Annals of Otology, Rhinology & Laryngology http://aor.sagepub.com/
Laryngopharyngeal Reflux: Paradigms for Evaluation, Diagnosis, and Treatment Zhen Gooi, Stacey L. Ishman, Jonathan M. Bock, Joel H. Blumin and Lee M. Akst Ann Otol Rhinol Laryngol published online 1 May 2014 DOI: 10.1177/0003489414532777 The online version of this article can be found at: http://aor.sagepub.com/content/early/2014/05/01/0003489414532777
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research-article2014
AORXXX10.1177/0003489414532777Annals of Otology, Rhinology & LaryngologyGooi et al
Article
Laryngopharyngeal Reflux: Paradigms for Evaluation, Diagnosis, and Treatment
Annals of Otology, Rhinology & Laryngology 1–9 © The Author(s) 2014 Reprints and permissions: sagepub.com/journalsPermissions.nav DOI: 10.1177/0003489414532777 aor.sagepub.com
Zhen Gooi, MBBS1, Stacey L. Ishman, MD, MPH2, Jonathan M. Bock, MD3, Joel H. Blumin, MD3, and Lee M. Akst, MD1
Abstract Objective: This study aimed to describe current patterns for diagnosis and treatment of laryngopharyngeal reflux (LPR) and analyze differences between laryngologists and non-laryngologists. Methods: American Academy of Otolaryngology–Head and Neck Surgery and American Broncho-Esophagological Association members were invited to complete an online survey regarding evaluation, diagnosis, and treatment of LPR. Subgroup analysis was performed to identify differences between respondents who completed laryngology fellowships (LF) and those who did not (NL). Results: Of 159 respondents, 40 were LF. Video documentation of laryngopharyngeal exams was almost universal among LF (97% vs 38%, P < .0001). Use of rigid (100%, P = .002) and flexible distal-chip technologies (94%, P = .004) was more common among LF. Diagnostic criteria were similar between the groups, with symptoms of heartburn, globus, and throat clearing thought most suggestive of LPR. Adjunctive tests most commonly used were barium esophagram and dual-probe pH testing with impedance. Laryngology fellowship-trained respondents used dual pH probes with impedance more often (P = .004). They were more likely to prescribe twice daily proton pump inhibitors with concurrent H2-blocker medication initially (P = .004) and to treat for longer than 4 weeks (P = .0003). Conclusion: Otolaryngologists are in agreement on symptoms and physical features of LPR; however, significant differences exist between laryngologists and non-laryngologists on the use of adjunctive testing and treatment strategies. Keywords laryngopharyngeal reflux, symptoms and signs, treatment, diagnosis
Introduction Laryngopharyngeal reflux (LPR) is recognized as the extraesophageal manifestation of reflux and is a commonly treated condition in the field of otolaryngology. Although efforts have been made to develop diagnostic criteria for this clinical entity, no universally accepted system currently exists. Variations in use of diagnostic investigations and treatment also differ between practicing otolaryngologists. In a survey of American Broncho-Esophagological Association (ABEA) members in 2002, Book et al1 sought to elicit respondents’ views on symptoms, physical findings, and diagnostic tests pertaining to laryngopharyngeal reflux. Respondents to this survey identified throat clearing, persistent cough, heartburn, and voice quality change as symptoms most indicative of reflux. Respondents broadly agreed that physical signs of LPR are arytenoid erythema, arytenoid edema, vocal cord erythema, and posterior commissure hypertrophy.1 The respondents to the 2002 survey also considered flexible fiberoptic laryngoscopy to be the
