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

Publication ,  Journal Article
Nipp, RD; Currow, DC; Cherny, NI; Strasser, F; Abernethy, AP; Zafar, SY
Published in: Br J Cancer
June 30, 2015

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.

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Published In

Br J Cancer

DOI

EISSN

1532-1827

Publication Date

June 30, 2015

Volume

113

Issue

1

Start / End Page

6 / 11

Location

England

Related Subject Headings

  • Palliative Care
  • Oncology & Carcinogenesis
  • Neoplasms
  • Humans
  • Delphi Technique
  • Clinical Trials as Topic
  • 3211 Oncology and carcinogenesis
  • 1117 Public Health and Health Services
  • 1112 Oncology and Carcinogenesis
 

Citation

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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. Br J Cancer, 113(1), 6–11. https://doi.org/10.1038/bjc.2015.192
Nipp, R. D., D. C. Currow, N. I. Cherny, F. Strasser, A. P. Abernethy, and S. Y. Zafar. “Best supportive care in clinical trials: review of the inconsistency in control arm design.Br J Cancer 113, no. 1 (June 30, 2015): 6–11. https://doi.org/10.1038/bjc.2015.192.
Nipp RD, Currow DC, Cherny NI, Strasser F, Abernethy AP, Zafar SY. Best supportive care in clinical trials: review of the inconsistency in control arm design. Br J Cancer. 2015 Jun 30;113(1):6–11.
Nipp, R. D., et al. “Best supportive care in clinical trials: review of the inconsistency in control arm design.Br J Cancer, vol. 113, no. 1, June 2015, pp. 6–11. Pubmed, doi:10.1038/bjc.2015.192.
Nipp RD, Currow DC, Cherny NI, Strasser F, Abernethy AP, Zafar SY. Best supportive care in clinical trials: review of the inconsistency in control arm design. Br J Cancer. 2015 Jun 30;113(1):6–11.

Published In

Br J Cancer

DOI

EISSN

1532-1827

Publication Date

June 30, 2015

Volume

113

Issue

1

Start / End Page

6 / 11

Location

England

Related Subject Headings

  • Palliative Care
  • Oncology & Carcinogenesis
  • Neoplasms
  • Humans
  • Delphi Technique
  • Clinical Trials as Topic
  • 3211 Oncology and carcinogenesis
  • 1117 Public Health and Health Services
  • 1112 Oncology and Carcinogenesis