Abstract
Purpose
To evaluate the effectiveness of a protocol for management of patients with laryngopharyngeal reflux (LPR) in a multi-provider clinic.
Materials and Methods
This is a retrospective cohort study of 188 patients treated for LPR. A standardized clinical protocol for diagnosis and management was instituted in 2012. Two cohorts were established: those managed according to the protocol, and those who were not. For patients managed with the LPR protocol, diagnosis was made using clinical judgment, guided by the Reflux Symptom Index (RSI) and Reflux Finding Score (RFS). Patients were treated with proton pump inhibitors (PPI) with the goal of weaning therapy after symptom resolution. Response to therapy was rated using a global rating scale with three response levels: no response, partial response, and complete response. The primary outcome measure was complete response to therapy and the secondary outcome measures were any response (complete or partial) and successful wean off PPI therapy.
Results
The patients treated with the LPR protocol had higher rates of complete response (p < 0.001). There was no statistically significant difference in rates of any response (complete or partial) between the two groups (p = 0.08). Patients treated using the LPR protocol were more likely to be successfully weaned off PPI therapy (p = 0.006).
Conclusions
The use of an LPR protocol improved treatment effectiveness in our clinic, highlighting the role of clinical protocols in reducing variability in care, thereby improving patient outcomes.
1
Introduction
Laryngopharyngeal reflux (LPR) is defined as the retrograde movement of gastric contents into the larynx, pharynx, and upper aerodigestive tract. Common symptoms include hoarseness, throat clearing, cough, dysphagia, globus sensation, and postnasal drip. LPR has been implicated as a cause or contributing factor to diseases such as subglottic stenosis, laryngeal granuloma, asthma, and sinusitis . LPR symptomatology differs from that of gastroesophageal reflux disease (GERD), as it often does not include the classic symptoms of heartburn and regurgitation . The most frequently reported symptoms of LPR are nonspecific and may be due to other factors such as allergy, smoking, environmental irritants, infection, or vocal abuse, possibly leading to overdiagnosis . This dilemma has thus prompted validated measures such as the reflux symptom index (RSI) and the reflux finding score (RFS) for improved diagnostic reliability. Ford proposed an approach to assessment and management of LPR including diagnosis with RSI and RFS, then empiric treatment, and further diagnostic studies for poorly or nonresponsive patients . However, in general otolaryngology practice, the diagnosis relies on empiric evaluation of symptomatology and physical examination.
LPR is often treated with empiric proton pump inhibitor (PPI) therapy . PPIs have become one of the most commonly prescribed medications in the past two decades . However, recent studies have shown detrimental side effects of PPI therapy such as fractures due to altered calcium absorption and increased community-acquired pneumonia . In addition, PPIs have been shown to be less effective than expected in the treatment of LPR, possibly due to other components in gastric aspirate, such as pepsin, which have been implicated in the pathogenesis of LPR .
The Otolaryngology Clinic at our institution is staffed by physician assistants and rotating residents, under the supervision of an attending otolaryngologist. The senior author (UCM) noted significant variability among providers in the frequency of diagnosis of LPR in patients with throat complaints, and the management of patients diagnosed with LPR. This prompted the creation of a standardized LPR management protocol in our clinic in 2012. The purpose of this study is to evaluate the impact of this protocol on treatment outcomes. Our hypothesis was that use of the protocol would improve selection of patients with LPR, who would be more likely to improve with PPI therapy, and would facilitate earlier weaning of patients off PPI therapy.
