"Staged-and-Tailored" Informed Consent
Tuesday 6th June 2023
10am - 4pm BST
Welcome to the TwiCs network where we share information about the Trials within Cohorts (TwiCs) approach for designing and conducting practical randomised controlled trials. The Trials within Cohorts (TwiCs) approach uses infrastructures (cohorts) to facilitate the conduct of multiple randomised controlled trials. Trials within Cohorts have been used to study interventions for cardiovascular diseases as well as multiple types of malignancies. The TwiCs approach is being adopted by researchers working in diverse settings, including primary care and specialized hospitals, to study a broad range of medical conditions, from cystic fibrosis to HIV.
See COVIDENCE for an example of this approach for tackling questions on how to manage COVID-19 in the UK population.
SYMPOSIUM: Staged and tailored informed consent, June 6th 2023.
Most patients reported positively or neutrally of having served as controls in the TwiCs design. Verweij et al, 2022
CONSORT extension for reporting RCTs using cohorts and routinely collected data (CONSORT-ROUTINE) Kwakkenbos et al
Methods and results used in the development of CONSORT-ROUTINE
Imran et al
Scoping review of randomised controlled trials conducted using cohorts Nickolls, et al
The term 'TwiCs' was coined at the first symposium on the 'cohort multiple RCT' (cmRCT) design. This approach to trial design (the cmRCT design) was first described in the BMJ in 2010 article in the context of healthcare.
Key features of the cmRCT design are:
A large observational cohort of people with the condition
Repeated measurement of outcomes for the whole cohort
Capacity for multiple randomised controlled trials over time
Patient-centred informed consent
The advantages of the design are that the cohort serves as a representative pool from which eligible people can be selected and approached for trial participation. This provides a platform for testing multiple interventions.
The standard approach to informed consent is the 'everything up front' approach. The TwiCs approach advocates the use of a patient-centred approach to informed consent procedure - one which is more similar to how information is provided in healthcare settings where information is staged in order to maximise relevance for the patient.
More than 80 studies have or are using the design. Researchers in the UK, Canada, USA, France, Netherlands, Finland, and Australia; are use the TwiCs design approach to help address questions in a variety of fields (breast cancer, bone metastases, rectal cancer, mental health, care of the elderly, rare diseases, etc). The design is now being used to trial both medicinal products (CTIMPs) and non-medicinal products.
This website describes key features of the TwiCs approach. There is a list of examples of use of the TwiCs approach in hospital, primary care and population settings. There are also articles discussing methodological issues, reporting guidelines, ethical questions, and the role of the TwiCs approach in relation to the development of Learning Health Systems.
Though originating in healthcare, the TwiCs approach to trial design can be used to inform decision making in any area, e.g. education, social care, crime, energy use.