A comparison of observational studies and randomized, controlled trials

New England Journal of Medicine

Volumn 342, Issue 25, 2000, Pages 1878-1886

  Benson, Kjell ^a   Hartz, Arthur J ^a  

^a UNIVERSITY OF IOWA   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CALCIUM CHANNEL BLOCKING AGENT;

APPENDECTOMY; ARTICLE; CLINICAL OBSERVATION; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CORONARY ARTERY DISEASE; HUMAN; MEDICAL INFORMATION; MEDICAL RESEARCH; MORTALITY; PRIORITY JOURNAL; RANDOMIZATION; RANDOMIZED CONTROLLED TRIAL; SUBFERTILITY; TREATMENT OUTCOME;

BONE DENSITY; COHORT STUDIES; CROSS-SECTIONAL STUDIES; FEMALE; HEART DISEASES; HORMONE REPLACEMENT THERAPY; HUMANS; ODDS RATIO; RANDOMIZED CONTROLLED TRIALS; RESEARCH DESIGN; RETROSPECTIVE STUDIES; THERAPEUTICS; TREATMENT OUTCOME;

EID: 0034702233     PISSN: 00284793     EISSN: None     Source Type: Journal    
DOI: 10.1056/NEJM200006223422506     Document Type: Article

References (79)

1. Feinstein AR. Epidemiologic analyses of causation: the unlearned scientific lessons of randomized trials. J Clin Epidemiol 1989;42:481-9.
2. Moses LE. Measuring effects without randomized trials? Options, problems, challenges. Med Care 1995;33:Suppl:AS8-AS14.
3. Kunz R, Oxman AD. The unpredictability paradox: review of empirical comparisons of randomised and non-randomised clinical trials. BMJ 1998; 317:1185-90.
4. Naylor CD, Guyatt GH. Users' guides to the medical literature. X. How to use an article reporting variations in the outcomes of health services. JAMA 1996;275:554-8.
5. Chalmers TC, Matta RJ, Smith H Jr, Kunzler A-M. Evidence favoring the use of anticoagulants in the hospital phase of acute myocardial infarction. N Engl J Med 1977;297:1091-6.
6. Chalmers TC, Celano P, Sacks HS, Smith H Jr. Bias in treatment assignment in controlled clinical trials. N Engl J Med 1983;309:1358-61.
7. Sacks H, Chalmers TC, Smith H Jr. Randomized versus historical controls for clinical trials. Am J Med 1982;72:233-40.
8. Colditz GA, Miller JN, Mosteller F. How study design affects outcomes in comparisons of therapy. I. Medical. Stat Med 1989;8:441-54.
9. Miller JN, Colditz GA, Mosteller F. How study design affects outcomes in comparisons of therapy. II. Surgical. Stat Med 1989;8:455-66.
10. Sackett DL, Richardson WS, Rosenberg W, Haynes RB. Evidence-based medicine: how to practice and teach EBM. New York: Churchill Livingtone, 1997.
11. Jadad AR, Haynes RB. The Cochrane Collaboration - advances and challenges in improving evidence-based decision making. Med Decis Making 1998;18:2-9.
12. Schulz KF, Chalmers I, Hayes RJ, Altman DG. Empirical evidence of bias: dimensions of methodological quality associated with estimates of treatment effects in controlled trials. JAMA 1995;273:408-12.
13. Britton A, McPherson K, McKee M, Sanderson C, Black N, Bain C. Choosing between randomised and non-randomised studies: a systematic review. Health Technol Assess 1998;2(13):i-iv, 1-124.
14. Braun S, Boyko V, Behar S, et al. Calcium antagonists and mortality in patients with coronary artery disease: a cohort study of 11,575 patients. J Am Coll Cardiol 1996;28:7-11.
15. Furberg CD, Psaty BM, Meyer JV. Nifedipine: dose-related increase in mortality in patients with coronary heart disease. Circulation 1995;92: 1326-31.
16. Detre KM, Guo P, Holubkov R, et al. Coronary revascularization in diabetic patients: a comparison of the randomized and observational components of the Bypass Angioplasty Revascularization Investigation (BARI). Circulation 1999;99:633-40.
17. Coronary Artery Surgery Study (CASS): a randomized trial of coronary artery bypass surgery: comparability of entry characteristics and survival in randomized patients and nonrandomized patients meeting randomization criteria. J Am Coll Cardiol 1984;3:114-28.
