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Original research
Validity of the COmprehensive Score for financial Toxicity (COST) in patients with gynecologic cancer
  1. Yusuke Kajimoto1,2,
  2. Takashi Shibutani3,
  3. Shoji Nagao3,4,
  4. Satoshi Yamaguchi3,
  5. Shiro Suzuki5,
  6. Masahiko Mori5,
  7. Hirofumi Tsubouchi5,
  8. Kohshiro Nakao6,
  9. Anri Azuma6,
  10. Takahiro Koyanagi7,
  11. Izumi Kohara8,
  12. Shuko Tamaki9,
  13. Midori Yabuki9,
  14. Lida Teng1,
  15. Kazunori Honda10 and
  16. Ataru Igarashi1,11
  1. 1 Graduate School of Pharmaceutical Sciences, The University of Tokyo, Tokyo, Japan
  2. 2 Oncology Science Unit, MSD K.K, Tokyo, Japan
  3. 3 Department of Gynecologic Oncology, Hyogo Cancer Center, Hyogo, Japan
  4. 4 Department of Obstetrics and Gynecology, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama University, Okayama, Japan
  5. 5 Department of Gynecologic Oncology, Aichi Cancer Center Hospital, Aichi, Japan
  6. 6 Department of Obstetrics and Gynecology, Gunma University Graduate School of Medicine, Gunma, Japan
  7. 7 Department of Obstetrics and Gynecology, Jichi Medical University, Tochigi, Japan
  8. 8 School of Nursing, Jichi Medical University, Tochigi, Japan
  9. 9 Nursing Department, Saitama Medical University International Medical Center, Saitama, Japan
  10. 10 Department of Clinical Oncology, Aichi Cancer Center Hospital, Aichi, Japan
  11. 11 Unit of Public Health and Preventive Medicine, Yokohama City University School of Medicine, Kanagawa, Japan
  1. Correspondence to Yusuke Kajimoto, Graduate School of Pharmaceutical Sciences, The University of Tokyo, Tokyo, Japan; ykajimoto234{at}gmail.com

Abstract

Objective Financial toxicity is a financial burden of cancer care itself, which leads to worse quality of life and higher mortality and is considered an adverse effect. The COmprehensive Score for financial Toxicity (COST) tool is a patient-reported outcome measurement used to evaluate financial toxicity. We aimed to validate the internal consistency and reproducibility of the COST tool in patients with gynecologic cancer.

Methods In this multicenter study covering the period April 2019 to July 2021, using the COST tool in Japan, patients diagnosed with ovarian, cervical, or endometrial cancer receiving systemic anti-cancer drug therapy for more than 2 months were eligible. Patients with no out-of-pocket costs for direct medical costs were excluded. The patients answered the initial test and a retest, which was completed from 2 to 14 days after the initial test. Internal consistency and reproducibility were assessed using Cronbach’s alpha and intraclass correlation coefficient (ICC), respectively. Cronbach’s alpha ≥0.8 indicates good internal consistency, and ICC ≥0.8 is highly reliable.

Results A total of 112 patients (ovarian: 50, cervical: 26, endometrial: 36) responded to the initial test, and 89 patients answered the retest from 2 to 14 days after the initial test. The median patient age was 58 (range, 28–78) years. The median COST score was 19. Cronbach’s alpha showed good internal consistency at 0.83 (95% CI 0.78 to 0.87). The ICC at 0.850 (95% CI 0.777 to 0.900) showed high reliability.

Conclusions The COST tool has good internal consistency and reliable reproducibility in patients with gynecologic cancer in Japan. The COST tool quantifies financial toxicity in the insurance system, where patients have limited out-of-pocket direct medical costs. The results support the use of the COST tool in patients with gynecologic cancer.

  • quality of life (PRO)/palliative care
  • ovarian cancer
  • cervical cancer
  • uterine cancer
  • medical oncology

Data availability statement

Data are available upon reasonable request. Individual participant data that underlie the results reported in this article after deidentification and study materials of the study is available upon reasonable request.

https://doi.org/10.1136/ijgc-2022-003410

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    Data availability statement

    Data are available upon reasonable request. Individual participant data that underlie the results reported in this article after deidentification and study materials of the study is available upon reasonable request.

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    Footnotes

    • Contributors YK: garantor for the overall content, conceptualization, methodology, formal analysis, resources, data curation, writing – original draft, project administration. KH: conceptualization, methodology, resources, investigation, writing – original draft. LT: writing the original draft, project administration. AI: conceptualization, methodology, formal analysis, writing – review and editing, supervision. Other authors: investigation, resources, writing – review and editing.

    • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

    • Competing interests YK is an employee of the MSD K.K. AI received a consultant fee, grants, and other from Pfizer Japan Inc. and Terumo Corporation; a consultant fee and grants from Becton Dickinson and Company, Milliman Inc., and Taiho Pharmaceutical Co. Ltd.; a consultant fee and other from Abbvie GK, Ayumi Pharmaceutical Inc., Chugai Pharmaceuticals Inc., Eisai Inc., GSK, Nippon Boehringer Ingelheim Inc., Novartis Pharma K.K., Novo Nordisk Japan Inc., Ono Pharmaceutical Inc., Sumitomo Dainippon Pharma Inc., and Takeda Pharmaceutical Inc.; a consultant fee from Otsuka Pharmaceutical Co., Ltd. and Sanofi Japan Inc.; grants and other from Gilead Sciences K.K.; grants from Boston Scientific Japan Inc. and Intuitive Surgical GK.; other from Astellas Pharma Inc., CSL Behring Japan Inc., Fuji film Inc., and Medilead Inc.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.