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Multicenter Study
. 2019 Oct 10;9(10):e031639.
doi: 10.1136/bmjopen-2019-031639.

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

Rosanne van Maanen  1 , Frans H Rutten  2 , Frederikus A Klok  3 , Menno V Huisman  3 , Jeanet W Blom  4 , Karel G M Moons  2 , Geert-Jan Geersing  2
Affiliations
Multicenter Study

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

Rosanne van Maanen et al. BMJ Open. .

Abstract

Introduction: Combined 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 analysis: The PECAN (Diagnosing Pulmonary Embolism in the context of Common Alternative 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 dissemination: The 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 registration: NTR 7431.

Keywords: primary care; thromboembolism; vascular medicine.

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Conflict of interest statement

Competing interests: FHR and G-JG have received educational institutional grants from Boehringer Ingelheim, Daiichi Sankyo, Bayer Healthcare and Pfizer-BMS and an unrestricted institutional grant from Boehringer Ingelheim. In addition, G-JG is supported by a research grant on diagnosing pulmonary embolism from the Netherlands Organization for Scientific Research (non-profit, ZonMw 016.166.030). FAK has received research grants from Bayer, BMS/Pfizer, Boehringer Ingelheim, Daiichi Sankyo, MSD, Actelion, Dutch Heart foundation and Dutch Thrombosis association. MVH has received research grants and consultancy fees from Boehringer Ingelheim, Bayer Healthcare, Pfizer-BMS and Aspen.

Figures

Figure 1
Figure 1
Flowchart study procedures. CRF, case report form; CRP, C reactive protein; DVT, deep venous thrombosis.
See this image and copyright information in PMC

References

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