18. Hlatky MA, Califf RM, Harrell FE Jr, Lee KL, Mark DB, Pryor DB. Comparison of predictions based on observational data with the results of randomized controlled clinical trials of coronary artery bypass surgery. J Am Coll Cardiol 1988;11:237-45.
19. Horwitz RI, Viscoli CM, Clemens JD, Sadock RT. Developing improved observational methods for evaluating therapeutic effectiveness. Am J Med 1990;89:630-8.
20. A randomized trial of propranolol in patients with acute myocardial infarction. I. Mortality results. JAMA 1982;247:1707-14.
21. Tangkanakul C, Counsell C, Warlow C. Local versus general anaesthesia for carotid endarterectomy (Cochrane review). In: The Cochrane library, 2. Oxford, England: Update Software, 1999.
22. Teasdale TA, Shuman L, Snow E, Luchi RJ. A comparison of placement outcomes of geriatric cohorts receiving care in a geriatric assessment unit and on general medicine floors. J Am Geriatr Soc 1983;31:529-34.
23. Stuck AE, Siu AL, Wieland GD, Adams J, Rubenstein LZ. Comprehensive geriatric assessment: a meta-analysis of controlled trials. Lancet 1993;342:1032-6.
24. Han DP, Mohsin NC, Guse CE, Hartz A, Tarkanian CN. Comparison of pneumatic retinopexy and scleral buckling in the management of primary rhegmatogenous retinal detachment. Am J Ophthalmol 1998;126: 658-68.
25. McAllister IL, Meyers SM, Zegarra H, Gutman FA, Zakov ZN, Beck GJ. Comparison of pneumatic retinopexy with alternative surgical techniques. Ophthalmology 1988;95:877-83.
26. Tornambe PE, Hilton GF. Pneumatic retinopexy: a multicenter randomized controlled clinical trial comparing pneumatic retinopexy with scierai buckling. Ophthalmology 1989;96:772-84.
27. Friberg TR, Rosenstock J, Sanborn G, Vaghefi A, Raskin P. The effect of long-term near normal glycemic control on mild diabetic retinopathy. Ophthalmology 1985;92:1051-8.
28. Rosenstock J, Friberg T, Raskin P. Effect of glycemic control on microvascular complications in patients with type I diabetes mellitus. Am J Med 1986;81:1012-8.
29. Reichard P, Nilsson B-Y, Rosenqvist U. The effect of long-term intensified insulin treatment on the development of microvascular complications of diabetes mellitus. N Engl J Med 1993;329:304-9.
30. The Diabetes Control and Complications Trial Research Group. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin dependent diabetes mellitus. N Engl J Med 1993;329:977-86.
31. Carlsson P, Kinn AC, Tiselius HG, Ohlsen H, Rahmqvist M. Cost effectiveness of extracorporeal shock wave lithotripsy and percutaneous nephrolithotomy for medium-sized kidney stones: a randomised clinical trial. Scand J Urol Nephrol 1992;26:257-63.
32. Mays N, Petruckevitch A, Burney PG. Results of one and two year follow-up in a clinical comparison of extracorporcal shock wave lithotripsy and percutaneous nephrolithotomy in the treatment of renal calculi. Scand J Urol Nephrol 1992;26:43-9.
33. Watson A, Vandekerckhove P, Lilford R. Techniques for pelvic surgery in subfertility (Cochrane review). In: The Cochrane library, 2. Oxford, England: Update Software, 1999.
34. Nicolaides K, de Lourdes Brizot M, Patel F, Snijders R. Comparison of chorionic villus sampling and amniocentesis for fetal karyotyping at 10-13 weeks' gestation. Lancet 1994;344:435-9. [Erratum, Lancet 1994;344: 830.]
35. Curtis RE, Boice JD Jr, Stovall M, et al. Risk of leukemia after chemotherapy and radiation treatment for breast cancer. N Engl J Med 1992; 326:1745-51.
36. Fisher B, Rackette H, Fisher ER, Wickerham DL, Redmond C, Brown A. Leukemia in breast cancer patients following adjuvant chemotherapy or postoperative radiation: the NSABP experience. J Clin Oncol 1985;3:1640-58.
