Systematic Review of Volume and Methodological Quality of Randomized Trials in Acute Pancreatitis.

BACKGROUND

This systematic review assessed the volume and methodological quality of randomized controlled trials (RCTs) in relation to management of acute pancreatitis (AP).

MATERIALS AND

METHODS

The PubMed, MEDLINE, and CENTRAL databases were systematically searched for RCTs published across 3 time periods: <1996 (P1), 1996-2008 (P2), and >2008 (P3). RCT quality was assessed using the Cochrane Risk of Bias (RoB) 2 tool and sample size recalculation, and for spin (interpretation of nonstatistically 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 3 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 randomized trials in AP are required to improve the evidence base in this field.