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    Quality of life assessment in clinical trials--guidelines and a checklist for protocol writers: the U.K. Medical Research Council experience. MRC Cancer Trials Office.

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    Authors
    Fayers, P M
    Hopwood, Penelope
    Harvey, A
    Girling, D J
    Machin, D
    Stephens, R
    Affiliation
    CRC Psychological Medicine Group, Christie Hospital NHS Trust, Withington, Manchester, U.K.
    Issue Date
    1997-01
    
    Metadata
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    Abstract
    Many clinical trials groups now routinely consider including Quality of Life (QoL) assessment in trials. Indeed, several have policies stating that QoL should be considered as a potential endpoint in all new trials and that if it is not to be evaluated the applicants should justify not doing so. However, inclusion of QoL in clinical trials presents a number of difficult organisational issues, and serious problems in compliance have frequently been reported. Thus, in multicentre clinical trials many of the expected QoL questionnaires fail to be successfully completed and returned, although a few groups have claimed high success rates. However, it is well recognised that if questionnaires are missing, there may be bias in the interpretation of trial results, and the estimates of treatment differences and the overall level of QoL may be inaccurate and misleading. Hence it is important to seek methods of improving compliance, at the level of both the participating institution and the patient. We describe a number of methods for addressing these issues, which we suggest should be considered by all those writing clinical trial protocols involving QoL assessment. These are based upon over a decade of experience with assessing QoL in Medical Research Council (MRC) cancer clinical trials. In particular, we provide a checklist for points that should be covered in protocols. Examples are given from a range of current MRC Cancer Trials Office protocols, which it is proposed might act as templates when writing new protocols.
    Citation
    Quality of life assessment in clinical trials--guidelines and a checklist for protocol writers: the U.K. Medical Research Council experience. MRC Cancer Trials Office. 1997, 33 (1):20-8 Eur. J. Cancer
    Journal
    European Journal of Cancer
    URI
    http://hdl.handle.net/10541/94750
    DOI
    10.1016/S0959-8049(96)00412-1
    PubMed ID
    9071894
    Type
    Article
    Language
    en
    ISSN
    0959-8049
    ae974a485f413a2113503eed53cd6c53
    10.1016/S0959-8049(96)00412-1
    Scopus Count
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