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1.
Res Pract Thromb Haemost ; 6(4): e12732, 2022 May.
Article in English | MEDLINE | ID: mdl-35765669

ABSTRACT

Background: The Pulmonary Embolism Quality of Life questionnaire (PEmb-QoL) assesses quality of life (QoL) in patients with previous pulmonary embolism (PE). Objective: Our aim was to assess the agreement between the PEmb-QoL and interviews and to explore other QoL concerns in patients diagnosed with PE. Methods: This mixed-method study included interviews with 21 patients about QoL after PE, followed by the PEmb-QoL questionnaire. In interviews, patients were asked about their lived experiences and impact of PE. Our analysis identified the frequency and severity of decreased QoL in qualitative interviews and compared with the PEmb-QoL score. Excerpts that described the effect of PE on QoL in interview transcripts were transcoded to match the answers corresponding to the 1 to 6 numeric values for each question from the PEmb-QoL using a predetermined matrix (eg, "constant" and "daily" = all of the time = value 1) and directly compared with responses on the PEmb-QoL in the areas of emotional complaints and activities of daily living/social limitations. Results: Interviews showed more functional impairment than predicted by PEmb-QoL. For fear of recurrence, 86% of participants had disagreements between PEmb-QoL scores and transcoded interview scores. We found 42% disagreement between reported descriptions of the inability to do or enjoy hobbies in interviews and the PEmb-QoL score. Conclusion: Patient interviews showed discordances compared with a validated psychometric tool. To capture a more detailed and accurate picture of the effect of PE on QoL, providers and researchers should consider the addition of qualitative methods to assess outcomes.

2.
Res Pract Thromb Haemost ; 6(1): e12647, 2022 Jan.
Article in English | MEDLINE | ID: mdl-35071970

ABSTRACT

BACKGROUND: Establishing trust and effective communication can be challenging in the emergency department, where a prior relationship between patient and provider is lacking and decisions have to be made rapidly. Venous thromboembolism (VTE) represents an emergent condition that requires immediate decision making. OBJECTIVE: The aim of this paper was to document the experiences, perceptions, and the overall impact of health care provider communication on patients during the diagnosis of VTE in the emergency department. METHODS: This was a qualitative method study using semistructured interviews to increase understanding of the patient experience during the diagnosis of VTE and impact of the health care provider communication on subsequent patient perceptions. RESULTS: A total of 24 interviews were conducted. Content analysis revealed that certain aspects of health care providers' communication-namely, word choice, incomplete information, imbalance between fear over reassurance and nonverbal behavior-used to deliver and explain VTE diagnosis, treatment, and prognosis increases patients' fears. CONCLUSION: These interviews elucidate areas for improvement of communication in the emergency care setting for acute VTE.

3.
J Am Coll Emerg Physicians Open ; 2(6): e12588, 2021 Dec.
Article in English | MEDLINE | ID: mdl-34950930

ABSTRACT

The outpatient treatment of select emergency department patients with acute pulmonary embolism (PE) or deep vein thrombosis (DVT) has been shown to be safe, cost effective and associated with high patient satisfaction. Despite this, outpatient PE and DVT treatment remains uncommon. To address this, the American College of Emergency Physicians assembled a multidisciplinary team of content experts to provide evidence-based recommendations and practical advice to help clinicians safely treat patients with low-risk PE and DVT without hospitalization. The emergency clinician must stratify the patient's risk of clinical decompensation due to their PE or DVT as well as their risk of bleeding due to anticoagulation. The clinician must also select and start an anticoagulant and ensure that the patient has access to the medication in a timely manner. Reliable follow-up is critical, and the patient must also be educated about signs or symptoms that should prompt a return to the emergency department. To facilitate access to these recommendations, the consensus panel also created 2 web-based "point-of-care tools."