most sensitive and specific diagnostic test for LPR and regarded dual pH probe studies as the most valuable adjunctive test.1 In the decade since that study was published, new knowledge and new technologies have influenced how LPR is diagnosed and managed. An increasing body of evidence documents potential harm from prolonged proton pump inhibitor (PPI) use even as the potential benefit of PPI in 1
Department of Otolaryngology–Head and Neck Surgery, Johns Hopkins University, Baltimore, Maryland, USA 2 Department of Otolaryngology–Head and Neck Surgery, Cincinnati Children’s Medical Center, Cincinnati, Ohio, USA 3 Department of Otolaryngology & Communication Sciences, Medical College of Wisconsin, Milwaukee, Wisconsin, USA Corresponding Author: Lee M. Akst, MD, Johns Hopkins Outpatient Center, Department of Otolaryngology–Head and Neck Surgery, 601 N. Caroline Street, Baltimore, MD 21287, USA. Email: [email protected]
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Table 1. Symptoms in Terms of Their Relationship to Reflux.a Please rate each of the following symptoms in terms of their relationship to reflux (Scale: 1 to 5, where 1 = highly related, 3 = somewhat related, 5 = not related). Answer Option Dysphagia Choking episodes Persistent cough Change in voice quality Pain with phonation Globus sensation Throat clearing Heartburn/dyspepsia Postnasal drip Nasal obstruction
1
2
3
4
5
13.0 15.6 29.1 21.1 33.4 48.3 50.0 53.1 6.2 0.7
35.6 38.8 47.3 38.8 11.7 34.0 36.5 20.0 26.7 1.4
39 31.3 18.9 26.5 33.1 11.6 9.5 15.9 28.8 21.9
8.9 9.5 4.1 10.9 35.9 2.7 2.0 9.0 27.4 41.1
3.4 4.8 0.7 2.7 15.9 3.4 2.0 2.1 11.0 34.9
a
All values are percentages.
LPR has been called into question.2,3 At the same time, pH probe testing and transnasal esophagoscopy (TNE) have entered more widespread practice. With these changes in mind, the aim of this study was to characterize current patterns in the diagnosis and treatment of LPR within the broader otolaryngologic community, with particular attention to the role that has been adopted for use of new technologies in reflux care. A second aim was to examine any significant differences between those with subspecialty training in laryngology and other otolaryngologists in approaches to LPR diagnosis, testing, and treatment.
Methods This study was reviewed by the Johns Hopkins Medicine Institutional Review Board and was granted exempt status. A link to an online survey was published in an October 2012 edition of American Academy of Otolaryngology–Head and Neck Surgery (AAO-HNS) The News, a weekly newsletter emailed to members of the AAO-HNS. At that same time, an email link was sent to ABEA members. Respondents were directed to an online survey and were asked to answer a series of multiple-choice questions related to their training, views on signs and symptoms of LPR, and patterns for diagnosis and treatment of LPR. All questions were optional and consent for participation was obtained at the beginning of the survey. During analysis of those signs or symptoms, which were most highly related to particular aspects of reflux care, answers were stratified by the proportion of respondents selecting “1–highly related” or “2” on the 5-point Likert-type scale. Similarly, those answer choices that garnered the highest proportion of “4” or “5–not related” were considered to be least related to a particular aspect of reflux care. Tests were placed in rank order in terms of utility for care, diagnosis, and treatment of reflux
patients based on these Likert-scale responses. Twosample t tests were used to assess for statistically significant differences, defined as P < .05 between laryngology fellowship-trained respondents (LF) and non-laryngology fellowship-trained respondents (NL). The complete survey is listed as an appendix.
