Title: Enhancing safe and transparent rectal cancer surgery innovation
Funder: Department of Health and Social Care

Abstract: Colorectal cancer affects 1.4 million patients each year worldwide, of which one third have rectal cancer. For these patients, surgery offers the best chance of cure, although it is associated with detrimental impacts on quality of life. Improving surgery and quality of life outcomes is a research priority by patients, surgeons and research funders.Many innovations have been developed in colorectal surgery but the extent of current novel rectal cancer surgery (NRCS) innovation is unclear. Although innovation is facilitated by the NIHR Colorectal Therapies Health Technology Co-operative (HTC), it is limited by a lack of research methodology. Specifically, there are no agreed ways to measure and report the safety and efficacy of novel surgery. This lack of consistency puts patients at risk because innovation continues without dissemination of adverse results. Heterogeneity of outcome reporting also limits evidence synthesis, creates research waste and delays treatment evaluation.Furthermore, there is little evidence that surgeons routinely discuss the novelty of surgery with patients in a way that supports informed consent. Surgeons' optimism bias leads to overly positive representation of new treatment whilst not addressing unknown risk profiles. Surgical innovation also usually falls outside of established research regulations, with less oversight of informed consent. Surgeons may have a conflict of interest, professional or financial, in persuading people to have a new operation. It is therefore important that informed consent is optimised.Aims and objectives The aim of this Fellowship is to enhance safe and transparent rectal cancer surgical innovation. Specific objectives are to: Identify contemporaneous innovations and innovators in NRCS, and establish and describe current standards of safety and efficacy outcome measurement and information provision for NRCS to inform subsequent objectives. Improve the quality and consistency of safety and efficacy outcomes of NRCS by developing core outcome and measurement sets. Improve the communication of risks and benefits of NRCS through the development of an intervention to optimise informed consent to use in early phase studies of surgical innovation. Plan of investigation Work package 1 will use systematic review methodology to identify contemporaneous NRCS and surgical innovators. It will summarise the selection, measurement and reporting of safety and efficacy outcomes of NRCS in selected case studies, and summarise current standards of information provision and research governance for patients undergoing NRCS.Work package 2 will develop a core set of safety and efficacy outcomes, and corresponding measurement instruments, for surgical innovators to report when performing NRCS. This will involve Delphi surveys with patients and healthcare professionals, and consensus meetings to determine the final core sets. Uptake will be promoted through active dissemination to funding-bodies, journal editors and patient advocacy groups.Work package 3 will develop an intervention to optimise communication of risks and benefits of novel rectal cancer surgery for informed consent. An empirical bioethical study, combining qualitative methods with bioethical argumentation, will define how information provision for NRCS ought to occur. An intervention will then be developed to optimise informed consent through iterative audio-recording consultations and interviews with patients and surgeons. This will maximise participation in research whilst safeguarding patients.Summary of potential benefits to patients and the NHS This fellowship will identify NRCS innovations that need further investment, and research gaps that could be filled through new innovations. It will develop reporting standards that will reduce research waste, and improve data synthesis to enhance individual and policy level decision-making for patient care. Research will ensure that patients receive consistent and appropriate information, and be protected from undue harm and unethical experimentation with a balanced informed consent.

Lay abstract: Background Bowel cancer affects 1.5 million patients each year worldwide, of which one third have cancer in the last part of the bowel (rectum). Surgery is the best way to cure rectal cancer, however, it has a major impact on patients' quality of life. Improving surgery for rectal cancer is therefore considered a research priority by patients, surgeons and research funders.Several new operations involving novel technologies and devices are currently being developed. There are, however, no agreed ways to measure the safety and success (also called outcomes) of novel surgical treatments. This means that different surgeons across the world may be performing new operations but reporting different outcomes. This limits comparison of results and benefits of learning from one another. It means that vulnerable patients may be subjected to undue harm.Furthermore, there is little evidence that surgeons routinely discuss the novelty of new rectal cancer surgery in a way that supports patients making an informed treatment choice (informed consent). Typically, surgeons are overoptimistic about the benefits of new treatments and underestimate the harms, thereby encouraging the view that new surgery is the same as better surgery. Trying out new surgery may also fall outside of established research regulations, meaning that there is potentially less oversight of the informed consent process. For example, surgeons may have a vested interest in persuading people to have a new operation (conflict of interest). It is therefore important to ensure informed consent is optimised.Aim To work out how to improve outcome measurement and information provision for new rectal cancer surgical treatments by establishing: What outcomes were measured and what information was provided to patients in studies of recent new rectal cancer surgery Standard ways to measure outcomes of such surgery How to best communicate the risks and benefits of such surgery to optimise informed consent Design and methods Firstly, I will search the medical literature to identify recent new rectal cancer surgeries and select examples for further study. The next step is to perform a detailed analysis of these surgeries to find what outcomes were used and how they were measured. I will also analyse published records to identify what was reportedly said to patients, and by who, as part of informed consent including potential benefits and harms and the systems in place around this. These results will inform the rest of this project.Next, I will work with patients and healthcare professionals to agree on what outcomes should be measured when trying new rectal cancer surgery (a core outcome set, COS). Furthermore, I will then determine how and when these outcomes should be measured (a core measurement set, CMS). This will be done using scientific survey methods and meetings with patients and professionals. I will then work with research organisations, funding-bodies, surgeons, journal editors and patient groups to encourage researchers to use the CMS when trying new rectal cancer surgery.Finally, I will develop a way to optimise the informed consent process for new rectal cancer surgery. In-depth interviews will be conducted with patients, surgeons and experts in informed consent to identify key issues around the communication of risks and harms, and how to balance these issues to achieve informed consent. Then, real-life consultations (where surgeons discuss new operations with patients) will be audio-recorded, followed by interviews with the patients and surgeons to find out what went well and badly. I will use this information to develop a way to improve informed consent, which will then be tested in more real-life consultations.Patient and public involvement Patient involvement is central to this project. Patients have been involved at all stages of the application and fully support the need to safely develop new rectal cancer surgery. Patients will be involved on the steering groups of each proposed project and will benefit the research by bringing their rich experiences and ensuring the work is patient focused. Patients will play a particularly important part in determining the COS and CMS, as well as working out how to best communicate the risks and harms of new rectal cancer surgery.Dissemination This work will be presented at national and international conference as published in peer reviewed journals. We will collaborate closely with organisations involved with rectal cancer surgical innovation, together with patient advocacy groups, charities, and funding-bodies to facilitate the implementation of the COS and CMS, and optimise informed consent.

Research activity codes: 6.4 SURGERY
Health categories: CANCER AND NEOPLASMS