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Best supportive care in clinical trials: review of the inconsistency in control arm design.
Nipp, R D; Currow, D C; Cherny, N I; Strasser, F; Abernethy, A P; Zafar, S Y.
Afiliación
  • Nipp RD; Department of Medicine, Division of Medical Oncology, Dana-Farber/Harvard Cancer Center, Massachusetts General Hospital, 55 Fruit Street, Yawkey 7B, Boston, MA 02114, USA.
  • Currow DC; Discipline of Palliative and Supportive Services, School of Health Sciences, Flinders University, GPO Box 2100, Adelaide 5001, South Australia, Australia.
  • Cherny NI; Department of Oncology, Cancer Pain and Palliative Medicine Unit, 12 Bayit Street, Jerusalem 91031, Israel.
  • Strasser F; Department of Internal Medicine and Palliative Care Center, Division of Oncology, Oncological Palliative Medicine, Cantonal Hospital, 9007 St Gallen, Switzerland.
  • Abernethy AP; Department of Medicine, Division of Medical Oncology, Duke University Medical Center, 200 Trent Drive, Durham, NC 27710, USA.
  • Zafar SY; Department of Medicine, Division of Medical Oncology, Duke University Medical Center, 200 Trent Drive, Durham, NC 27710, USA.
Br J Cancer ; 113(1): 6-11, 2015 Jun 30.
Article en En | MEDLINE | ID: mdl-26068397
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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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Cuidados Paliativos / Ensayos Clínicos como Asunto / Neoplasias Tipo de estudio: Guideline / Prognostic_studies / Systematic_reviews Límite: Humans Idioma: En Revista: Br J Cancer Año: 2015 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Reino Unido
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Cuidados Paliativos / Ensayos Clínicos como Asunto / Neoplasias Tipo de estudio: Guideline / Prognostic_studies / Systematic_reviews Límite: Humans Idioma: En Revista: Br J Cancer Año: 2015 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Reino Unido