CONSORT 2010 statement: extension to randomised crossover trials

Kerry Dwan, Tianjing Li, Douglas G Altman, Diana Elbourne, Kerry Dwan, Tianjing Li, Douglas G Altman, Diana Elbourne

Abstract

Evidence shows the quality of reporting of randomised controlled trials is not optimal. The lack of transparent reporting impedes readers from judging the reliability and validity of trial findings, prevents researchers from extracting information for systematic reviews, and results in research waste. The Consolidated Standards of Reporting Trials (CONSORT) statement was developed to improve the reporting of randomised controlled trials. The primary focus of the statement was on parallel group trials with two treatment groups. Crossover trials are a particular type of trial for chronic conditions in which participants are randomised to a sequence of interventions. They are a useful and efficient design because participants act as their own control. However, the reporting of crossover trials has been variable and incomplete, which hinders their use in clinical decision making and by future researchers. We present the CONSORT extension to randomised crossover trials, which aims to facilitate better reporting of crossover trials. The CONSORT 2010 checklist is revised for crossover designs, and introduces a modified flowchart and baseline table to enhance transparency. Examples of good reporting and evidence based rationale for CONSORT crossover checklist items are provided.

Figures

Fig 1
Fig 1
CONSORT flow diagram for crossover trials (would need modification if more than two groups and/or periods). A=intervention; B=control or other intervention; CONSORT=Consolidated Standards of Reporting Trials. In many cases a washout period can be shown
Fig 2
Fig 2
Example of flow diagram. NCEP=National Cholesterol Education Program
Fig 3
Fig 3
Example of flow diagram

