abstract
June 13, 2016
PURPOSE:
Patient-reported
outcomes (PROs) provide the patient's perspective of the impact of
treatment. Evidence suggests that PRO content of randomised controlled
trials (RCTs) protocols is generally sub-optimal. This study aimed to
describe and evaluate the PRO-specific content of ovarian cancer RCT protocols.
METHODS:
Published, phase III, ovarian cancer
RCTs with PRO endpoints were identified following a systematic search
of Medline and Cochrane databases (Jan 2000 to Feb 2016). Corresponding
RCT protocols were downloaded (if published) or obtained by contacting
authors. Two investigators independently assessed adherence of
PRO-specific content of included protocols to a checklist of 58
recommended PRO protocol items currently being developed by the
International Society for Quality of Life Research. Discrepancies were
resolved with a third investigator.
RESULTS:
Of
41 eligible trials identified, 26 protocols were assessed (developed
1995-2010). We were unable to obtain the remaining 15 protocols.
Protocols addressed a mean of 28 % PRO checklist items (range 8-66 %).
Fifteen (58 % of assessed protocols) provided a rationale for PRO
assessment, 8 (31 %) described a PRO objective, 24 (92 %) included a PRO
assessment schedule, but only 6 (23 %) justified timing of PRO
assessments. Twelve protocols (46 %) provided staff data collection
instructions, 4 (15 %) included plans for monitoring PRO compliance, and
16 (62 %) included a PRO analysis plan.
CONCLUSIONS:
On
average, protocols addressed less than one-third of PRO protocol
checklist items. In some cases, key guidance regarding PRO
administration was lacking, which may lead to inconsistent and
sub-optimal PRO methodology. Efforts are needed to improve PRO protocol
content in cancer trials.
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