Placebo effect-adjusted assessment of quality of life in placebo-controlled clinical trials.

Placebo effect-adjusted assessment of quality of life in placebo-controlled clinical trials. Research Abstract Details 

Research Abstract Table of Contents

Jump to the:

Placebo effect-adjusted assessment of quality of life in placebo-controlled clinical trials. Abstract Text:

Quality of life (QoL) has become an accepted and widely used endpoint in clinical trials. The analytical tools used for QoL evaluations in clinical trials differ from those used for the more traditional endpoints, such as response to disease, overall survival or progression-free survival. Since QoL assessments are generally performed on self-administered questionnaires, QoL endpoints are more prone to a placebo effect than traditional clinical endpoints. The placebo effect is a well-documented phenomenon in clinical trials, which has led to dramatic consequences on the clinical development of new therapeutic agents. In order to account for the placebo effect, a multivariate latent variable model is proposed, which allows for misclassification in the QoL item responses. The approach is flexible in the sense that it can be used for the analysis of a wide variety of multi-dimensional QoL instruments. For statistical inference, maximum likelihood estimates and their standard errors are obtained using a Monte Carlo EM algorithm. The approach is illustrated with analysis of data from a cardiovascular phase III clinical trial. Copyright (c) 2008 John Wiley & Sons, Ltd.

Placebo effect-adjusted assessment of quality of life in placebo-controlled clinical trials. Publishing Authors By Initials

For similar abstracts research abstracts see: abstracts research

PUBMED ID PMID:

MEDLINE DATE:

Placebo effect-adjusted assessment of quality of life in placebo-controlled clinical trials. Journal Published:

PUBLICATION TYPE: Journal Article

Journal: Statistics in medicine

VOLUME: 27

Page Numbers: 1387-402

Journal Abbreviation:

ISSN: 0277-6715

DAY: 30

MONTH: Apr

YEAR: 2008

Placebo effect-adjusted assessment of quality of life in placebo-controlled clinical trials. Information

Number of References:

LANGUAGE: eng

NlmUniqueID: 8215016

Placebo effect-adjusted assessment of quality of life in placebo-controlled clinical trials. Keywords Mesh Terms:

KEYWORDS:

MESH TERMS:

Chemical & Substance for Abstract: Placebo effect-adjusted assessment of quality of life in placebo-controlled clinical trials. Information

Substance Name:

Registry Number:

Grant and Affiliation Information for Placebo effect-adjusted assessment of quality of life in placebo-controlled clinical trials.

AFFILIATION: Department of Biostatistics and Medical Informatics, University of Wisconsin-Madison, Madison, WI 53726-2397, U.S.A.

Country: England

AGENCY:

GRANT:

ACRONYM:

MEDLINETA: Stat Med

REFSOURCE:

DATABASENAME:

ACCESSION NUMBER:

Number Hits: 0

Placebo effect-adjusted assessment of quality of life in placebo-controlled clinical trials Related Publications

• Appendico-vesical fistula. A new case and a brief review of the literature.
• Application of four methods to the study of the susceptibility of yeast to 5-fluorocytosine.
• Atrophic arthritis, splenomegaly and leukopenia; report of two cases.
• Forefoot vasoconstrictor response to increased venous pressure in normal subjects and in arteriosclerotic patients.
• Leben als Konflikt. Zur Biographie Alexander Mitscherlich [Living as conflict: The life of Alexander Mitscherlich].
• Letter: Abortion and promiscuity.
• Measurement of central hemodynamic parameters during preoperative exercise testing in patients suspected of arteriosclerotic heart disease. Value in predicting postoperative cardiac complications.
• Non-inflammable cyclopropane-helium and oxygen mixtures for use in the reserve midget anesthesia machine.
• Placebo effect-adjusted assessment of quality of life in placebo-controlled clinical trials.
• Reply to frain and warye.
• Second-generation argon plasma coagulation: two-center experience with 600 patients.
• The design of clinical graft studies.
• The development of non-flammable cyclopropane-helium and oxygen mixtures for use in the reserve midget anesthesia machine in miniature, color-designated steel cyclinders.
• Treatment of thromboangiitis obliterans and thrombophlebitis with tetraethylammonium chloride.
• Who is steering the ship? External influences on infection control programs.
• [Not Available.]
• [Not Available.]
• [Not Available.]
• [Not Available.]
• [Not Available.]
• [ON THE THYROID GLANDS OF SEALS AND ALPINE RABBITS.]