A proposed staging system and stage-specific interventions for familial adenomatous polyposis

Patrick M Lynch, Jeffrey S Morris, Sijin Wen, Shailesh M Advani, William Ross, George J Chang, Miguel Rodriguez-Bigas, Gottumukkala S Raju, Luigi Ricciardiello, Takeo Iwama, Benedito M Rossi, Maria Pellise, Elena Stoffel, Paul E Wise, Lucio Bertario, Brian Saunders, Randall Burt, Andrea Belluzzi, Dennis Ahnen, Nagahide Matsubara, Steffen Bülow, Niels Jespersen, Susan K Clark, Steven H Erdman, Arnold J Markowitz, Inge Bernstein, Niels De Haas, Sapna Syngal, Gabriela Moeslein, Patrick M Lynch, Jeffrey S Morris, Sijin Wen, Shailesh M Advani, William Ross, George J Chang, Miguel Rodriguez-Bigas, Gottumukkala S Raju, Luigi Ricciardiello, Takeo Iwama, Benedito M Rossi, Maria Pellise, Elena Stoffel, Paul E Wise, Lucio Bertario, Brian Saunders, Randall Burt, Andrea Belluzzi, Dennis Ahnen, Nagahide Matsubara, Steffen Bülow, Niels Jespersen, Susan K Clark, Steven H Erdman, Arnold J Markowitz, Inge Bernstein, Niels De Haas, Sapna Syngal, Gabriela Moeslein

Abstract

Background and aims: It is not possible to accurately count adenomas in many patients with familial adenomatous polyposis (FAP). Nevertheless, polyp counts are critical in evaluating each patient's response to interventions. However, the U.S. Food and Drug Administration no longer recognizes the decrease in polyp burden as a sufficient chemoprevention trial treatment endpoint requiring a measure of "clinical benefit." To develop endpoints for future industry-sponsored chemopreventive trials, the International Society for Gastrointestinal Hereditary Tumors (InSIGHT) developed an FAP staging and intervention classification scheme for lower-GI tract polyposis.

Methods: Twenty-four colonoscopy or sigmoidoscopy videos were reviewed by 26 clinicians familiar with diagnosis and treatment of FAP. The reviewers independently assigned a stage to a case by using the proposed system and chose a stage-specific intervention for each case. Our endpoint was the degree of concordance among reviewers staging and intervention assessments.

Results: The staging and intervention ratings of the 26 reviewers were highly concordant (ρ = 0.710; 95% credible interval, 0.651-0.759). Sixty-two percent of reviewers agreed on the FAP stage, and 90% of scores were within ±1 stage of the mode. Sixty percent of reviewers agreed on the intervention, and 86% chose an intervention within ±1 level of the mode.

Conclusions: The proposed FAP colon polyposis staging system and stage-specific intervention are based on a high degree of agreement on the part of experts in the review of individual cases of polyposis. Therefore, reliable and clinically relevant means for measuring trial outcomes can be developed. Outlier cases showing wide scatter in stage assignment call for individualized attention and may be inappropriate for enrollment in clinical trials for this reason.

Copyright © 2016 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.

Figures

Fig. 1
Fig. 1
Proposed InSiGHT staging system classification and clinical interventions for colonic polyposis
Fig. 2
Fig. 2
Proposed InSiGHT staging system classification and clinical interventions for post-colectomy cases with ileorectal anastomosis.
Fig. 3
Fig. 3
Fig. 3a. Heat map displaying proportion of IPSS scores by video, with videos ordered from lowest average stage (video 17) to highest average stage (video 10). IPSS: InSiGHT polyposis staging system Fig. 3b. Heat map displaying InSiGHT polyposis staging system scores from 14 endoscopists by video Fig. 3c. Heat map displaying InSiGHT polyposis staging system scores from 12 surgeons by video
Fig. 3
Fig. 3
Fig. 3a. Heat map displaying proportion of IPSS scores by video, with videos ordered from lowest average stage (video 17) to highest average stage (video 10). IPSS: InSiGHT polyposis staging system Fig. 3b. Heat map displaying InSiGHT polyposis staging system scores from 14 endoscopists by video Fig. 3c. Heat map displaying InSiGHT polyposis staging system scores from 12 surgeons by video
Fig. 3
Fig. 3
Fig. 3a. Heat map displaying proportion of IPSS scores by video, with videos ordered from lowest average stage (video 17) to highest average stage (video 10). IPSS: InSiGHT polyposis staging system Fig. 3b. Heat map displaying InSiGHT polyposis staging system scores from 14 endoscopists by video Fig. 3c. Heat map displaying InSiGHT polyposis staging system scores from 12 surgeons by video
Fig. 4
Fig. 4
Heat map displaying the proportion of raters (N=26) who assigned each intervention to each video, with rows representing reviewer-selected intervention scores ranging from A to E, and videos ordered from lowest to highest average scores
Fig. 5
Fig. 5
Heat maps displaying differences between recommended interventions and IPSS scores (intervention minus IPSS score) for each reviewer. Positive values indicate the reviewer recommended a higher intervention level than that corresponding to the assigned stage; negative values indicate the reviewer recommended a lower intervention level. IPSS: InSiGHT polyposis staging Fig. 5a. Heat map displaying proportion of videos with each difference value by rater Fig. 5b. Heat map displaying proportion of raters with each difference value by video Fig. 5c. Heat map displaying proportion of endoscopists with each difference value by video Fig. 5d. Heat map displaying proportion of surgeons with each difference value by video
Fig. 5
Fig. 5
Heat maps displaying differences between recommended interventions and IPSS scores (intervention minus IPSS score) for each reviewer. Positive values indicate the reviewer recommended a higher intervention level than that corresponding to the assigned stage; negative values indicate the reviewer recommended a lower intervention level. IPSS: InSiGHT polyposis staging Fig. 5a. Heat map displaying proportion of videos with each difference value by rater Fig. 5b. Heat map displaying proportion of raters with each difference value by video Fig. 5c. Heat map displaying proportion of endoscopists with each difference value by video Fig. 5d. Heat map displaying proportion of surgeons with each difference value by video
Fig. 5
Fig. 5
Heat maps displaying differences between recommended interventions and IPSS scores (intervention minus IPSS score) for each reviewer. Positive values indicate the reviewer recommended a higher intervention level than that corresponding to the assigned stage; negative values indicate the reviewer recommended a lower intervention level. IPSS: InSiGHT polyposis staging Fig. 5a. Heat map displaying proportion of videos with each difference value by rater Fig. 5b. Heat map displaying proportion of raters with each difference value by video Fig. 5c. Heat map displaying proportion of endoscopists with each difference value by video Fig. 5d. Heat map displaying proportion of surgeons with each difference value by video
Fig. 5
Fig. 5
Heat maps displaying differences between recommended interventions and IPSS scores (intervention minus IPSS score) for each reviewer. Positive values indicate the reviewer recommended a higher intervention level than that corresponding to the assigned stage; negative values indicate the reviewer recommended a lower intervention level. IPSS: InSiGHT polyposis staging Fig. 5a. Heat map displaying proportion of videos with each difference value by rater Fig. 5b. Heat map displaying proportion of raters with each difference value by video Fig. 5c. Heat map displaying proportion of endoscopists with each difference value by video Fig. 5d. Heat map displaying proportion of surgeons with each difference value by video

Source: PubMed

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