title: Designing studies that would address the multilayered nature of health care.
abstract: We review design and analytic methods available for multilevel interventions in cancer research with particular attention to study design, sample size requirements, and potential to provide statistical evidence for causal inference. The most appropriate methods will depend on the stage of development of the research and whether randomization is possible. Early on, fractional factorial designs may be used to screen intervention components, particularly when randomization of individuals is possible. Quasi-experimental designs, including time-series and multiple baseline designs, can be useful once the intervention is designed because they require few sites and can provide the preliminary evidence to plan efficacy studies. In efficacy and effectiveness studies, group-randomized trials are preferred when randomization is possible and regression discontinuity designs are preferred otherwise if assignment based on a quantitative score is possible. Quasi-experimental designs may be used, especially when combined with recent developments in analytic methods to reduce bias in effect estimates.
authors.affiliation: Division of Epidemiology, College of Public Health, The Ohio State University, Columbus, OH, USA. dmurray@cph.osu.edu
authors.forename: David M
authors.initials: DM
authors.lastname: Murray
authors.forename: Michael
authors.initials: M
authors.lastname: Pennell
authors.forename: Dale
authors.initials: D
authors.lastname: Rhoda
authors.forename: Erinn M
authors.initials: EM
authors.lastname: Hade
authors.forename: Electra D
authors.initials: ED
authors.lastname: Paskett
mesh_terms: D006302:Health Services Research / Q000379:methods*; D006801:Humans; D008327:Mammography; D016347:Medical Records Systems, Computerized; D008962:Models, Theoretical; D009369:Neoplasms / Q000628:therapy*; D017063:Outcome Assessment, Health Care; D010865:Pilot Projects; D016032:Randomized Controlled Trials as Topic; D012107:Research Design; D018401:Sample Size
references.citation: Behav Res Methods. 2009 May;41(2):477-85
references.pmid: 19363188
references.citation: Eval Health Prof. 2006 Dec;29(4):407-23
references.pmid: 17102063
references.citation: Annu Rev Public Health. 2007;28:413-33
references.pmid: 17150029
references.citation: CA Cancer J Clin. 1984 Nov-Dec;34(6):328-32
references.pmid: 6437624
references.citation: Clin Trials. 2006;3(3):259-71
references.pmid: 16895043
references.citation: Contemp Clin Trials. 2007 Feb;28(2):182-91
references.pmid: 16829207
references.citation: J Natl Cancer Inst. 2004 Apr 21;96(8):594-603
references.pmid: 15100337
references.citation: Health Educ Res. 2000 Oct;15(5):615-23
references.pmid: 11184220
references.citation: Am J Epidemiol. 1978 Aug;108(2):100-2
references.pmid: 707470
references.citation: BMJ. 2000 Sep 16;321(7262):694-6
references.pmid: 10987780
references.citation: Am J Prev Med. 2007 Aug;33(2):162-8
references.pmid: 17673105
references.citation: Annu Rev Public Health. 2009;30:1-25
references.pmid: 19296774
references.citation: BMC Med Res Methodol. 2006 Apr 03;6:16
references.pmid: 16579864
references.citation: Obesity (Silver Spring). 2007 Sep;15(9):2163-70
references.pmid: 17890483
references.citation: Am J Public Health. 2006 Jul;96(7):1181-6
references.pmid: 16735622
references.citation: BMJ. 1997 Aug 9;315(7104):361-3
references.pmid: 9270462
references.citation: Am J Prev Med. 2007 Aug;33(2):155-61
references.pmid: 17673104
references.citation: Control Clin Trials. 2003 Jun;24(3):306-23
references.pmid: 12757996
references.citation: Qual Saf Health Care. 2003 Feb;12(1):47-52
references.pmid: 12571345
references.citation: Eval Rev. 1996 Jun;20(3):313-37
references.pmid: 10182207
references.citation: Am J Public Health. 2004 Mar;94(3):423-32
references.pmid: 14998806
references.citation: Health Technol Assess. 1999;3(5):iii-92
references.pmid: 10982317
references.citation: Am J Public Health. 2008 Aug;98(8):1359-66
references.pmid: 18556609
references.citation: Cancer Epidemiol Biomarkers Prev. 1999 May;8(5):453-9
references.pmid: 10350442
references.citation: Behav Modif. 1994 Jan;18(1):6-31
references.pmid: 8037646
references.citation: Am J Prev Med. 2007 Aug;33(2):139-154
references.pmid: 17673103
references.citation: J Natl Cancer Inst Monogr. 2010;2010(40):3-10
references.pmid: 20386048
references.citation: Prev Med. 1986 Sep;15(5):451-74
references.pmid: 3534875
references.citation: J Public Health Manag Pract. 2001 Mar;7(2):33-40
references.pmid: 12174398
references.citation: Annu Rev Psychol. 2009;60:607-29
references.pmid: 18616391
references.citation: BMC Med Res Methodol. 2006 Nov 08;6:54
references.pmid: 17092344
references.citation: Control Clin Trials. 1992 Jun;13(3):190-212
references.pmid: 1320557
references.citation: Prev Sci. 2000 Mar;1(1):31-49
references.pmid: 11507793
references.citation: Eval Rev. 2001 Aug;25(4):440-53
references.pmid: 11480307
references.citation: Health Serv Res. 2000 Mar;34(7):1519-34
references.pmid: 10737451
references.citation: Behav Res Methods. 2009 May;41(2):372-84
references.pmid: 19363177
references.citation: Am J Public Health. 2008 Aug;98(8):1354-9
references.pmid: 18556602