Consort 2010 statement: Extension to cluster randomised trials

BMJ (Online)

Volumn 345, Issue 7881, 2012, Pages

  Campbell, Marion K ^a   Piaggio, Gilda ^b   Elbourne, Diana R ^b   Altman, Douglas G ^c  

^a UNIVERSITY OF ABERDEEN   (United Kingdom)

^b LONDON SCHOOL OF HYGIENE AND TROPICAL MEDICINE   (United Kingdom)

^c UNIVERSITY OF OXFORD   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

ANALYTICAL RESEARCH; ARTICLE; CLUSTER ANALYSIS; CONSOLIDATION STANDARDS OF REPORTING TRIALS; HEALTH SERVICE; HUMAN; MEDICAL INFORMATION; MEDICAL LITERATURE; MEDICAL PRACTICE; OUTCOME ASSESSMENT; PRACTICE GUIDELINE; PRIORITY JOURNAL; PUBLISHING; RANDOMIZATION; RANDOMIZED CONTROLLED TRIAL (TOPIC); STATISTICAL ANALYSIS; METHODOLOGY; SAMPLE SIZE; STANDARD;

CLUSTER ANALYSIS; DATA INTERPRETATION, STATISTICAL; HUMANS; RANDOM ALLOCATION; RANDOMIZED CONTROLLED TRIALS AS TOPIC; SAMPLE SIZE;

EID: 84868325759     PISSN: None     EISSN: 17561833     Source Type: Journal    
DOI: 10.1136/bmj.e5661     Document Type: Article

References (108)

