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1.
Curr Probl Cardiol ; : 100429, 2019 Jun 29.
Artigo em Inglês | MEDLINE | ID: mdl-31326099

RESUMO

Myocardial injury after noncardiac surgery (MINS) includes patients with traditional myocardial infarction and those with ischemic myocardial injury after surgery. This study evaluated the prognostic value of MINS on major cardiovascular events and 30-day mortality, and determined independent preoperative predictors of MINS in patients after noncardiac surgery. This multicenter prospective cohort study was part of the VISION Study. The sample consisted of 2504 patients who underwent noncardiac surgery at 2 tertiary hospitals in Brazil between September 2008 and July 2012. Troponin Ts were measured 6-12 hours, and on days 1-3 after surgery. Cox regression analyses were performed to identify independent variables of major outcomes. A total of 314 (13%) patients were diagnosed with MINS, of which 26 (8%) died. Length-of-hospital stay of MINS patients was 3 times higher (18 ± 22 days vs 5.8 ± 11 days). In multivariate analysis, 30-day mortality was significantly higher among patients with MINS (hazard ratio [HR] 3.17 (95% confidence interval [CI] 1.56-6.41)), and major bleeding (HR 5.76 (95% CI 2.75-12.05)), sepsis (HR 5.08 (95% CI 2.25-11.46)), active cancer (HR 4.22 (95% CI 1.98-8.98)), and general surgery (HR 3.11 (95% CI 1.51-6.41)). Multivariable analysis indicated a higher chance of MINS in patients ≥75 years of age, history of diabetes mellitus, hypertension, heart failure, coronary disease, and end-stage renal failure. The incidence of MINS within 30 days after noncardiac surgery is related to higher mortality. Postoperative troponin monitoring in elder patients and with risk factors for atherosclerotic disease may help reduce postoperative cardiovascular events.

2.
Eur Heart J Acute Cardiovasc Care ; : 2048872618799748, 2018 Nov 07.
Artigo em Inglês | MEDLINE | ID: mdl-30403364

RESUMO

OBJECTIVE:: There is uncertainty about the incidence of and prognosis associated with atrial fibrillation that is documented for the first time in the setting of an acute stressor, such as surgery or medical illness. Our objective was to perform a systematic review of the incidence and long-term recurrence rates for atrial fibrillation occurring transiently with stress in the setting of acute medical illness. DATA SOURCES:: Medline, Embase and Cochrane Central to September 2017. STUDY SELECTION:: We included retrospective and prospective observational studies, and randomised controlled trials. The population of interest included patients hospitalised for medical (i.e. non-surgical) illness who developed newly diagnosed atrial fibrillation. Studies were included if they included data on either the incidence of atrial fibrillation or the rate of atrial fibrillation recurrence in atrial fibrillation occurring transiently with stress patients following hospital discharge. DATA EXTRACTION:: Two reviewers collected data independently and in duplicate. We characterised each study's methodology for ascertainment of prior atrial fibrillation history, atrial fibrillation during hospitalisation and atrial fibrillation recurrence after hospital discharge. DATA SYNTHESIS:: Thirty-six studies reported the incidence of atrial fibrillation. Ten used a prospective design and included a period of continuous electrocardiographic (ECG) monitoring. Atrial fibrillation incidence ranged from 1% to 44%, which was too heterogeneous to justify meta-analysis ( I2=99%). In post-hoc meta-regression models, the use of continuous ECG monitoring explained 13% of the variance in atrial fibrillation incidence, while care in an intensive care unit explained none. Two studies reported the long-term rate of atrial fibrillation recurrence following atrial fibrillation occurring transiently with stress. Neither of these studies used prospective, systematic monitoring. Recurrence rates at 5 years ranged from 42% to 68%. CONCLUSIONS:: The incidence of atrial fibrillation with medical illness may be as high as 44%, with higher estimates in reports using continuous ECG monitoring. Within 5 years following hospital discharge, atrial fibrillation recurrence is documented in approximately half of patients; however, the true rate may be higher. PROTOCOL REGISTRATION: PROSPERO CRD42016043240.

3.
Can J Surg ; 61(3): 185-194, 2018 06.
Artigo em Inglês | MEDLINE | ID: mdl-29806816

RESUMO

BACKGROUND: Myocardial injury after noncardiac surgery (MINS) is a mostly asymptomatic condition that is strongly associated with 30-day mortality; however, it remains mostly undetected without systematic troponin T monitoring. We evaluated the cost and consequences of postoperative troponin T monitoring to detect MINS. METHODS: We conducted a model-based cost-consequence analysis to compare the impact of routine troponin T monitoring versus standard care (troponin T measurement triggered by ischemic symptoms) on the incidence of MINS detection. Model inputs were based on Canadian patients enrolled in the Vascular Events in Noncardiac Surgery Patients Cohort Evaluation (VISION) study, which enrolled patients aged 45 years or older undergoing inpatient noncardiac surgery. We conducted probability analyses with 10 000 iterations and extensive sensitivity analyses. RESULTS: The data were based on 6021 patients (48% men, mean age 65 [standard deviation 12] yr). The 30-day mortality rate for MINS was 9.6%. We determined the incremental cost to avoid missing a MINS event as $1632 (2015 Canadian dollars). The cost-effectiveness of troponin monitoring was higher in patient subgroups at higher risk for MINS, e.g., those aged 65 years or more, or with a history of atherosclerosis or diabetes ($1309). CONCLUSION: The costs associated with a troponin T monitoring program to detect MINS were moderate. Based on the estimated incremental cost per health gain, implementation of postoperative troponin T monitoring seems appealing, particularly in patients at high risk for MINS.

