Publications

• Thiébaut ACM,  Perperoglou A, Sedki M, Guerra SF, Gustafson P, Frank E. Harrell FEJ, Sauerbrei W, Abrahamowicz M,  Freedman LS On behalf of Selection of Variables and Functional Forms in Multivariable Analysis Topic Group (TG2) and Measurement Error and Misclassification Topic Group (TG4) of the international STRATOS initiative (2026): Methods for Adjusting for Covariate Measurement Error in Flexible Modeling of Functional Form: Designing a Blinded, Controlled Neutral Comparison Simulation Study Biometrical Journal, 2026; 68:e70155 DOI: 10.1002/bimj.70155

• Van Calster B, Collins GS, Vickers AJ, Wynants L, Kerr KF, Barreñada L, Varoquaux G, Singh K, GM Moons KGM, Hernandez-Boussard T, Timmerman D, McLernon DJ, van Smeden M, Steyerberg EW, on behalf of TG6 of the STRATOS initiative (2025): Evaluation of performance measures in predictive artificial intelligence models to support medical decisions: overview and guidance. The Lancet Digital Health. https://doi.org/10.1016/j.landig.2025.100916

• Sekula P, Steinbrenner I, Schultheiss UT, Valveny N, Rebora P, Halabi S, Cadarette SM ,Riley RD, Collins GS,Sauerbrei W, Gail MH, for topic group 5 of the STRATOS initiative (2025). Design aspects for prognostic factor studies. BMJ open, 15(8), e095065. doi:10.1136/bmjopen-2024-095065

• Ullmann T, Heinze G, Abrahamowicz M, Perperoglou A, Sauerbrei W, Schmid M, Dunkler D (2025): A Systematic Categorization of Performance Measures for Estimated Non‐Linear Associations Between an Outcome and Continuous Predictors. WIREs Computational Statistics 17. https://doi.org/10.1002/wics.70042 

• Stolte M, Schreck N, Slnko A, Saadati M, Benner A, Rahnenführer J, Bommert for the topic group “High-dimensional data” (TG9) of the STRATOS Initiative Simulation study to evaluate when Plasmode simulation is superior to parametric simulation in comparing classification methods on high-dimensional data. PLoS One 20(6): e0322887. https://doi.org/10.1371/journal.pone.0322887 

• Lusa L, Kappenberg F, Collins GS, Schmid M, Sauerbrei W, Rahnenführer J on behalf of the Topic Group for High-Dimensional data of the STRATOS initiative (2025): Evaluation of changes in prediction modelling in biomedicine using systematic reviews. BMC Med Res Methodol, 25(1), 167. https://doi.org/10.1186/s12874-025-02605-2

• Lusa L, Proust-Lima C, Schmidt CO, Lee KJ, le Cessie S, Baillie M, Lawrence F, Huebner M, on behalf of TG3 of the STRATOS Initiative (2024): Initial data analysis for longitudinal studies to build a solid foundation for reproducible analysis. PLoS ONE 19(5): e0295726. https://doi.org/10.1371/journal.pone.0295726

• Abrahamowicz M, Beauchamp ME, Boulesteix AL, Morris TP, Sauerbrei W, Kaufman JS, on behalf of the STRATOS Simulation Panel (2024): Data-driven simulations to assess the impact of study imperfections in time-to-event analyses. American Journal of Epidemiology; kwae058, https://doi.org/10.1093/aje/kwae058

• Ullmann T, Heinze G, Hafermann L, Schilhart-Wallisch C, Dunkler D, for TG2 of the STRATOS initiative (2024): Evaluating variable selection methods for multivariable regression models: A simulation study protocol. PLoS ONE 19(8): e0308543. https://doi.org/10.1371/journal.pone.0308543

• Heinze G, Baillie M, Lusa L, Sauerbrei W, Schmidt CO, Harrell FE, Huebner M on behalf of TG2 and TG3 of the STRATOS initiative (2024): Regression without regrets –initial data analysis is a prerequisite for multivariable regression. BMC Med Res Methodol 24(178). https://doi.org/10.1186/s12874-024-02294-3