Results There was a total of 161 survey respondents; 2 were excluded from the final analysis, as they were not practicing otolaryngologists. Thirty-five percent of respondents were in academic practice, 53% were community based, and 11% classified their practices as a combination of academic and community based. Forty respondents (26%) indicated that they had completed laryngology fellowships, 146 respondents (90%) indicated that they were AAO-HNS members, and 64 were ABEA members (41%). Fifty percent of respondents completed their training before 1993. Overall, NL respondents had been practicing longer than LF respondents (mean, 19.6 vs 11.4 years; P = .0001). Seventy-one percent of respondents indicated that < 50% of their practice is devoted to laryngology/bronchoesophagology; 62% of respondents also indicated that < 50% of their laryngobronchoesophagology patients present with chief complaints that are directly attributable to LPR. When asked about the prevalence of LPR in respondents’ laryngobronchoesophagology patients, 54% reported diagnosing LPR in ≤ 50%, 33% in 51% to 75%, and 13% in > 75% of their patients. The ratings of LPR-related patient symptoms are shown in Table 1. The 4 most frequently selected symptoms were throat clearing (87%), globus sensation (82%), persistent cough (76%), and heartburn/dyspepsia (73%). The 4 symptoms thought to be least related to reflux were nasal obstruction (76%), pain with phonation
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Gooi et al Table 2. Physical Exam Findings in Terms of Their Relationship to Reflux.a
Please rate each of the following physical exam findings in terms of their relationship to reflux (Scale: 1 to 5, where 1 = highly related, 3 = somewhat related, 5 = not related). Answer Option Pachydermia laryngis Vocal cord paralysis/paresis Vocal cord polyp Vocal cord nodule Laryngotracheal stenosis Laryngeal carcinoma Vocal cord erythema Vocal cord edema Ventricular obliteration Posterior commissure hypertrophy Arytenoid erythema Arytenoid edema Arytenoid blood vessel obliteration Subcordal edema
1
2
3
4
5
41.7 0 2.1 2.0 11.5 2.1 17.0 23.6 16.2 45.6 43.2 46.6 9.4 15.5
26.4 1.4 15.2 15.0 14.9 9.7 42.9 39.2 29.1 32.0 32.9 33.8 21.7 27.0
22.9 7.5 29.7 33.3 37.8 29.2 25.9 25.7 29.7 15.6 17.8 14.2 46.4 35.8
5.6 20.4 27.6 25.2 23.6 42.4 8.2 9.5 18.2 4.8 17.8 4.1 14.5 16.2
3.5 70.7 25.5 24.5 12.2 16.7 6.1 2.0 6.8 2.0 2.1 1.4 8.0 5.4
a
All values are percentages.
(52%), postnasal drip (38%), and choking episodes (14%). The ratings of reflux-related physical exam findings are shown in Table 2. Respondents most highly ranked arytenoid edema (80%), posterior commissure hypertrophy (77%), arytenoid erythema (76%), and pachydermia laryngis (68%). Conversely, the physical exam findings thought to be least related to LPR were vocal cord paralysis/paresis (91%), laryngeal carcinoma (59%), vocal cord polyp (53%), and vocal cord nodule (50%). There were no significant differences in the selection of LPR-related symptoms and physical signs between LF and NL respondents. Fifty-three percent of respondents routinely video-documented their laryngeal examinations. There was a significant difference in the video documentation of laryngopharyngeal exams between LF (97%) and NL (38%, P < .0001). Rigid laryngeal endoscopy, flexible fiberoptic transnasal endoscopy, and distal-chip transnasal endoscopy were available to 100%, 84.4%, and 94% of LF respondents, respectively, whereas among NL respondents, these diagnostic adjuncts were available to 78.4%, 95.2%, and 62.9%, respectively. The availability of rigid laryngeal endoscopy (P = .002) and distal-chip transnasal endoscopy (P = .004) was significantly higher among the LF compared to the NL group. Table 3 shows the most commonly obtained adjunctive diagnostic tests for LPR. Eighty percent of LF and 69.4% of NL indicated that they most commonly did not order any further adjunctive diagnostic tests (P = .481). Review of the survey tool in the appendix makes clear that several different types of pH probe were available for selection by respondents; the survey allowed for the separate selection of pharyngeal and esophageal probes with or without
