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Hypertension and outcomes research. From clinical trials to clinical epidemiology.

TitleHypertension and outcomes research. From clinical trials to clinical epidemiology.
Publication TypeJournal Article
Year of Publication1996
AuthorsPsaty, BM, Siscovick, DS, Weiss, NS, Koepsell, TD, Rosendaal, FR, Lin, D, Heckbert, SR, Wagner, EH, Furberg, CD
JournalAm J Hypertens
Volume9
Issue2
Pagination178-83
Date Published1996 Feb
ISSN0895-7061
KeywordsClinical Trials as Topic, Epidemiologic Methods, Evidence-Based Medicine, Humans, Hypertension, Outcome Assessment (Health Care)
Abstract<p>Outcomes research seeks to identify effective evidence-based methods of providing the best medical care. While randomized clinical trials (RCT) usually provide the clearest answers, they are often not done or not practicable. More than a decade after the introduction of calcium channel blockers and angiotensin converting enzyme (ACE) inhibitors, clinical trial data about their effect on major disease endpoints in patients with hypertension are still not available. The primary alternatives are the use of randomized trials that include surrogate endpoints, such as level of blood pressure or extent of carotid atherosclerosis, and the use of observational studies that include major disease endpoints. Both approaches, their strengths and limitations, are discussed in detail. The possibility of residual confounding limits the strength of inferences that can be drawn from observational studies. Similarly, the possibility of important drug effects, other than those involving the surrogate endpoint, limits the inferences that can be drawn from randomized trials that rely solely on surrogate outcomes as guides to therapy. In the absence of evidence from large clinical trials that include major disease endpoints, treatment decisions and guidelines need to synthesize the best available information from a variety of sources. Consistency of findings across various study designs, outcomes, and populations is critical to the practice of evidence-based medicine and the effort to maximize the health benefits of antihypertensive therapies.</p>
Alternate JournalAm. J. Hypertens.
PubMed ID8924268
Grant ListHL40628 / HL / NHLBI NIH HHS / United States
HL43201 / HL / NHLBI NIH HHS / United States