Make innovations in surgery safer

A study to help develop surgical innovations more safely and efficiently has published a “set of baseline results” for new surgical techniques and devices in the Annals of surgery. The COHESIVE study, led by researchers funded by the National Institute for Health Research (NIHR) at the University of Bristol, devised the set through a robust process involving patients, surgeons and other health professionals.

Before new drugs can be used in clinical practice, they are rigorously tested through a highly regulated process. However, new surgical techniques and devices can be introduced without firm evidence that they are safe and effective. This can be compromised patient safety and health. This problem is caused in part by uncertainty and inconsistency in the selection and notification of the results of new surgical techniques and devices.

One solution to this problem is to develop a set of basic outcomes, which is an agreed minimum set of outcomes that should be measured and reported in all uses of a new surgical. device in clinical practice, research studies or audits. A set of baseline outcomes should improve the quality of information available to patients and health professionals for decision-making and control of safety and efficacy.

To develop the set of baseline outcomes, the researchers found out from patients, surgeons, and other key stakeholders what the most important outcomes were for them, in addition to doing a literature search to see what outcomes had been reported. in studies. Through a series of surveys and a “consensus meeting” with stakeholders, a list of nearly 8,000 possible outcomes was reduced to eight basic outcome domains.

Some result domains were innovation-specific, such as file modifications surgical procedure, unexpected inconveniences, device problems, success in the technical procedure and experience in surgery. Others focused more generally on effectiveness, such as expected benefits and expected disadvantages. The COHESIVE team recommends that its set of basic results be used in all surgical innovation studies from the first opportunity and before reaching the randomized controlled trial stage, the gold standard test d ‘an intervention.

The study was co-directed by Dr. Kerry Avery, Professor at the University of Bristol and the Bristol NIHR Biomedical Research Center (BRC), and Miss Shelley Potter, NIHR Clinical Scientist at the University of Bristol and NIHR Bristol BRC and Associate Professor of Oncoplastic Breast Surgery at North Bristol NHS Trust. Dr. Avery said:

“It may surprise many people to know that surgical procedures have not traditionally been subject to the kind of regulation we see in other areas of medicine. But to ensure safety and improve efficiency, a set of basic results is an important step.

“Our set of basic results has been developed with the contribution of many health professionals, and patients have been involved in various stages of the design process. Surgeons and researchers who use ours core Therefore, the set of results can be trusted to be robust and representative of the priorities of both patients and healthcare professionals.

“We encourage all surgeons and researchers to use our set of results to help push the boundaries of surgery further, safely and efficiently.”

“A set of basic results for a uniform and uniform evaluation of innovative surgical procedures and devices (COHESIVE): a consensus study on interested patients and professionals” is published in Annals of surgery.