The incidence of postoperative vasopressor usage: protocol for a prospective international observational cohort study (SQUEEZE).

BACKGROUND: Postoperative hypotension is common after major non-cardiac surgery, due predominantly to vasodilation. Administration of infused vasopressors postoperatively may often be considered a surrogate indicator of vasodilation. The incidence of postoperative vasopressors has never been described for non-cardiac surgery, nor have outcomes associated with their use. This paper presents a protocol for a prospective international cohort study to address these gaps in knowledge. The primary objectives are to estimate the proportion of patients who receive postoperative vasopressor infusions (PVI) and to document the variation in this proportion between hospitals and internationally. Furthermore, we will identify factors in variation of care (patient, condition, surgery, and intraoperative management) associated with receipt of PVI and investigate how PVI use is associated with patient outcomes, including organ dysfunction, length of hospital stay, and 30-day in-hospital mortality. METHOD: This will be a prospective, international, multicentre cohort study that includes all adult (≥ 18 years) non-cardiac surgical patients in participating centres. Patients undergoing cardiac, obstetric, or day-case surgery will be excluded. We will recruit two cohorts of patients: cohort A will include all eligible patients admitted to participating hospitals for seven consecutive days. Cohort B will include 30 sequential patients per hospital, with the single additional inclusion criterion of postoperative vasopressor usage. We expect to collect data on approximately 40,000 patients for cohort A and 12,800 patients for cohort B. DISCUSSION: While in cardiac surgery, clinical trials have informed the choice of vasopressors used to treat postoperative vasoplegia; there remains equipoise over the best approach in non-cardiac surgery. Our study will represent the first large-scale assessment of the use of vasopressors after non-cardiac surgery. These data will inform future studies, including trials of different vasopressors and potential management options to improve outcomes and reduce resource use after surgery. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03805230, 15 January 2019.

Systematic reviews and consensus definitions for the Standardised Endpoints in Perioperative Medicine (StEP) initiative: mortality, morbidity, and organ failure.

BACKGROUND: Mortality, morbidity, and organ failure are important and common serious harms after surgery. However, there are many candidate measures to describe these outcome domains. Definitions of these measures are highly variable, and validity is often unclear. As part of the International Standardised Endpoints in Perioperative Medicine (StEP) initiative, this study aimed to derive a set of standardised and valid measures of mortality, morbidity, and organ failure for use in perioperative clinical trials. METHODS: Three domains of endpoints (mortality, morbidity, and organ failure) were explored through systematic literature review and a three-stage Delphi consensus process using methods consistently applied across the StEP initiative. Reliability, feasibility, and patient-centredness were assessed in round 3 of the consensus process. RESULTS: A high level of consensus was achieved for two mortality time points, 30-day and 1-yr mortality, and these two measures are recommended. No organ failure endpoints achieved threshold criteria for consensus recommendation. The Clavien-Dindo classification of complications achieved threshold criteria for consensus in round 2 of the Delphi process but did not achieve the threshold criteria in round 3 where it scored equivalently to the Post Operative Morbidity Survey. Clavien-Dindo therefore received conditional endorsement as the most widely used measure. No composite measures of organ failure achieved an acceptable level of consensus. CONCLUSIONS: Both 30-day and 1-yr mortality measures are recommended. No measure is recommended for organ failure. One measure (Clavien-Dindo) is conditionally endorsed for postoperative morbidity, but our findings suggest that no single endpoint offers a reliable and valid measure to describe perioperative morbidity that is not dependent on the quality of deli-vered care. Further refinement of current measures, or development of novel measures, of postoperative morbidity might improve consensus in this area.

Perioperative care for older people.

Increasing numbers of older people are undergoing surgery with benefits including symptom relief and extended longevity. Despite these benefits, older people are more likely than younger patients to experience postoperative complications, which are predominantly medical as opposed to surgical. Comprehensive Geriatric Assessment and optimisation offers a systematic approach to risk assessment and risk modification in the perioperative period. Clinical evidence shows that Comprehensive Geriatric Assessment and optimisation reduces postoperative medical complications and is cost effective in the perioperative setting. These benefits have been observed in patients undergoing elective and emergency surgery. Challenges in the implementation of perioperative Comprehensive Geriatric Assessment and optimisation services are acknowledged. These include the necessary involvement of a wide stakeholder group, limited available geriatric medicine workforce and ensuring fidelity to Comprehensive Geriatric Assessment methodology with adaptation to the local context. Addressing these challenges needs a cross-specialty, interdisciplinary approach underpinned by evidence-based medicine and implementation science with upskilling to facilitate innovative use of the extended workforce. Future delivery of quality patient-centred perioperative care requires proactive engagement with national audit, collaborative guidelines and establishment of networks to share best practice.

