Comparison of the unstructured clinician gestalt, the wells score, and the revised Geneva score to estimate pretest probability for suspected pulmonary embolism.

STUDY OBJECTIVE: The assessment of clinical probability (as low, moderate, or high) with clinical decision rules has become a cornerstone of diagnostic strategy for patients with suspected pulmonary embolism, but little is known about the use of physician gestalt assessment of clinical probability. We evaluate the performance of gestalt assessment for diagnosing pulmonary embolism. METHODS: We conducted a retrospective analysis of a prospective observational cohort of consecutive suspected pulmonary embolism patients in emergency departments. Accuracy of gestalt assessment was compared with the Wells score and the revised Geneva score by the area under the curve (AUC) of receiver operating characteristic curves. Agreement between the 3 methods was determined by κ test. RESULTS: The study population was 1,038 patients, with a pulmonary embolism prevalence of 31.3%. AUC differed significantly between the 3 methods and was 0.81 (95% confidence interval [CI] 0.78 to 0.84) for gestalt assessment, 0.71 (95% CI 0.68 to 0.75) for Wells, and 0.66 (95% CI 0.63 to 0.70) for the revised Geneva score. The proportion of patients categorized as having low clinical probability was statistically higher with gestalt than with revised Geneva score (43% versus 26%; 95% CI for the difference of 17%=13% to 21%). Proportion of patients categorized as having high clinical probability was higher with gestalt than with Wells (24% versus 7%; 95% CI for the difference of 17%=14% to 20%) or revised Geneva score (24% versus 10%; 95% CI for the difference of 15%=13% to 21%). Pulmonary embolism prevalence was significantly lower with gestalt versus clinical decision rules in low clinical probability (7.6% for gestalt versus 13.0% for revised Geneva score and 12.6% for Wells score) and non-high clinical probability groups (18.3% for gestalt versus 29.3% for Wells and 27.4% for revised Geneva score) and was significantly higher with gestalt versus Wells score in high clinical probability groups (72.1% versus 58.1%). Agreement between the 3 methods was poor, with all κ values below 0.3. CONCLUSION: In our retrospective study, gestalt assessment seems to perform better than clinical decision rules because of better selection of patients with low and high clinical probability.

Prevalence and characterization of forgoing care: comparison of two prospective multicentre cohorts between pre-COVID-19 era and a lockdown period.

BACKGROUND: Little is known about patients who forego healthcare, although it is an important provider of unfavorable health-related outcomes. Forgoing healthcare characterizes situations in which people do not initiate or interrupt a care process, even though they perceive the need for it, whether or not this need is medically proven. The aims of this study were to assess the prevalence and the determinants of patients who forego healthcare. The second aim was to compare the characteristics of patients who gave up healthcare during the French lockdown due to COVID-19. METHODS: We conducted two multicenter cross-sectional studies in 2017 and 2020 carried out in French patients presenting to the emergency departments. Patients who gave their consent to participate were interviewed with a standardized questionnaire. It consisted of two parts: epidemiological characteristics and health care refusal. A third part concerning the renunciation of care during the COVID-19 period was added to the second study period. RESULTS: A total of 1878 patients had completed the questionnaire during the interview with the physicians, 900 during the first period in 2017 (47.9%) and 978 (52.1%) during the second period. A total of 401/1878 patients reported not seeking care in the last 12 months (21.4% [95%CI: 19.5-23.3%]). In 2020, patients forewent care more during the confinement period than outside with different characteristics of the foregoing care populations. CONCLUSION: Forgoing care is common in a universal health care system such as France's and increased during the pandemic. Key public health messages targeted at the reasons for not seeking care must now be disseminated in order to combat this.

Risk of symptomatic venous thromboembolism in mild and moderate COVID-19: A comparison of two prospective European cohorts.

BACKGROUND: Severely ill patients with SARS-CoV-2 have an increased risk of venous thromboembolism (VTE) i.e., deep vein thrombosis and pulmonary embolism. However, the VTE risk in patients with mild and moderate COVID-19, hospitalized or managed at home, remain uncertain. The aims of this study were to assess the rate and the risk factors symptomatic VTE, in patients with mild and moderate COVID-19 and to compare them to a cohort of similar patients without COVID-19. METHODS: Patients presenting to the emergency department (ED) of participating centers for confirmed or probable mild or moderate COVID-19 and not having acute VTE were included. This COVID-19 cohort was retrospectively compared to a prospective cohort of similar ED patients using propensity score matching. The main outcome was the rate of symptomatic VTE within the 28 days after ED presentation. RESULTS: A total of 2292 patients were included in the COVID-19 cohort. The 28-day incidence of symptomatic VTE was 1.3% (n = 29/2292, 95%CI: 0.9 to 1.8), 2.3% (n = 20/866, 95%CI: 1.5 to 3.5) in moderate COVID-19 patients and 0.6% (n = 9/1426; 95%CI: 0.3 to 1.2) in mild COVID-19 patients managed as outpatients. An age over 65 years and hospitalization were independent risk factors of VTE. After adjustment, patients in the COVID-19 cohort had an absolute increase in over symptomatic VTE risk of +1.69% (95%CI, 0.88 to 2.51) versus patients in the comparison cohort (n = 1539). CONCLUSIONS: Patients with moderate COVID-19 presenting to the ED had a high risk of subsequent VTE. TRIAL REGISTRATION: Ethics committee of the CHU of Angers (N°2020/87).

