Paul Kempen, MD, PhD shares a rejection letter from Pediatrics:
NOTE: No response regarding the costs to patients or the actual lack of science with only 1/3 cohorts reaching “statistical significance.”
The Executive Editorial Board has reviewed the e-letter that you submitted on June 18, 2014, and has decided not to publish it.
The issues that you raised about human subjects protection and quality improvement have been previously addressed by the US Department of Health and Human Services. Based on this federal guidance, there has been no ethical breach and no reason to consider retraction of this work. Please refer to: http://answers.hhs.gov/ohrp/search/results?category_id=1569
The Executive Editorial Board is aware of your position on MOC based on your recent publications in Medical Economics and elsewhere. The consensus of the Executive Editorial Board is that your criticism of MOC is not directly germane to the article, and has therefore reached the decision described above.
Alex R. Kemper, MD, MPH, MS
Deputy Editor, PEDIATRICS
Maintenance of Certification research, publications, practice improvement modules and questionable ethics
The article by Vernacchio is a published research project cleared by the home Institutional Review Board after being classified as a Quality Improvement (QI) project. (1) This absolved the researchers from obtaining informed consents from the 56 physicians or the 395 patients, circumventing the Nuremberg Code, Declaration of Helsinki and probably their institutional guidelines for research subjects as well. (2) A QI project is typically an internal event and not subject to subsequent publication as a research paper. That typically requires formal advanced review as a research project prior to submission, including all aspects of informed consent. Publication as research in this specialty Journal should require conformance to research guidelines. These circumstances raise significant questions regarding these American Board of Medical Specialties (ABMS) Maintenance of Certification (MOC) program’s related ethical research involving human subjects: physicians and patients. MOC apparently seduces good physicians to neglect human research subject’s and fundamental patient rights.
The physicians who participated in the program overwhelmingly “qualified to receive 25 Part 4 credits toward their recertification by American Board of Pediatrics” (payment = personal rewards for their work) , conscripting unwitting or otherwise uninformed patients into this research project. There was no randomization or patient information provided. While the paper states: “FUNDING: This work was funded by internal funds of the Pediatric Physicians’ Organization at Children’s.” and “but requires a substantial investment of organizational time and staff”, there is no indication, whether patients or insurance programs were either offered or actually reimbursed for time, drugs and incidental and material expenses associated with this research. Completing the MOC module for MOC credit removes the “patient first” principle under the guise of QI, making it subservient to personal physician gain-irrespective of research submission for publication. This alone seems unethical.
While the title exclaims “Effectiveness of an Asthma Quality Improvement Program Designed for Maintenance of Certification”, in reality only one of the 3 cohorts reportedly produced any statistically significant outcome reduction in asthmatic attacks. This does not support this title. With only 1/3 of these cohorts showing reductions in asthma attacks, I must ask if this is even a significant “finding”? Perhaps we have merely documented a Hawthorn effect (Improvements due to the study situation), which is not significant. Clearly increased expenses for “asthma action plans and control tests, seasonal influenza vaccines, controller medications, and asthma follow-up visits” were documented. There is no follow up of the “improved groups” after an interval, even attempting to demonstrate long term effects/benefits, without the intensive and expensive formal QI program mechanisms. Is the program effective in changing behavior and increasing health long term? Does it have VALUE?
Value = Quality/Cost and costs are increasingly targeted by those paying for healthcare. Costs are completely ignored in this report and by the MOC program itself: MOC tests all physicians to document quality improvement, yet never has quality improvement been validated in research trials or even the ABMS’s own meta-analysis. (3) What is the cost of this program to the sponsors and patients in dollars/patient? Finally, QI initiatives are not research trials, but apparently can be served up as such, as a means to avoid IRB review (Quality control for research) and informed consent.
This paper exemplifies the increasing attempts to sell the new and evolving requirements of Maintenance of Certification to the general physician population, as well as the solicitation of “MOC Products”, which may result in financial gains to the producers. The problems described here raise many ethical questions and specifically, if retraction of this article is warranted at this time. With increased pressure by the ABMS to convince everyone their products have value, it is time to place all requirements equal to other types of scientific research. No longer should a publication advantage be provided to Pro MOC groups, especially as physicians are increasingly skeptical of any value or utility of MOC programs, beyond simple corporate profit. (4)
1) Vernacchio L1, Francis ME2, Epstein DM3, Santangelo J2, Trudell EK2, Reynolds ME2, Risko W3. Effectiveness of an Asthma Quality Improvement Program Designed for Maintenance of Certification. Pediatrics. 2014 Jun 16. pii: peds.2013-2643. [Epub ahead of print]
2) Kempen PM: Maintenance of Certification and Licensure: Regulatory Capture of Medicine. Anesth Analg. 2014 Jun;118(6):1378-86.
3) Sharp LK, Bashook PG, Lipsky MS, Horowitz SD, Miller SH. Specialty board certification and clinical outcomes: the missing link. Acad Med 2002;77:534–42
4) Ault A: Backlash Grows Against MOC Process. GI and Hepatology News. Vol 8 (6) June 2014 Page 1. Available at: GI & Hepatology News – June 2014 accessed 6/18/2014