Point of Care Ultrasound for Evaluation of Suspected Appendicitis in the Emergency Department
Point of Care Ultrasound for Evaluation of Suspected Appendicitis in the Emergency Department
The primary purpose of this study is to determine the accuracy of ultrasound (US) in
 diagnosing appendicitis in emergency department (ED) patients, as compared to the criterion
 standards of computed tomography, operative reports, or discharge diagnosis.

 The secondary purposes of the study include evaluation of the effect of ultrasound for
 appendicitis on the patient length of stay in the emergency department, the diagnostic
 utility of specific ultrasound findings in the diagnosis of appendicitis, the role of body
 mass index (BMI) in the utility of ultrasound for appendicitis and relation of ultrasound
 findings to the Alvarado score. The study will also examine the inter-rater agreement between
 point-of- care sonographers' interpretation and blinded reviewers' interpretation of the
 ultrasound images.
BACKGROUND:

 Increasing concerns have been raised over the past several years regarding the degree of
 radiation exposure in patients being evaluated for abdominal complaints. A deepening body of
 literature supports the use of ultrasound for the evaluation of appendicitis. In particular,
 ultrasound is being promoted as first line testing in the evaluation of appendicitis in
 pediatric populations and adults with BMI < 25. This approach reduces the risks related to
 radiation exposure and IV contrast dye. Unfortunately, in many practice settings, the
 availability of radiology-based sonographers is limited and there can be significant delays
 in obtaining ultrasound images. For these reasons, many ED physicians (EP) have begun to
 perform bedside ultrasound to evaluate for appendicitis.

 Studies have demonstrated a wide range in the accuracy of ultrasound for appendicitis.
 Sensitivities and specificities vary and no standardized diagnostic criterion exist.
 Additionally, little has been published directly studying EP point of care ultrasound in the
 evaluation for acute appendicitis. One study has shown that EP-performed ultrasounds had a
 relatively low sensitivity, but a high specificity. However, this study was performed by a
 wide range of users with varying skill levels and older ultrasound machines. The surgical
 literature suggests that the ability of the clinician to integrate the history, the physical
 exam and the ultrasound findings in real time improves the diagnostic accuracy of ultrasound
 for appendicitis.

 Currently there are 4 physicians on staff in the ED who are fellowship trained in point of
 care emergency ultrasound, fully credentialed and are already performing ED based evaluations
 for appendicitis on a limited basis. The current standard of care is a point of care
 ultrasound as first-line imaging for patients with suspected appendicitis when a credentialed
 EP is available to perform the scan. We intend to evaluate the performance of EP-performed
 point of care ultrasound in the diagnosis of acute appendicitis in ED patients. This study
 would primarily investigate the accuracy of ultrasound as compared to the criterion standard
 of either abdominal CT results or surgical pathology report.

 STUDY DESIGN:

 This will be a prospective, descriptive study of Emergency Department patients suspected of
 having acute appendicitis. Initial screening of potential enrollees will be performed by ED
 nurses, residents, and attendings. Once consented and enrolled, a study sonographer will
 interview and examine the patient, preferably before lab results are available. The
 ultrasound must be completed and adequate images obtained before other imaging modalities are
 completed. Ultrasound of the right lower quadrant (RLQ) will performed using the graded
 compression technique described previously in the literature. All participating EP
 sonographers are already trained in this technique, fully credentialed and no additional
 training will be performed. A "Bedside" standardized data collection form will be used at the
 bedside to record ultrasound findings and clinical information. The sonographer will
 designate the appendix as "not visualized", "visualized and normal", or "visualized and
 abnormal" and the ultrasound as "positive for appendicitis", "negative for appendicitis" or
 "indeterminate" based on the exam and ultrasound findings.

 A second sonographer, blinded to all clinical information and the primary sonographer's
 ultrasound interpretation, will review the de-identified ultrasound images remotely. This
 overreading sonographer will record his interpretation and secondary findings on a "Blinded
 Reviewer" standardized data collection sheet.

 CT imaging, surgical pathology reports, and a two week telephone follow up will be utilized
 to determine final outcome of patient's clinical course. At this time, a third "Follow Up"
 standardized data collection sheet will be used to record patient outcomes and demographic
 information.

 Based on expected proportion of patients with proven appendicitis of 15% with desired
 precision of 0.15, the estimated sample size for this study is 261.

 STUDY POPULATION AND RECRUITMENT METHODS:

 Study population will include patients of any age presenting to the emergency department with
 abdominal pain and a clinical suspicion of appendicitis. Patients will initially be seen by a
 treating attending physician or resident. If there is a concern for appendicitis the treating
 physician will contact one of the ultrasound credentialed EP sonographers to perform a point
 of care ultrasound. Of note, this is the current standard practice in the ED. By choosing to
 participate in the study, the patient's treatment is not altered in any way from the current
 standard practice, but simply is agreeing to allow us to collect data and contact them by
 phone at the two week follow up. The study sonographer will obtain consent. Parental consent
 will be obtained for patients under the age of 18.