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.

Safety of the Combination of PERC and YEARS Rules in Patients With Low Clinical Probability of Pulmonary Embolism: A Retrospective Analysis of Two Large European Cohorts.

BACKGROUND: This study aimed to determine the failure rate of a combination of the PERC and the YEARS rules for the diagnosis of pulmonary embolism (PE) in the emergency department (ED). METHODS: We performed a retrospective analysis of two European cohorts of emergency patients with low gestalt clinical probability of PE (PROPER and PERCEPIC). All patients we included were managed using a conventional strategy (D-dimer test, followed, if positive, by computed tomographic pulmonary angiogram (CTPA). We tested a diagnostic strategy that combined PERC and YEARS to rule out PE. The primary endpoint was a thromboembolic event diagnosed in the ED or at 3-months follow-up. Secondary endpoints included a thromboembolic event at baseline in the ED and a CTPA in the ED. Ninety-five percent confidence intervals (CIs) of proportions were calculated with the use of Wilson's continuity correction. RESULTS: We analyzed 1,951 patients (mean ± SD age = 47 ± 18 years, 56% women) with an overall proportion of patients with PE of 3.5%. Both PERC and YEARS strategies were associated with 11 missed PE in the ED: failure rate 0.57 (95% CI = 0.32-1.02). At 3-month follow-up, the overall failure rate was 0.83% (95% CI = 0.51-1.35). Among the 503 patients who underwent a CTPA (26%), the use of the PERC-YEARS combination would have ruled out PE without CTPA in 249 patients (50% [95%CI = 45%-54%], absolute reduction 13% (95% CI = 11%-14%]). CONCLUSION: The combination of PERC then YEARS was associated with a low risk of PE diagnostic failure and would have resulted in a relative reduction of almost half of CTPA.

Pulmonary embolism rule-out criteria (PERC) rule in European patients with low implicit clinical probability (PERCEPIC): a multicentre, prospective, observational study.

BACKGROUND: The ability of the pulmonary embolism rule-out criteria (PERC) to exclude pulmonary embolism without further testing remains debated outside the USA, especially in the population with suspected pulmonary embolism who have a high prevalence of the condition. Our main objective was to prospectively assess the predictive value of negative PERC to rule out pulmonary embolism among European patients with low implicit clinical probability. METHODS: We did a multicentre, prospective, observational study in 12 emergency departments in France and Belgium. We included consecutive patients aged 18 years or older with suspected pulmonary embolism. Patients were excluded if they had already been hospitalised for more than 2 days, had curative anticoagulant therapy in progress for more than 48 h, or had a diagnosis of thromboembolic disease documented before admission to emergency department. Physicians completed a standardised case report form comprising implicit clinical probability assessment (low, moderate, or high) and a list of risk factors including criteria of the PERC rule. They were asked to follow international recommendations for diagnostic strategy, masked to PERC assessment. The primary endpoint was the proportion of patients with low implicit clinical probability and negative PERC who had venous thromboembolic events, diagnosed during initial diagnostic work-up or during 3-month follow-up, as externally adjudicated by an independent committee masked to the PERC and clinical probability assessment. The upper limit of the 95% CI around the 3-month thromboembolic risk was set at 3%. We did all analyses by intention to treat, including all patients with complete follow-up. This trial is registered with ClinicalTrials.gov, number NCT02360540. FINDINGS: Between May 1, 2015, and April 30, 2016, 1773 consecutive patients with suspected pulmonary embolism were prospectively assessed for inclusion, of whom 1757 were included. 1052 (60%) patients were classed as having low clinical probability, 49 (4·7%, 95% CI 3·5-6·1) of whom had a venous thromboembolic event. In patients with a low implicit clinical probability, 337 (32%) patients had negative PERC, of whom four (1·2%; 95% CI 0·4-2·9) went on to have a pulmonary embolism. INTERPRETATION: In European patients with low implicit clinical probability, PERC can exclude pulmonary embolism with a low percentage of false-negative results. The results of our prospective, observational study allow and justify an implementation study of the PERC rule in Europe. FUNDING: French Ministry of Health.