Feature

Playing by the Rules: Using Decision Rules Wisely Part 2, Nontraumatic Conditions

Emergency Medicine. 2018 December;50(12):1-14

References

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35. Poldervaart JM, Langedijk M, Backus BE, et al. Comparison of the GRACE, HEART and TIMI score to predict major adverse cardiac events in chest pain patients at the emergency department. Int J Cardiol. 2017;227:656-661.

36. Nieuwets A, Poldervaart JM, Reitsma JB, et al. Medical consumption compared for TIMI and HEART score in chest pain patients at the emergency department: a retrospective cost analysis. BMJ Open. 2016;6:e010694.

37. Wells PS, Ginsberg JS, Anderson DR, et al. Use of a clinical model for safe management of patients with suspected pulmonary embolism. Ann Intern Med. 1998;129:997-1005.

38. Wells PS, Anderson DR, Rodger M, et al. Derivation of a simple clinical model to categorize patients’ probability of pulmonary embolism: increasing the model’s utility with the SimpliRED D-dimer. Thromb Haemost. 2000;83(3):416-420.

39. Wells PS, Anderson DR, Rodger M, et al. Excluding pulmonary embolism at the bedside without diagnostic imaging: management of patients with suspected pulmonary embolism presenting to the emergency department by using a simple clinical model and D-dimer. Ann Intern Med. 2001;135:98-107.

40. Wolf SJ, McCubbin TR, Feldhaus KM, Faragher JP, Adcock DM. Prospective validation of Wells’ criteria in the evaluation of patients with suspected pulmonary embolism. Ann Emerg Med. 2004;44:503-510.

41. Chagnon I, Bounameaux H, Aujesky D, et al. Comparison of two clinical prediction rules and implicit assessment among patients with suspected pulmonary embolism. Am J Med. 2002;113:269-275.

42. Christopher Study Investigators. Effectiveness of managing suspected pulmonary embolism using an algorithm combining clinical probability, D-dimer testing, and computed tomography. JAMA. 2006;295:172-179.

43. Kline JA, Mitchell AM, Kabrhel C, Richman PB, Courtney DM. Clinical criteria to prevent unnecessary diagnostic testing in emergency department patients with suspected pulmonary embolism. J Thromb Haemost. 2004;2:1247-1255.

44. Kline JA, Courtney DM, Kabrhel C, et al. Propsective multicenter evaluation of the pulmonary embolism rule-out criteria. J Thromb Haemost. 2008;6:772-780.

45. Penaloza A, Soulie C, Moumneh T, et al. Pulmonary embolism rule-out criteria (PERC) rule in European patients with low implicit clinical probability (PERCEPIC): a multicenter, prospective, observational study. Lancet Haematol. 2017;4:e615-e621.

46. Freund Y, Cachanado M, Aubry A, et al. Effect of the Pulmonary Embolism Rule-Out Criteria on subsequent thromboembolic events among low-risk emergency department patients. The PROPER randomized clinical trial. JAMA. 2018;319(6):559-566.

47. Hugli O, Righini M, Le Gal G, et al. The pulmonary embolism rule-out criteria (PERC) rule does not safely exclude pulmonary embolism. J Thromb Haemost. 2011;9:300-4.

48. Theunissen JMG, Scholing C, van Hasselt WE, van der Maten J, ter Avest E. A retrospective analysis of the combined use of PERC rule and Wells score to exclude pulmonary embolism in the Emergency Department. Emerg Med J. 2016;33:696-701.

49. Singh B, Parsaik AK, Aharwal D, Surana A, Mascarenhas SS, Chandra S. Diagnostic accuracy of Pulmonary Embolism Rule-Out Criteria: a systematic review and meta-analysis. Ann Emerg Med. 2012;59(6):517-520.

50. Shapiro NI, Wolfe RE, Moore RB, Smith E, Burdick E, Bates DW. Mortality in Emergency Department Sepsis (MEDS) score: a prospectively derived and validated clinical prediction rule. Crit Care Med. 2003;31(3):670-675.

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The investigators specifically linked the use of their instrument to the D-dimer assay, using their score to determine pretest probability and seeking to exclude the diagnosis in patients with low pretest probability and negative D-dimer result.^37,38 They reported a three-tiered classification, with low risk at a score less than 2, moderate risk at scores from 2-6, and high risk at scores greater than 6. The risk for PE with a low risk score coupled with a negative D-dimer result were 1.5% and 2.7% in the derivation and validation cohorts. Using a two-tiered classification of PE unlikely at scores less than or equal to 4 and PE likely at scores 5 or greater, a PE unlikely score and a negative D-dimer had a 2.2% and 1.7% risk in the derivation and validation cohorts.

A subsequent study by Wells et al on 930 ED patients using the score plus D-dimer found a negative predictive value of 99.5% for a low risk score and a negative D-dimer.³⁹ This allowed for reduced imaging in 53% of patients.³⁹ Another external validation study found acceptable interrater agreement between physicians for the Wells’ score at kappa 0.62 for the three-tiered system and 0.7 for the two-tiered system.⁴⁰ The Wells’ Criteria has been compared against the Geneva score with receiver operating characteristic curve analysis showing no difference between the two rules.⁴¹ In a large cohort of 3306 patients being evaluated for PE using the Wells’ score and D-dimer, for the 1028 patients with PE unlikely and a negative D-dimer, there was a 3-month incidence of venous thromboembolism (VTE) of 0.5%—none of which were fatal events.⁴²

Comment: The Wells’ Criteria for pulmonary embolism combined with D-dimer is now the preferred approach for many EPs seeking to risk-stratify their patients for PE. Advances in age-adjusted cutoffs for D-dimer provide additional support for this powerful tool.

Pulmonary Embolism Rule-Out Criteria (PERC)

Given the low specificity of the D-dimer assay for VTE, researchers post–Wells’ Criteria have sought to further reduce unnecessary testing by reassessing the D-dimer’s role in the diagnostic pathway. The PERC rule was designed to reduce D-dimer use—and downstream CT scan testing—in low-risk patients. The investigators derived the rule from a population of patients for whom the pretest probability of PE was less than 15%, seeking a risk for PE less than 2% if the rule was satisfied. Using logistic regression in 3148 ED patients, 8 clinical criteria were obtained:

Age < 50 years Pulse <100
Pulse oximetry >94%
No unilateral leg swelling
No hemoptysis
No recent surgery
No prior PE/DVT
No hormone use

The variables were tested in 1427 low-risk and 382 very-low-risk patients (defined as being evaluated for dyspnea, but not part of the derivation or low-risk validation groups). In the low-risk group, the sensitivity, specificity, and false-negative rate was 96%, 27%, and 1.4% respectively. In the very-low-risk group, the sensitivity, specificity, and false-negative rate was 100%, 15%, and 0% respectively.⁴³ The rule was further validated in a prospective multicenter study of 8138 patients; among patients with pretest probability less than 15% who were PERC negative, 1% had PE/DVT within 45 days.⁴⁴ The large PERCEPIC trial on 1757 patients found low pretest probability patients who were PERC negative had a false-negative rate of 1.2% and estimated that the use of PERC could decrease the median length of stay in the ED by at least 2 hours.⁴⁵ The PROPER study, a non-inferiority, crossover cluster-randomized trial in 14 EDs across France, found that use of the PERC rule was not inferior to conventional care and that it was associated with reduced ED length of stay and CT use.^45,46