The Perioperative Quality Improvement Programme (PQIP patient study): protocol for a UK multicentre, prospective cohort study to measure quality of care and outcomes after major surgery.

INTRODUCTION: Major surgery accounts for a substantial proportion of health service activity, due not only to the primary procedure, but the longer-term health implications of poor short-term outcome. Data from small studies or from outside the UK indicate that rates of complications and failure to rescue vary between hospitals, as does compliance with best practice processes. Within the UK, there is currently no system for monitoring postoperative complications (other than short-term mortality) in major non-cardiac surgery. Further, there is variation between national audit programmes, in the emphasis placed on quality assurance versus quality improvement, and therefore the principles of measurement and reporting which are used to design such programmes. METHODS AND ANALYSIS: The PQIP patient study is a multi-centre prospective cohort study which recruits patients undergoing major surgery. Patient provide informed consent and contribute baseline and outcome data from their perspective using a suite of patient-reported outcome tools. Research and clinical staff complete data on patient risk factors and outcomes in-hospital, including two measures of complications. Longer-term outcome data are collected through patient feedback and linkage to national administrative datasets (mortality and readmissions). As well as providing a uniquely granular dataset for research, PQIP provides feedback to participating sites on their compliance with evidence-based processes and their patients' outcomes, with the aim of supporting local quality improvement. ETHICS AND DISSEMINATION: Ethical approval has been granted by the Health Research Authority in the UK. Dissemination of interim findings (non-inferential) will form a part of the improvement methodology and will be provided to participating centres at regular intervals, including near-real time feedback of key process measures. Inferential analyses will be published in the peer-reviewed literature, supported by a comprehensive multi-modal communications strategy including to patients, policy makers and academic audiences as well as clinicians.

Validation of the days alive and out of hospital outcome measure after emergency laparotomy: a retrospective cohort study.

BACKGROUND: Days alive and out of hospital (DAOH) is a composite, patient-centred outcome measure describing a patient's postoperative recovery, encompassing hospitalisation and mortality. DAOH is the number of days not in hospital over a defined postoperative period; patients who die have DAOH of zero. The Standardising Endpoints in Perioperative Medicine (StEP) group recommended DAOH as a perioperative outcome. However, DAOH has never been validated in patients undergoing emergency laparotomy. Here, we validate DAOH after emergency laparotomy and establish the optimal duration of observation. METHODS: Prospectively collected data of patients having emergency laparotomy in England (December 1, 2013-November 30, 2017) were linked to national hospital admission and mortality records for the year after surgery. We evaluated construct validity by assessing DAOH variation with known perioperative risk factors and predictive validity for 1 yr mortality using a multivariate Bayesian mixed-effects logistic regression. The optimal postoperative DAOH period (30 or 90 days) was judged on distributional and pragmatic properties. RESULTS: We analysed 78 921 records. The median 30-day DAOH (DAOH30) was 16 (inter-quartile range [IQR], 0-22) days and the median DAOH90 was 75 (46-82) days. DAOH was shorter in the presence of known perioperative risk factors. For patients surviving the first 30 postoperative days, shorter DAOH30 was associated with higher 1-yr mortality (odds ratio=0.94; 95% credible interval, 0.94-0.94). CONCLUSION: DAOH is a valid, patient-centred outcome after emergency laparotomy. We recommend its use in clinical trials, quality assurance, and quality improvement, measured at 30 days as mortality heavily skews DAOH measured at 90 days and beyond.

Seasonality in surgical outcome data: a systematic review and narrative synthesis.

