The DOI matches its Crossref record; 16 of the 16 references it cites were found in a registry or an index.
Clinical trials with multiple outcomes: A statistical perspective on their design, analysis, and interpretation
Abstract
This article tackles both practical and statistical issues in the handling of multiple outcomes in clinical trials, with relevance to trial design, analysis, and reporting. Specific topics illustrated by examples include: the advantage of prespecifying priorities amongst outcomes and analyses, corrections for multiple significance testing and their limited value, problems with adverse event data, the use of a single global test of significance for clinically related outcomes, the use of a combined outcome for clinical event data, and the value of exploring interrelationships amongst outcomes. The problems in handling multiple outcomes are enhanced by trials being too small, dichotomous attitudes (is the trial "positive" or not?), obsession with p-values, and the manipulative instincts of human nature. While predeclarations of priorities in analysis and reporting of multiple outcomes are important in suppressing distortive claims, it would be unfortunate if too inflexible an approach suppressed unpredictable findings from being seriously considered.
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
“It is very important to emphasize that clinical trial design parameters strongly influence data outcome, interpretation, and conclusions [267, 268].”
From Inorganic nitrite therapy: historical perspective and future directions (2011) · cites this paper as [267]
Citations
Cites
OLSSON, A. G., McMurray, J. J. V., Thorgeirsson, G., Spaulding, C. M., Slattery, J., Pyörälà, K., Færgeman, O., Wright, R. S., Berg, K. M., Wilhelmsen, L., et al. (1994) · The Lancet · Cited by 8,467
A sharper Bonferroni procedure for multiple tests of significance
HOCHBERG, Y. (1988) · Biometrika · doi:10.1093/biomet/75.4.800 · Cited by 4,829
An improved Bonferroni procedure for multiple tests of significance
SIMES, R. J. (1986) · Biometrika · doi:10.1093/biomet/73.3.751 · Cited by 2,396
Final Report on the Aspirin Component of the Ongoing Physicians' Health Study
Steering Committee of the Physicians' Health Study Research Group (1989) · New England Journal of Medicine · doi:10.1056/nejm198907203210301 · Cited by 2,267
Procedures for Comparing Samples with Multiple Endpoints
O’Brien, P. C. (1984) · Biometrics · doi:10.2307/2531158 · Cited by 1,163
Statistical Problems in the Reporting of Clinical Trials
Pocock, S., Hughes, M. D., & Lee, R. J. (1987) · New England Journal of Medicine · doi:10.1056/nejm198708133170706 · Cited by 663
Effect of simvastatin on coronary atheroma: the Multicentre Anti-Atheroma Study (MAAS)
MAAS Investigators (1994) · The Lancet · doi:10.1016/s0140-6736(94)92082-6 · Cited by 644
participants, R. T. (1993) · The Lancet · doi:10.1016/0140-6736(93)90348-k · Cited by 600
Meta-analysis of randomised trials comparing coronary angioplasty with bypass surgery
Pocock, S., Henderson, R. A., Rickards, A. F., Hampton, J. R., King, S. B., Hamm, C. W., Puel, J., Hueb, W. A., Goy, J. J., & Rodriguez, A. (1995) · The Lancet · doi:10.1016/s0140-6736(95)92897-9 · Cited by 527
The Analysis of Multiple Endpoints in Clinical Trials
Pocock, S. J., Geller, N. L., & Tsiatis, A. A. (1987) · Biometrics · doi:10.2307/2531989 · Cited by 524
Cited by
Sorted by citations
Adjusting for multiple testing—when and how?
Bender, R., & Lange, S. (2001) · Journal of Clinical Epidemiology · doi:10.1016/s0895-4356(00)00314-0 · Cited by 3,168
Wykes, T., Steel, C., Everitt, B., & Tarrier, N. (2007) · Schizophrenia Bulletin · doi:10.1093/schbul/sbm114 · Cited by 1,029
Follow-up of glycemic control and cardiovascular outcomes in type 2 diabetes
Hayward, R. A., Reaven, P. D., Wiitala, W. L., Bahn, G. D., Reda, D. J., Ge, L., McCarren, M., Duckworth, W. C., & Emanuele, N. V. (2015) · New England Journal of Medicine · doi:10.1056/nejmoa1414266 · Cited by 668
Trastuzumab containing regimens for early breast cancer
Moja, L., Tagliabue, L., Balduzzi, S., Parmelli, E., Pistotti, V., Guarneri, V., & D’Amico, R. (2012) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd006243.pub2 · Cited by 621
McCambridge, J., & Strang, J. (2003) · Addiction · doi:10.1111/j.1360-0443.2004.00564.x · Cited by 435
Metadata
- Authors
- Pocock, S. J.
- Affiliations
- London School of Hygiene & Tropical Medicine (GB)
- Corresponding author
- Pocock, Stuart J.
- ORCID
- Pocock, Stuart J.
- Venue
- Controlled Clinical Trials
- Publisher
- Elsevier BV
- Published
- 1997-12
- Volume
- 18
- Issue
- 6
- Pages
- 530-545
- ISSN
- 0197-2456 (ISSN-L)
- OpenAlex
- W2021056870
- Cited by
- 184
- References
- 16
- Citations by year
- 2026: 4 · 2025: 4 · 2024: 14 · 2022: 3 · 2021: 5 · 2020: 4 · 2019: 1 · 2018: 4 · 2017: 11 · 2016: 8 · 2015: 19 · 2014: 9 · 2013: 14 · 2012: 8
- FWCI
- 2.33
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Controlled Clinical Trials (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 and Bayesian Inference
- Keywords
- multiple outcomes, clinical trial design, outcome prioritization, trial reporting, p-values, trial size
- MeSH terms
- Clinical Trials as Topic, Coronary Disease, Humans, Research Design, Cluster Analysis, Outcome Assessment, Health Care
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
