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Meta-analyses involving cross-over trials: methodological issues
Abstract
BACKGROUND: Meta-analysis of randomized controlled trials (RCTs) is usually based on trials where patients are randomized individually into two different, parallel, treatment groups. This paper concentrates on RCTs of a different design-two-period, two-treatment cross-over trials. METHODS: The characteristics of these trials are outlined, with detailed examples of methods for analysis for both continuous and binary data. These case studies are then extended into the context of a meta-analysis. The Cochrane Library was surveyed to assess current practice for synthesis. RESULTS: Methods are described for continuous and binary data for use both when the necessary paired data are given and also when they need to be calculated or imputed, and some suggestions are provided to help people wishing to synthesize data from cross-over trials into meta-analyses. The survey suggested that about 8% of the trials in the Cochrane library were cross-over trials and 18% of the reviews referred to such trials, although there was no consistent approach to their inclusion into the reviews. CONCLUSIONS: Methods do exist for including valuable information from two-period, two-treatment cross-over trials into quantitative reviews. However, poor reporting of cross-over trials will often impede attempts to perform a meta-analysis using the available methods.
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“In such cases, a conservative correlation value of 0.5 is commonly used (80).”
From Carbohydrate ingestion during prolonged exercise and net skeletal muscle glycogen utilization: A meta-analysis. (2026) · cites this paper as [80]
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“Since all included studies utilised a cross-over design, dependency was accounted for when computing sampling variance using previously described methods [49].”
From The effect of caffeine on subsequent sleep: A systematic review and meta-analysis (2023) · cites this paper as [49]
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“cross-over trials are not appropriate if the condition of interest is unstable (Elbourne 2002).”
From Compulsory community and involuntary outpatient treatment for people with severe mental disorders. (2017) · cites this paper as Elbourne 2002
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“For the implementation of cross-over trials in the meta-analysis, we used the method according to Becker/Balagtas [34]. This method ensures that no participants were counted double in the meta-analysis.”
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“In order to include cross-over trials in our trials using the method by Becker/Balagtas, OR was used to provide a stable effects measure [34].”
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“Non-daily vs. daily statin dosing resulted in an OR of 0.58 (95% CI 0.23–1.43). [34,51,52].”
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Hutton, E. K., & Hofmeyr, G. J. (2006) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd000084.pub2 · Cited by 317
Dimidi, E., Christodoulides, S., Fragkos, K. C., Scott, S. M., & Whelan, K. (2014) · The American Journal of Clinical Nutrition · doi:10.3945/ajcn.114.089151 · Cited by 316
The effect of caffeine on subsequent sleep: A systematic review and meta-analysis
Gardiner, C., Weakley, J., Burke, L. M., Roach, G. D., Sargent, C., Maniar, N., Townshend, A., & Halson, S. L. (2023) · Sleep Medicine Reviews · doi:10.1016/j.smrv.2023.101764 · Cited by 357
“Since all included studies utilised a cross-over design, dependency was accounted for when computing sampling variance using previously described methods [49].”
MethodChiu, S., Sievenpiper, J. L., de Souza, R. J., Cozma, A. I., Mirrahimi, A., Carleton, A. J., Ha, V, Di Buono, M., Jenkins, A. L., Leiter, L. A., et al. (2014) · European Journal of Clinical Nutrition · doi:10.1038/ejcn.2014.8 · Cited by 314
Citalopram versus other anti-depressive agents for depression
Cipriani, A., Purgato, M., Furukawa, T. A., Trespidi, C., Imperadore, G., Signoretti, A., Churchill, R. C., Watanabe, N., & Barbui, C. (2012) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd006534.pub2 · Cited by 314
Psychosocial interventions for self-harm in adults
Hawton, K. E., Witt, K., Salisbury, T. T., Arensman, E., Gunnell, D., Hazell, P., Townsend, E., & van Heeringen, K. (2016) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd012189 · Cited by 319
Nonsteroidal anti-inflammatory drugs for pain in women with endometriosis