1. Begg C, Cho M, Eastwood S, Horton R, Moher D, Olkin I, et al. Improving the quality of reporting of randomised controlled trials. The CONSORT statement. JAMA 1996;276:637-9.
2. Moher D, Schulz KF, Altman DG, CONSORT Group. The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomised trials. Lancet 2001;357:1191-4.
3. Schulz KF, Altman DG, Moher D. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. BMJ 2010;340:c332.
4. Moher D, Hopewell S, Schulz KF, Montori V, Gøtzsche PC, Devereaux PJ, et al. CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. BMJ 2010;340:c869.
5. Puffer S, Torgerson D, Watson J. Evidence for risk of bias in cluster randomised trials: review of recent trials published in three general medical journals. BMJ 2003;327:785-9.
6. Fayers PM, Jordhøy MS, Kaasa S. Cluster-randomized trials. Palliat Med 2002;26:69-70.
7. Grimshaw JM, Campbell MK, Eccles M, Steen IN. Experimental and quasi-experimental designs for evaluating guideline implementation strategies. Fam Pract 2000;17:S11-8.
8. Donner A, Klar N. Design and analysis of cluster randomization trials in health research . Arnold, 2000.
9. Elbourne DR, Campbell MK. Extending the CONSORT statement to cluster randomised trials: for discussion. Stat Med 2001;20:489-96.
10. Campbell MK, Elbourne DR, Altman DG. CONSORT statement: extension to cluster randomised trials. BMJ 2004;328:702-8.
11. Hopewell S, Clarke M, Moher D, Wager E, Middleton P, Altman DG, et al. CONSORT for reporting randomised trials in journal and conference abstracts. Lancet 2008;371:281-3.
12. Hopewell S, Clarke M, Moher D, Wager E, Middleton P, Altman DG, at al. CONSORT for reporting randomized controlled trials in journal and conference abstracts: explanation and elaboration. PLoS Med 2008;5:e20.
13. Lesaffre E, Garcia Zattera MJ, Redmond C, Huber H, Needleman I. Reported methodological quality of split-mouth studies. J Clin Periodontol 2007;34:756-61.
14. Roberts C, Roberts SA. Design and analysis of clinical trials with clustering effects due to treatment. Clin Trials 2002;2:152-62.
15. Boutron I, Moher D, Altman DG, Schulz KF, Ravaud P. Extending the CONSORT statement to randomized trials of nonpharmacologic treatment: explanation and elaboration. Ann Intern Med 2008;148:295-309.
16. Varnell SP, Murray DM, Baker WL. An evaluation of analysis options for the one-group-per-condition design. Can any of the alternatives overcome the problems inherent in this design? Eval Review 2001;25:440-53.
17. Hayes RJ, Moulton LH. Cluster randomised trials . Chapman and Hall/CRC, 2008.
18. Fagevik Olsén M, Hahn I, Nordgren S, Lönroth H, Lundholm K. Randomized controlled trial of prophylactic chest physiotherapy in major abdominal surgery. Br J Surg 1997;84:1535-8.
19. Turner RM, White IR, Croudace T, for the PIP Study Group. Analysis of cluster randomized cross-over trial data: a comparison of methods. Stat Med 2007;26:274-89.
20. Mdege ND, Man M-S, Taylor (nee Brown) CA, Torgerson DJ. Systematic review of stepped wedge cluster randomized trials shows that design is particularly used to evaluate interventions during routine implementation, J Clin Epidemiol, 2011;64:936-48.
21. Brown CA, Lilford RJ. The stepped wedge trial design: a systematic review. BMC Med Res Methodol 2006;6:54.
22. Muckelbauer R, Libuda L, Clausen K, Toschke AM, Reinehr T, Kersting M. Promotion and provision of drinking water in schools for overweight prevention: randomized, controlled cluster trial. Pediatrics 2009;123:e661-7.
23. Zwarenstein M, Treweek S, Altman DG, Gagnier J, Tunis S, Haynes RB, et al. Improving the reporting of pragmatic trials: an extension of the CONSORT statement. BMJ 2008;337:a2390.
24. Campbell MJ, Donner A, Klar N. Developments in cluster randomized trials. Stat Med 2007;26:2-19.
25. Murray DM, Varnell SP, Blitstein JL. Design and analysis of group-randomized trials: a review of recent methodological developments. Am J Public Health 2004;94:423-32.
26. Eldridge S, Kerry S. A practical guide to cluster randomised trials in health services research. Wiley, 2012.
27. Simpson JM, Klar N, Donner A. Accounting for cluster randomization: a review of primary prevention trials, 1990 through 1993. Am J Public Health 1995;85:1378-83.
28. Divine GW, Brown JT, Frazier LM. The unit of analysis error in studies about physicians' patient care behaviour. J Gen Intern Med 1992;7:623-9.
29. Donner A, Brown KS, Brasher P. A methodological review of non-therapeutic intervention trials employing cluster randomization, 1979-1989. Int J Epidemiol 1990;19:795-800.
30. Chuang JH, Hripcsak G, Jenders RA. Considering clustering: a methodological review of clinical decision support system studies. Proc AMIA Symp 2000;146-50.
31. Maclennan GS, Ramsay CR, Thomas RE, Grimshaw JM. Unit of analysis errors in cluster randomised trials to evaluate the effectiveness of the introduction of clinical guidelines into medical practice. Proc Int Soc Clin Biostat 2001;186.
