Surgical outcomes research based on administrative data: Inferior or complementary to prospective randomized clinical trials?

World Journal of Surgery

Volumn 30, Issue 3, 2006, Pages 255-266

  Guller, Ulrich ^a  

^a UNIVERSITY HOSPITAL BASEL   (Switzerland)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; DATA BASE; FOLLOW UP; HEALTH CARE; HEALTH CARE COST; HUMAN; MEDICAL RESEARCH; PROSPECTIVE STUDY; RANDOMIZATION; STATISTICAL ANALYSIS; SURGEON; SURGICAL TECHNIQUE; TREATMENT OUTCOME; WEAKNESS;

BIOMEDICAL RESEARCH; DATABASES, FACTUAL; HEALTH SERVICES ACCESSIBILITY; HUMANS; OUTCOME ASSESSMENT (HEALTH CARE); PROSPECTIVE STUDIES; RANDOMIZED CONTROLLED TRIALS; RESEARCH DESIGN; RETROSPECTIVE STUDIES; STATISTICS; SURGERY;

EID: 32944464062     PISSN: 03642313     EISSN: None     Source Type: Journal    
DOI: 10.1007/s00268-005-0156-0     Document Type: Article

References (86)

1. Porter GA, Skibber JM. Outcomes research in surgical oncology. Ann Surg Oncol 2000;7:367-75.
2. Brenneman FD, Wright JG, Kennedy ED, et al. Outcomes research in surgery. World J Surg 1999;23:1220-1223.
3. Epstein AM. The outcomes movement - will it get us where we want to go? N Engl J Med 1990;323:266-270.
4. Iezzoni LI (1997) Risk Adjustment for Measuring Health Care Outcomes Health Administrative Press, Foundation of the American College of Excecutives, Chicago.
5. Best AE. Secondary data bases and their use in outcomes research: a review of the area resource file and the Healthcare Cost and Utilization Project. J Med Syst 1999;23:175-181.
6. Iezzoni LI. Using risk-adjusted outcomes to assess clinical practice: an overview of issues pertaining to risk adjustment. Ann Thorac Surg 1994;58:1822-1826.
7. Lewis NJ, Patwell JT, Briesacher BA. The role of insurance claims databases in drug therapy outcomes research. Pharmacoeconomics 1993;4:323-330.
8. Wennberg JE, Roos N, Sola L, et al. Use of claims data systems to evaluate health care outcomes: mortality and reoperation following prostatectomy. JAMA 1987;257:933-936.
9. Coleman AL, Morgenstern H. Use of insurance claims databases to evaluate the outcomes of ophthalmic surgery. Surv Ophthalmol 1997;42:271-278.
10. Armstrong EP, Manuchehri F. Ambulatory care databases for managed care organizations. Am J Health Syst Pharm 1997;54:1973-2005.
11. Wennberg J, Gittelsohn. Small area variations in health care delivery. Science 1973;182:1102-1108.
12. Farrow DC, Hunt WC, Samet JM. Geographic variation in the treatment of localized breast cancer. N Engl J Med 1992;326:1097-1101.
13. Sainsbury R, Rider L, Smith A, et al. Does it matter where you live? Treatment variation for breast cancer in Yorkshire; The Yorkshire Breast Cancer Group. Br J Cancer 1995;71:1275-1278.
14. Nilasena DS, Vaughn RJ, Mori M, et al. Surgical trends in the treatment of diseases of the lumbar spine in Utah's Medicare population, 1984 to 1990. Med Care 1995;33:585-597.
15. Cooper GS, Yuan Z, Stange KC, et al. Use of Medicare claims data to measure county-level variations in the incidence of colorectal carcinoma. Cancer 1998;83: 673-678.
16. Skinner J, Weinstein JN, Sporer SM, et al. Racial, ethnic, and geographic disparities in rates of knee arthroplasty among Medicare patients. N Engl J Med 2003;349: 1350-1359.
17. McPherson K, Wennberg JE, Hovind OB, et al. Small-area variations in the use of common surgical procedures: an international comparison of New England, England, and Norway. N Engl J Med 1982;307:1310-1314.