4.
Anesth Analg ; 126(4): 1150-1157, 2018 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-29369093

RESUMO

BACKGROUND: Perioperative ß-blockade reduces the incidence of myocardial infarction but increases that of death, stroke, and hypotension. The elderly may experience few benefits but more harms associated with ß-blockade due to a normal effect of aging, that of a reduced resting heart rate. The tested hypothesis was that the effect of perioperative ß-blockade is more significant with increasing age. METHODS: To determine whether the effect of perioperative ß-blockade on the primary composite event, clinically significant hypotension, myocardial infarction, stroke, and death varies with age, we interrogated data from the perioperative ischemia evaluation (POISE) study. The POISE study randomly assigned 8351 patients, aged ≥45 years, in 23 countries, undergoing major noncardiac surgery to either 200 mg metoprolol CR daily or placebo for 30 days. Odds ratios or hazard ratios for time to events, when available, for each of the adverse effects were measured according to decile of age, and interaction term between age and treatment was calculated. No adjustment was made for multiple outcomes. RESULTS: Age was associated with higher incidences of the major outcomes of clinically significant hypotension, myocardial infarction, and death. Age was associated with a minimal reduction in resting heart rate from 84.2 (standard error, 0.63; ages 45-54 years) to 80.9 (standard error, 0.70; ages >85 years; P < .0001). We found no evidence of any interaction between age and study group regarding any of the major outcomes, although the limited sample size does not exclude any but large interactions. CONCLUSIONS: The effect of perioperative ß-blockade on the major outcomes studied did not vary with age. Resting heart rate decreases slightly with age. Our data do not support a recommendation for the use of perioperative ß-blockade in any age subgroup to achieve benefits but avoid harms. Therefore, current recommendations against the use of ß-blockers in high-risk patients undergoing noncardiac surgery apply across all age groups.

5.
Anesth Analg ; 126(6): 1936-1945, 2018 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-29077608

RESUMO

BACKGROUND: The association between intraoperative cardiovascular changes and perioperative myocardial injury has chiefly focused on hypotension during noncardiac surgery. However, the relative influence of blood pressure and heart rate (HR) remains unclear. We investigated both individual and codependent relationships among intraoperative HR, systolic blood pressure (SBP), and myocardial injury after noncardiac surgery (MINS). METHODS: Secondary analysis of the Vascular Events in Noncardiac Surgery Cohort Evaluation (VISION) study, a prospective international cohort study of noncardiac surgical patients. Multivariable logistic regression analysis tested for associations between intraoperative HR and/or SBP and MINS, defined by an elevated serum troponin T adjudicated as due to an ischemic etiology, within 30 days after surgery. Predefined thresholds for intraoperative HR and SBP were: maximum HR >100 beats or minimum HR <55 beats per minute (bpm); maximum SBP >160 mm Hg or minimum SBP <100 mm Hg. Secondary outcomes were myocardial infarction and mortality within 30 days after surgery. RESULTS: After excluding missing data, 1197 of 15,109 patients (7.9%) sustained MINS, 454 of 16,031 (2.8%) sustained myocardial infarction, and 315 of 16,061 patients (2.0%) died within 30 days after surgery. Maximum intraoperative HR >100 bpm was associated with MINS (odds ratio [OR], 1.27 [1.07-1.50]; P < .01), myocardial infarction (OR, 1.34 [1.05-1.70]; P = .02), and mortality (OR, 2.65 [2.06-3.41]; P < .01). Minimum SBP <100 mm Hg was associated with MINS (OR, 1.21 [1.05-1.39]; P = .01) and mortality (OR, 1.81 [1.39-2.37]; P < .01), but not myocardial infarction (OR, 1.21 [0.98-1.49]; P = .07). Maximum SBP >160 mm Hg was associated with MINS (OR, 1.16 [1.01-1.34]; P = .04) and myocardial infarction (OR, 1.34 [1.09-1.64]; P = .01) but, paradoxically, reduced mortality (OR, 0.76 [0.58-0.99]; P = .04). Minimum HR <55 bpm was associated with reduced MINS (OR, 0.70 [0.59-0.82]; P < .01), myocardial infarction (OR, 0.75 [0.58-0.97]; P = .03), and mortality (OR, 0.58 [0.41-0.81]; P < .01). Minimum SBP <100 mm Hg with maximum HR >100 bpm was more strongly associated with MINS (OR, 1.42 [1.15-1.76]; P < .01) compared with minimum SBP <100 mm Hg alone (OR, 1.20 [1.03-1.40]; P = .02). CONCLUSIONS: Intraoperative tachycardia and hypotension are associated with MINS. Further interventional research targeting HR/blood pressure is needed to define the optimum strategy to reduce MINS.