impedance testing. The most popular adjunctive diagnostic tests were esophagogastroduodenoscopy (EGD), barium esophagram, and dual pH probe with impedance. Laryngology fellowship-trained respondents were more likely to list dual pH probe with impedance among their top 3 choices for testing than were NL respondents (85.0% LF vs 36.4% NL, P = .004). The least commonly ordered adjunctive diagnostic tests were pharyngeal pH probe testing, esophageal manometry, and wired single esophageal pH probe. When asked which tests were most sensitive and specific for diagnosis of LPR, dual pH probe with impedance was selected most often, with dual pH probe (pharyngeal and esophageal) and pharyngeal pH probe testing being the next 2 most commonly selected tests. Tests thought least sensitive or specific were wired or wireless (Bravo) single esophageal pH probe, TNE, and EGD. No statistically significant differences existed between LF and NL in their interpretation of the sensitivity and specificity of these tests. The full results for ranking of perceived sensitivity/specificity of diagnostic tools are shown in Table 4. When respondents were asked what adjunctive tests they obtained themselves without referral to a gastroenterologist, barium esophagram (67%) and TNE (47%) were the tests most commonly listed by respondents. However, LF respondents were significantly more likely to use TNE without making a referral to a gastroenterologist compared to NL respondents (80% vs 33.3%, P < .0001). Greater than 80% of respondents overall referred patients to a gastroenterologist for pH probe studies, esophageal manometry, and EGD. Respondents offered a wide variety of explanations when identifying barriers to
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Table 3. Adjunctive Diagnostic Tests Most Commonly Obtained to Further Validate or Investigate the Diagnosis of Laryngopharyngeal Reflux.a Which of the following adjunctive diagnostic tests do you most commonly obtain to further validate or investigate your diagnosis of laryngopharyngeal reflux? (Rank as many tests as you obtain, starting with 1 being the most commonly obtained and 12 being the least commonly obtained; please stop numbering when you have finished listing all of the tests you order. You do not have to rank every test.) Answer Option “None. I do not order other tests.” Barium esophagram Endoscopy: esophagogastroduodenoscopy Endoscopy: transnasal esophagoscopy Esophageal manometry pH probe: pharyngeal testing (Restech) pH probe: esophageal, single-probe, wired pH probe: esophageal, single-probe, wireless (Bravo) pH probe: dual probe (pharyngeal and esophageal) pH probe: dual probe (proximal and distal esophageal) pH probe: dual probe with impedance Other
1
2
3
4
5
6
7
8
9
11
12
73.2 35.6 11.1 13.6 0.0 10.8 0.0 2.6 2.9 0.0 28.3 15.4
5.4 18.9 39.5 20.3 6.4 2.7 6.5 7.9 11.4 7.9 17.4 15.4
5.4 12.2 16.0 10.2 19.1 10.8 0.0 18.4 22.9 23.7 10.9 0.0
3.6 8.9 13.6 13.6 10.6 8.1 9.7 5.3 5.7 15.8 2.2 23.1
0.0 7.8 8.6 11.9 12.8 16.2 6.5 5.3 5.7 2.6 8.7 0.0
0.0 2.2 4.9 6.8 10.6 21.6 12.9 15.8 2.9 7.9 0.0 0.0
0.0 2.2 2.5 8.5 6.4 2.7 19.4 10.5 11.4 10.5 0.0 0.0
0.0 3.3 3.7 0.0 8.5 2.7 6.5 21.1 17.1 2.6 2.2 0.0
0.0 4.4 0.0 3.4 12.8 5.4 12.9 5.3 14.3 7.9 6.5 0.0
7.1 3.3 0.0 1.7 6.4 8.1 6.5 5.3 0.0 21.1 8.7 15.4
5.4 1.1 0.0 10.2 6.4 10.8 19.4 2.6 5.7 0.0 15.2 30.8
a
All values are percentages.