BACKGROUND: Seasonal trends in patient outcomes are an under-researched area in perioperative care. This systematic review evaluates the published literature on seasonal variation in surgical outcomes worldwide. METHODS: MEDLINE, Embase, Cochrane, CINHAL, and Web of Science were searched for studies on major surgical procedures, examining mortality or other patient-relevant outcomes, across seasonal periods up to February 2019. Major surgery was defined as a procedure requiring an overnight stay in an inpatient medical facility. We included studies exploring variation according to calendar and meteorological seasons and recurring annual events including staff turnover. Quality was assessed using an adapted Downs and Black scoring system. RESULTS: The literature search identified 82 studies, including 22 210 299 patients from four continents. Because of the heterogeneity of reported outcomes and literature scope, a narrative synthesis was undertaken. Mass staff changeover was investigated in 37 studies; the majority (22) of these did not show strong evidence of worse outcomes. Of the 47 studies that examined outcomes across meteorological or calendar seasons, 33 found evidence of seasonal variation. Outcomes were often worse in winter (16 studies). This trend was particularly prominent amongst surgical procedures classed as an 'emergency' (five of nine studies). There was evidence for increased postoperative surgical site infections during summer (seven of 12 studies examining this concept). CONCLUSION: This systematic review provides tentative evidence for an increased risk of postoperative surgical site infections in summer, and an increased risk of worse outcomes after emergency surgery in winter and during staff changeover times. CLINICAL TRIAL REGISTRATION: PROSPERO CRD42019137214.

Quality metrics for emergency abdominal surgery in children: a systematic review.

BACKGROUND: There is variation in care quality and outcomes for children undergoing emergency abdominal surgery, such as appedectomy. Addressing this requires paediatric-specific quality metrics. The aim of this study was to identify perioperative structure and process measures that are associated with improved outcomes for these children. METHODS: We performed a systematic review searching MEDLINE, Embase, CINAHL, Cochrane Library, and Google Scholar for articles published between January 1, 1980 and September 29, 2020 about the perioperative care of children undergoing emergency abdominal surgery. We also conducted secondary searching of references and citations, and we included international professional publications. RESULTS: We identified and analysed 383 peer-reviewed articles and 18 grey literature publications. High-grade evidence pertaining to the perioperative care of this patient group is limited. Most of the evidence available relates to improving diagnostic accuracy using preoperative blood testing, imaging, and clinical decision tools. Processes associated with clinical outcomes include time lapse between time of presentation or initial assessment and surgery, and the use of particular analgesia and antibiotic protocols. Structural factors identified include hospital and surgeon caseload and the use of perioperative care pathways. CONCLUSIONS: This review summarises the structural and process measures associated with outcome in paediatric emergency abdominal surgery. Such measures provide a means of evaluating care and identifying areas of practice that require quality improvement, especially in children with appendicitis. CLINICAL TRIAL REGISTRATION: PROSPERO CRD42017055285.

Peak power output testing: novel method for preoperative assessment of exercise capacity.

BACKGROUND: Assessment of exercise capacity is an important component of risk assessment before major surgery. Cardiopulmonary exercise testing (CPET) provides comprehensive assessment but is resource-intensive, limiting widespread adoption. Measurement of a patient's peak power output (PPO) using a simplified test on a cycle ergometer has the potential to identify patients likely to have abnormal CPET findings and to be at increased perioperative risk. The aim of this study was to investigate the potential for PPO to identify those with abnormal CPET and to determine whether PPO predicted the risk of adverse postoperative outcomes. METHODS: In a retrospective analysis of a single-centre cohort, the ability of PPO to predict a high-risk CPET result in patients undergoing major cancer surgery was analysed. The assessment was validated in patients undergoing major abdominal surgery from a UK national multicentre cohort. The association between PPO and adverse postoperative outcomes to traditional CPET-derived variables were compared. RESULTS: In 2262 patients from a single centre, PPO was an excellent discriminator of high-risk CPET, with an area under the receiver operating characteristic curve (AUROC) of 0.901 (95 per cent c.i. 0.888 to 0.913). In the national cohort of 2742 patients, there was excellent discrimination, with an AUROC of 0.856 (0.842 to 0.871). A PPO cut-off of 1.5 W/kg may be appropriate for use in screening, with a sensitivity of 90 per cent in both cohorts. PPO and traditional CPET-derived predictors demonstrated similar discrimination of major postoperative complications and death. The association between PPO and major postoperative complications persisted on multivariable analysis. CONCLUSION: These results suggest a role for the PPO test in preoperative screening and risk stratification for major surgery. Prospective evaluation is recommended.

