Limitations of the Randomized Controlled Trial in Evaluating Population-Based Health Interventions

American Journal of Preventive Medicine

Volumn 33, Issue 2, 2007, Pages 155-161

  Sanson Fisher, Robert William ^a   Bonevski, Billie ^a   Green, Lawrence W ^b   D'Este, Cate ^a  

^a UNIVERSITY OF NEWCASTLE   (Australia)

^b UNIVERSITY OF CALIFORNIA   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

COST; ETHICS; EVIDENCE BASED MEDICINE; EXTERNAL VALIDITY; FOLLOW UP; GOVERNMENT; HEALTH SERVICES RESEARCH; INFORMED CONSENT; POLITICS; RANDOMIZATION; RANDOMIZED CONTROLLED TRIAL; REVIEW; SAMPLE SIZE; UNITED STATES;

BIOMEDICAL RESEARCH; EVIDENCE-BASED MEDICINE; HUMANS; RANDOMIZED CONTROLLED TRIALS; RESEARCH DESIGN;

EID: 34547172234     PISSN: 07493797     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.amepre.2007.04.007     Document Type: Review

References (61)

1. Kindig D., and Stoddard G. What is population health?. Am J Public Health 93 (2003) 380-383
2. Green L.W., and Ottoson J.M. Community and population health. 8th ed. (1999), McGraw Hill, New York
3. Kreuter M., and Lezin N. Improving everyone's quality of life: a primer on population health (2001), Group Health Community Foundation, Seattle
4. Kickbusch I. The contribution of the World Health Organization to a new public health and health promotion. Am J Public Health 93 (2003) 383-388
5. Wallack L., and Wallerstein N. Health education and prevention: designing community initiatives. Int Q Community Health Educ 7 (1987) 319-342
6. Campbell D.T., and Stanley J.C. Experimental and quasi-experimental designs for research (1963), Rand McNally, Chicago
7. COMMIT Research Group. Community Intervention Trial for Smoking Cessation (COMMIT): summary of design and intervention. J Natl Cancer Inst 83 (1991) 1620-1628
8. Hancock L., Sanson-Fisher R., Perkins J., Girgis A., Howey P., and Schofield M. The effect of a community action intervention on adolescent smoking rates in rural Australian towns: the CART project. Cancer Action in Rural Towns. Prev Med 32 (2001) 332-340
9. Hancock L., Sanson-Fisher R., Perkins J., McClintock A., Howey P., and Gibberd R. Effect of a community action intervention on adult quit smoking rates in rural Australian towns: the CART project. Prev Med 32 (2001) 118-127
10. Byers T., Mullis R., Anderson J., et al. The costs and effects of a nutrition education program following work-site cholesterol screening. Am J Public Health 85 (1995) 650-655
11. Lynagh M., Perkins J., and Schofield M. An evidence-based approach to health promoting schools. J Sch Health 72 (2002) 300-302
12. Rychetnik L., Frommer M., Hawe P., and Shiell A. Criteria for evaluating evidence on public health interventions. J Epidemiol Community Health 56 (2002) 119-127
13. Green L.W., and Lewis F.M. Measurement and evaluation in health education and health promotion (1984), Mayfield Publishing Co, Mountain View CA
14. Canadian Task Force on the Periodic Health Examination. The periodic health examination. CAMJ 121 (1979) 1193-1254
15. Gibbons R.J., Smith S., Antman E., and American College of Cardiology/American Heart Association. Clinical practice guidelines. Part I. Where do they come from?. Circulation 107 (2003) 2979-2986
16. U.S. Preventive Services Task Force. Guide to clinical preventive services. 2nd ed. (1996), Williams and Wilkins, Baltimore
17. Centre for Evidence Based Medicine. Levels of evidence (2001), Institute of Health Sciences, Headington, Oxford, United Kingdom. http://cebm.jr2.ox.ac.uk/docs/levels.htm Available at: http://cebm.jr2.ox.ac.uk/docs/levels.htm.
