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      Measurement of Quality of Life in Clinical Trials of Therapy

      ,

      Cardiology

      S. Karger AG

      Measurement, Quality of life, Clinical trials

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          Abstract

          This article discusses some of the issues involved in the use of quality of life methods to evaluate treatment, primarily in trials of cardiovascular disease. The choice of aspects to measure is influenced by the severity and nature of the disease, the expected benefits and adverse effects of treatment and pragmatic considerations such as the length of the trial, and availability of the methods. The choice of specific instruments should take account of good measurement criteria such as validity and reliability, and, most importantly, sensitivity to the effects of treatment. The advantages and disadvantages of interviewer and self-completed questionnaires are discussed. The choice of respondent is primarily the patient. In some circumstances it may be appropriate to also include family members, either for their views on the patient, or for an assessment of their own quality of life as this may also be disrupted. Withdrawals are a major problem in the analysis of all trial results. The inclusion of a Health Index is one method of obtaining quality of life scores from patients who withdraw or die. The interpretation of quality of life results from trials is not simple, for example, the benefit of trial inclusion needs to be distinguished from the effect of treatment. Moreover, changes in quality of life scores should correspond to changes in the patients’ own experiences of their daily lives.

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          Author and article information

          Journal
          CRD
          Cardiology
          10.1159/issn.0008-6312
          Cardiology
          S. Karger AG
          978-3-8055-4929-5
          978-3-318-01863-9
          0008-6312
          1421-9751
          1988
          1988
          11 November 2008
          : 75
          : Suppl 1
          : 41-52
          Affiliations
          Epidemiology Research Unit, Division of Geriatric Medicine, Royal Postgraduate Medical School, Hammersmith Hospital, London, UK
          Article
          174444 Cardiology 1988;75(suppl. 1):41–52
          10.1159/000174444
          3069215
          © 1988 S. Karger AG, Basel

          Copyright: All rights reserved. No part of this publication may be translated into other languages, reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying, recording, microcopying, or by any information storage and retrieval system, without permission in writing from the publisher. Drug Dosage: The authors and the publisher have exerted every effort to ensure that drug selection and dosage set forth in this text are in accord with current recommendations and practice at the time of publication. However, in view of ongoing research, changes in government regulations, and the constant flow of information relating to drug therapy and drug reactions, the reader is urged to check the package insert for each drug for any changes in indications and dosage and for added warnings and precautions. This is particularly important when the recommended agent is a new and/or infrequently employed drug. Disclaimer: The statements, opinions and data contained in this publication are solely those of the individual authors and contributors and not of the publishers and the editor(s). The appearance of advertisements or/and product references in the publication is not a warranty, endorsement, or approval of the products or services advertised or of their effectiveness, quality or safety. The publisher and the editor(s) disclaim responsibility for any injury to persons or property resulting from any ideas, methods, instructions or products referred to in the content or advertisements.

          Page count
          Pages: 3
          Categories
          Session I

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