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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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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. 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. 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. 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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Graphical models have emerged as a tool to map out the interplay between multiple measured and unmeasured variables, and can help strengthen the case for a causal association between exposures and outcomes in observational studies. In Part 1 of this methods series, we will introduce the reader to graphical models for causal inference in perioperative medicine, and set the framework for Part 2 of the series involving advanced methods for causal inference. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]