Statistical analysis and handling of missing data in cluster randomized trials: A systematic review

Trials

Volumn 17, Issue 1, 2016, Pages

  Fiero, Mallorie H ^a   Huang, Shuang ^a   Oren, Eyal ^a   Bell, Melanie L ^a  

^a UNIVERSITY OF ARIZONA   (United States)

Author keywords

Cluster randomized trials; Dropout; Missing data; Sensitivity analysis

Indexed keywords

CLUSTER ANALYSIS; RANDOMIZED CONTROLLED TRIAL (TOPIC); SAMPLE SIZE; STATISTICAL ANALYSIS;

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

EID: 84957882755     PISSN: None     EISSN: 17456215     Source Type: Journal    
DOI: 10.1186/s13063-016-1201-z     Document Type: Article

References (44)

1. Donner A, Klar N. Design and analysis of cluster randomization trials in health research. London: Arnold Publishers; 2000.
2. Campbell MK, Grimshaw JM. Cluster randomised trials: time for improvement. The implications of adopting a cluster design are still largely being ignored. BMJ (Clinical research ed). 1998;317:1171-2.
3. Hayes RJ, Moulten LH. Cluster Randomised Trials. Boca Raton, FL: Chapman & Hall/CRC Press; 2009.
4. Sox HC, Goodman SN. The methods of comparative effectiveness research. Annu Rev Public Health. 2012;33:425-45.
5. Council NR. The Prevention and Treatment of Missing Data in Clinical Trials. Washington DC: National Academies Press. 2010.
6. Wood AM, White IR, Thompson SG. Are missing outcome data adequately handled? A review of published randomized controlled trials in major medical journals. Clin Trials (London, England). 2004;1:368-76.
7. Bell ML, Fiero M, Horton NJ, Hsu CH. Handling missing data in RCTs; a review of the top medical journals. BMC Med Res Methodol. 2014;14:118. doi: 10.1186/1471-2288-14-118.
8. Patient-Centered Outcomes Research Institute. PCORI Methodology Standards. Washington, DC: Patient Centered Outcomes Research Institute; 2012.
9. Rubin DB. Inference and missing data. Biometrika. 1976;63:581-92.
10. National Research Council. The Prevention and Treatment of Missing Data in Clinical Trials. In: Committee on National Statistics, Division of Behavioral and Social Sciences and Education. Washington D.C: National Academies Press; 2010.
11. Bell ML, Fairclough DL. Practical and statistical issues in missing data for longitudinal patient-reported outcomes. Stat Methods Med Res. 2014;23:440-59. doi: 10.1177/0962280213476378.
12. Mallinckrod CH, Lane PW, Schnell D, Peng Y, Mancuso JP. Recommendations for the primary analysis of continuous endpoints in longitudinal clinical trials. Drug Inform J. 2008;42:303-19.
13. Molnar FJ, Man-Son-Hing M, Hutton B, Fergusson DA. Have last-observation-carried-forward analyses caused us to favour more toxic dementia therapies over less toxic alternatives? A systematic review Open Med. 2009;3:e31.
14. Kenward MG, Molenberghs G. Last observation carried forward: a crystal ball? J Biopharm Stat. 2009;19:872-88. doi: 10.1080/10543400903105406.
15. Van Buuren S. Multiple imputation of multilevel data. In: Hox JJ, Roberts JK, editors. Handbook of advanced multilevel analysis. Milton Park: Routledge; 2011. p. 173-96.
16. Robins J, Rotnitzky A, Zhao LP. Analysis of semiparametric regression models for repeated outcomes in the presence of missing data. J Am Stat Assoc. 1995;90:106-21.
17. Campbell MJ, Donner A, Klar N. Developments in cluster randomized trials and Statistics in Medicine. Stat Med. 2007;26:2-19. doi: 10.1002/sim.2731.
18. Robins JM, Rotnitzky A, Zhao LP. Estimation of regression coefficients when some regressors are not always observed. J Am Stat Assoc. 1994;89:846-66.
19. Cornfield J. Randomization by group: a formal analysis. Am J Epidemiol. 1978;108:100-2.
20. Campbell MK, Mollison J, Steen N, Grimshaw JM, Eccles M. Analysis of cluster randomized trials in primary care: a practical approach. Fam Pract. 2000;17:192-6.
21. Wears RL. Advanced statistics: statistical methods for analyzing cluster and cluster-randomized data. Acad Emerg Med. 2002;9:330-41.
22. Donner A. Some aspects of the design and analysis of cluster randomization trials. J R Stat Soc: Ser C: Appl Stat. 1998;47:95-113.
23. Liang K-Y, Zeger SL. Longitudinal data analysis using generalized linear models. Biometrika. 1986;73:13-22.
