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Best supportive care in clinical trials: Review of the inconsistency in control arm design

Journal Article


Abstract


  • Best supportive care (BSC) as a control arm in clinical trials is poorly defined. We conducted a review to evaluate clinical trials' concordance with published, consensus-based framework for BSC delivery in trials.Methods:A consensus-based Delphi panel previously identified four key domains of BSC delivery in trials: multidisciplinary care; supportive care documentation; symptom assessment; and symptom management. We reviewed trials including BSC control arms from 2002 to 2014 to assess concordance to BSC standards and to selected items from the CONSORT 2010 guidelines.Results:Of 408 articles retrieved, we retained 18 after applying exclusion criteria. Overall, trials conformed to the CONSORT guidelines better than the BSC standards (28% vs 16%). One-third of articles offered a detailed description of BSC, 61% reported regular symptom assessment, and 44% reported using validated symptom assessment measures. One-third reported symptom assessment at identical intervals in both arms. None documented evidence-based symptom management. No studies reported educating patients about symptom management or goals of therapy. No studies reported offering access to palliative care specialists.Conclusions:Reporting of BSC in trials is incomplete, resulting in uncertain internal and external validity. Such studies risk systematically over-estimating the net clinical effect of the comparator arms.

Publication Date


  • 2015

Citation


  • Nipp, R. D., Currow, D. C., Cherny, N. I., Strasser, F., Abernethy, A. P., & Zafar, S. Y. (2015). Best supportive care in clinical trials: Review of the inconsistency in control arm design. British Journal of Cancer, 113(1), 6-11. doi:10.1038/bjc.2015.192

Scopus Eid


  • 2-s2.0-84934435139

Start Page


  • 6

End Page


  • 11

Volume


  • 113

Issue


  • 1

Place Of Publication


Abstract


  • Best supportive care (BSC) as a control arm in clinical trials is poorly defined. We conducted a review to evaluate clinical trials' concordance with published, consensus-based framework for BSC delivery in trials.Methods:A consensus-based Delphi panel previously identified four key domains of BSC delivery in trials: multidisciplinary care; supportive care documentation; symptom assessment; and symptom management. We reviewed trials including BSC control arms from 2002 to 2014 to assess concordance to BSC standards and to selected items from the CONSORT 2010 guidelines.Results:Of 408 articles retrieved, we retained 18 after applying exclusion criteria. Overall, trials conformed to the CONSORT guidelines better than the BSC standards (28% vs 16%). One-third of articles offered a detailed description of BSC, 61% reported regular symptom assessment, and 44% reported using validated symptom assessment measures. One-third reported symptom assessment at identical intervals in both arms. None documented evidence-based symptom management. No studies reported educating patients about symptom management or goals of therapy. No studies reported offering access to palliative care specialists.Conclusions:Reporting of BSC in trials is incomplete, resulting in uncertain internal and external validity. Such studies risk systematically over-estimating the net clinical effect of the comparator arms.

Publication Date


  • 2015

Citation


  • Nipp, R. D., Currow, D. C., Cherny, N. I., Strasser, F., Abernethy, A. P., & Zafar, S. Y. (2015). Best supportive care in clinical trials: Review of the inconsistency in control arm design. British Journal of Cancer, 113(1), 6-11. doi:10.1038/bjc.2015.192

Scopus Eid


  • 2-s2.0-84934435139

Start Page


  • 6

End Page


  • 11

Volume


  • 113

Issue


  • 1

Place Of Publication