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Prospective Validation of a Biomarker Panel to Identify Pediatric Emergency Department Patients with Abdominal Pain Who Are at Low Risk of Acute Appendicitis

David S. Huckins
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David S. Huckins
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Affiliations

  • Division of Emergency Medicine, Newton-Wellesley Hospital, Newton, MA

Correspondence

  • Corresponding author at: Department of Emergency Medicine, Newton-Wellesley Hospital, 2014 Washington St., Newton, MA, 02462.
, MDcorrespondence
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David S. Huckins
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Affiliations

  • Division of Emergency Medicine, Newton-Wellesley Hospital, Newton, MA

Correspondence

  • Corresponding author at: Department of Emergency Medicine, Newton-Wellesley Hospital, 2014 Washington St., Newton, MA, 02462.
,
Harold K. Simon
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Harold K. Simon
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Affiliations

  • Emory University, Children's Healthcare of Atlanta, Atlanta, GA
, MD, MBA
,
Karen Copeland
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Karen Copeland
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Affiliations

  • Boulder Statistics, LLC, Boulder, CO
, PhD
,
Truman J. Milling Jr.
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Truman J. Milling
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Affiliations

  • Seton University of Texas Southwestern Clinical Research Institute, University Medical Center at Brackenridge, Austin, TX
  • Dell Children's Medical Center, Austin, TX
, MD
,
Philip R. Spandorfer
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Philip R. Spandorfer
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Affiliations

  • Scottish Rite Hospital, Children's Healthcare of Atlanta, Atlanta, GA
, MD, MSCE
,
Halim Hennes
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Halim Hennes
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Affiliations

  • Children’s Medical Center, Dallas, TX
, MD
,
Coburn Allen
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Coburn Allen
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Affiliations

  • Dell Children’s Medical Center, Austin, TX
, MD
,
Joseph Gogain
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Joseph Gogain
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Affiliations

  • Venaxis, Inc., Castle Rock, CO
, PhD
, for the APAB Study Grouplow asterisk
10Acute Pediatric Appendicitis Biomarker (APAB) Study GroupDavid S. Huckins, MD – Newton-Wellesley Hospital, Newton, MAHarold K. Simon, MD, MBA – Emory University, Children’s Healthcare of Atlanta, Atlanta, GATruman J. Milling, Jr., MD - Dell Children’s Medical Center, Austin, TXPhilip R. Spandorfer, MD, MSCE – Children’s Health Care of Atlanta at Scottish Rite, Atlanta, GAHalim Hennes, MD – UT Southwestern, Children’s Medical Center, Dallas, TXDaniel M. Cohen, MD – Nationwide Children’s Hospital, Columbus, OHCoburn Allen, MD – Dell Children’s Medical Center, Austin, TXBlake Bulloch, MD – Phoenix Children’s Hospital, Phoenix, AZJames Linakis, MD – Hasbro Children’s Hospital, Providence, RIHolly Depinet, MD – Cincinnati Children’s Hospital, Cincinnati, OHMicheal Spohn, MD, FACEP – St. Joseph’s Regional Health Center, Bryan, TXRobert Hickey, MD, FAAP, FAHA – Children’s Hospital of Pittsburgh, Pittsburgh, PACheryl Vance, MD – University of California, Davis, Sacramento, CAPhyllis Hendry, MD, FAAP, FACEP – University of Florida College of Medicine, Jacksonville, FLRebecca Andrews-Dickert, MD – Spectrum Health, Grand Rapids, MINorman A. Paradis, MD– Dartmouth-Hitchcock Medical Center, Lebanon, NHJeffrey Johnson, MD – South Shore Hospital, Weymouth, MAAlex J. Rogers, MD – University of Michigan Hospital and Health System, Ann Arbor, MIBarry Hahn, MD, FACEP – Staten Island University Hospital, Staten Island, NYShireen M. Atabaki, MD, MPH – Children’s National Medical Center, Washington, DCDavid Spiro, MD – Oregon Health Sciences University, Portland, OregonHoward A Smithline, MD – Baystate Medical Center, Springfield, MASharon E. Mace, MD – Cleveland Clinic, Cleveland, OHKeith Borg, MD – Medical University of South Carolina, Charleston, SCDon Arnold, MD, MPH – Vanderbilt Children’s Hospital, Nashville, TNTom Abramo, MD – Arkansas Children’s Hospital, Little Rock, AKKelly Sinclair, MD – Children’s Mercy Hospital, Kansas City, MOWassam Rahman, MD – All Children’s Hospital, St. Petersburg, FLMilan Nadkarni, MD– Wake Forest Medical Center, Winston-Salem, NC
DOI: http://dx.doi.org/10.1016/j.ajem.2016.03.066

