Evaluating patient factors, operative management and postoperative outcomes in trauma laparotomy patients worldwide: a protocol for a global observational multicentre trauma study.

INTRODUCTION: Trauma contributes to the greatest loss of disability-adjusted life-years for adolescents and young adults worldwide. In the context of global abdominal trauma, the trauma laparotomy is the most commonly performed operation. Variation likely exists in how these patients are managed and their subsequent outcomes, yet very little global data on the topic currently exists. The objective of the GOAL-Trauma study is to evaluate both patient and injury factors for those undergoing trauma laparotomy, their clinical management and postoperative outcomes. METHODS: We describe a planned prospective multicentre observational cohort study of patients undergoing trauma laparotomy. We will include patients of all ages who present to hospital with a blunt or penetrating injury and undergo a trauma laparotomy within 5 days of presentation to the treating centre. The study will collect system, patient, process and outcome data, following patients up until 30 days postoperatively (or until discharge or death, whichever is first). Our sample size calculation suggests we will need to recruit 552 patients from approximately 150 recruiting centres. DISCUSSION: The GOAL-Trauma study will provide a global snapshot of the current management and outcomes for patients undergoing a trauma laparotomy. It will also provide insight into the variation seen in the time delays for receiving care, the disease and patient factors present, and patient outcomes. For current standards of trauma care to be improved worldwide, a greater understanding of the current state of trauma laparotomy care is paramount if appropriate interventions and targets are to be identified and implemented.

Obstetric services in the UK during the COVID-19 pandemic: A national survey.

BACKGROUND: The management of obstetric patients with coronavirus disease 2019 (COVID-19) due to human-to-human transmission of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) requires unique considerations. Many aspects of labour and delivery practice required adaptation in response to the global pandemic and were supported by guidelines from the Royal College of Obstetrics and Gynaecologists. The adoption and adherence to these guidelines is unknown. METHODS: Participating centres in "Quality of Recovery in Obstetric Anaesthesia study-a multicentre study" (ObsQoR) completed an electronic survey based on the provision of services and care related to COVID-19 in October 2021. The survey was designed against the Royal College of Obstetricians and Gynaecologists COVID-19 guidelines. RESULTS: One hundred and five of the 107 participating centres completed the survey (98% response rate representing 54% of all UK obstetric units). The median [IQR] annual number of deliveries among the included sites was 4389 [3000-5325]. Ninety-nine of the 103 (94.3%) sites had guidelines for the management of peripartum women with COVID-19. Sixty-one of 105 (58.1%) sites had specific guidance for venous thromboembolism (VTE) prophylaxis. Thirty-seven of 104 (35.6%) centres restricted parturient birthing plans if a positive diagnosis of COVID-19 was made. A COVID-19 vaccination referral pathway encouraging full vaccination for all pregnant women was present in 63/103 centres (61.2%). CONCLUSION: We found variability in care delivered and adherence to guidelines related to COVID-19. The clinical implications for this related to quality of peripartum care is unclear, however there remains scope to improve pathways for immunisation, birth plans and VTE prophylaxis.

Intensive care physicians' perceptions of the diagnosis & management of patients with acute hypoxic respiratory failure associated with COVID-19: A UK based survey.

Background: Whilst the management of Coronavirus disease-2019 (COVID-19) has evolved in response to the emerging data, treating such patients remains a challenge, and many treatments lack robust clinical evidence. We conducted a survey to evaluate Intensive Care Unit (ICU) management of COVID-19 patients with acute hypoxic respiratory failure and compared the results with data from a similar survey focusing on Acute Respiratory Distress Syndrome (ARDS) that was conducted in 2013. Methods: The questionnaire was refined from a previous survey of ARDS-related clinical practice using an online electronic survey engine (Survey Monkey®) and all UK intensivists were encouraged to participate. The survey was conducted between 16/05/2020 and 17/06/2020. Results: There were 137 responses from 89 UK centres. Non-invasive ventilation was commonly used in the form of CPAP. The primary ventilation strategy was the ARDSnet protocol, with 63% deviating from its PEEP recommendations. Similar to our previous ARDS survey, most allowed permissive targets for hypoxia (94%), hypercapnia (55%) and pH (94%). The routine use of antibiotics was common, and corticosteroids were frequently used, usually in the context of a clinical trial (45%). Late tracheostomy (>7 days) was preferred (92%). Routine follow-up was offered by 66% with few centres providing routine dedicated rehabilitation programmes following discharge. Compared to the ARDS survey, there is an increased use of neuromuscular agents, APRV ventilation and improved provision of rehabilitation services. Conclusions: Similar to our previous ARDS survey, this survey highlights variations in the management strategies used for patients with acute hypoxic respiratory failure due to COVID-19.

