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1.
J Med Internet Res ; 23(2): e25187, 2021 Feb 04.
Artigo em Inglês | MEDLINE | ID: mdl-33538696

RESUMO

BACKGROUND: Timely identification of patients at a high risk of clinical deterioration is key to prioritizing care, allocating resources effectively, and preventing adverse outcomes. Vital signs-based, aggregate-weighted early warning systems are commonly used to predict the risk of outcomes related to cardiorespiratory instability and sepsis, which are strong predictors of poor outcomes and mortality. Machine learning models, which can incorporate trends and capture relationships among parameters that aggregate-weighted models cannot, have recently been showing promising results. OBJECTIVE: This study aimed to identify, summarize, and evaluate the available research, current state of utility, and challenges with machine learning-based early warning systems using vital signs to predict the risk of physiological deterioration in acutely ill patients, across acute and ambulatory care settings. METHODS: PubMed, CINAHL, Cochrane Library, Web of Science, Embase, and Google Scholar were searched for peer-reviewed, original studies with keywords related to "vital signs," "clinical deterioration," and "machine learning." Included studies used patient vital signs along with demographics and described a machine learning model for predicting an outcome in acute and ambulatory care settings. Data were extracted following PRISMA, TRIPOD, and Cochrane Collaboration guidelines. RESULTS: We identified 24 peer-reviewed studies from 417 articles for inclusion; 23 studies were retrospective, while 1 was prospective in nature. Care settings included general wards, intensive care units, emergency departments, step-down units, medical assessment units, postanesthetic wards, and home care. Machine learning models including logistic regression, tree-based methods, kernel-based methods, and neural networks were most commonly used to predict the risk of deterioration. The area under the curve for models ranged from 0.57 to 0.97. CONCLUSIONS: In studies that compared performance, reported results suggest that machine learning-based early warning systems can achieve greater accuracy than aggregate-weighted early warning systems but several areas for further research were identified. While these models have the potential to provide clinical decision support, there is a need for standardized outcome measures to allow for rigorous evaluation of performance across models. Further research needs to address the interpretability of model outputs by clinicians, clinical efficacy of these systems through prospective study design, and their potential impact in different clinical settings.

2.
Can J Anaesth ; 2021 Feb 23.
Artigo em Inglês | MEDLINE | ID: mdl-33624255

RESUMO

PURPOSE: This systematic review aimed to summarize reports of the incidence and long-term recurrence of new-onset atrial fibrillation (AF) associated with non-cardiac surgery. SOURCES: We searched CENTRAL, MEDLINE and EMBASE from inception to November 2019. We included studies that reported on the incidence of new-onset perioperative AF during hospitalization for non-cardiac surgery and/or AF recurrence in such patients following discharge. Reviewers screened articles and abstracted data independently and in duplicate. We assessed study quality by appraising methodology for collecting AF history, incident AF during hospitalization, and AF recurrence after discharge. PRINCIPAL FINDINGS: From 39,233 citations screened, 346 studies that enrolled a total of 5,829,758 patients met eligibility criteria. Only 27 studies used prospective, continuous inpatient electrocardiographic (ECG) monitoring to detect incident AF. Overall, the incidence of postoperative AF during hospitalization ranged from 0.004 to 50.3%, with a median [interquartile range] of 8.7 [3.8-15.0]%. Atrial fibrillation incidence varied with type of surgery. Prospective studies using continuous ECG monitoring reported significantly higher incidences of AF than those that did not (13.9% vs 1.9%, respectively; P < 0.001). A total of 13 studies (25,726 patients) with follow-up up to 5.4 years reported on AF recurrence following hospital discharge; only one study used a prospective systematic monitoring protocol. Recurrence rates ranged from 0 to 37.3%. CONCLUSIONS: Rates of AF incidence first detected following non-cardiac surgery and long-term AF recurrence vary markedly. Differences in the intensity of ECG monitoring and type of surgery may account for this variation. TRIAL REGISTRATION: PROSPERO (CRD42017068055); registered 1 September 2017.

