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"Staged-and-Tailored" Informed Consent 

Symposium

Wednesday 13th September 2023 

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This online international symposium brought together trialists, clinicians, members of the public, bioethicists to share perspectives and experiences of staged-and-tailored approaches to informed consent for individually randomised pragmatic trials (including studies using the TwiCs design approach

 

Dr Clare Relton opened the symposium with an Introduction to Staged & Tailored Informed Consent  and the Informed Consent Decisions and Choices ToolThis was followed with two Reviews of published studies using staged and tailored informed consent.

 

Key note speaker Professor Lenny Verkooijen opened the Real World Examples session with her talk about the pioneering work using this design approach in a hospital setting at UMC in the Netherlands in oncology. This was followed by five presentations on studies in hospital settings and then five presentations on real world examples in community and criminal justice settings.

 

The Thinking about Staged and Tailored Informed Consent session began with twin keynote talks on the ethics of the staged and tailored approach to informed consent from Dr Scott Kim and Professor Julius Sim. This session continued with presentations on interviews with professionals , layered patient information sheets and refining the Estimand framework for TwiCs. The day concluded with a short panel discussion.

REAL WORLD EXAMPLES - REVIEWS

Randomized controlled trials using the Trials within Cohorts (TwiCs) design: A scoping review

Dr Christof Schönenberger, University Hospital Basel, Switzerland

Use of Staged Informed Consent in Trials within Cohorts (TwiCs): a scoping review

Bev Nickolls, Queen Mary University of London, UK

REAL WORLD EXAMPLES - HOSPITAL SETTINGS

Europe

A Trials within Cohorts (TwiCs) approach in a pan-European setting – The EORTC experience with OligoCare 

Dr Beatrice Fournier, European Organisation for Research and Treatment of Cancer (EORTC)

UK

Evaluating the utility and acceptability of a structured consent process in a cell replacement therapy trial

Dr Cheney Drew, Cardiff University Centre for Trials Research

Canada

TargetKids cohort

Nutrition Recommendation Intervention trials in children’s Healthcare (NuRISH) Breastfeeding Support Internal Pilot Study: Feasibility of a modified staged informed consent model in a Trial within Cohort design   

Dr Curtis D'Hollander, St Michael's Hospital, Toronto, Canada

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Internal pilot study evaluating the feasibility and acceptability of a staged consent model within a primary care embedded randomized controlled trial to determine the effect of a childcare navigator on child health and development

Dr Michaela Kucab, St Michael's Hospital, Toronto, Canada

USA

Low-stakes intervention in cancer centre - A randomized comparison of two-stage versus traditional one-stage consent for a low-stakes randomized trial

Dr Andrew Vickers, Memorial Sloan Kettering Cancer Center, USA

THINKING ABOUT INFORMED CONSENT

Professionals’ experiences of using staged and tailored approaches to informed consent with randomised controlled intervention trials

Bev Nickolls, Queen Mary University of London, UK

Guiding principles and acceptability tests for ‘layered’ clinical trial patient information sheets

William Cragg, Clinical Trials Unit, University of Leeds, UK

Refining the estimand framework for ‘Trial within Cohort’ (TwiCs) Studies: Addressing methodological challenges and providing tailored guidance 

Dr Lois Daamen & Dr Roxanne Gal, University Medical Centre, Utrecht, The Netherlands

KEYNOTE TALKS 

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Tailoring informed consent within hospital settings

Professor Lenny Verkooijen

In this talk, Lenny Verkooijen demonstrated how oncologic care can be organized in such a way that that it is possible to learn from each patient and that randomized trials can be embedded in routine care. At the so-called innovation clinic, (new) cancer patients are systematically invited and offered broad informed consent, including consent to be randomized into (cohort) based trials. Using this approach, several innovations have been evaluated efficiently in highly generalizable trial populations, and the ones that have proven to be effective, were quickly employed in routine care.

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Staged-and-tailored informed consent: what are the ethical challenges?

Professor Julius Sim

The standard formulation of consent, as typically demonstrated in the conventional RCT, requires adequate disclosure by the researcher and a corresponding level of comprehension on the part of the potential participant, in order for consent to be autonomously given or refused. Alternative clinical trial designs that involve different models of consent must demonstrate that such consent meets an equivalent ethical standard. This talk outlined some of the challenges that this may pose to staged models of consent.

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Staged-and-tailored informed consent: what makes it ethical?

Dr Scott Kim 

RCTs embedded in clinical settings with high fidelity to pragmatic principles can be impossible to conduct if a traditional informed consent is required. This talk addressed how staged consent models can be conducted ethically by: (1) reviewing the conditions under which altered/modified consent or waivers of consent are usually considered to be ethical; and (2) engaging the key ethical challenges and objections to staged consent.

Scientific & Organising Committee

Background

Some trialists are using alternative approaches to informed consent for intervention trials with usual care comparators. 

In the stage-and-tailored approach to informed consent initial broad consent to take part in research is sought from all potential participants.

After random allocation to groups, detailed/specific information about the experimental intervention is provided only to the experimental intervention group and specific consent to be in the experimental group sought, and no detailed/ specific information about the experimental intervention is offered to the usual care group. 

 

Staged-and-tailored approaches to informed consent have been variously described. The most common examples are found in studies using the Trials within Cohorts (TwiCs) design [1, 2, and 3]. A more recent example of this approach is Just-in-time consent [4, 5]. It is thought that these stage-and tailored approaches reduce or avoid expectation and disappointment bias, improve recruitment efficiency and enhance representativeness.  Although growing in use there is limited knowledge of these alternative structured approaches.

Guidance on when (and when not) to use these type of alternative informed consent approaches in pragmatic trials is now needed.

By bringing together a wide range of stakeholders in pragmatic trial design the purpose of this symposium was to help address the James Lind Priority Setting Partnership on Recruitment in Randomised Trials Top Priority Question: "What are the best approaches to optimise the informed consent process (who should take consent, timing of consent, method and format of consent) to improve recruitment of members of the public to randomised trials?"

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