Statistical considerations in the design and analysis of community intervention trials
Abstract
Community intervention trials are often characterized by the allocation of intact social units to different intervention groups. The assessment of adequate sample size for such trials must take into account the statistical dependencies among responses observed within an allocated unit. However, the small numbers of units typically involved in such trials imply that many methods of analysis that have been proposed for analyzing correlated data, particularly in the case of a dichotomous outcome variable, are not applicable to such designs. In this article we investigate this issue and determine the minimum number of units required per group, for the case of both a dichotomous and a continuous outcome variable, needed to provide adequate statistical power for detecting various levels of treatment effect. The use of significance testing as a method of detecting intracluster correlation is also investigated, and, in general, discouraged.
Integrity signals
Registry
Cites
Statistics
Claims the paper makes
Claims other papers make about this one
Each is checked against this paper’s own text: does it say what the citing paper says it does?
A sample size of 12 clusters per study arm (total 24 clusters) with 10 people with multiple sclerosis per cluster (total sample size 240) achieves 94.6% power to detect a mean difference of 9.66 between the two arms.
“A sample size of 12 clusters per study arm (total number of clusters = 24) with 10 PwMS per cluster (total sample size 240) achieves 94.6% power to detect a mean difference of 9.66 between the two arms [82].”
Cites
Longitudinal data analysis using generalized linear models
LIANG, K.-Y., & ZEGER, S. L. (1986) · Biometrika · doi:10.1093/biomet/73.1.13 · Cited by 18,550 · see citing works
Practical Nonparametric Statistics
Groggel, D. J., & Conover, W. J. (2000) · Technometrics · doi:10.2307/1271101 · Cited by 11,071 · see citing works
Cohen, J. (1992) · Psychological Bulletin · doi:10.1037//0033-2909.112.1.155 · Cited by 8,771 · see citing works
Scheffé, H. (1960) · Soil Science · doi:10.1097/00010694-196006000-00016 · Cited by 5,625 · see citing works
Edgington, E. S., Edgington, E., & Onghena, P. (1964) · Encyclopedia of Statistical Sciences · doi:10.1002/0471667196.ess2169 · Cited by 2,034 · see citing works
Practical Nonparametric Statistics (2nd ed).
Groeneveld, R. A., & Conover, W. J. (1981) · Journal of the American Statistical Association · doi:10.2307/2287607 · Cited by 1,869 · see citing works
When small effects are impressive
Prentice, D. A., & Miller, D. T. (1992) · Psychological Bulletin · doi:10.1037/0033-2909.112.1.160 · Cited by 1,008 · see citing works
Donner, A. P., Birkett, N., & Buck, C. W. (1981) · American Journal of Epidemiology · doi:10.1093/oxfordjournals.aje.a113261 · Cited by 698 · see citing works
Self-citationA Simple Method for the Analysis of Clustered Binary Data
Rao, J. N. K., & Scott, A. J. (1992) · Biometrics · doi:10.2307/2532311 · Cited by 696 · see citing works
(1986) · CERN Document Server (European Organization for Nuclear Research) · Cited by 583 · see citing works
Harwell, M. R., Rubinstein, E. N., Hayes, W. S., & Olds, C. C. (1992) · Journal of Educational Statistics · doi:10.3102/10769986017004315 · Cited by 485 · see citing works
Wr, L., Freedman, L., Green, S., Corle, D., Gail, M. H., Re, G., Hartwell, T., Km, C., Ockene, J., & Giffen, C. (1995) · American Journal of Public Health · doi:10.2105/ajph.85.2.183 · Cited by 452 · see citing works
Farquhar, J. W. (1990) · JAMA · doi:10.1001/jama.1990.03450030083037 · Cited by 448 · see citing works
Methods for Comparing Event Rates in Intervention Studies When the Unit of Allocation is a Cluster
Donner, A. P., & Klar, N. S. (1994) · American Journal of Epidemiology · doi:10.1093/oxfordjournals.aje.a117247 · Cited by 241 · see citing works
Self-citationCornfield, J. (1978) · American Journal of Epidemiology · doi:10.1093/oxfordjournals.aje.a112592 · Cited by 235 · see citing works
The Healthy Worker Project: a work-site intervention for weight control and smoking cessation.
Jeffery, R. W., Forster, J. L., French, S. A., Kelder, S. H., Lando, H. A., McGovern, P. G., Jacobs, D. R., & Baxter, J. E. (1993) · American Journal of Public Health · doi:10.2105/ajph.83.3.395 · Cited by 233 · see citing works
Randomised controlled trial of effects of coordinating care for terminally ill cancer patients.
