Performance of single serum progesterone in the evaluation of symptomatic first-trimester pregnant patients: a systematic review and meta-analysis.

OBJECTIVES: Pain and bleeding complicate 30% of pregnancies, raising concerns for viability. The objective is to evaluate the diagnostic characteristics of a single serum progesterone level in assessing pregnancy viability among symptomatic patients. METHODS: We conducted a predefined literature search in MEDLINE, Embase (OVID), CINAHL and Cochrane databases for studies that enrolled patients in first trimester with miscarriage symptoms, measured progesterone and reported pregnancy viability, from inception to July 2020. We extracted data for 2 × 2 tables, progesterone threshold levels and viability. We obtained summary estimates of sensitivity, specificity, Diagnostic Odds Ratio (DOR), and predictive values at given prevalence rates. RESULTS: We identified 54 publications. There was a total of 15,878 patients enrolled, of whom 7864 patients (49.5%) were confirmed to have a viable pregnancy and 8014 patients (50.5%) were confirmed to have a non-viable pregnancy. The cut-off value of progesterone ranged from 3.2 to 25 ng/mL (20.034-79.5 nmol/L). We evaluated the performance of the following progesterone cut-off categories: < 6.3, 6.3-12.6, 12.7-19.9, and 20-25 ng/mL. To detect non-viable pregnancy, progesterone with cut-off < 6.3 ng/mL had sensitivity 73.1%, specificity 99.2% and DOR 322.0 (PPV 0.91, 0.97 and 0.99 at prevalences 0.1, 0.25, 0.5, respectively, indicating higher likelihood of non-viable pregnancy), and cut-off category 20-25 ng/mL had sensitivity 91.3%, specificity 75% and DOR 31.4 (NPV 0.99, 0.96 and 0.89 at the prevalences above indicating higher likelihood of viable pregnancy). CONCLUSION: A single progesterone level provides a clinically useful prognostic information on pregnancy viability. More than nine out of ten patients with a level < 6.3 ng/mL (< 20.034 nmol/L) will be diagnosed with a non-viable pregnancy, and more than 90% of patients with a level ≥ 20-25 ng/mL (63.6-79.5 nmol/L) will have a viable pregnancy confirmed.

RéSUMé: OBJECTIVES: La douleur et les saignements compliquent 30% des grossesses, ce qui soulève des inquiétudes quant à la viabilité. L'objectif est d'évaluer les caractéristiques diagnostiques d'un seul taux sérique de progestérone dans l'évaluation de la viabilité de la grossesse chez les patientes symptomatiques. MéTHODES: Nous avons effectué une recherche littérature prédéfinie dans les bases de données MEDLINE, Embase (OVID), CINAHL et Cochrane pour des études qui ont recruté des patientes au cours du premier trimestre présentant des symptômes de fausse couche, mesuré la progestérone et signalé la viabilité de la grossesse, du début à juillet 2020. Nous avons extrait les données pour les tableaux 2 × 2, les niveaux de seuil de progestérone et la viabilité. Nous avons obtenu des estimations sommaires de la sensibilité, de la spécificité, du rapport de cotes diagnostiques (DOR) et des valeurs prédictives à des taux de prévalence donnés. RéSULTATS: On a identifié 54 publications. Il y avait un total de 15 878 patientes recrutées, dont 7864 patientes (49.5%) ont été confirmées comme ayant une grossesse viable et 8014 patientes (50,5%) ont été confirmées comme ayant une grossesse non viable. La valeur seuil de la progestérone variait de 3.2 ­ 25 ng/mL (20.034 ­ 79.5 nmol/L). Nous avons évalué les performances des catégories de seuil de progestérone suivantes: < 6.3, 6.3­12.6, 12.7­19.9 et 20­25 ng/mL. Pour détecter une grossesse non viable, la progestérone avec seuil < 6.3 ng/mL avait une sensibilité de 73.1%, une spécificité de 99.2% et une DOR 322.0 (PPV 0.91, 0.97 et 0.99 à des prévalences de 0.1, 0.25, 0.5 respectivement indiquant une probabilité plus élevée de grossesse non viable), et la catégorie de coupure 20­25 ng/mL avait une sensibilité de 91,3%, une spécificité de 75% et une DOR 31,4 (NPV 0.99, 0.96 et 0.89 aux prévalences ci-dessus indiquant une probabilité plus élevée de grossesse viable). CONCLUSION: Un seul niveau de progestérone fournit une information pronostique cliniquement utile sur la viabilité de la grossesse. Plus de neuf patientes sur dix avec un niveau < 6.3 ng/mL (< 20.034 nmol/L) sera diagnostiqué de grossesse non viable, et plus de 90% des patientes ayant un niveau ≥ 20­25 ng/mL (63.6­79.5 nmol/L) auront une grossesse viable confirmée.

