Perioperative Resumption of Direct Oral Anticoagulants: Review of the Mayo Clinic Experience.

OBJECTIVE: We aimed to review recommendations for the postoperative resumption of direct oral anticoagulants (DOACs) and report complications 30 days postoperatively. METHODS: We retrospectively reviewed patients receiving DOAC therapy who underwent preoperative evaluations from January 1, 2015 through May 30, 2018. We noted days that DOAC therapy was withheld, postoperative time until resumption of the DOAC, and complications within 30 postoperative days. RESULTS: A total of 317 patients were included. Ten had complications. Complication rates among patients stratified by time to resumption were not significantly different, except for the deep vein thrombosis rate when DOACs were resumed after 72 hours (n = 2 [4.17%]; P = 0.02). The total time without DOACs did not affect the complication rates. CONCLUSIONS: We suggest withholding DOACs for 48 to 72 hours before surgery and resuming them 48 to 72 hours after surgery, if safe. The interruption of therapy was not associated with an increase in thrombotic events for patients who resumed DOACs within 72 hours postoperatively. Patients who resumed DOACs after 72 hours postoperatively had a low rate of thrombotic complications.

Evaluación de la eficacia de los protocolos de recuperación mejorada en cirugía cardiaca. Protocolo de Ensayo Clínico Aleatorizado / Assessment of the efficacy of improved recovery protocols in cardiac surgery. Randomized Clinical Trial Protocol

Introducción: Múltiples son los artículos publicados que abordan el tema de la ciencia abierta y su importancia para la sociedad, especialmente para la comunidad de investigadores. Esta constituye, ineludiblemente, el presente y futuro de las revistas científicas como método de expandir las investigaciones con alta calidad y credibilidad. La ciencia abierta como movimiento, tiene varios componentes y dentro de ellos, la gestión de citas y referencias de datos, códigos y materiales, que fundamentan la necesidad de que los autores tengan disponibles los contenidos subyacentes a los artículos que se publican y que constituyen la base de los resultados obtenidos en cada investigación. Objetivo: Evaluación de la eficacia de los protocolos de recuperación mejorada en cirugía cardiaca. Métodos: El protocolo que se propone fue elaborado por la investigadora principal (registro público cubano de ensayos clínicos RPCEC00000304) y se describe acorde a las recomendaciones de la lista internacional de chequeo para ensayos clínicos (SPIRIT). Conclusiones: Estarían en relación a si se puede demostrar, después de terminada la investigación, si el protocolo motivo de la Intervención, es mejor, igual o peor que el protocolo de control(AU)

Introduction: There are multiple articles published that address the subject of open science and its importance for society, especially for the research community. This constitutes, inevitably, the present and future of scientific journals as a method of expanding research with high quality and credibility. Open science, as a movement, has several components including the management of citations and references of data, codes and materials, which support the need for authors to have available the underlying content of the articles published and constituting the base for the results obtained in each investigation. Objective: Assessment of the efficacy of improved recovery protocols in cardiac surgery. Methods: The proposed protocol was prepared by the main researcher (Cuban public registry of clinical trials: RPCEC00000304) and is described according to the recommendations of the international checklist for clinical trials (SPIRIT). Conclusions: They would be related to whether it can be demonstrated, after the end of the investigation, if the protocol reason for the intervention is better, equal to, or worse than the control protocol(AU)

Methodologies for systematic reviews with meta-analysis of randomised clinical trials in pain, anaesthesia, and perioperative medicine.

Systematic reviews and meta-analyses (SRMAs) are increasing in popularity, but should they be used to inform clinical decision-making in anaesthesia? We present evidence that the certainty of evidence from SRMAs in anaesthesia (and in general) may be unacceptably low because of risks of bias exaggerating treatment effects, unexplained heterogeneity reducing certainty in estimates, random errors, and widespread prevalence of publication bias. We also present the latest methodological advances to help improve the certainty of evidence from SRMAs. The target audience includes both review authors and practising clinicians to help with SRMA appraisal. Issues discussed include minimising risks of bias from included trials, trial sequential analysis to reduce random error, updated methods for presenting effect estimates, and novel publication bias tests for commonly used outcome measures. These methods can help to reduce spurious conclusions on clinical significance, explain statistical heterogeneity, and reduce false positives when evaluating small-study effects. By reducing concerns in these domains of Grading of Recommendations, Assessment, Development and Evaluation, it should help improve the certainty of evidence from SRMAs used for decision-making in anaesthesia, pain, and perioperative medicine.

Systematic review and consensus definitions for the Standardized Endpoints in Perioperative Medicine (StEP) initiative: cardiovascular outcomes.

BACKGROUND: Adverse cardiovascular events are a leading cause of perioperative morbidity and mortality. The definitions of perioperative cardiovascular adverse events are heterogeneous. As part of the international Standardized Endpoints in Perioperative Medicine initiative, this study aimed to find consensus amongst clinical trialists on a set of standardised and valid cardiovascular outcomes for use in future perioperative clinical trials. METHODS: We identified currently used perioperative cardiovascular outcomes by a systematic review of the anaesthesia and perioperative medicine literature (PubMed/Ovid, Embase, and Cochrane Library). We performed a three-stage Delphi consensus-gaining process that involved 55 clinician researchers worldwide. Cardiovascular outcomes were first shortlisted and the most suitable definitions determined. These cardiovascular outcomes were then assessed for validity, reliability, feasibility, and clarity. RESULTS: We identified 18 cardiovascular outcomes. Participation in the three Delphi rounds was 100% (n=19), 71% (n=55), and 89% (n=17), respectively. A final list of nine cardiovascular outcomes was elicited from the consensus: myocardial infarction, myocardial injury, cardiovascular death, non-fatal cardiac arrest, coronary revascularisation, major adverse cardiac events, pulmonary embolism, deep vein thrombosis, and atrial fibrillation. These nine cardiovascular outcomes were rated by the majority of experts as valid, reliable, feasible, and clearly defined. CONCLUSIONS: These nine consensus cardiovascular outcomes can be confidently used as endpoints in clinical trials designed to evaluate perioperative interventions with the goal of improving perioperative outcomes.

