Multi-national observational study to assess quality of life and treatment preferences in patients with Crohn’s perianal fistulas
Chitra Karki, Amod Athavale, Vijay Abilash, Gary Hantsbarger, Parnia Geransar, Kate Lee, Slobodan Milicevic, Marko Perovic, Leanne Raven, Magdalena Sajak-Szczerba, Abigail Silber, Annabelle Yoon, Phil Tozer
Chitra Karki, Global Evidence and Outcomes-Gastroenterology, Takeda Pharmaceuticals United States, Inc, Cambridge, MA 02139, United States
Amod Athavale, Vijay Abilash, Abigail Silber, Trinity Partners, LLC, Waltham, MA 02451-7528, United States
Gary Hantsbarger, Observational Research, Takeda Pharmaceuticals United States, Inc, Cambridge, MA 02139, United States
Parnia Geransar, Slobodan Milicevic, Medical Affairs, Takeda Pharmaceuticals International Co., Opfikon 8152, Zurich, Switzerland
Kate Lee, Research and Patient Programs, Crohn’s and Colitis Canada, 600-60 St. Clair Avenue East, Toronto M4T 1N5, Ontario, Canada
Marko Perovic, Treasurer, European Federation of Crohn’s & Ulcerative Colitis Associations, Brussels B 1000, Belgium
Leanne Raven, Crohn’s and Colitis Australia, Camberwell South, VIC 3124, Australia
Magdalena Sajak-Szczerba, European Federation of Crohn’s & Ulcerative Colitis Associations, Brussels B 1000, Belgium
Annabelle Yoon, Japan Medical Office, Takeda Pharmaceutical Company Limited, Tokyo 103-8668, Japan
Phil Tozer, Department of Colorectal Surgery, St Mark’s Hospital and Academic Institute, London HA1 3UJ, United Kingdom
Author contributions: Karki C, Athavale A, Abilash V, Hantsbarger G, Geransar P, Lee K, Milicevic S, Perovic M, Raven L, Sajak-Szczerba M, Silber A, Yoon A, and Tozer P contributed to the conceptualization of the study; Athavale A, Abilash V, and Silber A contributed to the data curation; Athavale A, Abilash V, and Silber A contributed to the formal analysis; Karki C contributed to the funding acquisition; Karki C, Athavale A, Abilash V, and Silber A contributed to the investigation; Karki C, Athavale A, Abilash V, Hantsbarger G, and Tozer P performed the methodology; Athavale A, Abilash V, and Silber A contributed to the project administration; Karki C and Athavale A contributed to the resourcing; Athavale A provided software expertise; Karki C and Athavale A contributed to the supervision of the study; Athavale A, Abilash V, Hantsbarger G, Geransar P, Lee K, Milicevic S, Perovic M, Raven L, Sajak-Szczerba M, Silber A, Yoon A, and Tozer P contributed to the validation; Athavale A, Abilash V, and Silber A contributed to the visualization; Karki C, Athavale A, Abilash V, Hantsbarger G, Geransar P, Lee K, Milicevic S, Perovic M, Raven L, Sajak-Szczerba M, Silber A, Yoon A, and Tozer P contributed to the writing, review, and editing of the manuscript.
Institutional review board statement: This study was conducted in accordance with the World Medical Association Declaration of Helsinki and Guidelines for Good Pharmacoepidemiology Practices (GPP) and submitted to all applicable local Institutional Review Boards and Ethics Committees to ensure compliance with all ethical standards in each country.
Informed consent statement: Personally identifiable data were not collected in this study. As this was an observational study, consent to any interventional procedure or treatment was not applicable. Consent for participation in the study was solicited by requesting participants to agree to a statement indicating the purpose of the study and a brief summary of the information to be collected. This was carried out prior to entry into the web-enabled questionnaire with a description of the study and its purpose, and responses.
Conflict-of-interest statement: CK is an employee and shareholder of Takeda Pharmaceuticals. AA is an employee of Trinity Life Sciences, commissioned by Takeda Pharmaceuticals to conduct this study. VA is an employee of Trinity Life Sciences, commissioned by Takeda Pharmaceuticals to conduct this study. GH is an employee and shareholder of Takeda Pharmaceuticals. PG is an employee and shareholder of Takeda Pharmaceuticals. KL has served on advisory boards for Takeda Pharmaceuticals. SM is an employee and shareholder of Takeda Pharmaceuticals. MP has no conflicts of interest to disclose. LR has served on advisory boards for Roche and Takeda Pharmaceuticals. MSS has nothing to disclose. AS is an employee of Trinity Life Sciences, commissioned by Takeda Pharmaceuticals to conduct this study. AY is an employee of Takeda Pharmaceuticals. PT has received speaker’s fees from Ferring and Takeda Pharmaceuticals and served on advisory boards for Takeda Pharmaceuticals.
Data sharing statement: Data sets supporting the results from this study are available from the corresponding author upon reasonable request. The data sets will be provided after deidentification, in compliance with applicable privacy laws, data protection, and requirements for consent and anonymization.
STROBE statement: The authors have read the STROBE Statement—checklist of items, and the manuscript was prepared and revised according to the STROBE Statement—checklist of items.
Open-Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See:
https://creativecommons.org/Licenses/by-nc/4.0/ Corresponding author: Chitra Karki, Director, Global Evidence and Outcomes-Gastroenterology, Takeda Pharmaceuticals United States, Inc, 350 Massachusetts Avenue, Cambridge, MA 02139, United States. chitra.karki@takeda.com
Received: July 21, 2023
Peer-review started: July 21, 2023
First decision: August 15, 2023
Revised: September 27, 2023
Accepted: October 30, 2023
Article in press: October 30, 2023
Published online: November 27, 2023