Impact of the first wave of COVID-19 on outcomes following emergency admissions for common acute surgical conditions: analysis of a national database in England.

BACKGROUND: This study assessed the impact of the first COVID-19 wave in England on outcomes for acute appendicitis, gallstone disease, intestinal obstruction, diverticular disease, and abdominal wall hernia. METHODS: Emergency surgical admissions for patients aged 18 years and older to 124 NHS Trust hospitals between January and June in 2019 and 2020 were extracted from Hospital Episode Statistics. The risk of 90-day mortality after admission during weeks 11-19 in 2020 (national lockdown) and 2019 (pre-COVID-19) was estimated using multilevel logistic regression with case-mix adjustment. The primary outcome was all-cause mortality at 90 days. RESULTS: There were 12 231 emergency admissions and 564 deaths within 90 days during weeks 11-19 in 2020, compared with 18 428 admissions and 542 deaths in the same interval in 2019. Overall, 90-day mortality was higher in 2020 versus 2019, with an adjusted OR of 1.95 (95 per cent c.i. 0.78 to 4.89) for appendicitis, 2.66 (1.81 to 3.92) for gallstone disease, 1.99 (1.44 to 2.74) for diverticular disease, 1.70 (1.13 to 2.55) for hernia, and 1.22 (1.01 to 1.47) for intestinal obstruction. After emergency surgery, 90-day mortality was higher in 2020 versus 2019 for gallstone disease (OR 3.37, 1.26 to 9.02), diverticular disease (OR 2.35, 1.16 to 4.73), and hernia (OR 2.34, 1.23 to 4.45). For intestinal obstruction, the corresponding OR was 0.91 (0.59 to 1.41). For admissions not leading to emergency surgery, mortality was higher in 2020 versus 2019 for gallstone disease (OR 2.55, 1.67 to 3.88), diverticular disease (1.90, 1.32 to 2.73), and intestinal obstruction (OR 1.30, 1.06 to 1.60). CONCLUSION: Emergency admission was reduced during the first lockdown in England and this was associated with higher 90-day mortality.

Perioperative Care Pathways in Low- and Lower-Middle-Income Countries: Systematic Review and Narrative Synthesis.

BACKGROUND: Safe and effective care for surgical patients requires high-quality perioperative care. In high-income countries (HICs), care pathways have been shown to be effective in standardizing clinical practice to optimize patient outcomes. Little is known about their use in low- and middle-income countries (LMICs) where perioperative mortality is substantially higher. METHODS: Systematic review and narrative synthesis to identify and describe studies in peer-reviewed journals on the implementation or evaluation of perioperative care pathways in LMICs. Searches were conducted in MEDLINE, EMBASE, CINAHL Plus, WHO Global Index, Web of Science, Scopus, Global Health and SciELO alongside citation searching. Descriptive statistics, taxonomy classifications and framework analyses were used to summarize the setting, outcome measures, implementation strategies, and facilitators and barriers to implementation. RESULTS: Twenty-seven studies were included. The majority of pathways were set in tertiary hospitals in lower-middle-income countries and were focused on elective surgery. Only six studies were assessed as high quality. Most pathways were adapted from international guidance and had been implemented in a single hospital. The most commonly reported barriers to implementation were cost of interventions and lack of available resources. CONCLUSIONS: Studies from a geographically diverse set of low and lower-middle-income countries demonstrate increasing use of perioperative pathways adapted to resource-poor settings, though there is sparsity of literature from low-income countries, first-level hospitals and emergency surgery. As in HICs, addressing patient and clinician beliefs is a major challenge in improving care. Context-relevant and patient-centered research, including qualitative and implementation studies, would make a valuable contribution to existing knowledge.

Anaesthesia Choice for Creation of Arteriovenous Fistula (ACCess) study protocol : a randomised controlled trial comparing primary unassisted patency at 1 year of primary arteriovenous fistulae created under regional compared to local anaesthesia.

INTRODUCTION: Arteriovenous fistulae (AVF) are the 'gold standard' vascular access for haemodialysis. Universal usage is limited, however, by a high early failure rate. Several small, single-centre studies have demonstrated better early patency rates for AVF created under regional anaesthesia (RA) compared with local anaesthesia (LA). The mechanistic hypothesis is that the sympathetic blockade associated with RA causes vasodilatation and increased blood flow through the new AVF. Despite this, considerable variation in practice exists in the UK. A high-quality, adequately powered, multicentre randomised controlled trial (RCT) is required to definitively inform practice. METHODS AND ANALYSIS: The Anaesthesia Choice for Creation of Arteriovenous Fistula (ACCess) study is a multicentre, observer-blinded RCT comparing primary radiocephalic/brachiocephalic AVF created under regional versus LA. The primary outcome is primary unassisted AVF patency at 1 year. Access-specific (eg, stenosis/thrombosis), patient-specific (including health-related quality of life) and safety secondary outcomes will be evaluated. Health economic analysis will also be undertaken. ETHICS AND DISSEMINATION: The ACCess study has been approved by the West of Scotland Research and ethics committee number 3 (20/WS/0178). Results will be published in open-access peer-reviewed journals within 12 months of completion of the trial. We will also present our findings at key national and international renal and anaesthetic meetings, and support dissemination of trial outcomes via renal patient groups. TRIAL REGISTRATION NUMBER: ISRCTN14153938. SPONSOR: NHS Greater Glasgow and Clyde GN19RE456, Protocol V.1.3 (8 May 2021), REC/IRAS ID: 290482.

