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Quality of patient-reported outcome reporting across cancer randomized controlled trials according to the CONSORT patient-reported outcome extension: A pooled analysis of 557 trials
Keywords:
- cancer;
- clinical trials;
- Consolidated Standards of Reporting Trials (CONSORT);
- patient-reported outcomes;
- quality of life
BACKGROUND
The
main objectives of this study were to identify the number of randomized
controlled trials (RCTs) including a patient-reported outcome (PRO)
endpoint across a wide range of cancer specialties and to evaluate the
completeness of PRO reporting according to the Consolidated Standards of
Reporting Trials (CONSORT) PRO extension.
METHODS
RCTs
with a PRO endpoint that had been performed across several cancer
specialties and published between 2004 and 2013 were considered. Studies
were evaluated on the basis of previously defined criteria, including
the CONSORT PRO extension and the Cochrane Collaboration's tool for
assessing the risk of bias of RCTs. Analyses were also conducted by the
type of PRO endpoint (primary vs secondary) and by the cancer disease
site.
RESULTS
A
total of 56,696 potentially eligible records were scrutinized, and 557
RCTs with a PRO evaluation, enrolling 254,677 patients overall, were
identified. PROs were most frequently used in RCTs of breast (n = 123),
lung (n = 85), and colorectal cancer (n = 66). Overall, PROs were
secondary endpoints in 421 RCTs (76%). Four of 6 evaluated CONSORT PRO
items were documented in less than 50% of the RCTs. The level of
reporting was higher in RCTs with a PRO as a primary endpoint. The
presence of a supplementary report was the only statistically
significant factor associated with greater completeness of reporting for
both RCTs with PROs as primary endpoints (β = .19, P = .001) and RCTs with PROs as secondary endpoints (β = .30, P < .001).
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