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"Staged-and-Tailored" Informed Consent

International Symposium

Tuesday 6th June 2023

10am - 4pm BST

 

A growing number of trials with usual care comparators use an informed consent process that is both staged for, and tailored to, the individual.  This symposium brings together triallists, clinicians, patients, bioethicists, and health regulators to share their perspectives and experiences of staged-and-tailored approaches to informed consent for individually randomised pragmatic trials (including those using the TwiCs design approach).

This one-day free online symposium will include invited keynote talks interspersed with discussions, mini presentations and posters. 

The objectives are to share and explore what is known about the use, acceptability and efficiency of staged-and-tailored approaches to informed consent and to provide a forum for discussion.

Outputs from this symposium will support the future development of guidance on these type of approaches to informed consent for pragmatic trials.

 

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Key note speakers tbc 

Call for Abstracts 

Prospective authors of posters or presentations are invited to submit a title and maximum 400 word abstract.

Submission deadline: 3rd April 2023.

Scientific and Organising Committee

Bev Nickolls (Lead Co-ordinator)

PhD Research Student - Centre for Evaluation & Methods, Queen Mary University London, UK

Dr Clare Relton (Chair)

Senior Lecturer Clinical/Public Health Trials - Centre for Evaluation & Methods, Queen Mary University, London, UK

Dr Alain Amstutz

Physician Researcher, CLEAR Methods Center, Division of Clinical Epidemiology, Department of Clinical Research, University Hospital Basel, University of Basel, Switzerland

Dr Andrew Vickers

Biostatistician & Research Methodologist - Memorial Sloan Kettering Cancer Centre, USA

Professor Lenny Verkooijen

Professor of Evaluation of Image-Guided Treatment - Utrecht Mecial Centre, Netherlands

Professor Julius Sim
Statistician & Ethicist, School of Medicine, Keele University, UK

Indrani Manoharan

Clinical Trial Manager, Oxford Population Health, Oxford University

Dr Roxanne Gal

Post doctoral researcher - Utrecht Medical Centre, Utrecht, Netherlands

Lois Daamen

Clinical Epidemiologist, Post doctoral researcher - Utrecht Medical Centre, Utrecht, Netherlands

Dr Julia Wade

Senior Lecturer in Qualitative Health Science - Bristol Medical School, University of Bristol, UK

 

Background

Standard guidance on informed consent process for randomised controlled trials of health interventions is useful for trial designs where all participants will receive either an experimental intervention or placebo i.e. something other than usual care. However, there is little specific guidance on informed consent approaches for trials with usual care comparators.

 

A growing number of triallists are using alternative approaches to informed consent for trials with usual care comparators in order to reduce or avoid expectation and disappointment bias, improve recruitment efficiency and enhance representativeness. These alternative approaches either stage and/or tailor the informed consent processes. For example, the usual care group is not informed about a specific intervention if they will not eventually offered that intervention during the trial. Examples of these staged-and-tailored approaches include the Trials within Cohorts (TwiCs) design [1] now being used in a range of clinical contexts [2] and the One-stage versus Two [3] currently being tested in cancer.

However, there is limited knowledge of these alternative structured approaches and little guidance on informed consent approaches for these types of pragmatic trials.

This symposium addresses 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?

References

1.       Relton C, Torgerson D, O'Cathain A, Nicholl J. Rethinking pragmatic randomised controlled trials: introducing the "cohort multiple randomised controlled trial" design. BMJ. 2010;340:c1066.

2.       Nickolls B, Relton C, Eldridge S, Zwarenstein M, McCall S, Hemkens L, et al. Protocol for a scoping review of randomised controlled trials conducted using cohorts. Open Science Framework. 2021.

3.       Vickers AJ, Young-Afat DA, Ehdaie B, Kim SY. Just-in-time consent: The ethical case for an alternative to traditional informed consent in randomized trials comparing an experimental intervention with usual care. Clin Trials. 2018;15(1):3-8.

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This international symposium is supported by a PPI grant from the Research Design Service (London, UK)

Abstract Submission Guidelines

 

"Staged-and-tailored" approaches to informed consent
for individually randomised trials: perspectives and experiences

International Symposium  

6th June 2023

The objectives are to share and explore what is known about the use, acceptability and efficiency of staged-and-tailored approaches to informed consent and to provide a forum for discussion.

Outputs from this symposium will support the development of guidance on these approaches to informed consent for pragmatic trials.

 

To submit an abstract please email it to b.nickolls@qmul.ac.ukThe deadline to submit an abstract for this symposium is Monday 3rd April.  The word limit for each abstract is 400 words (excluding title and references). Maximum 5 references. All abstracts to be written and presented in English.

 

Presentation Type

State whether you would prefer to be considered for Oral or Poster Presentation or Either.

If awarded, an Oral Presentation would be a talk (likely 8 to 12 minutes) plus an allowance for Q&A, accompanied by a presentation (PowerPoint). 

If awarded, a Poster would be displayed electronically during the conference for delegates to view.

There may be a session of quick Poster talks (5 mins each).

 

Affiliations

Please list all authors and their affiliations as per this example.

Jennifer Taylor1, Stefan Polanski2, Juliet Stein1

 1 Department of…., UK

2 Center for…., USA

 

Suggested structure

*Introduction (covering aims/objectives/settings)

*Methods/Approach (making clear the approach e.g. applications and implementation, mixed methods, opinion, qualitative, quantitative, review, simulation, survey, SWATs) *Results (or the form that the results will take)

* Discussion including potential relevance and impact

 

Unstructured abstracts are welcome for non-empirical work.

 

Review Process

Each abstract will be reviewed by at least 2 reviewers appointed by the Scientific Committee. Authors will be notified about the outcome of their submission(s) by Friday 12th May. Notification will be sent to the submitting author only.  All symposium presenters will be invited to contribute to a report on the symposium.

 

For any queries please email Beverley Nickolls (b.nickolls@qmul.ac.uk)

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