4.
Res Pract Thromb Haemost ; 5(6): e12593, 2021 Aug.
Article in English | MEDLINE | ID: mdl-34532630

ABSTRACT

INTRODUCTION: Qualitative research has been increasingly used in health care research to allow in-depth insights and understanding of patients' lived experiences for poorly understood phenomena. The psychological stress mechanisms underlying fear, dyspnea, and pain after venous thromboembolism (VTE) remain poorly understood. However, novice VTE researchers may not be familiar with the process of undertaking qualitative research. OBJECTIVE: The aim of this article is to describe the planning, methodology and execution of qualitative methods, using the example of patients' lived experiences during and after the diagnosis of VTE. We discuss challenges and solutions in implementing qualitative research methods in health care research. METHODS: Patients were recruited from the emergency department and clinic using in-person and phone contact. We used both in-person and video format to interview 24 patients. Interviews were guided by a set of questions to be explored but conducted to elucidate unique thoughts and opinions from patients. RESULTS: For recruitment, "cold-calling" was found to be largely unsuccessful. Many patients have preexisting diagnoses of anxiety and depression. Video interviews were found to be at least as effective as in-person interviews. Interviews revealed unique post-VTE experiences from all participants, with a wide range of impact on quality of life. Themes that were most common included perceptions of physician communication, fear of recurrence, and concerns of death. CONCLUSION: A qualitative research approach can reveal individual experiences and psychosocial impact in patients diagnosed with VTE, which allow the researchers to better comprehend the complexity of this phenomenon and its impact in health care.

6.
Ann Emerg Med ; 69(2): 184-191.e1, 2017 Feb.
Article in English | MEDLINE | ID: mdl-27745763

ABSTRACT

STUDY OBJECTIVE: Seizures account for 1.2% of all emergency department (ED) visits, with 24% of those representing first-time seizures. Our primary goal is to determine whether obtaining an electroencephalogram (EEG) in the ED after a first-time seizure can identify individuals appropriate for initiation of anticonvulsant therapy on ED discharge. Our secondary goals are to determine the association of historical and clinical seizure features with epileptic EEGs and to determine the interobserver agreement for the EEG interpretation. METHODS: We conducted a prospective study including patients older than 17 years with either a first-time seizure or previous seizures without a previous EEG, all of whom were candidates for discharge home from the ED without antiepileptic drug treatment. We based seizure diagnosis on provider impression. We excluded patients with laboratory studies or neuroimaging deemed to be the seizure cause. EEG technicians performed a 30-minute EEG in the ED, which was immediately remotely interpreted by an epileptologist, who made a recommendation on antiepileptic drug initiation. We categorized EEGs as normal, abnormal but not epileptic, or epileptic. In accordance with duplicate EEG interpretation by a second, blinded epileptologist, we calculated interrater agreement for EEG interpretation and antiepileptic drug initiation. As a secondary analysis, according to questionnaires completed by patients and seizure observers, we explored the association of aura, focal symptoms, provocation, or historical risk factors with epilepsy. RESULTS: We enrolled 73 patients, 71 of whom had an EEG performed. All EEGs were performed within 11 hours of seizure, with an average of 3.85 hours. Twenty-four percent of patients (95% confidence interval 15% to 36%) received a diagnosis of epilepsy, and all began receiving antiepileptic drug therapy from the ED. Our final study sample size afforded only an exploratory analysis about an association between aura, focal onset, provocation, or historical risk factors with an epilepsy diagnosis. Weighted κ agreement for EEG interpretation was 0.69 (95% confidence interval 0.55 to 0.82). Of the 34 patients who followed up with an epileptologist, 9 had received a diagnosis of epilepsy in the ED, and none had antiepileptic drug medication stopped at initial follow-up. CONCLUSION: ED EEG performance in adults with first-time seizures results in a substantial yield of an epilepsy diagnosis and immediate initiation of antiepileptic drug treatment. A larger study is required to determine whether historical and clinical seizure features are associated with an ED epilepsy diagnosis.


Subject(s)
Electroencephalography , Emergency Service, Hospital , Seizures/diagnosis , Adult , Anticonvulsants/therapeutic use , Female , Humans , Male , Patient Discharge , Prospective Studies , Seizures/drug therapy , Seizures/physiopathology
7.
Chest ; 136(5): 1202-1210, 2009 Nov.
Article in English | MEDLINE | ID: mdl-19542256