37. Shapiro CL, Recht A. Late effects of adjuvant therapy for breast cancer. In: Breast cancer in younger women. Journal of the National Cancer Institute monographs. No. 16. Washington, D.C.: Government Printing Office, 1994:101-12. (NIH publication no. 93-03559.)
38. Paradise JL, Bluestone CD, Rogers KD, et al. Efficacy of adenoidectomy for recurrent otitis media in children previously treated with tympanostomy-tube placement: results of parallel randomized and nonrandomized trials. JAMA 1990;263:2066-73.
39. Yamamoto H, Hughes RW Jr, Schroeder KW, Viggiano TR, DiMagno EP. Treatment of benign esophageal stricture by Eder-Puestow or balloon dilators: a comparison between randomized and prospective nonrandomized trials. Mayo Clin Proc 1992;67:228-36.
40. Vandekerckhove P, Watson A, Lilford R, Harada T, Hughes E. Oil-soluble versus water-soluble media for assessing tubal patency with hysterosalpingography or laparoscopy in subfertile women (Cochrane review). In: The Cochrane library, 2. Oxford, England: Update Software, 1999.
41. Brewster AC, Karlin BG, Hyde LA, Jacobs CM, Bradbury RC, Chae YM. MEDISGRPS: a clinically based approach to classifying hospital patients at admission. Inquiry 1985;22:377-87
42. Gayton D, Wood-Dauphinee S, de Lorimer M, Tousignant P, Hanley J. Trial of a geriatric consultation team in an acute care hospital. J Am Geriatr Soc 1987;35:726-36.
43. Ettinger B, Genant HK, Cann CE. Postmenopausal bone loss is prevented by treatment with low-dosage estrogen with calcium. Ann Intern Med 1987;106:40-5.
44. Felson DT, Zhang Y, Hannan MT, Kiel DP, Wilson PWF, Anderson JJ. The effect of postmenopausal estrogen therapy on bone density in elderly women. N Engl J Med 1993;329:1141-6.
45. Grey AB, Cundy TF, Reid IR. Continuous combined oestrogen/ progestin therapy is well tolerated and increases bone density at the hip and spine in post-menopausal osteoporosis. Clin Endocrinol (Oxf) 1994;40: 671-7.
46. Hillard TC, Whitcroft SJ, Marsh MS, et al. Long-term effects of transdermal and oral hormone replacement therapy on postmenopausal bone loss. Osteoporos Int 1994;4:341-8.
47. Cosman F, Nieves J, Walliser J, Lindsay R. Postmenopausal osteoporosis: patient choices and outcomes. Maturitas 1995;22:137-43.
48. Lufkin ED, Wahner HW, O'Fallon WM, et al. Treatment of postmenopausal osteoporosis with transdermal estrogen. Ann Intern Med 1992;117: 1-9.
49. Meschia M, Brincat M, Barbacini P, Crossignani PG, Albisetti W. A clinical trial on the effects of a combination of elcatonin (carbocalcitonin) and conjugated estrogens on vertebral bone mass in early postmenopausal women. Calcif Tissue Im 1993;53:17-20.
50. Aloia J, Vaswani A, Yeh JK, Ross PL, Flaster E, Dilmanian FA. Calcium supplementation with and without hormone replacement therapy to prevent postmenopausal bone loss. Ann Intern Med 1994;120:97-103.
51. Doren M, Reuther G, Minne HW, Schneider HP. Superior compliance and efficacy of continuous combined oral estrogen-progestogen replacement therapy in postmenopausal women. Am J Obstet Gynecol 1995;173: 1446-51.
52. Gambacciani M, Spinetti A, Orlandi R, et al. Effects of a new estrogen/progestin combination in the treatment of postmenopausal syndrome. Maturitas 1995;22:115-20.
53. Speroff L, Rowan J, Symons J, Genant H, Wilborn W. The comparative effect on bone density, endometrium, and lipids of continuous hormones as replacement therapy (CHART study): a randomized controlled trial. JAMA 1996;276:1397-403.
54. Heikkenen J, Kyllonen E, Kurttila-Matero E, et al. HRT and exercise: effects on bone density, muscle strength and lipid metabolism: a placebo controlled 2-year prospective trial on two estrogen-progestin regimens in healthy postmenopausal women. Maturitas 1997;26:139-49.