Core Outcome Measures for Perioperative and Anaesthetic Care (COMPAC): a modified Delphi process to develop a core outcome set for trials in perioperative care and anaesthesia.

BACKGROUND: Outcome selection underpins clinical trial interpretation. Inconsistency in outcome selection and reporting hinders comparison of different trials' results, reducing the utility of research findings. METHODS: We conducted an iterative consensus process to develop a set of Core Outcome Measures for Perioperative and Anaesthetic Care (COMPAC), following the established Core Outcome Measures for Effectiveness Trials (COMET) methodology. First, we undertook a systematic review of RCTs in high-impact journals to describe current outcome reporting trends. We then surveyed patients, carers, researchers, and perioperative clinicians about important outcomes after surgery. Finally, a purposive stakeholder sample participated in a modified Delphi process to develop a core outcome set for perioperative and anaesthesia trials. RESULTS: Our systematic review revealed widespread inconsistency in outcome reporting, with variable or absent definitions, levels of detail, and temporal criteria. In the survey, almost all patients, carers, and clinicians rated clinical outcome measures critically important, but clinicians rated patient-centred outcomes less highly than patients and carers. The final core outcome set was: (i) mortality/survival (postoperative mortality, long-term survival); (ii) perioperative complications (major postoperative complications/adverse events; complications/adverse events causing permanent harm); (iii) resource use (length of hospital stay, unplanned readmission within 30 days); (iv) short-term recovery (discharge destination, level of dependence, or both); and (v) longer-term recovery (overall health-related quality of life). CONCLUSIONS: This core set, incorporating important outcomes for both clinicians and patients, should guide outcome selection in future perioperative medicine or anaesthesia trials. Mapping these alongside standardised endpoint definitions will yield a comprehensive perioperative outcome framework.

Preoperative assessment and optimisation: the key to good outcomes after the pandemic.

Complications following surgery are common, predictable and often preventable. New preoperative assessment and optimisation guidance recommends clear pathways with triggers for interventions, patient involvement, shared decision making and team education, to help both patients and service efficiency.

Socioeconomic deprivation and long-term outcomes after elective surgery: analysis of prospective data from two observational studies.

BACKGROUND: Socioeconomic deprivation is associated with health inequalities. We explored relationships between socioeconomic group and outcomes after elective surgery in the UK National Health Service (NHS). METHODS: We combined data from two observational studies in 115 NHS hospitals and determined socioeconomic group using the Index of Multiple Deprivation (IMD) quintiles based on place of residence. Postoperative complications and 3-yr survival were assessed using logistic and Cox regression. Univariate analyses were adjusted for age differences between IMD quintiles. Multivariable analyses were used to account for other baseline risk factors including sex and comorbid disease. Results are reported as n (%), hazard ratios (HR) or odds ratios (OR) with 95% confidence intervals. RESULTS: Postoperative complications developed in 971/9051 patients (10.7%) and 1597/9043 patients (17.7%) died within 3 yr. Complication rates increased with deprivation (reference group least-deprived IMD5): IMD1 (OR=1.44 [1.17-1.78]; P<0.001), IMD2 (OR=1.38 [1.12-1.70]; P<0.01), IMD3 (OR=1.09 [0.88-1.35]: P=0.44), IMD4 (OR=0.89 [0.71-1.11]; P=0.30). More patients from the most deprived quintile died (IMD1) (n=349, 18.8%) compared with the least deprived (IMD5) (n=297, 15.9%) with a trend across the socioeconomic spectrum (P=0.01). After age adjustment, patients in the most deprived areas experienced reduced 3-yr survival: IMD1 (HR=1.43 [1.23-1.67]; P<0.0001), IMD2 (HR=1.35 [1.15-1.57]; P<0.001), IMD3 (HR=1.04 [0.89-1.23]; P=0.60), and IMD4 (HR=1.11 [0.95-1.30]; P=0.19). This finding persisted in risk-adjusted analyses. Increased complication rates only partially explained this reduced survival. CONCLUSIONS: Socioeconomic deprivation is associated with worse long-term outcomes after elective surgery. This risk factor should be considered when planning perioperative care for patients from deprived areas.

Developing and validating subjective and objective risk-assessment measures for predicting mortality after major surgery: An international prospective cohort study.