Table 4. Tests Regarded as Most Sensitive and Specific for the Diagnosis of Laryngopharyngeal Reflux.a Of the possible tests listed, which do you feel is most sensitive and specific for the diagnosis of laryngopharyngeal reflux? (Please rank on a scale of 1 to 10, with 1 as the most sensitive/specific and 10 as the least sensitive/specific.) Answer Option Barium esophagram Endoscopy: esophagogastroduodenoscopy Endoscopy: transnasal esophagoscopy Esophageal manometry pH probe: pharyngeal testing (Restech) pH probe: esophageal, single-probe, wired or wireless (Bravo) pH probe: dual probe (pharyngeal and esophageal) pH probe: dual probe (proximal and distal esophageal) pH probe: dual probe with impedance Other
1
2
3
4
5
6
7
8
9
10
2.8 10.0 10.7 1.9 26.3 2.0 32.4 10.5 65.7 30.0
9.9 11.4 5.4 9.6 10.5 7.8 36.8 28.1 9.0 10.0
9.9 10.0 14.3 7.7 14.0 5.9 16.2 29.8 6.0 0.0
2.8 8.6 10.7 7.7 8.8 31.1 7.4 8.8 9.0 0.0
7.0 4.3 3.6 3.8 22.8 29.4 4.4 12.3 3.0 10.0
8.5 14.3 8.9 15.4 12.3 15.7 0.0 3.5 1.5 0.0
7.0 18.6 26.8 9.6 3.5 0.0 2.9 1.8 3.0 0.0
19.7 14.3 12.5 11.5 1.8 5.9 0.0 1.8 1.5 0.0
19.7 7.1 3.6 30.8 0.0 0.0 0.0 3.5 1.5 0
12.7 1.4 3.6 1.9 0.0 2.0 0.0 0.0 0.0 50.0
a
All values are percentages.
performing pH probe testing as part of their practice (Table 5). The most commonly selected options for “most important barrier” were not enough time (33%), do not believe it adds meaningfully to patient care (25%), and concern for cost (22%). An almost equal number of respondents indicated concern for patient tolerance (20%) and being unfamiliar with interpretation (18%) as the most important barrier for not performing pH probe testing. A greater proportion of LF respondents indicated “not enough time” as the most important barrier compared with NL, whereas “concern for cost” was cited by a greater proportion of NL as the most important barrier (P = .08). When asked to identify the most important
barriers that prevented respondents from incorporating TNE as part of their practice, concern for cost (49%), unfamiliarity with interpretation (20%), concern for patient tolerance (20%), and not enough time (17%) were the most popular choices, as shown in Table 6. A majority (82%) of respondents indicated that they would treat presumed LPR empirically without further testing more than 60% of the time. The most popular empiric treatment options selected were twice daily PPI (39%), once daily high-dose PPI (29%), and once daily low-dose PPI (21%). Laryngology fellowship-trained respondents were significantly more likely to prescribe twice daily PPI with concurrent H2-blocker medication
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Gooi et al Table 5. Barriers Toward pH Probe Testing.a If you do NOT currently perform your own pH probe testing as part of your practice, what are the barriers that have kept you from doing so? Please rank in order of importance, from 1 to 7 (1 = most important barrier, 8 = least important barrier). If you do perform your own pH probe testing, please skip this question. Answer Option Concern for cost Concern for patient scheduling/convenience Concern for patient tolerance Do not believe it adds meaningfully to patient care Not enough time Unclear on appropriate indications Unfamiliar with interpretation
1
2
3
4
5
6
21.9 8.8 19.7 25.0 32.9 4.5 18.4
28.8 25.0 15.2 10.0 5.7 17.9 14.5
13.7 23.5 21.2 10.0 17.1 6.0 14.5
16.4 13.2 18.2 8.3 15.7 11.9 13.2
8.2 14.7 7.6 5.0 8.6 28.4 10.5
5.5 10.3 13.6 13.3 5.7 19.4 14.5
7 5.5 4.4 4.5 28.3 14.3 11.9 14.5
a
All values are percentages.
