The level of patient-reported outcome reporting in randomised controlled trials of brain tumour patients: A systematic review

Linda Dirven* (Corresponding Author), Martin J.B. Taphoorn, Jaap C. Reijneveld, Jane Blazeby, Marc Jacobs, Andrea Pusic, Roger Stupp, Peter Fayers, Fabio Efficace, EORTC Quality of Life Group (Patient Reported Outcome Measurements Over Time In ONcology-PROMOTION Registry)

*Corresponding author for this work

Research output: Contribution to journalReview articlepeer-review

45 Citations (Scopus)


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.

Original languageEnglish
Pages (from-to)2432-2448
Number of pages17
JournalEuropean Journal of Cancer
Issue number14
Early online date14 Jul 2014
Publication statusPublished - Sept 2014

Bibliographical note

Role of the funding source
This paper stems from a larger project (i.e. Patient Reported Outcome
Measurements Over Time In ONcology-PROMOTION Project) funded by a research grant from the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Group. Also, additional support for the conduct of the study was provided by the Italian Group for Adult Hematologic Diseases (GIMEMA).

The authors acknowledge Alessandro Perreca and Salvatore Soldati, from the GIMEMA, for their contribution to data management.


  • Brain tumour
  • Clinical decision-making
  • Clinical trial
  • Patient-reported outcome
  • Quality of life


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