Brown, J., Crawford, T. J., Allen, C., Hopewell, S., & Prentice, A. (2017) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd004753.pub4 · Cited by 308
Hooren, B. V., FULLER, J. T., Buckley, J. D., Miller, J. R., Sewell, K. B., Rao, G., Barton, C. J., Bishop, C., & Willy, R. W. (2019) · Sports Medicine · doi:10.1007/s40279-019-01237-z · Cited by 306
Pharmacological interventions for borderline personality disorder
Stoffers, J., Völlm, B. A., Rücker, G., Timmer, A., Huband, N., & Lieb, K. (2010) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd005653.pub2 · Cited by 302
Efficacy, Acceptability, and Tolerability of Antipsychotics in Treatment-Resistant Schizophrenia
Samara, M. T., Dold, M., Gianatsi, M., Nikolakopoulou, A., Helfer, B., Salanti, G., & Leucht, S. (2016) · JAMA Psychiatry · doi:10.1001/jamapsychiatry.2015.2955 · Cited by 305
Gastro-oesophageal reflux treatment for prolonged non-specific cough in children and adults
Chang, A. B., Lasserson, T. J., Gaffney, J., Connor, F. L., & Garske, L. A. (2011) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd004823.pub4 · Cited by 293
Nebulised hypertonic saline for cystic fibrosis
Wark, P. A. B., & McDonald, V. M. (2018) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd001506.pub4 · Cited by 291
Neuromuscular electrical stimulation for muscle weakness in adults with advanced disease
Jones, S. E., Man, W. D., Gao, W., Higginson, I. J., Wilcock, A., & Maddocks, M. M. (2016) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd009419.pub3 · Cited by 293
Effect of Fructose on Body Weight in Controlled Feeding Trials
Sievenpiper, J. L., de Souza, R. J., Mirrahimi, A., Yu, M. E., Carleton, A. J., Beyene, J., Chiavaroli, L., Buono, M. D., Jenkins, A. L., Leiter, L. A., et al. (2012) · Annals of Internal Medicine · doi:10.7326/0003-4819-156-4-201202210-00007 · Cited by 297
Music therapy for autistic spectrum disorder
Gold, C., Wigram, T., & Elefant, C. (2006) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd004381.pub2 · Cited by 293
Gabapentin for chronic neuropathic pain and fibromyalgia in adults
Moore, R. A., Wiffen, P. J., Derry, S., & Rice, A. S. C. (2014) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd007938.pub3 · Cited by 297
Newer generation antidepressants for depressive disorders in children and adolescents
Hetrick, S. E., McKenzie, J. E., Cox, G. R., Simmons, M. B., & Merry, S. N. (2012) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd004851.pub3 · Cited by 291
Esposito, M. A., Grusovin, M. G., Felice, P., Karatzopoulos, G., Worthington, H. V., & Coulthard, P. (2009) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd003607.pub4 · Cited by 291
Self-citationChristensen, R., Lorenzen, J. K., Svith, C. R., Bartels, E. M., Melanson, E. L., Saris, W. H., Tremblay, A., & Astrup, A. (2009) · Obesity Reviews · doi:10.1111/j.1467-789x.2009.00599.x · Cited by 290
Metadata
- Authors
- Elbourne, D. R., Altman, D. G., Higgins, J. P., Curtin, F., Worthington, H. V., & Vail, A.
- Affiliations
- London School of Hygiene & Tropical Medicine (GB)
- Merck KGaA, Darmstadt (Germany) (DE)
- University Dental Hospital of Manchester (GB)
- Salford Royal Hospital (GB)
- Corresponding author
- Elbourne, Diana R
- Venue
- International Journal of Epidemiology
- Publisher
- Oxford University Press (OUP)
- Published
- 2002-02
- Volume
- 31
- Issue
- 1
- Pages
- 140-149
- ISSN
- 0300-5771 (ISSN-L)
- 1464-3685
- OpenAlex
- W2130235475
- Cited by
- 2,305
- References
- 37
- Citations by year
- 2026: 58 · 2025: 58 · 2024: 72 · 2023: 87 · 2022: 116 · 2021: 129 · 2020: 107 · 2019: 111 · 2018: 128 · 2017: 131 · 2016: 145 · 2015: 147 · 2014: 174 · 2013: 135 · 2012: 144
- FWCI
- 47.29
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- International Journal of Epidemiology (publishedVersion)
- PubMed (publishedVersion)
- Research Explorer (The University of Manchester) (submittedVersion)
- Funders
- Medical Research Council
- Topics
- Social Sciences › Decision Sciences › Statistics, Probability and Uncertainty › Meta-analysis and systematic reviews
- Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
- Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Epidemiology
- Keywords
- crossover trial, meta-analysis, randomized controlled trials, continuous data, binary data, missing data imputation, trial reporting quality, Cochrane Library
- MeSH terms
- Humans, Review Literature as Topic, Meta-Analysis as Topic, Randomized Controlled Trials as Topic, Cross-Over Studies
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.
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