Prehospital Tranexamic Acid for Severe Trauma.

BACKGROUND: Whether prehospital administration of tranexamic acid increases the likelihood of survival with a favorable functional outcome among patients with major trauma and suspected trauma-induced coagulopathy who are being treated in advanced trauma systems is uncertain. METHODS: We randomly assigned adults with major trauma who were at risk for trauma-induced coagulopathy to receive tranexamic acid (administered intravenously as a bolus dose of 1 g before hospital admission, followed by a 1-g infusion over a period of 8 hours after arrival at the hospital) or matched placebo. The primary outcome was survival with a favorable functional outcome at 6 months after injury, as assessed with the use of the Glasgow Outcome Scale-Extended (GOS-E). Levels on the GOS-E range from 1 (death) to 8 ("upper good recovery" [no injury-related problems]). We defined survival with a favorable functional outcome as a GOS-E level of 5 ("lower moderate disability") or higher. Secondary outcomes included death from any cause within 28 days and within 6 months after injury. RESULTS: A total of 1310 patients were recruited by 15 emergency medical services in Australia, New Zealand, and Germany. Of these patients, 661 were assigned to receive tranexamic acid, and 646 were assigned to receive placebo; the trial-group assignment was unknown for 3 patients. Survival with a favorable functional outcome at 6 months occurred in 307 of 572 patients (53.7%) in the tranexamic acid group and in 299 of 559 (53.5%) in the placebo group (risk ratio, 1.00; 95% confidence interval [CI], 0.90 to 1.12; P = 0.95). At 28 days after injury, 113 of 653 patients (17.3%) in the tranexamic acid group and 139 of 637 (21.8%) in the placebo group had died (risk ratio, 0.79; 95% CI, 0.63 to 0.99). By 6 months, 123 of 648 patients (19.0%) in the tranexamic acid group and 144 of 629 (22.9%) in the placebo group had died (risk ratio, 0.83; 95% CI, 0.67 to 1.03). The number of serious adverse events, including vascular occlusive events, did not differ meaningfully between the groups. CONCLUSIONS: Among adults with major trauma and suspected trauma-induced coagulopathy who were being treated in advanced trauma systems, prehospital administration of tranexamic acid followed by an infusion over 8 hours did not result in a greater number of patients surviving with a favorable functional outcome at 6 months than placebo. (Funded by the Australian National Health and Medical Research Council and others; PATCH-Trauma ClinicalTrials.gov number, NCT02187120.).

Characterisation of Plasma Mitochondrial DNA, MMP-9 and Neutrophil Elastase in Patients Undergoing Coronary Artery Bypass Grafting: Effects of Tranexamic Acid and Postoperative Pneumonia.

BACKGROUND: Postoperative pneumonia is a major cause of morbidity and mortality following cardiac surgery. The inflammatory response to cardiac surgery has been widely studied, but specific mechanisms for postoperative pneumonia have not been determined. Tranexamic acid is renowned for its effect on bleeding but can also modulate inflammatory processes. Cardiac surgery is known to release mitochondrial DAMPs (mtDAMPs) and is linked to postoperative inflammation and atrial fibrillation. We speculated that mtDAMPs might be related to postoperative pneumonia and that this might be modulated by tranexamic acid. METHODS: Forty-one (41) patients from the Aspirin and Tranexamic Acid for Coronary Artery Surgery (ATACAS) trial were studied. Levels of mitochondrial DNA, matrix metallopeptidase 9 (MMP-9) and neutrophil elastase (NE) were determined in plasma preoperatively, at 24 and 72 hours post-surgery and correlated with clinical outcome. RESULTS: mtDNA was significantly elevated postoperatively in the placebo and tranexamic acid (TXA) groups. Neutrophil elastase increased immediately postoperatively and at 24 hours. MMP-9 was elevated in the placebo group early postoperatively and in the TXA group at the immediate postoperative time point and after 24 hours. Six (6) of the 41 (14.6%) patients subsequently developed pneumonia. mtDNA levels were significantly increased at the early postoperative period and the 24-hour time point in patients with pneumonia. CONCLUSIONS: Cardiac surgery releases mtDNA, increases MMP-9 and NE and this was not influenced by TXA. Inflammation postoperatively might be linked to pneumonia since mtDNA was further elevated in these patients. Due to the low number of individuals developing pneumonia, further studies are warranted to clearly identify whether TXA impacts on the inflammatory response in postoperative pneumonia.

A Dual-Antigen Enzyme-Linked Immunosorbent Assay Allows the Assessment of Severe Acute Respiratory Syndrome Coronavirus 2 Antibody Seroprevalence in a Low-Transmission Setting.

Estimates of seroprevalence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) antibodies have been hampered by inadequate assay sensitivity and specificity. Using an enzyme-linked immunosorbent assay-based approach that combines data about immunoglobulin G responses to both the nucleocapsid and spike receptor binding domain antigens, we show that excellent sensitivity and specificity can be achieved. We used this assay to assess the frequency of virus-specific antibodies in a cohort of elective surgery patients in Australia and estimated seroprevalence in Australia to be 0.28% (95% Confidence Interval, 0-1.15%). These data confirm the low level of transmission of SARS-CoV-2 in Australia before July 2020 and validate the specificity of our assay.

