The DOI matches its Crossref record; 29 of the 29 references it cites were found in a registry or an index.
Multiplicity in randomised trials I: endpoints and treatments
Abstract
Multiplicity problems emerge from investigators looking at many additional endpoints and treatment group comparisons. Thousands of potential comparisons can emanate from one trial. Investigators might only report the significant comparisons, an unscientific practice if unwitting, and fraudulent if intentional. Researchers must report all the endpoints analysed and treatments compared. Some statisticians propose statistical adjustments to account for multiplicity. Simply defined, they test for no effects in all the primary endpoints undertaken versus an effect in one or more of those endpoints. In general, statistical adjustments for multiplicity provide crude answers to an irrelevant question. However, investigators should use adjustments when the clinical decision-making argument rests solely on one or more of the primary endpoints being significant. In these cases, adjustments somewhat rescue scattershot analyses. Readers need to be aware of the potential for under-reporting of analyses.
Overview
Integrity signals
Registry
Cites
Statistics
Verification
Claims the paper makes
Claims other papers make about this one
Each is checked against this paper’s own text: does it say what the citing paper says it does?
In the citing paper
“However, given that the approach here is of planned comparisons, where all analyses are pre-specified, it is not necessarily appropriate to apply these corrections (Feise, 2002; Schulz and Grimes, 2005).”
From Sleep duration and psychotic experiences in patients at risk of psychosis: a secondary analysis of the EDIE-2 trial (2019) · cites this paper as Schulz and Grimes, 2005
In the citing paper
“Such trials provide more information than two-arm trials can provide [6].”
From Reporting of analyses from randomized controlled trials with multiple arms: a systematic review (2013) · cites this paper as [6]
In the citing paper
“For instance, in an RCT with three arms, there are seven theoretically possible comparisons [6].”
From Reporting of analyses from randomized controlled trials with multiple arms: a systematic review (2013) · cites this paper as [6]
Citations
Cites
Practical Statistics for Medical Research.
Walter, S., & Altman, D. G. (1992) · Biometrics · doi:10.2307/2532320 · Cited by 11,666
Peto, R., Pike, M. C., Armitage, P., Breslow, N. E., Cox, D. R., Howard, S. V., Mantel, N., McPherson, K., Peto, J., & Smith, P. G. (1977) · British Journal of Cancer · doi:10.1038/bjc.1977.1 · Cited by 8,285
No adjustments are needed for multiple comparisons.
Rothman, K. J. (1990) · Epidemiology · doi:10.1097/00001648-199001000-00010 · Cited by 5,965
What's wrong with Bonferroni adjustments
Perneger, T. V. (1998) · BMJ · doi:10.1136/bmj.316.7139.1236 · Cited by 5,900
Moher, D., Schulz, K. F., & Altman, D. G. (2001) · The Lancet · doi:10.1016/s0140-6736(00)04337-3 · Cited by 5,373
Self-citationPractical Statistics for Medical Research.
Bartko, J. J., & Altman, D. G. (1992) · Journal of the American Statistical Association · doi:10.2307/2290246 · Cited by 4,834
The Revised CONSORT Statement for Reporting Randomized Trials: Explanation and Elaboration
Altman, D. G., Schulz, K. F., Moher, D., Egger, M., Davidoff, F., Elbourne, D., Gøtzsche, P. C., Lang, T., & for the CONSORT Group (2001) · Annals of Internal Medicine · doi:10.7326/0003-4819-134-8-200104170-00012 · Cited by 3,835
Self-citationClinical Trials: A Practical Approach.
Hill, I. D., & Pocock, S. (1984) · Biometrics · doi:10.2307/2531186 · Cited by 2,918
Peto, R., Pike, M. C., Armitage, P., Breslow, N. E., Cox, D. R., Howard, S. V., Mantel, N., McPherson, K., Peto, J., & Smith, P. G. (1976) · British Journal of Cancer · doi:10.1038/bjc.1976.220 · Cited by 2,294
Fundamentals of Clinical Trials
Friedman, L. M., Furberg, C. D., DeMets, D. L., Reboussin, D. M., & Granger, C. B. (2015) · doi:10.1007/978-3-319-18539-2 · Cited by 2,237
Chan, A.-W., Hróbjartsson, A., Haahr, M. T., Gøtzsche, P. C., & Altman, D. G. (2004) · JAMA · doi:10.1001/jama.291.20.2457 · Cited by 1,845
Sterne, J. A. C. (2001) · BMJ · doi:10.1136/bmj.322.7280.226 · Cited by 1,466
Multiple Comparisons: Theory and Methods
Christensen, R., & Hsu, J. C. (1997) · Technometrics · doi:10.2307/1270920 · Cited by 1,105
Composite Outcomes in Randomized Trials
