Understanding decision making about major surgery: protocol for a qualitative study of shared decision making by high-risk patients and their clinical teams.

INTRODUCTION: Surgical treatments are being offered to more patients than ever before, and increasingly to high-risk patients (typically multimorbid and over 75). Shared decision making is seen as essential practice. However, little is currently known about what 'good' shared decision making involves nor how it applies in the context of surgery for high-risk patients. This new study aims to identify how high-risk patients, their families and clinical teams negotiate decision making for major surgery. METHODS AND ANALYSIS: Focusing on major joint replacement, colorectal and cardiac surgery, we use qualitative methods to explore how patients, their families and clinicians negotiate decision making (including interactional, communicative and informational aspects and the extent to which these are perceived as shared) and reflect back on the decisions they made. Phase 1 involves video recording 15 decision making encounters about major surgery between patients, their carers/families and clinicians; followed by up to 90 interviews (with the same patient, carer and clinician participants) immediately after a decision has been made and again 3-6 months later. Phase 2 involves focus groups with a wider group of (up to 90) patients and (up to 30) clinicians to test out emerging findings and inform development of shared decision making scenarios (3-5 summary descriptions of how decisions are made). ETHICS AND DISSEMINATION: The study forms the first part in a 6-year programme of research, Optimising Shared decision-makIng for high-RIsk major Surgery (OSIRIS). Ethical challenges around involving patients at a challenging time in their lives will be overseen by the programme steering committee, which includes strong patient representation and a lay chair. In addition to academic outputs, we will produce a typology of decision making scenarios for major surgery to feed back to patients, professionals and service providers and inform subsequent work in the OSIRIS programme.

Quality improvement and emergency laparotomy care: what have we learnt from recent major QI efforts?

More than 1.53 million adults undergo inpatient surgery in the UK NHS. Patients undergoing emergency abdominal surgery have a much greater risk of death than patients admitted for elective surgery. Widespread variations in key standards of care between hospitals exist and are associated with differences in mortality rates.Recently there have been three large-scale initiatives to improve quality of care for emergency laparotomy patients: the National Emergency Laparotomy Audit, the enhanced perioperative care for high-risk patients trial and the Emergency Laparotomy Collaborative. Here we provide a critical review of what we currently know about the use of structured methods for improving the quality of healthcare services, with reference to the three initiatives. We find that using structured methods to improve care is the hallmark of quality improvement but attention must too be paid to the context in which these methods are used.

Cost-effectiveness of a national quality improvement programme to improve survival after emergency abdominal surgery: Learning from 15,856 patients.

BACKGROUND: Patients undergoing emergency abdominal surgery are exposed to a high risk of death. A quality improvement (QI) programme to improve the survival for these patients was evaluated in the Enhanced Peri-Operative Care for High-risk patients (EPOCH) trial. This study aims to assess its cost-effectiveness versus usual care from a UK health service perspective. METHODS: Data collected in a subsample of trial participants were employed to estimate costs and quality-adjusted life years (QALYs) for the QI programme and usual care within the 180-day trial period, with results also extrapolated to estimate lifetime costs and QALYs. Cost-effectiveness was estimated using incremental cost-effectiveness ratios (ICERs). The probability of being cost-effective was determined for different cost-effectiveness thresholds (£13,000 to £30,000 per QALY). Analyses were performed for lower-risk and higher-risk subgroups based on the number of surgical indications (single vs multiple). RESULTS: Within the trial period, QI was more costly (£467) but less effective (-0.002 QALYs). Over a lifetime, it was more costly (£1395) and more effective (0.018 QALYs), but did not appear to be cost-effective (ICER: £77,792 per QALY, higher than all cost-effectiveness thresholds; probability of being cost-effective: 28.7%-43.8% across the thresholds). For lower-risk patients, QI was more costly and less effective both within trial period and over a lifetime and it did not appear to be cost-effective. For higher-risk patients, it was more costly and more effective, and did not appear cost-effective within the trial period (ICER: £158,253 per QALY) but may be cost-effective over a lifetime (ICER: £14,293 per QALY). CONCLUSION: The QI programme does not appear cost-effective at standard cost-effectiveness thresholds. For patients with multiple surgical indications, this programme is potentially cost-effective over a lifetime, but this is highly uncertain.

Effectiveness of a national quality improvement programme to improve survival after emergency abdominal surgery (EPOCH): a stepped-wedge cluster-randomised trial.

BACKGROUND: Emergency abdominal surgery is associated with poor patient outcomes. We studied the effectiveness of a national quality improvement (QI) programme to implement a care pathway to improve survival for these patients. METHODS: We did a stepped-wedge cluster-randomised trial of patients aged 40 years or older undergoing emergency open major abdominal surgery. Eligible UK National Health Service (NHS) hospitals (those that had an emergency general surgical service, a substantial volume of emergency abdominal surgery cases, and contributed data to the National Emergency Laparotomy Audit) were organised into 15 geographical clusters and commenced the QI programme in a random order, based on a computer-generated random sequence, over an 85-week period with one geographical cluster commencing the intervention every 5 weeks from the second to the 16th time period. Patients were masked to the study group, but it was not possible to mask hospital staff or investigators. The primary outcome measure was mortality within 90 days of surgery. Analyses were done on an intention-to-treat basis. This study is registered with the ISRCTN registry, number ISRCTN80682973. FINDINGS: Treatment took place between March 3, 2014, and Oct 19, 2015. 22 754 patients were assessed for elegibility. Of 15 873 eligible patients from 93 NHS hospitals, primary outcome data were analysed for 8482 patients in the usual care group and 7374 in the QI group. Eight patients in the usual care group and nine patients in the QI group were not included in the analysis because of missing primary outcome data. The primary outcome of 90-day mortality occurred in 1210 (16%) patients in the QI group compared with 1393 (16%) patients in the usual care group (HR 1·11, 0·96-1·28). INTERPRETATION: No survival benefit was observed from this QI programme to implement a care pathway for patients undergoing emergency abdominal surgery. Future QI programmes should ensure that teams have both the time and resources needed to improve patient care. FUNDING: National Institute for Health Research Health Services and Delivery Research Programme.