 DATA TO BE UTILIZED:

 The following data will be recorded:

 -  Patients initials

 -  Patient Medical Record Number (MRN)/Financial Identification Number (FIN)

 -  Age

 -  Sex

 -  Height

 -  Weight

 -  Symptom Duration

 -  Chief complaint

 -  Presence of RLQ pain

 -  Anorexia

 -  Migration of pain to RLQ

 -  Rebound tenderness

 -  Nausea/vomiting

 -  Maximum recorded temperature in the Emergency Department

 -  White Blood Cell (WBC) count

 -  Visualization of the iliac vessels?

 -  Visualization of the appendix?

 -  Maximum outer diameter of the appendix

 -  Thickness of the appendix wall

 -  Edema of the wall of the appendix?

 -  Peri-appendiceal edema or free fluid?

 -  Non compressible appendix?

 -  Pain with compression over the appendix?

 -  Evidence of dilated bowel loops in the RLQ?

 -  Increased vascularity of the appendix wall?

 -  Appendicolith?

 -  Free fluid in the right upper quadrant (RUQ)?

 -  Diagnostic impression of the sonographer

 -  Diagnostic impression of the blinded reviewer

 -  CT diagnosis

 -  Pathology diagnosis

 -  Operative report classification

 -  Time to disposition

 -  Final diagnosis

 -  Symptoms/Subsequent diagnosis at two weeks

 DATA ANALYSIS:

 For the primary outcome, data will be used to calculate the sensitivity and specificity of
 point of care (POC) US for the diagnosis of appendicitis compared to the criterion standard
 of CT, operative report, discharge diagnosis and two week follow up phone call.

 For secondary outcomes, likelihood ratios for specific ultrasound findings will be
 determined. Inter-rater agreement between the bedside sonographer and the blinded reviewer
 will be calculated using Cohen's kappa coefficient. Continuous, time-to-disposition data will
 be compared utilizing a two-tailed t-test.

 Statistical analysis will be performed using SPSS software (IBM, Armonk, NY).

 RISKS AND RISK MANAGEMENT:

 There are minimal risks to patients participating in this study since ultrasound is
 non-invasive and known to be safe. There is a slight risk of the participants' privacy or
 confidentiality being breached. Standard precautions will be taken to ensure privacy and
 confidentiality is maintained during the study.

 BENEFITS:

 Patients who have ultrasounds highly suspicious for appendicitis may be referred directly to
 surgery without further imaging being performed. In these instances study patients would
 benefit from reduced radiation exposure and faster referral for appropriate surgical care.
 The results of this study may be used to improve future patient care.

 COMPENSATION / INCENTIVES AND RESEARCH-RELATED COSTS:

 No compensation will be given to the participants. There will be no research-related costs.

 ALTERNATIVE PROCEDURES:

 Patients who refuse to participate in the study will not have the quality of their treatment
 affected in any way.

 RESEARCH MATERIALS, METHODS AND CONFIDENTIALITY:

 Research records will be stored in locked offices, filing cabinets, and computers using
 passwords.

 SUBJECT INFORMED CONSENT:

 We will seek documented informed consent and HIPAA Authorization. ED patients meeting all of
 the inclusion and exclusion criteria will be asked if they would like to participate in the
 study by a research sonographer at the time of the ultrasound.

 If the patient agrees to participate, the informed consent document will be given to them for
 their review. If patient declines to participate they will continue their treatment course in
 the Emergency Department.

 REFERENCES:

 Burford JM, Dassinger MS, Smith SD. Surgeon-performed ultrasound as a diagnostic tool in
 appendicitis. Journal of Pediatric Surgery. 2011;46;1115-1120

 Estey A, Poonai N, Lim R. Appendix Not Seen: The Predictive Value of Secondary Inflammatory
 Sonographic Signs. Pediatric Emergency Care. 2013;29(4):435-9.

 Fox JC, Solley M, et al. Prospective evaluation of emergency physician performed ultrasound
 to detect acute appendicitis. European Journal of Emergency Medicine. 2008;15:80-85.

 Hulley et al. Designing Clinical Reasearch. 4th ed. Philadelphia, PA: Lippincott, Williams &
 Wilkins; 2013: Chapter 6.

 Karakas SP, Guelfguat M, Leonidas JC, et al. Acute appendicitis in children: comparison of
 clinical diagnosis with ultrasound and CT imaging. Pediatric Radiology. 2000;30:94-8.

 Pacharn P, Ying J, Linam LE, Brody AS, Babcock DS. Sonography in the Evaluation of Acute
 Appendicitis: Are Negative Sonographic Findings Good Enough? Journal of Ultrasound Medicine.
 2010;29;1749-1755.

 Puylaert JB. Acute appendicitis: US evaluation using graded compression. Radiology.
 1986;158:355-60.
Inclusion Criteria:

 -  RLQ pain with clinical suspicion for acute appendicitis

 Exclusion Criteria:

 -  History of appendectomy

 -  Imaging prior to ED ultrasound performed to evaluate the RLQ

 -  Patients who are decisionally impaired or cannot provide consent