Establishing a Multicentre Trauma Registry in India: An Evaluation of Data Completeness.

BACKGROUND: The completeness of a trauma registry's data is essential for its valid use. This study aimed to evaluate the extent of missing data in a new multicentre trauma registry in India and to assess the association between data completeness and potential predictors of missing data, particularly mortality. METHODS: The proportion of missing data for variables among all adults was determined from data collected from 19 April 2016 to 30 April 2017. In-hospital physiological data were defined as missing if any of initial systolic blood pressure, heart rate, respiratory rate, or Glasgow Coma Scale were missing. Univariable logistic regression and multivariable logistic regression, using manual stepwise selection, were used to investigate the association between mortality (and other potential predictors) and missing physiological data. RESULTS: Data on the 4466 trauma patients in the registry were analysed. Out of 59 variables, most (n = 51; 86.4%) were missing less than 20% of observations. There were 808 (18.1%) patients missing at least one of the first in-hospital physiological observations. Hospital death was associated with missing in-hospital physiological data (adjusted OR 1.4; 95% CI 1.02-2.01; p = 0.04). Other significant associations with missing data were: patient arrival time out of hours, hospital of care, 'other' place of injury, and specific injury mechanisms. Assault/homicide injury intent and occurrence of chest X-ray were associated with not missing any of first in-hospital physiological variables. CONCLUSION: Most variables were well collected. Hospital death, a proxy for more severe injury, was associated with missing first in-hospital physiological observations. This remains an important limitation for trauma registries.

Early Identification of Acute Traumatic Coagulopathy Using Clinical Prediction Tools: A Systematic Review.

: Background and objectives: Prompt identification of patients with acute traumatic coagulopathy (ATC) is necessary to expedite appropriate treatment. An early clinical prediction tool that does not require laboratory testing is a convenient way to estimate risk. Prediction models have been developed, but none are in widespread use. This systematic review aimed to identify and assess accuracy of prediction tools for ATC. Materials and Methods: A search of OVID Medline and Embase was performed for articles published between January 1998 and February 2018. We searched for prognostic and predictive studies of coagulopathy in adult trauma patients. Studies that described stand-alone predictive or associated factors were excluded. Studies describing prediction of laboratory-diagnosed ATC were extracted. Performance of these tools was described. Results: Six studies were identified describing four different ATC prediction tools. The COAST score uses five prehospital variables (blood pressure, temperature, chest decompression, vehicular entrapment and abdominal injury) and performed with 60% sensitivity and 96% specificity to identify an International Normalised Ratio (INR) of >1.5 on an Australian single centre cohort. TICCS predicted an INR of >1.3 in a small Belgian cohort with 100% sensitivity and 96% specificity based on admissions to resuscitation rooms, blood pressure and injury distribution but performed with an Area under the Receiver Operating Characteristic (AUROC) curve of 0.700 on a German trauma registry validation. Prediction of Acute Coagulopathy of Trauma (PACT) was developed in USA using six weighted variables (shock index, age, mechanism of injury, Glasgow Coma Scale, cardiopulmonary resuscitation, intubation) and predicted an INR of >1.5 with 73.1% sensitivity and 73.8% specificity. The Bayesian network model is an artificial intelligence system that predicted a prothrombin time ratio of >1.2 based on 14 clinical variables with 90% sensitivity and 92% specificity. Conclusions: The search for ATC prediction models yielded four scoring systems. While there is some potential to be implemented effectively in clinical practice, none have been sufficiently externally validated to demonstrate associations with patient outcomes. These tools remain useful for research purposes to identify populations at risk of ATC.

Non-clinical interventions for reducing unnecessary caesarean section.