6.
Eur J Cardiothorac Surg ; 53(4): 822-827, 2018 04 01.
Artigo em Inglês | MEDLINE | ID: mdl-29186389

RESUMO

OBJECTIVES: This substudy of the colchicine for prevention of perioperative atrial fibrillation (COP-AF) pilot trial seeks to assess the effect of colchicine administration on the volume of postoperative pleural drainage, duration of chest tube in situ and length of stay following lung resection. METHODS: Between April 2014 and April 2015, 100 patients undergoing lung resection at 2 tertiary care centres participated in a pilot blinded randomized trial comparing perioperative twice daily 0.6 mg of colchicine orally (n = 49) or placebo (n = 51) twice daily for 10 days. The primary outcome was total pleural drainage volume, which was recorded in 8-h intervals for the first 2 postoperative days per standardized protocol. RESULTS: Only 1 patient did not complete the trial. The mean volume of pleural drainage at 40-h mark postoperation was significantly less in the colchicine group (550.9 ml) compared with the placebo group (741.3 ml, P = 0.039). Compared with the placebo group, the colchicine group showed significantly less mean pleural drainage on postoperative Day 2 (583.8 vs 763.3 ml, P = 0.039) and beyond. There were no differences in mean time to chest tube removal (6.8 days for the colchicine group vs 5.9 days for the placebo group, P = 0.585) and mean hospital length of stay (7.4 vs 6.9 days, P = 0.641). CONCLUSIONS: Oral colchicine is potentially effective in diminishing the amount of pleural drainage following lung resection and can be considered in patients at high risk of large postoperative pleural effusion. A full-scale, prospective placebo-controlled randomized trial is needed to assess the clinical significance of perioperative colchicine administration following oncological lung resection.

7.
Lancet Haematol ; 4(11): e544-e552, 2017 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-29021123

RESUMO

BACKGROUND: No randomised trials have addressed whether exposure to red blood cells (RBCs) stored longer than 35 days is associated with harm in patients. We aimed to assess the risk of in-hospital mortality associated with transfusing blood stored longer than 35 days. METHODS: We did a secondary analysis of the INforming Fresh versus Old Red cell Management (INFORM) trial, a pragmatic, multicentre, randomised controlled trial of patients (≥18 years) admitted to one of six hospitals in Australia, Canada, Israel, and the USA and expected to need RBC transfusions. Patients were randomly assigned (2:1) to receive blood in inventory stored for the longest time (standard care) or the shortest time, using a random allocation schedule and stratified by centre and patient ABO blood group. The primary objective of the INFORM trial was to assess all-cause in-hospital mortality in patients with blood group A and O who were transfused. For our exploratory secondary analysis, we classified individuals into one of three mutually exclusive exposure categories on the basis of the maximum storage duration of any blood unit patients had received on each day in hospital: exclusively exposed to RBCs stored no longer than 7 days, exposed to at least one unit of RBCs stored 8-35 days, and exposed to least one unit of RBCs stored longer than 35 days. Our primary objective was to determine the effect on risk of in-hospital death of time-dependent exposure to RBCs stored longer than 35 days compared with exclusive exposure to RBCs stored no longer than 7 days, both in patients of blood groups A and O and all patients. The INFORM trial is registered as an International Standard Randomised Controlled Trial, number ISRCTN08118744. FINDINGS: Between April 2, 2012, and Oct 21, 2015, 31 497 patients were recruited, and 24 736 patients were eligible for inclusion in this analysis. We excluded nine patients for whom information about the storage duration of transfused blood was missing and one patient whose sex was unknown. 4480 (18%) patients were exposed to RBCs with longest storage, 1392 (6%) patients were exposed exclusively to RBCs with shortest storage, and 18 854 (76%) patients were exposed to RBCs stored 8-35 days. Median follow-up was 11 days (IQR 6-20). Exposure to RBCs stored longer than 35 days was not associated with increased risk of in-hospital death compared with exclusive exposure to the freshest RBC units after adjusting for demographic variables, diagnosis category, and blood product use history (in patients with blood group A or O: hazard ratio 0·94, 95% CI 0·73-1·20, p=0·60; in all patients: 0·91, 0·72-1·14, p=0·40). The risk of in-hospital death also did not differ between patients exposed to blood stored 8-35 days and patients exposed to blood stored 7 days or less (in patients with blood group A or O: 0·92, 0·74-1·15, p=0·48; in all patients: 0·90, 0·73-1·10, p=0·29). INTERPRETATION: These data provide evidence that transfusion of blood stored for longer than 35 days has no effect on in-hospital mortality, which suggests that current approaches to blood storage and inventory management are reasonable. FUNDING: Canadian Institutes for Health Research, Canadian Blood Services, and Health Canada.


Assuntos
Transfusão de Eritrócitos/efeitos adversos , Mortalidade Hospitalar , Manejo de Espécimes , Idoso , Idoso de 80 Anos ou mais , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Risco , Fatores de Tempo
8.
Pharmacoepidemiol Drug Saf ; 26(12): 1513-1519, 2017 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-28984050

RESUMO

OBJECTIVE: As covariates are not always adequately balanced after propensity score matching and double- adjustment can be used to remove residual confounding, we compared the performance of several double-robust estimators in different scenarios. METHODS: We conducted a series of Monte Carlo simulations on virtual observational studies. After estimating the propensity scores by logistic regression, we performed 1:1 optimal, nearest-neighbor, and caliper matching. We used 4 estimators on each matched sample: (1) a crude estimator without double-adjustment, (2) double-adjustment for the propensity scores, (3) double-adjustment for the unweighted unbalanced covariates, and (4) double-adjustment for the unbalanced covariates, weighted by their strength of association with the outcome. RESULTS: The crude estimator led to highest bias in all tested scenarios. Double-adjustment for the propensity scores effectively removed confounding only when the propensity score models were correctly specified. Double-adjustment for the unbalanced covariates was more robust to misspecification. Double-adjustment for the weighted unbalanced covariates outperformed the other approaches in every scenario and using any matching algorithm, as measured by the mean squared error. CONCLUSION: Double-adjustment can be used to remove residual confounding after propensity score matching. The unbalanced covariates with the strongest confounding effects should be adjusted.


