Skip to main content
Top
Published in: BMC Medical Research Methodology 1/2005

Open Access 01-12-2005 | Research article

A priori postulated and real power in cluster randomized trials: mind the gap

Authors: Lydia Guittet, Bruno Giraudeau, Philippe Ravaud

Published in: BMC Medical Research Methodology | Issue 1/2005

Login to get access

Abstract

Background

Cluster randomization design is increasingly used for the evaluation of health-care, screening or educational interventions. The intraclass correlation coefficient (ICC) defines the clustering effect and be specified during planning. The aim of this work is to study the influence of the ICC on power in cluster randomized trials.

Methods

Power contour graphs were drawn to illustrate the loss in power induced by an underestimation of the ICC when planning trials. We also derived the maximum achievable power given a specified ICC.

Results

The magnitude of the ICC can have a major impact on power, and with low numbers of clusters, 80% power may not be achievable.

Conclusion

Underestimating the ICC during planning cluster randomized trials can lead to a seriously underpowered trial. Publication of a priori postulated and a posteriori estimated ICCs is necessary for a more objective reading: negative trial results may be the consequence of a loss of power due to a mis-specification of the ICC.
Appendix
Available only for authorised users
Literature
1.
go back to reference Donner A, Klar N: Design and Analysis of Cluster Randomization Trials in Health Research. 2000, London, England: Arnold Donner A, Klar N: Design and Analysis of Cluster Randomization Trials in Health Research. 2000, London, England: Arnold
2.
go back to reference Murray DM: Design and Analysis of Group-Randomized Trials. 1998, New York, NY: Oxford University Press Inc Murray DM: Design and Analysis of Group-Randomized Trials. 1998, New York, NY: Oxford University Press Inc
3.
go back to reference Reading R, Harvey I, McLean M: Cluster randomised trials in maternal and child health: implications for power and sample size. Arch Dis Child. 2000, 82: 79-83. 10.1136/adc.82.1.79.CrossRefPubMedPubMedCentral Reading R, Harvey I, McLean M: Cluster randomised trials in maternal and child health: implications for power and sample size. Arch Dis Child. 2000, 82: 79-83. 10.1136/adc.82.1.79.CrossRefPubMedPubMedCentral
4.
go back to reference 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: 423-432.CrossRefPubMedPubMedCentral 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: 423-432.CrossRefPubMedPubMedCentral
6.
go back to reference Eldridge SM, Ashby D, Feder GS, Rudnicka AR, Ukoumunne OC: Lessons for cluster randomized trials in the twenty-first century: a systematic review of trials in primary care. Clinical trials. 2004, 1: 80-90. 10.1191/1740774504cn006rr.CrossRefPubMed Eldridge SM, Ashby D, Feder GS, Rudnicka AR, Ukoumunne OC: Lessons for cluster randomized trials in the twenty-first century: a systematic review of trials in primary care. Clinical trials. 2004, 1: 80-90. 10.1191/1740774504cn006rr.CrossRefPubMed
7.
9.
go back to reference 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: 785-794. 10.1016/j.jclinepi.2003.12.013.CrossRefPubMed 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: 785-794. 10.1016/j.jclinepi.2003.12.013.CrossRefPubMed
10.
go back to reference Turner RM, Prevost AT, Thompson SG: Allowing for imprecision of the intracluster correlation coefficient in the design of cluster randomized trials. Stat Med. 2004, 23: 1195-1214. 10.1002/sim.1721.CrossRefPubMed Turner RM, Prevost AT, Thompson SG: Allowing for imprecision of the intracluster correlation coefficient in the design of cluster randomized trials. Stat Med. 2004, 23: 1195-1214. 10.1002/sim.1721.CrossRefPubMed
11.
go back to reference Lake S, Kammann E, Klar N, Betensky R: Sample size re-estimation in cluster randomization trials. Stat Med. 2002, 21: 1337-1350. 10.1002/sim.1121.CrossRefPubMed Lake S, Kammann E, Klar N, Betensky R: Sample size re-estimation in cluster randomization trials. Stat Med. 2002, 21: 1337-1350. 10.1002/sim.1121.CrossRefPubMed
12.
go back to reference Ukoumunne OC, Gulliford MC, Chinn C, Sterne JAC, Burney PGJ: Methods for evaluating area-wide and organisation-based interventions in health and health care: a systematic review. Health Technology Assessment (Winchester, England). 1999, 3: iii-92. Ukoumunne OC, Gulliford MC, Chinn C, Sterne JAC, Burney PGJ: Methods for evaluating area-wide and organisation-based interventions in health and health care: a systematic review. Health Technology Assessment (Winchester, England). 1999, 3: iii-92.