Addington-Hall, J. M., Macdonald, L., ANDERSON, H. R., Chamberlain, J., FREELING, P., Bland, J. M., & Raftery, J. (1992) · BMJ · doi:10.1136/bmj.305.6865.1317 · Cited by 212 · see citing works
Koepsell, T. D., Wagner, E. H., Cheadle, A. D., Patrick, D. L., Martin, D. C., Diehr, P. H., Perrin, E. B., Kristal, A. R., Allan-Andrilla, C. H., & Dey, L. J. (1992) · Annual Review of Public Health · doi:10.1146/annurev.pu.13.050192.000335 · Cited by 193 · see citing works
Robustness of the two independent samplest‐test when applied to ordinal scaled data
Heeren, T., & D’Agostino, R. B. (1987) · Statistics in Medicine · doi:10.1002/sim.4780060110 · Cited by 192 · see citing works
Sample size formulae for intervention studies with the cluster as unit of randomization
Hsieh, F. Y. (1988) · Statistics in Medicine · doi:10.1002/sim.4780071113 · Cited by 130 · see citing works
Murray, D. M., Rooney, B. L., Hannan, P. J., Peterson, A. V., Ary, D. V., Biglan, A., Botvin, G. J., Evans, R. I., Flay, B. R., Futterman, R., et al. (1994) · American Journal of Epidemiology · doi:10.1093/oxfordjournals.aje.a117194 · Cited by 126 · see citing works
The effect of matching on the power of randomized community intervention studies
Martin, D. C., Diehr, P. K., Perrin, E. B., & Koepsell, T. D. (1993) · Statistics in Medicine · doi:10.1002/sim.4780120315 · Cited by 106 · see citing works
Harwell, M. R., Rubinstein, E. N., Hayes, W. S., & Olds, C. C. (1992) · Journal of Educational Statistics · doi:10.2307/1165127 · Cited by 105 · see citing works
An Empirical Study of Cluster Randomization
Donner, A. P. (1982) · International Journal of Epidemiology · doi:10.1093/ije/11.3.283 · Cited by 104 · see citing works
Self-citationSample size requirements for stratified cluster randomization designs
Donner, A. P. (1992) · Statistics in Medicine · doi:10.1002/sim.4780110605 · Cited by 103 · see citing works
Self-citationPARAMETERS TO AID IN THE DESIGN AND ANALYSIS OF COMMUNITY TRIALS
Hannan, P. J., Murray, D. M., Jacobs, D. R., & McGovern, P. G. (1994) · Epidemiology · doi:10.1097/00001648-199401000-00013 · Cited by 99 · see citing works
Results from a statewide approach to adolescent tobacco use prevention
Murray, D. M., Perry, C. L., Griffin, G., Harty, K. C., Jacobs, D. R., Schmid, L. A., Daly, K., & Pallonen, U. E. (1992) · Preventive Medicine · doi:10.1016/0091-7435(92)90053-k · Cited by 87 · see citing works
The statistical analysis of multiple binary measurements
Donner, A. P. (1988) · Journal of Clinical Epidemiology · doi:10.1016/0895-4356(88)90107-2 · Cited by 73 · see citing works
Self-citationDonner, A. P., & Eliasziw, M. (1994) · Biometrics · doi:10.2307/2533400 · Cited by 66 · see citing works
Self-citationEstimation Bias Using the Beta-Binomial Distribution in Teratology
Williams, D. A., Kupper, L. L., Portier, C. J., & Hogan, M. D. (1988) · Biometrics · doi:10.2307/2531921 · Cited by 64 · see citing works
Feng, Z., & Grizzle, J. E. (1992) · Statistics in Medicine · doi:10.1002/sim.4780111208 · Cited by 61 · see citing works
On Testing Departure from the Binomial and Multinomial Assumptions
Paul, S. R., Liang, K.-Y., & Self, S. G. (1989) · Biometrics · doi:10.2307/2532048 · Cited by 52 · see citing works
Worksite smoking cessation initiatives: Review and recommendations
Orleans, C. S., & Shipley, R. H. (1982) · Addictive Behaviors · doi:10.1016/0306-4603(82)90019-3 · Cited by 48 · see citing works
Calculation of Power for Matched Pair Studies when Randomization is by Group
Shipley, M. J., Smith, P. G., & Dramaix, M. (1989) · International Journal of Epidemiology · doi:10.1093/ije/18.2.457 · Cited by 42 · see citing works
Tests for Trend in Developmental Toxicity Experiments with Correlated Binary Data
Fung, K. Y., Krewski, D. R., Rao, J. N. K., & Scott, A. J. (1994) · Risk Analysis · doi:10.1111/j.1539-6924.1994.tb00277.x · Cited by 38 · see citing works
A comparison of methods for testing homogeneity of proportions in teratologic studies
Donner, A. P., Eliasziw, M., & Klar, N. S. (1994) · Statistics in Medicine · doi:10.1002/sim.4780131207 · Cited by 32 · see citing works
Self-citationHigh Intercommunity Variation in Adolescent Cigarette Smoking in a 10-Community Field Experiment