• Boe LA, Shaw PA, Midthune D, Gustafson P, Kipnis V, Park E, Sotres-Alvarez D, Freedman L, on behalf of the Measurement Error and Misclassification Topic Group (TG4) of the STRATOS Initiative (2024): Issues in Implementing Regression Calibration Analyses. American Journal of Epidemiology, 192(8):1406–1414. https://doi.org/10.1093/aje/kwad098

• McLernon DJ, Giardiello D, Van Calster B, Wynants L, van Geloven N, van Smeden M, Therneau T, Steyerberg EW, topic groups 6 and 8 of the STRATOS Initiative (2023): Assessing performance and clinical usefulness in prediction models with survival outcomes: practical guidance for Cox proportional hazards models. Annals of Internal Medicine. DOI: https://doi.org/10.7326/M22-0844

• Rahnenführer J, De Bin R, Benner A, Ambrogi F, Lusa L, Boulesteix AL, Migliavacca E, Binder H, Michiels S, Sauerbrei W, McShane L, for topic group “High-dimensional data” (TG9) of the STRATOS initiative (2023): Statistical analysis of high-dimensional biomedical data: a gentle introduction to analytical goals, common approaches and challenges. BMC Medicine. DOI: https://doi.org/10.1186/s12916-023-02858-y

• Heinze G, Boulesteix AL, Kammer M, Morris TP, White IR for the Simulation Panel of the STRATOS initiative (2023): Phases of methodological research in biostatistics – Building the evidence base for new methods. Biometrical Journal. DOI: https://doi.org/10.1002/bimj.202200222 short summary

• Little R.J., Carpenter J.R. and Lee K.J. (2022): A Comparison of Three Popular Methods for Handling Missing Data: Complete-Case Analysis, Inverse Probability Weighting, and Multiple Imputation. Sociological Methods & Research short summary

• van Geloven N, Giardiello D, Bonneville EF, Teece L, Ramspek CL, van Smeden M, Snell KIE, van Calster B, Pohar-Perme M, Riley RD, Putter H, Steyerberg E, on behalf of the STRATOS initiative (2022): Validation of predicition models in the presence of comepting risks: a guide through modern methods. BMJ. DOI: https://www.bmj.com/content/377/bmj-2021-069249 short summary

• Baillie M, le Cessie S, Schmidt CO, Lusa L, Huebner M, for the Topic Group “Initial Data Analysis” of the STRATOS Initiative (2022): Ten simple rules for initial data analysis. PLoS Comput Biol 18(2): e1009819. https://doi.org/10.1371/journal.pcbi.1009819 short summary

• Wallisch C, Bach P, Hafermann L, Klein N, Sauerbrei W, Steyerberg EW, et al. (2022): Review of guidance papers on regression modeling in statistical series of medical journals. PLoS ONE 17(1): e0262918. DOI: https://doi.org/10.1371/journal.pone.0262918  selected parts short summary

• Lee KJ, Tilling K, Cornish RP, Little RJ, Bell ML, Goetghebeur E, Hogan JW, Carpenter JR for the STRATOS initiative (2021): Framework for the Treatment And Reporting of Missing data in Observational Studies: The TARMOS framework. DOI: https://doi.org/10.1016/j.jclinepi.2021.01.008 short summary

• Bach P, Wallisch C, Klein N, Hafermann L, Sauerbrei W, Steyerberg EW, Heinze G, Rauch G, for topic group 2 of the STRATOS initiative (2020): Systematic review of education and practical guidance on regression modeling for medical researchers who lack a strong statistical background: Study protocol. Plos One. https://doi.org/10.1371/journal.pone.0241427

• Boulesteix AL, Groenwold R, Abrahamowicz M, Binder H, Briel M, Hornung R, Morris TP, Rahnenführer J, Sauerbrei W for the STRATOS Simulation Panel (2020): Introduction to statistical simulations in health research. DOI: 10.1136/bmjopen-2020-039921 short summary

