Consensus-based standards for best supportive care in clinical trials in advanced cancer.
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.
Division of Medical Oncology, Department of Medicine, Duke University Medical Center, Durham, NC 27710, USA. yousuf.zafar@duke.edu
S Yousuf
SY
Zafar
David C
DC
Currow
Nathan
N
Cherny
Florian
F
Strasser
Robin
R
Fowler
Amy P
AP
Abernethy
D002986:Clinical Trials as Topic / Q000592:standards*; D003697:Delphi Technique; D055317:Evidence-Based Practice; D006801:Humans; D009367:Neoplasm Staging; D009369:Neoplasms / Q000628:therapy*; D010166:Palliative Care / Q000592:standards*; D012015:Reference Standards