Title: OSIRIS: Optimising Shared decision-makIng for high-RIsk major Surgery
Funder: Department of Health and Social Care

Abstract: Background Each year in the NHS, more than 250,000 high-risk patients contemplate major surgery. These patients are typically older with long-term disease. One in three high-risk patients choosing surgery will experience serious medical complications leading to long-term decline in health and quality of life. Awareness of these long-term risks is poor amongst both doctors and patients. Consequently, many high-risk patients do not receive the information they need to make an informed decision about surgery. Aims To understand values and beliefs about long-term outcomes amongst high-risk patients contemplating major surgery, how these differ from doctors opinions, how these affect decisions about surgical treatments, and whether opinions change after surgery. To describe the healthcare burden, long-term mortality, components of quality of life and other outcomes that high-risk patients consider when contemplating major surgery. To co-design a decision support intervention with patients and doctors, utilising a series of computational models, to provide individual patient forecasts of long-term outcomes following surgical and non-surgical treatments. To evaluate this intervention in a clinical trial. Methods Population: High-risk surgical patients aged &ge;60 years contemplating surgery in one of three contrasting scenarios: major joint replacement for osteoarthritis, colorectal resection for bowel cancer and coronary artery bypass grafting for ischaemic heart disease. Project 1: Ninety interviews within 15 patient-doctor case studies and 12 patient and doctor focus groups, to identify and weigh the importance of different post-operative health outcomes to patients. In a qualitative dynamic decision making analysis, including 50 high-risk patients and 20 doctors, we will explore how decisions are made about major surgery and how framing of information influences this. Project 2: Analysis of Hospital Episode Statistics data describing 15 million surgical episodes from 2005-2015 to describe long-term (&ge;2 years) mortality, morbidity and other outcomes. Analysis of data from 5000 primary care patients undergoing high-risk major surgery to determine factors associated with increased primary and secondary healthcare use in the years following surgery. Creation of a detailed quality of life resource using published and unpublished data. Project 3: We will co-design a decision support intervention with patients and doctors, incorporating a series of computational risk models, for use on a tablet computer during the shared decision making process. Project 4: We will evaluate the clinical effectiveness of the intervention in a cluster randomised trial of 568 high-risk patients contemplating major surgery in 60 NHS hospitals (clusters) with integrated health economic and process evaluations. Timelines for delivery Projects 1 & 2 complete by end of year 2; Intervention ready for clinical feasibility study by middle of year 3; Trial recruitment complete by end of year 5; Programme delivered by end of year 6. Impact & dissemination We will work with the Centre for Perioperative Care (hosted by the Royal College of Anaesthetists) to engage all the relevant stakeholder groups, along with 173 local Perioperative Medicine leads to promote implementation in every NHS surgical hospital. We will work with patients to publicise our work using social and mainstream media, at major scientific meetings, and in scientific journals.

Lay abstract: Background Each year in the NHS, 250,000 high-risk patients contemplate major surgery. High-risk patients are typically older with long-term disease. They often experience serious medical problems after surgery, such as pneumonia or heart attacks, causing a lasting decline in health and quality of life. This can occur even when surgery and anaesthesia have been uneventful. Older patients with long-term health problems have different hopes and expectations of medical treatments, but these may not be understood by doctors. As a result, high-risk patients may not receive the information they need when contemplating surgery. We want to help patients better understand their risks, and choose the treatments that best suit them, by improving how they decide about surgery with their doctors. Aims Aim 1: We will study how high-risk patients and their doctors make decisions about surgery and which long-term outcomes patients consider most important. Aim 2: We will accurately describe the rates of death, quality of life, visits to the GP and hospital, and other important health measures for high-risk patients in the years following major surgery, and alternative non-surgical treatments. Aim 3: We will co-design a decision support intervention for use on a touch-screen tablet computer, to provide clear information about the long-term outcomes most important to each patient. This personalised forecast will support the deliberation between doctors and patients regarding the best treatment option. Aim 4: We will test the decision support intervention in a clinical trial to establish whether it is acceptable to patients and doctors, and helps them make better decisions about high-risk surgery. Methods We will look at three conditions where surgical treatment is often used: severe arthritis of the hip or knee, bowel cancer, and severe heart disease. Our initial studies will involve interviews and surveys with patients and doctors. We will then study large NHS databases to determine what happens to patients during the years after surgery, combining this with existing research to provide an overall picture of surgical outcomes. We will use this knowledge to co-design, with patients and doctors, a decision support intervention that provides an accurate forecast of the long-term outcomes which matter most to patients. We will test this intervention in a clinical trial to confirm benefit and acceptability to patients and doctors. Patient and public involvement Patients will play a central role from research leadership to intervention co-design. We are supported by two patient co-applicants, a patient advisory group and four patient engagement groups. Dissemination We will work with patients and the Centre for Perioperative Care (hosted at the Royal College of Anaesthetists) to disseminate our findings to all relevant professional groups in every NHS hospital, to patient groups and the public through scientific reports, social and mainstream media.

Research activity codes: 7.1 INDIVIDUAL CARE NEEDS;6.4 SURGERY;7.3 MANAGEMENT AND DECISION MAKING;8.1 ORGANISATION AND DELIVERY OF SERVICES
Health categories: GENERIC HEALTH RELEVANCE;CARDIOVASCULAR