• Andersen PK, Perme MP, van Houwelingen HC, Cook RJ, Joly P, Martinussen T, Taylor JMG, Abrahamowicz M, Therneau TM for the STRATOS TG8 topic group (2020): Analysis of time-to-event for observational studies: Guidance to the use of intensity models. Statistics in Medicine. DOI: 10.1002/sim.8757 Lay Abstract

• Goetghebeur E, le Cessie S, De Stavola B, Moodie E, Waernbaum I on behalf of the topic group Causal Inference (TG7) of the STRATOS initiative (2020): Formulating causal questions and principled statistical answers. Statistics in Medicine. DOI: 10.1002/sim.8757 Lay Abstract

• Keogh RH, Shaw PA, Gustafson P, Carroll RJ, Deffner V, Dodd KW, Küchenhoff H, Tooze JA, Wallace M, Kipnis V, Freedman L (2020): STRATOS guidance document on measurement error and misclassification of variables in observational epidemiology: Part 1 – Basic theory and simple methods of adjustment. Statistics in Medicine. https://doi.org/10.1002/sim.8532

• Shaw PA, Gustafson P, Carroll RJ, Deffner V, Dodd KW, Keogh RH, Kipnis V, Tooze JA, Wallace M, Küchenhoff H, Freedman L (2020): STRATOS guidance document on measurement error and misclassification of variables in observational epidemiology: Part 2 – More complex methods of adjustment and advanced topics. Statistics in Medicine. https://doi.org/10.1002/sim.8531

• Sauerbrei W, Perperoglou A, Schmid M, Abrahamowicz M, Becher H, Binder H, Dunkler D, Harrell Jr. FE, Royston P, Heinze G for TG2 of the STRATOS initiative (2020). State of the art in selection of variables and functional forms in multivariable analysis – outstanding issues. Diagnostic and Prognostic Research, 4:3, 1-18.

• Huebner M, Vach W, le Cessie S, Schmidt CO, Lusa L on behalf of the Topic Group ‘Initial Data Analysis’ of the STRATOS Initiative (2020): Hidden analyses: a review of reporting practice and recommendations for more transparent reporting of initial data analyses. BMC Medical Research Methodology, 20(1), 1-10. short summary

• Wallace M on behalf of the measurement error topic group of the STRATOS Initiative (2020): Analysis in an imperfect world. Significance, 17: 14-19. short summary

• Van Calster B, McLernon DJ, van Smeden M, Wynants L, Steyerberg EW on behalf of the Topic Group ‘Evaluating diagnostic tests and prediction models’ of the STRATOS initiative (2019): Calibration: the Achilles heel of predictive analytics. BMC Medicine, 17:230, 1-7. short summary

• Gail MH, Altman DG, Cadarette SM, Collins G, Evans SJ, Sekula P, Williamson E, Woodward M (2019): Design choices for observational studies of the effect of exposure on disease incidence. BMJ open, 9:e031031 short summary

• Wynants L, van Smeden M, McLernon DJ, Timmerman D, Steyerberg EW, Van Calster B on behalf of the Topic Group ‘Evaluating diagnostic tests and prediction models’ of the STRATOS initiative (2019): Three myths about risk thresholds for prediction models. BMC Medicine, 17:192, 1-7. short summary

• Shaw PA, Deffner V, Keogh R, Tooze JA, Dodd KW, Küchenhoff H, Kipnis V, Freedman LS on behalf of Measurement Error and Misclassification Topic Group (TG4) of the STRATOS Initiative (2018): Epidemiologic analyses with error-prone exposures: review of current practice and recommendations. Annals of epidemiology 28 (11): 821–828. DOI: 10.1016/j.annepidem.2018.09.001

• Perperoglou A, Sauerbrei W, Abrahamowicz M, Schmid M on behalf of TG2 of the STRATOS initiative (2019): A review of spline function procedures in R. BMC Medical Research Methodology (19:46). DOI: 10.1186/s12874-019-0666-3 short summary