ABSTRACT

BACKGROUND: No published data have systematically documented pulmonary artery pressure over an intermediate time period after submassive pulmonary embolism (PE). The aim of this work was to document the rate of pulmonary hypertension, as assessed noninvasively by estimated right ventricular systolic pressure (RVSP) of >or= 40 mm Hg 6 months after the diagnosis of submassive PE. METHODS: We enrolled 200 normotensive patients with CT angiography-proven PE and a baseline echocardiogram to estimate RVSP. All patients received therapy with unfractionated heparin initially, but 21 patients later received alteplase in response to circulatory shock or respiratory failure. Patients returned at 6 months for repeat RVSP measurement, and assessments of the New York Heart Association (NYHA) score and 6-min walk distance (6MWD). RESULTS: Six months after receiving a diagnosis, 162 of 180 survivors (90%) returned for follow-up, including 144 patients who had been treated with heparin (heparin-only group) and 18 patients who had been treated with heparin plus alteplase (heparin-plus-alteplase group). Among the heparin-only patients, the RVSP at diagnosis was >or= 40 mm Hg in 50 of 144 patients (35%; 95% CI, 27% to 43%), compared with 10 of 144 patients at follow-up (7%; 95% CI, 3% to 12%). However, the RVSP at follow-up was higher than the baseline RVSP in 39 of 144 patients (27%; 95% CI, 9% to 35%), and 18 of these 39 patients had a NYHA score of >or= 3 or exercise intolerance (6MWD, < 330 m). Among heparin-plus-alteplase patients, the RVSP was >or= 40 mm Hg in 11 of 18 patients at diagnosis (61%; 95% CI, 36% to 83%), compared with 2 of 18 patients at follow-up (11%; 95% CI, 1% to 35%). The RVSP at follow-up was not higher than at the time of diagnosis in any of the heparin-plus-alteplase patients (95% CI, 0% to 18%). CONCLUSIONS: Six months after experiencing submassive PE, a significant proportion of patients had echocardiographic and functional evidence of pulmonary hypertension.


Subject(s)
Hypertension, Pulmonary/epidemiology , Pulmonary Artery/physiopathology , Pulmonary Embolism/physiopathology , Ventricular Function, Right/physiology , Adolescent , Adult , Aged , Aged, 80 and over , Blood Pressure , Dopamine/therapeutic use , Echocardiography , Fibrinolytic Agents/therapeutic use , Follow-Up Studies , Heparin/therapeutic use , Humans , Middle Aged , Patient Selection , Pulmonary Embolism/diagnostic imaging , Pulmonary Embolism/drug therapy , Pulmonary Embolism/mortality , Survivors , Tissue Plasminogen Activator/therapeutic use , Tomography, X-Ray Computed , Treatment Outcome , Young Adult
8.
Ann Emerg Med ; 53(6): 727-35.e1, 2009 Jun.
Article in English | MEDLINE | ID: mdl-19135281

ABSTRACT

STUDY OBJECTIVE: We hypothesize that the presentation of a quantitative pretest probability of acute coronary syndrome would safely reduce unnecessary resource use in low-risk emergency department (ED) chest pain patients. METHODS: Randomized controlled trial of adult patients with chest pain paired with their clinicians. Patients had neither obvious evidence of acute coronary syndrome nor obvious other reason for admission. Clinicans provided their unstructured point estimate for pretest probability before randomization. Clinicans and patients in the intervention group received a printout of pretest probability of acute coronary syndrome result displayed numerically and graphically. Controls received no printout. Patients were followed for 45 days for predefined criteria of acute coronary syndrome and efficacy endpoints. Endpoints were compared between groups, with 95% confidence intervals (CIs) for differences. RESULTS: Four hundred were enrolled, and 31 were excluded for cocaine use or elopement from care. The mean pretest probability estimates of acute coronary syndrome were 4 (SD 5%) from clinicians and 4 (SD 6%) from the computer. Safety and efficacy endpoints for controls (n=185) versus intervention patients (n=184) were as follows: (1) delayed or missed diagnosis of acute coronary syndrome: 1 of 185 versus 0 of 184 (95% CI for difference -2.8% to 15.0%); (2) hospital admission with no significant cardiovascular diagnosis, 11% versus 5% (-0.2% to 11%); (3) thoracic imaging imparting greater than 5 mSv radiation with a negative result, 20% versus 9% (95% CI for difference = 3.8% to 18.0%); (4) median length of stay, 11.4 hours versus 9.2 hours (95% CI for difference = -2.9 to 7.6 hours); (5) reported feeling "very satisfied" with clinician explanation of problem on follow-up survey, 38% versus 49% (95% CI for difference = 0.9% to 21.0%); (6) readmitted within 7 days, 11% versus 4% (95% CI for difference = 2.5% to 13.2%). CONCLUSION: Presentation of a quantitative estimate of the pretest probability of acute coronary syndrome to clinicians and low-risk ED chest pain patients was associated with reduced resource use, without evidence of increased rate of premature discharge of patients with acute coronary syndrome.


