title: The level of patient-reported outcome reporting in randomised controlled trials of brain tumour patients: a systematic review.
abstract: BACKGROUND
  To determine the net clinical benefit of a new treatment strategy, information on both survival and patient-reported outcomes (PROs) is required. However, to make an adequately informed decision, PRO evidence should be of sufficiently high quality.
  
  
  OBJECTIVE
  To investigate the methodological quality of PRO reporting in randomised controlled trials (RCTs) in patients with brain tumours, and to assess the proportion of studies that should impact clinical decision-making.
  
  
  METHODS
  We conducted a systematic literature search in several databases covering January 2004 to March 2012. We selected relevant RCTs and retrieved the following data: (1) basic trial demographics and PRO characteristics, (2) quality of PRO reporting and (3) risk of bias. Studies that should impact clinical decision-making based on their methodological robustness were analysed systematically.
  
  
  RESULTS
  We identified 14 RCTs, representing over 3000 glioma patients. Only two RCTs (14%) satisfied sufficiently many key methodological criteria to provide high-quality PRO evidence, and should therefore impact clinical decision-making. Important methodological limitations in other studies were lack of reporting of the extent (43%) and reasons (86%) of missing data and statistical approaches to handle this (71%). PRO results were not interpreted in 79% of the studies and clinical significance was not discussed in 86%. Studies with high-quality PRO evidence generally showed lower risk of bias.
  
  
  CONCLUSIONS
  Investigators involved in brain tumour research should pay special attention to methodological challenges identified in current work. The level of PRO reporting should continue to improve in order to facilitate a critical appraisal of study results.
authors.affiliation: VU University Medical Center, Department of Neurology, Amsterdam, The Netherlands. Electronic address: l.dirven@vumc.nl.
authors.forename: Linda
authors.initials: L
authors.lastname: Dirven
authors.affiliation: VU University Medical Center, Department of Neurology, Amsterdam, The Netherlands; Medical Center Haaglanden, Department of Neurology, The Hague, The Netherlands.
authors.forename: Martin J B
authors.initials: MJ
authors.lastname: Taphoorn
authors.affiliation: VU University Medical Center, Department of Neurology, Amsterdam, The Netherlands; Academic Medical Center, Department of Neurology, Amsterdam, The Netherlands.
authors.forename: Jaap C
authors.initials: JC
authors.lastname: Reijneveld
authors.affiliation: University of Bristol, Centre for Surgical Research and Division of Surgery, Head & Neck, University Hospitals Bristol NHS Foundation Trust, Bristol, United Kingdom.
authors.forename: Jane
authors.initials: J
authors.lastname: Blazeby
authors.affiliation: Academic Medical Center, University of Amsterdam, Department of Medical Psychology, Amsterdam, The Netherlands.
authors.forename: Marc
authors.initials: M
authors.lastname: Jacobs
authors.affiliation: Memorial Sloan Kettering Cancer Center, Department of Surgery, New York, NY, USA.
authors.forename: Andrea
authors.initials: A
authors.lastname: Pusic
authors.affiliation: Italian Group for Adult Hematologic Diseases (GIMEMA), Data Center and Health Outcomes Research Unit, Rome, Italy.
authors.forename: Edoardo
authors.initials: E
authors.lastname: La Sala
authors.affiliation: University Hospital Zurich, Department of Oncology and Cancer Centre, Zurich, Switzerland.
authors.forename: Roger
authors.initials: R
authors.lastname: Stupp
authors.affiliation: University of Aberdeen, Institute of Applied Health Sciences, Aberdeen, United Kingdom; Norwegian University of Science and Technology, Department of Cancer Research and Molecular Medicine, Faculty of Medicine, Trondheim, Norway.
authors.forename: Peter
authors.initials: P
authors.lastname: Fayers
authors.affiliation: Italian Group for Adult Hematologic Diseases (GIMEMA), Data Center and Health Outcomes Research Unit, Rome, Italy.
authors.forename: Fabio
authors.initials: F
authors.lastname: Efficace
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001932:Brain Neoplasms / Q000628:therapy*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D063868:Patient Outcome Assessment; D011788:Quality of Life; D016032:Randomized Controlled Trials as Topic / Q000379:methods*; D057566:Self Report; D015996:Survival Rate
keywords: Brain tumour; Clinical decision-making; Clinical trial; Patient-reported outcome; Quality of life