John, L., Bauman, K. E., & Koch, G. G. (1992) · Evaluation Review · doi:10.1177/0193841x9201600201 · Cited by 18 · see citing works
Analysis of Dichotomous Response Variables in Teratology
Marubini, E., Leite, M. L. C., & Milani, S. (1988) · Biometrical Journal · doi:10.1002/bimj.4710300813 · Cited by 7 · see citing works
Flagged first, then by citations
Cited by
Sorted by citations
Ukoumunne, Gulliford, M. C., Chinn, Sterne, & Burney, P. (1999) · Health Technology Assessment · doi:10.3310/hta3050 · Cited by 1,209 · see citing works
A Controlled Trial of a Critical Pathway for Treatment of Community-Acquired Pneumonia
Marrie, T. J. (2000) · JAMA · doi:10.1001/jama.283.6.749 · Cited by 731 · see citing works
Eldridge, S. M., Ashby, D., & Kerry, S. (2006) · International Journal of Epidemiology · doi:10.1093/ije/dyl129 · Cited by 529 · see citing works
Limitations of the Randomized Controlled Trial in Evaluating Population-Based Health Interventions
Sanson-Fisher, R. W., Bonevski, B., Green, L. W., & D’Este, C. (2007) · American Journal of Preventive Medicine · doi:10.1016/j.amepre.2007.04.007 · Cited by 514 · see citing works
Kumar, V., Mohanty, S. R., Kumar, A., Misra, R., Santosham, M., Awasthi, S., Baqui, A. H., Singh, P. K., Singh, V. K., Ahuja, R. C., et al. (2008) · The Lancet · doi:10.1016/s0140-6736(08)61483-x · Cited by 497 · see citing works
Methods for sample size determination in cluster randomized trials
Rutterford, C., Copas, A., & Eldridge, S. (2015) · International Journal of Epidemiology · doi:10.1093/ije/dyv113 · Cited by 429 · see citing works
Pitfalls of and controversies in cluster randomization trials
Donner, A., & Klar, N. (2004) · American Journal of Public Health · doi:10.2105/ajph.94.3.416 · Cited by 442 · see citing works
Self-citationMartin, C. M., Doig, G. S., Heyland, D. K., Morrison, T., & Sibbald, W. J. (2004) · PubMed Central · Cited by 380 · see citing works
IMPLICATIONS OF THE RESULTS OF COMMUNITY INTERVENTION TRIALS
Sorensen, G., Emmons, K. M., Hunt, M. K., & Johnston, D. (1998) · Annual Review of Public Health · doi:10.1146/annurev.publhealth.19.1.379 · Cited by 314 · see citing works
Extending the CONSORT statement to cluster randomized trials: for discussion
Elbourne, D. R., & Campbell, M. (2001) · Statistics in Medicine · doi:10.1002/1097-0258(20010215)20:3 · Cited by 91 · see citing works
Eldridge, S. M., Ashby, D., Feder, G. S., Rudnicka, A. R., & Ukoumunne, O. C. (2004) · Clinical Trials · doi:10.1191/1740774504cn006rr · Cited by 288 · see citing works
The Ottawa Statement on the Ethical Design and Conduct of Cluster Randomized Trials
Weijer, C., Grimshaw, J., Eccles, M., McRae, A. D., White, A., Brehaut, J., Taljaard, M., & Ottawa Ethics of Cluster Randomized Trials Consensus Group (2012) · PLoS Medicine · doi:10.1371/journal.pmed.1001346 · Cited by 293 · see citing works
Covariate-based constrained randomization of group-randomized trials
Moulton, L. H. (2004) · Clinical Trials · doi:10.1191/1740774504cn024oa · Cited by 284 · see citing works
Emery, C. A., Rose, M. S., McAllister, J., & Meeuwisse, W. H. (2007) · Clinical Journal of Sport Medicine · doi:10.1097/jsm.0b013e31802e9c05 · Cited by 281 · see citing works
How to design efficient cluster randomised trials
Hemming, K., Eldridge, S., Forbes, G., Weijer, C., & Taljaard, M. (2017) · BMJ · doi:10.1136/bmj.j3064 · Cited by 270 · see citing works
Quality of Life in Palliative Cancer Care: Results From a Cluster Randomized Trial
Slaaen, M., Fayers, P. M., Loge, J. H., Ahlner‐Elmqvist, M., & Kaasa, S. (2001) · Journal of Clinical Oncology · doi:10.1200/jco.2001.19.18.3884 · Cited by 245 · see citing works
He, J., Irazola, V., Mills, K. T., Poggio, R., Beratarrechea, A., Dolan, J., Chen, C.-S., Gibbons, L., Krousel-Wood, M., Bazzano, L. A., et al. (2017) · JAMA · doi:10.1001/jama.2017.11358 · Cited by 241 · see citing works
Feldman, R. D., Zou, G. Y., Vandervoort, M. K., Wong, C. J., Nelson, S. A. E., & Feagan, B. G. (2009) · Hypertension · doi:10.1161/hypertensionaha.108.123455 · Cited by 239 · see citing works
Internal and external validity of cluster randomised trials: systematic review of recent trials
Eldridge, S., Ashby, D., Bennett, C., Wakelin, M., & Feder, G. (2008) · BMJ · doi:10.1136/bmj.39517.495764.25 · Cited by 224 · see citing works