Subject(s)
Acute Coronary Syndrome/diagnosis , Chest Pain/etiology , Decision Making, Computer-Assisted , Emergency Service, Hospital , Acute Coronary Syndrome/complications , Adult , Coronary Angiography/statistics & numerical data , Female , Hospitals, University , Humans , Male , Middle Aged , Risk Factors , Severity of Illness Index , Urban Population
9.
Am Heart J ; 156(2): 308-14, 2008 Aug.
Article in English | MEDLINE | ID: mdl-18657661

ABSTRACT

BACKGROUND: Elevated blood concentrations of troponin proteins or brain natriuretic peptide (BNP) worsen the prognosis of patients with pulmonary embolism (PE). Novel biomarkers that reflect mechanisms of right ventricle (RV) damage from PE may provide additional prognostic value. We compare the prognostic use of BNP, troponin I, D-dimer, monocyte chemoattractant protein-1, matrix metalloproteinase, myeloperoxidase, C-reactive protein, and caspase 3 as biomarkers of RV damage and adverse outcomes in submassive PE. METHODS: This article used a prospective cohort study of normotensive (systolic blood pressure always >100 mm Hg) patients with computed tomographic angiography-diagnosed PE. All patients underwent echocardiography and phlebotomy at diagnosis, and survivors had another echocardiography 6 months later. We tested each biomarker for prognostic significance, requiring a lower limit 95% CI >0.50 for the area under the receiver operating characteristic curve (AUROC) with a reference standard positive of RV hypokinesis on either echocardiogram. Biomarkers with prognostic significance were dichotomized at the concentration that yielded highest likelihood ratio positive and mortality rates compared (Fisher exact test). RESULTS: We enrolled 152 patients with complete data. Thirty-seven (24%, 95% CI 18%-32%) had RV hypokinesis. Only BNP and troponin had significant AUROC values as follows: 0.71 (95% CI 0.60-0.81) and 0.71 (95% CI 0.62-0.82), respectively. Overall mortality was 13/153 (8.5%); mortality rate for BNP >100 versus < or =100 pg/mL was 23% versus 3% (P = .003), respectively. Mortality rate for troponin I >0.1 versus < or =0.1 ng/mL was 13% versus 6% (P = .205), respectively. CONCLUSIONS: Of 8 mechanistically plausible biomarkers, only BNP and troponin I had significant prognostic use with BNP having an advantage for predicting mortality.


Subject(s)
Biomarkers/blood , Natriuretic Peptide, Brain/blood , Pulmonary Embolism/blood , Troponin I/blood , Ventricular Dysfunction, Right/blood , C-Reactive Protein/analysis , Caspase 3/blood , Chemokine CCL2/blood , Fibrin Fibrinogen Degradation Products/analysis , Humans , Matrix Metalloproteinases/blood , Middle Aged , Peroxidase/analysis , Prognosis , Prospective Studies , Pulmonary Embolism/complications , ROC Curve , Ultrasonography , Ventricular Dysfunction, Right/diagnostic imaging , Ventricular Dysfunction, Right/etiology
10.
Eur Heart J ; 28(20): 2517-24, 2007 Oct.
Article in English | MEDLINE | ID: mdl-17670755