55. Mizunuma H, Okano H, Soda M, et al. Prevention of postmenopausal bone loss with minimal uterine bleeding using low dose continuous estrogen/progestin therapy: a 2-year prospective study. Maturitas 1997;27:69-76.
56. Hosking D, Chilvers CED, Christiansen C, et al. Prevention of bone loss with alendronate in postmenopausal women under 60 years of age. N Engl J Med 1998;338:485-92.
57. Wimalawansa SJ. A four-year randomized controlled trial of hormone replacement and bisphosphonate, alone or in combination, in women with postmenopausal osteoporosis. Am J Med 1998;104:219-26.
58. Solez K, Racusen LC, Keown PA, Vaughn WK, Burdick JF. The influence of antihypertensive drug therapy on renal transplant function and outcome. Transplant Proc 1988;20:Suppl 3:618-22.
59. Ferguson CJ, Hillis AN, Williams JD, Griffin PJ, Salaman JR. Calcium-channel blockers and other factors influencing delayed function in renal allografts. Nephrol Dial Transplant 1990;5:816-20.
60. Palmer BF, Dawidson I, Sagalowsky A, Sandor Z, Lu CY. Improved outcome of cadaveric renal transplantation due to calcium channel blockers. Transplantation 1991;52:640-5.
61. Puig JM, Lloveras J, Oliveras A, Costa A, Aubia J, Masramon J. Usefulness of diltiazem in reducing the incidence of acute tubular necrosis in Euro-Collins-preserved cadaveric renal grafts. Transplant Proc 1991;23:2368-9.
62. Nicholson ML, Dennis MJ, Beckingham IJ, Smith SJ. Effect of nifedipine on renal transplant rejection. Br J Surg 1993;80:1318-21.
63. Ladefoged SD, Andersen CB. Calcium channel blockers in kidney transplantation. Clin Transplant 1994;8:128-33.
64. McAnena OJ, Austin O, O'Connell PR, Hederman WP, Gorey TF, Fitzpatrick J. Laparoscopic versus open appendicectomy: a prospective evaluation. Br J Surg 1992;79:818-20.
65. Buckley RC, Hall TJ, Muakkassa FF, Anglin B, Rhodes RS, Scott-Conner CE. Laparoscopic appendectomy: is it worth it? Am Surg 1994;60:30-4.
66. Lujan Mompean JA, Robles Campos R, Parrilla Paricio P, Soria Aledo V, Garcia Ayllon J. Laparoscopic versus open appendicectomy: a prospective assessment. Br J Surg 1994;81:133-5.
67. Schirmer BD, Schmieg RE Jr, Dix J, Edge SB, Hanks JB. Laparoscopic versus traditional appendectomy for suspected appendicitis. Am J Surg 1993;165:670-5.
68. Vallina VL, Velasco JM, McCulloch CS. Laparoscopic versus conventional appendectomy. Ann Surg 1993;218:685-92.
69. Bonanni F, Reed J III, Hartzell G, et al. Laparoscopic versus conventional appendectomy. J Am Coll Surg 1994;179:273-8.
70. Pruett B, Pruett J. Laparoscopic appendectomy: have we found a better way? J Miss State Med Assoc 1994;35:347-51.
71. Richards KF, Fisher KS, Flores JH, Christensen BJ. Laparoscopic appendectomy, comparison with open appendectomy in 720 patients. Surg Laparosc Endosc 1996;6:205-9.
72. Golub R, Siddiqui F, Pohl D. Laparoscopic versus open appendectomy: a metaanalysis. J Am Coll Surg 1998;186:545-53.
73. Hartz AJ, Kuhn EM, Pryor DB, et al. Mortality after coronary angioplasty and coronary artery bypass surgery (the national Medicare experience). Am J Cardiol 1992;70:179-85.
74. Hartz AJ, Kuhn EM. Coronary angioplasty compared with bypass grafting. N Engl J Med 1995;332:888.
75. Juni P, Witschi A, Bloch R, Egger M. The hazards of scoring the quality of clinical trials for meta-analysis. JAMA 1999;282:1054-60.
76. Gillman MW, Runyan DK. Bias in treatment assignment in controlled clinical trials. N Engl J Med 1983;310:1610-1.
77. Ottenbacher K. Impact of random assignment on study outcome: an empirical examination. Control Clin Trials 1992;13:50-61.
78. Emanuel EJ. Cost savings at the end of life: what do the data show? JAMA 1996;275:1907-14.
79. Green SB, Byar DE. Using observational data from registries to compare treatments: the fallacy of omnimetrics. Stat Med 1984;3:361-73.