Cantrell, R. A., Sinkala, M., Megazzini, K., Lawson-Marriott, S., Washington, S., Chi, B. H., Chapula, B. T., Levy, J., Stringer, E. M., Mulenga, L., et al. (2008) · JAIDS Journal of Acquired Immune Deficiency Syndromes · doi:10.1097/qai.0b013e31818455d2 · Cited by 224 · see citing works
Wawer, M. J., Gray, R. H., Sewankambo, N. K., Serwadda, D., Paxton, L. A., Berkley, S., McNairn, D., Wabwire‐Mangen, F., Li, C., Nalugoda, F., et al. (1998) · AIDS · doi:10.1097/00002030-199810000-00014 · Cited by 224 · see citing works
Azad, K., Barnett, S., Banerjee, B., Shaha, S. K., Khan, K., Rego, A. R., Barua, S., Flatman, D., Pagel, C., Prost, A., et al. (2010) · The Lancet · doi:10.1016/s0140-6736(10)60142-0 · Cited by 222 · see citing works
The Renaissance of Field Experimentation in Evaluating Interventions
Shadish, W. R., & Cook, T. D. (2008) · Annual Review of Psychology · doi:10.1146/annurev.psych.60.110707.163544 · Cited by 208 · see citing works
Moher, M., Yudkin, P., Wright, L., Turner, R., Fuller, A., Schofield, T., & Mant, D. (2001) · BMJ · doi:10.1136/bmj.322.7298.1338 · Cited by 184 · see citing works
Bingenheimer, J. B., & Raudenbush, S. W. (2004) · Annual Review of Public Health · doi:10.1146/annurev.publhealth.25.050503.153925 · Cited by 180 · see citing works
Some Aspects of the Design and Analysis of Cluster Randomization Trials
Donner, A. P. (1998) · Journal of the Royal Statistical Society Series C (Applied Statistics) · doi:10.1111/1467-9876.00100 · Cited by 178 · see citing works
Self-citationSoofi, S. B., Cousens, S. N., Imdad, A., Bhutto, N. S., Ali, N., & Bhutta, Z. A. (2012) · The Lancet · doi:10.1016/s0140-6736(11)61877-1 · Cited by 171 · see citing works
Enhanced Protein-Energy Provision via the Enteral Route Feeding Protocol in Critically Ill Patients
Heyland, D. K., Murch, L., Cahill, N. E., McCall, M., Muscedere, J., Stelfox, H. T., Bray, T., Tanguay, T., Jiang, X., & Day, A. G. (2013) · Critical Care Medicine · doi:10.1097/ccm.0b013e31829efef5 · Cited by 170 · see citing works
Intraclass correlation coefficients for cluster randomized trials in primary care
Smeeth, L. L., & Ng, E. S.-W. (2002) · Controlled Clinical Trials · doi:10.1016/s0197-2456(02)00208-8 · Cited by 168 · see citing works
Flottorp, S., Oxman, A. D., Håvelsrud, K., Treweek, S., & Herrin, J. (2002) · BMJ · doi:10.1136/bmj.325.7360.367 · Cited by 154 · see citing works
Reder, S., Cummings, P., & Quan, L. (2006) · Resuscitation · doi:10.1016/j.resuscitation.2005.08.020 · Cited by 148 · see citing works
Promoting social–emotional competence: An evaluation of the elementary version of Second Step®
Low, S. K., Cook, C. R., Smolkowski, K., & Buntain‐Ricklefs, J. (2015) · Journal of School Psychology · doi:10.1016/j.jsp.2015.09.002 · Cited by 143 · see citing works
Carter, B. L., Coffey, C. S., Ardery, G., Uribe, L., Ecklund, D. J., James, P. A., Egan, B. M., Weg, M. W. V., Chrischilles, E. A., & Vaughn, T. E. (2015) · Circulation Cardiovascular Quality and Outcomes · doi:10.1161/circoutcomes.114.001283 · Cited by 142 · see citing works
Danquah, I. H., Kloster, S., Holtermann, A., Aadahl, M., Bauman, A. E., Ersbøll, A. K., & Tolstrup, J. S. (2016) · International Journal of Epidemiology · doi:10.1093/ije/dyw009 · Cited by 131 · see citing works
Effects of Individual Physician-Level and Practice-Level Financial Incentives on Hypertension Care
Petersen, L. A., Simpson, K., Pietz, K., Urech, T. H., Hysong, S. J., Profit, J., Conrad, D. A., Dudley, R. A., & Woodard, L. (2013) · JAMA · doi:10.1001/jama.2013.276303 · Cited by 125 · see citing works
Community-based Health Intervention Trials: An Overview of Methodological Issues
Atienza, A. A. (2002) · Epidemiologic Reviews · doi:10.1093/epirev/24.1.72 · Cited by 115 · see citing works
Saint, S. K., Scholes, D., Fihn, S. D., Farrell, R. G., & Stamm, W. E. (1999) · The American Journal of Medicine · doi:10.1016/s0002-9343(99)00122-9 · Cited by 114 · see citing works
Implementation of the Ottawa Ankle Rules in France
Auleley, G.-R. (1997) · JAMA · doi:10.1001/jama.1997.03540480035035 · Cited by 116 · see citing works
Community interventions for reducing smoking among adults.
