Ruling Out Pulmonary Embolism in Primary Care: Comparison of the Diagnostic Performance of "Gestalt" and the Wells Rule

Background:The Rotterdam Early Arthritis Cohort (REACH) rule [1] and Clinical Arthritis RulE (CARE) [2] are both evidence-based and easy-to-use methods developed to identify the presence of inflammatory arthritis (IA) in patients suspected by their general practitioner (GP). However, the clinical utility of both models in daily clinical practice in an independent primary care setting has not yet been established. While developed for recognizing IA, we believe that it is also important that the broader spectrum of inflammatory rheumatic diseases (IRDs) is correctly classified from primary care, to facilitate appropriate referral towards outpatient rheumatology clinics.Objectives:The primary objective was to determine the diagnostic performance and clinical utility of the REACH and CARE referral rules in identifying IA in an independent population of unselected suspected patients from primary care. Secondly we will assess the diagnostic performance and clinical utility of both models in identifying IRDs.Methods:This prospective observational diagnostic study consisted of adults newly suspected by their GP for the need of referral to the rheumatology outpatient clinic of the Maasstad Hospital in Rotterdam. Primary outcome was IA, consisting of rheumatoid arthritis, axial spondylitis and psoriatic arthritis. Secondary outcome was IRD, defined as IA plus arthritis in systemic disorders such as systemic lupus erythematosus, systemic sclerosis and morbus sjögren. Rheumatologist diagnosis was used as gold standard. To evaluate the clinical performance of the REACH and CARE referral rules in this population, diagnostic accuracy measures were investigated using the Youden index (J) [3]. Moreover, a net benefit approach [4] was used to determine clinical utility of both rules when compared to usual care.Results:This study consisted of 250 patients (22.8% male) with a mean age of 50.8 years (SD 13.9 years). In total 42 (17%) patients were diagnosed with IA and 55 (22%) with an IRD. Figure 1 presents the diagnostic performance in IA (Figure 1A) and in IRD (Figure 1B). For the primary outcome, the REACH model shows an AUC of 0.72 (95% CI 0.64-0.80) and the optimal cut-off point is indicated (J). The CARE model shows an AUC of 0.82 (95% CI 0.75-0.88) and at J there is a somewhat higher sensitivity and specificity. When taking the broader spectrum of IRDs as outcome, the AUC was 0.66 (95% CI 0.58-0.74) for the REACH and 0.76 (95% CI 0.69-0.83) for the CARE model. The net benefit analysis with either IA or IRD as outcome showed that the CARE was of the highest clinical value when compared to usual care.Conclusion:Both the REACH and CARE model showed a good diagnostic performance for detecting IA in an independent population of unselected suspected patients from primary care. Although not specifically developed to recognize the entire spectrum of IRDs, the CARE shows a good performance in doing so. When evaluating clinical utility, we see that both rules have a net benefit in recognizing IA as well as IRDs compared to usual care, however the CARE shows superiority over the REACH. By using the CARE, over half of all suspected patients can be withheld from expensive outpatient rheumatology care, implied by the high specificity of 70%. These results support the idea that incorporating these easy-to-use methods into primary care could lead to providing patients the right care at the right place and improving value based health care.References:[1]ten Brinck RM, van Dijk BT, van Steenbergen HW, le Cessie S, Numans ME. Development and validation of a clinical rule for recognition of early inflammatory arthritis. BMJ Open; 2018: 8[2]Alves, C. Improving early referral of inflammatory arthritis. In Early detection of patients at risk for rheumatoid arthritis – a challenge for primary and secondary care; 2015: 27-38 Ridderkerk, the Netherlands.[3]Fluss R, Faraggi D, Reiser B. Estimation of the Youden Index and its associated cutoff point. Biom J; 2005: 47(4): 458-472[4]Vickers AJ, Elkin EB. Decision curve analysis: a novel method for evaluating prediction models. Med Decis Making; 2006: 26(6): 565-574Disclosure of Interests:None declared

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The Role of Clinical “Experience” in Diagnostic Performance

Medical Decision Making ◽

10.1177/0272989x9801800205 ◽

1998 ◽

Vol 18 (2) ◽

pp. 163-167 ◽

Cited By ~ 12

Author(s):

Angelo Fasoli ◽

Silvia Lucchelli ◽

Renato Fasoli

Keyword(s):

Pulmonary Embolism ◽

Multiple Regression ◽

Clinical Experience ◽

Diagnostic Performance ◽

Roc Curves ◽

Clinical Findings ◽

X Ray ◽

Biochemical Studies ◽

Recorded Data

Twenty-one physicians examined records of 43 patients who had attended the hospital because of chest pain. Of these patients, 20 had had coronary heart disease (CHD), 15 had had nonspecific pain, and eight had had pulmonary embolism. The physicians indicated the probability of CHD in each case on the basis of 18 clinical findings, not including ECG, x-ray, or biochemical studies. The trial was repeated five years later, using the same records, by 16 of the same physicians. Diagnostic accuracy was evaluated by ROC curves, and the weight ascribed to each cue was inferred by multiple regression with estimated probability of CHD as the dependent variable. No significant change of areas under the ROC curves with increasing length of clinical experience was observed. Multiple regression was significant in 30 of 37 analyses. The distributions of most physicians' estimates of probabilities had similar shapes five years apart. It is concluded that “experience” does not have a clear role in diagnostic performance based on recorded data and that personal calibration and preferences in estimating probabilities often persist for years.

