¹Institut für Medizinische Biometrie und Informatik, Universitätsklinikum Freiburg, Freiburg, Germany

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Introduction: For many years, the quality of health science research has been heavily criticized. It is argued that significant improvement would be possible, if research were better chosen, designed, done, analyzed, regulated, managed, disseminated, and reported [1]. Although some of these issues may be difficult to address, there are also some low hanging fruits to improve research. Appropriate reporting guidelines are available, the EQUATOR (Enhancing the QUAlity and Transparency Of health Research; https://www.equator-network.org/) network acts as an umbrella organization, and authors should adhere to them. An improvement of reporting is easily achievable by following a structured reporting approach [2]. Study registration is standard in pharmaceutical research but less popular in other types of studies. The STRengthening Analytical Thinking for Observational Studies (STRATOS, https://www.stratos-initiative.org/en) initiative was launched in 2013 with the main aim to provide accessible, evidence-based guidance for key topics in the design and analysis of observational studies. Guidance is intended for applied statisticians and other data analysts with varying levels of statistical background and experience [3]. Developing such guidance for analysis is much more difficult than proposing guidelines for reporting, but guidance is urgently needed to help standardize and improve analyses of observational studies.

Methods: In this talk, we will concentrate on two issues. First, we will provide a short overview of the main aims of the STRATOS initiative. Second, for prognostic factor research, we will introduce the two-part REMARK profile, a structured display summarizing key aspects of a study, especially the derivation of the sample and information about all analyses performed. We will discuss some REMARK profiles derived for 15 articles published in five cancer journals [4]. Furthermore, we will show that the concept of the REMARK profile can be transferred to studies in methodological research [5].

Results: We will illustrate that the REMARK profile is a suitable way to improve completeness and transparency of reporting and helps to identify weaknesses of analyses. Adapted versions of the profile can be used to provide an informative overview of all analyses conducted in simulation studies.

Conclusion: The concept of structured reporting can be applied to various types of studies in clinical and methodological research. The REMARK profile and adapted versions of structured reporting for other types of studies are suitable instruments for improving the quality of reporting and transparency of many types of studies. Together with study registration and guidance for analysis, structured reporting increases the trustworthiness of results from observational studies.

The authors declare that they have no competing interests.

The authors declare that an ethics committee vote is not required.

References

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[2] Altman DG, McShane LM, Sauerbrei W, Taube SE. Reporting recommendations for tumor marker prognostic studies (REMARK): explanation and elaboration. BMC Med. 2012;10(1):51. DOI: 10.1186/1741-7015-10-51
[3] Sauerbrei W, Abrahamowicz M, Altman DG, le Cessie S, Carpenter J, STRATOS initiative. STRengthening analytical thinking for observational studies: the STRATOS initiative. Stat Med. 2014;33(30):5413–32. DOI: 10.1002/sim.6265
[4] Sauerbrei W, Haeussler T, Balmford J, Huebner M. Structured reporting to improve transparency of analyses in prognostic marker studies. BMC Med. 2022;20(1):184. DOI: 10.1186/s12916-022-02304-5
[5] Sauerbrei W, Kipruto E, Balmford J. Effects of influential points and sample size on the selection and replicability of multivariable fractional polynomial models. Diagn Progn Res. 2023;7(1):7. DOI: 10.1186/s41512-023-00145-1