Implementation research: Beyond the traditional randomized controlled trial

Essentials of Clinical Research

Volumn , Issue , 2008, Pages 217-244

  Salanitro, Amanda H ^a   Estrada, Carlos A ^a,b   Allison, Jeroan J ^a,b  

^a BIRMINGHAM VA MEDICAL CENTER   (United States)

^b UNIVERSITY OF ALABAMA AT BIRMINGHAM   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

EID: 74549149148     PISSN: None     EISSN: None     Source Type: Book    
DOI: 10.1007/978-1-4020-8486-7_13     Document Type: Chapter

References (98)

1. Berwick DM. Disseminating innovations in health care. JAMA 2003; 289:1969-75
2. Lenfant C. Shattuck lecture-clinical research to clinical practice-lost in translation? N Engl J Med 2003; 349:868-74
3. Kiefe CI, Sales A. A state-of-The-Art conference on implementing evidence in health care. Reasons and recommendations. J Gen Intern Med 2006; 21 Suppl 2:S67-70
4. McGlynn EA, Asch SM, Adams J, et al. The quality of health care delivered to adults in the United States. N Engl J Med 2003; 348:2635-45
5. Rubenstein LV, Pugh J. Strategies for promoting organizational and practice change by advancing implementation research. J Gen Intern Med 2006; 21 Suppl 2:S58-64
6. Kiefe CI, Safford M, Allison JJ. Forces influencing the care of complex patients: A framework. In: Academy Health Annual Meeting, 2007. Orlando, Fl; 2007
7. Unequal treatment: Confronting racial and ethnic disparities in health care. Washington, DC: National Academies Press; 2003
8. Allison JJ. Health disparity: Causes, consequences, and change. Med Care Res Rev 2007; 64:5S-6S.
9. Chin MH, Walters AE, Cook SC, Huang ES. Interventions to reduce racial and ethnic disparities in health care. Med Care Res Rev 2007; 64:7S-28S.
10. Kilbourne AM, Switzer G, Hyman K, Crowley-Matoka M, Fine MJ. Advancing health disparities research within the health care system: A conceptual framework. Am J Public Health 2006; 96:2113-21
11. Smedley BD, Stith AY, Nelson AR. Unequal treatment: Confronting racial and ethnic disparities in health care. Washington, DC: Institute of Medicine; 2003
12. Flaskerud JH, Nyamathi AM. Attaining gender and ethnic diversity in health intervention research: Cultural responsiveness versus resource provision. ANS Adv Nurs Sci 2000; 22:1-15
13. Hayward RA, Asch SM, Hogan MM, Hofer TP, Kerr EA. Sins of omission: Getting too little medical care may be the greatest threat to patient safety. J Gen Intern Med 2005; 20:686-91
14. Kohn LT, Corrigan JM, Donaldson MS. To err is human: Building a safer health system. Washington, DC: Institute of Medicine; 1999
15. Public Health Action Plan to Combat Antimicrobial Resistance Centers for Disease Control and Prevention, 1999. (Accessed November 2007, at http://www.cdc.gov/drugresistance/ actionplan/html/index.htm
16. Snow V, Mottur-Pilson C, Gonzales R. Principles of appropriate antibiotic use for treatment of acute bronchitis in adults. Ann Intern Med 2001; 134:518-20
17. Wenzel RP, Fowler AA, 3rd. Clinical practice. Acute bronchitis. N Engl J Med 2006; 355:2125-30
18. Roumie CL, Halasa NB, Grijalva CG, et al. Trends in antibiotic prescribing for adults in the United States-1995 to 2002. J Gen Intern Med 2005; 20:697-702
19. Metlay JP, Camargo CA, Jr., MacKenzie T, et al. Cluster-randomized trial to improve antibiotic use for adults with acute respiratory infections treated in emergency departments. Ann Emerg Med 2007; 50:221-30
20. Crossing the quality chasm: A new health system for the 21st century. Washington, DC: Institute of Medicine; 2001
21. Berwick DM, Calkins DR, McCannon CJ, Hackbarth AD. The 100,000 lives campaign: Setting a goal and a deadline for improving health care quality. JAMA 2006; 295:324-7
22. Auerbach AD, Landefeld CS, Shojania KG. The tension between needing to improve care and knowing how to do it. N Engl J Med 2007; 357:608-13
23. Smith GC, Pell JP. Parachute use to prevent death and major trauma related to gravitational challenge: Systematic review of randomised controlled trials. BMJ 2003; 327:1459-61
