Improving how patients are selected for early evaluations of new surgical procedures and devices: the ADAPT-E (Adaptive PatienT Eligibility) framework

About the study

Early evaluations of new or modified surgical procedures and devices are typically studies involving a small number of participants that happen before larger clinical trials. The aim of early evaluations is to help understand how safe a new treatment might be, its possible benefits and risks, and whether it’s ready to be tested in a bigger study.

One challenge in conducting early evaluation studies is deciding which patients are suitable to be offered the procedure or device. Sometimes it becomes apparent part way through an evaluation that the procedure or device being tested works better or has less risks for a particular group of patients, and is less suitable or safe for others. When this happens, surgeons and researchers may want to change who they offer the procedure to, and therefore which patients they invite next to take part in the evaluation. This ensures the evaluation is as safe and efficient as possible, and avoids causing patients unnecessary harm.

This project will develop a new approach (a new framework), to help surgeons and researchers design and safely conduct early evaluation studies of surgical innovations, which includes planned changes to which patients are invited to take part, part way through the study.

How are we doing this?

We are working with a diverse group of stakeholders to co-develop the framework so that it meets the needs of all relevant people. This includes surgeons, patients, researchers, people from the NHS, medical organisations, device manufacturers, regulators, and funders of surgical research. As well as co-developing the framework, stakeholders will have an important role in making sure the framework can be implemented and used in future.

Our project involves three work packages:

  • Firstly, we will co-develop a draft framework. This will be informed by existing guidance (for example, the IDEAL framework), stakeholder interviews and workshops.
  • Secondly, we will test the framework in real-life early evaluations of new or modified surgical procedures and devices that are happening within NHS hospitals. This will examine how practical and acceptable to surgeons the framework is and allow us to make changes to improve it.
  • Thirdly, we will produce and share a report with our stakeholders on the framework and how it may be tested for the future.

This work links with the Lotus study, the NIHR Bristol Biomedical Research Centre and the NIHR Surgical and Peri-operative Care Translational Research Collaboration.

Patient and Public Involvement and Engagement (PPIE)

We have established a PPIE Advisory Group (PAG) and will collaborate with them throughout the project. Our Project Steering Committee includes a patient representative to ensure the patient voice is included the oversight of our project.