BACKGROUND: Caesarean section rates are increasing globally. The factors contributing to this increase are complex, and identifying interventions to address them is challenging. Non-clinical interventions are applied independently of a clinical encounter between a health provider and a patient. Such interventions may target women, health professionals or organisations. They address the determinants of caesarean births and could have a role in reducing unnecessary caesarean sections. This review was first published in 2011. This review update will inform a new WHO guideline, and the scope of the update was informed by WHO's Guideline Development Group for this guideline. OBJECTIVES: To evaluate the effectiveness and safety of non-clinical interventions intended to reduce unnecessary caesarean section. SEARCH METHODS: We searched CENTRAL, MEDLINE, Embase, CINAHL and two trials registers in March 2018. We also searched websites of relevant organisations and reference lists of related reviews. SELECTION CRITERIA: Randomised trials, non-randomised trials, controlled before-after studies, interrupted time series studies and repeated measures studies were eligible for inclusion. The primary outcome measures were: caesarean section, spontaneous vaginal birth and instrumental birth. DATA COLLECTION AND ANALYSIS: We followed standard methodological procedures recommended by Cochrane. We narratively described results of individual studies (drawing summarised evidence from single studies assessing distinct interventions). MAIN RESULTS: We included 29 studies in this review (19 randomised trials, 1 controlled before-after study and 9 interrupted time series studies). Most of the studies (20 studies) were conducted in high-income countries and none took place in low-income countries. The studies enrolled a mixed population of pregnant women, including nulliparous women, multiparous women, women with a fear of childbirth, women with high levels of anxiety and women having undergone a previous caesarean section.Overall, we found low-, moderate- or high-certainty evidence that the following interventions have a beneficial effect on at least one primary outcome measure and no moderate- or high-certainty evidence of adverse effects.Interventions targeted at women or familiesChildbirth training workshops for mothers alone may reduce caesarean section (risk ratio (RR) 0.55, 95% confidence interval (CI) 0.33 to 0.89) and may increase spontaneous vaginal birth (RR 2.25, 95% CI 1.16 to 4.36). Childbirth training workshops for couples may reduce caesarean section (RR 0.59, 95% CI 0.37 to 0.94) and may increase spontaneous vaginal birth (RR 2.13, 95% CI 1.09 to 4.16). We judged this one study with 60 participants to have low-certainty evidence for the outcomes above.Nurse-led applied relaxation training programmes (RR 0.22, 95% CI 0.11 to 0.43; 104 participants, low-certainty evidence) and psychosocial couple-based prevention programmes (RR 0.53, 95% CI 0.32 to 0.90; 147 participants, low-certainty evidence) may reduce caesarean section. Psychoeducation may increase spontaneous vaginal birth (RR 1.33, 95% CI 1.11 to 1.61; 371 participants, low-certainty evidence). The control group received routine maternity care in all studies.There were insufficient data on the effect of the four interventions on maternal and neonatal mortality or morbidity.Interventions targeted at healthcare professionalsImplementation of clinical practice guidelines combined with mandatory second opinion for caesarean section indication slightly reduces the risk of overall caesarean section (mean difference in rate change -1.9%, 95% CI -3.8 to -0.1; 149,223 participants). Implementation of clinical practice guidelines combined with audit and feedback also slightly reduces the risk of caesarean section (risk difference (RD) -1.8%, 95% CI -3.8 to -0.2; 105,351 participants). Physician education by local opinion leader (obstetrician-gynaecologist) reduced the risk of elective caesarean section to 53.7% from 66.8% (opinion leader education: 53.7%, 95% CI 46.5 to 61.0%; control: 66.8%, 95% CI 61.7 to 72.0%; 2496 participants). Healthcare professionals in the control groups received routine care in the studies. There was little or no difference in maternal and neonatal mortality or morbidity between study groups. We judged the certainty of evidence to be high.Interventions targeted at healthcare organisations or facilitiesCollaborative midwifery-labourist care (in which the obstetrician provides in-house labour and delivery coverage, 24 hours a day, without competing clinical duties), versus a private practice model of care, may reduce the primary caesarean section rate. In one interrupted time series study, the caesarean section rate decreased by 7% in the year after the intervention, and by 1.7% per year thereafter (1722 participants); the vaginal birth rate after caesarean section increased from 13.3% before to 22.4% after the intervention (684 participants). Maternal and neonatal mortality were not reported. We judged the certainty of evidence to be low.We studied the following interventions, and they either made little or no difference to caesarean section rates or had uncertain effects.Moderate-certainty evidence suggests little or no difference in caesarean section rates between usual care and: antenatal education programmes for physiologic childbirth; antenatal education on natural childbirth preparation with training in breathing and relaxation techniques; computer-based decision aids; individualised prenatal education and support programmes (versus written information in pamphlet).Low-certainty evidence suggests little or no difference in caesarean section rates between usual care and: psychoeducation; pelvic floor muscle training exercises with telephone follow-up (versus pelvic floor muscle training without telephone follow-up); intensive group therapy (cognitive behavioural therapy and childbirth psychotherapy); education of public health nurses on childbirth classes; role play (versus standard education using lectures); interactive decision aids (versus educational brochures); labourist model of obstetric care (versus traditional model of obstetric care).We are very uncertain as to the effect of other interventions identified on caesarean section rates as the certainty of the evidence is very low. AUTHORS' CONCLUSIONS: We evaluated a wide range of non-clinical interventions to reduce unnecessary caesarean section, mostly in high-income settings. Few interventions with moderate- or high-certainty evidence, mainly targeting healthcare professionals (implementation of guidelines combined with mandatory second opinion, implementation of guidelines combined with audit and feedback, physician education by local opinion leader) have been shown to safely reduce caesarean section rates. There are uncertainties in existing evidence related to very-low or low-certainty evidence, applicability of interventions and lack of studies, particularly around interventions targeted at women or families and healthcare organisations or facilities.

Mitochondrial DAMPs Are Released During Cardiopulmonary Bypass Surgery and Are Associated With Postoperative Atrial Fibrillation.

