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abstract
Background Information
about the impact of cancer treatments on patients' quality of life
(QoL) is of paramount importance to patients
and treating oncologists. Cancer trials that do
not specify QoL as an outcome or fail to report collected QoL data, omit
crucial
information for decision making. To estimate the
magnitude of these problems, we investigated how frequently QoL
outcomes
were specified in protocols of cancer trials and
subsequently reported.
Design Retrospective
cohort study of RCT protocols approved by six research ethics committees
in Switzerland, Germany, and Canada
between 2000 and 2003.
We compared protocols to corresponding publications, which were identified through literature searches and investigator surveys.
We compared protocols to corresponding publications, which were identified through literature searches and investigator surveys.
Results Of the 173
cancer trials, 90 (52%) specified QoL outcomes in their protocol, 2 (1%)
as primary and 88 (51%) as secondary
outcome. Of the 173 trials, 35 (20%) reported
QoL outcomes in a corresponding publication (4 modified from the
protocol),
18 (10%) were published but failed to report QoL
outcomes in the primary or a secondary publication, and 37 (21%) were
not
published at all. Of the 83 (48%) trials that
did not specify QoL outcomes in their protocol, none subsequently
reported QoL
outcomes. Failure to report pre-specified QoL
outcomes was not associated with industry sponsorship (vs.
non-industry), sample
size, and multi centre (vs. single centre)
status but possibly with trial discontinuation.
Conclusions About half
of cancer trials specified QoL outcomes in their protocols. However,
only 20% reported any quality of life data
in associated publications. Highly relevant
information for decision-making is often unavailable to patients,
oncologists,
and health-policy makers.
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