3.
Clin Chem ; 67(1): 308-316, 2021 Jan 08.
Artigo em Inglês | MEDLINE | ID: mdl-33418576

RESUMO

BACKGROUND: The effect of hemodialysis on cardiac biomarkers is unclear. We sought to evaluate the degree and causes of intradialytic variability of high sensitivity troponin I (hs-TnI), galectin-3 (gal-3), and heart-type fatty acid binding protein (hFABP). METHODS: hs-TnI, gal-3, and hFABP were prospectively measured pre-dialysis and post-dialysis for 1 week every month for 6 months in 178 prevalent adult hemodialysis patients at a single center in Hamilton, Canada. The degree of change from pre-dialysis to post-dialysis for each cardiac biomarker was estimated with multilevel linear regression models. RESULTS: The median change in the concentration of hs-TnI during hemodialysis was -1 ng/L (interquartile range [IQR] -1 to 2 ng/L) while gal-3 and hFABP changed by -36.3 ng/mL (IQR -27.7 to -46.8 ng/mL) and -19.41 ng/mL (IQR -13.61 to -26.87 ng/mL), respectively. The median (IQR) percentage intradialytic changes for hs-TnI, gal-3, and hFABP were 2.6% (-4.4% to 12.5%), -59.8% (-54.7% to -64.8%) and -35.3% (-28.4% to -42.1%), respectively. Ultrafiltration was associated with an increase in concentration of hs-TnI, gal-3, and hFABP (mean 0.99 ng/L, 1.05 ng/mL, and 1.9 ng/mL per L ultrafiltration, respectively, P < 0.001). Both gal-3 and hFABP concentrations decreased in association with the volume of blood processed (P < 0.001) and with hemodialysis treatment time (P = 0.02 and P = 0.04) while hs-TnI concentration decreased only in association with hemodialysis treatment time (P < 0.001). CONCLUSIONS: Ultrafiltration volume and hemodialysis treatment time influenced hs-TnI, gal-3, and hFABP concentrations during hemodialysis and should be considered when interpreting their measurement.

5.
Can J Cardiol ; 2020 Nov 30.
Artigo em Inglês | MEDLINE | ID: mdl-33271225

RESUMO

BACKGROUND: Atrial fibrillation (AF) is often detected during hospitalization for surgery or medical illness and is often assumed to be due to the acute condition. METHODS: ASSERT enrolled patients >65 years old without AF. Pacemakers or implantable cardioverter defibrillators recorded device-detected AF. We identified participants who were hospitalized and compared the prevalence of AF before and after hospitalization. RESULTS: Among 2580 participants, 436 (16.9%) had a surgical or medical hospitalization. In the 30 days following a first hospitalization, 43 participants (9.9%, 95% confidence interval [CI] 7.2%-13.1%) had >6 minutes of device-detected AF; 20 (4.6%, 95% CI 2.8%-7.0%) had >6 hours. More participants had AF >6 minutes in the 30 days following hospitalization, as compared to the period 30-60 days before hospitalization (9.9% versus 4.4%, P < 0.001). Similar results were observed for episodes >6 hours (4.6% versus 2.3%, P = 0.03). Roughly half of participants with device-detected AF in the 30 days following hospitalization had ≥1 episodes of the same duration in the 6 months prior (50% [95% CI 31.3%-68.7%] for >6 minutes; 68.8% [95% CI 41.3%-89.0%] for >6 hours). Those with AF in the 30 days following hospitalization were more likely to have had AF in the past (adjusted OR 7.2 95%CI 3.2-15.8 for episodes >6 minutes; adjusted OR 32.6, 95%CI 10.3-103.4 for >6 hours). CONCLUSIONS: The prevalence of device-detected AF increases around the time of hospitalization for non-cardiac surgery or medical illness. About half of patients with AF around the time of hospitalization previously had similar episodes.

6.
CMAJ ; 192(49): E1715-E1722, 2020 Dec 07.
Artigo em Inglês | MEDLINE | ID: mdl-33288505

RESUMO

BACKGROUND: Postoperative atrial fibrillation (POAF) is associated with clinically significant short- and long-term complications after noncardiac surgery. Our aim was to describe the incidence of clinically important POAF after noncardiac surgery and establish the prognostic value of N-terminal pro-brain-type natriuretic peptide (NT-proBNP) in this context. METHODS: The Vascular events In noncardiac Surgery patIents cOhort evaluatioN (VISION) Study was a prospective cohort study involving patients aged 45 years and older who had inpatient noncardiac surgery that was performed between August 2007 and November 2013. We determined 30-day incidence of clinically important POAF (i.e., resulting in angina, congestive heart failure, symptomatic hypotension or requiring treatment) using logistic regression models to analyze the association between preoperative NT-proBNP and POAF. RESULTS: In 37 664 patients with no history of atrial fibrillation, we found that the incidence of POAF was 1.0% (95% confidence interval [CI] 0.9%-1.1%; 369 events); 3.2% (95% CI 2.3%-4.4%) in patients undergoing major thoracic surgery, 1.3% (95% CI 1.2%-1.5%) in patients undergoing major nonthoracic surgery and 0.2% (95% CI 0.1%-0.3%) in patients undergoing low-risk surgery. In a subgroup of 9789 patients with preoperative NT-proBNP measurements, the biomarker improved the prediction of POAF risk over conventional prognostic factors (likelihood ratio test p < 0.001; fraction of new information from NT-proBNP was 16%). Compared with a reference NT-proBNP measurement set at 100 ng/L, adjusted odds ratios for the occurrence of POAF were 1.31 (95% CI 1.15-1.49) at 200 ng/L, 2.07 (95% CI 1.27-3.36) at 1500 ng/L and 2.39 (95% CI 1.26-4.51) at 3000 ng/L. INTERPRETATION: We determined that the incidence of clinically important POAF after noncardiac surgery was 1.0%. We also found that preoperative NT-proBNP levels were associated with POAF independent of established prognostic factors. Trial registration: ClinicalTrials.gov, no. NCT00512109.

