1. A proposed staging system and stage-specific interventions for familial adenomatous polyposis
- Author
-
Steffen Bülow, Lucio Bertario, Maria Pellise, Sijin Wen, Randall W. Burt, Andrea Belluzzi, Gottumukkala S. Raju, Shailesh Advani, George J. Chang, Susan K. Clark, Brian D. Saunders, Niels Jespersen, Sapna Syngal, Arnold J. Markowitz, Jeffrey S. Morris, William A. Ross, Takeo Iwama, Nagahide Matsubara, Steven H. Erdman, Luigi Ricciardiello, Patrick M. Lynch, Paul E. Wise, Niels de Haas, Gabriela Moeslein, Benedito Mauro Rossi, Elena M. Stoffel, Dennis J. Ahnen, Inge Bernstein, Miguel A. Rodriguez-Bigas, Lynch, Patrick M, Morris, Jeffrey S., Wen, Sijin, Advani, Shailesh M., Ross, William, Chang, George J., Rodriguez-Bigas, Miguel, Raju, Gottumukkala S., Ricciardiello, Luigi, Iwama, Takeo, Rossi, Benedito M., Pellise, Maria, Stoffel, Elena, Wise, Paul E., Bertario, Lucio, Saunders, Brian, Burt, Randall, Belluzzi, Andrea, Ahnen, Denni, Matsubara, Nagahide, Bülow, Steffen, Jespersen, Niel, Clark, Susan K., Erdman, Steven H., Markowitz, Arnold J., Bernstein, Inge, De Haas, Niel, Syngal, Sapna, and Moeslein, Gabriela
- Subjects
Male ,medicine.medical_specialty ,Consensus ,Endoscopic Mucosal Resection ,Adenomatous polyposis coli ,Concordance ,Psychological intervention ,Video Recording ,Colonoscopy ,Severity of Illness Index ,Article ,Familial adenomatous polyposis ,Neoplasms, Multiple Primary ,03 medical and health sciences ,0302 clinical medicine ,Internal medicine ,medicine ,Humans ,Radiology, Nuclear Medicine and imaging ,Stage (cooking) ,Sigmoidoscopy ,Colectomy ,Neoplasm Staging ,Gastroenterology & Hepatology ,biology ,medicine.diagnostic_test ,business.industry ,Gastroenterologists ,Gastroenterology ,1103 Clinical Sciences ,medicine.disease ,Surgery ,Clinical trial ,Sulfasalazine ,Adenomatous Polyposis Coli ,030220 oncology & carcinogenesis ,biology.protein ,030211 gastroenterology & hepatology ,Female ,business ,Colorectal Surgery - 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.
- Published
- 2016
- Full Text
- View/download PDF