American Journal of Epidemiology Vol. 140, No. 3: 279-289
Copyright © 1994 by The Johns Hopkins University School of Hygiene and Public Health
research-article |
Methods for Comparing Event Rates in Intervention Studies When the Unit of Allocation is a Cluster
From the Department of Epidemiology and Biostatistics, The University of Western Ontario London, Ontario, Canada N6A 5C1
Reprint requests to Dr. Allan Donner, Department of Epidemiology and Biostatistics, The University of Western Ontario, London, Ontario, Canada N6A 5C1
The aim of many research investigations is to compare the proportion of individuals in each of several groups that have a certain characteristic. The unit of allocation for such investigations is often an intact social unit, as in randomizing families, medical practices, schools, or entire communities, to different intervention groups. Standard statistical methods are not appropriate for these designs, since they do not take into account the dependencies among individuals within the same cluster. The authors review the strengths and weaknesses of several approaches for dealing with this problem, using data from a school-based smoking cessation trial. A principal conclusion is that the choice of method should depend on whether or not random allocation is used in the assignment of interventions. Am J Epidemiol 1994; 140:279–89.
trials; correlated binary data; group randomization
CiteULike 
Connotea 
Del.icio.us What's this?
This article has been cited by other articles:
|
|
 |
|
  F. Sun, M. Mikhaail-Philips, M. Oliver-Bonet, E. Ko, A. Rademaker, P. Turek, and R.H. Martin Reduced meiotic recombination on the XY bivalent is correlated with an increased incidence of sex chromosome aneuploidy in men with non-obstructive azoospermia Mol. Hum. Reprod., July 1, 2008; 14(7): 399 - 404. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 B. J Wilson, N. Torrance, J. Mollison, M S. Watson, A. Douglas, Z. Miedzybrodzka, R. Gordon, S. Wordsworth, M. Campbell, N. Haites, et al. Cluster randomized trial of a multifaceted primary care decision-support intervention for inherited breast cancer risk Fam. Pract., October 1, 2006; 23(5): 537 - 544. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 N. D. Desai, S. Miwa, D. Kodama, T. Koyama, G. Cohen, M. P. Pelletier, E. A. Cohen, G. T. Christakis, B. S. Goldman, and S. E. Fremes A randomized comparison of intraoperative indocyanine green angiography and transit-time flow measurement to detect technical errors in coronary bypass grafts J. Thorac. Cardiovasc. Surg., September 1, 2006; 132(3): 585 - 594. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 P. Guarino, D. Elbourne, J. Carpenter, and P. Peduzzi Consumer involvement in consent document development: a multicenter cluster randomized trial to assess study participants' understanding Clinical Trials, February 1, 2006; 3(1): 19 - 30. [Abstract] [PDF]
|
|
|
|
|
|
G. Y. Zou, A. Donner, and N. Klar Group sequential methods for cluster randomization trials with binary outcomes Clinical Trials, December 1, 2005; 2(6): 479 - 487. [Abstract] [PDF]
|
|
|
|
 |
|
 M. Apkon, J. A. Mattera, Z. Lin, J. Herrin, E. H. Bradley, M. Carbone, E. S. Holmboe, C. P. Gross, J. G. Selter, A. S. Rich, et al. A Randomized Outpatient Trial of a Decision-Support Information Technology Tool Arch Intern Med, November 14, 2005; 165(20): 2388 - 2394. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 A. G. Rockall, S. A. Sohaib, M. G. Harisinghani, S. A. Babar, N. Singh, A. R. Jeyarajah, D. H. Oram, I. J. Jacobs, J. H. Shepherd, and R. H. Reznek Diagnostic Performance of Nanoparticle-Enhanced Magnetic Resonance Imaging in the Diagnosis of Lymph Node Metastases in Patients With Endometrial and Cervical Cancer J. Clin. Oncol., April 20, 2005; 23(12): 2813 - 2821. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