7.
CJC Open ; 2(6): 577-584, 2020 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-33305218

RESUMO

Background: Physicians commonly judge whether a myocardial infarction (MI) is type 1 (thrombotic) vs type 2 (supply/demand mismatch) based on clinical information. Little is known about the accuracy of physicians' clinical judgement in this regard. We aimed to determine the accuracy of physicians' judgement in the classification of type 1 vs type 2 MI in perioperative and nonoperative settings. Methods: We performed an online survey using cases from the Optical Coherence Tomographic Imaging of Thrombus (OPTIMUS) Study, which investigated the prevalence of a culprit lesion thrombus based on intracoronary optical coherence tomography (OCT) in patients experiencing MI. Four MI cases, 2 perioperative and 2 nonoperative, were selected randomly, stratified by etiology. Physicians were provided with the patient's medical history, laboratory parameters, and electrocardiograms. Physicians did not have access to intracoronary OCT results. The primary outcome was the accuracy of physicians' judgement of MI etiology, measured as raw agreement between physicians and intracoronary OCT findings. Fleiss' kappa and Gwet's AC1 were calculated to correct for chance. Results: The response rate was 57% (308 of 536). Respondents were 62% male; median age was 45 years (standard deviation ± 11); 45% had been in practice for > 15 years. Respondents' overall accuracy for MI etiology was 60% (95% confidence interval [CI] 57%-63%), including 63% (95% CI 60%-68%) for nonoperative cases, and 56% (95% CI 52%-60%) for perioperative cases. Overall chance-corrected agreement was poor (kappa = 0.05), consistent across specialties and clinical scenarios. Conclusions: Physician accuracy in determining MI etiology based on clinical information is poor. Physicians should consider results from other testing, such as invasive coronary angiography, when determining MI etiology.

8.
CMAJ Open ; 8(4): E676-E684, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-33139388

RESUMO

BACKGROUND: The ability to rule out or in a major adverse cardiac event (MACE) in patients with suspected acute coronary syndrome at emergency department (ED) presentation would be beneficial to patient care and the health care system. The clinical chemistry score (CCS) was evaluated in this context. METHODS: This diagnostic accuracy study evaluated 2 different ED cohorts with suspected acute coronary syndrome. For patients in cohort 1, who presented to the ED of 3 hospitals in Hamilton, Ontario, between May and August 2013, retrospective measurements were taken using the Ortho Clinical Diagnostics high-sensitivity cardiac troponin I (hs-cTnI) assay; for patients in cohort 2, who presented to the ED of the same 3 hospitals in Hamilton between November 2012 and February 2013, an ED cardiac presentation blood test panel was performed with the Abbott Diagnostics hs-cTnI assay. The sensitivity and specificity of the CCS (cut-offs of ≥ 1 and 5) and hs-cTnI alone (published cut-offs) were compared for MACE (composite of death, myocardial infarction, unstable angina, revascularization) at 30 days for both cohorts and at 90 days for cohort 2. RESULTS: The incidence of MACE at 30 days was higher in cohort 1 (n = 1058) (19.4%, 95% confidence interval [CI] 16.8%-22.2%) than in cohort 2 (n = 5974) (14.6%, 95% CI 13.6%-15.6%). In cohort 1, a CCS of 1 or above yielded a sensitivity of 99.5% (95% CI 97.3%-99.9%). The sensitivity with an Ortho hs-cTnI cut-off of 1 ng/L or above was 91.2% (95% CI 86.5%-95.7%). The specificity of a CCS of 5 (97.8%, 95% CI 96.5%-98.7%) was higher than when the overall 99th-percentile cut-off for the Ortho hs-cTnI assay (> 11 ng/L; 90.1%, 95% CI 87.9%-92.0%) was used. A similar pattern was observed in cohort 2 at 30 days and persisted at 90 days with the Abbott hs-cTnI assay. INTERPRETATION: The CCS derived with 2 different hs-cTnI assays and ED populations yielded higher sensitivity and specificity estimates for MACE than hs-cTnI alone. An intervention study is needed to evaluate the impact of the CCS at both the patient and hospital levels. TRIAL REGISTRATION: ClinicalTrials.gov, no. NCT01994577.

