Fuller, G.W.

Goodacre, S.

Horspool, K.

Hunt, B.J.

Lecky, F.E.

Nelson-Piercy, C.

Thomas, S.

Gordon W. Fuller

Catherine Nelson-Piercy

Beverley J. Hunt

Fiona E. Lecky

Steve Thomas

Kimberley Horspool

Steve Goodacre

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European Journal of Emergency Medicine

Consensus-derived clinical decision rules to guide advanced imaging decisions for pulmonary embolism in pregnancy and the postpartum period

White Rose Research Online

This is a repository copy of Consensus-derived clinical decision rules to guide advanced imaging decisions for pulmonary embolism in pregnancy and the postpartum period.White Rose Research Online URL for this paper:http://eprints.whiterose.ac.uk/119441/Version: Accepted VersionArticle:Fuller, G.W., Nelson-Piercy, C., Hunt, B.J. et al. (4 more authors) (2017) Consensus-derived clinical decision rules to guide advanced imaging decisions for pulmonary embolism in pregnancy and the postpartum period. European Journal of Emergency Medicine. ISSN 0969-9546 https://doi.org/10.1097/MEJ.0000000000000477eprints@whiterose.ac.ukhttps://eprints.whiterose.ac.uk/Reuse Items deposited in White Rose Research Online are protected by copyright, with all rights reserved unless indicated otherwise. They may be downloaded and/or printed for private study, or other acts as permitted by national copyright laws. 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Consensus Derived Clinical Decision Rules to Guide Advanced Imaging Decisions for Pulmonary Embolism in Pregnancy and the Post-partum Period Fuller GW1, Nelson-Piercy C2, Hunt B3, Lecky FE1, Thomas S4, Horspool K1, Goodacre S1 1Centre for Urgent and Emergency Care Research, School of Health and Related Research (ScHARR), University of Sheffield, Sheffield, UK. 2Women's Health Academic Centre, Guy's & St Thomas's NHS Foundation Trust, London, UK. 3Departments of Haematology and Rheumatology, Guy's & St Thomas's NHS Foundation Trust, London, UK. 4 Department of Radiology, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, UK Corresponding author1:  Dr Gordon Ward Fuller  Work address:  Centre for Urgent and Emergency Care Research, School of Health and Related Research, University of Sheffield, Regent Court, 30 Regent Street, Sheffield, S1 4DA, UK Telephone:    +44 (0) 7968 280641 / +44 (0) 1484 684640  E-mail:    g.fuller@sheffield.ac.uk Keywords: Pulmonary embolism, consensus, clinical decision rule Word Count: 433 words Synopsis: Three consensus derived expert clinical decision rules are presented to guide advanced imaging decisions for pulmonary embolism in pregnancy and the post-partum period Acknowledgements: This work was supported by National Institute of Health Research Grant HTA/13/21/01 Author contributions: GF designed and conducted the study.  CPN, BH, FL, ST and SG participated in the consensus meetings. All authors contributed to the writing of the paper. Competing interests: None. Synopsis: Expert consensus derived clinical decision rules (CDRs) are presented to guide imaging decisions for PE in pregnant and post-partum patients.               Pulmonary Embolism (PE) is a leading cause of death during pregnancy and the postpartum period.[1] Existing clinical decision rules (CDRs) to guide imaging decisions in PE include d-dimer testing, which has been shown to be unreliable in pregnancy.[2] Current guidelines consequently recommend that all pregnant or postpartum women with suspected PE should receive advanced diagnostic imaging.[3] However this non-selective approach results in very low rates of detected PE, risks radiation exposure and reaction to contrast media, is inconvenient for patients, and incurs costs for the health services.[2] The Diagnosis of Pulmonary Embolism in Pregnancy (DIPEP) study is a prospective cohort study including pregnant and postpartum women with diagnosed and suspected PE in the UK.[4] The aim of the current study was to develop expert CDRs to guide imaging decisions in PE for validation in the DIPEP dataset. Three expert clinical decision rules were developed, each with a contrasting focus: (1) balancing sensitivity and specificity (primary CDR) (2) optimising sensitivity and (3) optimising specificity. To reduce biases arising from the subjectivity of expert views, and maximise content and face validity a two stage consensus process, guided by best practice guidelines, was conducted.[5-7] Ethical approval was given by a University of Sheffield ethics committee. All participants provided written informed consent. In the first stage, a web based Delphi survey was conducted to identify candidate clinical predictors of PE. Purposive sampling was used to recruit a heterogeneous group of 20 experts. The open first round of the classical Delphi approach was replaced with a systematic literature review to identify possible PE predictors.[2] Participants were then asked to rate the predictive value of each variable on a 1 to 5 Likert scale and justify their opinion. In subsequent Delphi iterations, participants were provided with quantitative and qualitative results of the previous round, and a summary of their previous opinions.   