Juliet June Ray1, Kara Diane Bowers2, Erin King-Mullins3, Sharon Dykes4, Anne Fabrizio5, Charles Friel6, Dana Hayden7, Christina Jenkins8, Carla F Justiniano9, Jonathan Laryea10, Lynn O'Connor11, Sahael Stapleton12, Wayne Tuckson13. 1. Colon and Rectal Surgery, JFK Medical Center, Atlantis, Florida, United States. 2. University of Miami - Palm Beach Consortium, JFK Medical Center, Atlantis, Florida United States. 3. Georgia Colon and Rectal Surgical Associates, Atlanta, Georgia, United States. 4. Minnesota Colon & Rectal Surgical Specialists, Minneapolis, Minnesota, United States. 5. Beth Israel Deaconess Medical Center, Boston, Massachusetts, United Stqates. 6. University of Virginia, Charlottesville, Virginia, United States. 7. Rush University Medical Center, Chicago, Illinois, United States. 8. Orange County Colorectal Clinic, Mission Viejo, California, United States. 9. University of Rochester Medical Center, Rochester, New York, United States. 10. University of Arkansas for Medical Sciences, Little Rock, Arkansas, United States. 11. Colon and Rectal Surgery of New York, Huntington, New York, United States. 12. Massachusetts General Hospital, Boston, Massachusetts, United States. 13. University Colorectal Surgery Associates, Louisville, Kentucky, United States.
We have reviewed the article entitled “Experience of nurse practitioners performing colonoscopy after endoscopic training in more than 1,000 patients” by Riegert et al. First, we would like to commend the authors on their efforts to address the disparities in access to screening colonoscopies due to the deficiency of trained physician endoscopists to meet the growing demand. As the trend toward using “physician extenders” in the form of advanced practice providers in other areas of health care has proven beneficial in decreasing cost and increasing access to care, it is clearly worthy of consideration in this field. However, we have several questions and concerns with the methodology, ethics, and external validity of this study that we would like to bring forth for consideration and discussion.
Were the basic principles of fair subject selection adhered to?
We do not intend in any terms to imply that the authors selectively targeted a minority community or mislead them regarding their options for access to care or treatment, but a point of consideration should be in designing studies that may potentially marginalize a population. We can all agree that the most important responsibility of the scientist is to protect their research participants. Fair subject selection is one of the National Institute of Health’s seven main principles to guide the conduct of ethical research
1
and this group of physicians is fully committed to supporting the fair and equitable treatment of patients of all genders, ethnicities, and backgrounds. It is concerning that vulnerability may have affected the selection of study participants, which among other things, decreases the external validity of the data.
While efforts to increase access to care should be studied, care should be taken to avoid a “two-tiered system”
In the discussion the authors state “NPs may be especially useful in these under-resourced settings where conventional access to a gastroenterologist is limited.” If the problem is truly a lack of qualified providers, should our attention be turned toward developing more training programs rather than promoting a separate, yet potentially “equal” standard of care? There are often delays in scheduling procedures for patients of all demographic and geographical locations; therefore, the discussion should surround providing improved and timely access to screening for all.The study references a 2009 statement by the American Society for Gastrointestinal Endoscopy (ASGE) that “there is insufficient data to support the use of non-physician endoscopists to perform colonoscopy
2
.” As much of the previously published data in this area are limited to flexible sigmoidoscopy, the authors attempt to show that with appropriate training to the level of “competence,” NPs can perform colonoscopy to the previously established standards. While nurse endoscopy is practiced widely in other countries like the United Kingdom, this is not yet the standard in the United States
3
and therefore, the concern is the lack of transparency on whether the study population, which was clearly not representative of the population at large with almost 74 % reported as African American, was fully informed of the difference in training and education during the informed consent process. These sentiments are echoed by endoscopists across the country in an article published in STAT
4
.It is the view of this group of physicians that while the intentions of the study were good, the methodology utilized is concerning regarding attention to critical details that may lead to potential harm to the patient population by creating separate standards of care. Our hope is that future research to validate this concept is conducted with more transparency regarding participant selection, informed consent, and result reporting to both the study participants and readers of the final product.
Authors: Steven O Ikenberry; Michelle A Anderson; Subhas Banerjee; Todd H Baron; Jason A Dominitz; Seng-Ian Gan; M Edwyn Harrison; Sanjay Jagannath; Michael Levy; David Lichtenstein; Bo Shen; Robert D Fanelli; Leslie Stewart; Khalid Khan Journal: Gastrointest Endosc Date: 2009-04 Impact factor: 9.427