• Huebner M, le Cessie S, Schmidt C, Vach W on behalf of the Topic Group “Initial Data Analysis” of the STRATOS Initiative (2018): A Contemporary Conceptual Framework for Initial Data Analysis. Observational Studies 4 (2018):171-192. short summary

• Boulesteix AL, Binder H, Abrahamowicz M, Sauerbrei W for the Simulation Panel of the STRATOS Initiative (2018): On the necessity and design of studies comparing statistical methods. DOI: 10.1002/bimj.201700129 short summary

• Sauerbrei W, Collins GS, Huebner M, Walter SD, Cadarette SM, Abrahamowicz M on behalf of the STRATOS initiative (2017): Guidance for designing and analysing observational studies: The STRengthening Analytical Thinking for Observational Studies (STRATOS) initiative. Medical Writing; 26(3):17-21.

• Sauerbrei W, Abrahamowicz M, le Cessie S for the STRATOS initiative (2016): The STRATOS initiative – Motivation, Mission, Structure and Main Aims, ISCB News 62: 6-7.

• Van Calster B, Steyerberg EW, Bourne T, Timmerman D, Collins GS on behalf of the TG6 of the STRATOS initiative (2016): Flawed external validation study of the ADNEX model to diagnose ovarian cancer. Gynecological Oncology Reports 18 (2016): 49-50.

• Sauerbrei W, Abrahamowicz M, Altman DG, le Cessie S and Carpenter J on behalf of STRATOS initiative (2014): STRengthening Analytical Thinking for Observational Studies: The STRATOS initiative. Statistics in Medicine, 33: 5413-5432.

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Series of Papers for the Biometric Bulletin:

• Sauerbrei W, Huebner M, Collins GS, Lee K, Freedman L, Gail M, Goetghebeur E, Rahnenfuehrer J, Abrahamowicz M on behalf of the STRATOS initiative (2017): STRATOS inititative – Guidance for designing and analyzing observational studies. Biometric Bulletin; 34(3):18-20.

• Carpenter J, Lee KJ on behalf of STRATOS TG1 (2017): STRengthening Analytical Thinking for Observational Studies (STRATOS): Introducing the Missing Data Topic Group (TG1). Biometric Bulletin; 34(4):11-13.

• Freedman L, Kipnis V on behalf of STRATOS TG4 (2018): STRengthening Analytical Thinking for Observational Studies (STRATOS): Introducing the Measurement error and Misclassification Topic Group (TG4). Biometric Bulletin; 35(1):10.

• Schmidt CO, Vach W, le Cessie S, Huebner M on behalf of STRATOS TG3 (2018): STRengthening Analytical Thinking for Observational Studies (STRATOS): Introducing the Initial Data Analysis topic group (TG3). Biometric Bulletin; 35(2):10-11.

• Perperoglou A, Heinze G, Sauerbrei W on behalf of STRATOS TG2 (2018): STRengthening Analytical Thinking for Observational Studies (STRATOS): Introducing the Topic Group on Selection of Variables and Functional Forms in Multivariable Analysis (TG2). Biometric Bulletin; 35(3):18-19.

• Waernbaum I, De Stavola B, Moodie E, le Cessie S, Goetghebeur E on behalf of STRATOS TG7 (2018): STRengthening Analytical Thinking for Observational Studies (STRATOS): Introducing the Causal Inference Topic Group (TG7). Biometric Bulletin; 35(4):12-13.

• McShane L, Rahnenführer J on behalf of STRATOS TG9 (2019): STRengthening Analytical Thinking for Observational Studies (STRATOS): Introducing the High-dimensional Data topic group (TG9). Biometric Bulletin; 36(1): 13-14.

• Gail MH, Cadarette S on behalf of STRATOS TG5 (2019): STRengthening Analytical Thinking for Observational Studies (STRATOS): Introducing the Study Design Topic Group (TG5). Biometric Bulletin; 36(2): 12-13.

• Andersen PK, Abrahamowicz M, Therneau TM on behalf of STRATOS TG8 (2019): STRengthening Analytical Thinking for Observational Studies (STRATOS): Introducing the Survival Analysis Topic Group (TG8). Biometric Bulletin; 36(3): 12-13.

