The American Academy of Otolaryngology – Head and Neck Surgery (AAOHNS) published “Hoarseness Clinical Practice Guidelines (CPG) in the September issue of Otolaryngology – Head and Neck Surgery. Though perhaps well-intentioned, the CPG seeks to set a profoundly inappropriate and dangerous precedent.
For Americans who are concerned about healthcare reform, the hoarseness CPG is an example of what can go wrong. Having “metrics” driven by “evidence-based medicine” is an unrealistic present day reality. The whole idea of “metrics” is new and there is very little worthwhile litterature yet on which to make such quidelines. (See article in the Wall Street Journal, “Why ‘Quality’ Care is Dangerous.”)
As a long-time academic surgeon and researcher, I can say that very little that we doctors do is based upon the idea “evidence-based research.” It’s a nice term for rigid data analysis. And as you will see, the “Rosenfeld CPG method” breaks down when the field — in this case laryngology — is developing and if the “evidence” is selectively evaluated. Furthermore, many supposedly “evidenced-based” studies currently in the medical literature are politically motivated or simply flawed. This is particularly the case for laryngopharyngeal reflux (LPR) outcomes studies.
The hoarseness CPG was written using a boilerplate formula by writers most of whom knew nothing about laryngology. There were no experts on the panel, and when experts (I was one of them) were asked to review the document, our concerns and recommendations were ignored. Not only did the document have no experts, there were no reviewers who could have tempered erroneous conclusions; the paper was not peer reviewed.
Not peer reviewed, how could that happen? Dr. Rosenfeld, the patriarch behind the hoarseness guideline — the one who set the rules and picked the panel members — also happens to the editor of the medical journal in which the CPG was published. The hoarseness CPG was submitted and accepted the same day without peer review. According to Dr. Rosenfeld, this was because the panel was actually an “AAO committee”; thus, the paper was accepted without peer review as a “committee report.” To my way of thinking, Dr. Rosenfeld has a conflict of interest — in fact the entire CPG program is his baby and he is editor of the journal in which they are published. In a nutshell, that is why the hoarseness CPG was NOT peer reviewed. Of course in my opinion, it could not have stood peer group scrutiny.
In the case of the hoarseness CPG, non-experts came up with rules about how to handle hoarseness based exclusively on what is in the medical literature, and not modified by judgment, experience or context. The hoarseness CPG only makes very little clinical sense, and it will actually harm patients.
While I have serious issues with many statements within the hoarseness guideline, at issue here in this editorial opinion is the CPG’s (page-one) conclusion, “The clinician should not prescribe antireflux medications for patients with hoarseness without signs or symptoms of gastroesophageal reflux disease.” The panel who wrote this guideline apparently does not know that most of our LPR reflux patients don’t have heartburn or esophagitis, i.e., they don’t have GERD (gastroesophageal reflux disease).
I have practiced laryngology for more than thirty years, and since 1981, I have focused my research on LPR. And about twenty years ago, I coined the terms “LPR” and “silent reflux” specifically to differentiate the clinical patterns of reflux disease in otolarygologic patients from gastroenterology patients with primary esophageal disease.
The hoarseness CPG seeks to influence the medical care our patients receive. Unfortunately, insurance companies sometimes use such documents to determine payment or nonpayment for treatments. If I were a third-party payer, based upon the recommendations of the hoarseness CPG, I would not cover PPI treatment for hoarseness unless the patient had heartburn and/or biopsy-proven esophagitis, because that is how the diagnosis of GERD is made. Would the panel who wrote this CPG recommend routine GI consultation and endoscopy for our hoarse patients suspected of having GERD?
Last spring, I was one of the expert reviewers, and I personally called Rich Rosenfeld, Seth Daley, and several other members of the CPG panel to express my concerns. Then I sent additional scientific evidence about LPR to the hoarseness CPG panel. These scientific papers were ignored, and none of data were incorporated into the CPG document. Alarmed about the hoarseness CPG and especially about the rigidity of the review process, on June 4th I wrote the Executive Director and the President of the American Academy of Otolaryngology — Head and Neck Surgery (AAO-HNS).
From: Jamie Koufman
Sent: Thursday, June 04, 2009 12:22 PM
Subject: Scrap the hoarseness guideline; it is a fiasco!
I reviewed the hoarseness clinical practice guideline; it is controversial, contentious, and profoundly inappropriate. Indeed, it is regressive and will set the field of laryngopharyngeal reflux (LPR) back 25 years. In addition, and most importantly, it will cause hardships for patients with LPR and for physicians prescribing antireflux medications for them.
The idea of the guidelines appears to be a rigid retrospective EBM literature review, but the hoarseness guideline is a referendum on LPR by junior and inexperienced people. I am astounded that my colleagues know so little about LPR! And the reasoning with this guideline is strange; if LPR doesn’t cause hoarseness, then LPR treatment shouldn’t be addressed. Furthermore, the literature that formed the basis of the review is dominated by flawed GI studies performed by people who generally had an axe to grind. There is another literature on LPR, including cell biology, but apparently no one on the panel read it.
Proton pump inhibitors (PPIs) for LPR are one of the greatest therapeutic advances in otolaryngology in the last 25 years. In my practice, we have reflux tested our patients and treated LPR successfully in 85%-90% of cases for decades. As it is, we have tremendous problems at present advocating for our patients to receive treatment for LPR. Just yesterday, a gastroenterologist in Washington DC blew off one of my patients who needs treatment. She had severe recalcitrant LPR with 293 pH-documented pharyngeal reflux episodes. He told her that she didn’t have reflux, and that she should live with her symptoms.
I am afraid that the negative impact on patients of the “hoarseness guidelines” will be disastrous and take a generation to fix. There are also other problems with the guideline, e.g., having to wait three months to have a laryngeal examination for hoarseness. The Academy would do well not to anger its membership for nothing. I vote to scrap this guideline completely. In addition, the Academy should reexamine the guideline program format. Giving heterogeneous and inexperienced people power to make recommendations that alter medical practice is wrong, particularly when there is not yet consensus in emerging fields.
In advance, thank you for your consideration: I await your reply.
Jamie A. Koufman, M.D., F.A.C.S., Past-President
American Broncho-Esophagological Association
First, amazingly, I never received a response. Second, it’s time that we use the term “LPR” to describe reflux disease in patients with laryngopharyngeal reflux. To use the term GERD helps perpetuate misunderstanding. Third, we must examine the process by which CPGs are created and demand oversight and peer review. If this CPG is an example of what is coming, our patients (and we) are in for a lot of trouble.
Laryngology is an emerging field with many controversial areas. Indeed there are factions, based upon where one trained, and there’s very little evidence-based medicine. Why? Because there is not yet a consensus in many areas among experts. This is neither surprising nor problematic. However, for a group of diverse non-experts to attempt to define any aspect of the field of laryngology is dead wrong; and that the Academy (AAOHNS) leadership turned a deaf ear to our warnings and pleas is a serious betrayal of our trust and purpose.
The AAO-HNS leadership should be held accountable for what has been done. Please join me in asking that the hoarseness CPG be amended or repealed and for a moratorium on new CPGs until the entire process has been scrutinized and improved. Please don’t forget that it is singularly the welfare of patients that comes first.
In the guise of improving healthcare and cutting costs, a few zealots are now trying to determine how medicine is practiced in America … both the concept and the reality are bad ideas at present. Why healthcare is too expensive and what healthcare reform should actually entail are separate but related issues.
Medical colleagues, please contact me if you would like to contribute an opinion to this debate.