BACKGROUND: Preoperative risk prediction is important for guiding clinical decision-making and resource allocation. Clinicians frequently rely solely on their own clinical judgement for risk prediction rather than objective measures. We aimed to compare the accuracy of freely available objective surgical risk tools with subjective clinical assessment in predicting 30-day mortality. METHODS AND FINDINGS: We conducted a prospective observational study in 274 hospitals in the United Kingdom (UK), Australia, and New Zealand. For 1 week in 2017, prospective risk, surgical, and outcome data were collected on all adults aged 18 years and over undergoing surgery requiring at least a 1-night stay in hospital. Recruitment bias was avoided through an ethical waiver to patient consent; a mixture of rural, urban, district, and university hospitals participated. We compared subjective assessment with 3 previously published, open-access objective risk tools for predicting 30-day mortality: the Portsmouth-Physiology and Operative Severity Score for the enUmeration of Mortality (P-POSSUM), Surgical Risk Scale (SRS), and Surgical Outcome Risk Tool (SORT). We then developed a logistic regression model combining subjective assessment and the best objective tool and compared its performance to each constituent method alone. We included 22,631 patients in the study: 52.8% were female, median age was 62 years (interquartile range [IQR] 46 to 73 years), median postoperative length of stay was 3 days (IQR 1 to 6), and inpatient 30-day mortality was 1.4%. Clinicians used subjective assessment alone in 88.7% of cases. All methods overpredicted risk, but visual inspection of plots showed the SORT to have the best calibration. The SORT demonstrated the best discrimination of the objective tools (SORT Area Under Receiver Operating Characteristic curve [AUROC] = 0.90, 95% confidence interval [CI]: 0.88-0.92; P-POSSUM = 0.89, 95% CI 0.88-0.91; SRS = 0.85, 95% CI 0.82-0.87). Subjective assessment demonstrated good discrimination (AUROC = 0.89, 95% CI: 0.86-0.91) that was not different from the SORT (p = 0.309). Combining subjective assessment and the SORT improved discrimination (bootstrap optimism-corrected AUROC = 0.92, 95% CI: 0.90-0.94) and demonstrated continuous Net Reclassification Improvement (NRI = 0.13, 95% CI: 0.06-0.20, p < 0.001) compared with subjective assessment alone. Decision-curve analysis (DCA) confirmed the superiority of the SORT over other previously published models, and the SORT-clinical judgement model again performed best overall. Our study is limited by the low mortality rate, by the lack of blinding in the 'subjective' risk assessments, and because we only compared the performance of clinical risk scores as opposed to other prediction tools such as exercise testing or frailty assessment. CONCLUSIONS: In this study, we observed that the combination of subjective assessment with a parsimonious risk model improved perioperative risk estimation. This may be of value in helping clinicians allocate finite resources such as critical care and to support patient involvement in clinical decision-making.

Patient-reported outcomes for ambulatory surgery.

PURPOSE OF REVIEW: To discuss the importance of validated tools that measure patient-reported outcomes and their use in ambulatory surgery. RECENT FINDINGS: Sustained increases in ambulatory surgical care reflect advances in surgical techniques and perioperative anaesthetic care. Use of patient-reported outcomes allows identification of minor adverse events that are more common in this population compared with traditional endpoints such as mortality. Variability in reported outcomes restricts research potential and limits the ability to benchmark providers. The standardized endpoints in perioperative medicine initiative's recommendations on patient-reported outcomes and patient comfort measures are relevant to evaluating ambulatory care. Combining validated generic and disease-specific patient-reported outcome measures (PROMs) examines the widest spectrum of outcomes. Technological advances can be used to facilitate outcome measurement in ambulatory surgery with digital integration optimizing accurate real-time data collection. Telephone or web-based applications for reviewing ambulatory patients were found to be acceptable in multiple international settings and should be harnessed to allow remote follow-up. SUMMARY: Use of validated tools to measure patient-reported outcomes allows internal and external quality comparison. Tools can be combined to measure objective outcomes and patient satisfaction. These are both key factors in driving forward improvements in perioperative ambulatory surgical care.

Distance travelled to hospital for emergency laparotomy and the effect of travel time on mortality: cohort study.