References

    1. Page MJ, Higgins JP, Clayton G, Sterne JA, Hróbjartsson A, Savović J. Empirical evidence of study design biases in randomized trials: systematic review of meta-epidemiological studies. PLoS One 2016;11:e0159267. 10.1371/journal.pone.0159267
    1. Schulz KF, Chalmers I, Hayes RJ, Altman DG. Empirical evidence of bias. Dimensions of methodological quality associated with estimates of treatment effects in controlled trials. JAMA 1995;273:408-12. 10.1001/jama.1995.03520290060030
    1. Schulz KF, Altman DG, Moher D, CONSORT Group CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. BMJ 2010;340:c332. 10.1136/bmj.c332
    1. Moher D, Hopewell S, Schulz KF, et al. CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. BMJ 2010;340:c869. 10.1136/bmj.c869
    1. Shamseer L, Hopewell S, Altman DG, Moher D, Schulz KF. Update on the endorsement of CONSORT by high impact factor journals: a survey of journal “Instructions to Authors” in 2014. Trials 2016;17:301. 10.1186/s13063-016-1408-z
    1. Campbell MK, Piaggio G, Elbourne DR, Altman DG, CONSORT Group Consort 2010 statement: extension to cluster randomised trials. BMJ 2012;345:e5661. 10.1136/bmj.e5661
    1. Piaggio G, Elbourne DR, Pocock SJ, Evans SJ, Altman DG, CONSORT Group Reporting of noninferiority and equivalence randomized trials: extension of the CONSORT 2010 statement. JAMA 2012;308:2594-604. 10.1001/jama.2012.87802
    1. Vohra S, Shamseer L, Sampson M, et al. CENT Group CONSORT extension for reporting N-of-1 trials (CENT) 2015 Statement. BMJ 2015;350:h1738. 10.1136/bmj.h1738
    1. Zwarenstein M, Treweek S, Gagnier JJ, et al. CONSORT Group. Pragmatic Trials in Healthcare (Practihc) Group Improving the reporting of pragmatic trials: an extension of the CONSORT statement. BMJ 2008;337:a2390. 10.1136/bmj.a2390
    1. Pandis N, Chung B, Scherer RW, Elbourne D, Altman DG. CONSORT 2010 statement: extension checklist for reporting within person randomised trials. BMJ 2017;357:j2835. 10.1136/bmj.j2835
    1. Zeng, L., L.A. Drye, T. Li, Characterizing current registration of phase 3 crossover trials on . 2015. .
    1. Hui D, Zhukovsky DS, Bruera E. Which treatment is better? Ascertaining patient preferences with crossover randomized controlled trials. J Pain Symptom Manage 2015;49:625-31. 10.1016/j.jpainsymman.2014.11.294
    1. Cohlen BJ, te Velde ER, Looman CW, Eijckemans R, Habbema JD. Crossover or parallel design in infertility trials? The discussion continues. Fertil Steril 1998;70:40-5. 10.1016/S0015-0282(98)00114-9
    1. Makubate B, Senn S. Planning and analysis of cross-over trials in infertility. Stat Med 2010;29:3203-10. 10.1002/sim.3981
    1. Daya S. Differences between crossover and parallel study designs—debate? Fertil Steril 1999;71:771-3.
    1. Jones B, Kenward MG. Design and Analysis of Cross-over Trials. 2nd edition ed. 2003, London: Chapman&Hall/CRC.
    1. Senn S. Crossover-trials in Clinical Research. 2nd ed Wiley, 2002. 10.1002/0470854596.
    1. Wellek S, Blettner M. On the proper use of the crossover design in clinical trials: part 18 of a series on evaluation of scientific publications. Dtsch Arztebl Int 2012;109:276-81.
    1. Gart JJ. An exact test for comparing matched proportions in cross-over designs. Biometrika 1969;56:75-80 10.1093/biomet/56.1.75.
    1. Mainland D. Elementary Medical Statistics. W.B. Saunders, 1963.
    1. Freeman PR. The performance of the two-stage analysis of two-treatment, two-period crossover trials. Stat Med 1989;8:1421-32. 10.1002/sim.4780081202
    1. Chan AW, Altman DG. Epidemiology and reporting of randomised trials published in PubMed journals. Lancet 2005;365:1159-62. 10.1016/S0140-6736(05)71879-1
    1. Mills EJ, Chan AW, Wu P, Vail A, Guyatt GH, Altman DG. Design, analysis, and presentation of crossover trials. Trials 2009;10:27. 10.1186/1745-6215-10-27
    1. Yu LM, Chan AW, Hopewell S, Deeks JJ, Altman DG. Reporting on covariate adjustment in randomised controlled trials before and after revision of the 2001 CONSORT statement: a literature review. Trials 2010;11:59. 10.1186/1745-6215-11-59
    1. Inrig JK, Califf RM, Tasneem A, et al. The landscape of clinical trials in nephrology: a systematic review of . Am J Kidney Dis 2014;63:771-80. 10.1053/j.ajkd.2013.10.043
    1. Odutayo A, Emdin CA, Hsiao AJ, et al. Association between trial registration and positive study findings: cross sectional study (Epidemiological Study of Randomized Trials-ESORT). BMJ 2017;356:j917. 10.1136/bmj.j917