9.
Anesth Analg ; 131(5): 1430-1443, 2020 11.
Artigo em Inglês | MEDLINE | ID: mdl-33079867

RESUMO

BACKGROUND: Inadvertent perioperative hypothermia is a common complication of surgery, and active body surface warming (ABSW) systems are used to prevent adverse clinical outcomes. Prior data on certain outcomes are equivocal (ie, blood loss) or limited (ie, pain and opioid consumption). The objective of this study was to provide an updated review on the effect of ABSW on clinical outcomes and temperature maintenance. METHODS: We conducted a systematic review of randomized controlled trials evaluating ABSW systems compared to nonactive warming controls in noncardiac surgeries. Outcomes studied included postoperative pain scores and opioid consumption (primary outcomes) and other perioperative clinical variables such as temperature changes, blood loss, and wound infection (secondary outcomes). We searched Ovid MEDLINE daily, Ovid MEDLINE, EMBASE, CINHAL, Cochrane CENTRAL, and Web of Science from inception to June 2019. Quality of evidence (QoE) was rated according to the Grading of Recommendations, Assessment, Development and Evaluations (GRADE) approach. Subgroup analysis sought to determine the effect of preoperative + intraoperative warming versus intraoperative warming alone. Metaregression evaluated the effect of year of publication, use of neuromuscular blockers, anesthesia, and surgery type on outcomes. RESULTS: Fifty-four articles (3976 patients) were included. Pooled results demonstrated that ABSW maintained normothermia compared to controls, during surgery (30 minutes postinduction [mean difference {MD}: 0.3°C, 95% confidence interval {CI}, 0.2-0.4, moderate QoE]), end of surgery (MD: 1.1°C, 95% CI, 0.9-1.3, high QoE), and up to 4 hours postoperatively (MD: 0.3°C, 95% CI, 0.2-0.5, high QoE). ABSW was not associated with difference in pain scores (<24 hours postoperatively, moderate to low QoE) or perioperative opioid consumption (very low QoE). ABSW increased patient satisfaction (MD: 2.2 points, 95% CI, 0.9-3.6, moderate QoE), reduced blood transfusions (odds ratio [OR] = 0.6, 95% CI, 0.4-1.0, moderate QoE), shivering (OR = 0.2, 95% CI, 0.1-0.4, high QoE), and wound infections (OR = 0.3, 95% CI, 0.2-0.7, high QoE). No significant differences were found for fluid administration (low QoE), blood loss (very low QoE), major adverse cardiovascular events (very low QoE), or mortality (very low QoE). Subgroup analysis and metaregression suggested increased temperature benefit with pre + intraoperative warming, use of neuromuscular blockers, and recent publication year. ABSW seemed to confer less temperature benefit in cesarean deliveries and neurosurgical/spinal cases compared to abdominal surgeries. CONCLUSIONS: ABSW is effective in maintaining physiological normothermia, decreasing wound infections, shivering, blood transfusions, and increasing patient satisfaction but does not appear to affect postoperative pain and opioid use.


Assuntos
Analgésicos/uso terapêutico , Anestesia/métodos , Reaquecimento , Temperatura Corporal , Humanos , Ensaios Clínicos Controlados Aleatórios como Assunto , Resultado do Tratamento
10.
J Clin Epidemiol ; 128: 148-156, 2020 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-33002638

RESUMO

OBJECTIVE: To systematically review the epidemiology of prerandomized run-in periods in randomized controlled trials (RCTs) of chronic diseases. STUDY DESIGN AND SETTING: Meta-epidemiologic study of all RCTs from the four highest impact medical journals from 2011 to 2016. Eligible trials included parallel RCTs that evaluated pharmacologic therapies in adults with chronic diseases with a minimum follow-up of 24 weeks. RESULTS: Of 262 eligible manuscripts, 48 (18.3%), representing 42 unique RCTs, included run-in periods. Run-in periods were most common in cardiovascular disease and diabetes trials. Of the 42 RCTs, in 22 patients received the experimental therapy, 15 placebo, 4 both (either sequentially or in combination), and one did not report the run-in period drug. The median run-in period duration was 28 days (Q1: Q3 14: 66 days). Reasons for including a run-in period included ensuring eligibility criteria were met (18, 42.9%), excluding participants with nonadherence (18, 42.9%) and intolerances to therapy (15, 35.7%), and to standardize therapy prior to randomization (8, 19.0%). The median run-in completion rate was 77.4% (Q1: Q3 62.2:87.8%). CONCLUSIONS: Run-in periods are uncommon in RCTs of chronic drug treatments and when used, their reporting is heterogeneous. Further research to improve the design, use, and reporting of run-in periods is necessary.