BACKGROUND: Atrial fibrillation (AF) is the most frequent complication of surgery performed on cardiopulmonary bypass (CPB) and recent work associates CPB with postoperative inflammation. We have shown that all tissue injury releases mitochondrial damage associated molecular patterns (mtDAMPs) including mitochondrial DNA (mtDNA). This can act as a direct, early activator of neutrophils (PMN), eliciting a systemic inflammatory response syndrome (SIRS) while suppressing PMN function. Neutrophil Extracellular Traps (NETs) are crucial to host defence. They carry out NETosis wherein webs of granule proteins and chromatin trap and kill bacteria. We hypothesised that surgery performed on CPB releases mtDAMPs into the circulation. Molecular patterns thus mobilised during CPB might then participate in the pathogenesis of SIRS and predict postoperative complications like AF [1]. METHODS: We prospectively studied 16 patients undergoing elective operations on CPB. Blood was sampled preoperatively, at the end of CPB and on days 1-2 postoperatively. Plasma samples were analysed for mtDNA. Neutrophil IL-6 gene expression was studied to assess induction of SIRS. Neutrophils were also assayed for the presence of neutrophil extracellular traps (NETs/NETosis). These biologic findings were then correlated to clinical data and compared in patients with and without postoperative AF (POAF). RESULTS: Mitochondrial DNA was significantly elevated following CPB (six-fold increase post-CPB, p=0.008 and five-fold increase days 1-2, p=0.02). Patients with POAF showed greater increases in mtDNA post-CPB than those without. Postoperative AF was seen in all patients with a ≥2-fold increase of mtDNA (p=0.037 vs. <2-fold). Neutrophil IL-6 gene transcription increased postoperatively demonstrating SIRS that was greatest days 1-2 (p=0.039). Neutrophil extracellular trap (NET) formation was markedly suppressed in the post-CPB state. CONCLUSION: Mitochondrial DNA is released by CPB surgery and is associated with POAF. IL-6 gene expression increases after CPB, demonstrating the evolution of postoperative SIRS. Lastly, cardiac surgery on CPB also suppressed PMN NETosis. Taken together, our data suggest that mtDNA released during surgery on CPB, may be involved in the pathogenesis of SIRS and related postoperative inflammatory events like POAF and infections. Mitochondrial DNA may therefore prove to be an early biomarker for postoperative complications with the degree of association to be determined in appropriately sized studies. If mtDNA is directly involved in cardiac inflammation, mtDNA-induced toll-like receptor-9 (TLR9) signalling could also be targeted therapeutically.

Development and Validation of Quality Criteria for Providing Patient- and Family-centered Injury Care.

OBJECTIVE: The aim of this study was to develop and evaluate the content validity of quality criteria for providing patient- and family-centered injury care. BACKGROUND: Quality criteria have been developed for clinical injury care, but not patient- and family-centered injury care. METHODS: Using a modified Research AND Development Corporation (RAND)/University of California, Los Angeles (UCLA) Appropriateness Methodology, a panel of 16 patients, family members, injury and quality of care experts serially rated and revised criteria for patient- and family-centered injury care identified from patient and family focus groups. The criteria were then sent to 384 verified trauma centers in the United States, Canada, Australia, and New Zealand for evaluation. RESULTS: A total of 46 criteria were rated and revised by the panel over 4 rounds of review producing 14 criteria related to clinical care (n = 4; transitions of care, pain management, patient safety, provider competence), communication (n = 3; information for patients/families; communication of discharge plans to patients/families, communication between hospital and community providers), holistic care (n = 4; patient hygiene, kindness and respect, family access to patient, social and spiritual support) and end-of-life care (n = 3; decision making, end-of-life care, family follow-up). Medical directors, managers, or coordinators representing 254 trauma centers (66% response rate) rated 12 criteria to be important (95% of responses) for patient- and family-centered injury care. Fewer centers rated family access to the patient (80%) and family follow-up after patient death (65%) to be important criteria. CONCLUSIONS: Fourteen-candidate quality criteria for patient- and family-centered injury care were developed and shown to have content validity. These may be used to guide quality improvement practices.

Implementation of the World Health Organization Trauma Care Checklist Program in 11 Centers Across Multiple Economic Strata: Effect on Care Process Measures.

BACKGROUND: Trauma contributes more than ten percent of the global burden of disease. Initial assessment and resuscitation of trauma patients often requires rapid diagnosis and management of multiple concurrent complex conditions, and errors are common. We investigated whether implementing a trauma care checklist would improve care for injured patients in low-, middle-, and high-income countries. METHODS: From 2010 to 2012, the impact of the World Health Organization (WHO) Trauma Care Checklist program was assessed in 11 hospitals using a stepped wedge pre- and post-intervention comparison with randomly assigned intervention start dates. Study sites represented nine countries with diverse economic and geographic contexts. Primary end points were adherence to process of care measures; secondary data on morbidity and mortality were also collected. Multilevel logistic regression models examined differences in measures pre- versus post-intervention, accounting for patient age, gender, injury severity, and center-specific variability. RESULTS: Data were collected on 1641 patients before and 1781 after program implementation. Patient age (mean 34 ± 18 vs. 34 ± 18), sex (21 vs. 22 % female), and the proportion of patients with injury severity scores (ISS) ≥ 25 (10 vs. 10 %) were similar before and after checklist implementation (p > 0.05). Improvement was found for 18 of 19 process measures, including greater odds of having abdominal examination (OR 3.26), chest auscultation (OR 2.68), and distal pulse examination (OR 2.33) (all p < 0.05). These changes were robust to several sensitivity analyses. CONCLUSIONS: Implementation of the WHO Trauma Care Checklist was associated with substantial improvements in patient care process measures among a cohort of patients in diverse settings.

