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This project aims to address the challenges in informed consent and decisions under time-constrained medical settings, via both improving risk communication and seeking optimal decision modes. We focus on time-sensitive clinical trials, which are increasingly common (e.g., stroke trials, various surgical trials and infectious disease clinical trials), often of high stake (e.g., life-threatening), and can be crucial to public health crises (e.g., antimicrobial resistance trials, COVID-19 antiviral trials). Timely recruitment and consent are crucial for developing critical medical interventions and generating evidence for managing diseases.
However, low recruitment rates and poor consent quality pose a threat to timely completion of trials and statistical power and validity of trials, and damage patients\u2019 and public\u2019s trust in healthcare, medicine and research. A recent review of published randomised control trials over past two decades in the UK found only half of the trials reached the original recruitment target, and one third of the trials had to extend recruitment duration. These result in significant increase in costs of medical research, which in turns drives pharmaceutical prices and increases healthcare expenditures.
While several guidelines and regulations have been introduced to regulate informed consent in clinical trials, most regulations and guidelines focus on the contents of the provided information. There is a lack of consideration regarding the processes of communication. Time-sensitive medical settings require a decision to be reached quickly to avoid the delay of treatment. However, people experience information overload and emotional distress under time pressure, which leads to limited information processing and maladaptive behavioural responses such as avoidance (i.e., refusal without consideration). Both quality and rate of consent can be severely compromised if the challenge left unaddressed.
Therefore, this project aims to:
Understand Singaporeans\u2019 experiences of decision-making and consent under time pressure in time-sensitive clinical trials either for themselves or for family members, more specifically, to<\/span>- Identify their needs for information and gaps in information processing. <\/li>
- identify key social, cognitive, and psychological factors affecting the process and quality of informed decisions.<\/li>
- Identify both common and unique patterns in [A1] across decision settings (non-ICU vs ICU) and consent roles (for oneself vs for others). <\/li>
- Explore the solutions to address informed consent under time-constrained situations, by <\/li>
- Exploring Singaporeans\u2019 views on accepted ways of risk communication (e.g., multimedia) and consent modes (e.g., early enrolment\/advanced consent) in clinical trials. <\/li>
- Developing recommendations to inform potential policy changes and clinical guidelines.<\/li><\/ol><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"
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