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.

2.50
Hdl Handle:
http://hdl.handle.net/10541/94750
Title:
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.
Authors:
Fayers, P M; Hopwood, Penelope; Harvey, A; Girling, D J; Machin, D; Stephens, R
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.
Affiliation:
CRC Psychological Medicine Group, Christie Hospital NHS Trust, Withington, Manchester, U.K.
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
Issue Date:
Jan-1997
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
Appears in Collections:
All Christie Publications

Full metadata record

DC FieldValue Language
dc.contributor.authorFayers, P Men
dc.contributor.authorHopwood, Penelopeen
dc.contributor.authorHarvey, Aen
dc.contributor.authorGirling, D Jen
dc.contributor.authorMachin, Den
dc.contributor.authorStephens, Ren
dc.date.accessioned2010-03-23T17:01:54Z-
dc.date.available2010-03-23T17:01:54Z-
dc.date.issued1997-01-
dc.identifier.citationQuality 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. Canceren
dc.identifier.issn0959-8049-
dc.identifier.pmid9071894-
dc.identifier.doi10.1016/S0959-8049(96)00412-1-
dc.identifier.urihttp://hdl.handle.net/10541/94750-
dc.description.abstractMany 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.en
dc.language.isoenen
dc.subjectCanceren
dc.subject.meshClinical Protocols-
dc.subject.meshGreat Britain-
dc.subject.meshHumans-
dc.subject.meshNeoplasms-
dc.subject.meshPatient Compliance-
dc.subject.meshQuality of Life-
dc.subject.meshQuestionnaires-
dc.subject.meshRandomized Controlled Trials as Topic-
dc.subject.meshResearch Design-
dc.subject.meshTreatment Outcome-
dc.subject.meshWriting-
dc.titleQuality of life assessment in clinical trials--guidelines and a checklist for protocol writers: the U.K. Medical Research Council experience. MRC Cancer Trials Office.en
dc.typeArticleen
dc.contributor.departmentCRC Psychological Medicine Group, Christie Hospital NHS Trust, Withington, Manchester, U.K.en
dc.identifier.journalEuropean Journal of Canceren

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