OBJECTIVES: To evaluate whether distance and estimated travel time to hospital for patients undergoing emergency laparotomy is associated with postoperative mortality. DESIGN: National cohort study using data from the National Emergency Laparotomy Audit. SETTING: 171 National Health Service hospitals in England and Wales. PARTICIPANTS: 22 772 adult patients undergoing emergency surgery on the gastrointestinal tract between 2013 and 2016. MAIN OUTCOME MEASURES: Mortality from any cause and in any place at 30 and 90 days after surgery. RESULTS: Median on-road distance between home and hospital was 8.4 km (IQR 4.7-16.7 km) with a median estimated travel time of 16 min. Median time from hospital admission to operating theatre was 12.7 hours. Older patients live on average further from hospital and patients from areas of increased socioeconomic deprivation live on average less far away.We included estimated travel time as a continuous variable in multilevel logistic regression models adjusting for important confounders and found no evidence for an association with 30-day mortality (OR per 10 min of travel time=1.02, 95% CI 0.97 to 1.06, p=0.512) or 90-day mortality (OR 1.02, 95 % CI 0.97 to 1.06, p=0.472).The results were similar when we limited our analysis to the subgroup of 5386 patients undergoing the most urgent surgery. 30-day mortality: OR=1.02 (95% CI 0.95 to 1.10, p=0.574) and 90-day mortality: OR=1.01 (95% CI 0.94 to 1.08, p=0.858). CONCLUSIONS: In the UK NHS, estimated travel time between home and hospital was not a primary determinant of short-term mortality following emergency gastrointestinal surgery.

Perioperative interventions for prevention of postoperative pulmonary complications: systematic review and meta-analysis.

OBJECTIVE: To identify, appraise, and synthesise the best available evidence on the efficacy of perioperative interventions to reduce postoperative pulmonary complications (PPCs) in adult patients undergoing non-cardiac surgery. DESIGN: Systematic review and meta-analysis of randomised controlled trials. DATA SOURCES: Medline, Embase, CINHAL, and CENTRAL from January 1990 to December 2017. ELIGIBILITY CRITERIA: Randomised controlled trials investigating short term, protocolised medical interventions conducted before, during, or after non-cardiac surgery were included. Trials with clinical diagnostic criteria for PPC outcomes were included. Studies of surgical technique or physiological or biochemical outcomes were excluded. DATA EXTRACTION AND SYNTHESIS: Reviewers independently identified studies, extracted data, and assessed the quality of evidence. Meta-analyses were conducted to calculate risk ratios with 95% confidence intervals. Quality of evidence was summarised in accordance with GRADE methods. The primary outcome was the incidence of PPCs. Secondary outcomes were respiratory infection, atelectasis, length of hospital stay, and mortality. Trial sequential analysis was used to investigate the reliability and conclusiveness of available evidence. Adverse effects of interventions were not measured or compared. RESULTS: 117 trials enrolled 21 940 participants, investigating 11 categories of intervention. 95 randomised controlled trials enrolling 18 062 participants were included in meta-analysis; 22 trials were excluded from meta-analysis because the interventions were not sufficiently similar to be pooled. No high quality evidence was found for interventions to reduce the primary outcome (incidence of PPCs). Seven interventions had low or moderate quality evidence with confidence intervals indicating a probable reduction in PPCs: enhanced recovery pathways (risk ratio 0.35, 95% confidence interval 0.21 to 0.58), prophylactic mucolytics (0.40, 0.23 to 0.67), postoperative continuous positive airway pressure ventilation (0.49, 0.24 to 0.99), lung protective intraoperative ventilation (0.52, 0.30 to 0.88), prophylactic respiratory physiotherapy (0.55, 0.32 to 0.93), epidural analgesia (0.77, 0.65 to 0.92), and goal directed haemodynamic therapy (0.87, 0.77 to 0.98). Moderate quality evidence showed no benefit for incentive spirometry in preventing PPCs. Trial sequential analysis adjustment confidently supported a relative risk reduction of 25% in PPCs for prophylactic respiratory physiotherapy, epidural analgesia, enhanced recovery pathways, and goal directed haemodynamic therapies. Insufficient data were available to support or refute equivalent relative risk reductions for other interventions. CONCLUSIONS: Predominantly low quality evidence favours multiple perioperative PPC reduction strategies. Clinicians may choose to reassess their perioperative care pathways, but the results indicate that new trials with a low risk of bias are needed to obtain conclusive evidence of efficacy for many of these interventions. STUDY REGISTRATION: Prospero CRD42016035662.