ABSTRACT

AIMS: We hypothesized that first-time submassive pulmonary embolism (PE) can cause persistent, significant cardiopulmonary problems, including right ventricular damage and worsened quality of life in patients with no prior cardiopulmonary disease. METHODS AND RESULTS: We prospectively enrolled 205 patients without end-stage comorbidity diagnosed with submassive PE (systolic blood pressure always > 100 mmHg). Using explicit criteria, we identified a subgroup of 127 'previously healthy' patients who were free of cardiopulmonary disease or other disabling process. All patients had transthoracic echocardiography (echo) at the time of diagnosis. Six months later, survivors returned for repeat echo, 6 min walk distance (6MWD), and a quality-of-life survey. We defined a significant cardiopulmonary problem as either: (i) abnormal RV on echo (RV dilation or RV hypokinesis); or (ii) NYHA score > II or a 6MWD < 330 m at 6 months. Of 127 study patients, five had inadequate echos, nine were lost to follow-up, and four died, leaving 109 with complete data. Of 109 patients, 45 (41%) had cardiopulmonary problems 6 months after PE: 18 of 109 (17%) had only an abnormal RV, 18 of 109 (17%) had only functional limitation, and nine of 109 (8%) had both. Twenty-two patients (20%) indicated at least one index of poor quality-of-life: health status worse, not currently shopping, or perceived need for oxygen at home. Patients with cardiopulmonary problems demonstrated a significant decrease in SaO(2)% after 6MWD (97 +/- 1.3 pre-6MWD vs. 96 +/- 1.8% post-6MWD, P = 0.004 by paired t-test). CONCLUSION: Six months after first-time PE, 41% of previously healthy patients had either an abnormal RV on echo, an NYHA score > II or a 6MWD < 330 m. Treatment studies of PE should include these persistent cardiopulmonary problems as study endpoints.


Subject(s)
Pulmonary Embolism/complications , Ventricular Dysfunction, Right/etiology , Adult , Cross-Sectional Studies , Disease Progression , Echocardiography/methods , Female , Heart Function Tests/methods , Humans , Male , Middle Aged , Prognosis , Prospective Studies , Pulmonary Embolism/diagnostic imaging , Regression Analysis , Ventricular Dysfunction, Right/diagnostic imaging
11.
Acad Emerg Med ; 14(7): 592-8, 2007 Jul.
Article in English | MEDLINE | ID: mdl-17554011

ABSTRACT

OBJECTIVES: The authors hypothesized that emergency department (ED) patients with a delayed diagnosis of pulmonary embolism (PE) will have a higher frequency of altered mental status, older age, comorbidity, and worsened outcomes compared with patients who have PE diagnosed by tests ordered in the ED. METHODS: For 144 weeks, all patients with PE diagnosed by computed tomographic angiography were prospectively screened to identify ED diagnosis (testing ordered from the ED) versus delayed diagnosis (less than 48 hours postadmission). Serum troponin I level, right ventricular hypokinesis on echocardiography, and percentage pulmonary vascular occlusion were measured at diagnosis; patients were prospectively followed up for adverse events (death, intubation, or circulatory shock). RESULTS: Among 161 patients with PE, 141 (88%) were ED diagnosed and 20 (12%) had a delayed diagnosis. Patients with a delayed diagnosis were older than ED-diagnosed patients (61 [+/-15] vs. 51 [+/-17] years; p < 0.001), had a longer median time to heparin administration (33 vs. 8 hours; p < 0.001), and had a higher frequency of altered mental status (30% vs. 8%; p = 0.01) but did not have a higher frequency of prior cardiopulmonary disease (25% vs. 23%). Patients with a delayed diagnosis had equal or worse measures of PE severity (right ventricular hypokinesis on echocardiography, 60% vs. 58%; abnormal troponin I level, 55% vs. 24%); on computed tomographic angiography, ten of 20 patients with a delayed diagnosis had PE in lobar or larger arteries and >50% vascular obstruction. Patients with a delayed diagnosis had a higher rate of in-hospital adverse events (9% vs. 30%; p = 0.01). CONCLUSIONS: In this single-center study, the diagnosis of PE was frequently delayed and outcomes of patients with delayed diagnosis were worse than those of patients with PE diagnosed in the ED.


Subject(s)
Cognition Disorders/diagnosis , Diagnostic Services/statistics & numerical data , Emergency Service, Hospital/standards , Medical Audit , Outcome and Process Assessment, Health Care , Pulmonary Embolism/diagnosis , Adult , Aged , Aged, 80 and over , Cognition Disorders/epidemiology , Cognition Disorders/etiology , Comorbidity , Emergency Service, Hospital/statistics & numerical data , Humans , Mental Health , Middle Aged , Prospective Studies , Pulmonary Embolism/complications , Pulmonary Embolism/epidemiology , Pulmonary Embolism/psychology , Severity of Illness Index , Time Factors , Tomography, X-Ray Computed/statistics & numerical data , Troponin I/blood , Utilization Review
12.
Acad Emerg Med ; 14(7): 587-91, 2007 Jul.
Article in English | MEDLINE | ID: mdl-17513689