18. Nattinger AB, Gottlieb MS, Veum J, et al. Geographic variation in the use of breast-conserving treatment for breast cancer. N Engl J Med 1992;326:1102-1107.
19. Wright JG, Hawker GA, Bombardier C, et al. Physician enthusiasm as an explanation for area variation in the utilization of knee replacement surgery. Med Care 1999;37:946-956.
20. Gilligan MA, Kneusel RT, Hoffmann RG, et al. Persistent differences in sociodemographic determinants of breast conserving treatment despite overall increased adoption. Med Care 2002;40:181-189.
21. Jerome-D'Emilia B, Begun JW. Diffusion of breast conserving surgery in medical communities. Soc Sci Med 2005;60:143-151.
22. Birkmeyer JD, Siewers AE, Finlayson EV, et al. Hospital volume and surgical mortality in the United States. N Engl J Med 2002;346:1128-1137.
23. Begg CB, Cramer LD, Hoskins WJ, et al. Impact of hospital volume on operative mortality for major cancer surgery. JAMA 1998;280:1747-1751.
24. Glasgow RE, Mulvihill SJ. Hospital volume influences outcome in patients undergoing pancreatic resection for cancer. West J Med 1996;165:294-300.
25. Lieberman MD, Kilburn H, Lindsey M, et al. Relation of perioperative deaths to hospital volume among patients undergoing pancreatic resection for malignancy. Ann Surg 1995;222:638-645.
26. Romano PS, Mark DH. Patient and hospital characteristics related to in-hospital mortality after lung cancer resection. Chest 1992;101:1332-1337.
27. Harmon JW, Tang DG, Gordon TA, et al. Hospital volume can serve as a surrogate for surgeon volume for achieving excellent outcomes in colorectal resection. Ann Surg 1999;230:404-413.
28. Yao SL, Lu-Yao G. Population-based study of relationships between hospital volume of prostatectomies, patient outcomes, and length of hospital stay. J Natl Cancer Inst 1999;91:1950-1956.
29. Gordon TA, Burleyson GP, Tielsch JM, et al. The effects of regionalization on cost and outcome for one general high-risk surgical procedure. Ann Surg 1995;221:43-49.
30. Purves H, Pietrobon R, Hervey S, et al. Relationship between surgeon caseload and sphincter preservation in patients with rectal cancer. Dis Colon Rectum 2005;48:195-204.
31. Schulman KA, Berlin JA, Harless W, et al. The effect of race and sex on physicians' recommendations for cardiac catheterization. N Engl J Med 1999;340:618-626.
32. Greenwald HP, Polissar NL, Borgatta EF, et al. Social factors, treatment, and survival in early-stage non-small cell lung cancer. Am J Public Health 1998;88:1681-1684.
33. Richards RJ, Reker DM. Racial differences in use of colonoscopy, sigmoidoscopy, and barium enema in Medicare beneficiaries. Dig Dis Sci 2002;47:2715-2719.
34. Eley JW, Hill HA, Chen VW, et al. Racial differences in survival from breast cancer: results of the National Cancer Institute Black/White Cancer Survival Study. JAMA 1994;272:947-954.
35. Dayal HH, Polissar L, Dahlberg S. Race, socioeconomic status, and other prognostic factors for survival from prostate cancer. J Natl Cancer Inst 1985;74:1001-1006.
36. Dayal H, Polissar L, Yang CY, et al. Race, socioeconomic status, and other prognostic factors for survival from colorectal cancer. J Chronic Dis 1987;40:857-864.
37. Cooper GS, Yuan Z, Landefeld CS, et al. Surgery for colorectal cancer: race-related differences in rates and survival among Medicare beneficiaries. Am J Public Health 1996;86:582-586.
38. Bach PB, Cramer LD, Warren JL, et al. Racial differences in the treatment of early-stage lung cancer. N Engl J Med 1999;341:1198-1205.
