Pediatric Appendicitis Risk Calculator (pARC) in Children With Appendix Ultrasounds
NCT ID: NCT03522233
Last Updated: 2018-05-11
Study Results
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Basic Information
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UNKNOWN
800 participants
OBSERVATIONAL
2017-09-23
2019-10-01
Brief Summary
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Detailed Description
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Various strategies exist for the diagnostic approach to the patient after equivocal US with symptoms of AA. While select patients may be safely discharged based on clinical judgment,9 emergency providers often obtain CT or admit patients for clinical observation. In a study conducted by Garcia et al., they concluded that a protocol of US followed by CT in children with negative or equivocal US exam results in beneficial management as well as cost savings.10 In a study by Gregory et al., they concluded that a clinical decision rule followed by staged imaging was found to be the most cost-effective approach for diagnosis of AA in children.11 Bachur et al. integrated PAS score with US findings and concluded that patients with high risk (PAS 7-10) but negative US or low risk (PAS 0-3) benefit from serial exam or further work up. 12 The addition of US to the strategy reduced CT utilization.11 Standardized radiology reports have also been shown to reduce CT scans and admissions for observation.13 At a network of institutions nationwide a tool called the pediatric appendicitis risk calculator (pARC)1 is being studied to assess patient's true risk of appendicitis and provide guidance for clinical management to ER physicians. Preliminary studies have found the pARC to be more accurate at predicting risk of appendicitis in children when compared to PAS score.
The study objective is to assess acute care charges and clinical outcomes among children with appendix US and pARC \< 25%. To the investigator's knowledge, this is the first study to do so in a tertiary care pediatric hospital.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* Patients who had an appendix ultrasound in one of our EDs
Exclusion Criteria
* Previous significant abdominal surgery (for example appendectomy, short gut, ileostomy, Hirschsprungs with pull through)
* No CBC obtained (i.e. cannot determine pARC)
* Developmental or cognitive delay that impedes communication
* If there is suspected abuse
5 Years
18 Years
ALL
Yes
Sponsors
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Children's Hospitals and Clinics of Minnesota
OTHER
Responsible Party
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Principal Investigators
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Callie Becker, MD
Role: PRINCIPAL_INVESTIGATOR
Children's Minnesota
Locations
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Children's Minnesota
Minneapolis, Minnesota, United States
Children's Minnesota
Saint Paul, Minnesota, United States
Countries
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Central Contacts
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Facility Contacts
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Brianna McMichael, MPH
Role: primary
Brianna McMichael, MPH
Role: primary
References
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Kharbanda AB, Vazquez-Benitez G, Ballard DW, Vinson DR, Chettipally UK, Kene MV, Dehmer SP, Bachur RG, Dayan PS, Kuppermann N, O'Connor PJ, Kharbanda EO. Development and Validation of a Novel Pediatric Appendicitis Risk Calculator (pARC). Pediatrics. 2018 Apr;141(4):e20172699. doi: 10.1542/peds.2017-2699. Epub 2018 Mar 13.
Pena BM, Taylor GA, Lund DP, Mandl KD. Effect of computed tomography on patient management and costs in children with suspected appendicitis. Pediatrics. 1999 Sep;104(3 Pt 1):440-6. doi: 10.1542/peds.104.3.440.
Samuel M. Pediatric appendicitis score. J Pediatr Surg. 2002 Jun;37(6):877-81. doi: 10.1053/jpsu.2002.32893.
Schneider C, Kharbanda A, Bachur R. Evaluating appendicitis scoring systems using a prospective pediatric cohort. Ann Emerg Med. 2007 Jun;49(6):778-84, 784.e1. doi: 10.1016/j.annemergmed.2006.12.016. Epub 2007 Mar 26.
Ebell MH, Shinholser J. What are the most clinically useful cutoffs for the Alvarado and Pediatric Appendicitis Scores? A systematic review. Ann Emerg Med. 2014 Oct;64(4):365-372.e2. doi: 10.1016/j.annemergmed.2014.02.025. Epub 2014 Apr 14.
Smith MP, Katz DS, Lalani T, Carucci LR, Cash BD, Kim DH, Piorkowski RJ, Small WC, Spottswood SE, Tulchinsky M, Yaghmai V, Yee J, Rosen MP. ACR Appropriateness Criteria(R) Right Lower Quadrant Pain--Suspected Appendicitis. Ultrasound Q. 2015 Jun;31(2):85-91. doi: 10.1097/RUQ.0000000000000118.
Howell JM, Eddy OL, Lukens TW, Thiessen ME, Weingart SD, Decker WW; American College of Emergency Physicians. Clinical policy: Critical issues in the evaluation and management of emergency department patients with suspected appendicitis. Ann Emerg Med. 2010 Jan;55(1):71-116. doi: 10.1016/j.annemergmed.2009.10.004.
Ross MJ, Liu H, Netherton SJ, Eccles R, Chen PW, Boag G, Morrison E, Thompson GC. Outcomes of children with suspected appendicitis and incompletely visualized appendix on ultrasound. Acad Emerg Med. 2014 May;21(5):538-42. doi: 10.1111/acem.12377.
Pena BM, Taylor GA, Fishman SJ, Mandl KD. Costs and effectiveness of ultrasonography and limited computed tomography for diagnosing appendicitis in children. Pediatrics. 2000 Oct;106(4):672-6. doi: 10.1542/peds.106.4.672.
Gregory S, Kuntz K, Sainfort F, Kharbanda A. Cost-Effectiveness of Integrating a Clinical Decision Rule and Staged Imaging Protocol for Diagnosis of Appendicitis. Value Health. 2016 Jan;19(1):28-35. doi: 10.1016/j.jval.2015.10.007. Epub 2015 Dec 2.
Bachur RG, Callahan MJ, Monuteaux MC, Rangel SJ. Integration of ultrasound findings and a clinical score in the diagnostic evaluation of pediatric appendicitis. J Pediatr. 2015 May;166(5):1134-9. doi: 10.1016/j.jpeds.2015.01.034. Epub 2015 Feb 21.
Partain KN, Patel AU, Travers C, Short HL, Braithwaite K, Loewen J, Heiss KF, Raval MV. Improving ultrasound for appendicitis through standardized reporting of secondary signs. J Pediatr Surg. 2017 Aug;52(8):1273-1279. doi: 10.1016/j.jpedsurg.2016.11.045. Epub 2016 Dec 5.
Other Identifiers
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1708-113
Identifier Type: -
Identifier Source: org_study_id
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