24. Brennan TA, Gawande A, Thomas E, Studdert D. Accidental deaths, saved lives, and improved quality. N Engl J Med 2005; 353:1405-9
25. Berwick D. The stories beneath. Medical Care 2007; 45:1123-5
26. Bhattacharyya O, Reeves S, Garfinkel S, Zwarenstein M. Designing theoretically-informed implementation interventions: Fine in theory, but evidence of effectiveness in practice is needed. Implement Sci 2006;1 Feb 23:5
27. Effective health care: Getting evidence into practice. National Health Service Center for Reviews and Dissemination, Royal Society of Medicine Press, 1999; 5(1). (Accessed November 2007, at http://www.york.ac.uk/inst/crd/ehc51.pdf
28. Rogers EM. Diffusion of innovations (5th ed.). New York: Free Press; 2003
29. Glasgow RE, Emmons KM. How can we increase translation of research into practice? Types of evidence needed. Annu Rev Public Health 2007; 28:413-33
30. Sung NS, Crowley WF, Jr., Genel M, et al. Central challenges facing the national clinical research enterprise. JAMA 2003; 289:1278-87
31. Nelson EC, Batalden PB, Huber TP, et al. Microsystems in health care: Part 1. Learning from high-performing front-line clinical units. Joint Comm J Qual Im 2002; 28:472-93
32. Zerhouni EA. Medicine. The NIH roadmap. Science 2003; 302:63-72
33. Zerhouni EA. US biomedical research: Basic, translational, and clinical sciences. JAMA 2005; 294:1352-8
34. Chao SR. The state of quality improvement and implementation research: Expert views-workshop summary. Washington, DC: National Academies Press; 2007
35. Shojania KG, Grimshaw JM. Evidence-based quality improvement: The state of the science. Health Aff (Millwood) 2005; 24:138-50
36. Shojania KG, McDonald KM, Wachter RM, Owens DK. Closing The Quality Gap: A Critical Analysis of Quality Improvement Strategies, Volume 1 -Series Overview and Methodology. Technical Review 9. (Contract No. 290-02-0017 to the Stanford University -UCSF Evidencebased Practices Center). AHRQ Publication No. 04-0051-1. Rockville, MD: Agency for Healthcare Research and Quality. August 2004
37. Williams GC, Deci EL. Activating patients for smoking cessation through physician autonomy support. Med Care 2001; 39:813-23
38. Williams GC, McGregor H, Zeldman A, Freedman ZR, Deci EL, Elder D. Promoting glycemic control through diabetes self-management: Evaluating a patient activation intervention. Patient Educ Couns 2005; 56:28-34
39. Turner RC, Waivers LE, O'Brien K. The effect of patient-carried reminder cards on the performance of health maintenance measures. Arch Intern Med 1990; 150:645-7
40. Bodenheimer T, Lorig K, Holman H, Grumbach K. Patient self-management of chronic disease in primary care. JAMA 2002; 288:2469-75
41. Eng E, Parker E, Harlan C. Lay health advisor intervention strategies: A continuum from natural helping to paraprofessional helping. Health Educ Behav 1997; 24:413-7
42. Swider SM. Outcome effectiveness of community health workers: An integrative literature review. Public Health Nurs 2002; 19:11-20
43. Institute of Medicine. Clinical practice guidelines: Directions for a new program. Washington, DC: National Academy Press; 1990
44. Grimshaw J, Eccles M, Thomas R, et al. Toward evidence-based quality improvement. Evidence (and its limitations) of the effectiveness of guideline dissemination and implementation strategies 1966-1998. J Gen Intern Med 2006; 21 Suppl 2:S14-20
45. Cabana MD, Rand CS, Powe NR, et al. Why don't physicians follow clinical practice guidelines? A framework for improvement. JAMA 1999; 282:1458-65
46. Boyd CM, Darer J, Boult C, Fried LP, Boult L, Wu AW. Clinical practice guidelines and quality of care for older patients with multiple comorbid diseases: Implications for pay for performance. JAMA 2005; 294:716-24