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PO-07 - Excluding pulmonary embolism in cancer patients using the Wells rule and age-adjusted D-dimer testing: an individual patient data meta-analysis

Thrombosis Research ◽

10.1016/s0049-3848(16)30140-2 ◽

2016 ◽

Vol 140 ◽

pp. S179 ◽

Cited By ~ 3

Author(s):

N. van Es ◽

T. van der Hulle ◽

J. van Es ◽

P.L. den Exter ◽

R.A. Douma ◽

...

Keyword(s):

Pulmonary Embolism ◽

Cancer Patients ◽

Individual Patient Data ◽

Meta Analysis ◽

Patient Data ◽

Wells Rule ◽

D Dimer

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Validity of four clinical prediction scores for pulmonary embolism in a sub-Saharan African setting: a protocol for a Cameroonian multicentre cross-sectional study

BMJ Open ◽

10.1136/bmjopen-2019-031322 ◽

2019 ◽

Vol 9 (10) ◽

pp. e031322

Author(s):

Agnès Esiéné ◽

Paul Owono Etoundi ◽

Joel Noutakdie Tochie ◽

Junette Arlette Mbengono Metogo ◽

Jacqueline Ze Minkande

Keyword(s):

Pulmonary Embolism ◽

Emergency Departments ◽

Diagnostic Performance ◽

Cross Sectional Study ◽

Sub Saharan Africa ◽

Receiver Operating Curve ◽

Clinical Prediction ◽

Sectional Study ◽

Cross Sectional ◽

Sub Saharan

IntroductionPulmonary embolism poses one of the most challenging diagnoses in medicine. Resolving these diagnostic difficulties is more crucial in emergency departments where fast and accurate decisions are needed for a life-saving purpose. Here, clinical pretest evaluation is an important step in the diagnostic algorithm of pulmonary embolism. Although clinical probability scores are widely used in emergency departments of sub-Saharan Africa, no study has cited their diagnostic performance in this resource-constrained environment. This study will seek to assess the performance of four routinely used clinical prediction models in Cameroonians presenting with suspicion of pulmonary embolism at the emergency department.Methods and analysisIt will be a cross-sectional study comparing the sensitivity, specificity, positive and negative predictive values and accuracy of the Wells, Simplified Wells, Revised Geneva and the Simplified Revised Geneva Scores to CT pulmonary angiography as gold standard in all consecutive consenting patients aged above 15 years admitted for clinical suspicion of pulmonary embolism to the emergency departments of seven major referral hospitals of Cameroon between 1 July 2019 and 31 December 2020. The area under the receiver operating curve, calibration plots, Hosmer and Lemeshow statistics, observed/expected event rates, net benefit and decision curve will be measured of each the clinical prediction test to ascertain the clinical score with the best diagnostic performance.Ethics and disseminationClearance has been obtained from the Institutional Review Board of the Faculty of medicine and biomedical sciences of the University of Yaounde I, Cameroon and the directorates of all participating hospitals to conduct this study. Also, informed consent will be sought from each patient or their legal next of kin and parents for minors, before enrolment into this study. The final study will be published in a peer-review journal and the findings presented to health authorities and healthcare providers.

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Validation and impact of a simplified clinical decision rule for diagnosing pulmonary embolism in primary care: design of the PECAN prospective diagnostic cohort management study

BMJ Open ◽

10.1136/bmjopen-2019-031639 ◽

2019 ◽

Vol 9 (10) ◽

pp. e031639 ◽

Cited By ~ 4

Author(s):

Rosanne van Maanen ◽

Frans H Rutten ◽

Frederikus A Klok ◽

Menno V Huisman ◽

Jeanet W Blom ◽

...

Keyword(s):

