Improving how patients are selected for early evaluations of new surgical procedures and devices

Early evaluations are small studies about new or modified surgical procedures and devices. These studies happen before larger clinical trials. Their aim is to help researchers 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 these early evaluations is deciding which patients are suitable to be offered the procedure or device and take part in its early evaluation.

Ideally, surgeons and researchers would agree which patients to include in an evaluation before the evaluation begins, and before the first patient is offered the new procedure or device. However, 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 to take part in the evaluation next. This ensures the evaluation is as safe and efficient as possible, and avoids causing patients unnecessary harm.

To do this, researchers need a method to help them better design early surgical evaluations. This method would help them agree in advance which patients should be the first to be offered the procedure once the evaluation starts. It would also help them to make changes to the selection of patients after the evaluation starts, once more information about the benefits and harms of the new surgical procedure or device in groups of patients becomes available.

Project aims

The aim of our project is to create a method for designing early surgical evaluations, which includes planned changes to which patients are invited to take part, part way through the study. We have named this the LOTUS-DESIGN method.

We will work with surgeons, patients, researchers, people from the NHS, medical organisations, device manufacturers, regulators, and surgical research funders to develop the LOTUS-DESIGN method. We will then put it into practice in real-life early studies of surgical innovation, to test how feasible and acceptable it is to use.

What we hope to achieve

Our long-term goal is for the method to be used by surgeons doing early-phase surgical research studies within the NHS and worldwide.