Institut für Medizinische Biometrie
und Statistik (IMBI)

Inhalt:

For many years the quality of research in the health sciences has been heavily criticized. It is argued that serious improvement would be possible if biomedical research is better chosen, designed, executed, analyzed, regulated, managed, disseminated, and reported. Serious improvements are far from being simple for many of the issues mentioned, but suitable guidance documents have been developed to improve the reporting of research. Severe weaknesses in this area are unnecessary and can be avoided. Concerning issues in reporting of health sciences the EQUATOR (Enhancing the QUAlity and Transparency Of health Research, https://www.equator-network.org/) network acts as an umbrella organization (Simera et al. 2009).

Unfortunately, many reviews of publications have clearly shown that the quality of reporting of studies is still bad. Problems seem to be less severe for randomized controlled trials (RCTs) than for observational studies. In the latter even basic items of the study population and relevant details of statistical analyses are often not provided. A large systematic review and critical appraisal of the quality and usefulness of published prediction models for diagnosis and prognosis of covid-19 has clearly demonstrated the importance of complete, transparent and unbiased reporting of research in the health sciences (Wynants et al. 2022).

The seminar will start with a brief overview of guidelines for many different types of studies. To illustrate more specific issues, we will consider randomized controlled trials (CONSORT statement, Schulz et al. 2010), prognostic factor studies (REMARK recommendations, Mc Shane et al. 2005, Sauerbrei et al. 2018) and prediction models (TRIPOD statement, Collins et al. 2015).

The REMARK reporting guideline supports researchers in reporting key aspects of tumor marker prognostic studies. A ‘REMARK profile’ was proposed to augment these guidelines to aid in structured reporting with an emphasis on including all aspects of analyses conducted. Sauerbrei et al. (2022) assessed fifteen studies published in 2015: three from each of five oncology journals and summarized the key information in a REMARK profile consisting of details about the patient population with available variables and follow-up data, and a list of all analyses conducted. Some of these studies will be discussed in more detail and we will work on profiles for several studies published in 2022.

The principle of structured reporting can also be transferred to methodological studies, such as simulation studies or meta-analyses (De Bin et al. 2019, Sauerbrei and Royston 2022). We will also consider examples of methodological research.

References

• Collins, G. S., Reitsma, J. B., Altman, D. G., & Moons, K. G. (2015). Transparent reporting of a multivariable prediction model for individual prognosis or diagnosis (TRIPOD): the TRIPOD statement. Journal of British Surgery, 102(3), 148-158.
• De Bin, R., Boulesteix, A. L., Benner, A., Becker, N., & Sauerbrei, W. (2020). Combining clinical and molecular data in regression prediction models: insights from a simulation study. Briefings in Bioinformatics, 21(6), 1904-1919.
• McShane, L. M., Altman, D. G., Sauerbrei, W., Taube, S. E., Gion, M., & Clark, G. M. (2005). Reporting recommendations for tumor marker prognostic studies (REMARK). Journal of the National Cancer Institute, 97(16), 1180-1184.
• Moher D, Altman DG, Schulz KF, Simera I, Wager E (editors) (2014). Guidelines for Reporting Health Research: A User’s Manual, John Wiley & Sons.
• Sauerbrei, W., Haeussler, T., Balmford, J., & Huebner, M. (2022). Structured reporting to improve transparency of analyses in prognostic marker studies. BMC medicine, 20(1), 1-19.
• Sauerbrei, W., Royston, P. (2022). Investigating treatment-effect modification by a continuous covariate in IPD meta-analysis: an approach using fractional polynomials. BMC medical research methodology, 22(1), 1-13.
• Sauerbrei W, Taube SE, McShane LM, Cavenagh MM, Altman DG (2018). Reporting Recommendations for Tumor Marker Prognostic Studies (REMARK): An Abridged Explanation and Elaboration. J Natl Cancer Inst. 110(8): 803-811.
• Schulz KF, Altman DG, Moher D; CONSORT Group. CONSORT 2010 statement: updated guidelines for reporting parallel group randomized trials. Ann Intern Med. 2010 1;152(11):726-32.
• Simera I, Moher D, Hoey J, Schulz KF, Altman DG. The EQUATOR Network and reporting guidelines: Helping to achieve high standards in reporting health research studies. Maturitas. 2009 May 20;63(1):4-6. doi: 10.1016/j.maturitas.2009.03.011. Epub 2009 Apr 15. PMID: 19372017
• Wynants, L., Van Calster, B., Collins, G. S., Riley, R. D., Heinze, G., Schuit, E., ... & van Smeden, M. (2020). Prediction models for diagnosis and prognosis of covid-19: systematic review and critical appraisal. bmj, 369.