Development of a Communication Tool between Patients and Physicians for Recognizing COPD Exacerbations in Japan

Abstract

In Japan, exacerbations are underreported compared with other countries, possibly due in part to a failure to recognize them. This study aimed to create a simple chronic obstructive pulmonary disease (COPD) Exacerbation Recognition Tool (CERT-J) specifically for Japanese patients. Patients ≥40 years with confirmed COPD or asthma-COPD overlap were included. Focus groups were held to identify words and phrases used by patients to describe symptoms associated with an exacerbation, resulting in candidate items being identified. Following cognitive debriefing, the items were refined based on item frequency, level of endorsement and effect of demographic factors. Exploratory factor analysis (EFA) was then performed to inform an expert panel’s choice of items to form the new tool. A total of 41 patients were included in the focus groups and nine patients performed the cognitive debrief. Following this, the expert panel identified 26 items for testing in a further 100 patients (mean age 72 years, forced expiratory volume in 1 s 54.8% predicted and 1.8 exacerbations in the preceding 12 months). Eleven items were associated with breathlessness or activity limitation and seven of these were the most frequently endorsed. EFA identified four factors, with one (breathlessness) being dominant. The expert panel recommended that the CERT-J should include six items: breathlessness and activity limitation (3 items), cough (1 item) and phlegm (2 items). The final CERT-J should benefit patients with COPD by providing them with an increased understanding and recognition of exacerbations.

Clinical Trial Registration: GSK K.K (jRCT1080224526).

Keywords:

• Patient-reported outcome
• focus group discussion
• CERT
• cognitive debriefing
• factor analysis
• communication tool

Acknowledgments

We would like to pay our gratitude and our respects to our colleague, respiratory specialist and Visiting Professor Shu Hashimoto who passed away in July of 2022. He was a dedicated professor in the Department of Internal Medicine, Nihon University, Division of Respiratory Medicine, Tokyo, Japan, and as the leader of the study expert panel, had made significant contributions to the conception and design of this study, and the analysis and interpretation of the data.

Editorial support in the form of preparation of the first draft based on input from all authors, and collation and incorporation of author feedback to develop subsequent drafts, was provided by Alexandra Berry, PhD, at Fishawack Indicia Ltd, UK, part of Fishawack Health, and was funded by GSK. We thank the patients and investigators in Japan who participated in this study.

Authors’ contributions

All authors made substantial contributions to conception and design, or analysis and interpretation of data; took part in drafting the article or revising it critically for important intellectual content; agreed to submit to the current journal; gave final approval of the version to be published; and agree to be accountable for all aspects of the work.

Paul Jones, Keiko Sato, Eri Sasaki, Osamu Hataji, Toru Oga, Yoshimi Suzukamo, Bruce Crawford and Yoko Sakai contributed to the conception and design of the study. Osamu Hataji contributed to the acquisition of data. All authors contributed to the data analysis and interpretation.

Disclosure statement

The corresponding author had full access to all the data and the final responsibility to submit for publication. Kenichi Hashimoto and Paul Jones are employees of GSK and hold stocks/shares. Eri Sasaki is an employee of GSK. Takeo Ishii and Keiko Sato are former employees of GSK and holds stocks/shares. Toru Oga, Osamu Hataji and Yoshimi Suzukamo have no conflicts of interest to declare. Bruce Crawford and Yoko Sakai are former employees of Syneos Health. Syneos Health received funding from GSK to conduct the study, and were involved in Part 1 and 2 interviews, Part 3 site monitoring, analysis of the study, and study report. Employees of Syneos Health were not paid for manuscript development.

Funding

This study was funded by GSK (Study 208637). The funders of the study had a role in study design, data analysis, data interpretation, and writing of the report.

Consent for publication

All authors have provided final approval of the published version of the manuscript.

Data availability

Due to the nature of this research, participants of this study did not agree for their data to be shared publicly, so supporting data is not available.