Patient reported outcomes in randomized controlled cancer trials in advanced disease: a structured literature review. Issue 6 (2nd June 2016)

• Record Type: Journal Article
• Authors: Weingärtner, V.; Dargatz, N.; Weber, C.; Mueller, D.; Stock, S.; Voltz, R.; Gaertner, J.
• Is Part Of: Expert review of clinical pharmacology. Volume 9:Issue 6(2016)
• Page Start: 821
• Page End: 829
• Publication Date: 2016-06-02
• Subjects: Quality of life -- palliative care -- early palliative care -- early integration -- decision-making -- oncology -- advanced cancer; Clinical pharmacology -- Periodicals; 615.105
• DOI: 10.1586/17512433.2016.1164595
• Languages: English
• ISSNs: 1751-2433

Abstract

ABSTRACT: 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.