Assuntos
Pontuação de Propensão , Viés , Simulação por Computador , Interpretação Estatística de Dados , Humanos , Modelos Logísticos , Modelos Estatísticos , Método de Monte Carlo , Período Perioperatório , Projetos de Pesquisa/normas
9.
PLoS Med ; 14(8): e1002369, 2017 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-28809936

RESUMO

BACKGROUND AND OBJECTIVE: Chronic Low Back Pain (CLBP) is very common, with a lifetime prevalence between 51% and 80%. In majority, it is nonspecific in nature and multifactorial in etiology. Pregabalin (PG) and Gabapentin (GB) are gabapentinoids that have demonstrated benefit in neuropathic pain conditions. Despite no clear rationale, they are increasingly used for nonspecific CLBP. They necessitate prolonged use and are associated with adverse effects and increased cost. Recent guidelines from the National Health Service (NHS), England, expressed concerns on their off-label use, in addition to the risk of misuse. We aimed to assess the effectiveness and safety of gabapentinoids in adult CLBP patients. METHODS: Electronic databases of MEDLINE, EMBASE, and Cochrane were searched from their inception until December 20th, 2016. We included randomized control trials reporting the use of gabapentinoids for the treatment of CLBP of >3 months duration, in adult patients. Study selection and data extraction was performed independently by paired reviewers. Outcomes were guided by Initiative on Methods, Measurement and Pain Assessment in Clinical Trials guidelines, with pain relief and safety as the primary outcomes. Meta-analyses were performed for outcomes reported in 3 or more studies. Outcomes were reported as mean differences (MDs) or risk ratios (RRs) with their corresponding 95% confidence intervals (CIs), and I2 in percentage representing the percentage variability in effect estimates that could be explained by heterogeneity. GRADE (Grading of Recommendations Assessment, Development, and Evaluation) was used to assess the quality of evidence. RESULTS: Out of 1,385 citations, eight studies were included. Based on the interventions and comparators, studies were analyzed in 3 different groups. GB compared with placebo (3 studies, n = 185) showed minimal improvement of pain (MD = 0.22 units, 95% CI [-0.5 to 0.07] I2 = 0%; GRADE: very low). Three studies compared PG with other types of analgesic medication (n = 332) and showed greater improvement in the other analgesic group (MD = 0.42 units, 95% CI [0.20 to 0.64] I2 = 0; GRADE: very low). Studies using PG as an adjuvant (n = 423) were not pooled due to heterogeneity, but the largest of them showed no benefit of adding PG to tapentadol. There were no deaths or hospitalizations reported. Compared with placebo, the following adverse events were more commonly reported with GB: dizziness-(RR = 1.99, 95% CI [1.17 to 3.37], I2 = 49); fatigue (RR = 1.85, 95% CI [1.12 to 3.05], I2 = 0); difficulties with mentation (RR = 3.34, 95% CI [1.54 to 7.25], I2 = 0); and visual disturbances (RR = 5.72, 95% CI [1.94 to 16.91], I2 = 0). The number needed to harm with 95% CI for dizziness, fatigue, difficulties with mentation, and visual disturbances were 7 (4 to 30), 8 (4 to 44), 6 (4 to 15), and 6 (4 to 13) respectively. The GRADE evidence quality was noted to be very low for dizziness and fatigue, low for difficulties with mentation, and moderate for visual disturbances. Functional and emotional improvements were reported by few studies and showed no significant improvements. CONCLUSIONS AND RELEVANCE: Existing evidence on the use of gabapentinoids in CLBP is limited and demonstrates significant risk of adverse effects without any demonstrated benefit. Given the lack of efficacy, risks, and costs associated, the use of gabapentinoids for CLBP merits caution. There is need for large high-quality trials to more definitively inform this issue. TRIAL REGISTRATION: PROSPERO CRD42016034040.


Assuntos
Aminas/uso terapêutico , Analgésicos/uso terapêutico , Ácidos Cicloexanocarboxílicos/uso terapêutico , Dor Lombar/tratamento farmacológico , Pregabalina/uso terapêutico , Ácido gama-Aminobutírico/uso terapêutico , Aminas/efeitos adversos , Analgésicos/efeitos adversos , Ácidos Cicloexanocarboxílicos/efeitos adversos , Inglaterra , Gabapentina , Humanos , Pregabalina/efeitos adversos , Ensaios Clínicos Controlados Aleatórios como Assunto , Ácido gama-Aminobutírico/efeitos adversos
10.
Can J Cardiol ; 33(7): 898-903, 2017 07.
Artigo em Inglês | MEDLINE | ID: mdl-28668141

RESUMO

The optimal high-sensitivity cardiac troponin (hs-cTn) cutoffs for determining risk in patients who present with acute coronary syndrome symptoms are unknown. In 1137 emergency department patients we calculated adjusted relative risks for a composite outcome (myocardial infarction, unstable angina, heart failure, ventricular arrhythmia, or cardiovascular death) within 7 days for the presentation of hs-cTnT (Roche) and hs-cTnI (Abbott) assay concentrations on the basis of literature cutoffs. Patients with hs-cTn concentrations ≥ 14 ng/L had an adjusted relative risk of 4.9 for the composite outcome, with different hs-cTnT/hs-cTnI concentration ranges yielding higher risks. A common low-risk cutoff of 14 ng/L may be used for hs-cTn with higher cutoffs identifying high-risk patients.


