STRengthening analytical thinking for observational studies: The STRATOS initiative

Willi Sauerbrei; Michal Abrahamowicz; Douglas G. Altman; Saskia le Cessie; James Carpenter; Michal Abrahamowicz; Per Kragh Andersen; Doug Altman; Heiko Becher; Harald Binder; Maria Blettner; Danielle Bodicoat; Patrick Bossuyt; James Carpenter; Raymond Carroll; Harbajan Chadha-Boreham; Gary Collins; Bianca De Stavola; Luc Duchateau; Stephen Evans; Laurence Freedman; Mitchell Gail; Els Goetghebeur; Paul Gustafson; Frank Harrell; Marianne Huebner; Carolin Jenkner; Victor Kipnis; Helmut Kuechenhoff; Saskia le Cessie; Kate Lee; Petra Macaskill; Erica Moodie; Neil Pearce; Catherine Quantin; Joerg Rahnenfuehrer; Patrick Royston; Willi Sauerbrei; Martin Schumacher; Peggy Sekula; Len Stefanski; Ewout Steyerberg; Terry Therneau; Kate Tilling; Werner Vach; Andrew Vickers; Sholom Wacholder; Ingeborg Waernbaum; Ian White; Mark Woodward

doi:10.1002/sim.6265

STRengthening analytical thinking for observational studies: The STRATOS initiative

Willi Sauerbrei, Michal Abrahamowicz, Douglas G. Altman, Saskia le Cessie, James Carpenter, Michal Abrahamowicz, Per Kragh Andersen, Doug Altman, Heiko Becher, Harald Binder, Maria Blettner, Danielle Bodicoat, Patrick Bossuyt, James Carpenter, Raymond Carroll, Harbajan Chadha-Boreham, Gary Collins, Bianca De Stavola, Luc Duchateau, Stephen EvansLaurence Freedman, Mitchell Gail, Els Goetghebeur, Paul Gustafson, Frank Harrell, Marianne Huebner, Carolin Jenkner, Victor Kipnis, Helmut Kuechenhoff, Saskia le Cessie, Kate Lee, Petra Macaskill, Erica Moodie, Neil Pearce, Catherine Quantin, Joerg Rahnenfuehrer, Patrick Royston, Willi Sauerbrei, Martin Schumacher, Peggy Sekula, Len Stefanski, Ewout Steyerberg, Terry Therneau, Kate Tilling, Werner Vach, Andrew Vickers, Sholom Wacholder, Ingeborg Waernbaum, Ian White, Mark Woodward

Section of Biostatistics

50 Citations (Scopus)

Abstract

The validity and practical utility of observational medical research depends critically on good study design, excellent data quality, appropriate statistical methods and accurate interpretation of results. Statistical methodology has seen substantial development in recent times. Unfortunately, many of these methodological developments are ignored in practice. Consequently, design and analysis of observational studies often exhibit serious weaknesses. The lack of guidance on vital practical issues discourages many applied researchers from using more sophisticated and possibly more appropriate methods when analyzing observational studies. Furthermore, many analyses are conducted by researchers with a relatively weak statistical background and limited experience in using statistical methodology and software. Consequently, even 'standard' analyses reported in the medical literature are often flawed, casting doubt on their results and conclusions. An efficient way to help researchers to keep up with recent methodological developments is to develop guidance documents that are spread to the research community at large. These observations led to the initiation of the strengthening analytical thinking for observational studies (STRATOS) initiative, a large collaboration of experts in many different areas of biostatistical research. The objective of STRATOS is to provide accessible and accurate guidance in the design and analysis of observational studies. The guidance is intended for applied statisticians and other data analysts with varying levels of statistical education, experience and interests.In this article, we introduce the STRATOS initiative and its main aims, present the need for guidance documents and outline the planned approach and progress so far. We encourage other biostatisticians to become involved.

Original language	English
Journal	Statistics in Medicine
Volume	33
Issue number	30
Pages (from-to)	5413-5432
Number of pages	20
ISSN	0277-6715
DOIs	https://doi.org/10.1002/sim.6265
Publication status	Published - 30 Dec 2014

Keywords

Guidance for analysis
Level of statistical knowledge
Observational studies

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10.1002/sim.6265

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Sauerbrei, W., Abrahamowicz, M., Altman, D. G., le Cessie, S., Carpenter, J., Abrahamowicz, M., Andersen, P. K., Altman, D., Becher, H., Binder, H., Blettner, M., Bodicoat, D., Bossuyt, P., Carpenter, J., Carroll, R., Chadha-Boreham, H., Collins, G., De Stavola, B., Duchateau, L., ... Woodward, M. (2014). STRengthening analytical thinking for observational studies: The STRATOS initiative. Statistics in Medicine, 33(30), 5413-5432. https://doi.org/10.1002/sim.6265