M. R. Ferreira, N. C. Dolan, M. L. Fitzgibbon, T. C. Davis, N. Gorby, L. Ladewski, D. Liu, A. W. Rademaker, F. Medio, B. P. Schmitt, et al. Health Care Provider-Directed Intervention to Increase Colorectal Cancer Screening Among Veterans: Results of a Randomized Controlled Trial J. Clin. Oncol., March 1, 2005; 23(7): 1548 - 1554. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 S. Ornstein, R. G. Jenkins, P. J. Nietert, C. Feifer, L. F. Roylance, L. Nemeth, S. Corley, L. Dickerson, W. D. Bradford, and C. Litvin A Multimethod Quality Improvement Intervention To Improve Preventive Cardiovascular Care: A Cluster Randomized Trial Ann Intern Med, October 5, 2004; 141(7): 523 - 532. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
C. P Herbert, J. M Wright, M. Maclure, J. Wakefield, C. Dormuth, P. Brett-MacLean, J. Legare, and J. Premi Better Prescribing Project: a randomized controlled trial of the impact of case-based educational modules and personal prescribing feedback on prescribing for hypertension in primary care Fam. Pract., October 1, 2004; 21(5): 575 - 581. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 M.-V. Senat, J. Deprest, M. Boulvain, A. Paupe, N. Winer, and Y. Ville Endoscopic Laser Surgery versus Serial Amnioreduction for Severe Twin-to-Twin Transfusion Syndrome N. Engl. J. Med., July 8, 2004; 351(2): 136 - 144. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 K I Proper, A J van der Beek, V H Hildebrandt, J W R Twisk, and W van Mechelen Worksite health promotion using individual counselling and the effectiveness on sick leave; results of a randomised controlled trial Occup. Environ. Med., March 1, 2004; 61(3): 275 - 279. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
S. M Eldridge, D. Ashby, G. S Feder, A. R Rudnicka, and O. C Ukoumunne Lessons for cluster randomized trials in the twenty-first century: a systematic review of trials in primary care Clinical Trials, February 1, 2004; 1(1): 80 - 90. [Abstract] [PDF]
|
|
|
|
 |
|
 P. Isaakidis and J. P. A. Ioannidis Evaluation of Cluster Randomized Controlled Trials in Sub-Saharan Africa Am. J. Epidemiol., November 1, 2003; 158(9): 921 - 926. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
J. A. Hanley, A. Negassa, M. D. deB. Edwardes, and J. E. Forrester Statistical Analysis of Correlated Data Using Generalized Estimating Equations: An Orientation Am. J. Epidemiol., February 15, 2003; 157(4): 364 - 375. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 G. Meyer, A. Warnke, R Bender, and I Muhlhauser Effect on hip fractures of increased use of hip protectors in nursing homes: cluster randomised controlled trial BMJ, January 11, 2003; 326(7380): 76 - 76. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 S. Bennett, T. Parpia, R. Hayes, and S. Cousens Methods for the analysis of incidence rates in cluster randomized trials Int. J. Epidemiol., August 1, 2002; 31(4): 839 - 846. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 R. Hristova, E. Ko, C. Greene, A. Rademaker, J. Chernos, and R. Martin Chromosome Abnormalities in Sperm From Infertile Men with Asthenoteratozoospermia Biol Reprod, June 1, 2002; 66(6): 1781 - 1783. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
S. Greenfield, S. H. Kaplan, R. Kahn, J. Ninomiya, and J. L. Griffith Profiling Care Provided by Different Groups of Physicians: Effects of Patient Case-Mix (Bias) and Physician-Level Clustering on Quality Assessment Results Ann Intern Med, January 15, 2002; 136(2): 111 - 121. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 M S Jordhuy, P M Fayers, M Ahlner-Elmqvist, and S Kaasa Lack of concealment may lead to selection bias in cluster randomized trials of palliative care Palliative Medicine, January 1, 2002; 16(1): 43 - 49. [Abstract] [PDF]
|
|
|
|
 |
|
 S. GILBODY and P. WHITTY Improving the delivery and organisation of mental health services: beyond the conventional randomised controlled trial The British Journal of Psychiatry, January 1, 2002; 180(1): 13 - 18. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