Interventions for managing skeletal muscle spasticity following traumatic brain injury.

BACKGROUND: Skeletal muscle spasticity is a major physical complication resulting from traumatic brain injury (TBI), which can lead to muscle contracture, joint stiffness, reduced range of movement, broken skin and pain. Treatments for spasticity include a range of pharmacological and non-pharmacological interventions, often used in combination. Management of spasticity following TBI varies from other clinical populations because of the added complexity of behavioural and cognitive issues associated with TBI. OBJECTIVES: To assess the effects of interventions for managing skeletal muscle spasticity in people with TBI. SEARCH METHODS: In June 2017, we searched key databases including the Cochrane Injuries Group Specialised Register, CENTRAL, MEDLINE (Ovid), Embase (Ovid) and others, in addition to clinical trials registries and the reference lists of included studies. SELECTION CRITERIA: We included randomised controlled trials (RCTs) and cross-over RCTs evaluating any intervention for the management of spasticity in TBI. Only studies where at least 50% of participants had a TBI (or for whom separate data for participants with TBI were available) were included. The primary outcomes were spasticity and adverse effects. Secondary outcome measures were classified according to the World Health Organization International Classification of Functioning, Disability and Health including body functions (sensory, pain, neuromusculoskeletal and movement-related functions) and activities and participation (general tasks and demands; mobility; self-care; domestic life; major life areas; community, social and civic life). DATA COLLECTION AND ANALYSIS: We used standard methodological procedures expected by Cochrane. Data were synthesised narratively; meta-analysis was precluded due to the paucity and heterogeneity of data. MAIN RESULTS: We included nine studies in this review which involved 134 participants with TBI. Only five studies reported between-group differences, yielding outcome data for 105 participants with TBI. These five studies assessed the effects of a range of pharmacological (baclofen, botulinum toxin A) and non-pharmacological (casting, physiotherapy, splints, tilt table standing and electrical stimulation) interventions, often in combination. The studies which tested the effect of baclofen and tizanidine did not report their results adequately. Where outcome data were available, spasticity and adverse events were reported, in addition to some secondary outcome measures.Of the five studies with results, three were funded by governments, charities or health services and two were funded by a pharmaceutical or medical technology company. The four studies without useable results were funded by pharmaceutical or medical technology companies.It was difficult to draw conclusions about the effectiveness of these interventions due to poor reporting, small study size and the fact that participants with TBI were usually only a proportion of the overall total. Meta-analysis was not feasible due to the paucity of data and heterogeneity of interventions and comparator groups. Some studies concluded that the intervention they tested had beneficial effects on spasticity, and others found no difference between certain treatments. The most common adverse event was minor skin damage in people who received casting. We believe it would be misleading to provide any further description of study results given the quality of the evidence was very low for all outcomes. AUTHORS' CONCLUSIONS: The very low quality and limited amount of evidence about the management of spasticity in people with TBI means that we are uncertain about the effectiveness or harms of these interventions. Well-designed and adequately powered studies using functional outcome measures to test the interventions used in clinical practice are needed.

Use and definitions of perioperative mortality rates in low-income and middle-income countries: a systematic review.

BACKGROUND: Aggregate and risk-stratified perioperative mortality rates (POMR) are well-documented in high-income countries where surgical databases are common. In many low-income and middle-income country (LMIC) settings, such data are unavailable, compromising efforts to understand and improve surgical outcomes. We undertook a systematic review to determine how POMR is used and defined in LMICs and to inform baseline rates. METHODS: We searched PubMed for all articles published between Jan 1, 2009, and Sept 1, 2014, reporting surgical mortality in LMICs. Search criteria, inclusion and exclusion criteria, and study assessment methodology are reported in the appendix. Titles and abstracts were screened independently by two reviewers. Full-text review and data extraction were completed by four trained clinician coders with regular validation for consistency. We extracted the definition of POMR used, clinical risk scores reported, and strategies for risk adjustment in addition to reported mortality rates. FINDINGS: We screened 2657 abstracts and included 373 full-text articles. 493 409 patients in 68 countries and 12 surgical specialties were represented. The most common definition for the numerator of POMR was in-hospital deaths following surgery (55·3%) and for the denominator it was the number of operative patients (96·2%). Few studies reported preoperative comorbidities (41·8%), ASA status (11·3%), and HIV status (7·8%), with a smaller proportion stratifying on or adjusting mortality for these factors. Studies reporting on planned procedures recorded a median mortality of 1·2% (n=121 [IQR 0·0-4·7]). Median mortality was 10·1% (n=182 [IQR 2·5-16·2) for emergent procedures. INTERPRETATION: POMR is frequently reported in LMICs, but a standardised approach for reporting and risk stratification is absent from the literature. There was wide variation in POMR across procedures and specialties. A quality assessment checklist for surgical mortality studies could improve mortality reporting and facilitate benchmarking across sites and countries. FUNDING: None.