Sauerbrei, W, Abrahamowicz, M, Altman, DG, le Cessie, S, Carpenter, J, Abrahamowicz, M, Andersen, PK, Altman, D, Becher, H, Binder, H, Blettner, M, Bodicoat, D, Bossuyt, P, Carpenter, J, Carroll, R, Chadha-Boreham, H, Collins, G, De Stavola, B, Duchateau, L, Evans, S, Freedman, L, Gail, M, Goetghebeur, E, Gustafson, P, Harrell, F, Huebner, M, Jenkner, C, Kipnis, V, Kuechenhoff, H, Cessie, SL, Lee, K, Macaskill, P, Moodie, E, Pearce, N, Quantin, C, Rahnenfuehrer, J, Royston, P, Sauerbrei, W, Schumacher, M, Sekula, P, Stefanski, L, Steyerberg, E, Therneau, T, Tilling, K, Vach, W, Vickers, A, Wacholder, S, Waernbaum, I, White, I & Woodward, M 2014, 'STRengthening analytical thinking for observational studies: The STRATOS initiative', Statistics in Medicine, vol. 33, no. 30, pp. 5413-5432. https://doi.org/10.1002/sim.6265

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abstract = "The validity and practical utility of observational medical research depends critically on good study design, excellent data quality, appropriate statistical methods and accurate interpretation of results. Statistical methodology has seen substantial development in recent times. Unfortunately, many of these methodological developments are ignored in practice. Consequently, design and analysis of observational studies often exhibit serious weaknesses. The lack of guidance on vital practical issues discourages many applied researchers from using more sophisticated and possibly more appropriate methods when analyzing observational studies. Furthermore, many analyses are conducted by researchers with a relatively weak statistical background and limited experience in using statistical methodology and software. Consequently, even 'standard' analyses reported in the medical literature are often flawed, casting doubt on their results and conclusions. An efficient way to help researchers to keep up with recent methodological developments is to develop guidance documents that are spread to the research community at large. These observations led to the initiation of the strengthening analytical thinking for observational studies (STRATOS) initiative, a large collaboration of experts in many different areas of biostatistical research. The objective of STRATOS is to provide accessible and accurate guidance in the design and analysis of observational studies. The guidance is intended for applied statisticians and other data analysts with varying levels of statistical education, experience and interests.In this article, we introduce the STRATOS initiative and its main aims, present the need for guidance documents and outline the planned approach and progress so far. We encourage other biostatisticians to become involved.",

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AU - Abrahamowicz, Michal

AU - Andersen, Per Kragh

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AU - Gustafson, Paul

AU - Harrell, Frank

AU - Huebner, Marianne

AU - Jenkner, Carolin

AU - Kipnis, Victor

AU - Kuechenhoff, Helmut

AU - Cessie, Saskia le

AU - Lee, Kate

AU - Macaskill, Petra

AU - Moodie, Erica

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AU - Rahnenfuehrer, Joerg

AU - Royston, Patrick

AU - Sauerbrei, Willi

AU - Schumacher, Martin

AU - Sekula, Peggy

AU - Stefanski, Len

AU - Steyerberg, Ewout

AU - Therneau, Terry

AU - Tilling, Kate

AU - Vach, Werner

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AB - The validity and practical utility of observational medical research depends critically on good study design, excellent data quality, appropriate statistical methods and accurate interpretation of results. Statistical methodology has seen substantial development in recent times. Unfortunately, many of these methodological developments are ignored in practice. Consequently, design and analysis of observational studies often exhibit serious weaknesses. The lack of guidance on vital practical issues discourages many applied researchers from using more sophisticated and possibly more appropriate methods when analyzing observational studies. Furthermore, many analyses are conducted by researchers with a relatively weak statistical background and limited experience in using statistical methodology and software. Consequently, even 'standard' analyses reported in the medical literature are often flawed, casting doubt on their results and conclusions. An efficient way to help researchers to keep up with recent methodological developments is to develop guidance documents that are spread to the research community at large. These observations led to the initiation of the strengthening analytical thinking for observational studies (STRATOS) initiative, a large collaboration of experts in many different areas of biostatistical research. The objective of STRATOS is to provide accessible and accurate guidance in the design and analysis of observational studies. The guidance is intended for applied statisticians and other data analysts with varying levels of statistical education, experience and interests.In this article, we introduce the STRATOS initiative and its main aims, present the need for guidance documents and outline the planned approach and progress so far. We encourage other biostatisticians to become involved.

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STRengthening analytical thinking for observational studies: The STRATOS initiative

Abstract

Keywords

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