Conflict of interests: Dr. Saito received personal fees from TAIHO Pharmaceutical Co. Ltd, outside the scope of the submitted work. Drs. Ozaki and Tanimoto received personal fees from Medical Network Systems outside the scope of the submitted work. Dr. Tanimoto also received personal fees from Bionics Co. Ltd, outside the scope of the submitted work.

Author contributions: Anju Murayama: Study concept and design, data collection, statistical analysis, study supervision, manuscript preparation and review, study administration. Sae Kamamoto: Study concept and design, data collection, statistical analysis, visualization, and manuscript preparation and review. Nanami Murata: Study concept and design, data collection, statistical analysis, and manuscript preparation. Ryota Yamasaki: Study concept and design and data collection. Kohki Yamada: Data collection and manuscript preparation. Erika Yamashita: Study concept, study design, and data collection. Hiroaki Saito: Study concept and design and manuscript preparation and review. Tetsuya Tanimoto: Study concept and design and manuscript preparation and review. Akihiko Ozaki: Study concept and design, funding acquisition, and manuscript review, and study supervision. Anju Murayama and Sae Kamamoto had full access to all study data. All authors take responsibility for the integrity of the data and the accuracy of data analysis.

Funding sources: This study was funded in part by the Medical Governance Research Institute. This nonprofit enterprise receives donations from a dispensing pharmacy, Ain Pharmacies, Inc., and private individuals. This study also received support from Tansa (formerly known as the Waseda Chronicle), an independent nonprofit news organization dedicated to investigative journalism. None of the entities providing financial support for this study contributed to the design, execution, data analyses, interpretation of study findings, or manuscript preparation.

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Abstract

Background

Clinical practice guidelines assist healthcare professionals in providing evidence-based care. However, pharmaceutical companies' financial interests often influence guideline content. This study aimed to elucidate the magnitude of financial ties among Japanese gastroenterology guideline authors and the pharmaceutical industry.

Methods

Using pharmaceutical company disclosed payment data, we evaluated financial conflicts of interest (COI) among Japanese Society of Gastroenterology guideline authors between 2016 and 2021. Additionally, we assessed the evidence quality supporting guideline recommendations and associations with financial COI. Finally, we evaluated author COI management during guideline development against global standards.

Results

Overall, 88.2% (231/262) of guideline authors received a median of $12 968 (interquartile range [IQR]: $1839–$70 374) in payments between 2016 and 2019 for lectures, writings, and consulting. Chairpersons received significantly higher payments (median: $86 444 [IQR: $15 455–$165 679]). Notably, 41 (15.6%) authors had undeclared payments exceeding declaration requirements. Low or very low-quality evidence supported 41.0% of recommendations. There was a negative association between the median 4-year payment per author and the proportion of recommendations based on low-quality evidence (odds ratio: 0.966 [95% confidence interval [95% CI]: 0.945–0.987], P = 0.002) and positive association with moderate-quality evidence (odds ratio: 1.018 [95% CI: 1.011–1.025], P < 0.001). Still, the Japanese Society of Gastroenterology guideline development process remains less transparent, with insufficient COI policies relative to global standards.

Conclusion

There were extensive financial COI between pharmaceutical companies and guideline authors, and more than 40% of recommendations were based on low-quality evidence. More rigorous and transparent COI policies for guideline development adhering to global standards are warranted.

Supporting Information

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Volume38, Issue4

April 2023

Pages 565-573

Evaluation of financial conflicts of interest and quality of evidence in Japanese gastroenterology clinical practice guidelines

Abstract

Background

Methods

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Conclusion

Supporting Information

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Evaluation of financial conflicts of interest and quality of evidence in Japanese gastroenterology clinical practice guidelines

Abstract

Background

Methods

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Conclusion

Supporting Information

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Citing Literature

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