32. Isaakidis P, Ioannidis JPA. Evaluation of cluster randomized controlled trials in sub-Saharan Africa. Am J Epidemiol 2003;158:921-6.
33. Varnell SP, Murray DM, Janega JB, Blitstein JL. Design and analysis of group-randomized trials: a review of recent practices. Am J Public Health 2004;94:393-9.
34. Bland JM. Cluster randomised trials in the medical literature: two bibliometric surveys. BMC Med Res Methodol 2004;4:21.
35. Calhoun AW, Guyatt GH, Cabana MD, Lu D, Turner DA, Valentine S, et al. Addressing the unit of analysis in medical care studies: a systematic review. Med Care 2008;46:635-43.
36. Eldridge S, Ashby D, Bennett C, Wakelin M, Feder G. Internal and external validity of cluster randomised trials: systematic review of recent trials. BMJ 2008;336:876-80.
37. Murray DM, Pals SL, Blitstein JL, Alfano CM, Lehman J. Design and analysis of group-randomized trials in cancer: a review of current practices. J Natl Cancer Inst 2008;100:483-91.
38. Bowater RJ, Abdelmalik SM, Lilford RJ. The methodological quality of cluster randomised controlled trials for managing tropical parasitic disease: a review of trials published from 1998 to 2007. Trans R Soc Trop Med Hyg 2009;103:429-36.
39. Handlos LN, Chakraborty H, Sen PK. Evaluation of cluster-randomized trials on maternal and child health research in developing countries. Trop Med Int Health 2009;14:947-56.
40. Crespi CM, Maxwell AE, Wu S. Cluster randomized trials of cancer screening interventions: are appropriate statistical methods being used? Contemp Clin Trials 2011;32:477-84.
41. Walleser S, Hill SR, Bero LA. Characteristics and quality of reporting of cluster randomized trials in children: reporting needs improvement. J Clin Epidemiol 2011;64:1331-40.
42. Ivers NM, Taljaard M, Dixon S, Bennett C, McRae A, Taleban J, et al. Impact of the CONSORT extension for cluster randomised trials on quality of reporting and study methodology: review of a random sample of 300 trials from 2000 to 2008. BMJ 2011;343:d5886.
43. Cumming RG, Sherrington C, Lord SR, Simpson JM, Vogler C, Cameron ID, et al Prevention of Older People's Injury Falls Prevention in Hospitals Research Group. Cluster randomised trial of a targeted multifactorial intervention to prevent falls among older people in hospital. BMJ 2008;336:758-60.
44. Cavalcante SC, Durovni B, Barnes GL, Souza FBA, Silva RF, Barroso PF, et al. Community-randomized trial of enhanced DOTS for tuberculosis control in Rio de Janeiro, Brazil. Int J Tuberc Lung Dis 2010;14:203-9.
45. Taljaard M, McGowan J, Grimshaw JM, Brehaut JC, McRae A, Eccles MP, et al. Electronic search strategies to identify reports of cluster randomized trials in MEDLINE: low precision will improve with adherence to reporting standards. BMC Med Res Methodol 2010;10:15.
46. Wyatt JC, Paterson-Brown S, Johanson R, Altman DG, Bradburn MJ, Fisk NM. Randomised trial of educational visits to enhance use of systematic reviews in 25 obstetric units. BMJ 1998;317:1041-6.
47. Siebers AG, Klinkhamer PJJM, Grefte JMM, Massuger LFAG, Vedder JEM, Beijers-Broos A, et al. Comparison of liquid-based cytology with conventional cytology for detection of cervical cancer precursors: a randomized controlled trial. JAMA 2009;302:1757-64.
48. World Medical Association. Recommendations guiding physicians in biomedical research involving human subjects. World Medical Association Declaration of Helsinki. JAMA 1997;277:925-6.
49. Donner A, Brown KS, Brasher P. A methodological review of non-therapeutic intervention trials employing cluster randomization, 1979-1989. Int J Epidemiol 1990;19:795-800.
50. Brierley G, Brabyn S, Torgerson D, Watson J. Bias in recruitment to cluster randomized trials: a review of recent publications. J Eval Clin Pract 2012;18:878-86.
51. Puffer S, Torgerson DJ, Watson J. Cluster randomized controlled trials. J Eval Clin Pract 2005;11:479-83.
52. Acolet D, Allen E, Houston R, Wilkinson AR, Costeloe K, Elbourne D. Improvement in neonatal intensive care unit care: a cluster randomised controlled trial of active dissemination of information. Arch Dis Child Fetal Neonatal Ed 2011;96:F434-9.
53. Atienza AA, King AC. Community-based health intervention trials: an overview of methodological issues. Epidemiol Rev 2002;24:72-9.
54. Dangour AD, Albala C, Allen E, Grundy E, Walker D, Aedo C, et al. Effect of a nutrition supplement and physical activity program on pneumonia and walking capacity in Chilean older people: a factorial cluster randomized trial. PLoS Med 2011;8:e1001023.
55. Cals JWL, Butler CC, Hopstaken RM, Hood K, Dinant GJ. Effect of point of care testing for C reactive protein and training in communication skills on antibiotic use in lower respiratory tract infections: cluster randomised trial. BMJ 2009;338:b1374.