In the second stage, the Nominal Group Technique (NGT) was used to formulate the content and scope of the three expert clinical decision rules. A series of face-to-face meetings, including rating rounds and structured group discussions, were conducted with a consensus panel consisting of DIPEP co-investigators, facilitated by an independent researcher experienced in the NGT. Moderately or strongly predictive variables identified during the Delphi survey were considered for inclusion.  The systematic literature review identified 45 potential variables for evaluation in the Delphi Survey. Three Delphi rounds were then conducted before stability of opinion was evident. Twenty four variables felt to be moderately or strongly predictive of PE were carried forward for consideration in the NGT meetings. Consensus was subsequently achieved for inclusion of 13 predictors in the final CDRs, with variable weightings and cut-point differing according to the focus of individual rules.  The scope of the CDRs, including inclusion and exclusion criteria, were also confirmed. The final CDRs are presented in Table 1. The performance of these rules now requires testing in appropriate populations, such as the DIPEP sample, prior to any introduction into clinical practice.              Table 1. Consensus Derived CDRs to Guide Advanced Imaging Decisions for Pulmonary Embolism in Pregnancy and the Post-partum Period The CDRs apply to pregnant or post-partum women presenting with symptoms that prompt consideration of pulmonary embolism (e.g. chest pain, shortness of breath). The rule does not apply if: critically ill and/or in need of resuscitation; a clear non-PE diagnosis is identified by clinical assessment, including ECG, chest x-ray and blood tests where appropriate (e.g. chest infection); or an uncommon, but powerful, VTE risk factor exists, e.g. thrombophilia, intravenous illicit drug misuse.    VARIABLE WEIGHTING§ INCLUDED VARIABLES:   Primary CDR Sensitive CDR Specific CDR Haemoptysis   3 1 4 Pleuritic chest pain   0 1 0 Previous VTE   3 1 4 Family history of VTE in first degree relative   0 1 0 Hospital admission, surgery or significant injury within 90 days [excluding Normal vaginal delivery or caesarean section]    2 1 1 Obstetric complication*   1 1 0 Active medical co-morbiditiesゆ   2 1 1 Post partum or third trimester   1 1 0 R;ｷゲWS BMI дンヰ   1 1 0 Clinical symptoms or signs of DVT**   3 1 4 Oxygen sats<94% on room air   3 1 3 Tachycardia >100bpm (in 1st or second trimester, or post-partum) / Tachycardia >110bpm (in third trimester)   2 1 2 Increased respiratory rate >24 b/m   2 1 2 CDR CUT POINT: 3 1 4 *Obstetric complications - Apply once if any of the following are present: Pre-eclampsia in current pregnancy. Assisted reproductive technology (antenatal only), multiple pregnancy, Caesarean section in labour, elective caesarean section, mid-cavity or rotational operative delivery, prolonged labour (> 24 hours), post-partum haemorrhage (> 1 litre or transfusion), preterm birth < 37+0 weeks in current pregnancy, stillbirth in current pregnancy, hyperemesis, Ovarian hyper-stimulation syndrome (first trimester only). ゆActive medical co-morbidities - Apply once if any of the following are present: cancer, heart failure; systemic lupus erythematosus, inflammatory polyarthropathy or inflammatory bowel disease; nephrotic syndrome; type I or type 2 diabetes mellitus with nephropathy; sickle cell disease. ** Patients presenting with symptoms and / or signs of DVT and suspicion of PE would initially undergo Duplex ultrasound of the leg(s). If positive patients would be treated for DVT and presumed PE. Negative leg imaging does not rule out DVT and these patients would still be considered higher risk for PE. §The scoring systems for the primary and specific rules allow the three rules to be presented alongside each other. In practice these scores can be simplified by removing zero scoring variables.  References 1. Brown HL, Hiett AK. Deep vein thrombosis and pulmonary embolism in pregnancy: diagnosis, complications, and management. Clinical obstetrics and gynecology. 2010 Jun;53(2):345-59.   2. Goodacre S, Nelson-Piercy C, Hunt B, Chan WS. When should we use diagnostic imaging to investigate for pulmonary embolism in pregnant and postpartum women? Emergency medicine journal : EMJ. 2015 Jan;32(1):78-82.   3. Royal College of Obstetricians and Gynaecologists (2015) Thrombosis and Embolism During Pregnancy and the Puerperium, the Acute Management of (Green-top 37b); Available at: https://www.rcog.org.uk/globalassets/documents/guidelines/gtg-37b.pdf [Accessed 2nd May 2017]  4. University of Sheffield (2017). Diagnosis of Pulmonary Embolism in Pregnancy (DIPEP) study; available at: https://www.sheffield.ac.uk/scharr/sections/dts/ctru/dipep [Accessed 2nd May 2017]  5. Hasson F, Keeney S, McKenna H. Research guidelines for the Delphi survey technique. Journal of advanced nursing. 2000 Oct;32(4):1008-15.   6. Jones J, Hunter D. Consensus methods for medical and health services research. BMJ (Clinical research ed). 1995 Aug 5;311(7001):376-80.   7. McMillan SS, King M, Tully MP. How to use the nominal group and Delphi techniques. International journal of clinical pharmacy. 2016 Jun;38(3):655-62.    

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Consensus-derived clinical decision rules to guide advanced imaging decisions for pulmonary embolism in pregnancy and the postpartum period

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