ABSTRACT

OBJECTIVES: The authors sought to determine the effect of in vitro time, temperature, and removable tourniquet use on changes in venous point-of-care lactate concentrations. METHODS: This was a prospective randomized trial on healthy volunteers. Subjects were randomized to one of three groups: group 1 had venous lactate concentrations measured on blood drawn without a tourniquet and the sample placed in ice (-1 degrees C), group 2 had lactate concentrations measured on blood drawn without a tourniquet and the sample left at 23 degrees C, and group 3 had lactate concentrations measured on blood drawn with a tourniquet placed 5 minutes before venipuncture and the sample placed in ice (-1 degrees C). Lactate concentrations were measured on a point-of-care device at time 0, 3, 6, 9, 12, and 15 minutes in all three groups. Mean lactate concentrations were analyzed using a two-way repeated-measures analysis of variance. RESULTS: Eighty subjects were randomized, with complete data available in 63 (21 per group). Over the 15-minute period, lactate concentrations increased 10% (0.14 +/- 0.12 mmol/L) in group 1, 25% (0.33 +/- 0.003 mmol/L) in group 2, and 6% (0.08 +/- 0.22 mmol/L) in group 3. No significant differences in mean lactate concentrations were found between any group or time point by analysis of variance (p > 0.90). A 50% relative increase in lactate concentrations between time 0 and 15 minutes occurred in zero of 21 subjects in group 1, four of 21 in group 2, and one of 21 in group 3 (p = 0.05 group 1 vs. group 2, Fisher's exact test). CONCLUSIONS: Whole blood point-of-care lactate concentrations in healthy subjects do not change significantly over 15 minutes at either -1 degrees C or 23 degrees C, and the use of a tourniquet has no appreciable effect on lactate concentrations.


Subject(s)
Lactates/blood , Phlebotomy , Temperature , Tourniquets , Humans , Point-of-Care Systems , Prospective Studies , Research Design , Time Factors
13.
J Thromb Thrombolysis ; 23(2): 101-5, 2007 Apr.
Article in English | MEDLINE | ID: mdl-17221330

ABSTRACT

Tenecteplase, a mutant form of alteplase, possesses pharmacological properties that might favor its use for emergent fibrinolysis of acute pulmonary embolism. Contemporaneous search of the World's literature reveals 14 humans with acute pulmonary embolism treated with tenecteplase. Here, we summarize those cases and report the presentation features, dosing details and outcomes of eight additional patients with acute pulmonary embolism treated with tenecteplase in an academic emergency department. None of our eight patients had a significant hemorrhagic event after tenecteplase, and the outcomes of all eight appear to be acceptable. Taken together, we submit that the present case report and prior case reports are sufficient to comprise a phase I study of the safety and efficacy of tenecteplase to treat acute pulmonary embolism.


Subject(s)
Emergency Medical Services/methods , Fibrinolytic Agents/therapeutic use , Pulmonary Embolism/drug therapy , Tissue Plasminogen Activator/therapeutic use , Aged , Clinical Trials, Phase I as Topic , Female , Humans , Male , Middle Aged , Tenecteplase , Treatment Outcome
14.
Crit Care Med ; 34(11): 2773-80, 2006 Nov.
Article in English | MEDLINE | ID: mdl-16943732