18. Green L.W., and Glasgow R. Evaluating the relevance, generalization, and applicability of research: issues in external validation and translation methodology. Eval Health Prof 29 (2006) 126-153
19. Pilote L., and Tager I.B. Outcomes research in the development and evaluation of practice guidelines. BMC Health Serv Res 2 (2002) 7
20. Paul C.L., and Sanson-Fisher R.W. Experts' agreement on the relative effectiveness of 29 smoking reduction strategies. Prev Med 25 (1996) 517-526
21. Humphrey L.L., Helfand M., Chan B.K., and Woolf S.H. Breast cancer screening: a summary of the evidence for the US Preventive Services Task Force. Ann Intern Med 137 (2002) 347-360
22. Olsen O., and Gotzsche P.C. Cochrane review on screening for breast cancer with mammography. Lancet 358 (2001) 1340-1342 (letter)
23. Olsen O., and Gotzsche P.C. Screening for breast cancer with mammography. Cochrane Database Syst Rev (2001) CD001877.
24. Goodman S.N. The mammography dilemma: a crisis for evidence-based medicine?. Ann Intern Med 13 (2002) 363-365
25. Stanley D.E. The mammography dilemma. Ann Intern Med 138 (2003) 771
26. Ferreira H., Ferreira M.L., Maher C.G., Refshauge K., Herbert R.D., and Latimer J. Effect of applying different "levels of evidence" criteria on conclusions of Cochrane reviews of interventions for low back pain. J Clin Epidemiol 55 (2002) 1126-1129
27. Green L.W. From research to "best practices" in other settings and populations. Am J Health Behav 25 (2001) 165-178
28. Sorensen G., Emmons K., Hunt M.K., and Johnston D. Implications of the results of community intervention trials. Annu Rev Public Health 19 (1998) 379-416
29. Donner A., and Klar N. Statistical considerations in the design and analysis of community intervention trials. J Clin Epidemiol 49 (1996) 435-439
30. Green S.B. The advantages of community-randomized trials for evaluating lifestyle modification. Control Clin Trials 18 (1997) 506-513
31. Kirkwood B.R., Cousens S., Victora C.G., and de Zoysa I. Issues in the design and interpretation of studies to evaluate the impact of community-based interventions. Trop Med Int Health 2 (1997) 1022-1029
32. Klar N., and Donner A. The merits of matching in community intervention trials: a cautionary tale. Stat Med 16 (1997) 1753-1764
33. Guilford M., Ukoumunne O., and Chinn S. Components of variance and intraclass correlations for the design of community-based surveys and intervention studies. Am J Epidemiol 149 (1999) 876-883
34. Hayes R.J., and Bennett S. Simple sample size calculation for cluster randomized trials. Int J Epidemiol 28 (1999) 319-326
35. Hsieh F. Sample size formulae for intervention studies with the cluster as the unit of randomization. Stat Med 8 (1988) 1195-1201
36. Mickey R., Goodwin G., and Constanza M. Estimation of the design effect in community intervention studies. Stat Med 10 (1991) 53-64
37. Shipley M., Smith P., and Dramaix M. Calculation of power for matched pair studies when randomization is by group. Int J Epidemiol 18 (1989) 457-461
38. Green S.B., Corle D.K., Gail M.H., et al. Interplay between design and analysis for behavioral intervention trials with community as the unit of randomization. Am J Epidemiol 142 (1995) 587-593
39. Gail M., Mark S., Carroll R., Green S., and Pee D. On design considerations and randomization-based inference for community intervention trials. Stat Med 15 (1996) 1069-1092
40. Martin D., Diehr P., Perrin E., and Koepsell T. The effect of matching on the power of randomized community intervention studies. Stat Med 12 (1993) 329-338
41. Knight J., Bowman J., Considine R., Sanson-Fisher R., and Redman S. The Adolescent Project: reducing adolescent smoking and unsafe drinking in rural towns in the Hunter area of NSW. Health Promot J Aust 4 (1994) 54-56