Monitoring and evaluating surgical care: defining perioperative mortality rate and standardising data collection.

BACKGROUND: Case volume per 100 000 population and perioperative mortality rate (POMR) are key indicators to monitor and strengthen surgical services. However, comparisons of POMR have been restricted by absence of standardised approaches to when it is measured, the ideal denominator, need for risk adjustment, and whether data are available. We aimed to address these issues and recommend a minimum dataset by analysing four large mixed surgical datasets, two from well-resourced settings with sophisticated electronic patient information systems and two from resource-limited settings where clinicians maintain locally developed databases. METHODS: We obtained data from the New Zealand (NZ) National Minimum Dataset, the Geelong Hospital patient management system in Australia, and purpose-built surgical databases in Pietermaritzburg, South Africa (PMZ) and Port Moresby, Papua New Guinea (PNG). Information was sought on inclusion and exclusion criteria, coding criteria, and completeness of patient identifiers, admission, procedure, discharge and death dates, operation details, urgency of admission, and American Society of Anesthesiologists (ASA) score. Date-related errors were defined as missing dates and impossible discrepancies. For every site, we then calculated the POMR, the effect of admission episodes or procedures as denominator, and the difference between in-hospital POMR and 30-day POMR. To determine the need for risk adjustment, we used univariate and multivariate logistic regression to assess the effect on relative POMR for each site of age, admission urgency, ASA score, and procedure type. FINDINGS: 1 365 773 patient admissions involving 1 514 242 procedures were included, among which 8655 deaths were recorded within 30 days. Database inclusion and exclusion criteria differed substantially. NZ and Geelong records had less than 0·1% date-related errors and greater than 99·9% completeness. PMZ databases had 99·9% or greater completeness of all data except date-related items (94·0%). PNG had 99·9% or greater completeness for date of birth or age and admission date and operative procedure, but 80-83% completeness of patient identifiers and date related items. Coding of procedures was not standardised, and only NZ recorded ASA status and complete post-discharge mortality. In-hospital POMR range was 0·38% in NZ to 3·44% in PMZ, and in NZ it underestimated 30-day POMR by roughly a third. The difference in POMR by procedures instead of admission episodes as denominator ranged from 10% to 70%. Age older than 65 years and emergency admission had large independent effects on POMR, but relatively little effect in multivariate analysis on the relative odds of in-hospital death at each site. INTERPRETATION: Hospitals can collect and provide data for case volume and POMR without sophisticated electronic information systems. POMR should initially be defined by in-hospital mortality because post-discharge deaths are not usually recorded, and with procedures as denominator because details allowing linkage of several operations within one patient's admission are not always present. Although age and admission urgency are independently associated with POMR, and ASA and case mix were not included, risk adjustment might not be essential because the relative odds between sites persisted. Standardisation of inclusion criteria and definitions is needed, as is attention to accuracy and completeness of dates of procedures, discharge and death. A one-page, paper-based form, or alternatively a simple electronic data collection form, containing a minimum dataset commenced in the operating theatre could facilitate this process. FUNDING: None.

Bellwether Procedures for Monitoring and Planning Essential Surgical Care in Low- and Middle-Income Countries: Caesarean Delivery, Laparotomy, and Treatment of Open Fractures.

BACKGROUND: Surgical conditions represent a significant proportion of the global burden of disease, and therefore, surgery is an essential component of health systems. Achieving universal health coverage requires effective monitoring of access to surgery. However, there is no widely accepted standard for the required capabilities of a first-level hospital. We aimed to determine whether a group of operations could be used to describe the delivery of essential surgical care. METHODS: We convened an expert panel to identify procedures that might indicate the presence of resources needed to treat an appropriate range of surgical conditions at first-level hospitals. Using data from the World Health Organization Emergency and Essential Surgical Care Global database, collected using the WHO Situational Analysis Tool (SAT), we analysed whether the ability to perform each of these procedures-which we term "bellwether procedures"-was associated with performing a full range of essential surgical procedures. FINDINGS: The ability to perform caesarean delivery, laparotomy, and treatment of open fracture was closely associated with performing all obstetric, general, basic, emergency, and orthopaedic procedures (p < 0.001) in the population that responded to the WHO SAT Survey. Procedures including cleft lip, cataract, and neonatal surgery did not correlate with performing the bellwether procedures. INTERPRETATION: Caesarean delivery, laparotomy, and treatment of open fractures should be standard procedures performed at first-level hospitals. With further validation in other populations, local managers and health ministries may find this useful as a benchmark for what first-level hospitals can and should be able to perform on a 24/7 basis in order to ensure delivery of emergency and essential surgical care to their population. Those procedures which did not correlate with the bellwether procedures can be referred to a specialized centre or collected for treatment by a visiting specialist team.

Implementation research in emergency medicine: a systematic scoping review.

