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ARTICLES: J. R. Saper, A. E. Lake, III, R. L. Hamel, T. E. Lutz, B. Branca, D. B. Sims, and M. M. Kroll Daily scheduled opioids for intractable head pain: Long-term observations of a treatment program Neurology 2004; 62: 1687-1694 [Abstract] [Full text] [PDF]

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Daily scheduled opioids for intractable head pain: Long-term observations of a treatment program

Alan H Lockwood   (16 August 2004)

Reply to Lockwood

Joel R. Saper, MD, FACP, FAAN   (16 August 2004)

Editors' Note

Robert B. Daroff, MD, Robert C. Griggs, MD Editor-in-Chief, Neurology   (16 August 2004)

Daily scheduled opioids for intractable head pain: Long-term observations of a treatment program 16 August 2004
Alan H Lockwood, VA Western NY Healthcare System and University at Buffalo Center for PET (115P), VA WNYHS, 3495 Bailey Ave, Buffalo, NY 14215 Send Correspondence to journal: Re: Daily scheduled opioids for intractable head pain: Long-term observations of a treatment program ahl{at}buffalo.edu Alan H Lockwood	In their article, Saper et al make the following claim, “It should be noted that this treatment program was not a formal research project, but a highly structured clinical treatment program...” [1]. Their assertion is contrary to the clear definition in the Common Rule. Title 45 part 46.102(d) of the Code of Federal Regulations defines research as a “systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.” The study they report meets this definition. It was systematic, and, as evidenced by the publication, contributes to generalizable knowledge. However, it is not clear when the research began. If the original intent was to draw conclusions from the procedures employed, the authors should have sought approval from an appropriately constituted Institutional Review Board (IRB) and obtained written consent from the participants at the time they were enrolled. If their report was based on a retrospective, unplanned review of medical records, IRB approval should have been received before the records were reviewed, analyzed and ultimately published. To avoid the publication of manuscripts marred by ethical lapses, Neurology should include the explicit statement with regard to the protection of human research participants published by the International Committee of Medical Journal Editors (http://www.icmje.org accessed June 14, 2004) in its Information for Authors. References 1. Saper JR Lake AE, Hamel RL, et al. Daily scheduled opioids for intractable head pain: Long-term observations of a treatment program. Neurology 2004;62:1687-1694.
Reply to Lockwood 16 August 2004
Joel R. Saper, MD, FACP, FAAN, Michigan Pain and Neuro Institute 3120 Professional Drive, Ann Arbor, MI 48104 Send Correspondence to journal: Re: Reply to Lockwood jrsaper{at}aol.com Joel R. Saper, MD, FACP, FAAN	Dr. Lockwood’s concerns are appreciated. In 1992, our Institute developed a structured opioid treatment program for patients with intractable headache. The program was not conceived in a research perspective, nor was there an intent to publish results of routine treatment for patients entered into the structured program. Seeking IRB approval was not considered necessary and was confirmed through informal discussions with IRB personnel. As part of the structured program, routine quality care audits were performed as well as oversight by an Opioid Committee established to oversee the use of opioids in this tertiary center. As patients matriculated in and out of this treatment program, it became apparent to us by the mid-to late 1990s that interesting observations were emerging and it was felt that these observations, if published, would contribute to the improvement in care of intractable headache patients. Further contact was made with our IRB. We were told that retrospective consideration was, in general, not possible, but the features of this program appeared to fulfill IRB exemption status. It continues to be our belief that this observational/audit project fulfills criteria for exemption. We provided this background to Neurology in advance of the submission and responded to their appropriate inquiry regarding this matter. After diligent consideration, it was decided that compliance requirements had not been violated.
Editors' Note 16 August 2004
Robert B. Daroff, MD, Scientific Integrity Advisor, Neurology 1351 Mt. Hope Ave, Suite 203, Rochester, NY 14620, Robert C. Griggs, MD Editor-in-Chief, Neurology Send Correspondence to journal: Re: Editors' Note kathy_pieper{at}urmc.rochester.edu Robert B. Daroff, MD, et al.	Neurology relies on authors to obtain appropriate institutional review and patient consent for research. We are modifying Neurology’s Information for Authors to be certain that this is clearly stated: Authors must comply with the guidelines of the International Committee of Medical Journal Editors (http://www.icmje.org) with regard to patient consent for research. We will usually bring issues raised by reviewers or correspondents to the authors’ attention and also refer them to the authors’ institutions for review. Individual countries and institutions have differing policies. We expect authors to comply with their own institutional policies. Robert B. Daroff, MD - Scientific Integrity Advisor Robert C. Griggs, MD - Editor-in-Chief