56. Althabe F, Belizán JM, Villar J, Alexander S, Bergel E, Ramos S, et al. Mandatory second opinion to reduce rates of unnecessary caesarean sections in Latin America: a cluster randomised controlled trial. Lancet 2004;363:1934-40.
57. Altman DG, Doré CJ. Randomisation and baseline comparisons in clinical trials. Lancet 1990;335:149-53.
58. Kinmonth AL, Woodcock A, Griffin S, Spiegal N, Campbell MJ, Diabetes Care from Diagnosis Research Team. Randomised controlled trial of patient centred care of diabetes in general practice: impact of current wellbeing and future disease risk. BMJ 1998;317:1202-8.
59. Kroeger A, Avilla EC, Morison L. Insecticide impregnated curtains to control domestic transmission of cutaneous leishmaniasis in Venezuela: cluster randomised trial. BMJ 2002;325:810-3.
60. Murphy AW, Cupples ME, Smith SM, Byrne M, Byrne MC, Newell J. Effect of tailored practice and patient care plans on secondary prevention of heart disease in general practice: cluster randomised controlled trial. BMJ 2009;339:b4220.
61. Naughton C, Feely J, Bennett KA. Clustered randomized trial of the effects of feedback using academic detailing compared to postal bulletin on prescribing of preventative cardiovascular therapy. Fam Pract 2007;24:475-80.
62. Montgomery AA, Fahey T, Peters TJ, MacIntosh C, Sharp DJ. Evaluation of computer based clinical decision support system and risk chart for management of hypertension in primary care: randomised controlled trial. BMJ 2000;320:686-90.
63. Majoko F, Munjanja SP, Nyström L, Mason E, Lindmark G. Randomised controlled trial of two antenatal care models in rural Zimbabwe. BJOG 2007;114:802-11.
64. Grosskurth H, Mosha F, Todd J, Mwijarubi E, Klokke A, Senkoro K, et al. Impact of improved treatment of sexually transmitted diseases on HIV infection in rural Tanzania: randomised controlled trial. Lancet 1995;346:530-6.
65. Eldridge S, Kerry S, Ashby D. Sample size for cluster randomized trials: effect of coefficient of variation of cluster size and analysis method. Int J Epidemiol 2006;35:1292-300.
66. Carter B. Cluster size variability and imbalance in cluster randomized controlled trials. Stat Med 2010;29:2984-93.
67. Kirkwood BR, Hurt L, Amenga-Etego S, Tawiah C, Zandoh C, Danso S, et al. Effect of vitamin A supplementation in women of reproductive age on maternal survival in Ghana (ObaapaVitA): a cluster-randomised, placebo-controlled trial. Lancet 2010;375:1640-9.
68. Ellenberg SS, Fleming TR, De Mets DL. Data monitoring committees in clinical trials: a practical perspective. Wiley, 2002.
69. Grant AM, Altman DG, Babiker AB, Campbell MK, Clemens FJ, Darbyshire JH, et al. Issues in data monitoring and interim analysis of trials. Health Technol Assess 2005;9:1-238.
70. Zou GY, Donner A, Klar N. Group sequential methods for cluster randomization trials with binary outcomes. Clin Trials 2005;2:479-87.
71. Flynn TN, Whitley E, Peters TJ. Recruitment strategies in a cluster randomize trial-cost implications. Stat Med 2002;21:397-405.
72. Villar J, Ba'aqeel H, Piaggio G, Lumbiganon P, Miguel Belizán J, Farnot U, et al. WHO antenatal care randomised trial for the evaluation of a new model of routine antenatal care. Lancet 2001;357:1551-64.
73. Schulz K, Grimes D. Generation of allocation sequences in randomised trials: chance, not choice. Lancet 2002;359:515-9.
74. Schulz K, Chalmers I, Hayes R, Altman DG. Empirical evidence of bias: dimensions of methodological quality associated with estimates of treatment effects in controlled trials. JAMA 1995;273:408-12.
75. Weijer C, Grimshaw JM, Eccles MP, McRae AD, White A, Brehaut JC, et al. The Ottawa Consensus Statement on the ethical design and conduct of CRTs. PloS Med (in press).
76. Clarke SE, Jukes MC, Njagi JK, Khasakhala L, Cundill B, Otido J, et al. Effect of intermittent preventive treatment of malaria on health and education in schoolchildren: a cluster randomised double-blind, placebo-controlled trial. Lancet 2008;372:127-38.
77. Sur D, Ochiai RL, Bhattacharya SK, Ganguly NK, Ali M, Manna B, et al. Cluster-randomized effectiveness trial of Vi typhoid vaccine in India. N Engl J Med 2009;361:335-44.
78. Altman DG, Schulz KF, Moher D, Egger M, Davidoff F, Elbourne D, et al. The revised CONSORT statement for reporting randomised trials: explanation and elaboration. Ann Intern Med 2001;134:663-94.
79. Taljaard M, McRae A, Weijer C, Bennett C, Dixon S, Taleban J, et al. Inadequate reporting of research ethics review and informed consent in cluster randomized trials: review of a representative sample of published trials. BMJ 2011;342:d2496.
80. Weijer C, Grimshaw JM, Taljaard M, Binik A, Boruch R, Brehaut JC, et al. Ethical issues posed by cluster randomized trials in health research. Trials 2011;12:100.
81. Flottorp S, Oxman AD, Havelsrud K, Treweek S, Herrin J. Cluster randomised trial of tailored interventions to improve the management of urinary tract infections in women and sore throat. BMJ 2002;325:367-72.
