Originally published as JCO Early Release 10.1200/JCO.2009.21.9592 on June 29 2009

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Improving the Methodologic and Ethical Validity of Best Supportive Care Studies in Oncology: Lessons From a Systematic Review

From the Shaare Zedek Medical Center, Department of Oncology, Cancer Pain and Palliative Medicine Unit, Jerusalem, Israel; Division of Medical Oncology, Department of Internal Medicine, Duke University Medical Center, Durham, NC; Palliative and Supportive Services, Flinders University, South Australia, Australia; and Oncological Palliative Care, Oncology Department Internal Medicine and Palliative Care Center, Cantonal Hospital, St Gallen, Switzerland.

Corresponding author: Nathan I. Cherny, MBBS, FRACP, FRCP, Cancer Pain and Palliative Medicine Service, Department of Medical Oncology, Shaare Zedek Medical Center, Jerusalem, Israel 91031; e-mail: chernyn{at}netvision.net.il.

Purpose To systematically review the best supportive care (BSC) literature and to evaluate the ethical and methodologic validity issues by using widely acknowledged criteria.

Methods Two search strings that included both cancer and supportive as terms (with random article type, or review or meta-analysis) explored databases from 1966 to 2008. Citations, abstracts, and papers were reviewed for inclusion criteria, and relevant data were extracted by two independent researchers. Data were validated for accuracy. Ethical and methodologic validity were evaluated by using the criteria derived from the Helsinki Requirements of the WMA; CONSORT statements for the evaluation of reports of randomized, controlled trials; and the universal requirements for ethical clinical research.

Results Forty-three published papers were identified that described 32 studies, 20 of which incorporated the design of treatment plus supportive care (SC) versus SC alone, and 12 of which incorporated the design of treatment versus SC. Most of the studies had poor compliance to critical Helsinki requirements, to methodologic precautions derived from the CONSORT statement for studies involving a nonpharmacologic arm, and to four of seven universal requirements for ethical clinical research.

Conclusion Lack of rigor in BSC studies has contributed to a generation of research with widespread ethical and methodologic shortcomings. Ad hoc SC and lack of standardization of SC delivery may be sources of systematic bias or error in BSC trials. Rectifying these shortcomings in future studies demands greater vigilance toward these issues by researchers, institutional review boards, editors, and peer reviewers. Given the prevalence of overlooked problems that are later identified, currently open BSC studies should be reevaluated by institutional review boards and researchers to check for ethical and methodologic validity, and identified shortcomings should be addressed.

Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article.

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