BMJ 1996;312:1215-1218 (11 May)
Education and debate
Why we need observational studies to evaluate the effectiveness of health care
Nick Black,
professor of health services research aa Health Services Research Unit, Department of Public Health and Policy, London School of Hygiene and Tropical Medicine, Keppel Street, London WC1E 7HT
The view is widely held that experimental methods (randomised controlled trials) are the "gold standard" for evaluation and that observational methods (cohort and case control studies) have little or no value. This ignores the limitations of randomised trials, which may prove unnecessary, inappropriate, impossible, or inadequate. Many of the problems of conducting randomised trials could often, in theory, be overcome, but the practical implications for researchers and funding bodies mean that this is often not possible. The false conflict between those who advocate randomised trials in all situations and those who believe observational data provide sufficient evidence needs to be replaced with mutual recognition of the complementary roles of the two approaches. Researchers should be united in their quest for scientific rigour in evaluation, regardless of the method used.
Despite the essential role of observational methods in shedding light on the effectiveness of . . . [Full text of this article]

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-
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-
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-
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-
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-
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[Abstract]
[Full text]
-
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[Abstract]
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-
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[Abstract]
[Full text]
-
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[Full text]
-
Rychetnik, L, Frommer, M, Hawe, P, Shiell, A
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[Abstract]
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-
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-
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-
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-
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-
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215: 445-451
[Abstract]
[Full text]
-
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20: 1689-1691
-
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(1999). Comparing outcomes of percutaneous transluminal coronary angioplasty with coronary artery bypass grafting. Can routine health service data complement and enhance randomized controlled trials?. Eur Heart J
20: 1731-1735
[Abstract]
-
Khunti, K.
(1999). Use of multiple methods to determine factors affecting quality of care of patients with diabetes. Fam Pract
16: 489-494
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[Full text]
-
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319: 709a-709
[Full text]
-
Ukoumunne, O. C, Gulliford, M. C, Chinn, S., Sterne, J. A C, Burney, P. G J, Donner, A.
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319: 376-379
[Full text]
-
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319: 312-315
[Full text]
-
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318: 1209-1209
[Full text]
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