The INITIATE trial protocol: a randomized controlled trial testing the effectiveness of a "quit card" intervention on long-term abstinence among tobacco smokers presenting to the emergency department.

BACKGROUND: Smoking cessation interventions implemented in emergency department (ED) settings have resulted in limited success, owing to factors such as lack of time, motivation, and incentives. A dynamic yet simple and effective approach that addresses the fast-paced nature of acute-care ED settings is needed. This study proposes a multi-center randomized controlled trial (RCT) to compare the effectiveness of an easy to deliver proactive, multi-component tobacco treatment intervention to usual care in the ED setting. METHODS: This will be a prospective four-site, single-blind, blinded-endpoint (PROBE) RCT. Participants will be recruited directly in the ED and will be approached strictly in order of arrival time. Those randomized to the Quit Card Intervention (QCI) group will receive a "quit kit" which will include: a "Quit Card" worth $300 that can be used at any Canadian pharmacy to purchase any form of nicotine replacement therapy (NRT); a self-help booklet; and proactive enrolment in 6 months of telephone follow-up counseling. The usual care (UC) group will receive a "quit kit" which will include a brochure for a local smoking cessation program. Quit kits for both groups will be delivered in opaque, sealed envelopes, and identical in size and weight so to conceal group allocation from the blinded research coordinator. Randomization will be stratified by site and by the Canadian Triage Acuity Scale (CTAS), a value assigned to each ED patient based on the severity of the condition. An equal number of quit kits will be prepared for each CTAS level. The primary outcome will be bio-chemically verified smoking abstinence at 26 weeks. Secondary outcomes include smoking behavior at weeks 4, 52, and 104 as well as mortality and health care utilization outcomes. Investigators, outcome assessors, and data analysts will be blinded to group allocation until after primary analyses are completed. It is hypothesized that the QCI group will have higher a abstinence rate, improved health outcomes, and decreased healthcare utilization. DISCUSSION: There are few examples of hospital EDs in Canada that systematically initiate tobacco cessation interventions for patients who smoke. Given the high smoking prevalence among ED patients and the relation of tobacco smoking to the majority of ambulatory care sensitive conditions, EDs are a missed opportunity in the initiation of tobacco treatment interventions. We have designed and will test an evidence-based tobacco treatment intervention that is simple and highly scalable. TRIAL REGISTRATION: ClinicalTrials.gov NCT04163081 . Registered on November 14, 2019.

Adverse Events Among Emergency Department Patients With Cardiovascular Conditions: A Multicenter Study.