Assuntos
Serviço Hospitalar de Emergência , Cardiopatias/diagnóstico , Troponina I/sangue , Doença Aguda , Biomarcadores/sangue , Causas de Morte/tendências , Seguimentos , Cardiopatias/sangue , Cardiopatias/epidemiologia , Humanos , Incidência , Ontário/epidemiologia , Prevalência , Estudos Prospectivos , Curva ROC , Reprodutibilidade dos Testes , Fatores de Risco , Taxa de Sobrevida/tendências
11.
Semin Thorac Cardiovasc Surg ; 29(1): 35-44, 2017 Spring.
Artigo em Inglês | MEDLINE | ID: mdl-28683994

RESUMO

Cardiopulmonary bypass (CPB) surgery, despite heparin administration, elicits activation of coagulation system resulting in coagulopathy. Anti-inflammatory effects of steroid treatment have been demonstrated, but its effects on coagulation system are unknown. The primary objective of this study is to assess the effects of methylprednisolone on coagulation function by evaluating thrombin generation, fibrinolysis, and platelet activation in high-risk patients undergoing cardiac surgery with CPB. The Steroids In caRdiac Surgery study is a double-blind, randomized, controlled trial performed on 7507 patients worldwide who were randomized to receive either intravenous methylprednisolone, 250 mg at anesthetic induction and 250 mg at initiation of CPB (n = 3755), or placebo (n = 3752). A substudy was conducted in 2 sites to collect blood samples perioperatively to measure prothrombin fragment 1.2 (PF1+2, thrombin generation), plasmin-antiplasmin complex (PAP, fibrinolysis), platelet factor 4 (PF4 platelet activation), and fibrinogen. Eighty-one patients were enrolled in the substudy (37 placebo vs 44 in treatment group). No difference in clinical outcome was detected, including postoperative bleeding and need for blood products transfusion. All patients showed changes of all plasma biomarkers with greater values than baseline in both groups. This reaction was attenuated significantly in the treatment group for PF1.2 (P = 0.040) and PAP (P = 0.042) values at the first intraoperative measurement. No difference between groups was detected for PF4. Methylprednisolone treatment attenuates activation of coagulation system in high-risk patients undergoing CPB surgery. Reduction of thrombin generation and fibrinolysis activation may lead to reduced blood loss after surgery.


Assuntos
Coagulação Sanguínea/efeitos dos fármacos , Perda Sanguínea Cirúrgica/prevenção & controle , Procedimentos Cirúrgicos Cardíacos/efeitos adversos , Ponte Cardiopulmonar/efeitos adversos , Glucocorticoides/administração & dosagem , Metilprednisolona/administração & dosagem , Hemorragia Pós-Operatória/prevenção & controle , Administração Intravenosa , Idoso , Idoso de 80 Anos ou mais , Biomarcadores/sangue , Testes de Coagulação Sanguínea , Método Duplo-Cego , Esquema de Medicação , Feminino , Fibrinólise/efeitos dos fármacos , Glucocorticoides/efeitos adversos , Humanos , Itália , Masculino , Metilprednisolona/efeitos adversos , Pessoa de Meia-Idade , Ontário , Ativação Plaquetária/efeitos dos fármacos , Testes de Função Plaquetária , Hemorragia Pós-Operatória/sangue , Hemorragia Pós-Operatória/etiologia , Fatores de Risco , Trombina/metabolismo , Fatores de Tempo , Resultado do Tratamento
12.
Respiration ; 94(1): 18-25, 2017.
Artigo em Inglês | MEDLINE | ID: mdl-28395291

RESUMO

BACKGROUND: The prevalence of undiagnosed obstructive sleep apnea (OSA) during preoperative evaluation and the best method to screen OSA and its association with postoperative complications remain unclear. OBJECTIVES: To determine the prevalence of undiagnosed OSA in preoperative Indian patients undergoing noncardiac surgery, to compare the diagnostic accuracy of the STOP-BANG questionnaire to a preoperative level III sleep study, and to assess the association of OSA with postoperative complications. METHODS: A prospective cohort of 245 consecutive adults with ≥2 risk factors for OSA who underwent noncardiac surgery between July 2011 and February 2013 were studied. The STOP-BANG questionnaire was administered to all patients, and 182/245 (74.2%) patients underwent a preoperative level III sleep study. Patients were followed for postoperative complications in hospital and contacted at 30 days after surgery. RESULTS: 70/182 (38.5%) obtained a new diagnosis of OSA, including 11/182 (6%) with moderate to severe OSA (apnea-hypopnea index ≥15/h). On logistic regression analyses, the presence of OSA was independently associated with postoperative oxygen desaturation (OR 5.96, 95% CI 2.35-15.1, p < 0.01), a postoperative complication within 7 days (OR 3.63, 95% CI 1.77-7.45, p < 0.01) and within 30 days (OR 3.5, 95% CI 1.74-7.1, p < 0.01). The STOP-BANG questionnaire did not identify 12/70 (17%) of the patients diagnosed with OSA and classified 28% of the cohort as OSA when the level III sleep study was negative. CONCLUSIONS: Unrecognized OSA is common in preoperative patients and is independently associated with postoperative complications. The STOP-BANG questionnaire had a lower performance in the diagnosis of OSA in a South Indian population than the level III sleep study.