47. Davis D, O'Brien MA, Freemantle N, Wolf FM, Mazmanian P, Taylor-Vaisey A. Impact of formal continuing medical education: Do conferences, workshops, rounds, and other traditional continuing education activities change physician behavior or health care outcomes? JAMA 1999; 282:867-74
48. Davis DA, Thomson MA, Oxman AD, Haynes RB. Changing physician performance. A systematic review of the effect of continuing medical education strategies. JAMA 1995; 274:700-5
49. Mazmanian PE, Davis DA. Continuing medical education and the physician as a learner: Guide to the evidence. JAMA 2002; 288:1057-60
50. Centor R, Casebeer L, Klapow J. Using a combined CME course to improve physicians' skills in eliciting patient adherence. Acad Med 1998; 73:609-10
51. Fordis M, King JE, Ballantyne CM, et al. Comparison of the instructional efficacy of Internetbased CME with live interactive CME workshops: A randomized controlled trial. JAMA 2005; 294:1043-51
52. Soumerai SB, Avorn J. Principles of educational outreach ('academic detailing') to improve clinical decision making. JAMA 1990; 263:549-56
53. Valente TW, Pumpuang P. Identifying opinion leaders to promote behavior change. Health Educ Behav 2007; 34(6):881-96
54. Kiefe CI, Allison JJ, Williams OD, Person SD, Weaver MT, Weissman NW. Improving quality improvement using achievable benchmarks for physician feedback: A randomized controlled trial. JAMA 2001; 285:2871-9
55. Davidoff F, Batalden P. Toward stronger evidence on quality improvement. Draft publication guidelines: The beginning of a consensus project. Qual Saf Health Care 2005; 14:319-25
56. Jha AK, Perlin JB, Kizer KW, Dudley RA. Effect of the transformation of the Veterans Affairs Health Care System on the quality of care. N Engl J Med 2003; 348:2218-27
57. Payne TH. Computer decision support systems. Chest 2000; 118:47S-52S.
58. Walton RT, Harvey E, Dovey S, Freemantle N. Computerised advice on drug dosage to improve prescribing practice. Cochrane Database Syst Rev 2001:CD002894
59. Han YY, Carcillo JA, Venkataraman ST, et al. Unexpected increased mortality after implementation of a commercially sold computerized physician order entry system. Pediatrics 2005; 116:1506-12
60. Nebeker JR, Hoffman JM, Weir CR, Bennett CL, Hurdle JF. High rates of adverse drug events in a highly computerized hospital. Arch Intern Med 2005; 165:1111-6
61. Scalise D. Technology. CPOE: Are you really ready? Hosp Health Netw 2006; 80:14, 6
62. Ash JS, Sittig DF, Poon EG, Guappone K, Campbell E, Dykstra RH. The extent and importance of unintended consequences related to computerized provider order entry. J Am Med Inform Assoc 2007; 14:415-23
63. Werner RM, Asch DA. The unintended consequences of publicly reporting quality information. JAMA 2005; 293:1239-44
64. Werner RM, Asch DA, Polsky D. Racial profiling: The unintended consequences of coronary artery bypass graft report cards. Circulation 2005; 111:1257-63
65. Rosenthal MB, Frank RG, Li Z, Epstein AM. Early experience with pay-for-performance: From concept to practice. JAMA 2005; 294:1788-93
66. Glickman SW, Ou FS, DeLong ER, et al. Pay for performance, quality of care, and outcomes in acute myocardial infarction. JAMA 2007; 297:2373-80
67. Lindenauer PK, Remus D, Roman S, et al. Public reporting and pay for performance in hospital quality improvement. N Engl J Med 2007; 356:486-96
68. Murray DM. Design and analysis of group-randomized trials. New York: Oxford University Press; 1998
69. Begg C, Cho M, Eastwood S, et al. Improving the quality of reporting of randomized controlled trials. The CONSORT statement. JAMA 1996; 276:637-9
70. Moher D, Schulz KF, Altman D. The CONSORT statement: Revised recommendations for improving the quality of reports of parallel-group randomized trials. JAMA 2001; 285:1987-91
71. Campbell MK, Elbourne DR, Altman DG. CONSORT statement: Extension to cluster randomised trials. BMJ 2004; 328:702-8
72. Elbourne DR, Campbell MK. Extending the CONSORT statement to cluster randomized trials: For discussion. Stat Med 2001; 20:489-96
