title: Patient reported outcomes in randomized controlled cancer trials in advanced disease: a structured literature review.
abstract: BACKGROUND
  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.
  
  
  CONCLUSIONS
  PRO are insufficiently reported in advanced cancer trials. Yet, this is paramount to enable an informed and patient-oriented decision making process.
authors.affiliation: a Department of Palliative Medicine, Clinical Trials Unit and Center for Integrated Oncology (CIO) Cologne/Bonn , University Hospital of Cologne , Cologne , Germany.
authors.forename: V
authors.initials: V
authors.lastname: Weingärtner
authors.affiliation: a Department of Palliative Medicine, Clinical Trials Unit and Center for Integrated Oncology (CIO) Cologne/Bonn , University Hospital of Cologne , Cologne , Germany.
authors.forename: N
authors.initials: N
authors.lastname: Dargatz
authors.affiliation: b Institute of Health Economics and Clinical Epidemiology (IGKE) , University Hospital of Cologne , Cologne , Germany.
authors.forename: C
authors.initials: C
authors.lastname: Weber
authors.affiliation: b Institute of Health Economics and Clinical Epidemiology (IGKE) , University Hospital of Cologne , Cologne , Germany.
authors.forename: D
authors.initials: D
authors.lastname: Mueller
authors.affiliation: b Institute of Health Economics and Clinical Epidemiology (IGKE) , University Hospital of Cologne , Cologne , Germany.
authors.forename: S
authors.initials: S
authors.lastname: Stock
authors.affiliation: a Department of Palliative Medicine, Clinical Trials Unit and Center for Integrated Oncology (CIO) Cologne/Bonn , University Hospital of Cologne , Cologne , Germany.
authors.forename: R
authors.initials: R
authors.lastname: Voltz
authors.affiliation: a Department of Palliative Medicine, Clinical Trials Unit and Center for Integrated Oncology (CIO) Cologne/Bonn , University Hospital of Cologne , Cologne , Germany.|c Department of Palliative Care , University Hospital Freiburg , Freiburg , Germany.|d Competence Center Palliative Care Baden-Württemberg , University Medical Center Freiburg , Freiburg , Baden-Württemberg , Germany.
authors.forename: J
authors.initials: J
authors.lastname: Gaertner
mesh_terms: D003657:Decision Making; D006801:Humans; D009369:Neoplasms / Q000473:pathology / Q000628:therapy*; D000071066:Patient Reported Outcome Measures; D011788:Quality of Life; D016032:Randomized Controlled Trials as Topic / Q000379:methods*; D012107:Research Design; D015996:Survival Rate
keywords: Quality of life; advanced cancer; decision-making; early integration; early palliative care; oncology; palliative care