On November 7-8, 2016, the 2nd international symposium on the ethics of 'Trials within Cohorts' (TwiCs) took place in London. This event brought together researchers and practitioners to discuss the ethical implications and practical applications of the TwiCs design in randomized controlled trials (RCTs). For practitioners in the field of online therapy and special education, understanding and implementing the findings from this symposium can significantly enhance their professional skills and improve service delivery.
Understanding TwiCs
The TwiCs design involves recruiting a large observational cohort of patients with the condition of interest, regularly measuring outcomes for the entire cohort, and then conducting multiple RCTs within this cohort over time. This approach has several key features:
- Recruitment of a large observational cohort
- Regular measurement of outcomes
- Capacity for multiple RCTs
- Identification of all eligible individuals in the cohort
- Random selection of individuals for trial interventions
- Comparison of outcomes between randomly selected individuals and those receiving usual care
- "Patient-centered" informed consent process
Ethical Considerations
One of the main topics discussed at the symposium was the ethical implications of the TwiCs design. Key findings include:
- Making a compelling case to ethics committees that TwiCs designs are appropriate and ethical
- Addressing wider considerations around the ethics of inefficient trial designs
- Deciding on a case-by-case basis the ethical requirements for informed consent in TwiCs studies
Practical Applications for Practitioners
For practitioners in the field of online therapy, implementing the TwiCs design can lead to more efficient and ethical research practices. Here are some practical steps to consider:
- Develop a comprehensive cohort: Start by recruiting a large and diverse cohort of students or patients. Regularly measure outcomes to ensure data accuracy and relevance.
- Ethical Approval: Work closely with ethics committees to ensure that your TwiCs design meets all ethical requirements. Present a clear and compelling case for the design's appropriateness and ethical considerations.
- Informed Consent: Develop a patient-centered informed consent process that mirrors routine care as closely as possible. This can help in gaining the trust and cooperation of participants.
- Multiple RCTs: Utilize the cohort to conduct multiple RCTs over time. This approach not only saves resources but also allows for the testing of various interventions within the same cohort.
Encouraging Further Research
While the TwiCs design offers numerous advantages, it also raises several ethical questions that need further exploration. Practitioners are encouraged to engage in continuous research and dialogue with ethics boards to refine the TwiCs approach. Areas for future research include:
- Comparing the efficiency and acceptability of different informed consent pathways
- Introducing an 'Information and Consent' extension to the CONSORT flow diagram
- Exploring the potential of TwiCs to transform healthcare systems into learning healthcare environments
By staying informed and actively participating in the ongoing research, practitioners can ensure that their practices remain ethical, efficient, and effective.
To read the original research paper, please follow this link: The ethics of ‘Trials within Cohorts’ (TwiCs): 2nd international symposium.