Secker-Walker, R., Gnich, W., Platt, S., & Lancaster, T. (2002) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd001745 · Cited by 119 · see citing works
Pettersson, E., Vernby, Å., Mölstad, S., & Lundborg, C. S. (2011) · Journal of Antimicrobial Chemotherapy · doi:10.1093/jac/dkr312 · Cited by 92 · see citing works
Walwyn, R., & Roberts, C. (2010) · Statistical Methods in Medical Research · doi:10.1177/0962280209105017 · Cited by 93 · see citing works
Taljaard, M., Weijer, C., Grimshaw, J., Eccles, M. P., & the Ottawa Ethics of Cluster Randomised Trials Consensus Group (2013) · BMJ · doi:10.1136/bmj.f2838 · Cited by 89 · see citing works
Heo, M., & Leon, A. C. (2009) · Statistics in Medicine · doi:10.1002/sim.3527 · Cited by 91 · see citing works
Cluster randomized trials with treatment noncompliance.
Jo, B., Asparouhov, T., Muthén, B. O., Ialongo, N. S., & Brown, C. H. (2008) · Psychological Methods · doi:10.1037/1082-989x.13.1.1 · Cited by 83 · see citing works
Smolkowski, K., Seeley, J. R., Gau, J. M., Dishion, T. J., Stormshak, E. A., Moore, K. J., Falkenstein, C. A., Fosco, G. M., & Garbacz, S. A. (2017) · Journal of School Psychology · doi:10.1016/j.jsp.2017.03.004 · Cited by 85 · see citing works
Melanocytic nevi in very young children: The role of phenotype, sun exposure, and sun protection
Whiteman, D. C., Brown, R. M., Purdie, D. M., & Hughes, M. C. B. (2004) · Journal of the American Academy of Dermatology · doi:10.1016/j.jaad.2004.07.053 · Cited by 85 · see citing works
Jafar, T. H., Islam, S., Hatcher, J., Hashmi, S., Bux, R., Khan, A., Poulter, N. R., Badruddin, S. H., & Chaturvedi, N. (2010) · BMJ · doi:10.1136/bmj.c2641 · Cited by 83 · see citing works
Smolkowski, K., & Gunn, B. (2011) · Early Childhood Research Quarterly · doi:10.1016/j.ecresq.2011.09.004 · Cited by 76 · see citing works
Rosenberger, P. H., Ickovics, J. R., Epel, E. S., Nadler, E., Jokl, P., Fulkerson, J. P., Tillie, J. M., & Dhabhar, F. S. (2009) · Journal of Bone and Joint Surgery · doi:10.2106/jbjs.h.00989 · Cited by 76 · see citing works
Fien, H., Smith, J. L. M., Smolkowski, K., Baker, S. K., Nelson, N. J., & Chaparro, E. A. (2014) · Journal of Learning Disabilities · doi:10.1177/0022219414521664 · Cited by 73 · see citing works
Heo, M., & Leon, A. C. (2008) · Biometrics · doi:10.1111/j.1541-0420.2008.00993.x · Cited by 71 · see citing works
Methods in Translation Science
Titler, M. G. (2004) · Worldviews on Evidence-Based Nursing · doi:10.1111/j.1741-6787.2004.04008.x · Cited by 71 · see citing works
Burke, V., Milligan, R. A. K., Thompson, C., Taggart, A. C., Dunbar, D. L., Spencer, M. J., Medland, A., Gracey, M. P., Vandongen, R., & Beilin, L. J. (1998) · The Journal of Pediatrics · doi:10.1016/s0022-3476(98)70315-4 · Cited by 68 · see citing works
Evaluation of Cluster Randomized Controlled Trials in Sub-Saharan Africa
Isaakidis, P. (2003) · American Journal of Epidemiology · doi:10.1093/aje/kwg232 · Cited by 65 · see citing works
Evaluation of a bicycle skills training program for young children: a randomized controlled trial
Macarthur, C., Parkin, P. C., Sidky, M., & Wallace, W. (1998) · Injury Prevention · doi:10.1136/ip.4.2.116 · Cited by 64 · see citing works
Intention‐to‐treat analysis in cluster randomized trials with noncompliance
Jo, B., Asparouhov, T., & Muthén, B. (2008) · Statistics in Medicine · doi:10.1002/sim.3370 · Cited by 64 · see citing works
Rossi, J. S. (2012) · Wiley eBooks · doi:10.1002/9781118133880.hop202003 · Cited by 64 · see citing works