Assuntos
Hipóxia/epidemiologia , Complicações Pós-Operatórias/epidemiologia , Apneia Obstrutiva do Sono/epidemiologia , Adulto , Estudos de Coortes , Erros de Diagnóstico , Distúrbios do Sono por Sonolência Excessiva/epidemiologia , Feminino , Humanos , Hipertensão/epidemiologia , Modelos Logísticos , Masculino , Programas de Rastreamento , Pessoa de Meia-Idade , Obesidade/epidemiologia , Polissonografia , Cuidados Pré-Operatórios , Prevalência , Estudos Prospectivos , Medição de Risco , Apneia Obstrutiva do Sono/diagnóstico , Ronco/epidemiologia , Procedimentos Cirúrgicos Operatórios , Inquéritos e Questionários
13.
J Clin Epidemiol ; 87: 87-97, 2017 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-28412467

RESUMO

OBJECTIVE: Propensity score (PS) analysis allows an unbiased estimate of treatment effects but assumes that all confounders are measured. We assessed the impact of omitting confounders from a PS analysis on clinical decision making. STUDY DESIGN AND SETTING: We conducted Monte Carlo simulations on hypothetical observational studies based on virtual populations and on the population from a large randomized trial (CRASH-2). In both series of simulations, PS analysis was conducted with all confounders and with omitted confounders, which were defined to have different strengths of association with the outcome and treatment exposure. After inverse probability of treatment weighting, we calculated the absolute risk differences and numbers needed to treat (NNT). RESULTS: In both series of simulations, omitting a confounder that was moderately associated with the outcome and exposure led to negligible bias on the NNT scale. The bias induced by omitting strongly positive confounding variables remained less than 15 patients to treat. Major bias and reversed effects were found only when omitting highly prevalent, strongly negative confounders that were similarly associated with the outcome and exposure with odds ratios greater than 4.00 (or <0.25). This omission was accompanied by a substantial decrease in analysis power. CONCLUSION: The omission of strongly negative confounding variables from a PS analysis can lead to incorrect clinical decision making. However, omitting these variables also decreases the analysis power, which may prevent the reporting of significant but misleading effects.


Assuntos
Tomada de Decisão Clínica , Fatores de Confusão (Epidemiologia) , Método de Monte Carlo , Pontuação de Propensão , Ensaios Clínicos Controlados Aleatórios como Assunto/estatística & dados numéricos , Viés , Simulação por Computador , Humanos , Estudos Observacionais como Assunto/estatística & dados numéricos , Razão de Chances , Risco
14.
J Clin Epidemiol ; 84: 105-113, 2017 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-28257927

RESUMO

OBJECTIVES: By removing systematic differences across treatment groups, simple randomization is assumed to protect against bias. However, random differences may remain if the sample size is insufficiently large. We sought to determine the minimal sample size required to eliminate random differences, thereby allowing an unbiased estimation of the treatment effect. STUDY DESIGN AND SETTING: We reanalyzed two published multicenter, large, and simple trials: the International Stroke Trial (IST) and the Coronary Artery Bypass Grafting (CABG) Off- or On-Pump Revascularization Study (CORONARY). We reiterated 1,000 times the analysis originally reported by the investigators in random samples of varying size. We measured the covariates balance across the treatment arms. We estimated the effect of aspirin and heparin on death or dependency at 30 days after stroke (IST), and the effect of off-pump CABG on a composite primary outcome of death, nonfatal stroke, nonfatal myocardial infarction, or new renal failure requiring dialysis at 30 days (CORONARY). In addition, we conducted a series of Monte Carlo simulations of randomized trials to supplement these analyses. RESULTS: Randomization removes random differences between treatment groups when including at least 1,000 participants, thereby resulting in minimal bias in effects estimation. Later, substantial bias is observed. In a short review, we show such an enrollment is achieved in 41.5% of phase 3 trials published in the highest impact medical journals. CONCLUSIONS: Conclusions drawn from completely randomized trials enrolling a few participants may not be reliable. In these circumstances, alternatives such as minimization or blocking should be considered for allocating the treatment.


Assuntos
Ponte de Artéria Coronária/estatística & dados numéricos , Projetos de Pesquisa Epidemiológica , Distribuição Aleatória , Acidente Vascular Cerebral/epidemiologia , Viés , Humanos , Tamanho da Amostra
15.
Am Heart J ; 184: 88-96, 2017 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-27892891

RESUMO

Preliminary evidence suggests that statins may prevent major perioperative vascular complications. METHODS: We randomized 648 statin-naïve patients who were scheduled for noncardiac surgery and were at risk for a major vascular complication. Patients were randomized to a loading dose of atorvastatin or placebo (80 mg anytime within 18hours before surgery), followed by a maintenance dose of 40 mg (or placebo), started at least 12hours after the surgery, and then 40 mg/d (or placebo) for 7days. The primary outcome was a composite of all-cause mortality, nonfatal myocardial injury after noncardiac surgery, and stroke at 30days. RESULTS: The primary outcome was observed in 54 (16.6%) of 326 patients in the atorvastatin group and 59 (18.7%) of 316 patients in the placebo group (hazard ratio [HR] 0.87, 95% CI 0.60-1.26, P=.46). No significant effect was observed on the 30-day secondary outcomes of all-cause mortality (4.3% vs 4.1%, respectively; HR 1.14, 95% CI 0.53-2.47, P=.74), nonfatal myocardial infarction (3.4% vs 4.4%, respectively; HR 0.76, 95% CI 0.35-1.68, P=.50), myocardial injury after noncardiac surgery (13.2% vs 16.5%; HR 0.79, 95% CI 0.53-1.19, P=.26), and stroke (0.9% vs 0%, P=.25). CONCLUSION: In contrast to the prior observational and trial data, the LOAD trial has neutral results and did not demonstrate a reduction in major cardiovascular complications after a short-term perioperative course of statin in statin-naïve patients undergoing noncardiac surgery. We demonstrated, however, that a large multicenter blinded perioperative statin trial for high-risk statin-naïve patients is feasible and should be done to definitely establish the efficacy and safety of statin in this patient population.


