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The protocol contents will be validated by health care professionals, investigators and other content experts associated with the research project and be pre-tested during a home care visit.
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We did not see a relationship overall between protocol content and CONSORT-PRO reporting scores in this sample.
To our knowledge, no studies to date have explored associations among PRO protocol content, compliance and reporting.
We hypothesised that RCTs with more complete PRO protocol content would have more complete reporting and higher PRO compliance rates.
Poor compliance appeared related to poor PRO protocol content, and in one case prevented PRO results from being reported, highlighting the need to address compliance strategies in the protocol.
This study aimed to evaluate the patient-reported outcome (PRO) content of ovarian cancer randomised-controlled trial (RCT) publications, describe PRO compliance, and explore potential relationships among these and completeness of PRO protocol content.
Further work on the impact of PRO protocol content on the quality of data and reporting is needed in other clinical sub-groups for which PROs are of particular importance, and in oncology generally.
MB, RW and JP gave advice on protocol content.
Furthermore, improved protocol content would help facilitate the critical appraisal of final trial reports and results.
Drift will be defined as teaching less than 80% of the protocol content.
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Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com