2
Materials and methods
This was a retrospective cohort study. Data were extracted from patients’ charts. The study cohort included patients from the Queens Hospital Center Otolaryngology Clinic, who were treated for LPR between April 1, 2011 and April 30, 2014. It is customary in our clinic to treat LPR with twice daily PPI therapy. Patients were included if they were started on twice daily PPI therapy, and had a diagnosis of “laryngopharyngeal reflux,” “probable laryngopharyngeal reflux,” “possible laryngopharyngeal reflux,” or “esophageal reflux” with documentation of upper aerodigestive tract symptoms in the chart. Patients were excluded if they were younger than 18 years old, or if they had other obvious laryngopharyngeal pathology that could confound the diagnosis and treatment outcomes of LPR (e.g. vocal polyps, vocal nodules, laryngeal or pharyngeal masses, etc). Data collection was performed by all 3 authors. Each chart was reviewed by at least 2 people. Charts were reviewed by N.G. and U.C.M. if there were inconsistencies, and agreement was reached by consensus. Data were collected on demographic and clinical factors such as: age, sex, prior history of GERD, and prior PPI use. In our facility, we are required to provide telephone interpretation to patients who prefer a different language other than English. We are also required to document this in the patient’s medical record. Data on limited English proficiency was obtained using documentation of use of telephone interpreters in the chart.
Response to therapy was rated using a global rating scale with three response levels: no response, partial response, and complete response. The response to therapy was coded as a complete response if symptoms were noted as “resolved” or “significantly improved” (or similar comments) in the patient’s chart. It was coded as partial response if symptoms were noted as “partially improved” or “slightly improved” (or similar comments) in the patient’s chart. Time to wean off PPI was calculated based on the visit during which the patient was told to discontinue PPI therapy, as long as there was no subsequent return of LPR or GERD symptoms. For patients who discontinued therapy on their own, this was based on the visit during which the patient reported discontinuing PPI therapy, as long as there was no return of symptoms.
The Otolaryngology Clinic at Queens Hospital Center is staffed by physician assistants and rotating residents, under the supervision of an attending otolaryngologist. In August 2012, a standardized clinical protocol was introduced for the diagnosis and management of LPR in the otolaryngology clinic in order to reduce management variability and improve outcomes. This protocol included a modified version of the algorithm introduced by Ford , and utilized the RSI and RFS for the diagnosis of LPR. The algorithm is shown in Fig. 1 . The RSI is a nine-item symptom questionnaire for the diagnosis of LPR, with scores for each item ranging from 0 to 5. A score greater than 13 is considered positive for LPR . The RFS is a variably-weighted eight-item clinical severity scale for judging laryngoscopic findings in patients with LPR. A score greater than 7 is considered abnormal . The RSI and RFS were administered by the primary provider (attending physician, resident, or physician assistant) caring for the patient. The clinical protocol allowed healthcare providers to diagnose LPR using clinical judgment, but guided by the RSI and RFS. The provider was allowed to offer PPI therapy if they felt, in their judgment, that the patient’s symptoms were a due to LPR, even in the absence of positive RSI or RFS. However, the provider was required to justify the diagnosis and document the level of certainty of diagnosis using predetermined diagnostic terms. Patients with positive RSI and RFS were diagnosed with LPR. Patients who were positive on only one of the two scales, but who had symptoms or findings that were strongly suggestive of LPR were diagnosed as “probable LPR.” Patients who had negative RSI and RFS, but who had symptoms or findings that were strongly suggestive of LPR were diagnosed as “possible LPR.” PPI therapy was initiated only if the symptoms had been present for at least 4 weeks. Patients were treated with either esomeprazole or omeprazole at a starting dose of 20 mg twice daily. Patients were followed every three months, and the PPI was titrated as soon as complete resolution of LPR symptoms (complete response) was achieved. The titration involved reduction of PPI dose every 3 months with eventual cessation, if the patient remained asymptomatic.
Two patient cohorts were established: those who were treated according to the LPR clinical protocol, and those who were not. The protocol group included patients who were treated after the establishment of the LPR protocol in our clinic, while the non-protocol patients included patients who were treated prior to that. There were no set diagnostic criteria for the non-protocol patients; diagnosis was made based on clinical symptoms and judgment of findings on fiberoptic laryngoscopy, without the aid of symptom and finding scores. No set follow up regimen was used for the non-protocol patients. All patients received twice daily PPI therapy.
IBM SPSS version 20 was used for statistical analysis. Survival analysis was performed using Kaplan–Meier analysis. The primary outcome measure was complete response of LPR symptoms. The secondary outcome measures were any response to therapy (defined as either complete or partial improvement in LPR symptoms), and successful wean off PPI therapy. The primary independent variable was use of the LPR clinical protocol. Cox proportional hazards regression model was used for multivariable survival analysis. Age, gender, limited English proficiency, history of GERD, and prior PPI use were entered a priori into the model. This study was approved by the Icahn School of Medicine at Mount Sinai Institutional Review Board.