39. Guller U, Jain N, Curtis L, et al. Insurance status and race represent independent predictors of undergoing laparoscopic surgery for appendicitis: secondary data analysis of 145,546 patients. J Am Coll Surg 2004;199:567-577.
40. Flum DR, Morris A, Koepsell T, et al. Has misdiagnosis of appendicitis decreased over time? A population-based analysis. JAMA 2001;286:1748-1753.
41. Guller U, Hervey S, Purves H, et al. Laparoscopic versus open appendectomy: outcomes comparison based on a large administrative database. Ann Surg 2004;239:43-52.
42. Benson K, Hartz AJ. A comparison of observational studies and randomized, controlled trials. N Engl J Med 2000;342:1878-1886.
43. Lloyd SS, Rissing JP. Physician and coding errors in patient records. JAMA 1985;254:1330-1336.
44. Steiner C, Elixhauser A, Schnaier J. The healthcare cost and utilization project: an overview. Eff Clin Pract 2002;5:143-151.
45. Losina E, Barrett J, Baron JA, et al. Accuracy of Medicare claims data for rheumatologic diagnoses in total hip replacement recipients. J Clin Epidemiol 2003;56:515-519.
46. Romano PS, Roos LL, Luft HS, et al. A comparison of administrative versus clinical data: coronary artery bypass surgery as an example; Ischemic Heart Disease Patient Outcomes Research Team. J Clin Epidemiol 1994;47:249-260.
47. Jollis JG, Ancukiewicz M, DeLong ER, et al. Discordance of databases designed for claims payment versus clinical information systems: implications for outcomes research. Ann Intern Med 1993;119:844-850.
48. Cooper GS, Yuan Z, Stange KC, et al. The sensitivity of Medicare claims data for case ascertainment of six common cancers. Med Care 1999;37:436-444.
49. Cooper GS, Yuan Z, Stange KC, et al. The utility of Medicare claims data for measuring cancer stage. Med Care 1999;37:706-711.
50. Cooper GS, Yuan Z, Stange KC, et al. Agreement of Medicare claims and tumor registry data for assessment of cancer-related treatment. Med Care 2000;38:411-421.
51. Hsia DC, Krushat WM, Fagan AB, et al. Accuracy of diagnostic coding for Medicare patients under the prospective-payment system. N Engl J Med 1988;318:352-355.
52. Guller U, DeLong ER. Interpreting statistics in medical literature: a vade mecum for surgeons. J Am Coll Surg 2004;198:441-458.
53. Bender R, Lange S. Adjusting for multiple testing - when and how? J Clin Epidemiol 2001;54:343-349.
54. Katz MH. What are confounders and how does multivariate analysis help me to deal with them. In: Multivariable Analysis. Cambridge University Press, Cambridge, 1999.
55. Klungel OH, Martens EP, Psaty BM, et al. Methods to assess intended effects of drug treatment in observational studies are reviewed. J Clin Epidemiol 2004;57:1223-1231.
56. Byar DP, Simon RM, Friedewald WT, et al. Randomized clinical trials: perspectives on some recent ideas. N Engl J Med 1976;295:74-80.
57. Stewart LA, Parmar MK. Bias in the analysis and reporting of randomized controlled trials. Int J Technol Assess Health Care 1996;12:264-275.
58. Bailey KR. Generalizing the results of randomized clinical trials. Control Clin Trials 1994;15:15-23.
59. Abel U, Koch A. The role of randomization in clinical studies: myths and beliefs. J Clin Epidemiol 1999;52:487-497.
60. Altman DG. Better reporting of randomised controlled trials: the CONSORT statement. BMJ 1996;313:570-571.
61. McLeod RS. Issues in surgical randomized controlled trials. World J Surg 1999;23:1210-1214.
62. Young J, Harrison J, White G, et al. Developing measures of surgeons' equipoise to assess the feasibility of randomized controlled trials in vascular surgery. Surgery 2004;136:1070-1076.
