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Concerns About Consensus Guidelines for QTc Interval Screening in Methadone Treatment
TO THE EDITOR:
The clinical guidelines by Krantz and colleagues (1) raise important methodological concerns. Although Krantz and colleagues use a method for predicting adverse drug reactions, they neglect to use data extraction and quality assessment tools. In fact, they state that they “did not prespecify critical appraisal criteria.” This is contrary to Annals' “Information for Authors” (2), which requires guidelines to include a grading system, such as those described by the Conference on Guideline Standardization; the Grading of Recommendations Assessment, Development and Evaluation Working Group; or the U.S. Preventive Services Task Force (USPSTF).
On review of the 212 articles listed in Annals' online “Clinical Guidelines/Position Papers” collection (accessed 9 February 2009), I found 94 unique clinical guidelines. Excluding 2 updates on adult vaccination schedules, 54 of the remaining 92 guidelines used a grading system, whereas 28 guidelines systematically rated the quality of evidence supporting guideline recommendations. Eight of the 10 guidelines providing neither grade nor quality assessment were published before 1998, when such quality assessments became routine. Therefore, the guidelines by Krantz and colleagues are 1 of 2 guidelines published by Annals since 1998 that do not explicitly evaluate or grade the quality of evidence used in guideline recommendations. Using USPSTF criteria (3), the literature cited by Krantz and colleagues would result in a grade of I, indicating that the evidence is insufficient to determine the relationship between the benefits and harms of QTc screening. Had the authors expounded on this and incorporated recent methods (published in Annals) (4) for guidelines based on insufficient evidence, the reader would be better equipped to make rational clinical decisions.
Of further interest, although Krantz and colleagues summarize their recommendations in Table 2 under the title “Consensus Recommendations,” 2 of the panelists have declined acknowledgment in the publication, which raises the question: Was there consensus?
In addition, the online version (but not the print version) of this article states that 3 of the panel members have financial conflicts of interest related to support by Reckitt Benckiser (1 was formerly President and CEO), the producer of methadone's main competitor (buprenorphine) in the treatment of opiate dependence. These disclosures were not made in the original, withdrawn version of the guidelines.
These issues call into question the quality of Krantz and colleagues' recommendations, the independence of the authors, and the judgment of Annals in publishing clinical guidelines that fall well outside the normative standards.
Article and Author Information
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Potential Financial Conflicts of Interest: Dr. Bart received a National Institutes of Health–National Institute on Drug Abuse Career Development Award to study the pharmacokinetics and pharmacogenetics of methadone.