11.
Contemp Clin Trials ; 97: 106151, 2020 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-32942056

RESUMO

BACKGROUND: Randomized controlled trials (RCTs) are often used to inform clinical practice and it is desirable that their results be robust. A fragility index (FI), defined as the smallest number of participants in whom an outcome change from non-event to event would turn a statistically significant result to a non-significant result, can be computed to measure robustness. We sought to determine the distribution of fragility indices across various research areas and summarized the factors associated with fragility. METHODS: We searched PubMed between February 2014 and May 2019 and included reviews that reported on fragility indices and the associated factors. Two investigators independently screened articles for eligibility and extracted all relevant data from each review. Fragility indices were pooled using random effects meta-analysis. RESULTS: Twenty-four (24) reviews met the inclusion criteria. They contained a median of 41 trials (first quartile [Q1]-third quartile [Q3]: 17-120). The overall mean FI across different fields of research was 4 (95% confidence interval [CI] 3-5), indicating a high level of fragility. Higher journal impact factor, larger sample size, bigger effect size, more outcome events, a lower p-value, and adequate allocation concealment were reported to be associated with the higher FI. The ecological correlation between median FI and median sample size (22 studies) was 0.95 (95% CI 0.58-0.99). CONCLUSION: Trials across various fields of research are frequently fragile. We also identified some factors associated with fragility. Researchers should consider strategies to enhance the robustness of studies and minimize fragility.

12.
Can J Anaesth ; 67(11): 1497-1506, 2020 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-32767054

RESUMO

PURPOSE: Function describes an individual's ability to perform everyday activities. In the context of cardiac surgery, functional changes quantify the effect of surgery on one's day-to-day life. Decreases in regional cerebral oxygen saturation (rScO2) measured using near-infrared spectroscopy (NIRS) has been associated with postoperative cognitive decline but its relationship with function has not been studied. We sought to determine the feasibility of conducting a large observational study examining the relationship between decreases in rScO2 during cardiac surgery and postoperative functional decline. METHODS: We undertook a single-centre, pilot sub-study of the NeuroVISION-Cardiac Surgery pilot study, which included adults undergoing isolated coronary artery bypass grafting on cardiopulmonary bypass; all patients enrolled in NeuroVISION-Cardiac Surgery were included. Function was evaluated at baseline, 30 days, and three months using the Standardized Assessment of Global activities in the Elderly (SAGE) scale. Blinded NIRS monitors were affixed for the duration of surgery. Our feasibility outcomes were to recruit one patient per week, obtain complete NIRS data in ≥ 90%, obtain SAGE at all time-points in ≥ 90%, and determine the time required for NIRS data to be transcribed into case report forms. RESULTS: 49/50 patients enrolled in NeuroVISION-Cardiac Surgery were recruited over 48 weeks (1.02 patients/week). Of the 49 included patients, 49 (100%) had complete NIRS data and 44 (90%) had complete SAGE data. The time required for NIRS data collection was a mean (standard deviation) of 5.5 (1.8) min per patient. CONCLUSION: This pilot study shows the feasibility of conducting a large observational study examining the relationship between decreases in cerebral saturation during cardiac surgery and postoperative functional decline. TRIAL REGISTRATION: www.clinicaltrials.gov (NCT04241289); registered 27 January 2020.

13.
Trials ; 21(1): 752, 2020 Aug 28.
Artigo em Inglês | MEDLINE | ID: mdl-32859245

RESUMO

BACKGROUND: The hemodialysis setting is suitable for trials that use cluster randomization, where intact groups of individuals are randomized. However, cluster randomized trials (CRTs) are complicated in their design, analysis, and reporting and can pose ethical challenges. We reviewed CRTs in the hemodialysis setting with respect to reporting of key methodological and ethical issues. METHODS: We conducted a systematic review of CRTs in the hemodialysis setting, published in English, between 2000 and 2019, and indexed in MEDLINE or Embase. Two reviewers extracted data, and study results were summarized using descriptive statistics. RESULTS: We identified 26 completed CRTs and five study protocols of CRTs. These studies randomized hemodialysis centers (n = 17, 55%), hemodialysis shifts (n = 12, 39%), healthcare providers (n = 1, 3%), and nephrology units (n = 1, 3%). Trials included a median of 28 clusters with a median cluster size of 20 patients. Justification for using a clustered design was provided by 15 trials (48%). Methods that accounted for clustering were used during sample size calculation in 14 (45%), during analyses in 22 (71%), and during both sample size calculation and analyses in 13 trials (42%). Among all CRTs, 26 (84%) reported receiving research ethics committee approval; patient consent was reported in 22 trials: 10 (32%) reported the method of consent for trial participation and 12 (39%) reported no details about how consent was obtained or its purpose. Four trials (13%) reported receiving waivers of consent, and the remaining 5 (16%) provided no or unclear information about the consent process. CONCLUSION: There is an opportunity to improve the conduct and reporting of essential methodological and ethical issues in future CRTs in hemodialysis. REVIEW REGISTRATION: We conducted this systematic review using a pre-specified protocol that was not registered.