• Van Calster B, Steyerberg EW on behalf of STRATOS TG6 (2020): STRengthening Analytical Thinking for Observational Studies (STRATOS): Introducing the Topic Group on Evaluating Diagnostic Tests and Prediction Models (TG6). Biometric Bulletin; 37(1): 11-12.

• Boulesteix AL, Morris T, Sauerbrei W, Abrahamowicz M on behalf of the Simulation Panel (2020): STRengthening Analytical Thinking for Observational Studies (STRATOS): Introducing the Simulation Panel (SP). Biometric Bulletin; 37(2): 11-12.

• Baillie M, Vandemeulebroecke M on behalf of the Visualisation Panel (2020); STRengthening Analytical Thinking for Observational Studies (STRATOS): Introducing the Visualisation Panel (SP). Biometrical Bulletin; 37(3): 14-15.

• Boeker M, Tippmann P, Day S, Huebner M, Sauerbrei W on behalf of the Glossary Panel (2020): STRengthening Analytical Thinking for Observational Studies (STATOS): Defining common meaning for statistical Terms. Biometrical Bulletin; 37(4): 13-14.

• Shaw Pamela A, Boshuizen H, on behalf of STRATOS TG4 (2021): STRengthening Analytical Thinking for Observational Studies (STRATOS): Updates from the Measurement Error and Misclassification Topic Group (TG4). Biometric Bulletin; 38(1): 8-9.

• Heinze G, Perperoglou A, Sauerbrei W on behalf of Topic Group 2 of the STRATOS initiative (2021): STRengthening Analytical Thinking for Observational Studies (STRATOS): Recent activities of the Topic Group on Selection of Variables and Functional Forms in Multivariable Analysis (TG2). Biometric Bulletin; 38(2):7-8.

• le  Cessie S,  Schmidt CO,  Lusa L,  Baillie M, Huebner M on behalf of TG3 (2021): STRengthening Analytical Thinking for Observational Studies (STRATOS): Introducing the Initial Data Analysis Topic Group (TG3). Biometric Bulletin; 38(3):10-11.

• Carpenter J, Lee KJ on behalf of TG1 (2021): STRengthening Analytical Thinking for Observational Studies (STRATOS): Update on the Missing Data Topic Group (TG1). Biometric Bulletin; 38(4):9-10.

• Waernbaum I, De Stavola B, Didelez V, Moodie E, le Cessie S, Goetghebeur E on behalf of STRATOS TG7 (2022): STRengthening Analytical Thinking for Observational Studies (STRATOS): Report from the Causal Inference Topic Group (TG7). Biometric Bulletin; 39(1):10-12.

• Steyerberg EW, van Calster B, on behalf of STRATOS TG6 (2022): STRengthening Analytical Thinking for Observational Studies (STRATOS): Progress in the Topic Group on Evaluating Diagnostic Tests and Prediction Models (TG6). Biometric Bulletin; 39(2):13-14.

• Sauerbrei W, Abrahamowicz M, Baillie M, De Stavola B, Gail M, Huebner M, Keogh R and Shaw P for the STRATOS initiative (2022): STRengthening Analytical Thinking for Observational Studies – a very brief update on the achievements of the STRATOS initiative in the last 5 years. Biometric Bulletin; 39(3):17-19.

• Schmidt C.O., Heinze G, Lusa L and Huebner M  for the STRATOS initiative (2022): STRengthening Analytical Thinking for Observational Studies – On the importance of Data Quality Assessments and Initial Data Analysis. Biometric Bulletin; 39(4):14-15.

• Heinze G, Boulesteix AL, Dunkler D, Gail M, Lee KJ, van Calster B, Wallace M, Sauerbrei W (2023): STRengthening Analytical Thinking for Observational Studies (STRATOS): Guidance for analysts with limited statistical knowledge. Biometric Bulletin; 40(1):8-10.

• Hoffmann S, Luijken K, Sauerbrei W, Shaw P, Boulesteix AL (2023): STRengthening Analytical Thinking for Observational Studies (STRATOS): Introducing the Open Science Panel. Biometric Bulletin; 40(2):8-9.