STUDY OBJECTIVE: We aim to determine incidence and type of adverse events (adverse outcomes related to emergency care) among emergency department (ED) patients discharged with recent-onset atrial fibrillation, acute heart failure, and syncope. METHODS: This 5-year prospective cohort study included high-acuity adult patients discharged with the 3 sentinel diagnoses from 6 tertiary care Canadian EDs. We screened all ED visits for eligibility and performed telephone interviews 14 days postdischarge to identify flagged outcomes: death, hospital admission, return ED visit, health care provider visit, and new or worsening symptoms. We created case summaries describing index ED visit and flagged outcomes, and trained emergency physicians reviewed case summaries to identify adverse events. We reported adverse event incidence and rates with 95% confidence intervals and contributing factor themes. RESULTS: Among 4,741 subjects (mean age 70.2 years; 51.2% men), we observed 170 adverse events (3.6 per 100 patients; 95% confidence interval 3.1 to 4.2). Patients discharged with acute heart failure were most likely to experience adverse events (5.3%), followed by those with atrial fibrillation (2.0%) and syncope (0.8%). We noted variation in absolute adverse event rates across sites from 0.7 to 6.0 per 100 patients. The most common adverse event types were management issues, diagnostic issues, and unsafe disposition decisions. Frequent contributing factor themes included failure to recognize underlying causes and inappropriate management of dual diagnoses. CONCLUSION: Among adverse events after ED discharge for patients with these 3 sentinel cardiovascular diagnoses, we identified quality improvement opportunities such as strengthening dual diagnosis detection and evidence-based clinical practice guideline adherence.

Lung-Protective Ventilation and Associated Outcomes and Costs Among Patients Receiving Invasive Mechanical Ventilation in the ED.

BACKGROUND: Invasive mechanical ventilation is often initiated in the ED, and mechanically ventilated patients may be kept in the ED for hours before ICU transfer. Although lung-protective ventilation is beneficial, particularly in ARDS, it remains uncertain how often lung-protective tidal volumes are used in the ED, and whether lung-protective ventilation in this setting impacts patient outcomes. RESEARCH QUESTION: What is the association between the use of lung-protective ventilation in the ED and outcomes among invasively ventilated patients? STUDY DESIGN AND METHODS: A retrospective analysis (2011-2017) of a prospective registry from eight EDs enrolling consecutive adult patients (≥ 18 years) who received invasive mechanical ventilation in the ED was performed. Lung-protective ventilation was defined by use of tidal volumes ≤ 8 mL/kg predicted body weight. The primary outcome was hospital mortality. Secondary outcomes included development of ARDS, hospital length of stay, and total hospital costs. RESULTS: The study included 4,174 patients, of whom 2,437 (58.4%) received lung-protective ventilation in the ED. Use of lung-protective ventilation was associated with decreased odds of hospital death (adjusted OR [aOR], 0.91; 95% CI, 0.84-0.96) and development of ARDS (aOR, 0.87; 95% CI, 0.81-0.92). Patients who received lung-protective ventilation in the ED had shorter median duration of mechanical ventilation (4 vs 5 days; P < 0.01), shorter median hospital length of stay (11 vs 14 days; P < .001), and reduced total hospital costs (Can$44,348 vs Can$52,484 [US$34,153 vs US$40,418]; P = .03) compared with patients who received higher tidal volumes. INTERPRETATION: Use of lung-protective ventilation in the ED was associated with important patient- and system-centered outcomes, including lower hospital mortality, decreased incidence of ARDS, lower hospital length of stay, and decreased total costs. Protocol development promoting the regular use of lung-protective ventilation in the ED may be of value.

Prediction Model for 30-day Outcomes Among Emergency Department Patients with Lower Gastrointestinal Bleeding.

INTRODUCTION: There are currently no robust tools available for risk stratification of emergency department (ED) patients with lower gastrointestinal bleed (LGIB). Our aim was to identify risk factors and develop a preliminary model to predict 30-day serious adverse events among ED LGIB patients. METHODS: We conducted a health records review including adult ED patients with acute LGIB. We used a composite outcome of 30-day all-cause death, recurrent LGIB, need for intervention to control the bleeding, and severe adverse events resulting in intensive care unit admission. One researcher collected data for variables and a second researcher independently collected 10% of the variables for inter-observer reliability. We used backward multivariable logistic regression analysis and SELECTION=SCORE option to create a preliminary risk-stratification tool. We assessed the diagnostic accuracy of the final model. RESULTS: Of 372 patients, 48 experienced an adverse outcome. We found that age ≥75 years, hemoglobin ≤100 g/L, international normalized ratio ≥2.0, ongoing bleed in the ED, and a medical history of colorectal polyps were statistically significant predictors in the multivariable regression analysis. The area under the curve (AUC) for the model was 0.83 (95% confidence interval, 0.77-0.89). We developed a scoring system based on the logistic regression model and found a sensitivity 0.96 (0.90-1.00) and specificity 0.53 (0.48-0.59) for a cut-off score of 1. CONCLUSION: This model showed good ability to differentiate patients with and without serious outcomes as evidenced by the high AUC and sensitivity. The results of this study could be used in the prospective derivation of a clinical decision tool.