Preventive home visits to older people in Denmark: Methodology of a randomized controlled study
Vass, M., Avlund, K., Hendriksen, C., Andersen, C. K., & Keiding, N. (2002) · Aging Clinical and Experimental Research · doi:10.1007/bf03327352 · Cited by 62 · see citing works
Wong, C. J., Vandervoort, M. K., Vandervoort, S. L., DONNER, A. P., Zou, G., MacDonald, J. K., Freedman, J. J., Karkouti, K., MacDonald, S. J., & Feagan, B. G. (2007) · Transfusion · doi:10.1111/j.1537-2995.2007.01197.x · Cited by 59 · see citing works
Self-citationOoi, C. S., Rooney, R. M., Roberts, C. M., Kane, R. T., Wright, B. R., & Chatzisarantis, N. L. D. (2016) · Frontiers in Psychology · doi:10.3389/fpsyg.2016.01641 · Cited by 57 · see citing works
Martín, J., Girling, A. J., Nirantharakumar, K., Ryan, R. P., Marshall, T. P., & Hemming, K. (2016) · Trials · doi:10.1186/s13063-016-1532-9 · Cited by 56 · see citing works
Ravaud, P., Keïta, H., Porcher, R., Durand-Stocco, C., Desmonts, J.-M., & Mantz, J. (2004) · British journal of surgery · doi:10.1002/bjs.4506 · Cited by 55 · see citing works
Ward, E. C., & Brown, R. (2014) · American Journal of Orthopsychiatry · doi:10.1037/ort0000027 · Cited by 55 · see citing works
Leone, L. A., Tripicchio, G. L., Haynes‐Maslow, L., McGuirt, J. T., Smith, J. S. G., Armstrong-Brown, J., Gizlice, Z., & Ammerman, A. S. (2018) · International Journal of Behavioral Nutrition and Physical Activity · doi:10.1186/s12966-017-0637-1 · Cited by 55 · see citing works
DeHaven, M. J., Ramos-Román, M. A., Gimpel, N. E., Carson, J., deLemos, J. A., Pickens, S. S., Simmons, C., Powell‐Wiley, T. M., Banks, K., Shuval, K., et al. (2011) · Contemporary Clinical Trials · doi:10.1016/j.cct.2011.05.017 · Cited by 53 · see citing works
Ermetici, F., Zelaschi, R., Briganti, S., Dozio, E., Gaeta, M., Ambrogi, F., Pelissero, G., Tettamanti, G., Romanelli, M. M. C., Carruba, M. O., et al. (2016) · Obesity · doi:10.1002/oby.21365 · Cited by 53 · see citing works
Danquah, I. H., Kloster, S., Holtermann, A., Aadahl, M., & Tolstrup, J. S. (2017) · Scandinavian Journal of Work Environment & Health · doi:10.5271/sjweh.3639 · Cited by 53 · see citing works
THE GET UP GROUP, Ruggeri, M., Bonetto, C., Lasalvia, A., de Girolamo, G., Fioritti, A., Rucci, P., Santonastaso, P., Neri, G., Pileggi, F., et al. (2012) · Trials · doi:10.1186/1745-6215-13-73 · Cited by 52 · see citing works
Analysis of clustered and interval censored data from a community‐based study in asthma
Bellamy, S. L., Li, Y., RYAN, L. M., Lipsitz, S. R., Canner, M. J., & Wright, R. J. (2004) · Statistics in Medicine · doi:10.1002/sim.1918 · Cited by 51 · see citing works
Carroll, J. K., Tobin, J. N., Luque, A. E., Farah, S., Sanders, M., Cassells, A. N., Fine, S. M., Cross, W. F., Boyd, M., Holder, T., et al. (2019) · Journal of General Internal Medicine · doi:10.1007/s11606-019-05102-7 · Cited by 50 · see citing works
“Risk Watch”: Cluster randomised controlled trial evaluating an injury prevention program
Kendrick, D., Groom, L., Stewart, J. A., Watson, M. C., Mulvaney, C. A., & Casterton, R. (2007) · Injury Prevention · doi:10.1136/ip.2006.013862 · Cited by 50 · see citing works
Lack of concealment may lead to selection bias in cluster randomized trials of palliative care
Jordhùy, M. S., Fayers, P. M., Ahlner‐Elmqvist, M., & Kaasa, S. (2002) · Palliative Medicine · doi:10.1191/0269216302pm523oa · Cited by 47 · see citing works
Carter, B. L., Clarke, W. R., Ardery, G., Weber, C. A., James, P. A., Weg, M. W. V., Chrischilles, E. A., Vaughn, T. E., & Egan, B. M. (2010) · Circulation Cardiovascular Quality and Outcomes · doi:10.1161/circoutcomes.109.908038 · Cited by 46 · see citing works