14.
J Card Surg ; 35(10): 2754-2758, 2020 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-32720394

RESUMO

INTRODUCTION: The impact of sex on the outcomes after coronary artery bypass grafting (CABG) is controversial. The majority of CABG studies are retrospectively collected clinical or registry data, women comprise only a minority, and the reported findings represent the male predominated cohort. This individual patient meta-analysis is aimed at evaluating sex-related differences in outcomes after CABG using high quality data from randomized controlled trials (RCTs). METHODS AND ANALYSIS: A systematic literature search will be performed to identify all CABG RCTs (minimum follow-up: 5 years). Detailed specification for the minimum deidentified patient records' data requirements will be provided to RCT primary contact to request their deidentified data for pooling. The pooled analysis will follow the prospective register of systematic reviews (PROSPERO) and the preferred reporting items for systematic reviews and meta-analyses for individual patient data systematic reviews (PRISMA-IPD) recommendations and will compare sex-related outcomes after CABG. The main hypothesis is that outcomes after CABG are worse in women than in men. We will also test whether treatment effects for off-pump and the use of multiple arterial grafts are present within each sex, and also, whether there are differential treatment effects between sexes. The primary endpoint will be a composite of all-cause mortality, myocardial infarction, stroke, and repeat revascularization at long-term follow up. ETHICS AND DISSEMINATION: Ethics approval and participant consent for the study will be obtained locally by each study team if needed. Data will be disseminated and submitted to peer-reviewed scientific journals and meetings irrespective of study outcome.


Assuntos
Ponte de Artéria Coronária/métodos , Doença da Artéria Coronariana/cirurgia , Protocolos de Ensaio Clínico como Assunto , Ponte de Artéria Coronária/mortalidade , Ponte de Artéria Coronária sem Circulação Extracorpórea , Doença da Artéria Coronariana/mortalidade , Feminino , Humanos , Masculino , Infarto do Miocárdio , Complicações Pós-Operatórias , Ensaios Clínicos Controlados Aleatórios como Assunto , Reoperação , Fatores Sexuais , Acidente Vascular Cerebral , Resultado do Tratamento
15.
Pilot Feasibility Stud ; 6: 104, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32699643

RESUMO

Background: Surgical bleeding is associated with postoperative cardiovascular complications. The efficacy and safety of tranexamic acid (TXA) in noncardiac surgery are still uncertain. Statins may prevent perioperative cardiovascular complications. We conducted a pilot to assess the feasibility of a perioperative trial of TXA and rosuvastatin. Methods: Using a factorial design, we randomized patients at cardiovascular risk undergoing noncardiac surgery to intravenous TXA (1 g at the start and end of surgery) or placebo, and oral rosuvastatin (40 mg before and 20 mg daily for 30 days after surgery) or placebo. Feasibility outcomes included recruitment rates, follow-up, and compliance to interventions. Clinical outcomes were secondarily explored. Results: After 3 months, we changed the design to a partial factorial due to the difficult recruitment of statin-naive patients. Over 6 months, 100 patients were randomized in the TXA trial (49 TXA, 51 placebo), 34 in the rosuvastatin trial (18 rosuvastatin, 16 placebo). Ninety-two percent (95% CI 80-98) of TXA and 86% (95% CI 74-94) of TXA-placebo patients received the 2 study doses. Thirty-three percent (95% CI 13-59) of rosuvastatin patients and 37% (95% CI 15-65) of rosuvastatin-placebo patients discontinued the study drug. A major cardiovascular complication occurred at 30 days in 1 TXA and 6 TXA-placebo patients, and 1 rosuvastatin and no rosuvastatin-placebo patients. Conclusions: Our pilot study supports the feasibility of a perioperative TXA trial in noncardiac surgery. Feasibility of a perioperative rosuvastatin trial is uncertain because of a high prevalence of statin use in the target population and concerns about compliance. Trial registration: ClinicalTrials.govNCT02546648.

