In March 2021, AME Publishing Company translated the book “Guidelines for Reporting Health Research: A User’s Manual” into Chinese and completed the work in June 2021. While the Chinese edition is now beginning official publication, the AME editorial office launches alongside its publication interviews with the book editors and authors, hoping to highlight some updates on the status and trends of the reporting guidelines in the Chinese edition.
We take pleasure in interviewing Dr. Patrick M.M. Bossuyt; here, he shares his insights based on the book. Dr. Patrick M.M. Bossuyt is a chapter author of the book, and his chapter is titled, “STARD (STAndards for Reporting of Diagnostic Accuracy Studies)”.
Dr. Patrick M. Bossuyt is the professor of Clinical Epidemiology at the Amsterdam University Medical Centers, where he leads the Biomarker and Test Evaluation research program. The BiTE program aims to appraise and develop methods for evaluating medical tests and biomarkers, and to apply these methods in relevant clinical studies. In doing so, the program wants to strengthen the evidence base for rational decision-making about the use of tests and testing strategies in health care. Dr. Bossuyt spearheaded the STARD initiative for the improved reporting of diagnostic test accuracy studies.
Dr. Bossuyt has authored and co-authored several hundred publications in peer reviewed journals and serves on the editorial board of a number of these, including Radiology and Clinical Chemistry. He has supervised over 90 PhD students. Dr Bossuyt chairs the Scientific Advisory Committee of the Dutch Health Insurance Board, which oversees the health care benefits covered in the national insurance program.
AME: Thank you and your STARD group for sharing the STARD 2015 with our readers in Annals of Translational Medicine (published by AME) in 2016(https://atm.amegroups.com/article/view/9342/9957). What are the feedbacks received from users on the STARD 2015 since the STARD update?
Patrick M.M. Bossuyt: In general, the feedback has been very positive, both from authors, editors, and professional organizations. The effects of STARD are also visible beyond articles reporting on diagnostic accuracy studies. The terminology used in the STARD 2003 and the STARD 2015 is now more or less the standard in the field. Terms like “diagnostic accuracy”, “target condition” and “(clinical) reference standard” are used in many texts.
AME: To your knowledge, how many journals that regularly publish diagnostic accuracy studies have made STARD a strict requirement for submission? For example, we (AME) have required the compliance with STARD in the journals’ guidelines for authors and completion of the checklist for submission.
Patrick M.M. Bossuyt: We do not know exactly how many journals require actual submission of the completed checklist. Many years ago we counted already over 200 journals. We have previously noted that the language used in the instructions to authors varies enormously between journals.
AME: Our survey of four medical laboratory journals found that compliance with STARD guidelines in current diagnostic accuracy studies was not satisfactory(https://atm.amegroups.com/article/view/72061/html). What do you think is the main reason for the poor reporting of these items?
Patrick M.M. Bossuyt: Ignorance. Many authors are not aware, for example, that the diagnostic accuracy of a test is not a fixed characteristic, but a feature that varies with the intended use, the population tested, and the clinical setting. Ignorance about statistical imprecision may explain the absence of 95% confidence intervals.
AME: In the study mentioned in question 3, we interviewed the experts of diagnostic accuracy studies about the most important items in STARD for review and their answers show a big difference. Which are your prioritized items?
Patrick M.M. Bossuyt: This will depend on the reader’s purpose and questions for studying the manuscript. When finding out whether the study – of a test for SARS-CoV-2, for example – is informative of the clinical performance in a real-world setting, for example, the items about study design and recruitment of participants may be most relevant (items 5-9).
Acknowledgments
We would like to express our sincerest gratitude to Dr. Patrick M.M. Bossuyt for sharing his insights and opinions with us.