Krølner, R. F., Jørgensen, T. S., Aarestrup, A. K., Christiansen, A. H., Christensen, A. M., & Due, P. (2012) · BMC Public Health · doi:10.1186/1471-2458-12-191 · Cited by 46 · see citing works
Fink, J. C., Zhan, M., Blahut, S. A., Soucie, M., & McClellan, W. M. (2002) · Journal of the American Society of Nephrology · doi:10.1097/01.asn.0000027978.98194.1f · Cited by 44 · see citing works
Gittelsohn, J., Jock, B., Redmond, L. C., Fleischhacker, S. E., Eckmann, T., Bleich, S. N., Loh, H., Ogburn, E. L., Gadhoke, P., Swartz, J., et al. (2017) · BMC Public Health · doi:10.1186/s12889-017-4018-0 · Cited by 42 · see citing works
Considering Cluster Analysis in Sport Medicine and Injury Prevention Research
Emery, C. A. (2007) · Clinical Journal of Sport Medicine · doi:10.1097/jsm.0b013e3180592a58 · Cited by 40 · see citing works
Recruitment strategies in a cluster randomized trial – cost implications
Flynn, T. N., Whitley, E., & Peters, T. J. (2002) · Statistics in Medicine · doi:10.1002/sim.1025 · Cited by 40 · see citing works
Feldman, H. A., Proschan, M. A., Murray, D. M., Goff, D. C., Stylianou, M. P., Dulberg, E. M., McGovern, P. G., Chan, W., Mann, N. C., Bittner, V., et al. (1998) · Controlled Clinical Trials · doi:10.1016/s0197-2456(98)00014-2 · Cited by 40 · see citing works
Randomised controlled trials in primary care: scope and application.
Sheikh, A., Smeeth, L. L., & Ashcroft, R. E. (2002) · Europe PMC (PubMed Central) · Cited by 38 · see citing works
Checklists to Prevent Diagnostic Errors: A Pilot Randomized Controlled Trial
Ely, J. W., & Graber, M. A. (2015) · Diagnosis · doi:10.1515/dx-2015-0008 · Cited by 37 · see citing works
Siegrist, M., Hanssen, H., Lammel, C., Haller, B., & Halle, M. (2011) · BMC Public Health · doi:10.1186/1471-2458-11-258 · Cited by 37 · see citing works
Participation in Cervical Screening by Self-collection, Pap, or a Choice of Either in Brazil
Castle, P. E., da Silva, V. R. S., Consolaro, M. E. L., Kienen, N., Bittencourt, L., Pelloso, S. M., Partridge, E. E., Pierz, A. J., Dartibale, C. B., Uchimura, N. S., et al. (2019) · Cancer Prevention Research · doi:10.1158/1940-6207.capr-18-0419 · Cited by 40 · see citing works
Coldiron, M. E., Assao, B., Page, A., Hitchings, M. D. T., Alcoba, G., Ciglenečki, I., Langendorf, C., Mambula, C., Adehossi, E. O., Sidikou, F., et al. (2018) · PLoS Medicine · doi:10.1371/journal.pmed.1002593 · Cited by 35 · see citing works
Calculating Power by Bootstrap, with an Application to Cluster-randomized Trials
KLEINMAN, K. P., & Huang, S. S. (2017) · eGEMs (Generating Evidence & Methods to improve patient outcomes) · doi:10.13063/2327-9214.1202 · Cited by 33 · see citing works
A SAS macro for constrained randomization of group-randomized designs
Chaudhary, M. A., & Moulton, L. H. (2006) · Computer Methods and Programs in Biomedicine · doi:10.1016/j.cmpb.2006.04.011 · Cited by 33 · see citing works
Cluster size variability and imbalance in cluster randomized controlled trials
Carter, B. (2010) · Statistics in Medicine · doi:10.1002/sim.4050 · Cited by 33 · see citing works
Use of the bootstrap in analysing cost data from cluster randomised trials: some simulation results
Flynn, T. N., & Peters, T. J. (2004) · BMC Health Services Research · doi:10.1186/1472-6963-4-33 · Cited by 32 · see citing works
Best (but oft forgotten) practices: sample size planning for powerful studies
Anderson, S. F. (2019) · American Journal of Clinical Nutrition · doi:10.1093/ajcn/nqz058 · Cited by 34 · see citing works
