| Screening rules for determining blood pressure status in clinical trials. Application to the trials of hypertension prevention. | |
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MedLine Citation:
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PMID: 8333415 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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Multistage blood pressure screening rules are often used to select subjects for clinical trials. Multiple blood pressure readings are taken over successive visits, and the subject must meet eligibility criteria at each visit. In this paper, the authors present methods which depend on the distribution of the subject's underlying blood pressure values (the predictive value approach) or, alternatively, the subject's observed mean over all screening visits (the empirical predictive value approach) given the observed mean after one or more visits. The authors apply these methods to data from Phase I of the Trials of Hypertension Prevention, which attempts to identify subjects with mean diastolic blood pressures in the range 80-89 mmHg over three screening visits. The estimated efficiency of these rules is evaluated in terms of the number of clinic screening visits needed per eligible subject. Relative to reexamining all subjects at each visit (no screening), these approaches can reduce the number of visits required by 27%. This is in contrast to the standard rule in which a subject must have an observed mean diastolic blood pressure of 80-89 mmHg on each of three consecutive visits, which requires twice as many clinic visits per eligible subject as not screening. Thus, the approach presented is useful in identifying eligible subjects for clinical trials in an efficient manner. |
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Authors:
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N R Cook; B A Rosner |
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Publication Detail:
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Type: Clinical Trial; Clinical Trial, Phase I; Journal Article; Multicenter Study; Research Support, U.S. Gov't, P.H.S. |
Journal Detail:
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Title: American journal of epidemiology Volume: 137 ISSN: 0002-9262 ISO Abbreviation: Am. J. Epidemiol. Publication Date: 1993 Jun |
Date Detail:
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Created Date: 1993-08-19 Completed Date: 1993-08-19 Revised Date: 2007-11-15 |
Medline Journal Info:
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Nlm Unique ID: 7910653 Medline TA: Am J Epidemiol Country: UNITED STATES |
Other Details:
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Languages: eng Pagination: 1341-52 Citation Subset: IM |
Affiliation:
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Department of Medicine, Brigham and Women's Hospital, Boston, MA 02215. |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Adult Analysis of Variance Blood Pressure Determination* Clinical Trials, Phase I as Topic / methods* Computer Simulation Cost-Benefit Analysis Female Humans Hypertension / diagnosis* Male Mass Screening / economics, methods* Middle Aged Models, Statistical Predictive Value of Tests |
| Grant Support | |
ID/Acronym/Agency:
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HL37852/HL/NHLBI NIH HHS; HL40619/HL/NHLBI NIH HHS |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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