Pediatric perioperative outcomes: Protocol for a systematic literature review and identification of a core outcome set for infants, children, and young people requiring anesthesia and surgery.

Clinical outcomes are measurable changes in health, function, or quality of life that are important for evaluating the quality of care and comparing the efficacy of interventions. However, clinical outcomes and related measurement tools need to be well-defined, relevant, and valid. In adults, Core Outcome Measures in Effectiveness Trials (COMET) methodology has been used to develop core outcome sets for perioperative care. Systematic literature reviews identified standardized endpoints (StEP) and valid measurement tools, and consensus across a broader range of relevant stakeholders was achieved via a Delphi process to establish Core Outcome Measures in Perioperative and Anaesthetic Care (COMPAC). Core outcome sets for pediatric perioperative care cannot be directly extrapolated from adult data. The type and weighting of endpoints within particular domains can be influenced by age-dependent differences in the indications for and/or nature of surgery and medical comorbidities, and the validity and utility of many measurement tools vary significantly with developmental stage and age. The involvement of parents/carers is essential as they frequently act as surrogate responders for preverbal and developmentally delayed children, parental response may influence child outcome, and parental and/or child ranking of outcomes may differ from those of health professionals. Here, we describe the formation of the international Pediatric Perioperative Outcomes Group, which aims to identify and create validated, broadly applicable, patient-centered outcome measures for infants, children, and young people. Methodologies parallel that of the StEP and COMPAC projects, and systematic literature searches have been performed within agreed age-dependent subpopulations to identify reported outcomes and measurement tools. This represents the first steps for developing core outcome sets for pediatric perioperative care.

Qualitative process evaluation of the Perioperative Quality Improvement Programme (PQIP): study protocol.

INTRODUCTION: The Perioperative Quality Improvement Programme (PQIP) is designed to measure complications after major elective surgery and improve these through feedback of data to clinicians. Previous research suggests that despite the significant resources which go into collecting data for national clinical audits, the information they contain is not always used effectively to improve local services. METHODS AND ANALYSIS: We will conduct a formative process evaluation of PQIP comprising a multisited qualitative study to analyse PQIP's programme theory, barriers, facilitators and wider contextual factors that influence implementation. The research will be carried out with the PQIP project team and six National Health Service (NHS) Trusts in England, selected according to geographical location, type of hospital, size and level of engagement with PQIP. We will include one Trust which has not expressed interest in the PQIP for comparison and to explore the role of secular trend in any changes in practice. We will use semi-structured interviews (up to 144 in Trusts and 12 with the project team), non-participant observations (up to 150 hours) and documentary analysis. We will track the lifecycle of perioperative data, exploring the transformations it undergoes from creation to use. We will use framework analysis with categories both from our research questions and from themes emerging from the data. ETHICS AND DISSEMINATION: Ethical approval has been granted from the University College London Research Ethics Committee (ref 10375/001). Permissions to conduct research at NHS Trusts have been granted by local Research and Development offices in coordination with the Health Research Authority. We will follow guidelines for data security, confidentiality and information governance. Findings will be shared at regular time points with the PQIP project team to inform the implementation of the programme, and with participating NHS Trusts to help them reflect on how they currently use data for improvement of perioperative services.

Preoperative chronic beta-blocker prescription in elderly patients as a risk factor for postoperative mortality stratified by preoperative blood pressure: a cohort study.

BACKGROUND: Recent data suggest that beta blockers are associated with increased perioperative risk in hypertensive patients. We investigated whether beta blockers were associated with an increased risk in elderly patients with raised preoperative arterial blood pressure. METHODS: We conducted a propensity-score-matched cohort study of primary care data from the UK Clinical Practice Research Datalink (2004-13), including 84 633 patients aged 65 yr or over. Conditional logistic regression models, including factors that were significantly associated with the outcome, were constructed for 30-day mortality after elective noncardiac surgery. The effects of beta blockers (primary outcome), renin-angiotensin system (RAS) inhibitors, calcium-channel blockers, thiazides, loop diuretics, and statins were investigated at systolic and diastolic arterial pressure thresholds. RESULTS: Beta blockers were associated with increased odds of postoperative 30-day mortality in patients with systolic hypertension (defined as systolic BP >140 mm Hg; adjusted odds ratio [aOR]: 1.92; 95% confidence interval [CI]: 1.05-3.51). After excluding patients for whom prior data suggest benefit from perioperative beta blockade (patients with prior myocardial infarction or heart failure), rather than adjusting for them, the point estimate shifted slightly (aOR: 2.06; 95% CI: 1.09-3.89). Compared with no use, statins (aOR: 0.35; 95% CI: 0.17-0.75) and thiazides (aOR: 0.28; 95% CI: 0.10-0.78) were associated with lower mortality in patients with systolic hypertension. CONCLUSIONS: These data suggest that the safety of perioperative beta blockers may be influenced by preoperative blood pressure thresholds. A randomised controlled trial of beta-blocker withdrawal, in select populations, is required to identify a causal relationship.