Evaluation of the Ottawa 3DY as a screening tool for cognitive impairment in older emergency department patients.

OBJECTIVE: This study sought to evaluate the implementation of the Ottawa 3DY Tool, a simple screening instrument for cognitive impairment, by front-line ED clinicians. METHODS: We conducted a prospective cohort study in an academic ED. Patients ≥75 years underwent cognitive screening with the Ottawa 3DY by front-line nurses and physicians. Descriptive statistics were used to describe level of implementation and acceptability of the tool. Sensitivity and specificity was calculated using an Mini-Mental State Exam <25 as the cut-off for cognitive impairment. A weighted kappa was calculated to establish inter-rater agreement. RESULTS: Cognitive screening was completed in 260/332 eligible patients (78.3%), who were 60% female and had a mean age of 83.7 years. Facilitators to screening: perceived importance and ownership of screening and feasibility of Ottawa 3DY. Barriers to screening were: over confidence in clinical judgement and perceived lack of patient benefit. Ottawa 3DY had a sensitivity of 84.6% (64.3-95.0) and specificity of 54.2% (39.3-68.4) when completed by nurses. When completed by emergency physicians, sensitivity was 78.9% (53.9-93.0) and specificity was 70.0% (45.7-87.2). Inter-rater agreement kappa score was 0.67. DISCUSSION: This study demonstrated that incorporating the Ottawa 3DY tool into the routine evaluation of older ED patients by front-line ED clinicians is both feasible and effective. With its demonstrated good inter-rater reliability and moderate level of sensitivity and specificity when compared with the much longer MMSE, the routine adoption of this tool may help lead to improved recognition of cognitive impairment and ultimately patient and system outcomes.

The Yield of Computed Tomography of the Head Among Patients Presenting With Syncope: A Systematic Review.

BACKGROUND: Overuse of head computed tomography (CT) for syncope has been reported. However, there is no literature synthesis on this overuse. We undertook a systematic review to determine the use and yield of head CT and risk factors for serious intracranial conditions among syncope patients. METHODS: We searched Embase, Medline, and Cochrane databases from inception until June 2017. Studies including adult syncope patients with part or all of patients undergoing CT head were included. We excluded case reports, reviews, letters, and pediatric studies. Two independent reviewers screened the articles and collected data on CT head use, diagnostic yield (proportion with acute hemorrhage, tumors or infarct), and risk of bias. We report pooled percentages, I2 , and Cochran's Q-test. RESULTS: Seventeen articles with 3,361 syncope patients were included. In eight ED studies (n = 1,669), 54.4% (95% confidence interval [CI] = 34.9%-73.2%) received head CT with a 3.8% (95% CI = 2.6%-5.1%) diagnostic yield and considerable heterogeneity. In six in-hospital studies (n = 1,289), 44.8% (95% CI = 26.4%-64.1%) received head CT with a 1.2% (95% CI = 0.5%-2.2%) yield and no heterogeneity. In two articles, all patients had CT (yield 2.3%) and the third enrolled patients ≥ 65 years old (yield 7.7%). Abnormal neurologic findings, age ≥ 65 years, trauma, warfarin use, and seizure/stroke history were identified as risk factors. The quality of all articles referenced was strong. CONCLUSION: More than half of patients with syncope underwent CT head with a diagnostic yield of 1.1% to 3.8%. A future large prospective study is needed to develop a robust risk tool.