Table 6. Barriers Toward Transnasal Esophagoscopy.a If you do NOT currently perform transnasal esophagoscopy (TNE) as part of your practice, what are the barriers that have kept you from doing so? Please rank in order of importance, from 1 to 7 (1 = most important barrier, 7 = least important barrier). If you do perform TNE as part of your practice, then do not answer this question and skip to question 18. Answer Option Concern for cost Concern for patient scheduling/convenience Concern for patient tolerance Do not believe it adds meaningfully to patient care Not enough time Unclear on appropriate indications Unfamiliar with interpretation
1
2
3
4
5
6
7
48.9 7.1 19.6 12.2 17.4 7.1 20.4
17.0 19.0 30.4 4.9 19.6 11.9 14.8
6.4 26.2 19.6 12.2 17.4 11.9 13.0
12.8 19.0 15.2 7.3 15.2 9.5 13.0
6.4 14.3 8.7 12.2 6.5 23.8 14.8
4.3 11.9 6.5 7.3 4.3 31.0 14.8
4.3 2.4 0.0 43.9 19.6 4.8 9.3
a
All values are percentages.
initially (P = .004). The most common responses for duration of this empiric treatment trial were 2 months (43%), 3 months (34%), and 1 month (18%). Laryngology fellowship-trained respondents were significantly more likely to use empiric treatment duration of greater than 1 month compared to NL respondents (P = .0003). When asked what they would do for a patient who failed empiric treatment for LPR, 37% of respondents indicated that they would obtain further testing, 30% would refer to a gastroenterologist for further evaluation and management, 25% would continue empiric treatment with an increased PPI dose, and 5% indicated that they would prolong empiric treatment with the same medication regimen. A greater proportion of LF respondents chose further testing compared to NL (51% vs 31%, P = .053), whereas NL more commonly chose “refer to gastroenterologist for further evaluation and management” (30% vs 18%, P = .115). When respondents were asked their most commonly ordered diagnostic test for a patient who failed an empiric treatment trial for LPR, the top 3 overall selections were EGD, barium esophagram, and esophageal dual pH probe with impedance.
Discussion The current study examines practice patterns of otolaryngologists in the diagnosis, adjunct testing, and treatment of LPR. Overall, diagnosis and management of LPR remain frustrating, without true gold standards against which to measure current practice patterns. Regarding diagnosis of LPR, strategies vary from clinical diagnosis based on history and examination alone to diagnosis based on response to empiric treatment and on pH testing. Laryngology fellowship-trained and NL respondents demonstrated broad agreement in which patient complaints and exam findings they thought to be most related to LPR. Heartburn, throat clearing, globus sensation, and persistent cough were thought by respondents to correlate with LPR. This symptom complex mirrors those symptoms included on the reflux symptom index.4 Similarly, physical findings thought to be highly related to LPR by respondents mirror those included in the reflux finding score and include arytenoid edema, posterior commissure hypertrophy, pachydermia laryngis, and arytenoid erythema.5 Despite this broad agreement on signs and symptoms, there are
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statistically significant differences in practice patterns between NL and LF respondents, particularly related to use of diagnostic adjuncts and treatment strategies for LPR. As knowledge evolves, recommendations have evolved as well. It used to be that the recommended treatment for suspected LPR was twice daily PPI for at least 2 months.6 With more recent concerns about the efficacy of PPI in treatment of isolated LPR symptoms (in the absence of heartburn) and with concern for PPI side effects, a more recent recommendation from the gastroenterology and otolaryngology communities has been to restrict empiric treatment of possible LPR without some further indication based on signs or symptoms that reflux is indeed present; otolaryngology position statements support laryngeal exam as being able to document reflux, whereas the most recent gastroenterology guidelines do not consider flexible laryngoscopy as a credible tool for LPR diagnosis.2,3 In this changing environment, an understanding of current practice patterns in the diagnosis, evaluation, and treatment of reflux takes on practical significance as current paradigms must be understood before care can be optimized. The finding that the vast majority of LF video- documented their laryngeal examinations and that there is increased availability of rigid laryngeal endoscopy and distal-chip transnasal endoscopy in LF practices in comparison with NL practices is likely due to a combination of factors. These include the cost of this equipment, emphasis