16.
Int J Cardiol ; 319: 140-143, 2020 Nov 15.
Artigo em Inglês | MEDLINE | ID: mdl-32634494

RESUMO

BACKGROUND: We developed a biomarker algorithm encompassing the clinical chemistry score (CCS; which includes the combination of a random glucose concentration, an estimated glomerular filtration rate and high-sensitivity cardiac troponin; hs-cTn) with the Ortho Clinical Diagnostics hs-cTnI assay (CCS-serial) and compared it to the cutoffs derived from Ortho Clinical Diagnostics 0/1 h (h) algorithm for 7-day myocardial infarction (MI) or cardiovascular (CV)-death. METHODS: The study cohort was an emergency department (ED) population (n = 906) with symptoms suggestive of acute coronary syndrome (ACS) who had two Ortho hs-cTnI results approximately 3 h apart. Diagnostic parameters (sensitivity/specificity/negative predictive value; NPV/positive predictive value; PPV) were derived for the CCS-serial and the 0/1 h algorithm for 7-day MI/CV-death. A safety analysis was performed for patients in the rule-out arms of the algorithms for 30-day MI/death. RESULTS: The CCS-serial algorithm yielded 100% sensitivity/NPV (32% low-risk) and 95.7% specificity/65% PPV (11% high-risk). The 0/1 h algorithm-cutoffs yielded sensitivity/NPV/specificity/PPV of 97.8%/99.4%/91.3%/50%, which classified 38% of patients as low-risk and 16% of patients as high-risk. Four patients (1.2%) in the 0/1 h algorithm-cutoff rule-out arm had a 30-day MI/death outcome as compared to zero patients in the CCS-serial rule-out arm (p = 0.06). CONCLUSION: Both the CCS-serial and 0/1 h algorithm cutoffs yield high NPVs with a similar proportion of patients identified as low-risk. These data may be useful for sites who are unable to collect samples at 0/1 h in the emergency department.

18.
Br J Anaesth ; 125(1): 38-46, 2020 07.
Artigo em Inglês | MEDLINE | ID: mdl-32416996

RESUMO

BACKGROUND: Delirium is common after cardiac surgery and is associated with adverse outcomes. Perioperative benzodiazepine use is associated with delirium and is common during cardiac surgery, which may increase the risk of postoperative delirium. We undertook a pilot study to inform the feasibility of a large randomised cluster crossover trial examining whether an institutional policy of restricted benzodiazepine administration during cardiac surgery (compared with liberal administration) would reduce delirium. METHODS: We conducted a two-centre, pilot, randomised cluster crossover trial with four 4 week crossover periods. Each centre was randomised to a policy of restricted or liberal use, and then alternated between the two policies during the remaining three periods. Our feasibility outcomes were adherence to each policy (goal ≥80%) and outcome assessment (one delirium assessment per day in the ICU in ≥90% of participants). We also evaluated the incidence of intraoperative awareness in one site using serial Brice questionnaires. RESULTS: Of 800 patients undergoing cardiac surgery during the trial period, 127/800 (15.9%) had delirium. Of these, 355/389 (91.3%) received benzodiazepines during the liberal benzodiazepine periods and 363/411 (88.3%) did not receive benzodiazepines during the restricted benzodiazepine periods. Amongst the 800 patients, 740 (92.5%) had ≥1 postoperative delirium assessment per day in the ICU. Of 521 patients screened for intraoperative awareness, one patient (0.2%), managed during the restricted benzodiazepine period (but who received benzodiazepine), experienced intraoperative awareness. CONCLUSIONS: This pilot study demonstrates the feasibility of a large, multicentre, randomised, cluster crossover trial examining whether an institutional policy of restricted vs liberal benzodiazepine use during cardiac surgery will reduce postoperative delirium. CLINICAL TRIAL REGISTRATION: NCT03053869.


Assuntos
Anestesia em Procedimentos Cardíacos/métodos , Benzodiazepinas/administração & dosagem , Delírio/prevenção & controle , Complicações Pós-Operatórias/prevenção & controle , Idoso , Canadá , Análise por Conglomerados , Estudos Cross-Over , Relação Dose-Resposta a Droga , Feminino , Humanos , Masculino , Projetos Piloto
19.
Lancet Glob Health ; 8(5): e711-e720, 2020 05.
Artigo em Inglês | MEDLINE | ID: mdl-32353318