Pharmacogenomics, concepts for the future of perioperative medicine and pain management: A review.

Pharmacogenomics is the study of how genetic differences between individuals affect pharmacokinetics and pharmacodynamics. These differences are apparent to clinicians when taking into account the wide range of responses to medications given in clinical practice. A review of literature involving pharmacogenomics and pain management was performed. The implementation of preoperative pharmacogenomics will allow us to better care for our patients by delivering personalized, safer medicine. This review describes the current state of pharmacogenomics as it relates to many aspects of clinical practice and how clinicians can use these tools to improve patient outcomes.

Causal inference in perioperative medicine observational research: part 1, a graphical introduction.

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.

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.

Factors Affecting the Thermal Comfort of Perioperative Personnel in the OR.

Thermal comfort is an important component of any work setting and can be difficult to achieve in the complex OR environment. This comparative descriptive study sought to identify factors affecting the thermal comfort of perioperative personnel in the OR (N = 68). Researchers used the American Society of Heating, Refrigerating and Air-Conditioning Engineers Thermal Sensation Scale and researcher-developed surveys to collect data. The mean reported thermal comfort level was -0.44 (standard deviation 1.3), which is within acceptable parameters. Factors affecting thermal comfort were gender, professional role, and wearing additional clothing. Additionally, participants who complained about temperature or ventilation were less likely to report thermal comfort levels in the normal range. Health care facility leaders should consider the comfort needs of perioperative personnel when making purchasing decisions about ventilation systems and surgical clothing; however, they also should consider other factors (eg, surgeon comfort, permeability of protective clothing to blood and other body fluids).

Provider views on perioperative steroid use for patients with newly diagnosed pediatric brain tumors.

PURPOSE: Cerebral edema from brain tumors can cause neurological impairment. Steroids treat edema but with possible adverse effects. We surveyed providers regarding steroid use in newly diagnosed patients with brain tumors to determine if practices are standard or markedly variable. METHODS: An anonymous voluntary online survey was sent to members of neuro-oncology consortiums. Four clinical scenarios were provided and questions regarding initiation of steroids, type, dose, formulation, and duration were asked. Demographic information was collected. RESULTS: 369 providers received the survey, 76 responded (20.6% response rate). The proportion of providers who would start steroids significantly differed among scenarios (scenario 1 vs 2, p < 0.001; 2 vs 3, p < 0.001; 1 vs 3, p < 0.001). 75 (98.7%) providers would start steroids for vasogenic edema (scenario 1) and 55 (72.4%) for obstructive hydrocephalus (scenario 2). 16 (21.1%) would start steroids for vasogenic edema but not obstructive hydrocephalus. The odds of choosing to start steroids in patients with obstructive hydrocephalus were 7.59 times more (95% CI: 2.29, 25.13) if providers felt symptoms would improve within 24 h. All would use dexamethasone. A significant difference was seen between the proportion of providers who would give a loading dose if vasogenic edema with neurological deficits were noted versus vasogenic edema alone (57.9% vs 43.4%; p = 0.002). CONCLUSIONS: These results suggest that providers recommend dexamethasone for patients with vasogenic edema and obstructive hydrocephalus. Variability remains with dosing schedule. Further studies are needed to identify the most appropriate use of steroids for newly diagnosed CNS tumor patients with the goal to create steroid management guidelines.

Age, sex, race and ethnicity representativeness of randomised controlled trials in peri-operative medicine.

The applicability of the results of any clinical trial will depend to a large extent on whether the study population is representative of the population seen in clinical practice. The growing older surgical population presents challenges for peri-operative researchers to ensure there is adequate representation of patients in terms of their age, sex, race and ethnicity in clinical trials. A review of purposively sampled published randomised controlled trials was performed to establish the age, sex, race and ethnicity of study participants. These data were compared with national registry data for the relevant surgical populations. We included 224 peri-operative trials that were cited in 469 retrieved meta-analyses. Of these, 50 (22.3%) had an upper age limit to recruitment. The median (range [IQR]) difference in study population age from the registry population age was: -2.4 (-6.2 to 1.0 [-34.7 to 14.5]) years for all randomised controlled trials; -6.2 (-9.4 to -2.8 [-18.6 to 4.6]) years for randomised controlled trials of patients undergoing hip arthroplasty; and -3.4 (-9.6 to -1.1 [-34.7 to 2.9]) years for randomised controlled trials of patients undergoing hip fracture surgery. In 92 (41.1%) randomised controlled trials, the proportion of each sex in the study population was more than 25% different from the proportion in the registry population. Only 5 (2.2%) trials published data on the race or ethnicity of participants. We conclude that peri-operative randomised controlled trials are unlikely to be representative of the age and sex of clinically treated surgical populations. Researchers must endeavour to ensure representative study populations are recruited to future clinical trials.