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Figures

Fig. 1

Age Distribution

Fig. 2

Patient Disposition

AA+ = acute appendicitis, AA- = no acute appendicitis, LTFU = Lost to follow up.

*captured on return visit or follow up

Fig. 3

Diagnosis and Disposition by Biomarker Results

AA+ = acute appendicitis, AA- = no acute appendicitis, *Includes those diagnosed as AA+ but treated with antibiotics only, **Captured on return visit or follow up, +one negative appendectomy on follow up

Abstract

Objectives

To prospectively validate the diagnostic accuracy of a biomarker panel consisting of WBC, CRP, and MRP 8/14 levels in identifying pediatric patients with abdominal pain who are at low risk of appendicitis.

Methods

This prospective observational study enrolled subjects aged 2-20 years presenting to 29 U.S. emergency departments with abdominal pain suggesting possible acute appendicitis. Blood samples were analyzed for WBC, CRP, and MRP 8/14 levels from which the composite biomarker panel results were calculated, then correlated with the final diagnosis either positive or negative for acute appendicitis.

Results

2201 patients were enrolled, with 1887 completing all aspects of the study. Prevalence of appendicitis in this cohort was 25.3%. The biomarker panel exhibited a sensitivity of 97.1% (95% CI, 95.1-98.2%), negative predictive value of 97.4% (95% CI, 95.8-98.5%), negative likelihood ratio of 0.08 (95% CI, 0.05-0.13), with a specificity of 37.9% (95% CI, 35.4-40.4%) for appendicitis. The panel correctly identified 534 of 1410 (37.8%) patients who did not have appendicitis with 14 (2.9%) false negatives. Overall, 23.7% (132/557) of CT scans were done for patients with negative biomarker panel results, including 31.2% (131/420) of patients who had CT but did not have appendicitis.

Conclusion

This biomarker panel exhibited high sensitivity and negative predictive value for acute appendicitis in this large prospective cohort. This panel may be useful in identifying pediatric patients who are at low risk of appendicitis and might be followed clinically, potentially reducing the dependence on CT in the evaluation for acute appendicitis.

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Funding: This research was funded by Venaxis, Inc., Castle Rock, CO

Prior Presentations: ACEP 2014, Chicago, IL, October 27, 2014

Conflict of Interest Disclosure: David S. Huckins, MD - paid consulting fees by Venaxis Inc. for design, execution, and analysis of study results, and as member of Clinical Study Steering Committee and Chair of Publication Committee; reimbursed expenses for travel to FDA meetings and conferences.

Harold K. Simon, MD, MBA - served on the Venaxis Clinical Study Steering Committee and as a sponsored trial site investigator.

Karen Copeland, PhD - paid consulting fees by Venaxis Inc. as member of Clinical Study Steering Committee and for study design and analysis of study results.

Truman J. Milling, Jr. MD - paid consulting fees by Venaxis Inc. as Chair of Clinical Study Steering Committee.

Philip R. Spandorfer, MD - sponsored trial site investigator.

Halim Hennes, MD - sponsored trial site investigator.

Coburn Allen, MD - sponsored trial site investigator.

Joseph Gogain, PhD - employed by Venaxis, Inc.

© 2016 Published by Elsevier Inc.
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