    1. Gewandter JS, McDermott MP, McKeown A, et al. Reporting of cross-over clinical trials of analgesic treatments for chronic pain: Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks systematic review and recommendations. Pain 2016;157:2544-51. 10.1097/j.pain.0000000000000673
    1. Straube S, Werny B, Friede T. A systematic review identifies shortcomings in the reporting of crossover trials in chronic painful conditions. J Clin Epidemiol 2015;68:1496-503. 10.1016/j.jclinepi.2015.04.006
    1. Lathyris DN, Trikalinos TA, Ioannidis JP. Evidence from crossover trials: empirical evaluation and comparison against parallel arm trials. Int J Epidemiol 2007;36:422-30. 10.1093/ije/dym001
    1. Li T, Yu T, Hawkins BS, Dickersin K. Design, analysis, and reporting of crossover trials for inclusion in a meta-analysis. PLoS One 2015;10:e0133023. 10.1371/journal.pone.0133023
    1. Nolan SJ, Hambleton I, Dwan K. The use and reporting of the cross-over study design in clinical trials and systematic reviews: a systematic assessment. PLoS One 2016;11:e0159014. 10.1371/journal.pone.0159014
    1. Ioannidis JP, Evans SJ, Gøtzsche PC, et al. CONSORT Group Better reporting of harms in randomized trials: an extension of the CONSORT statement. Ann Intern Med 2004;141:781-8. 10.7326/0003-4819-141-10-200411160-00009
    1. Guo X, Kong X, Huang R, et al. Effect of Ginkgo biloba on visual field and contrast sensitivity in Chinese patients with normal tension glaucoma: a randomized, crossover clinical trial. Invest Ophthalmol Vis Sci 2014;55:110-6. 10.1167/iovs.13-13168
    1. Johansson DP, Lee I, Risérus U, Langton M, Landberg R. Effects of unfermented and fermented whole grain rye crisp breads served as part of a standardized breakfast, on appetite and postprandial glucose and insulin responses: a randomized cross-over trial. PLoS One 2015;10:e0122241. 10.1371/journal.pone.0122241
    1. Hopewell S, Clarke M, Moher D, et al. CONSORT Group CONSORT for reporting randomised trials in journal and conference abstracts. Lancet 2008;371:281-3. 10.1016/S0140-6736(07)61835-2
    1. Arruda-Olson AM, Mahoney DW, Nehra A, Leckel M, Pellikka PA. Cardiovascular effects of sildenafil during exercise in men with known or probable coronary artery disease: a randomized crossover trial. JAMA 2002;287:719-25. 10.1001/jama.287.6.719
    1. Equi A, Balfour-Lynn IM, Bush A, Rosenthal M. Long term azithromycin in children with cystic fibrosis: a randomised, placebo-controlled crossover trial. Lancet 2002;360:978-84. 10.1016/S0140-6736(02)11081-6
    1. Rubio-Aurioles E, Porst H, Kim ED, et al. A randomized open-label trial with a crossover comparison of sexual self-confidence and other treatment outcomes following tadalafil once a day vs. tadalafil or sildenafil on-demand in men with erectile dysfunction. J Sex Med 2012;9:1418-29. 10.1111/j.1743-6109.2012.02667.x
    1. Escudier B, Porta C, Bono P, et al. Randomized, controlled, double-blind, cross-over trial assessing treatment preference for pazopanib versus sunitinib in patients with metastatic renal cell carcinoma: PISCES Study. J Clin Oncol 2014;32:1412-8. 10.1200/JCO.2013.50.8267
    1. Konstas AG, Lake S, Economou AI, Kaltsos K, Jenkins JN, Stewart WC. 24-Hour control with a latanoprost-timolol fixed combination vs timolol alone. Arch Ophthalmol 2006;124:1553-7. 10.1001/archopht.124.11.1553
    1. Gelderblom H, Wüstenberg T, McLean T, et al. Bupropion for the treatment of apathy in Huntington’s disease: a multicenter, randomised, double-blind, placebo-controlled, prospective crossover trial. PLoS One 2017;12:e0173872. 10.1371/journal.pone.0173872
    1. Julious SA, Campbell MJ, Altman DG. Estimating sample sizes for continuous, binary, and ordinal outcomes in paired comparisons: practical hints. J Biopharm Stat 1999;9:241-51. 10.1081/BIP-100101174
    1. Fogel RB, Rosario N, Aristizabal G, et al. Effect of montelukast or salmeterol added to inhaled fluticasone on exercise-induced bronchoconstriction in children. Ann Allergy Asthma Immunol 2010;104:511-7. 10.1016/j.anai.2009.12.011
    1. Freemantle N, Satram-Hoang S, Tang ET, et al. DAPS Investigators Final results of the DAPS (Denosumab Adherence Preference Satisfaction) study: a 24-month, randomized, crossover comparison with alendronate in postmenopausal women. Osteoporos Int 2012;23:317-26. 10.1007/s00198-011-1780-1