RESUMO

BACKGROUND: The Lancet Commission on Global Surgery established the Three Delays framework, categorising delays in accessing timely surgical care into delays in seeking care (First Delay), reaching care (Second Delay), and receiving care (Third Delay). Globally, knowledge gaps regarding delays for fracture care, and the lack of large prospective studies informed the rationale for our international observational study. We investigated delays in hospital admission as a surrogate for accessing timely fracture care and explored factors associated with delayed hospital admission. METHODS: In this prospective observational substudy of the ongoing International Orthopaedic Multicenter Study in Fracture Care (INORMUS), we enrolled patients with fracture across 49 hospitals in 18 low-income and middle-income countries, categorised into the regions of China, Africa, India, south and east Asia, and Latin America. Eligible patients were aged 18 years or older and had been admitted to a hospital within 3 months of sustaining an orthopaedic trauma. We collected demographic injury data and time to hospital admission. Our primary outcome was the number of patients with open and closed fractures who were delayed in their admission to a treating hospital. Delays for patients with open fractures were defined as being more than 2 h from the time of injury (in accordance with the Lancet Commission on Global Surgery) and for those with closed fractures as being a delay of more than 24 h. Secondary outcomes were reasons for delay for all patients with either open or closed fractures who were delayed for more than 24 h. We did logistic regression analyses to identify risk factors of delays of more than 2 h in patients with open fractures and delays of more than 24 h in patients with closed fractures. Logistic regressions were adjusted for region, age, employment, urban living, health insurance, interfacility referral, method of transportation, number of fractures, mechanism of injury, and fracture location. We further calculated adjusted relative risk (RR) from adjusted odds ratios, adjusted for the same variables. This study was registered with ClinicalTrials.gov, NCT02150980, and is ongoing. FINDINGS: Between April 3, 2014, and May 10, 2019, we enrolled 31 255 patients with fractures, with a median age of 45 years (IQR 31-62), of whom 19 937 (63·8%) were men, and 14 524 (46·5%) had lower limb fractures, making them the most common fractures. Of 5256 patients with open fractures, 3778 (71·9%) were not admitted to hospital within 2 h. Of 25 999 patients with closed fractures, 7141 (27·5%) were delayed by more than 24 h. Of all regions, Latin America had the greatest proportions of patients with delays (173 [88·7%] of 195 patients with open fractures; 426 [44·7%] of 952 with closed fractures). Among patients delayed by more than 24 h, the most common reason for delays were interfacility referrals (3755 [47·7%] of 7875) and Third Delays (cumulatively interfacility referral and delay in emergency department: 3974 [50·5%]), while Second Delays (delays in reaching care) were the least common (423 [5·4%]). Compared with other methods of transportation (eg, walking, rickshaw), ambulances led to delay in transporting patients with open fractures to a treating hospital (adjusted RR 0·66, 99% CI 0·46-0·93). Compared with patients with closed lower limb fractures, patients with closed spine (adjusted RR 2·47, 99% CI 2·17-2·81) and pelvic (1·35, 1·10-1·66) fractures were most likely to have delays of more than 24 h before admission to hospital. INTERPRETATION: In low-income and middle-income countries, timely hospital admission remains largely inaccessible, especially among patients with open fractures. Reducing hospital-based delays in receiving care, and, in particular, improving interfacility referral systems are the most substantial tools for reducing delays in admissions to hospital. FUNDING: National Health and Medical Research Council of Australia, Canadian Institutes of Health Research, McMaster Surgical Associates, and Hamilton Health Sciences.


Assuntos
Países em Desenvolvimento , Fraturas Ósseas/terapia , Admissão do Paciente/estatística & dados numéricos , Tempo para o Tratamento/estatística & dados numéricos , Adulto , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Fatores Socioeconômicos
20.
Clin Biochem ; 80: 48-51, 2020 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-32304695

RESUMO

BACKGROUND: As more companies obtain regulatory approval for high-sensitivity cardiac troponin (hs-cTn) assays there is an urgent need for independent analytical and clinical evaluations. To this end, we have evaluated Ortho Clinical Diagnostics' hs-cTnI assay and compared it to their contemporary cTnI-ES assay in emergency department (ED) patients with suspected acute coronary syndrome (ACS). METHODS: The study cohort consisted of ED patients (n = 906) with symptoms suggestive of ACS who had Ortho hs-cTnI and cTnI-ES results at presentation and 3 h (with calculated delta (0-3 h) defined as the absolute concentration difference between paired results). The primary composite outcome was 7-day myocardial infarction (MI) or cardiovascular death, with secondary analyses performed for 7-day MI and index-MI. Analytical imprecision testing (i.e., coefficient of variation; CV), receiver-operating characteristic (ROC) curve analyses with area under the curve (AUC), and diagnostic parameters (sensitivity/specificity/predictive values) were calculated. RESULTS: The hs-cTnI assay had superior precision compared to the cTnI-ES assay below 5 ng/L in EDTA plasma (hs-cTnI CV ≤ 15% versus cTnI-ES CV ≥ 85%). The AUCs were higher for hs-cTnI as compared to cTnI-ES at 0 h (0.88 vs. 0.85), 3 h (0.94 vs. 0.92), and the delta (0-3 h) value (0.91 vs. 0.85) for the primary composite outcome (p < 0.05). At 3 h, the sensitivity/specificity for index-MI was ≥97%/≥82%, for 7-day MI was ≥89%/≥84%, and for the primary composite outcome was ≥90%/≥85% using the manufacturer's sex-specific 99th-percentile cutoffs. CONCLUSION: The Ortho hs-cTnI assay has superior analytical and clinical performance over their contemporary cTnI-ES assay in evaluating ED patients with symptoms suggestive of ACS.

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