The WHO safe community program for injury prevention
Lindqvist, K. S., Timpka, T., Schelp, L., & Åhlgren, M. (1998) · Public Health · doi:10.1038/sj.ph.1900505 · Cited by 32 · see citing works
Examining the Efficacy of a Multitiered Intervention for At-Risk Readers in Grade 1
Smith, J. L. M., Nelson, N. J., Smolkowski, K., Baker, S. K., Fien, H., & Kosty, D. B. (2016) · The Elementary School Journal · doi:10.1086/686249 · Cited by 31 · see citing works
Simas, T. A. M., Brenckle, L., Sankaran, P., Masters, G. A., Person, S. D., Weinreb, L., Ko, J. Y., Robbins, C. L., Allison, J. J., & Byatt, N. (2019) · BMC Pregnancy and Childbirth · doi:10.1186/s12884-019-2387-3 · Cited by 31 · see citing works
Gordon, J. S., Biglan, A., & Smolkowski, K. (2008) · Prevention Science · doi:10.1007/s11121-008-0089-6 · Cited by 31 · see citing works
Design and analysis of group-randomized trials: A review of recent developments
Murray, D. M. (1997) · Annals of Epidemiology · doi:10.1016/s1047-2797(97)80009-9 · Cited by 31 · see citing works
Datta, S., Halloran, M. E., & Longini, I. M. (1999) · Biometrics · doi:10.1111/j.0006-341x.1999.00792.x · Cited by 30 · see citing works
A Conceptual Replication Study of the Enhanced Core Reading Instruction MTSS-Reading Model
Fien, H., Nelson, N. J., Smolkowski, K., Kosty, D. B., Suhr, M. P., Baker, S. K., & Smith, J. L. M. (2020) · Exceptional Children · doi:10.1177/0014402920953763 · Cited by 29 · see citing works
Effects of the X:IT smoking intervention: a school-based cluster randomized trial
Andersen, A., Krølner, R. F., Bast, L. S., Thygesen, L. C., & Due, P. (2015) · International Journal of Epidemiology · doi:10.1093/ije/dyv145 · Cited by 29 · see citing works
Hutchins, S. S., Brown, C. J., Mayberry, R., & Sollecito, W. A. (2015) · Journal of Comparative Effectiveness Research · doi:10.2217/cer.15.11 · Cited by 28 · see citing works
Habib, M. A., Soofi, S. B., Sadiq, K., Samejo, T., Hussain, M. A., Mirani, M., Rehmatullah, A., Ahmed, I., & Bhutta, Z. A. (2013) · BMC Public Health · doi:10.1186/1471-2458-13-922 · Cited by 28 · see citing works
A priori postulated and real power in cluster randomized trials: mind the gap
Guittet, L., Giraudeau, B., & Ravaud, P. (2005) · BMC Medical Research Methodology · doi:10.1186/1471-2288-5-25 · Cited by 28 · see citing works
- Authors
- Donner, A., & Klar, N.
- Affiliations
- Western University (CA)
- ORCID
- Klar, Neil
- Venue
- Journal of Clinical Epidemiology
- Publisher
- Elsevier BV
- Published
- 1996-04
- Volume
- 49
- Issue
- 4
- Pages
- 435-439
- ISSN
- 0895-4356 (ISSN-L)
- OpenAlex
- W2050387573
- Cited by
- 230
- References
- 38
- Citations by year
- 2026: 3 · 2025: 1 · 2024: 2 · 2023: 2 · 2022: 10 · 2021: 6 · 2020: 10 · 2019: 7 · 2018: 13 · 2017: 16 · 2016: 8 · 2015: 12 · 2014: 8 · 2013: 8 · 2012: 9
- FWCI
- 6.47
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Journal of Clinical Epidemiology (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
- Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Epidemiology
- Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods and Bayesian Inference
- Keywords
- sample size determination, statistical power, intra-cluster correlation, binary outcomes, continuous outcomes, treatment effect detection
- MeSH terms
- Smoking Prevention, Adolescent, Clinical Trials as Topic, Humans, Random Allocation, Cluster Analysis, Sample Size
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
Are you an author, or do you see a problem with this page? Request a review