Documentation of individualized preoperative risk assessment: a multi-center study.

BACKGROUND: Individual surgical risk assessment (ISRA) enhances patient care experience and outcomes by informing shared decision-making, strengthening the consent process, and supporting clinical management. Neither the use of individual pre-surgical risk assessment tools nor the rate of individual risk assessment documentation is known. The primary endpoint of this study was to determine the rate of physician documented ISRAs, with or without a named ISRA tool, within the records of patients with poor outcomes. Secondary endpoints of this work included the effects of age, sex, race, ASA class, and time and type of surgery on the rate of documented presurgical risk. METHODS: The records of non-obstetric surgical patients within 22 community-based private hospitals in Arizona, Colorado, Nebraska, Nevada, and Wyoming, between January 1 and December 31, 2017, were evaluated. A two-sample proportion test was used to identify the difference between surgical documentation and anesthesiology documentation of risk. Logistic regression was used to analyze both individual and group effects associated with secondary endpoints. RESULTS: Seven hundred fifty-six of 140,756 inpatient charts met inclusion criteria (0.54%, 95% CI 0.50 to 0.58%). ISRAs were documented by 16.08% of surgeons and 4.76% of anesthesiologists (p < 0.0001, 95% CI -0.002 to 0.228). Cardiac surgeons documented ISRAs more frequently than non-cardiac surgeons (25.87% vs 16.15%) [p = 0.0086, R-squared = 0.970%]. Elective surgical patients were more likely than emergency surgical patients (19.57 vs 12.03%) to have risk documented (p = 0.023, R-squared = 0.730%). Patients over the age of 65 were more likely than patients under the age of 65 to have ISRA documentation (20.31 vs 14.61%) [p = 0.043, R-squared = 0.580%]. Only 10 of 756 (1.3%) records included documentation of a named ISRA tool. CONCLUSIONS: The observed rate of documented ISRA in our sample was extremely low. Surgeons were more likely than anesthesiologists to document ISRA. As these individualized risk assessment discussions form the bedrock of perioperative informed consent, the rate and quality of risk documentation must be improved.

Causal inference in perioperative medicine observational research: part 2, advanced methods.

Although RCTs represent the gold standard in clinical research, most clinical questions cannot be answered using this technique, because of ethical considerations, time, and cost. The goal of observational research in clinical medicine is to gain insight into the relationship between a clinical exposure and patient outcome, in the absence of evidence from RCTs. Observational research offers additional benefit when compared with data from RCTs: the conclusions are often more generalisable to a heterogenous population, which may be of greater value to everyday clinical practice. In Part 2 of this methods series, we will introduce the reader to several advanced methods for supporting the case for causality between an exposure and outcome, including: mediation analysis, natural experiments, and joint effects methods.

Socioeconomic deprivation and mortality after emergency laparotomy: an observational epidemiological study.

BACKGROUND: Socioeconomic circumstances can influence access to healthcare, the standard of care provided, and a variety of outcomes. This study aimed to determine the association between crude and risk-adjusted 30-day mortality and socioeconomic group after emergency laparotomy, measure differences in meeting relevant perioperative standards of care, and investigate whether variation in hospital structure or process could explain any difference in mortality between socioeconomic groups. METHODS: This was an observational study of 58 790 patients, with data prospectively collected for the National Emergency Laparotomy Audit in 178 National Health Service hospitals in England between December 1, 2013 and November 31, 2016, linked with national administrative databases. The socioeconomic group was determined according to the Index of Multiple Deprivation quintile of each patient's usual place of residence. RESULTS: Overall, the crude 30-day mortality was 10.3%, with differences between the most-deprived (11.2%) and least-deprived (9.8%) quintiles (P<0.001). The more-deprived patients were more likely to have multiple comorbidities, were more acutely unwell at the time of surgery, and required a more-urgent surgery. After risk adjustment, the patients in the most-deprived quintile were at significantly higher risk of death compared with all other quintiles (adjusted odds ratio [95% confidence interval]: Q1 [most deprived]: reference; Q2: 0.83 [0.76-0.92]; Q3: 0.84 [0.76-0.92]; Q4: 0.87 [0.79-0.96]; Q5 [least deprived]: 0.77 [0.70-0.86]). We found no evidence that differences in hospital-level structure or patient-level performance in standards of care explained this association. CONCLUSIONS: More-deprived patients have higher crude and risk-adjusted 30-day mortality after emergency laparotomy, but this is not explained by differences in the standards of care recorded within the National Emergency Laparotomy Audit.

