Evaluation of Planned Subgroup Analysis in Protocols of Randomized Clinical Trials
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This cross-sectional study compares randomized clinical trial protocols to assess the prevalence and reporting quality of planned subgroup analyses over time.
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Subgroup analyses are highly susceptible to bias and misinterpretation, particularly if they are inappropriately conducted or selectively reported.
“Although commonly performed,439 440 subgroup analyses are highly susceptible to bias and misinterpretation, particularly if they are inappropriately conducted or selectively reported.”
From SPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials (2025) · cites this paper as [439]
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Panitumumab–FOLFOX4 Treatment and <i>RAS</i> Mutations in Colorectal Cancer
Douillard, J.-Y., Oliner, K. S., Siena, S., Tabernero, J., Burkes, R., Barugel, M., Humblet, Y., Bodoky, G., Cunningham, D., Jassem, J., et al. (2013) · New England Journal of Medicine · doi:10.1056/nejmoa1305275 · Cited by 2,263 · see citing works
Yang, J. C.-H., Wu, Y.-L., Schuler, M., Sebastian, M., Popat, S., Yamamoto, N., Zhou, C., Hu, C.-P., O'Byrne, K., Feng, J., et al. (2015) · The Lancet Oncology · doi:10.1016/s1470-2045(14)71173-8 · Cited by 1,574 · cited 1× · see citing works
“1) Subgroup analyses Median (IQR) 3 (1-6) 6 (4-23.”
Schandelmaier, S., Briel, M., Varadhan, R., Schmid, C. H., Devasenapathy, N., Hayward, R. A., Gagnier, J., Borenstein, M., van der Heijden, G. J. M. G., Dahabreh, I. J., et al. (2020) · Canadian Medical Association Journal · doi:10.1503/cmaj.200077 · Cited by 749 · see citing works
Self-citationKasenda, B., Schandelmaier, S., Sun, X., von Elm, E. B., You, J., Blümle, A., Tomonaga, Y., Saccilotto, R. T., Amstutz, A., Bengough, T., et al. (2014) · BMJ · doi:10.1136/bmj.g4539 · Cited by 102 · see citing works
Self-citationSchandelmaier, S., Chang, Y., Devasenapathy, N., Devji, T., Kwong, J. S. W., Colunga‐Lozano, L. E., Lee, Y., Agarwal, A., Bhatnagar, N., Ewald, H., et al. (2019) · Journal of Clinical Epidemiology · doi:10.1016/j.jclinepi.2019.05.014 · Cited by 24 · see citing works
Self-citationGryaznov, D., Odutayo, A., von Niederhäusern, B., Speich, B., Kasenda, B., Ojeda–Ruiz, E., Blümle, A., Schandelmaier, S., Mertz, D., Tomonaga, Y., et al. (2020) · Trials · doi:10.1186/s13063-020-04808-y · Cited by 15 · see citing works
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SPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials
Hróbjartsson, A., Boutron, I., Hopewell, S., Moher, D., Schulz, K. F., Collins, G. S., Tunn, R., Aggarwal, R., Berkwits, M., Berlin, J. A., et al. (2025) · BMJ · doi:10.1136/bmj-2024-081660 · Cited by 171 · see citing works
Self-citationClinical data mining: challenges, opportunities, and recommendations for translational applications
Qiao, H., Chen, Y., Qian, C., & Guo, Y. (2024) · Journal of Translational Medicine · doi:10.1186/s12967-024-05005-0 · Cited by 27 · see citing works
Wei, L., Butterly, E. W., Rodriguez-Perez, J., Chowdhury, A., Shemilt, R., Hanlon, P., & McAllister, D. (2024) · BMJ Open · doi:10.1136/bmjopen-2023-081315 · Cited by 3 · see citing works
Alternative evidence in drug development and regulatory science
Janjan, N. A., Silva, P. J., Ramos, K. S., Ory, M. G., & Smith, M. L. (2023) · Elsevier eBooks · doi:10.1016/b978-0-12-824010-6.00075-7 · Cited by 1 · see citing works
Ramallo, H. R., Gutiérrez, N. B., Martín, L. A., & Otero, R. (2022) · Thrombosis Research · doi:10.1016/j.thromres.2022.09.023 · Cited by 1 · see citing works
- Authors
- Taji Heravi, A., Gryaznov, D., Schandelmaier, S., Kasenda, B., Briel, M., Adherence to SPIRIT Recommendations (ASPIRE) Study Group, von Niederhäusern, B., Speich, B., Ojeda-Ruiz, E., Blümle, A., Mertz, D., Odutayo, A., Tomonaga, Y., Amstutz, A., Pauli-Magnus, C., Gloy, V., Lohner, S., Bischoff, K., Wollmann, K., Rehner, L., Meerpohl, J. J., Nordmann, A., Klatte, K., Ghosh, N., McCord, K., Sricharoenchai, S., Busse, J. W., Agarwal, A., Saccilotto, R., Schwenkglenks, M., Moffa, G., Hemkens, L. G., Hopewell, S., von Elm, E., Wong, J., Chow, N., & Jiho Hong, P.
- Affiliations
- Department of Clinical Research, Basel Institute for Clinical Epidemiology and Biostatistics, University Hospital Basel and University of Basel, Basel, Switzerland
- University of Basel (CH)
- for the Adherence to SPIRIT Recommendations (ASPIRE) Study Group
- ORCID
- Gryaznov, Dmitry
- Schandelmaier, Stefan
- Kasenda, Benjamin
- Briel, Matthias
- Speich, Benjamin
- Blümle, Anette
- Mertz, Dominik
- Odutayo, Ayodele
- Tomonaga, Yuki
- Amstutz, Alain
- Gloy, Viktoria
- Lohner, Szimonetta
- Bischoff, Karin
- Wollmann, Katharina
- Rehner, Laura
- Meerpohl, Joerg J.
- Ghosh, Nilabh
- Sricharoenchai, Sirintip
- Busse, Jason W
- Agarwal, Arnav
- Saccilotto, Ramon
- Schwenkglenks, Matthias
- Moffa, Giusi
- Hemkens, Lars G
- Hopewell, Sally
- Chow, Ngai
- Venue
- JAMA Network Open
- Publisher
- American Medical Association (AMA)
- Published
- 2021-10-27
- Volume
- 4
- Issue
- 10
- Pages
- e2131503
- ISSN
- 2574-3805 (ISSN-L)
- PMC
- PMC8552052
- OpenAlex
- W3209678742
- Cited by
- 5
- References
- 6
- Citations by year
- 2025: 1 · 2024: 2 · 2023: 1 · 2022: 1
- FWCI
- 0.74
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- cc-by
- Locations
- JAMA Network Open (publishedVersion, cc-by)
- Europe PMC (PubMed Central) (publishedVersion, other-oa)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- Topics
- Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
- Social Sciences › Decision Sciences › Statistics, Probability and Uncertainty › Meta-analysis and systematic reviews
- Physical Sciences › Mathematics › Statistics and Probability › Advanced Causal Inference Techniques
- Keywords
- subgroup analysis, reporting quality, subgroup effects, temporal trends
- MeSH terms
- Cross-Sectional Studies, Female, Humans, Male, Research Design, Switzerland, Randomized Controlled Trials as Topic
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