Guideline-Based Clinical Assessment Versus Procalcitonin-Guided Antibiotic Use in Pneumonia: A Pragmatic Randomized Trial.

STUDY OBJECTIVE: Efforts to reduce unnecessary and unnecessarily long antibiotic treatment for community-acquired pneumonia have been attempted through use of procalcitonin and through guidelines based on serial clinical assessment. Our aim is to compare guideline-based clinical assessment- and procalcitonin algorithm-guided antibiotic use among patients with community-acquired pneumonia. METHODS: We performed a pragmatic, randomized, multicenter trial from November 2012 to April 2015 at 12 French hospitals. We included emergency department (ED) patients older than 18 years with community-acquired pneumonia. Patients were randomly assigned to either the procalcitonin-guided or clinical assessment group. In accordance with past studies, we hypothesized that serial clinical assessment would be superior to procalcitonin-guided care. The primary outcome was antibiotic duration, and secondary outcomes included rates of antibiotic duration less than or equal to 5 days, and clinical success and combined serious adverse outcomes at 30 days in the intention-to-treat population. RESULTS: Of 370 eligible patients, 285 (77%) were randomly assigned to either clinical assessment- (n=143) or procalcitonin-guided care (n=142). Median age was 67 years (range 18 to 93 years) and 40% of patients were deemed to have Pneumonia Severity Index class IV or V. Procalcitonin algorithm adherence was 76%. Antibiotic duration was not significantly different between clinical assessment- and procalcitonin-guided groups (median 9 versus 10 days, respectively). Clinical success rate was 92% in each group and serious adverse outcome rates were similar (15% versus 20%, respectively). CONCLUSION: Guideline-based serial clinical assessment did not reduce antibiotic exposure compared with procalcitonin-guided care among ED patients with community-acquired pneumonia. The strategies were similar in terms of duration of antibiotic use and clinical outcomes.

Evaluation of HEAR score to rule-out major adverse cardiac events without troponin test in patients presenting to the emergency department with chest pain.

BACKGROUND AND IMPORTANCE: Current guidelines for patients presenting to the emergency department with chest pain without ST-segment elevation myocardial infarction (non-STEMI) on electrocardiogram are based on troponin measurement. The HEART score is reportedly a reliable work-up strategy that combines clinical evaluation with troponin value. A clinical rule that could select very low-risk patients without the need for a blood test (HEAR score, being the HEART score without the troponin item) would be of great interest. OBJECTIVES: To prospectively assess the safety of a HEAR score <2 to rule-out non-STEMI without troponin measurement. Secondary objective was to assess the safety of a sequential strategy that combines HEAR score and HEART (defined as two-step HEART strategy). DESIGN, SETTINGS AND PARTICIPANTS: Prospective observational study in six emergency departments. Patients with nontraumatic chest pain and no alternative diagnosis were included and followed up for 45 day. Patients were considered at low-risk if the HEAR score was <2 or, for the two-step HEART strategy, if the HEART score was <4. OUTCOMES MEASURE AND ANALYSIS: The primary endpoint was the 45-day rate of major adverse cardiac events (MACE) in patients with a HEAR score <2. A HEAR score based strategy was consider safe if the rate of the primary endpoint was below 1%, with an upper margin of the 95% confidence interval (CI) below 3%. RESULTS: Among 1452 patients included, 1402 were analyzed and 97 (7%) had a MACE during the follow-up period. The HEAR score was <2 in 279 (20%) patients and one presented a MACE [0.4% (95% CI: 0.01-1.98)]. The two-step HEART strategy classified low-risk an additional 476 patients (34%) and one of these 476 patients had a MACE [0.3% (95% CI: 0.03-0.95)]. The two-step HEART strategy would have theoretically avoided 360 troponin measurements (19%). CONCLUSIONS: In our prospective multicenter study, a HEAR based work-up strategy was safe, with a very low risk of MACE at 45 day. We also report that a two-step HEART-based strategy may safely allow significant reduction of troponin measurements in patients presenting to the emergency department with chest pain.

Outpatient Management of Patients With COVID-19: Multicenter Prospective Validation of the Hospitalization or Outpatient Management of Patients With SARS-CoV-2 Infection Rule to Discharge Patients Safely.

BACKGROUND: The Hospitalization or Outpatient Management of Patients With SARS-CoV-2 Infection (HOME-CoV) rule is a checklist of eligibility criteria for home treatment of patients with COVID-19, defined using a Delphi method. RESEARCH QUESTION: Is the HOME-CoV rule reliable for identifying a subgroup of COVID-19 patients with a low risk of adverse outcomes who can be treated at home safely? STUDY DESIGN AND METHODS: We aimed to validate the HOME-CoV rule in a prospective, multicenter study before and after trial of patients with probable or confirmed COVID-19 who sought treatment at the ED of 34 hospitals. The main outcome was an adverse evolution, that is, invasive ventilation or death, occurring within the 7 days after patient admission. The performance of the rule was assessed by the false-negative rate. The impact of the rule implementation was assessed by the absolute differences in the rate of patients who required invasive ventilation or who died and in the rate of patients treated at home, between an observational and an interventional period after implementation of the HOME-CoV rule, with propensity score adjustment. RESULTS: Among 3,000 prospectively enrolled patients, 1,239 (41.3%) demonstrated a negative HOME-CoV rule finding. The false-negative rate of the HOME-CoV rule was 4 in 1,239 (0.32%; 95% CI, 0.13%-0.84%), and its area under the receiver operating characteristic curve was 80.9 (95% CI, 76.5-85.2). On the adjusted populations, 25 of 1,274 patients (1.95%) experienced an adverse evolution during the observational period vs 12 of 1,274 patients (0.95%) during the interventional period: -1.00 (95% CI, -1.86 to -0.15). During the observational period, 858 patients (67.35%) were treated at home vs 871 patients (68.37%) during the interventional period: -1.02 (95% CI, -4.46 to 2.26). INTERPRETATION: A large proportion of patients treated in the ED with probable or confirmed COVID-19 have a negative HOME-CoV rule finding and can be treated safely at home with a very low risk of complications. TRIAL REGISTRY: ClinicalTrials.gov; No.: NCT04338841; URL: www.clinicaltrials.gov.