Systematic review and consensus definitions for the Standardised Endpoints in Perioperative Medicine (StEP) initiative: patient comfort.

BACKGROUND: Maximising patient comfort during and after surgery is a primary concern of anaesthetists and other perioperative clinicians, but objective measures of what constitutes patient comfort in the perioperative period remain poorly defined. The Standardised Endpoints in Perioperative Medicine initiative was established to derive a set of standardised endpoints for use in perioperative clinical trials. METHODS: We undertook a systematic review to identify measures of patient comfort used in the anaesthetic, surgical, and other perioperative literature. A multi-round Delphi consensus process that included up to 89 clinician researchers was then used to refine a recommended list of outcome measures. RESULTS: We identified 122 studies in a literature search, which were the basis for a preliminary list of 24 outcome measures and their definitions. The response rates for Delphi Rounds 1, 2, and 3 were 100% (n=22), 90% (n=79), and 100% (n=13), respectively. A final list of six defined endpoints was identified: pain intensity (at rest and during movement) at 24 h postoperatively, nausea and vomiting (0-6 h, 6-24 h, and overall), one of two quality-of-recovery (QoR) scales (QoR score or QoR-15), time to gastrointestinal recovery, time to mobilisation, and sleep quality. CONCLUSIONS: As standardised outcomes will support benchmarking and pooling (meta-analysis) of trials, one or more of these recommended endpoints should be considered for inclusion in clinical trials assessing patient comfort and pain after surgery.

A novel inpatient complex pain team: protocol for a mixed-methods evaluation of a single-centre pilot study.

INTRODUCTION: Complex pain is a debilitating condition that is responsible for low quality of life and significant economic impacts. Although best practice in the treatment of complex pain employs a multidisciplinary team, many patients do not have access to this care, leading to poor outcomes. METHODS AND ANALYSIS: This study evaluates a novel inpatient complex pain team at a large London teaching hospital. A multidisciplinary pain team comprising specialist doctors, nurses, psychologists and physiotherapists was instituted for inpatients with complex pain who will undergo an intense and bespoke evidence-based programme which will then be integrated into the community. A mixed-methods evaluation will take place and patients will be recruited over the course of 1 year. A qualitative arm will interview 15 staff and 15 patients on recruitment and again 6 months later looking to compare and contrast the new pain team with past experiences of pain management. A quantitative arm will assess clinical outcomes using validated scoring tools. An economic evaluation will seek to evaluate the relative cost of the service by comparing healthcare costs before and after the intervention. ETHICS AND DISSEMINATION: The study was categorised as a service evaluation, so formal ethical approval was not considered necessary. Participant recruitment began in January 2016 and the 1-year follow-up will end in November 2017. The results of this study will be published in 2018.

Primum Non Nocere: is shared decision-making the answer?

Surgical ambition is rising, with the Royal College of Surgeons reporting an increase in the number of procedures by a million over the past decade (Royal College of Surgeons. Surgery and the NHS in Numbers. Available from https://www.rcseng.ac.uk). Underpinning, this is a rapidly growing population, especially those in the over 85 age group, coupled with rising perioperative expertise; options for surgery are now present where conditions were once managed conservatively. Matching the right patient to the right procedure has never been so pertinent (Bader, Am Soc Anesthesiol 78(6), 2014). At the heart of these increasingly complex decisions, which may prove fatal or result in serious morbidity, lies the aspiration of shared decision-making (SDM) (Glance et al., N Engl J Med 370:1379-81, 2014). Shared decision-making is a patient-centred approach taking into account the beliefs, preferences and views of the patient as an expert in what is right for them, supported by clinicians who are the experts in diagnostics and valid therapeutic options (Coulter and Collins, Making shared decision-making a reality: no decision about me, without me, 2011). It has been described as the pinnacle of patient-centred care (Barry et al., N Engl J Med 366:780-1, 2012). In this commentary, we explore further the concept of shared decision-making, supported by a recent article which highlights critical deficits in current perioperative practice (Ankuda et al., Patient Educ Couns 94(3):328-33, 2014). This article was chosen for the purposes of this commentary as it is a large study across several surgical specialties investigating preoperative shared decision-making, and to our knowledge, the only of this kind.