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Patient reported outcomes in randomized controlled cancer trials in advanced disease: a structured literature review
V Weingärtner1, N Dargatz1, C Weber2
1a Department of Palliative Medicine, Clinical Trials Unit and Center for Integrated Oncology (CIO) Cologne/Bonn , University Hospital of Cologne , Cologne , Germany.
Introduction:
In advanced cancer quality of life (QoL) is the most important goal of care. It is measured by patient-reported-outcomes (PRO). This structured review evaluated how randomized controlled trials (RCTs) on anti-cancer therapy in advanced cancer reported PRO.
Methods:
Search was performed in MEDLINE via PubMed for RCTs with median patient survival of ≤2 years. Reporting was rated with the Consolidated Standards of Reporting Trials (CONSORT) PRO extension.
Results:
Of 370 retrieved publications, 117 were eligible, but only 30/117 (26%) reported PRO. QoL was most frequently measured (29/30). On average, 4.4 (SD 2.5) of the 14 CONSORT items were met.
Conclusion:
PRO are insufficiently reported in advanced cancer trials. Yet, this is paramount to enable an informed and patient-oriented decision making process.
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