INTRODUCTION: Implementation research aims to increase the uptake of research findings into clinical practice to improve the quality of healthcare. This scoping systematic study aims to assess the volume and scope of implementation research in emergency medicine (EM) to obtain an overview and inform future implementation research. METHODS: Studies were identified by searching electronic databases and reference lists of included studies for the years 2002, 2007 and 2012. Titles/abstracts were screened, full papers checked and data extracted by one author, with a random sample checked by a second author. RESULTS: A total of 3581 citations were identified with 197 eligible papers included. The number of papers significantly increased over time from 26 in 2002 to 77 in 2007 and 94 in 2012 (p<0.05). Eighty-two (42%) focused on identifying evidence-practice gaps, 77 (39%) evaluated the effectiveness of implementation interventions and 38 (19%) explored barriers and enablers to change. Only two papers explicitly stated that theory was used. Five of the 77 effectiveness studies used a randomised design and few provided sufficient detail about the intervention undergoing evaluation. CONCLUSIONS: Although there was a significant increase in the number of implementation research papers, most studies focused on identifying evidence-practice gaps or used weak study designs to evaluate the effects of implementation interventions. Recommendations for improving implementation research in EM include identifying barriers and enablers to implementation, using theory in areas where proven important gaps exist, improving the reporting of the content of interventions and using rigorous study designs to evaluate their effectiveness.

Wound management in disaster settings.

BACKGROUND: Few guidelines exist for the initial management of wounds in disaster settings. As wounds sustained are often contaminated, there is a high risk of further complications from infection, both local and systemic. Healthcare workers with little to no surgical training often provide early wound care, and where resources and facilities are also often limited, and clear appropriate guidance is needed for early wound management. METHODS: We undertook a systematic review focusing on the nature of wounds in disaster situations, and the outcomes of wound management in recent disasters. We then presented the findings to an international consensus panel with a view to formulating a guideline for the initial management of wounds by first responders and subsequent healthcare personnel as they deploy. RESULTS: We included 62 studies in the review that described wound care challenges in a diverse range of disasters, and reported high rates of wound infection with multiple causative organisms. The panel defined a guideline in which the emphasis is on not closing wounds primarily but rather directing efforts toward cleaning, debridement, and dressing wounds in preparation for delayed primary closure, or further exploration and management by skilled surgeons. CONCLUSION: Good wound care in disaster settings, as outlined in this article, can be achieved with relatively simple measures, and have important mortality and morbidity benefits.

Perioperative mortality rate (POMR): a global indicator of access to safe surgery and anaesthesia.

INTRODUCTION: The unmet global burden of surgical disease is substantial. Currently, two billion people do not have access to emergency and essential surgical care. This results in unnecessary deaths from injury, infection, complications of pregnancy, and abdominal emergencies. Inadequately treated surgical disease results in disability, and many children suffer deformity without corrective surgery. METHODS: A consensus meeting was held between representatives of Surgical and Anaesthetic Colleges and Societies to obtain agreement about which indicators were the most appropriate and credible. The literature and state of national reporting of perioperative mortality rates was reviewed by the authors. RESULTS: There is a need for a credible national and/or regional indicator that is relevant to emergency and essential surgical care. We recommend introducing the perioperative mortality rate (POMR) as an indicator of access to and safety of surgery and anaesthesia. POMR should be measured at two time periods: death on the day of surgery and death before discharge from hospital or within 30 days of the procedure, whichever is sooner. The rate should be expressed as the number of deaths (numerator) over the number of procedures (denominator). The option of before-discharge or 30 days is practical for those low- to middle-income countries where postdischarge follow-up is likely to be incomplete, but it allows those that currently can report 30-day mortality rates to continue to do so. Clinical interpretation of POMR at a hospital or health service level will be facilitated by risk stratification using age, urgency (elective and emergency), procedure/procedure group, and the American Society of Anesthesiologists grade. CONCLUSIONS: POMR should be reported as a health indicator by all countries and regions of the world. POMR reporting is feasible, credible, achieves a consensus of acceptance for reporting at national level. Hospital and Service level POMR requires interpretation using simple measures of risk adjustment such as urgency, age, the condition being treated or the procedure being performed and ASA status.

Interventions for reducing wrong-site surgery and invasive clinical procedures.