ABSTRACT

BACKGROUND: Although echocardiography has proven utility in risk stratifying normotensive patients with pulmonary embolism, echocardiography is not always available. OBJECTIVE: Test if a novel panel consisting of pulse oximetry, 12-lead electrocardiography, and serum troponin T would have prognostic equivalence to echocardiography and to examine the prognostic performance of age, previous cardiopulmonary disease, D-dimer, brain natriuretic peptide, and percentage of pulmonary vascular occlusion on chest computed tomography. DESIGN: Prospective cohort study. PATIENTS AND SETTING: Normotensive (systolic blood pressure of >100 mm Hg) emergency department and hospital inpatients with diagnosed pulmonary embolism who underwent cardiologist-interpreted echocardiography and other measurements within 15 hrs of anticoagulation. MEASUREMENTS AND MAIN RESULTS: End points were in-hospital circulatory shock or intubation, or death, recurrent pulmonary embolism, or severe cardiopulmonary disability (defined as echocardiographic evidence of severe right ventricular dysfunction with New York Heart Association class III dyspnea or 6-min walk test of <330 m) at 6-month follow-up. The two-one-sided test tested the hypothesis of equivalence with one-tailed alpha = 0.05 and Delta = 5%. Of 200 patients enrolled, data were complete for 181 (88%); 51 of 181 patients (28%) had an adverse outcome, including in-hospital complication (n = 18), death (n = 11), recurrent pulmonary embolism (n = 2), or cardiopulmonary disability (n = 20). Right ventricular dysfunction on initial echocardiogram was 61% sensitive (95% confidence interval, 46-74%) and 57% specific (48-66%). The panel was 71% sensitive (56-83%) and 62% specific (53-71%). The two-one-sided procedure demonstrated superiority of the panel to echocardiography for both sensitivity and noninferiority for specificity. No other biomarker demonstrated equivalence, noninferiority, or superiority for sensitivity and specificity. CONCLUSION: Normotensive patients with pulmonary embolism have a high rate of severe adverse outcomes during 6-month follow-up. A panel of three widely available tests can be used to risk stratify patients with pulmonary embolism when formal echocardiography is not available.


Subject(s)
Electrocardiography , Oximetry , Pulmonary Embolism/diagnosis , Troponin T/blood , Ventricular Dysfunction, Right/diagnosis , Age Factors , Biomarkers/blood , Echocardiography , Female , Fibrin Fibrinogen Degradation Products/metabolism , Humans , Logistic Models , Male , Middle Aged , Multivariate Analysis , Natriuretic Peptide, Brain/blood , Predictive Value of Tests , Prognosis , Prospective Studies , Pulmonary Embolism/diagnostic imaging , Tomography, X-Ray Computed , Ventricular Dysfunction, Right/diagnostic imaging
15.
Clin Chem ; 51(5): 825-9, 2005 May.
Article in English | MEDLINE | ID: mdl-15764641

ABSTRACT

BACKGROUND: Pregnancy is known to increase the D-dimer concentration above the conventional normal threshold of 0.50 mg/L, leading to an increased false-positive D-dimer test when venous thromboembolism (VTE) is clinically suspected in a pregnant patient. Our aim was to determine the effect of normal pregnancy on the D-dimer concentration. METHODS: Healthy women who were seeking to become pregnant and had no preexisting condition known to increase the D-dimer concentration were identified. Quantitative D-dimer measurements (MDA turbidimetric assay) and fibrinogen assays were performed before conception, at each trimester, and at 4 weeks postpartum. Patients were excluded for fetal loss or preeclampsia. RESULTS: A total of 50 women were enrolled in the study, and blood samples were obtained at preconception and all trimesters from 23 women. The mean (SD) preconception D-dimer concentration was 0.43 (0.49) mg/L, and 79% of women had a D-dimer concentration <0.50 mg/L. D-Dimer increased with each trimester such that only 22% of women in the second trimester and none (of 23) in the third trimester (95% confidence interval, 0-14%) had a D-dimer concentration <0.50 mg/L. We found no correlation between either the D-dimer and fibrinogen concentrations or between the increases in D-dimer and fibrinogen with pregnancy. CONCLUSIONS: Normal pregnancy causes a progressive increase in circulating D-dimer. The D-dimer test has no use in ruling out VTE in the third trimester if a cutoff of 0.50 mg/L is used. A large management study is needed to establish new thresholds for the D-dimer to rule out VTE in each trimester.


Subject(s)
Fibrin Fibrinogen Degradation Products/analysis , Pregnancy/blood , Adult , Female , Fibrinogen/analysis , Humans , Pregnancy Trimesters , Reference Values
16.
Ann Emerg Med ; 44(5): 490-502, 2004 Nov.
Article in English | MEDLINE | ID: mdl-15520709

