent of therapy was curative in 375 (88%). There were 31 (7.3%) patients who did not know that they had participated in a clinical trial. The ICF was not completely read by 68 (16%) patients, due to the following reasons: excessive technical terms (38 [8.9%]), lengthy ICF (18 [4.2%]) and insufficient time provided (17 [4%]). Fifty-two (12.2%) patients did not understand the language of the ICF. Majority of patients (360 [84.5%]) suggested that ICF length be limited to 1-4 pages. Over half the patients wanted the ICF to include more information on standard treatments (230, 54%), side-effects (223, 52.3%), reason for study participation (214, 50%), and risks and benefits (249, 58.5%). Twenty-two (8%) patients felt over-burdened with the information provided in the ICF. Median satisfaction score was 8 (IQR 6 – 10); but only 56.6% patients were highly satisfied with the information in the ICF. Low satisfaction was reported by 167 (39.2%) patients with the information in the reimbursement/compensation section and 164 (38.%) with the alternative treatment options section. Age, sex, education, type of cancer, intent of cancer-directed therapy, and socioeconomic status did not significantly impact the level of satisfaction with the information in the ICF. Conclusions: The information in the ICF for interventional clinical trials needs to be concise, and in simple language. Addressing patient preferences and providing clear information in each section would enhance patient understanding and satisfaction, fostering a more effective and ethical informed consent process. Clinical trial information: CTRI/2023/01/048999 .