Every year, thousands of patients receive surgical innovations that have not been properly tested for safety or effectiveness. This project will create a standard method—called LOTUS-DESIGN—to help surgeons and researchers design early-phase studies of new procedures and devices, so that evidence is gathered before widespread use, not after harm has occurred. The problem is well-documented. National safety reviews, the General Medical Council, and the researchers’ own investigations have all identified that surgical innovations are often introduced into NHS practice without adequate prior research, leading to serious patient harm. Current study designs are poorly suited to the iterative, hands-on nature of surgical innovation, where personal bias and lack of transparency can delay the abandonment of unsafe treatments. If successful, the method will give surgeons a practical framework for testing innovations fairly, deciding when to continue or stop a procedure, and identifying which patients are most likely to benefit. This could reduce the number of patients exposed to untested or ineffective treatments, while speeding up access to genuinely beneficial ones. The approach will be developed with input from surgeons, patients, regulators, device manufacturers, and NHS bodies, ensuring it works in real hospital settings. The final output will be a publicly available report and guidance for future testing.
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Title Safely and quickly introducing and testing new surgical procedures and devices. Background Surgery is an essential part of the National Health Service (NHS). Developing surgical innovations (new surgical procedures and medical devices used within the body) is important to improve patient care and hospital efficiency. There have been big advances over the past two decades with innovations such as robotic and keyhole surgery, and the future holds more change. Despite this, serious patient harm has been caused. This is because surgical innovations are used on patients without research happening soon enough. These problems have been identified by a national safety review, by the UK General Medical Council, and by investigations our research team have undertaken. All agree urgent changes are needed. Aim This project will develop a new approach (a new method), to help surgeons and researchers design and safely conduct early research studies of surgical innovations. The method will: Involve research within the development of surgical innovations so that they can be tested earlier, and fewer patients are given unsafe or untested procedures. Ensure that surgeons understand how to test surgical innovations safely and fairly, without personal bias. Help surgeons and healthcare providers make better decisions about when to continue, change, or stop surgical innovations, based on more reliable information. Enable surgeons to study which patients are most suitable for surgical innovations, so that they can be offered to all appropriate patients. Prevent delays to future studies that will help the NHS decide whether the surgical innovation should be used more widely. Approach So that the method meets the needs of all relevant people, we will involve stakeholders in our project. This includes surgeons, patients, researchers, people from the NHS, medical organisations, device manufacturers, regulators, and funders of surgical research. Our project involves three pieces of work: Firstly, we will hold stakeholder interviews and workshops to develop a draft method. Secondly, we will explore how the method is used in real-life research studies of surgical innovations in NHS hospitals. This will examine how practical and acceptable to surgeons the method is and improve it. Thirdly, we will produce and share a report with our stakeholders on the method and how it may be tested in the future. Our project was developed with input from patients and the general public, who agree it is important and have helped shape it. We will continue to involve patients and the public throughout the project. We will share our findings with all stakeholders through scientific journal articles, meetings, patient groups, websites, and social media. Potential benefits Our project will improve how surgical innovations are developed and tested in the NHS by developing a new method for testing them. This will help surgeons use surgical innovations safely because the method will create reliable information about their benefits and harms. Patients will benefit by having harmful or ineffective treatments abandoned sooner and safer, beneficial treatments made available sooner.
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