Assuntos
Atorvastatina/uso terapêutico , Inibidores de Hidroximetilglutaril-CoA Redutases/uso terapêutico , Infarto do Miocárdio/prevenção & controle , Complicações Pós-Operatórias/prevenção & controle , Acidente Vascular Cerebral/prevenção & controle , Procedimentos Cirúrgicos Operatórios , Idoso , Eletrocardiografia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/sangue , Infarto do Miocárdio/diagnóstico , Isquemia Miocárdica/sangue , Isquemia Miocárdica/diagnóstico , Isquemia Miocárdica/prevenção & controle , Assistência Perioperatória/métodos , Modelos de Riscos Proporcionais , Medição de Risco , Troponina/sangue
16.
Int J Epidemiol ; 46(2): 746-755, 2017 04 01.
Artigo em Inglês | MEDLINE | ID: mdl-28025257

RESUMO

In clinical trials it is not uncommon to face a multiple testing problem which can have an impact on both type I and type II error rates, leading to inappropriate interpretation of trial results. Multiplicity issues may need to be considered at the design, analysis and interpretation stages of a trial. The proportion of trial reports not adequately correcting for multiple testing remains substantial. The purpose of this article is to provide an introduction to multiple testing issues in clinical trials, and to reduce confusion around the need for multiplicity adjustments. We use a tutorial, question-and-answer approach to address the key issues of why, when and how to consider multiplicity adjustments in trials. We summarize the relevant circumstances under which multiplicity adjustments ought to be considered, as well as options for carrying out multiplicity adjustments in terms of trial design factors including Population, Intervention/Comparison, Outcome, Time frame and Analysis (PICOTA). Results are presented in an easy-to-use table and flow diagrams. Confusion about multiplicity issues can be reduced or avoided by considering the potential impact of multiplicity on type I and II errors and, if necessary pre-specifying statistical approaches to either avoid or adjust for multiplicity in the trial protocol or analysis plan.


Assuntos
Ensaios Clínicos Controlados Aleatórios como Assunto/métodos , Ensaios Clínicos Controlados Aleatórios como Assunto/estatística & dados numéricos , Projetos de Pesquisa , Intervalos de Confiança , Interpretação Estatística de Dados , Humanos
17.
Transfus Med Rev ; 30(1): 25-9, 2016 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-26651419

RESUMO

Although red blood cell transfusion is a potentially lifesaving intervention in severely anemic and acutely bleeding patients, some observational studies have suggested that prolonged red cell storage before transfusion is associated with harm. INFORM is a large, pragmatic, randomized controlled trial comparing the effect of the shorter storage with longer storage red blood cell transfusions on inhospital mortality in hospitalized patients who require a blood transfusion. The trial is being conducted in centers in Australia, Canada, Israel, and the United States and is expected to enroll 31497 patients. If the results of INFORM indicate that shorter storage red blood cell transfusion is associated with superior outcomes compared with standard issue red blood cell transfusion, consideration may be given to shortening blood storage times. If, in contrast, the INFORM trial provides no evidence of harm from longer storage red blood cells, clinicians and patients may be reassured that current blood inventory management strategies are appropriate.


Assuntos
Preservação de Sangue/métodos , Transfusão de Eritrócitos/métodos , Projetos de Pesquisa , Adulto , Austrália , Preservação de Sangue/normas , Canadá , Transfusão de Eritrócitos/normas , Humanos , Israel , Seleção de Pacientes , Racionalização , Resultado do Tratamento , Estados Unidos
18.
BMJ Open ; 6(11): e013200, 2016 11 10.
Artigo em Inglês | MEDLINE | ID: mdl-28186946

RESUMO

INTRODUCTION: Chronic low back pain (CLBP) is a common condition and causes significant pain, distress and disability across the world. It is multifactorial in aetiology and is challenging to manage. Although the underlying mechanism of pain is predominantly non-specific, many argue that there is a substantial neuropathic pain element. Neuropathic pain is more severe, with significant disability. Gabapentinoids, including gabapentin and pregabalin, have proven efficacy in some neuropathic pain conditions. Despite no clear evidence, a substantial population of patients with CLBP are treated with gabapentinoids. OBJECTIVES: We aim to assess whether the use of gabapentinoids is effective and safe in the treatment of predominant CLBP, by conducting a systematic review and meta-analysis of randomised control trials (RCTs). METHODOLOGY: We will search the databases of MEDLINE, EMBASE and Cochrane for RCTs published in English language and have used gabapentinoids for the treatment of CLBP. Study selection and data extraction will be performed independently by paired reviewers using structured electronic forms, piloted between pairs of reviewers. The review outcomes will be guided by Initiative on Methods, Measurement and Pain Assessment in Clinical Trials guidelines, with pain relief as the primary outcome. We propose to carry out meta-analysis if there are three or more studies in a particular outcome domain, using a random effects model. Pooled outcomes will be reported as weighted mean differences or standardised mean differences and risk ratios with their corresponding 95% CIs, for continuous outcomes and dichotomous outcomes, respectively. Rating of quality of evidence will be reported using GRADE summary of findings table. DISCUSSION: The proposed systematic review will be able to provide valuable evidence to help decision-making in the use of gabapentinoids for the treatment of CLBP. This will help advance patient care and potentially highlight limitations in existing evidence to direct future research. ETHICS AND DISSEMINATION: Being a systematic review, this study would not necessitate ethical review and approval. We plan to report and publish our study findings in a high impact medical journal, with online access. TRIAL REGISTRATION NUMBER: CRD42016034040.