Mixed-methods evaluation of the Perioperative Medicine Service for High-Risk Patients Implementation Pilot (POMSHIP): a study protocol.

INTRODUCTION: Perioperative complications have a lasting effect on health-related quality of life and long-term survival. The Royal College of Anaesthetists has proposed the development of perioperative medicine (POM) services as an intervention aimed at improving postoperative outcome, by providing better coordinated care for high-risk patients. The Perioperative Medicine Service for High-risk Patients Implementation Pilot was developed to determine if a specialist POM service is able to reduce postoperative morbidity, failure to rescue, mortality and cost associated with hospital admission. The service involves individualised objective risk assessment, admission to a postoperative critical care unit and follow-up on the surgical ward by the POM team. This paper introduces the service and how it will be evaluated. METHODS AND ANALYSIS OF THE EVALUATION: A mixed-methods evaluation is exploring the impact of the service. Clinical effectiveness of the service is being analysed using a 'before and after' comparison of the primary outcome (the PostOperative Morbidity Score). Secondary outcomes will include length of stay, validated surveys to explore quality of life (EQ-5D) and quality of recovery (Quality of Recovery-15 Score). The impact on costs is being analysed using 'before and after' data from the Patient-Level Information and Costing System and the National Schedule of Reference Costs. The perceptions and experiences of staff and patients with the service, and how it is being implemented, are being explored by a qualitative process evaluation. ETHICS AND DISSEMINATION: The study was classified as a service evaluation. Participant information sheets and consent forms have been developed for the interviews and approvals required for the use of the validated surveys were obtained. The findings of the evaluation are being used formatively, to make changes in the service throughout implementation. The findings will also be used to inform the potential roll-out of the service to other sites.

SNAP-2 EPICCS: the second Sprint National Anaesthesia Project-EPIdemiology of Critical Care after Surgery: protocol for an international observational cohort study.

INTRODUCTION: The admission of high-risk patients to critical care after surgery is a recommended standard of care. Nevertheless, poor compliance against this recommendation has been repeatedly demonstrated in large epidemiological studies. It is unclear whether this is due to reasons of capacity, equipoise, poor quality clinical care or because hospitals are working creatively to create capacity for augmented care on normal surgical wards. The EPIdemiology of Critical Care after Surgery study aims to address these uncertainties. METHODS AND ANALYSIS: One-week observational cohort study in the UK and Australasia. All patients undergoing inpatient (overnight stay) surgery will be included. All will have prospective data collection on risk factors, surgical procedure and postoperative outcomes including the primary outcome of morbidity (measured using the Postoperative Morbidity Survey on day 7 after surgery) and secondary outcomes including length of stay and mortality. Data will also be collected on critical care referral and admission, surgical cancellations and critical care occupancy. The epidemiology of patient characteristics, processes and outcomes will be described. Inferential techniques (multilevel multivariable regression, propensity score matching and instrumental variable analysis) will be used to evaluate the relationship between critical care admission and postoperative outcome. ETHICS AND DISSEMINATION: The study has received ethical approval from the National Research Ethics Service in the UK and equivalent in Australasia. The collection of patient identifiable data without prior consent has been approved by the Confidentiality Advisory Group (England and Wales) and the Public Privacy and Patient Benefit Panel (Scotland). In these countries, patient identifiable data will be used to link prospectively collected data with national registers of death and inpatient administrative data. The study findings will be disseminated using a multimedia approach with the support of our lay collaborators, to patients, public, policy-makers, clinical and academic audiences.