TY - JOUR
T1 - Adjusting for treatment switching in oncology trials
T2 - a systematic review and recommendations for reporting
AU - Sullivan, Thomas R.
AU - Latimer, Nicholas R.
AU - Gray, Jodi
AU - Sorich, Michael J.
AU - Salter, Amy B.
AU - Karnon, Jonathan
PY - 2020/3
Y1 - 2020/3
N2 - Objectives: To systematically review the quality of reporting on the application of switching adjustment approaches in published oncology trials and industry submissions to the National Institute for Health and Care Excellence Although methods such as the rank preserving structural failure time model (RPSFTM) and inverse probability of censoring weights (IPCW) have been developed to address treatment switching, the approaches are not widely accepted within health technology assessment. This limited acceptance may partly be a consequence of poor reporting on their application. Methods: Published trials and industry submissions were obtained from searches of PubMed and nice.org.uk, respectively. The quality of reporting in these studies was judged against a checklist of reporting recommendations, which was developed by the authors based on detailed considerations of the methods. Results: Thirteen published trials and 8 submissions to nice.org.uk satisfied inclusion criteria. The quality of reporting around the implementation of the RPSFTM and IPCW methods was generally poor. Few studies stated whether the adjustment approach was prespecified, more than a third failed to provide any justification for the chosen method, and nearly half neglected to perform sensitivity analyses. Further, it was often unclear how the RPSFTM and IPCW methods were implemented. Conclusions: Inadequate reporting on the application of switching adjustment methods increases uncertainty around results, which may contribute to the limited acceptance of these methods by decision makers. The proposed reporting recommendations aim to support the improved interpretation of analyses undertaken to adjust for treatment switching.
AB - Objectives: To systematically review the quality of reporting on the application of switching adjustment approaches in published oncology trials and industry submissions to the National Institute for Health and Care Excellence Although methods such as the rank preserving structural failure time model (RPSFTM) and inverse probability of censoring weights (IPCW) have been developed to address treatment switching, the approaches are not widely accepted within health technology assessment. This limited acceptance may partly be a consequence of poor reporting on their application. Methods: Published trials and industry submissions were obtained from searches of PubMed and nice.org.uk, respectively. The quality of reporting in these studies was judged against a checklist of reporting recommendations, which was developed by the authors based on detailed considerations of the methods. Results: Thirteen published trials and 8 submissions to nice.org.uk satisfied inclusion criteria. The quality of reporting around the implementation of the RPSFTM and IPCW methods was generally poor. Few studies stated whether the adjustment approach was prespecified, more than a third failed to provide any justification for the chosen method, and nearly half neglected to perform sensitivity analyses. Further, it was often unclear how the RPSFTM and IPCW methods were implemented. Conclusions: Inadequate reporting on the application of switching adjustment methods increases uncertainty around results, which may contribute to the limited acceptance of these methods by decision makers. The proposed reporting recommendations aim to support the improved interpretation of analyses undertaken to adjust for treatment switching.
KW - economic evaluation
KW - statistical methods
KW - survival analysis
KW - technology assessment
KW - treatment switching
UR - http://www.scopus.com/inward/record.url?scp=85078112119&partnerID=8YFLogxK
UR - http://purl.org/au-research/grants/nhmrc/1128332
U2 - 10.1016/j.jval.2019.10.015
DO - 10.1016/j.jval.2019.10.015
M3 - Review article
C2 - 32197735
AN - SCOPUS:85078112119
SN - 1098-3015
VL - 23
SP - 388
EP - 396
JO - Value in Health
JF - Value in Health
IS - 3
ER -