24. Fitzmaurice GM, Laird NM, Ware JH. Applied longitudinal analysis. New York: John Wiley & Sons; 2012.
25. Zeger SL, Liang KY. Longitudinal data analysis for discrete and continuous outcomes. Biometrics. 1986;42:121-30.
26. Simpson JM, Klar N, Donnor A. Accounting for cluster randomization: a review of primary prevention trials, 1990 through 1993. Am J Public Health. 1995;85:1378-83.
27. Campbell MK, Elbourne DR, Altman DG, group C. CONSORT statement: extension to cluster randomised trials. BMJ (Clinical research ed). 2004;328:702-8. doi: 10.1136/bmj.328.7441.702.
28. Diaz-Ordaz K, Kenward MG, Cohen A, Coleman CL, Eldridge S. Are missing data adequately handled in cluster randomised trials? A systematic review and guidelines. Clin Trials (London, England). 2014. doi: 10.1177/1740774514537136.
29. Moher D, Liberati A, Tetzlaff J, Altman DG, Group P. Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. J Clin Epidemiol. 2009;62:1006-12. doi: 10.1016/j.jclinepi.2009.06.005.
30. Fiero M, Huang S, Bell ML. Statistical analysis and handling of missing data in cluster randomised trials: protocol for a systematic review. BMJ Open. 2015;5:e007378.
31. Hussey MA, Hughes JP. Design and analysis of stepped wedge cluster randomized trials. Contemp Clin Trials. 2007;28:182-91. doi: 10.1016/j.cct.2006.05.007.
32. Hemming K, Haines T, Chilton P, Girling A, Lilford R. The stepped wedge cluster randomised trial: rationale, design, analysis, and reporting. BMJ (Clinical research ed). 2015;350:h391.
33. Shakeshaft A, Doran C, Petrie D, Breen C, Havard A, Abudeen A, et al. The effectiveness of community action in reducing risky alcohol consumption and harm: a cluster randomised controlled trial. PLoS Med. 2014;11:e1001617. doi: 10.1371/journal.pmed.1001617.
34. Sullivan LM, Dukes KA, Losina E. Tutorial in biostatistics. An introduction to hierarchical linear modelling. Stat Med. 1999;18:855-88.
35. Freiberger E, Blank WA, Salb J, Geilhof B, Hentschke C, Landendoerfer P, et al. Effects of a complex intervention on fall risk in the general practitioner setting: a cluster randomized controlled trial. Clin Interv Aging. 2013;8:1079-88. doi: 10.2147/CIA.S46218.
36. Nauta J, Knol DL, Adriaensens L, Klein Wolt K, van Mechelen W, Verhagen EA. Prevention of fall-related injuries in 7-year-old to 12-year-old children: a cluster randomised controlled trial. Br J Sports Med. 2013;47:909-13. doi: 10.1136/bjsports-2012-091439.
37. Zlotkin S, Newton S, Aimone AM, Azindow I, Amenga-Etego S, Tchum K, et al. Effect of iron fortification on malaria incidence in infants and young children in Ghana: a randomized trial. JAMA. 2013;310:938-47. doi: 10.1001/jama.2013.277129.
38. Campbell MJ, Walters SJ. How to design, analyse and report cluster randomised trials in medicine and health related research. Chichester: John Wiley & Sons; 2014.
39. Taljaard M, Donner A, Klar N. Imputation strategies for missing continuous outcomes in cluster randomized trials. Biom J. 2008;50:329-45. doi: 10.1002/bimj.200710423.
40. Ma J, Raina P, Beyene J, Thabane L. Comparison of population-averaged and cluster-specific models for the analysis of cluster randomized trials with missing binary outcomes: a simulation study. BMC Med Res Methodol. 2013;13:9. doi: 10.1186/1471-2288-13-9.
41. Ma J, Akhtar-Danesh N, Dolovich L. Thabane L, investigators C. Imputation strategies for missing binary outcomes in cluster randomized trials BMC Med Res Methodol. 2011;11:18. doi: 10.1186/1471-2288-11-18.
42. Scott NW, McPherson GC, Ramsay CR, Campbell MK. The method of minimization for allocation to clinical trials. a review. Control Clin Trials. 2002;23:662-74.
43. Pullenayegum EM, Platt RW, Barwick M, Feldman BM, Offringa M, Thabane L. Knowledge translation in biostatistics: a survey of current practices, preferences, and barriers to the dissemination and uptake of new statistical methods. Stat Med. 2016;35:805-18. doi: 10.1002/sim.6633. Epub 2015 Aug 25.
44. White IR, Horton NJ, Carpenter J, Pocock SJ. Strategy for intention to treat analysis in randomised trials with missing outcome data. BMJ (Clinical research ed). 2011;342:d40.