13.
go back to reference Ukoumunne OC, Gulliford MC, Chinn S, Sterne JAC, Burney PGJ, Donner A: Evaluation of health interventions at area and organisation level. BMJ. 1999, 319: 376-379.CrossRefPubMedPubMedCentral Ukoumunne OC, Gulliford MC, Chinn S, Sterne JAC, Burney PGJ, Donner A: Evaluation of health interventions at area and organisation level. BMJ. 1999, 319: 376-379.CrossRefPubMedPubMedCentral
14.
go back to reference Flynn TN, Whitley E, Peters TJ: Recruitment strategies in a cluster randomized trial-cost implications. Stat Med. 2002, 21: 397-405. 10.1002/sim.1025.CrossRefPubMed Flynn TN, Whitley E, Peters TJ: Recruitment strategies in a cluster randomized trial-cost implications. Stat Med. 2002, 21: 397-405. 10.1002/sim.1025.CrossRefPubMed
15.
go back to reference Campbell MK, Thomson S, Ramsay CR, MacLennan GS, Grimshaw JM: Sample size calculator for cluster randomized trials. Comput Biol Med. 2004, 34: 113-25. 10.1016/S0010-4825(03)00039-8.CrossRefPubMed Campbell MK, Thomson S, Ramsay CR, MacLennan GS, Grimshaw JM: Sample size calculator for cluster randomized trials. Comput Biol Med. 2004, 34: 113-25. 10.1016/S0010-4825(03)00039-8.CrossRefPubMed
16.
go back to reference Gulliford MC, Adams G, Ukoumunne OC, Latinovic R, Chinn S, Campbell MJ: Intraclass correlation coefficient and outcome prevalence are associated in clustered binary data. J Clin Epidemiol. 2005, 58: 246-251. 10.1016/j.jclinepi.2004.08.012.CrossRefPubMed Gulliford MC, Adams G, Ukoumunne OC, Latinovic R, Chinn S, Campbell MJ: Intraclass correlation coefficient and outcome prevalence are associated in clustered binary data. J Clin Epidemiol. 2005, 58: 246-251. 10.1016/j.jclinepi.2004.08.012.CrossRefPubMed
17.
go back to reference Hannan PJ, Murray DM, David RJ, Mc Govern PG: Parameters to aid in the design and analysis of community trials: intraclass correlations from the Minnesota Heart Health Program. Epidemiology. 1994, 5: 88-95.CrossRefPubMed Hannan PJ, Murray DM, David RJ, Mc Govern PG: Parameters to aid in the design and analysis of community trials: intraclass correlations from the Minnesota Heart Health Program. Epidemiology. 1994, 5: 88-95.CrossRefPubMed
18.
go back to reference Siddiqui O, Hedeker D, Flay BR, Hu FB: Intraclass correlation estimates in a school-based smoking prevention study. Am J Epidemiol. 1996, 144: 425-433.CrossRefPubMed Siddiqui O, Hedeker D, Flay BR, Hu FB: Intraclass correlation estimates in a school-based smoking prevention study. Am J Epidemiol. 1996, 144: 425-433.CrossRefPubMed
19.
go back to reference Smeeth L, Siu-Woon Ng E: Intraclass correlation coefficients for cluster randomized trials in primary care: data from the MRC Trial of the Assessment and Management of Older People in the Community. Control Clin Trials. 2002, 23: 409-421. 10.1016/S0197-2456(02)00208-8.CrossRefPubMed Smeeth L, Siu-Woon Ng E: Intraclass correlation coefficients for cluster randomized trials in primary care: data from the MRC Trial of the Assessment and Management of Older People in the Community. Control Clin Trials. 2002, 23: 409-421. 10.1016/S0197-2456(02)00208-8.CrossRefPubMed
20.
go back to reference Martinson BC, Murray DM, Jeffery RW, Hennrikus DJ: Intraclass correlation for measures from a worksite health promotion study: estimates, correlates, and applications. Am J Health Promot. 1999, 13: 347-357.CrossRefPubMed Martinson BC, Murray DM, Jeffery RW, Hennrikus DJ: Intraclass correlation for measures from a worksite health promotion study: estimates, correlates, and applications. Am J Health Promot. 1999, 13: 347-357.CrossRefPubMed
21.
go back to reference Murray DM, Phillips GA, Birnbaum AS, Lytle LA: Intraclass correlation for measures from a middle school nutrition intervention study: estimates, correlates, and applications. Health Educ Behav. 2001, 28: 666-679.CrossRefPubMed Murray DM, Phillips GA, Birnbaum AS, Lytle LA: Intraclass correlation for measures from a middle school nutrition intervention study: estimates, correlates, and applications. Health Educ Behav. 2001, 28: 666-679.CrossRefPubMed
22.
go back to reference Murray DM, Clark MH, Alexander CW: Intraclass correlation from a community-based alcohol prevention study: the effect of repeat observations on the same communities. J Stud Alcohol. 2000, 61: 881-890.CrossRefPubMed Murray DM, Clark MH, Alexander CW: Intraclass correlation from a community-based alcohol prevention study: the effect of repeat observations on the same communities. J Stud Alcohol. 2000, 61: 881-890.CrossRefPubMed
