Gandhi, SeemaChimezi, MbachiPatel, PalakAgrawal, RohitOmar, Yazan AbuKamal, ShaheeraMajeed, MuhammadAttar, Bashar M.Demetria, MelchorBackground In 2012, the American Association for the Study of Liver Diseases published practice guidelines for the management of patients with ascites caused by cirrhosis, using data from randomized controlled trials (RCTs) and observational studies. We reexamined the strength of these RCTs by calculating the fragility index (FI), a novel metric proposed for evaluating the robustness of RCTs. Methods We screened all RCTs referenced in the guidelines for specific criteria. We calculated the FI and fragility quotient (FQ), and analyzed the correlation between FI and several variables. Results Twenty-one RCTs were included. The median (25th, 75th) FI and FQ were 1 (interquartile range [IQR] 0.5-6) and 0.070 (IQR 0.008-0.166), respectively. For studies that reported the number of patients lost to follow up (12 RCTs), the median of patients lost was 2 (IQR 0-6.5). There was no significant correlation between FI and sample size (rs=0.357), P-value (rs=-0.299), number lost to follow up (rs=0.355), Science Citation Index (rs=0.347), year of publication (rs=-0.085), blinding (rpb=-0.18) or number of centers (rpb=0.10). However, a significant correlation was seen between FI and number needed to treat (rs=-0.549; P=0.015). Conclusions RCTs in the field of cirrhosis-related ascites are fragile. Of the 21 trials analyzed, 13 had an FI of 3 or below and these trials influenced 13 of the 49 recommendations in the guidelines. We recommend the incorporation of FI and FQ in addition to P-value to better understand the meaning of the results in gastroenterological studies. Keywords Clinical practice guideline; gastroenterology, randomized clinical trial; biostatistics; fragility index Ann Gastroenterol 2019; 32 (6): 642-649text/htmlapplication/pdfhttp://www.annalsgastro.gr/index.php/annalsgastro/article/view/4591engHellenic Society of GastroenterologyCopyright (c) 2019 Annals of Gastroenterology1792-74631108-7471Annals of Gastroenterology; Volume 32, No 6 (2019); 642Reexamining the data used in the 2012 guidelines of the American Association for the Study of Liver Diseases for the management of adult patients with ascites due to cirrhosisinfo:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersion2019-11-14Δημοσίευση σε περιοδικόPublication in journalΓαστροεντερολογίαGastroenterologyisi -Gastroenterology & Hepatology covers resources on the anatomy, physiology, biochemistry, and pathology of the digestive system. This category includes specific resources on the prognosis and treatment of digestive diseases; stomach ulcers; metabolic, genetic, infectious and chemically induced diseases of the liver; colitis; diseases of the pancreas and diseases of the rectum.Επιστημονικό άρθροScientific articleΕλληνική Γαστροεντερολογική ΕταιρίαGreek Aggregator OpenArchives.gr | National Documentation Centre (EKT)other