on video documentation, and need in any particular practice for laryngeal stroboscopy, which would bring with it the necessity of video documentation and increase the likelihood of rigid endoscope and distal-chip technology availability. These perceived cost–benefit considerations may reduce the likelihood that NL practices will invest in distal-chip equipment and they fit with the finding of the current study that concern for cost was the most commonly identified barrier among NL practitioners not performing TNE as part of their practice. There is evidence to show that TNE has reduced overall patient costs compared to conventional esophagoscopy due to the avoidance of anesthetic and operating room charges.7 When weighing the costs and benefits of distal-chip technology, it is important to recognize that both distal-chip technology and rigid laryngeal exam may offer improved visualization of the larynx over flexible fiberoptic exam.8,9 Although potentially meaningful with regard to laryngeal lesions, the differences between these technologies as applied to reflux are more uncertain. Flexible exam may more often find signs of laryngeal tissue irritation in asymptomatic patients than rigid exam,10 perhaps suggesting reduced diagnostic specificity of flexible laryngoscopy in diagnosis of LPR; however, regardless of technique, there is a question as to whether laryngopharyngeal exam findings correlate with presence or absence of reflux in the first place.11
Moving beyond exam findings, although an almost equal proportion of LF and NL indicated that no further adjunctive diagnostic tests were obtained to validate the diagnosis of LPR, it was noted that a statistically significantly larger cohort of LF ordered pH probe: dual probe impedance studies as a diagnostic adjunct compared to NL. This is reflected in results showing an increased likelihood of LF respondents obtaining further testing and choosing pH probe studies as the preferred testing option compared to NL in the event of empiric treatment failure. The AAO-HNS has put forward that dual pH probe studies are the gold standard for objectively documenting LPR.6 Nevertheless, it is also acknowledged that the accuracy of pH probe testing is subject to variations in interpretation subject to positioning of the probe and artifactual errors caused by the local environment of the pharynx or upper esophageal sphincter and the inability to record non-acid reflux events.12 This uncertainty in diagnostic criteria may account for NL more commonly referring their patients to gastroenterologists and not using pH probe studies themselves as diagnostic adjuncts in the event of treatment failure, even as NL respondents indicate that a pH probe: dual probe test is one of the most sensitive and specific tests for the diagnosis of LPR. In this context, it is interesting that both NL and LF respondents list concern for interpretation as one of the most common reasons for not performing their own pH probes. The variation in treatment patterns of LPR observed in the current study between LF and NL is a likely reflection of ongoing evolvement in treatment recommendations by both gastroenterological and otolaryngological professional bodies. There seems to be some agreement between gastroenterology and otolaryngology communities that empiric treatment is to be undertaken cautiously and not without further evidence that reflux is related to patient complaints; for instance, the American Gastroenterology Association recommends against empiric treatment of extra-esophageal complaints of reflux with proton pump inhibitors unless there is concomitant patient complaint of heartburn.2 In relatively recent practice guidelines for management of hoarseness, empiric treatment with PPI was not recommended unless there were symptoms of GERD or laryngeal findings of inflammation to support reflux as a contributing factor to voice complaints.3 It is unfortunate that these guidelines do not suggest alternative strategies for treatment of extra-esophageal complaints in the absence of heartburn or laryngeal findings of reflux; otolaryngologists have expressed concern that most clinical practice guidelines for reflux disease are heavily biased toward the gastroenterological literature.13 Meanwhile, even as these guidelines recommend against empiric treatment, other guidelines suggest that if LPR is to be treated, then trials of therapy should be of twice daily PPI for at least 2 months to be considered adequate.6
