Commonly referred to as “silent reflux,” laryngopharyngeal reflux (LPR) has long been difficult for physicians to diagnose because of its nonspecific symptoms. The traditional approach to assessing LPR symptoms relies on response to empiric treatment and symptom improvement using the reflux symptom index (RSI) or reflux finding score (RFS). Without clear criteria in place, these tools are highly subjective.
RSI & pH Testing
The RSI is a nine-item questionnaire administered to patients to document LPR symptoms and severity over the past month. The scoring system uses a scale of 0 (no problem) to 5 (severe), with a maximum total score of 45. A total score of 13 or greater is considered a positive case of LPR.1
The degree of concurrence between symptom severity (as determined by the RSI) and pH findings (as determined by objective testing) is inconsistent. Self-reported symptom scores do not reliably predict presence or severity of acid reflux disease.2
Studies show that there is no significant difference in chronic laryngitis patients in their presenting symptoms, severity, or duration, with or without pharyngeal reflux.2 There was also no significant difference in RSI seen between RYAN+ and RYAN− patients.3 (The RYAN Score was created by Dr. Tom DeMeester with high specificity for severe reflux patients using thresholds of pH 5.5 for upright and pH 5.0 for supine positions.)
Data suggests that over 40% of patients with an RSI <13 will have a positive RYAN score.3
This finding highlights the RSI’s subjective nature and the high possibility of response bias in patient self-assessment questionnaires. Patients with a low RSI may still have severe reflux according to objective pH tests.
Anxiety and Depression
The presence of anxiety and depression impairs the predictive value of the RSI for LPR as patients with psychiatric disorders tend to exaggerate physical symptoms.
In Oyer’s retrospective study, patients in the psychiatric disorder (+PSY) group had a significantly higher RSI on average, but only half the rate of abnormal (LPR +) pH studies as compared to the non-psychiatric (−PSY) group.4 Among −PSY patients alone, the average RSI was significantly higher for patients with an abnormal pH study than for those with a normal pH study.4 These results highlight the effects of psychiatric disorders on patient-perceived symptoms reported on the RSI and indicate that anxiety and depression inflate the RSI, impairing its predictive value for LPR.
The mean RSI of the psychiatric disorder group was higher than that of the non-psychiatric disorder group. However, the psychiatric disorder group actually had a lower incidence of abnormal pH probe studies.
These findings pose a potential explanation for criticisms of the RSI’s subjective nature. With many outside variables affecting the accuracy of the RSI, including mental health, the diagnostic utility of the RSI in diagnosing LPR is limited.
Read more about evidence-ased pH testing for LPR symptoms.
Would you like to learn more about how Restech pH testing could benefit your practice?
References
Bree has been an integral part of Restech from the very beginning. She holds a Masters in Public Health from George Washington University, a BFA from The University of Kansas in Visual Communications, and is a National Board Certified Health & Wellness Coach. Her command of marketing, public health/health delivery systems, and human health behavior change gives her a unique perspective in developing effective marketing strategies for the company.
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Thomas previously worked as a polysomnographic technologist in the Virginia Mason system, before moving into sales with Restech in 2007. After spending 9 years working with distributors across Europe, he was moved into an organizational role at the head office in Houston. In this capacity he works closely with sales and marketing to provide clinical support, manages clinical studies, and provides clinical perspectives on business development. In his spare time Thomas plays rugby for Houston Athletic Rugby Club.
Jeff has over 30 years of experience in the medical device industry and previously worked in sales at companies such as Encision Inc., Interventional Therapies, LLC, Boston Scientific, and United States Surgical Corporation. He has been working as the VP of Sales for Mederi Therapeutics since 2009 and now brings his extensive expertise to Restech. Jeff was part of the team that bridged the Mederi asset sale to Restech. His clinical knowledge of the Stretta and Secca technologies is invaluable. Jeff has three decades of physician relations experience that he brings to Restech as part of the leadership team.
Ray joined Restech in May 2018 as the Vice President for Sales. He has been in the medical device, and specifically in the GERD space for more than 18 years. Starting in sales at Sandhill Scientific pH diagnostics, he moved on to Curon Medical when Stretta and Secca were first introduced to the market. He then worked for Given Imaging when Curon closed operations. When Stretta was relaunced he joined Mederi as VP of Sales. Ray was instrumental in keeping Stretta alive and the customer based informed when Mederi ceased operation and assets were purchased by Restech. He is part of the leadership team directing all product sales for Restech. Ray graduated from Old Dominion University in Norfolk with a BS in Marketing and Business Administration.
Mark is a seasoned professional and Certified Public Accountant in Texas who brings a unique blend of creative vision and financial expertise to any leadership team. He worked as a Senior Executive for 15 years on a leadership team which grew a private equity backed cash logistics company performing at negative EBITDA on $100 million revenue into an international industry leader with superior profitability on revenue exceeding $1.5 billion. In addition, he spent 10 years as a Senior Manager at Price Waterhouse delivering results-oriented merger & acquisition, audit and strategic consulting services to middle market clientele including over 40 manufacturing, distribution, service, nonprofit and technology clients. Mark currently serves as a Chief Financial Officer and consulting CFO (seven years) providing in-house and outsourced CFO and transactional services to the middle market.
Larry is the CTO for Restech and holds a B.S. in Computer Science. He is a software architect specializing in remote patient monitoring, medical sensors, and clinical trial software. Larry holds a patent on massively distributed computing and has worked for a number of major software startup companies including Sybase, Oracle, and Teradata. Larry was also the co-founder of a startup to deliver advanced clinical pathways to patients using mobile devices and medical sensors. Larry is truly a pioneer and now a veteran in the deployment.
Jeff has a breadth of experience with over 25 years in engineering and executive positions within major fortune 100 healthcare companies. He also has proven success in startup medical technology companies. Jeff provides leadership in securing and managing Restech’s patent portfolio. He also built Restech’s compliance platform that established regulatory acceptance in 25+ countries worldwide. Jeff’s scientific support and in-depth understanding of the device industry set the foundation for current and future commercial innovations at Restech.
With nearly 30 years of working with physician thought leaders developing novel and emerging technologies, Leo has played a key role in the development and evolution of balloon angioplasty and stent technologies that revolutionized the therapy of cardiac disease. His experience was instrumental in the development of the patented platform technology which drives the Restech sensor. Leo provides a vision and passion for effecting change in the diagnosis and management of atypical reflux.
With over 20 years of executive experience in both the private and public sector, Debra brings a broad understanding of healthcare delivery system. With experience managing products aimed at wide scale disease and population management for 20 million subscribers, Debra has extensive experience in effectively and efficiently developing models of delivery that address specific health issues. Debra has also been involved in the legislative process and served as the elected President of the Independent Physician Association of California. Debra is dedicated to bringing tools to the healthcare market that improve and support the clinical process.