BACKGROUND: Specific clinical interventions are needed to reduce wrong-site surgery, which is a rare but potentially disastrous clinical error. Risk factors contributing to wrong-site surgery are variable and complex. The introduction of organisational and professional clinical strategies have a role in minimising wrong-site surgery. OBJECTIVES: To evaluate the effectiveness of organisational and professional interventions for reducing wrong-site surgery (including wrong-side, wrong-procedure and wrong-patient surgery), including non-surgical invasive clinical procedures such as regional blocks, dermatological, obstetric and dental procedures and emergency surgical procedures not undertaken within the operating theatre. SEARCH METHODS: For this update, we searched the following electronic databases: the Cochrane Effective Practice and Organisation of Care (EPOC) Group Specialised Register (January 2014), the Cochrane Central Register of Controlled Trials (The Cochrane Library 2014), MEDLINE (June 2011 to January 2014), EMBASE (June 2011 to January 2014), CINAHL (June 2011 to January 2014), Dissertations and Theses (June 2011 to January 2014), African Index Medicus, Latin American and Caribbean Health Sciences database, Virtual Health Library, Pan American Health Organization Database and the World Health Organization Library Information System. Database searches were conducted in January 2014. SELECTION CRITERIA: We searched for randomised controlled trials (RCTs), non-randomised controlled trials, controlled before-after studies (CBAs) with at least two intervention and control sites, and interrupted-time-series (ITS) studies where the intervention time was clearly defined and there were at least three data points before and three after the intervention. We included two ITS studies that evaluated the effectiveness of organisational and professional interventions for reducing wrong-site surgery, including wrong-side and wrong-procedure surgery. Participants included all healthcare professionals providing care to surgical patients; studies where patients were involved to avoid the incorrect procedures or studies with interventions addressed to healthcare managers, administrators, stakeholders or health insurers. DATA COLLECTION AND ANALYSIS: Two review authors independently assesses the quality and abstracted data of all eligible studies using a standardised data extraction form, modified from the Cochrane EPOC checklists. We contacted study authors for additional information. MAIN RESULTS: In the initial review, we included one ITS study that evaluated a targeted educational intervention aimed at reducing the incidence of wrong-site tooth extractions. The intervention included examination of previous cases of wrong-site tooth extractions, educational intervention including a presentation of cases of erroneous extractions, explanation of relevant clinical guidelines and feedback by an instructor. Data were reported from all patients on the surveillance system of a University Medical centre in Taiwan with a total of 24,406 tooth extractions before the intervention and 28,084 tooth extractions after the intervention. We re-analysed the data using the Prais-Winsten time series and the change in level for annual number of mishaps was statistically significant at -4.52 (95% confidence interval (CI) -6.83 to -2.217) (standard error (SE) 0.5380). The change in slope was statistically significant at -1.16 (95% CI -2.22 to -0.10) (SE 0.2472; P < 0.05).This update includes an additional study reporting on the incidence of neurological WSS at a university hospital both before and after the Universal Protocol's implementation. A total of 22,743 patients undergoing neurosurgical procedures at the University of Illionois College of Medicine at Peoria, Illinois, United States of America were reported. Of these, 7286 patients were reported before the intervention and 15,456 patients were reported after the intervention. The authors found a significant difference (P < 0.001) in the incidence of WSS between the before period, 1999 to 2004, and the after period, 2005 to 2011.  Similarly, data were re-analysed using Prais-Winsten regression to correct for autocorrelation. As the incidences were reported by year only and the intervention occurred in July 2004, the intervention year 2004 was excluded from the analysis. The change in level at the point the intervention was introduced was not statistically significant at -0.078 percentage points (pp) (95% CI -0.176 pp to 0.02 pp; SE 0.042; P = 0.103). The change in slope was statistically significant at 0.031 (95% CI 0.004 to 0.058; SE 0.012; P < 0.05). AUTHORS' CONCLUSIONS: The findings of this update added one additional ITS study to the previous review which contained one ITS study. The original review suggested that the use of a specific educational intervention in the context of a dental outpatient setting, which targets junior dental staff using a training session that included cases of wrong-site surgery, presentation of clinical guidelines and feedback by an instructor, was associated with a reduction in the incidence of wrong-site tooth extractions. The additional study in this update evaluated the annual incidence rates of wrong-site surgery in a neurosurgical population before and after the implementation of the Universal Protocol. The data suggested a strong downward trend in the incidence of wrong-site surgery prior to the intervention with the incidence rate approaching zero. The effect of the intervention in these studies however remains unclear, as data reflect only two small low-quality studies in very specific population groups.

Living systematic reviews: an emerging opportunity to narrow the evidence-practice gap.

The current difficulties in keeping systematic reviews up to date leads to considerable inaccuracy, hampering the translation of knowledge into action. Incremental advances in conventional review updating are unlikely to lead to substantial improvements in review currency. A new approach is needed. We propose living systematic review as a contribution to evidence synthesis that combines currency with rigour to enhance the accuracy and utility of health evidence. Living systematic reviews are high quality, up-to-date online summaries of health research, updated as new research becomes available, and enabled by improved production efficiency and adherence to the norms of scholarly communication. Together with innovations in primary research reporting and the creation and use of evidence in health systems, living systematic review contributes to an emerging evidence ecosystem.

Computational modeling of heart failure in microgravity transitions.

The space tourism industry is growing due to advances in rocket technology. Privatised space travel exposes non-professional astronauts with health profiles comprising underlying conditions to microgravity. Prior research has typically focused on the effects of microgravity on human physiology in healthy astronauts, and little is known how the effects of microgravity may play out in the pathophysiology of underlying medical conditions, such as heart failure. This study used an established, controlled lumped mathematical model of the cardiopulmonary system to simulate the effects of entry into microgravity in the setting of heart failure with both, reduced and preserved ejection fraction. We find that exposure to microgravity eventuates an increased cardiac output, and in patients with heart failure there is an unwanted increase in left atrial pressure, indicating an elevated risk for development of pulmonary oedema. This model gives insight into the risks of space flight for people with heart failure, and the impact this may have on mission success in space tourism.