Pacing as a Treatment for Reflex-Mediated (Vasovagal, Situational, or Carotid Sinus Hypersensitivity) Syncope: A Systematic Review for the 2017 ACC/AHA/HRS Guideline for the Evaluation and Management of Patients With Syncope: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines and the Heart Rhythm Society.

OBJECTIVES: To determine, using systematic review of the biomedical literature, whether pacing reduces risk of recurrent syncope and relevant clinical outcomes among adult patients with reflex-mediated syncope. METHODS: MEDLINE (through PubMed), EMBASE, and the Cochrane Central Register of Controlled Trials (through October 7, 2015) were searched for randomized trials and observational studies examining pacing and syncope, and the bibliographies of known systematic reviews were also examined. Studies were rejected for poor-quality study methods and for the lack of the population, intervention, comparator, or outcome(s) of interest. RESULTS: Of 3188 citations reviewed, 10 studies met the inclusion criteria for systematic review, including a total of 676 patients. These included 9 randomized trials and 1 observational study. Of the 10 studies, 4 addressed patients with carotid sinus hypersensitivity, and the remaining 6 addressed vasovagal syncope. Among the 6 open-label (unblinded) studies, we found that pacing was associated with a 70% reduction in recurrent syncope (relative risk [RR]: 0.30; 95% confidence interval [CI]: 0.15-0.60). When the 2 analyzable studies with double-blinded methodology were considered separately, there was no clear benefit (RR: 0.73; 95% CI: 0.25-2.1), but confidence intervals were wide. The strongest evidence was from the randomized, double-blinded ISSUE-3 (Third International Study on Syncope of Uncertain Etiology) trial, which demonstrated a benefit of pacing among patients with recurrent syncope and asystole documented by implantable loop recorder. CONCLUSIONS: There are limited data with substantive evidence of outcome ascertainment bias, and only 2 studies with a double-blinded study design have been conducted. The evidence does not support the use of pacing for reflex-mediated syncope beyond patients with recurrent vasovagal syncope and asystole documented by implantable loop recorder.

Risk factors for serious underlying pathology in adult emergency department nontraumatic low back pain patients.

BACKGROUND: Nontraumatic low back pain (LBP) is a common emergency department (ED) complaint and can be caused by serious pathologies that require immediate intervention or that lead to death. OBJECTIVE: The primary goal of this study is to identify risk factors associated with serious pathology in adult nontraumatic ED LBP patients. METHODS: We conducted a health records review and included patients aged ≥ 16 years with nontraumatic LBP presenting to an academic ED from November 2009 to January 2010. We excluded those with previously confirmed nephrolithiasis and typical renal colic presentation. We collected 56 predictor variables and outcomes within 30 days. Outcomes were determined by tracking computerized patient records and performance of univariate analysis and recursive partitioning. RESULTS: There were 329 patients included, with a mean age of 49.3 years; 50.8% were women. A total of 22 (6.7%) patients suffered outcomes, including one death, five compression fractures, four malignancies, four disc prolapses requiring surgery, two retroperitoneal bleeds, two osteomyelitis, and one each of epidural abscess, cauda equina, and leaking abdominal aortic aneurysm graft. Risk factors identified for outcomes were: anticoagulant use (odds ratio [OR] 15.6; 95% confidence interval [CI] 4.2-58.5), decreased sensation on physical examination (OR 6.9; CI 2.2-21.2), pain that is worse at night (OR 4.3; CI 0.9-20.1), and pain that persists despite appropriate treatment (OR 2.2; CI 0.8-5.6). These four predictors identified serious pathology with 91% sensitivity (95% CI 70-98%) and 55% specificity (95% CI 54-56%). CONCLUSION: We successfully identified risk factors associated with serious pathology among ED LBP patients. Future prospective studies are required to derive a robust clinical decision rule.