    1. Abell TL, Johnson WD, Kedar A, et al. A double-masked, randomized, placebo-controlled trial of temporary endoscopic mucosal gastric electrical stimulation for gastroparesis. Gastrointest Endosc 2011;74:496-503.e3.
    1. Hill J, Bird HA, Fenn GC, Lee CE, Woodward M, Wright V. A double-blind crossover study to compare lysine acetyl salicylate (Aspergesic) with ibuprofen in the treatment of rheumatoid arthritis. J Clin Pharm Ther 1990;15:205-11. 10.1111/j.1365-2710.1990.tb00376.x
    1. Bonten TN, Snoep JD, Assendelft WJ, et al. Time-dependent effects of aspirin on blood pressure and morning platelet reactivity: a randomized cross-over trial. Hypertension 2015;65:743-50. 10.1161/HYPERTENSIONAHA.114.04980
    1. Fleiss JL, Wallenstein S, Rosenfeld R. Adjusting for baseline measurements in the two-period crossover study: a cautionary note. Control Clin Trials 1985;6:192-7. 10.1016/0197-2456(85)90002-9
    1. Willan AR, Pater JL. Using baseline measurements in the two-period crossover clinical trial. Control Clin Trials 1986;7:282-9. 10.1016/0197-2456(86)90036-X
    1. Carpenter JR, Kenward MG. Sensitivity Analysis with Multiple Imputation. In: Molenberghs G, et al., eds. Handbook of Missing Data Methodology. CRC Press New York, 2015: 446.
    1. Chen CY, Holbrook M, Duess MA, et al. Effect of almond consumption on vascular function in patients with coronary artery disease: a randomized, controlled, cross-over trial. Nutr J 2015;14:61. 10.1186/s12937-015-0049-5
    1. Marchetti E, Mummolo S, Di Mattia J, et al. Efficacy of essential oil mouthwash with and without alcohol: a 3-day plaque accumulation model. Trials 2011;12:262. 10.1186/1745-6215-12-262
    1. Markman JD, Frazer ME, Rast SA, et al. Double-blind, randomized, controlled, crossover trial of pregabalin for neurogenic claudication. Neurology 2015;84:265-72. 10.1212/WNL.0000000000001168
    1. Graff GR, Maguiness K, McNamara J, et al. Efficacy and tolerability of a new formulation of pancrelipase delayed-release capsules in children aged 7 to 11 years with exocrine pancreatic insufficiency and cystic fibrosis: a multicenter, randomized, double-blind, placebo-controlled, two-period crossover, superiority study. Clin Ther 2010;32:89-103. 10.1016/j.clinthera.2010.01.012
    1. Valentino LA, Rusen L, Elezovic I, Smith LM, Korth-Bradley JM, Rendo P. Multicentre, randomized, open-label study of on-demand treatment with two prophylaxis regimens of recombinant coagulation factor IX in haemophilia B subjects. Haemophilia 2014;20:398-406. 10.1111/hae.12344
    1. O’Connor DW, Eppingstall B, Taffe J, van der Ploeg ES. A randomized, controlled cross-over trial of dermally-applied lavender (Lavandula angustifolia) oil as a treatment of agitated behaviour in dementia. BMC Complement Altern Med 2013;13:315. 10.1186/1472-6882-13-315
    1. Elbourne DR, Altman DG, Higgins JP, Curtin F, Worthington HV, Vail A. Meta-analyses involving cross-over trials: methodological issues. Int J Epidemiol 2002;31:140-9. 10.1093/ije/31.1.140
    1. Stedman MR, Curtin F, Elbourne DR, Kesselheim AS, Brookhart MA. Meta-analyses involving cross-over trials: methodological issues. Int J Epidemiol 2011;40:1732-4. 10.1093/ije/dyp345
    1. Curtin F, Elbourne D, Altman DG. Meta-analysis combining parallel and cross-over clinical trials. II: Binary outcomes. Stat Med 2002;21:2145-59. 10.1002/sim.1206
    1. Solomon DH, Garg R, Lu B, et al. Effect of hydroxychloroquine on insulin sensitivity and lipid parameters in rheumatoid arthritis patients without diabetes mellitus: a randomized, blinded crossover trial. Arthritis Care Res (Hoboken) 2014;66:1246-51. 10.1002/acr.22285
    1. Juszczak E, Altman DG, Hopewell S, Schulz K. Reporting of Multi-Arm Parallel-Group Randomized Trials: Extension of the CONSORT 2010 Statement. JAMA 2019;321:1610–20. 10.1001/jama.2019.3087
    1. Rietbergen C, Moerbeck M. The Design of Cluster Randomized Crossover Trials. J Educ Behav Stat 2011;36:472-90 10.3102/1076998610379136.
    1. Arnup SJ, Forbes AB, Kahan BC, Morgan KE, McKenzie JE. Appropriate statistical methods were infrequently used in cluster-randomized crossover trials. J Clin Epidemiol 2016;74:40-50. 10.1016/j.jclinepi.2015.11.013
    1. Turner L, Shamseer L, Altman DG, Schulz KF, Moher D. Does use of the CONSORT Statement impact the completeness of reporting of randomised controlled trials published in medical journals? A Cochrane review. Syst Rev 2012;1:60. 10.1186/2046-4053-1-60

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