Development & validation of a format for reporting endoscopic colonic biopsies.

Abstract

Background & objectives Non-neoplastic diseases make a considerable part of daily workload of gastroenterologist and an endoscopist. As there are only a few endoscopic findings in literature to suggest a large era of colonic diseases, endoscopic biopsy is a must, to reach a definitive diagnosis. This needs a checklist or a similar format that contains all the important histological features to be seen in a colonic biopsy which is currently lacking in published literature. Hence, this study aimed to develop a format for reporting endoscopic colonic biopsies a first of a kind as per our knowledge particularly for non-neoplastic colonic diseases using modified kappa statistics. Methods Seventy one questions were included in this format after searching in various search engines using various phrases. These questions were reviewed by experts and changes were done accordingly. The finalized questionnaire was further shared with 20 subject matter experts. Their feedback was utilized to determine the Content Validity Index (CVI), calculated at both the item level (I-CVI) and the overall scale level (S-CVI), along with the modified kappa coefficient. For studies involving more than six experts, an I-CVI of 0.78 and an S-CVI/average of 0.9 were considered acceptable benchmarks. Results Fourteen out of 20 experts responded. Mean I-CVI for relevance across all items was 0.933, S-CVI/Average (based on proportion data) across all experts was 0.94 and Mean I-CVI was well above 0.78 (0.928). Interpretation & conclusions The scores indicated a strong agreement among experts on various histological features to be seen in an endoscopic colonic biopsy. These findings clearly indicates that the format met the content validity criteria and hence histological sections of endoscopic colonic biopsies can be read using this format.