2
Materials and methods
This was a retrospective cohort study. Data were extracted from patients’ charts. The study cohort included patients from the Queens Hospital Center Otolaryngology Clinic, who were treated for LPR between April 1, 2011 and April 30, 2014. It is customary in our clinic to treat LPR with twice daily PPI therapy. Patients were included if they were started on twice daily PPI therapy, and had a diagnosis of “laryngopharyngeal reflux,” “probable laryngopharyngeal reflux,” “possible laryngopharyngeal reflux,” or “esophageal reflux” with documentation of upper aerodigestive tract symptoms in the chart. Patients were excluded if they were younger than 18 years old, or if they had other obvious laryngopharyngeal pathology that could confound the diagnosis and treatment outcomes of LPR (e.g. vocal polyps, vocal nodules, laryngeal or pharyngeal masses, etc). Data collection was performed by all 3 authors. Each chart was reviewed by at least 2 people. Charts were reviewed by N.G. and U.C.M. if there were inconsistencies, and agreement was reached by consensus. Data were collected on demographic and clinical factors such as: age, sex, prior history of GERD, and prior PPI use. In our facility, we are required to provide telephone interpretation to patients who prefer a different language other than English. We are also required to document this in the patient’s medical record. Data on limited English proficiency was obtained using documentation of use of telephone interpreters in the chart.
Response to therapy was rated using a global rating scale with three response levels: no response, partial response, and complete response. The response to therapy was coded as a complete response if symptoms were noted as “resolved” or “significantly improved” (or similar comments) in the patient’s chart. It was coded as partial response if symptoms were noted as “partially improved” or “slightly improved” (or similar comments) in the patient’s chart. Time to wean off PPI was calculated based on the visit during which the patient was told to discontinue PPI therapy, as long as there was no subsequent return of LPR or GERD symptoms. For patients who discontinued therapy on their own, this was based on the visit during which the patient reported discontinuing PPI therapy, as long as there was no return of symptoms.
The Otolaryngology Clinic at Queens Hospital Center is staffed by physician assistants and rotating residents, under the supervision of an attending otolaryngologist. In August 2012, a standardized clinical protocol was introduced for the diagnosis and management of LPR in the otolaryngology clinic in order to reduce management variability and improve outcomes. This protocol included a modified version of the algorithm introduced by Ford , and utilized the RSI and RFS for the diagnosis of LPR. The algorithm is shown in Fig. 1 . The RSI is a nine-item symptom questionnaire for the diagnosis of LPR, with scores for each item ranging from 0 to 5. A score greater than 13 is considered positive for LPR . The RFS is a variably-weighted eight-item clinical severity scale for judging laryngoscopic findings in patients with LPR. A score greater than 7 is considered abnormal . The RSI and RFS were administered by the primary provider (attending physician, resident, or physician assistant) caring for the patient. The clinical protocol allowed healthcare providers to diagnose LPR using clinical judgment, but guided by the RSI and RFS. The provider was allowed to offer PPI therapy if they felt, in their judgment, that the patient’s symptoms were a due to LPR, even in the absence of positive RSI or RFS. However, the provider was required to justify the diagnosis and document the level of certainty of diagnosis using predetermined diagnostic terms. Patients with positive RSI and RFS were diagnosed with LPR. Patients who were positive on only one of the two scales, but who had symptoms or findings that were strongly suggestive of LPR were diagnosed as “probable LPR.” Patients who had negative RSI and RFS, but who had symptoms or findings that were strongly suggestive of LPR were diagnosed as “possible LPR.” PPI therapy was initiated only if the symptoms had been present for at least 4 weeks. Patients were treated with either esomeprazole or omeprazole at a starting dose of 20 mg twice daily. Patients were followed every three months, and the PPI was titrated as soon as complete resolution of LPR symptoms (complete response) was achieved. The titration involved reduction of PPI dose every 3 months with eventual cessation, if the patient remained asymptomatic.