Freemantle, N., Calvert, M., Wood, J., Eastaugh, J., & Griffin, C. (2003) · JAMA · doi:10.1001/jama.289.19.2554 · Cited by 798
Statistical Power, Sample Size, and Their Reporting in Randomized Controlled Trials
Moher, D. (1994) · JAMA: The Journal of the American Medical Association · doi:10.1001/jama.1994.03520020048013 · Cited by 608
Sample size calculations in randomised trials: mandatory and mystical
Schulz, K. F., & Grimes, D. A. (2005) · The Lancet · doi:10.1016/s0140-6736(05)61034-3 · Cited by 549
Self-citationMeinert, C. L. (1986) · DigitalGeorgetown (Georgetown University Library) · doi:10.1093/acprof:oso/9780195035681.001.0001 · Cited by 509
Multiple Comparisons and Related Issues in the Interpretation of Epidemiologic Data
Savitz, D. A., & Olshan, A. F. (1995) · American Journal of Epidemiology · doi:10.1093/oxfordjournals.aje.a117737 · Cited by 463
Multiplicity in randomised trials II: subgroup and interim analyses
Schulz, K. F., & Grimes, D. A. (2005) · The Lancet · doi:10.1016/s0140-6736(05)66516-6 · Cited by 357
Self-citationClinical Trials: Design, Conduct, and Analysis
Baker, L. H. (1987) · JAMA · doi:10.1001/jama.1987.03390090119041 · Cited by 231
Statistical Issues in Drug Development
Ziegel, E. R., & Senn, S. J. (1999) · Technometrics · doi:10.2307/1271380 · Cited by 224
Pocock, S. J. (1997) · Controlled Clinical Trials · doi:10.1016/s0197-2456(97)00008-1 · Cited by 184
Sankoh, A. J., D’Agostino, R. B., & Huque, M. F. (2003) · Statistics in Medicine · doi:10.1002/sim.1557 · Cited by 110
Sharp, S. J., & Thompson, S. G. (2000) · Statistics in Medicine · doi:10.1002/1097-0258(20001215)19:23 · Cited by 99
Quantitative Evaluation of Multiplicity in Epidemiology and Public Health Research
Ottenbacher, K. J. (1998) · American Journal of Epidemiology · doi:10.1093/oxfordjournals.aje.a009501 · Cited by 81
Statistical Issues in Drug Development
(1999) · Technometrics · doi:10.1080/00401706.1999.10485963 · Cited by 77
Fundamentals of Clinical Trials
Pocock, S. J., Friedman, L. M., Furberg, C. D., & Demets, D. L. (1982) · Biometrics · doi:10.2307/2530084 · Cited by 66
P-Value Interpretation and Alpha Allocation in Clinical Trials
Moyé, L. A. (1998) · Annals of Epidemiology · doi:10.1016/s1047-2797(98)00003-9 · Cited by 56
Bauer, P., Chi, G., Geller, N. L., Gould, A. L., Jordan, D., Mohanty, S., O’Neill, R. T., & Westfall, P. H. (2003) · Journal of Biopharmaceutical Statistics · doi:10.1081/bip-120024203 · Cited by 9
Cited by
Sorted by citations
Intensive blood glucose control and vascular outcomes in patients with type 2 diabetes
(2008) · New England Journal of Medicine · doi:10.1056/nejmoa0802987 · Cited by 7,397
SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials
Chan, A.-W., Tetzlaff, J. M., Gotzsche, P. C., Altman, D. G., Mann, H., Berlin, J. A., Dickersin, K., Hrobjartsson, A., Schulz, K. F., Parulekar, W. R., et al. (2013) · BMJ · doi:10.1136/bmj.e7586 · Cited by 6,251
Self-citationWhen to use the Bonferroni correction
Armstrong, R. A. (2014) · Ophthalmic and Physiological Optics · doi:10.1111/opo.12131 · Cited by 3,031
Glickman, M. E., Rao, S. R., & Schultz, M. R. (2014) · Journal of Clinical Epidemiology · doi:10.1016/j.jclinepi.2014.03.012 · Cited by 1,561
Metadata
- Authors
- Schulz, K. F., & Grimes, D. A.
- Affiliations
- Family Health International 360 (US)
- Corresponding author
- Schulz, Kenneth F
- Venue
- The Lancet
- Publisher
- Elsevier BV
- Published
- 2005-04
- Volume
- 365
- Issue
- 9470
- Pages
- 1591-1595
- ISSN
- 0099-5355 (ISSN-L)
- 0140-6736
- OpenAlex
- W2034698532
- Cited by
- 366
- References
- 29
- Citations by year
- 2026: 8 · 2025: 21 · 2024: 15 · 2023: 14 · 2022: 19 · 2021: 20 · 2020: 28 · 2019: 23 · 2018: 27 · 2017: 21 · 2016: 17 · 2015: 30 · 2014: 16 · 2013: 17 · 2012: 19
- FWCI
- 13.12
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- The Lancet (publishedVersion)
- 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 › Statistical Methods in Epidemiology
- Keywords
- multiplicity, multiple endpoints, network meta-analysis, statistical adjustment, primary endpoint, selective reporting, randomised trials, clinical decision-making
- MeSH terms
- Data Interpretation, Statistical, Research Design, Randomized Controlled Trials as Topic, Endpoint Determination
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
Are you an author, or do you see a problem with this page? Request a review
