e19507 Background: Best supportive care (BSC) is poorly-defined in clinical trials, with considerable variety in breadth, frequency, and documentation of care described. A standardized framework for delivery of BSC within clinical trials is needed utilizing best available evidence and allowing confirmatory replication of the studies.
METHODS
After conducting a systematic review of the literature (previously-published), we convened a panel of 36 experts internationally to develop consensus statements via the Delphi methodology. Experts were selected from fields including oncology, palliative care, clinical trial design, health services, nursing, and social work. Six rounds of surveys were completed. The first round included open-ended questions; subsequent rounds sought to develop consensus-based standards. Consensus was assessed by levels of agreement on a five-point Likert scale, and a score of 5 was required by >70% of panelists to meet the stringent definition set a priori for consensus.
RESULTS
The panel identified four key domains of BSC 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, 96% of panelists recommended routine similar assessment of symptoms in BSC and antineoplastic intervention arms, and 84% agreed that symptom management should be conducted in concordance with evidence-based guidelines. 92% recommended that published manuscripts should detail supportive care received in both arms. Availability of resources was most often cited as a challenge to implementation of the BSC standards. Participants rated new potential terms to describe standardized supportive care delivered in clinical trials (currently "BSC"); the highest-scoring term was "evidence-based supportive care."
CONCLUSIONS
Aspects of evidence-based supportive care in clinical trials can be standardized while accommodating for variability based on the patient's need at the bedside. This care should be clearly documented, thereby improving internal and external validity of trial results.