73. Casarett D, Karlawish JH, Sugarman J. Determining when quality improvement initiatives should be considered research: Proposed criteria and potential implications. JAMA 2000; 283:2275-80
74. Emanuel EJ, Wendler D, Grady C. What makes clinical research ethical? JAMA 2000; 283:2701-11
75. Lynn J, Baily MA, Bottrell M, et al. The ethics of using quality improvement methods in health care. Ann Intern Med 2007; 146:666-73
76. Van den Broeck J, Cunningham SA, Eeckels R, Herbst K. Data cleaning: Detecting, diagnosing, and editing data abnormalities. PLoS Med 2005; 2:e267
77. Uniform Requirements for Manuscripts Submitted to Biomedical Journals: Writing and Editing for Biomedical Publication: International Committee of Medical Journal Editors. Available at www.ICMJE.org (last accessed November 2007
78. Scriven M. Beyond formative and summative evaluation. In: McLaughlin MW, Phillips DC, eds. Evaluation and education: 90th yearbook of the National Society for the Study of Education. Chicago, IL: University of Chicago Press; 1991:18-64
79. Weston CB, McAlpine L, Bordonaro T. A model for understanding formative evaluation in instructional design. Education Tech Research Dev 1995; 43:29-49
80. Delbecq AL, Van de Ven AH, Gustafson DH. Group techniques for program planning: A guide to nominal group and Delphi processes. Glenview, IL: Scott Foresman; 1975
81. Krueger RA, Casey MA. Focus groups: A practical guide for applied research (3rd ed.). Thousand Oaks, CA: Sage; 2000
82. Nielsen J, Mack R. Usability inspection methods. New York: Wiley; 1994
83. Strauss A, Corbin J. Basics of qualitative research: Grounded theory, procedures, and techniques. Newbury Park, CA: Sage; 1990
84. Casebeer LL, Strasser SM, Spettell CM, et al. Designing tailored Web-based instruction to improve practicing physicians' preventive practices. J Med Internet Res 2003; 5:e20
85. Bootzin RR. The role of expectancy in behavior change. In: White L, Turskey B, Schwartz G, eds. Placebo: Theory, research, and mechanisms. New York: Guilford Press; 1985:196-210
86. Gross D. On the merits of attention-control groups. Res Nurs Health 2005; 28:93-4
87. Torgerson DJ. Contamination in trials: Is cluster randomisation the answer? BMJ 2001; 322:355-7
88. Puffer S, Torgerson D, Watson J. Evidence for risk of bias in cluster randomised trials: Review of recent trials published in three general medical journals. BMJ 2003; 327:785-9
89. Murray DM, Varnell SP, Blitstein JL. Design and analysis of group-randomized trials: A review of recent methodological developments. Am J Public Health 2004; 94:423-32
90. Lachin JM. Statistical considerations in the intent-To-Treat principle. Control Clin Trials 2000; 21:167-89
91. Schulz KF, Grimes DA. Sample size slippages in randomised trials: Exclusions and the lost and wayward. Lancet 2002; 359:781-5
92. Baron RM, Kenny DA. The moderator-mediator variable distinction in social psychological research: Conceptual, strategic, and statistical considerations. J Pers Soc Psychol 1986; 51:1173-82
93. Preacher KJ, Hayes AF. SPSS and SAS procedures for estimating indirect effects in simple mediation models. Behav Res Methods Instrum Comput 2004; 36:717-31
94. Donner A, Klar N. Pitfalls of and controversies in cluster randomization trials. Am J Public Health 2004; 94:416-22
95. Beach ML. Primer on group randomized trials. Eff Clin Pract 2001; 4:42-3
96. Campbell MK, Fayers PM, Grimshaw JM. Determinants of the intracluster correlation coefficient in cluster randomized trials: The case of implementation research. Clin Trials 2005; 2:99-107
97. Sculpher M. Evaluating the cost-effectiveness of interventions designed to increase the utilization of evidence-based guidelines. Fam Pract 2000;17 Suppl 1:S26-31
98. Institute of Medicine. Advancing quality improvement research: Challenges and opportunities-workshop summary. Washington, DC: National Academies Press; 2007. (Accessed November 2007, at www.nap.edu/catalog/11884.html