ABSTRACT

STUDY OBJECTIVE: This study tests the hypothesis that implementation of a point-of-care emergency department (ED) protocol to rule out pulmonary embolism would increase the rate of evaluation without increasing the rate of pulmonary vascular imaging or ED length of stay and that less than 1.0% of patients with a negative protocol would have an adverse outcome. METHODS: A baseline study was conducted on patients with suspected pulmonary embolism at an urban ED to establish baseline measurements performed when only pulmonary vascular imaging was available to rule out pulmonary embolism. The intervention protocol used pretest probability assessment, a whole-blood d -dimer assay, and an alveolar dead-space measurement to rule out pulmonary embolism. The main outcomes were diagnosis of venous thromboembolism or sudden unexpected death within 90 days. RESULTS: During baseline, 453 of 61,322 patients (0.74%; 95% confidence interval [CI] 0.67% to 0.81%) underwent pulmonary vascular imaging, and 8% (95% CI 6% to 11%) of scan results were positive; 1.20% (95% CI 0.39% to 2.78%) of untreated discharged patients were anticoagulated for venous thromboembolism or died unexpectedly within 90 days. The median length of stay was 385 minutes. After intervention, 1,460 of 102,848 patients (1.42%; 95% CI 1.35% to 1.49%) were evaluated for pulmonary embolism. Seven hundred fifty-two patients had a negative protocol and 5 of 752 (0.66%; 95% CI 0.20% to 1.54%) had venous thromboembolism within 90 days, none with unexpected death. After intervention, the rate of pulmonary vascular imaging tended to decrease (0.64%; 95% CI 0.59% to 0.69%), and more scans (11%; 95% CI 9% to 14%) were read as positive; the length of stay decreased to 297 minutes. CONCLUSION: A point-of-care pulmonary embolism rule-out protocol doubled the rate of screening for pulmonary embolism in the ED, had a false negative rate of less than 1.0%, did not increase the pulmonary vascular imaging rate, and decreased length of stay.


Subject(s)
Pulmonary Embolism/diagnosis , Adult , Algorithms , Angiography/methods , Clinical Protocols , Death, Sudden/epidemiology , Decision Support Techniques , Emergency Service, Hospital , Feasibility Studies , Female , Fibrin Fibrinogen Degradation Products/analysis , Hospitals, Urban , Humans , Length of Stay , Likelihood Functions , Lung/blood supply , Male , Middle Aged , North Carolina/epidemiology , Predictive Value of Tests , Pulmonary Embolism/epidemiology , Respiratory Dead Space , Tomography, X-Ray Computed , Venous Thrombosis/epidemiology , Ventilation-Perfusion Ratio
17.
Am J Med ; 115(3): 203-8, 2003 Aug 15.
Article in English | MEDLINE | ID: mdl-12935827

ABSTRACT

PURPOSE: A simple method is needed to risk stratify normotensive patients with pulmonary embolism. We studied whether bedside clinical data can predict in-hospital complications from pulmonary embolism. METHODS: We performed a multicenter derivation phase, followed by validation in a single center. All patients were normotensive; the diagnosis of pulmonary embolism was established by objective imaging. Classification and regression analysis was performed to derive a decision tree from 27 parameters recorded from 207 patients. The validation study was conducted on a separate group of 96 patients to determine the derived criterion's diagnostic accuracy for in-hospital complications (cardiogenic shock, respiratory failure, or death). RESULTS: Mortality in the derivation phase was 4% (n = 8) at 24 hours and 10% (n = 21) at 30 days. A room-air pulse oximetry reading <95% was the most important predictor of death; mortality was 2% (95% confidence interval [CI]: 0% to 6%) in patients with pulse oximetry >or=95% versus 20% (95% CI: 12% to 29%) with pulse oximetry <95%. In the validation phase, the room-air pulse oximetry was <95% at the time of diagnosis in 9 of 10 patients who developed an in-hospital complication (sensitivity, 90%) and >or=95% in 55 of 86 patients without complications (specificity, 64%). CONCLUSION: Mortality from pulmonary embolism in normotensive patients is high. A room-air pulse oximetry reading >or=95% at diagnosis is associated with a significantly lower probability of in-hospital complications from pulmonary embolism.


Subject(s)
Hospitalization , Oximetry/standards , Pulmonary Embolism/complications , Respiratory Insufficiency/prevention & control , Shock, Cardiogenic/prevention & control , Blood Pressure/physiology , Humans , Predictive Value of Tests , Prospective Studies , Pulmonary Embolism/mortality , Pulmonary Embolism/physiopathology , Reproducibility of Results , Respiratory Insufficiency/etiology , Risk Assessment/methods , Sensitivity and Specificity , Shock, Cardiogenic/etiology , Survival Analysis , United States/epidemiology
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