Reexamining 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 cirrhosis

Rohit Agrawal; Muhammad Majeed; Bashar M Attar; Yazan Abu Omar; Mbachi Chimezi; Palak Patel; Shaheera Kamal; Melchor Demetria; Seema Gandhi

doi:10.20524/aog.2019.0415

Reexamining 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 cirrhosis

Ann Gastroenterol. 2019 Nov-Dec;32(6):642-649. doi: 10.20524/aog.2019.0415. Epub 2019 Sep 23.

Authors

Rohit Agrawal¹, Muhammad Majeed¹, Bashar M Attar², Yazan Abu Omar¹, Mbachi Chimezi¹, Palak Patel³, Shaheera Kamal⁴, Melchor Demetria², Seema Gandhi²

Affiliations

¹ Department of Medicine, Cook County Health and Hospital System, IL, USA (Rohit Agrawal, Muhammad Majeed, Yazan Abu Omar, Mbachi, Chimezi).
² Division of Gastroenterology and Hepatology, Department of Medicine, Cook County Health and Hospital System, County, Chicago, IL, USA (Melchor Demetria, Seema Gandhi).
³ College of Medicine, Midwestern University, IL, USA (Palak Patel).
⁴ Jinnah Sindh Medical University, Rafiqi H J Rd, Karachi Cantonment Karachi, Pakistan (Shaheera Kamal).

Abstract

Background: 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 (25^th, 75^th) 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 (r_s=0.357), P-value (r_s=-0.299), number lost to follow up (r_s=0.355), Science Citation Index (r_s=0.347), year of publication (r_s=-0.085), blinding (r_pb=-0.18) or number of centers (r_pb=0.10). However, a significant correlation was seen between FI and number needed to treat (r_s=-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; biostatistics; fragility index; gastroenterology; randomized clinical trial.