82. Campbell MK, Fayers PM, Grimshaw JM. Determinants of the intracluster correlation coefficient in cluster randomized trials: the case of implementation research. Clin Trials 2005;2:99-107.
83. Turner RM, Thompson SG, Spiegelhalter DJ. Prior distributions for the intracluster correlation coefficient, based on multiple previous estimates, and their application in cluster randomized trials. Clin Trials 2005;2:108-18.
84. Adams G, Gulliford MC, Ukoumunne OC, Eldridge S, Chinn S, Campbell MJ. Patterns of intra-cluster correlation from primary care research to inform study design and analysis. J Clin Epidemiol 2004;57:785-94.
85. Taljaard M. Intracluster correlation coefficients from the 2005 WHO Global Survey on Maternal and Perinatal Health: implications for implementation research. Paediatr Perinat Epidemiol 2008;22:117-25.
86. Pagel C, Prost A, Lewycka S, Das S, Colbourn T, Mahapatra R, et al. Intracluster correlation coefficients and coefficients of variation for perinatal outcomes from five cluster-randomised controlled trials in low and middle-income countries: results and methodological implications. Trials 2011;12:151.
87. Moher M, Yudkin P, Wright L, Turner R, Fuller A, Schofield T, et al. Cluster randomised trial to compare three methods of promoting secondary prevention of coronary heart disease in primary care. BMJ 2001;322:1338-42.
88. Moher D, Turner L, Shamseer L, Plint A, Weeks L, Peters J, et al. The influence on CONSORT on the quality of RCTs: an updated review. Clin Trials 2011;8:485.
89. Piaggio G, Elbourne DR, Altman DG, Pocock SJ, Evans SJW. Reporting of noninferiority and equivalence randomized trials: an extension of the CONSORT statement. JAMA 2006;295:1152-60.
90. Hayes RJ, Bennett S. Simple sample size calculation for cluster-randomized trials. Int J Epidemiol 1999;28:319-26.
91. Thomson A, Hayes R, Cousens S. Measures of between-cluster variability in cluster randomized trials with binary outcomes. Stat Med 2009;28:1739-51.
92. Klar N, Donner A. The merits of matching in community intervention trials. Stat Med 1997;16:1753-64.
93. Eldridge SM, Ashby D, Feder GS. Informed patient consent to participation in cluster randomized trials: an empirical exploration of trials in primary care. Clin Trials 2005;2:91-8.
94. Farrin A, Russell I, Torgerson D, Underwood M. Differential recruitment in a cluster randomized trial in primary care: the experience of the UK back pain, exercise, active management and manipulation (UK BEAM) feasibility study. Clin Trials 2005;2:119-24.
95. Hutton J. Are distinctive ethical principles required for cluster randomised trials? In: Campbell MJ, Donner A, Elbourne D, eds. Design and analysis of cluster randomized trials. Stat Med 2001;20:473-88.
96. Hutton JL, Eccles MP, Grimshaw JM. Ethical issues in implementation research: a discussion of the problems in achieving informed consent. Implement Sci 2008;3:52.
97. Edwards SJ, Braunholtz DA, Lilford RJ, Stevens AJ. Ethical issues in the design and conduct of cluster randomised trials. BMJ 1999;318:1407-9.
98. Mazor KM, Sabin JE, Boudreau D, Goodman MJ, Gurwitz JH, Herrinton LJ, et al. Cluster randomized trials: opportunities and barriers identified by leaders of eight health plans. Med Care 2007;45(suppl 2):S29-37.
99. Zelen M. A new design for randomized clinical trials. N Engl J Med 1979;300:1242-5.
100. Zelen M. Randomized consent designs for clinical trials: an update. Stat Med 1990;9:645-56.
101. Snowdon C, Elbourne D, Garcia J. Zelen randomization: attitudes of parents participating in a neonatal clinical trial. Control Clin Trials 1999;20:149-71.
102. Mollison J, Simpson JA, Campbell MK, Grimshaw JM. Comparison of analytical methods for cluster randomised trials: an example from a primary care setting. J Epidemiol Biostat 2000;5:339-48.
103. Spiegelhalter DJ. Bayesian methods for cluster randomized trials with continuous response. Stat Med 2001;20:435-52.
104. Turner RM, Omar RZ, Thompson SG. Bayesian methods of analysis for cluster randomized trials with binary outcome data. Stat Med 2001;20:453-72.
105. Thompson SG, Warn DE, Turner RM. Bayesian methods for analysis of binary outcome data in cluster randomized trials on the absolute risk scale. Stat Med 2004;23:389-410.
106. Ioannidis JP, Evans SJ, Gotzsche PC, O'Neill RT, Altman DG, Schulz K, et al. Better reporting of harms in randomized trials: an extension of the CONSORT statement. Ann Intern Med 2004;141:781-8.
107. Feder G, Griffiths C, Eldridge S, Spence M. Effect of postal prompts to patients and general practitioners on the quality of primary care after a coronary event (POST): a randomised trial. BMJ 1999;318:1522-6.
108. Francis NA, Butler CC, Hood K, Simpson S, Wood F, Nuttall J. Effect of using an interactive booklet about childhood respiratory tract infections in primary care consultations on reconsulting and antibiotic prescribing: a cluster randomised controlled trial. BMJ 2009;339:b2885.