title: Best supportive care in clinical trials: review of the inconsistency in control arm design.
abstract: BACKGROUND
  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.
authors.affiliation: Department of Medicine, Division of Medical Oncology, Dana-Farber/Harvard Cancer Center, Massachusetts General Hospital, 55 Fruit Street, Yawkey 7B, Boston, MA 02114, USA.
authors.forename: R D
authors.initials: RD
authors.lastname: Nipp
authors.affiliation: Discipline of Palliative and Supportive Services, School of Health Sciences, Flinders University, GPO Box 2100, Adelaide 5001, South Australia, Australia.
authors.forename: D C
authors.initials: DC
authors.lastname: Currow
authors.affiliation: Department of Oncology, Cancer Pain and Palliative Medicine Unit, 12 Bayit Street, Jerusalem 91031, Israel.
authors.forename: N I
authors.initials: NI
authors.lastname: Cherny
authors.affiliation: Department of Internal Medicine and Palliative Care Center, Division of Oncology, Oncological Palliative Medicine, Cantonal Hospital, 9007 St Gallen, Switzerland.
authors.forename: F
authors.initials: F
authors.lastname: Strasser
authors.affiliation: Department of Medicine, Division of Medical Oncology, Duke University Medical Center, 200 Trent Drive, Durham, NC 27710, USA.
authors.forename: A P
authors.initials: AP
authors.lastname: Abernethy
authors.affiliation: Department of Medicine, Division of Medical Oncology, Duke University Medical Center, 200 Trent Drive, Durham, NC 27710, USA.
authors.forename: S Y
authors.initials: SY
authors.lastname: Zafar
mesh_terms: D002986:Clinical Trials as Topic; D003697:Delphi Technique; D006801:Humans; D009369:Neoplasms / Q000628:therapy*; D010166:Palliative Care / Q000592:standards*