Consensus-based standards for best supportive care in clinical trials in advanced cancer

Lancet Oncol. 2012 Feb;13(2):e77-82. doi: 10.1016/S1470-2045(11)70215-7.


Best supportive care is poorly defined in clinical trials, and a standard framework for delivery of such care is needed, using best available evidence and allowing replication of studies. We convened a panel of 36 experts to develop consensus statements via the Delphi method. The first round included open-ended questions; subsequent rounds sought to develop consensus-based standards. Consensus was assessed by use of a 5-point Likert agreement scale; more than 70% of panellists had to give a score of 5 to meet a-priori levels of consensus. The panel identified four key domains of best supportive care in clinical trials: multidisciplinary care; supportive care documentation; symptom assessment; and symptom management. Consensus was reached on 11 statements within these four domains. For example, 24 (96%) panellists recommended that the intervals between symptom assessments should be identical for control and experimental groups. Availability of resources was cited as a challenge to implementation of best supportive care standards.

Publication types

  • Research Support, N.I.H., Extramural
  • Research Support, Non-U.S. Gov't
  • Review

MeSH terms

  • Clinical Trials as Topic / standards*
  • Consensus
  • Delphi Technique*
  • Evidence-Based Practice
  • Humans
  • Neoplasm Staging
  • Neoplasms / therapy*
  • Palliative Care / standards*
  • Reference Standards