TY - JOUR
T1 - The level of patient-reported outcome reporting in randomised controlled trials of brain tumour patients
T2 - A systematic review
AU - Dirven, Linda
AU - Taphoorn, Martin J.B.
AU - Reijneveld, Jaap C.
AU - Blazeby, Jane
AU - Jacobs, Marc
AU - Pusic, Andrea
AU - Sala, Edoardo La
AU - Stupp, Roger
AU - Fayers, Peter
AU - Efficace, Fabio
AU - EORTC Quality of Life Group (Patient Reported Outcome Measurements Over Time In ONcology-PROMOTION Registry)
N1 - 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).
Acknowledgments
The authors acknowledge Alessandro Perreca and Salvatore Soldati, from the GIMEMA, for their contribution to data management.
PY - 2014/9
Y1 - 2014/9
N2 - 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.
AB - 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.
KW - Brain tumour
KW - Clinical decision-making
KW - Clinical trial
KW - Patient-reported outcome
KW - Quality of life
UR - http://www.scopus.com/inward/record.url?scp=84922268466&partnerID=8YFLogxK
U2 - 10.1016/j.ejca.2014.06.016
DO - 10.1016/j.ejca.2014.06.016
M3 - Review article
C2 - 25034656
AN - SCOPUS:84922268466
VL - 50
SP - 2432
EP - 2448
JO - European Journal of Cancer
JF - European Journal of Cancer
SN - 0959-8049
IS - 14
ER -
