TY - JOUR
T1 - Optimising diagnostics to discriminate complicated from uncomplicated appendicitis
T2 - a prospective cohort study protocol
AU - Bom, Wouter J.
AU - Scheijmans, Jochem C. G.
AU - Ubels, Sander
AU - van Geloven, Anna A. W.
AU - Gans, Sarah L.
AU - Tytgat, Kristien M. A. J.
AU - van Rossem, Charles C.
AU - Koens, Lianne
AU - Stoker, Jaap
AU - Bemelman, Willem A.
AU - Dijkgraaf, Marcel G. W.
AU - Boermeester, Marja A.
N1 - Funding Information: Funding This work was supported by the ‘Maag Lever Darm-Stichting’ through the ‘Slimme en snelle diagnostiek’ grant (no. D18-05). Publisher Copyright: ©
PY - 2022/4/1
Y1 - 2022/4/1
N2 - INTRODUCTION: Growing evidence is showing that complicated and uncomplicated appendicitis are two different entities that may be treated differently. A correct diagnosis of the type of appendicitis is therefore essential. The Scoring system of Appendicitis Severity (SAS) combines clinical, laboratory and imaging findings. The SAS rules out complicated appendicitis in 95% (negative predictive value, NPV) and detects 95% (sensitivity) of patients with complicated appendicitis in adults suspected of acute appendicitis. However, this scoring system has not yet been validated externally. In this study, we aim to provide a prospective external validation of the SAS in a new cohort of patients with clinical suspicion of appendicitis. We will optimise the score when necessary. METHODS AND ANALYSIS: The SAS will be validated in 795 consecutive adult patients diagnosed with acute appendicitis confirmed by imaging. Data will be collected prospectively in multiple centres. The predicted diagnosis based on the SAS score will be compared with the combined surgical and histological diagnosis. Diagnostic accuracy for ruling out complicated appendicitis will be calculated. If the SAS does not reach a sensitivity and NPV of 95% in its present form, the score will be optimised. After optimisation, a second external validation will be performed in a new group of 328 patients. Furthermore, the diagnostic accuracy of the clinical perspective of the treating physician for differentiation between uncomplicated and complicated appendicitis and the patient's preferences for different treatment options will be assessed. ETHICS AND DISSEMINATION: Ethical approval was granted by the Amsterdam UMC Medical Ethics Committee (reference W19_416 # 19.483). Because of the observational nature of this study, the study does not fall under the scope of the Medical Research Involving Human Subjects Act. Results will be presented in peer-reviewed journals. This protocol is submitted for publication before analysis of the results.
AB - INTRODUCTION: Growing evidence is showing that complicated and uncomplicated appendicitis are two different entities that may be treated differently. A correct diagnosis of the type of appendicitis is therefore essential. The Scoring system of Appendicitis Severity (SAS) combines clinical, laboratory and imaging findings. The SAS rules out complicated appendicitis in 95% (negative predictive value, NPV) and detects 95% (sensitivity) of patients with complicated appendicitis in adults suspected of acute appendicitis. However, this scoring system has not yet been validated externally. In this study, we aim to provide a prospective external validation of the SAS in a new cohort of patients with clinical suspicion of appendicitis. We will optimise the score when necessary. METHODS AND ANALYSIS: The SAS will be validated in 795 consecutive adult patients diagnosed with acute appendicitis confirmed by imaging. Data will be collected prospectively in multiple centres. The predicted diagnosis based on the SAS score will be compared with the combined surgical and histological diagnosis. Diagnostic accuracy for ruling out complicated appendicitis will be calculated. If the SAS does not reach a sensitivity and NPV of 95% in its present form, the score will be optimised. After optimisation, a second external validation will be performed in a new group of 328 patients. Furthermore, the diagnostic accuracy of the clinical perspective of the treating physician for differentiation between uncomplicated and complicated appendicitis and the patient's preferences for different treatment options will be assessed. ETHICS AND DISSEMINATION: Ethical approval was granted by the Amsterdam UMC Medical Ethics Committee (reference W19_416 # 19.483). Because of the observational nature of this study, the study does not fall under the scope of the Medical Research Involving Human Subjects Act. Results will be presented in peer-reviewed journals. This protocol is submitted for publication before analysis of the results.
KW - colorectal surgery
KW - gastroenterology
KW - radiology & imaging
KW - surgery
UR - http://www.scopus.com/inward/record.url?scp=85127426987&partnerID=8YFLogxK
U2 - https://doi.org/10.1136/bmjopen-2021-054304
DO - https://doi.org/10.1136/bmjopen-2021-054304
M3 - Article
C2 - 35365522
SN - 2044-6055
VL - 12
SP - e054304
JO - BMJ Open
JF - BMJ Open
IS - 4
M1 - e054304
ER -