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Br J Cancer. 2015 Jun 30;113(1):6-11. doi: 10.1038/bjc.2015.192. Epub 2015 Jun 11.

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

Author information

1
Department of Medicine, Division of Medical Oncology, Dana-Farber/Harvard Cancer Center, Massachusetts General Hospital, 55 Fruit Street, Yawkey 7B, Boston, MA 02114, USA.
2
Discipline of Palliative and Supportive Services, School of Health Sciences, Flinders University, GPO Box 2100, Adelaide 5001, South Australia, Australia.
3
Department of Oncology, Cancer Pain and Palliative Medicine Unit, 12 Bayit Street, Jerusalem 91031, Israel.
4
Department of Internal Medicine and Palliative Care Center, Division of Oncology, Oncological Palliative Medicine, Cantonal Hospital, 9007 St Gallen, Switzerland.
5
Department of Medicine, Division of Medical Oncology, Duke University Medical Center, 200 Trent Drive, Durham, NC 27710, USA.

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.

PMID:
26068397
PMCID:
PMC4647523
DOI:
10.1038/bjc.2015.192
[Indexed for MEDLINE]
Free PMC Article

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