Assuntos
Aminas/uso terapêutico , Dor Crônica/tratamento farmacológico , Ácidos Cicloexanocarboxílicos/uso terapêutico , Dor Lombar/tratamento farmacológico , Neuralgia/tratamento farmacológico , Pregabalina/uso terapêutico , Ácido gama-Aminobutírico/uso terapêutico , Gabapentina , Humanos , Manejo da Dor , Medição da Dor , Ensaios Clínicos Controlados Aleatórios como Assunto , Projetos de Pesquisa , Revisão Sistemática como Assunto
19.
Anesthesiology ; 123(6): 1404-10, 2015 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-26501386

RESUMO

BACKGROUND: Persistent incisional pain is common after cardiac surgery and is believed to be in part related to inflammation and poorly controlled acute pain. Methylprednisolone is a corticosteroid with substantial antiinflammatory and analgesic properties and is thus likely to ameliorate persistent surgical pain. Therefore, the authors tested the primary hypothesis that patients randomized to methylprednisolone have less persistent incisional pain than those given placebo. METHODS: One thousand forty-three patients having cardiopulmonary bypass for cardiac surgery via a median sternotomy were included in this substudy of Steroids in Cardiac Surgery (SIRS) trial. Patients were randomized to 500 mg intraoperative methylprednisolone or placebo. Incisional pain was assessed at 30 days and 6 months after surgery, and the potential risk factors were also evaluated. RESULTS: Methylprednisolone administration did not reduce pain at 30 days or persistent incisional pain at 6 months, which occurred in 78 of 520 patients (15.7%) in the methylprednisolone group and in 88 of 523 patients (17.8%) in the placebo group. The odds ratio for methylprednisolone was 0.93 (95% CI, 0.79 to 1.09, P = 0.37). Furthermore, there was no difference in worst pain and average pain in the last 24 h, pain interference with daily life, or use of pain medicine at 6 months. Younger age, female sex, and surgical infections were associated with the development of persistent incisional pain. CONCLUSIONS: Intraoperative methylprednisolone administration does not reduce persistent incisional pain at 6 months in patients recovering from cardiac surgery.


Assuntos
Anti-Inflamatórios/uso terapêutico , Procedimentos Cirúrgicos Cardíacos/efeitos adversos , Metilprednisolona/uso terapêutico , Dor Pós-Operatória/tratamento farmacológico , Fatores Etários , Idoso , Ponte Cardiopulmonar , Feminino , Seguimentos , Humanos , Masculino , Fatores de Risco , Fatores Sexuais , Resultado do Tratamento
20.
Spine J ; 15(10): 2188-97, 2015 Oct 01.
Artigo em Inglês | MEDLINE | ID: mdl-26072464

RESUMO

BACKGROUND CONTEXT: Randomized controlled trials (RCTs) are the most trustworthy source for evaluating treatment effects, but RCTs of spine surgery interventions often produce discordant results. The Fragility Index is a novel metric to inform about the robustness of statistically significant results. PURPOSE: The aim was to determine the robustness of statistically significant results from RCTs of spine surgery interventions. STUDY DESIGN/SETTING: This was a systematic survey. PATIENT SAMPLE: The sample included RCTs of spine surgery interventions. OUTCOME MEASURES: The Fragility Index is the minimum number of patients in a trial whose status would have to change from a nonevent to an event to change a statistically significant result to a nonsignificant result. Events refer to the occurrence of any dichotomous outcome, such as successful fusion, incident fracture, adjacent segment degeneration, or achievement of a certain functional score. A small Fragility Index indicates that the statistical significance of a result hinges on only a few events, and a large Fragility Index increases one's confidence in the observed treatment effects. METHODS: We systematically reviewed a database for evidence-based orthopedics and identified all the RCTs that reported at least one positive outcome (ie, p<.05). Two reviewers independently assessed eligibility and extracted data. We used the Fisher exact test to compute Fragility Index values and multivariable linear regression to evaluate potential associated factors. RESULTS: We identified 40 eligible RCTs with a median sample size of 132 patients (interquartile range [IQR] 79-208) and a median total number of outcome events for the chosen outcome of 31 (IQR 13-63). The median Fragility Index was two (IQR 1-3), which means that adding two events to one of the trial's treatment arms eliminated its statistical significance. The Fragility Index was less than or equal to three events in 75% of the trials, and was less than or equal to the number of patients lost to follow-up in 65% of the trials. Fragility Index values correlated positively with total sample size (r=0.35; p<.05). When adjusted for losses to follow-up and risk of bias, increasing Fragility Index values were associated only with increasingly significant reported p values (p<.01). CONCLUSIONS: Statistically significant results in spine surgery RCTs are frequently fragile. The addition of only a small number of outcome events can completely eliminate significance. Surgeons, researchers, and other evidence users should exercise caution when interpreting the findings from RCTs with low Fragility Index values and applying these results to patient care.


Assuntos
Procedimentos Neurocirúrgicos/efeitos adversos , Procedimentos Ortopédicos/efeitos adversos , Ensaios Clínicos Controlados Aleatórios como Assunto/estatística & dados numéricos , Traumatismos da Coluna Vertebral/cirurgia , Humanos , Procedimentos Neurocirúrgicos/estatística & dados numéricos , Procedimentos Ortopédicos/estatística & dados numéricos , Ensaios Clínicos Controlados Aleatórios como Assunto/normas
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