23.
go back to reference Murray DM, Short BJ: Intraclass correlation among measures related to tobacco use by adolescents: estimates, correlates, and applications in intervention studies. Addictive behaviours. 1997, 22: 1-12. 10.1016/0306-4603(95)00099-2.CrossRef Murray DM, Short BJ: Intraclass correlation among measures related to tobacco use by adolescents: estimates, correlates, and applications in intervention studies. Addictive behaviours. 1997, 22: 1-12. 10.1016/0306-4603(95)00099-2.CrossRef
24.
go back to reference Donner A, Klar N: Statistical considerations in the design and analysis of community intervention trials. J Clin Epidemiol. 1996, 49: 435-439. 10.1016/0895-4356(95)00511-0.CrossRefPubMed Donner A, Klar N: Statistical considerations in the design and analysis of community intervention trials. J Clin Epidemiol. 1996, 49: 435-439. 10.1016/0895-4356(95)00511-0.CrossRefPubMed
25.
go back to reference Manatunga AK, Hudgens MG, Chen S: Sample size estimation in cluster randomized studies with varying cluster size. Biom J. 2001, 1: 75-86. 10.1002/1521-4036(200102)43:1<75::AID-BIMJ75>3.0.CO;2-N.CrossRef Manatunga AK, Hudgens MG, Chen S: Sample size estimation in cluster randomized studies with varying cluster size. Biom J. 2001, 1: 75-86. 10.1002/1521-4036(200102)43:1<75::AID-BIMJ75>3.0.CO;2-N.CrossRef
26.
go back to reference Kerry SM, Bland JM: Unequal cluster sizes for trials in English and Welsh general practice: implications for sample size calculations. Stat Med. 2001, 20: 377-390. 10.1002/1097-0258(20010215)20:3<377::AID-SIM799>3.0.CO;2-N.CrossRefPubMed Kerry SM, Bland JM: Unequal cluster sizes for trials in English and Welsh general practice: implications for sample size calculations. Stat Med. 2001, 20: 377-390. 10.1002/1097-0258(20010215)20:3<377::AID-SIM799>3.0.CO;2-N.CrossRefPubMed
27.
go back to reference Donner A: Some aspects of the design and analysis of cluster randomization trials. Appl Statistics. 1998, 47: 95-113. Donner A: Some aspects of the design and analysis of cluster randomization trials. Appl Statistics. 1998, 47: 95-113.
28.
go back to reference Moore L, Campbell R, Whelan A, Mills N, Lupton P, Misselbrook E, Frohlich J: Self help smoking cessation in pregnancy: cluster randomised controlled trial. BMJ. 2002, 325: 1383-1388. 10.1136/bmj.325.7377.1383.CrossRefPubMedPubMedCentral Moore L, Campbell R, Whelan A, Mills N, Lupton P, Misselbrook E, Frohlich J: Self help smoking cessation in pregnancy: cluster randomised controlled trial. BMJ. 2002, 325: 1383-1388. 10.1136/bmj.325.7377.1383.CrossRefPubMedPubMedCentral
29.
go back to reference Murray DM, McKinlay SM, Martin D, Donner AP, Dwyer JH, Raudenbush SW, Graubard BI: Design and analysis issues in community trials. Evaluation Review. 1994, 18: 493-514.CrossRef Murray DM, McKinlay SM, Martin D, Donner AP, Dwyer JH, Raudenbush SW, Graubard BI: Design and analysis issues in community trials. Evaluation Review. 1994, 18: 493-514.CrossRef
30.
31.
go back to reference Elbourne DR, Campbell MK: Extending the CONSORT statement to cluster randomized trials: for discussion. Stat Med. 2001, 20: 489-496. 10.1002/1097-0258(20010215)20:3<489::AID-SIM806>3.0.CO;2-S.CrossRefPubMed Elbourne DR, Campbell MK: Extending the CONSORT statement to cluster randomized trials: for discussion. Stat Med. 2001, 20: 489-496. 10.1002/1097-0258(20010215)20:3<489::AID-SIM806>3.0.CO;2-S.CrossRefPubMed
32.
go back to reference Campbell MK, Grimshaw JM, Elbourne DR: Intracluster correlation coefficients in cluster randomized trials: empirical insights into how they should be reported. BMC Med Res Methodol. 2004, 4: 9-10.1186/1471-2288-4-9.CrossRefPubMedPubMedCentral Campbell MK, Grimshaw JM, Elbourne DR: Intracluster correlation coefficients in cluster randomized trials: empirical insights into how they should be reported. BMC Med Res Methodol. 2004, 4: 9-10.1186/1471-2288-4-9.CrossRefPubMedPubMedCentral
Metadata
Title
A priori postulated and real power in cluster randomized trials: mind the gap
Authors
Lydia Guittet
Bruno Giraudeau
Philippe Ravaud
Publication date
01-12-2005
Publisher
BioMed Central
Published in
BMC Medical Research Methodology / Issue 1/2005
Electronic ISSN: 1471-2288
DOI
https://doi.org/10.1186/1471-2288-5-25

Other articles of this Issue 1/2005

BMC Medical Research Methodology 1/2005 Go to the issue