Primary Care ◽

Pulmonary Embolism ◽

False Negative ◽

Diagnostic Algorithm ◽

Clinical Decision ◽

Final Diagnosis ◽

Hospital Environment ◽

Diagnostic Study ◽

The Impact ◽

D Dimer

IntroductionCombined with patient history and physical examination, a negative D-dimer can safely rule-out pulmonary embolism (PE). However, the D-dimer test is frequently false positive, leading to many (with hindsight) ‘unneeded’ referrals to secondary care. Recently, the novel YEARS algorithm, incorporating flexible D-dimer thresholds depending on pretest risk, was developed and validated, showing its ability to safely exclude PE in the hospital environment. Importantly, this was accompanied with 14% fewer computed tomographic pulmonary angiography than the standard, fixed D-dimer threshold. Although promising, in primary care this algorithm has not been validated yet.Methods and analysisThe PECAN (DiagnosingPulmonaryEmbolism in the context ofCommonAlternative diagNoses in primary care) study is a prospective diagnostic study performed in Dutch primary care. Included patients with suspected acute PE will be managed by their general practitioner according to the YEARS diagnostic algorithm and followed up in primary care for 3 months to establish the final diagnosis. To study the impact of the use of the YEARS algorithm, the primary endpoints are the safety and efficiency of the YEARS algorithm in primary care. Safety is defined as the proportion of false-negative test results in those not referred. Efficiency denotes the proportion of patients classified in this non-referred category. Additionally, we quantify whether C reactive protein measurement has added diagnostic value to the YEARS algorithm, using multivariable logistic and polytomous regression modelling. Furthermore, we will investigate which factors contribute to the subjective YEARS item ‘PE most likely diagnosis’.Ethics and disseminationThe study protocol was approved by the Medical Ethical Committee Utrecht, the Netherlands. Patients eligible for inclusion will be asked for their consent. Results will be disseminated by publication in peer-reviewed journals and presented at (inter)national meetings and congresses.Trial registrationNTR 7431.

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Use of a New Monoclonal Antibody-Based Enzyme Immunoassay for Soluble Fibrin to Exclude Pulmonary Embolism

Thrombosis and Haemostasis ◽

10.1055/s-0037-1614047 ◽

2000 ◽

Vol 84 (09) ◽

pp. 474-477 ◽

Cited By ~ 1

Author(s):

Bernd-Jan Sanson ◽

Wouter de Monyé ◽

Jeroen Lijmer ◽

Menno Huisman ◽

Harry Büller ◽

...

Keyword(s):

Monoclonal Antibody ◽

Pulmonary Embolism ◽

Diagnostic Accuracy ◽

Negative Predictive Value ◽

Predictive Value ◽

Diagnostic Performance ◽

Area Under The Curve ◽

Study Cohort ◽

Suspected Pulmonary Embolism ◽

Soluble Fibrin

SummaryWe prospectively evaluated the diagnostic performance of a new soluble fibrin assay in 303 consecutive patients with suspected pulmonary embolism and examined potentially useful cut-off levels at which this disease can be safely excluded. In addition, the diagnostic accuracy was calculated in the subgroups of in- and outpatients. The ROC curve of the assay in the total study cohort had an area under the curve of 0.69. The cut-off level associated with a sensitivity and negative predictive value of 100% was 20 ng/ml, but the specificity was only 4%. The cut-off level with a sensitivity of 90% was 30 ng/ml, which corresponded with a specificity and negative predictive value of 27% and 86%, respectively. The diagnostic performance was comparable in the subgroups of in- and outpatients. We conclude that the soluble fibrin assay has a low diagnostic accuracy and seems unsuitable as a screening test for the exclusion of pulmonary embolism.

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Safety and Clinical Utility of Four Clinical Decision Rules In the Diagnostic Management of Acute Pulmonary Embolism – the Prometheus Diagnosis Study

Blood ◽

10.1182/blood.v116.21.3186.3186 ◽

2010 ◽

Vol 116 (21) ◽

pp. 3186-3186

Author(s):

Inge CM Mos ◽

Renée A Douma ◽

Petra MG Erkens ◽

Tessa AC Nizet ◽

Marc F Durian ◽

...

Keyword(s):

Pulmonary Embolism ◽

Clinical Utility ◽

Acute Pulmonary Embolism ◽

Decision Rules ◽

Clinical Decision ◽

Clinical Decision Rules ◽

Wells Rule ◽

Revised Geneva Score ◽

Acute Pe ◽

D Dimer

Abstract Abstract 3186 Background Several clinical decision rules (CDRs) are available for the exclusion of acute pulmonary embolism (PE). This prospective multi-center study compared the safety and clinical utility of four CDRs (Wells rule, revised Geneva score, simplified Wells rule and simplified revised Geneva score) in excluding PE in combination with D-dimer testing. Methods Clinical probability of patients with suspected acute PE was assessed using a computerized based “black box”, which calculated all CDRs and indicated the next diagnostic step. A “PE unlikely” result according to all CDRs in combination with a normal D-dimer result excluded PE, while patients with “PE likely” according to at least one of the CDRs or an abnormal D-dimer result underwent CT-scanning. Patients in whom PE was excluded were followed for three months. Results 807 consecutive patients were included and PE prevalence was 23%. The number of patients categorized as “PE unlikely” ranged from 62% (simplified Wells rule) to 72% (Wells rule). Combined with a normal D-dimer level, the CDRs excluded PE in 22–24% of patients. The total failure rates of the CDR-D-dimer combinations were similar (1 failure, 0.5– 0.6%, upper 95% CI 2.9– 3.1%). Despite 30% of the patients had discordant CDR outcomes, PE was missed in none of the patients with discordant CDRs and a normal D-dimer result. Conclusions All four CDRs show similar safety and clinical utility for exclusion of acute PE in combination with a normal D-dimer level. With this prospective validation, the more straightforward simplified scores are ready for use in clinical practice. Disclosures: No relevant conflicts of interest to declare.

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