• De Bin R, McShane L, Rahnenführer J (2023):  STRengthening Analytical Thinking for Observational Studies (STRATOS): Overview of methodological issues when analyzing high-dimensional biomedical data. Biometric Bulletin; 40(3):11-12.

• Carpenter J, Abrahamowicz M, van Geloven N, Gustafson P, Huebner M, Keogh R, Sauerbrei W, Shaw P, Goetghebeur E (2023): STRengthening Analytical Thinking for Observational Studies (STRATOS): Six foci for the next three years. Biometric Bulletin; 40(4):7-9.

• Abrahamowicz M, Andersen PK, Gorfine M, Therneau TM (2024): STRengthening Analytical Thinking for Observational Studies (STRATOS): Update on 2020-2023 Research Activities of Topic Group 8: “Survival Analysis”. Biometric Bulletin; 41(1):15-17. 

• Boulesteix A-L, Baillie M, Edelmann D, Held L, Morris T, Sauerbrei W (2024): STRengthening Analytical Thinking for Observational Studies (STRATOS): Neutral comparison simulation studies as the cornerstone to compare statistical methods. Biometric Bulletin; 41(2):14-15.

• le Cessie S, Goetghebeur E, Amdal CD, Musoro JZ, Pe M, Reynders D, Roychoudhury S, Thomassen D, Sauerbrei W (2024): STRengthening Analytical Thinking for Observational Studies (STRATOS): Cooperation in the Setting International Standards in Analyzing Patient Reported Outcomes and Quality of Life Endpoints (SISAQOL-IMI) project. Biometric Bulletin; 41(3): 13-14. 

• Bakewell N, Bartlett J, Van Lancker K , Goetghebeur E, Shaw P, Thomassen D, Boutmy E, Cadarette SM, le Cessie S, van Geloven N (2024): STRengthening Analytical Thinking for Observational Studies (STRATOS): Estimands – Summary from the “STRATOS Accelerated Guidance for Real World Data Analysis” Workshop. Biometric Bulletin, 41(4): 12-14.

• Lusa L, Huebner M, Sauerbrei W, Heinze G on behalf of STRATOS TG3 and TG2 (2025): STRengthening Analytical Thinking for Observational Studies (STRATOS): Collaborative project on initial data analysis for regression models. Biometric Bulletin, 42(1): 15-16. 

• Schmidt CO, Klinger A, Sauerbrei W, Heinze G on behalf of the TED panel (2025): STRengthening Analytical Thinking for Observational Studies (STRATOS): Introducing the Towards Excellent Data (TED) Panel. Biometric Bulletin, 42(2): 15-16.

• Cadarette SM, Bakewell N, Gail MH on behalf of STRATOS TG5 (2025): Strengthening Analytical Thinking for Observational Studies (STRATOS): Updates from Topic Group on Study Design (TG5). Biometric Bulletin, 42(3): 19-21.

• le Cessie S, Roychoudhury S, Musoro JZ, Pe M, Alanya A, Amdal CD, Reynders D, Thomassen D, Sauerbrei W, Goetghebeur E (2025): STRengthening Analytical Thinking for Observational Studies (STRATOS): Recommendation for the Design and Analysis of Patient Reported Outcomes (The SISAQOL-IMI Project). Biometric Bulletin, 42(4): 17-19.

• Van Calster B, Collins GS, Wynants L, Kerr KF, Vickers AJ, Barreñada L, Moons KGM, McLernon DJ, van Smeden M, Steyerberg EW (2026): STRengthening Analytical Thinking for Observational Studies (STRATOS): TG6 – Overview and Guidance of Performance Measure for Clinical Prediction Models. Biometric Bulletin, 43(1): 13-15.

• Gorfine M and Cook RJ (2026): STRengthening Analytical Thinking for Observational Studies (STRATOS): A Short Summary of ‘An Overview and Recent Developments in the Analysis of Multiple Processes’. Biometric Bulletin, 43(2): 14-15.