Systematic Review of Volume and Methodological Quality of Randomised Trials in Acute Pancreatitis

Background This systematic review assessed the volume and methodological quality of randomised controlled trials (RCTs) in relation to management of acute pancreatitis (AP). Methods The PUBMED, MEDLINE, CENTRAL databases were systematically searched for RCTs published across 3 time periods: <1996(P1), 1996-2008 (P2), >2008(P3). RCT quality was assessed using the Cochrane Risk of Bias (RoB) 2 tool, sample size recalculation, and for spin (interpretation of non-statistically significant results as relevant, making the study appear to be positive). Results Overall, 263 RCTs with 23,232 patients with AP were included. The average number of RCTs per year increased from 1.4, 6.0, to 10.6 in P1, P2, and P3, respectively. The RoB assessment showed low, some, and high concerns in overall RoB in 21%, 56% and 24% of all RCTs. Selective reporting bias improved over time. Sample size calculation reporting significantly increased through the three time periods (17%, 38% and 47%, p<0.001). Spin was identified in 68 RCTs (26% of all RCTs). Conclusion The quantity and quality of published RCTs relating AP management has increased over time, however significant shortcomings of methodological quality persist. Significant improvements in the conduct and reporting of randomised trials in AP are required to improve the evidence base in this field.