Ensayos clínicos aleatorizados comunitarios (CONSORT CLUSTER)

Begg, 1996, Improving the quality of reporting of randomised controlled trials. The CONSORT Statement, JAMA, 276, 637, 10.1001/jama.276.8.637 Moher, 2001, The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomised trials, Lancet, 357, 1191, 10.1016/S0140-6736(00)04337-3 Altman, 2001, The revised CONSORT statement for reporting randomised trials: explanation and elaboration, Ann Intern Med, 134, 663, 10.7326/0003-4819-134-8-200104170-00012 Campbell, 2004, CONSORT statement: extension to cluster randomised trials, BMJ, 328, 702, 10.1136/bmj.328.7441.702 Donner, 2000 Farr, 1988, Two randomized controlled trials of virucidal nasal tissues in the prevention of natural upper respiratory infections, Am J Epidemiol, 128I 5, 1162, 10.1093/oxfordjournals.aje.a115059 Carmen, 2000, Effects of influenza vaccination of health-care workers on mortality of elderly people in long-term care: a randomised controlled trial, Lancet, 355, 93, 10.1016/S0140-6736(99)05190-9 Grosskurth, 1995, Impact of improved treatment of sexually transmitted disease on HIV infection in rural Tanzania: randomized controlled trial, Lancet, 345, 530, 10.1016/S0140-6736(95)91380-7 1997, Recommendations guiding physicians in biomedical research involving human subjects. World Medical Association Declaration of Helsinki, JAMA, 277, 925, 10.1001/jama.277.11.925 Ukoumunne, 1999, Methods for evaluating area-wide and organisation-based interventions in health and health care: a systematic review, Health Technol Assess, 3, 10.3310/hta3050 Campbell, 2000, Sample size calculations for cluster randomised trials, J Health Serv Res Pol, 5, 12, 10.1177/135581960000500105 Killip, 2004, What is an intracluster correlation coefficient? Crucial concepts for primary care researchers, Ann Fam Med, 2, 204, 10.1370/afm.141 Hayes, 1999, Simple sample size calculation for cluster-randomized trials, Int J Epidemiol, 28, 319, 10.1093/ije/28.2.319 Donner, 1981, Randomization by cluster. Sample size requirements and analysis, Am J Epidemiol, 114, 906, 10.1093/oxfordjournals.aje.a113261 Campbell, 2005, Determinants of the intracluster correlation coefficient in cluster randomised trials, Clin Trials, 2, 99, 10.1191/1740774505cn071oa Turner, 2005, Prior distributions for the intracluster correlation coefficient, based on multiple previous estimates, and their application in cluster randomized trials, Clin Trials, 2, 108, 10.1191/1740774505cn072oa Turner, 2004, Allowing for imprecision of the intracluster correlation coefficient in the design of cluster randomized trials, Stat Med, 23, 1195, 10.1002/sim.1721 2002 Puffer, 2003, Evidence for risk of bias in cluster randomized trials: review of recent trials published in three general medical journals, BMJ, 327, 785, 10.1136/bmj.327.7418.785 Farrin, 2005, 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, 2, 119, 10.1191/1740774505cn073oa Kerry, 2005, Reducing selection bias in a cluster randomized trial in West African villages, Clin Trials, 2, 125, 10.1191/1740774505cn074oa Hutton J. Are distinctive ethical principles required for cluster randomised trials? En: Campbell MJ, Donner A, Elbourne D, editors. Design and Analysis of Cluster Randomized Trials. Stat Med. 2001;20(3):473-88. Edwards, 1999, Ethical issues in the design and conduct of cluster randomised trials, BMJ, 318, 1407, 10.1136/bmj.318.7195.1407 Eldridge, 2005, Informed patient consent to randomization in cluster randomized trials: an empirical exploration of trials in primary care, Clin Trials, 2, 91, 10.1191/1740774505cn070oa Mollison, 2000, Comparison of analytic methods for cluster randomised trials: an example from a primary care setting, J Epidem Biostat, 5, 339 Campbell, 2004, Intracluster correlation coefficients in cluster randomised trials: empirical insights into how should they be reported, BMC Med Res Methodol, 4, 9, 10.1186/1471-2288-4-9 Simpson, 1995, Accounting for cluster randomization: a review of primary prevention trials, 1990 through 1993, Am J Public Health, 85, 1378, 10.2105/AJPH.85.10.1378 Donner, 1990, A methodological review of non-therapeutic intervention trials employing cluster randomization, 1979-1989, Int J Epidemiol, 19, 795, 10.1093/ije/19.4.795 Divine, 1992, The unit of analysis error in studies about physicians’ patient care behaviour, J Gen Intern Med, 7, 623, 10.1007/BF02599201 MacLennan, 2003, Room for improvement in the reporting of cluster randomized trials in behaviour change research, Control Clin Trials, 24, 69S Chuang, 2000, Considering clustering: a methodological review of clinical decision support system studies, Proc AMIA Symp, 146 Isaakidis, 2003, An evaluation of cluster randomized controlled trials in sub-Saharan Africa, Am J Epidemiol, 158, 921, 10.1093/aje/kwg232 Hannan, 2004, The review process fails to require appropriate statistical analysis of a group-randomized trial, Pediatrics, 114, 509, 10.1542/peds.114.2.509