63. Concato J, Shah N, Horwitz RI. Randomized, controlled trials, observational studies, and the hierarchy of research designs. N Engl J Med 2000;342:1887-1892.
64. Kennedy WA, Laurier C, Malo JL, et al. Does clinical trial subject selection restrict the ability to generalize use and cost of health services to "real life" subjects? Int J Technol Assess Health Care 2003;19:8-16.
65. Crawford ED. On the importance of clinical trials. J Urol 1990;143:787.
66. Cummings SR, Grady D, Hulley SB. (2001) Designing an Experiment: Clinical Trials I. Designing Clinical Research. Lippincott Williams & Wilkins, Philadelphia, pp 143-155.
67. Helms PJ. 'Real world' pragmatic clinical trials: what are they and what do they tell us? Pediatr Allergy Immunol 2002;13:4-9.
68. Roland M, Torgerson DJ. What are pragmatic trials? BMJ 1998;316:285.
69. Clarke CE. A "cure" for Parkinson's disease: can neuroprotection be proven with current trial designs? Mov Disord 2004;19:491-498.
70. Fleming TR, DeMets DL. Surrogate end points in clinical trials: are we being misled? Ann Intern Med 1996;125:605-613.
71. Guller U, Blumenstein BA. Trends in clinical trials in surgical oncology: implications for outcomes research. Clin Ther 2003;25:(2) 684-698.
72. Ellenberg S, Hamilton JM. Surrogate endpoints in clinical trials: cancer. Stat Med 1989;8:405-413.
73. D'Agostino RB Jr. Debate: the slippery slope of surrogate outcomes. Curr Control Trials Cardiovasc Med 2000;1:76-78.
74. Guller U, Oertli D. Sample size matters: a guide for surgeons. World J Surg 2005;29:601-605.
75. Berwick DM. Experimental power: the other side of the coin. Pediatrics 1980;65:1043-1045.
76. Moher D, Dulberg CS, Wells GA. Statistical power, sample size, and their reporting in randomized controlled trials. JAMA 1994;272:122-124.
77. Vandekerckhove P, O'Donovan PA, Lilford RJ, et al. Infertility treatment: from cookery to science: the epidemiology of randomised controlled trials. Br J Obstet Gynaecol 1993;100:1005-1036.
78. Freiman JA, Chalmers TC, Smith H Jr, et al. The importance of beta, the type II error and sample size in the design and interpretation of the randomized control trial: survey of 71 "negative" trials. N Engl J Med 1978;299:690-694.
79. Lilford R, Braunholtz D, Harris J, Gill T. Trials in surgery. Br J Surg 2004;91:6-16.
80. Montori VM, Kleinbart J, Newman TB, et al. Tips for learners of evidence-based medicine. 2. Measures of precision (confidence intervals). Can Med Assoc J 2004;171:611-615.
81. Hanley JA, Lippman-Hand A. If nothing goes wrong, is everything all right? Interpreting zero numerators. JAMA 1983;249:1743-1745.
82. Moseley JB, O'Malley K, Petersen NJ, et al. A controlled trial of arthroscopic surgery for osteoarthritis of the knee. N Engl J Med 2002;347:81-88.
83. Albin RL. Sham surgery controls: intracerebral grafting of fetal tissue for Parkinson's disease and proposed criteria for use of sham surgery controls. J Med Ethics 2002;28:322-325.
84. Macklin R. The ethical problems with sham surgery in clinical research. N Engl J Med 1999;341:992-996.
85. Devereaux PJ, Bhandari M, Clarke M, et al. Need for expertise based randomised controlled trials. BMJ 2005;330:88.
86. Bais JE, Bartelsman JF, Bonjer HJ, et al. Laparoscopic or conventional Nissen fundoplication for gastro-oesophageal reflux disease: randomised clinical trial: The Netherlands Antireflux Surgery Study Group. Lancet 2000;355:170-174.