Abstract
The advent of pharmacological agents that inhibit TLESRs has increased the need for accurate objective identification and scoring of these events. The only current objective criteria were published over 10 years ago (Am.J.Physiol,1995;268:G128-13) and have not been subject to rigorous evaluation. Aims: To assess the performance of the TLESR criteria with regard to intraand inter-assessor variability and to improve them where necessary. Methods: Two 3-hour post-prandial esophageal manometric and pH recordings were performed at least 1 week apart in 20 healthy volunteers. Each recording was duplicated and all recordings were given a unique identifier, creating two datasets of 40 recordings. The recordings were analysed by 5 experienced observers for the occurrence of TLESRs based on their expert opinion. Scored TLESRs were also analysed for the presence of the original 4 criteria as well as inhibition of the crural diaphragm (ID), a prominent after-contraction (AC), acid reflux and an esophageal common cavity. Results: For TLESRs based on the observer's expert opinion, the overall inter-observer agreement was 59% (range 56-67%) and the intra-observer agreement 75% (60-89%). When TLESRs were restricted to those fulfilling the original criteria, inter-observer agreement fell to 46% (40-53%) and the intra-observer agreement to 60% (44-67%). Cleaning the recordings by removal of technically flawed sections (up to 20% of any one recording) improved inter and intra-observer agreement by 5%. Inclusion of additional criteria (ID and AC) for the identification of TLESRs in the second dataset resulted in interand intra-observer agreements of 62% (52-70%) and 69% (53-79%) respectively, close to those based on the observers expert opinion (64% (56-71%), 71% (61-80%). A consensus analysis performed collectively by 3 observers and based on the new criteria (original ± ID and AC) resulted in agreement between the paired recordings of 84%. The remaining disagreement was largely the result of technical difficulties with the recordings.Conclusions: The original criteria for the definition of TLESRs allows for substantial interand intra-observer variability. Incorporation of additional objective criteria reduces the variability. However, the highest level of intra-observer agreement can be achieved by consensus analysis.
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