Post-recruitment confirmation of informed consent by SMS

Area of Science:

• Clinical Research
• Patient Recruitment
• Informed Consent

Background:

• Clinical trial guidelines recommend a 24-hour reflection period between informing patients and obtaining consent.
• This delay can potentially hinder patient recruitment in certain clinical settings.

Purpose of the Study:

• To evaluate the feasibility and patient acceptance of a 24-hour reflection period for clinical trial consent.
• To assess the impact of a communication skills course on patient consent procedures.

Main Methods:

• Patients received oral and written information, then provided initial consent.
• A 24-hour follow-up, potentially via SMS, was used to confirm or withdraw consent.
• A randomized controlled trial (RCT) investigated the effect of a communication skills course on physician-patient interactions during consent.

Main Results:

• Out of 553 approached patients, 530 (95.8%) provided initial consent.
• Only eight patients (1.5%) later regretted their initial consent after the 24-hour period.

Conclusions:

• The low rate of consent withdrawal indicates that the 24-hour reflection period is an acceptable procedure for patients.
• This approach may facilitate informed decision-making without significantly impeding clinical trial recruitment.