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. 2019 Nov 19;2019(11):CD009977. doi: 10.1002/14651858.CD009977.pub2

Kepner 2012.

Study characteristics
Patient sampling Patients 18 years of age or older with clinically suspected appendicitis were referred for CT by Emergency Department (ED) physicians
Exclusion criteria included pregnancy, allergy to intravenous or oral contrast material, creatine level ≥ 1.5 (unit not reported), current incarceration, inability to give informed consent, appendicitis not primary concern of the ED physician
Included patients were randomised to receive CT of the entire abdomen with either intravenous (IV) contrast material or IV and oral contrast material
Patient characteristics and setting IV contrast: age quartiles (median): 22 to 40 years (32). 59% women
IV and oral contrast: age quartiles (median): 25 to 43 years (32). 55% women
 Emergency Department in York, Pennsylvania, USA. Single‐centre study
 Disease spectrum: unclear
Index tests CT of the entire abdomen and pelvis via a 16‐slice CT‐scanner (Somatom Sensation, Siemens Medical Solutions). Slice thickness: 3 mm. Slice interval, voltage, and mAs product: not stated
Included patients were randomised to receive enhancement by either intravenous (IV) contrast material or intravenous and oral contrast material
Target condition and reference standard(s) Appendicitis. Intraoperative findings were used to confirm appendicitis in patients who were operated on. Patients who did not have surgery were followed up Follow‐up consisted of telephone calls within 1 week to 1 month after discharge. Letters with questionnaires and stamped return envelopes were sent to patients who could not be reached by telephone
Flow and timing Overall 244 patients were included. 17 patients were excluded, including 3 patients lost to follow‐up. 114 patients were allocated to IV contrast, and 113 were allocated to IV and oral contrast
IV contrast: 114 patients had CT. Appendicitis was found in 41 patients
IV and oral contrast: 113 patients had CT. Appendicitis was found in 34 patients
The number of patients who had surgery and the number who had follow‐up are not reported for any of the groups
Comparative  
Criteria for CT diagnosis of appendicitis Appendix diameter > 5 mm, localised abscess or fluid collection, appendicolith, periappendiceal fat stranding, hyperenhancement of the appendix mucosa, thickened appendix wall (> 2 mm)
After evaluating the CT‐scan, the radiologist had the option of 'yes', 'no', or 'possible' for the diagnosis of appendicitis. In the analyses, 'possible' assessments were counted as 'yes'
Assessors of the CT‐scan All CT‐scans were initially assessed by an attending radiologist. These assessments were not analysed
Subsequently, 2 board certified radiologists with 18 years' and 27 years' experience reassessed all CT‐scans independently. These reassessments were used in the analyses. The board certified radiologists were unaware of the initial assessment. It is unclear how the 2 radiologists' assessments were aggregated into the reported single estimates for sensitivity and specificity
Notes  
Methodological quality
Item Authors' judgement Risk of bias Applicability concerns
DOMAIN 1: Patient Selection
Was a consecutive or random sample of patients enrolled? Unclear    
Did the study avoid inappropriate exclusions? Yes    
Does the study population represent an unselected sample of adults with suspected appendicitis? Unclear    
    Unclear Unclear
DOMAIN 2: Index Test All tests
Were the index test results interpreted without knowledge of the results of the reference standard? Yes    
If a threshold was used, was it pre‐specified? Yes    
Is the index test described in sufficient detail to permit its replication? No    
Was the analysis based on the initial evaluation of the CT‐scan by the radiologist on call? No    
    Low High
DOMAIN 3: Reference Standard
Is the reference standards likely to correctly classify the target condition? Yes    
Were the reference standard results interpreted without knowledge of the results of the index tests? Unclear    
    Unclear Low
DOMAIN 4: Flow and Timing
Did all patients receive a reference standard? Yes    
Did all patients receive the same reference standard? No    
Did all patients with a positive CT‐scan have surgery? No    
Did all patients with a negative CT‐scan have clinical follow‐up? Yes    
Was the choice of reference standard independent of the result of the index test? No    
Were all patients included in the analyses? Yes    
    High