42. Wagenaar A.C., Grehan J.P., Jones-Webb R., et al. Communities mobilizing for change on alcohol: lessons and results from a 15 community randomized trial. J Community Psychol 27 (1999) 315-326
43. Black N. Why we need observational studies to evaluate the effectiveness of health care. BMJ 312 (1996) 1215-1218
44. Stiller C.A. Centralised treatment, entry to trials and survival. Br J Cancer 70 (1994) 352-362
45. Moher D., Jadad A.R., Nichol G., Penman M., Tugwell P., and Walsh S. Assessing the quality of randomized controlled trials: an annotated bibliography of scales and checklists. Control Clin Trials 16 (1995) 62-73
46. Oxman A.D. Preparing and maintaining systematic reviews. Section VI. Cochrane Collaboration handbook (1994), Cochrane Collaboration, Oxford
47. Task Force on Community Preventive Services. Guide to community preventive services (2007), Centers for Disease Control and Prevention, Atlanta GA. http://www.thecommunityguide.org Available at: www.thecommunityguide.org.
48. Biglan A., Ary D., and Wagenaar A.C. The value of interrupted time-series experiments for community intervention research. Prev Sci 1 (2000) 31-49
49. Perry C.L., Finnegan J.R., Forster J.L., Wagenaar A.C., and Wolfson M. Project Northland: outcomes of a community wide alcohol use prevention program during early adolescence. Am J Public Health 86 (1996) 956-965
50. Bawden D.L., and Sonenstein F.L. Quasi-experimental designs. Child Youth Serv Rev 14 (1992) 137-144
51. Hotz V.J. Recent experience in designing evaluations of social programs: the case of the national JTPA study (1990), University of Wisconsin, Institute for Research on Poverty, Madison
52. Misakian A.L., and Bero L. Publication bias and research on passive smoking: comparison of published and unpublished studies. JAMA 280 (1998) 250-253
53. Giannakaks I.A., Haidich A.B., Contopoulos-Ioannidis D.G., Papanikolaou G.N., Baltogianni M.S., and Ioannidis J.P. Citation of randomized evidence in support of guidelines of therapeutic and preventive interventions. J Clin Epidemiol 55 (2002) 545-555
54. Hardes G., Gibberd R.W., Lam P., Callcott R., Dobson A.J., and Leeder S.R. Effects of random breath testing on hospital admissions of traffic accident casualties in the Hunter Health region. Med J Aust 142 (1985) 625-626
55. Goldenhar L.M., LaMontagne A.D., Katz T., Heaney C., and Landsbergis P. The intervention research process in occupational safety and health: an overview from the national occupational research agenda intervention effectiveness research team. J Occup Environ Med 43 (2001) 616-622
56. McCulloch P., Taylor I., Sasako M., Lovett B., and Griffin D. Randomized trials in surgery: problems and possible solutions. BMJ 324 (2002) 1448-1451
57. Benson K., and Hartz A.J. A comparison of observational studies and randomized controlled trials. N Engl J Med 342 (2000) 1878-1886
58. Concat J., Shah N., and Horwitz R.I. Randomized controlled trials, observational studies and the hierarchy of research design. N Engl J Med 342 (2000) 1887-1892
59. Lipsey M.W., and Wilson D.B. The efficacy of psychological, educational, and behavioral treatment: confirmation from meta-analysis. Am Psychol 48 (1993) 1181-1209
60. Heller R.F., and Page J. A population perspective to evidence based medicine: evidence for population health. J Epidemiol Community Health 56 (2002) 45-47
61. Sherman L.W., Gottfredson D.C., MacKenzie D.L., Eck J., Reuter P., and Bushway S.D. Preventing crime: what works, what doesn't, what's promising. Report to the United States Congress, prepared for the National Institute of Justice (1998), University of Maryland at College Park, College Park MD