P. Priest, P. Yudkin, C. McNulty, D. Mant, and R. Wise Antibacterial prescribing and antibacterial resistance in English general practice: cross sectional study Commentary: antibiotic resistance is a dynamic process BMJ, November 3, 2001; 323(7320): 1037 - 1041. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
A. R. Localio, J. A. Berlin, T. R. Ten Have, and S. E. Kimmel Adjustments for Center in Multicenter Studies: An Overview Ann Intern Med, July 17, 2001; 135(2): 112 - 123. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
M. Moher, P. Yudkin, L. Wright, R. Turner, A. Fuller, T. Schofield, and D. Mant Cluster randomised controlled trial to compare three methods of promoting secondary prevention of coronary heart disease in primary care BMJ, June 2, 2001; 322(7298): 1338 - 1338. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 N. J. Patronas, N. Courcoutsakis, C. M. Bromley, G. L. Katzman, M. MacCollin, and D. M. Parry Intramedullary and Spinal Canal Tumors in Patients with Neurofibromatosis 2: MR Imaging Findings and Correlation with Genotype Radiology, February 1, 2001; 218(2): 434 - 442. [Abstract] [Full Text]
|
|
|
|
 |
|
 A. L. Morrow, R. C. Crews, H. J. Carretta, M. Altaye, A. B. Finch, and J. S. Sinn Effect of Method of Defining the Active Patient Population on Measured Immunization Rates in Predominantly Medicaid and Non-Medicaid Practices Pediatrics, July 1, 2000; 106(1): 171 - 176. [Abstract] [Full Text]
|
|
|
|
 |
|
 T Lang, V Nicaud, K Slama, A Hirsch, E Imbernon, M Goldberg, L Calvel, P Desobry, J P Favre-Trosson, C Lhopital, et al. Smoking cessation at the workplace. Results of a randomised controlled intervention study J. Epidemiol. Community Health, May 1, 2000; 54(5): 349 - 354. [Abstract] [Full Text]
|
|
|
|
 |
|
 R J Hayes, N D. Alexander, S Bennett, and S N Cousens Design and analysis issues in cluster-randomized trials of interventions against infectious diseases Statistical Methods in Medical Research, April 1, 2000; 9(2): 95 - 116. [Abstract] [PDF]
|
|
|
|
|
|
M. K Campbell, J. Mollison, N. Steen, J. M Grimshaw, and M. Eccles Analysis of cluster randomized trials in primary care: a practical approach Fam. Pract., April 1, 2000; 17(2): 192 - 196. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
G. Feder, C. Griffiths, S. Eldridge, and M. Spence Effect of postal prompts to patients and general practitioners on the quality of primary care after a coronary event (POST): randomised controlled trial BMJ, June 5, 1999; 318(7197): 1522 - 1526. [Abstract] [Full Text]
|
|
|
|
|
|
S. Saxena, A. Majeed, and M. Jones Socioeconomic differences in childhood consultation rates in general practice in England and Wales: prospective cohort study BMJ, March 6, 1999; 318(7184): 642 - 646. [Abstract] [Full Text]
|
|
|
|
 |
|
 B. Roe, L. Guinness, and A. M. Rafferty A systematic search of the literature on effectiveness of alliances for health promotion: some methodological issues and their implications for research Health Education Journal, January 1, 1999; 58(1): 78 - 90. [Abstract] [PDF]
|
|
|
|
 |
|
 C. Macarthur, P. C Parkin, M. Sidky, and W. Wallace Evaluation of a bicycle skills training program for young children: a randomized controlled trial Inj. Prev., June 1, 1998; 4(2): 116 - 121. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
J. D. Horbar, G. J. Badger, E. M. Lewit, J. Rogowski, and P. H. Shiono Hospital and Patient Characteristics Associated With Variation in 28-Day Mortality Rates for Very Low Birth Weight Infants Pediatrics, February 1, 1997; 99(2): 149 - 156. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
T P Fahey and T J Peters What constitutes controlled hypertension? Patient based comparison of hypertension guidelines BMJ, July 13, 1996; 313(7049): 93 - 96. [Abstract] [Full Text]
|
|