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Gooi et al Treatment patterns as revealed in this study do not closely follow either of the above approaches. The majority of respondents treat reflux empirically, without further testing; this study does not assess whether these physicians are seeking other evidence on history of exam such as complaint of heartburn to justify empiric treatment; it is presumed that laryngoscopy is often performed, although specificity of laryngoscopy findings for reflux may be low as noted. It is surprising that the most common NL strategy for empiric treatment seems to be once daily PPI rather than twice daily PPI, as the total for once daily high-dose and once daily low-dose therapies constitutes one-half of all treatment regimens; although 77% of respondents choose 2 or 3 months as their most common length of empiric treatment, nearly 1 in 5 respondents would treat empirically for only 1 month. The observed variation in treatment patterns for LPR refractory to an initial trial of medical therapy also indicates the current state of the field, with no agreed-upon standard for either initial empiric treatment or subsequent evaluation of patients whose complaints are refractory to empiric treatment. Similarly, the wide variation of responses on the barriers toward the performance of TNE and pH probe testing in the management of LPR is also reflective of the lack of consensus of practitioners on the indications for these tests. There is further need for well-designed studies to establish an algorithm incorporating the use of these investigative modalities in cases of diagnostic uncertainty or treatment failure. To conclude, LF and NL respondents in our survey are in broad agreement regarding the symptoms and physical signs thought to be related to LPR. Laryngology fellowship-trained respondents were more likely to videodocument their laryngeal examinations and to use TNE and pH probe: dual probe with impedance compared to NL; these differences are a likely reflection of increased exposure from subspecialty training. Barriers that have been identified among practitioners to the use of these technologies include lack of familiarity, cost, and uncertainty with interpretation of results. There exists a need to refine clinical practice guidelines for the diagnosis and treatment of LPR in collaboration with gastroenterological specialties.
Appendix Respondents were asked about the nature of their practice (academic, community, and combination of academic and community) and the year in which they completed their training. They were asked to indicate if they had fellowship training in laryngology, head and neck surgery, pediatric otolaryngology, rhinology, facial plastic and reconstructive surgery, otology, allergy, thoracic surgery, or sleep medicine. Membership status in the American Academy of Otolaryngologic Allergy, American Academy of Otolaryngology–Head and Neck Surgery, American Broncho-Esophagological Association, American Head and
Neck Society, American Laryngological Association, American Rhinologic Society, and American Society of Pediatric Otolaryngology was elicited. Respondents were then asked, “What percentage of your clinical practice is devoted to laryngology or bronchoesophagology?” with options presented (0%-25%, 26%-50%, 51%-75%, and 76%-100%). Next, they were asked, “What percentage of your laryngobronchoesophagology patients present with chief complaints that you believe are directly or mainly attributable to laryngopharyngeal reflux?” with options presented (0%-25%, 26%-50%, 51%-75%, and 76%-100%), followed by, “What percentage of your laryngobronchoesophagology patients overall have laryngopharyngeal reflux?” with options presented (0%-25%, 26%-50%, 51%75%, and 76%-100%). Respondents were then asked to rate the following symptoms of dysphagia, choking episodes, persistent cough, change in voice quality, pain with phonation, globus sensation, throat clearing, heartburn and dyspepsia, postnasal drip, and nasal obstruction in terms of their relationship to reflux on a scale of 1 to 5 (where 1 = highly related, 3 = somewhat related, and 5 = not related). Next, they were asked to rate each of the following physical exam findings of pachydermia laryngis, vocal cord paralysis/paresis, vocal cord polyp, vocal cord nodule, laryngotracheal stenosis, laryngeal carcinoma, vocal cord erythema, vocal cord edema, ventricular obliteration, posterior commissure hypertrophy, arytenoid erythema, arytenoid edema, arytenoid blood vessel obliteration, and subcordal edema in terms of their relationship toward reflux on a scale of 1 to 5 (where 1 = highly related, 3 = somewhat related, and 5 = not related). Respondents were asked if they routinely performed video documentation of their laryngeal examinations. They were asked if rigid laryngeal endoscopy, flexible fiberoptic transnasal endoscopy, and distal-chip transnasal endoscopy were available in their practice. Next, respondents ranked the adjunctive diagnostic tests most commonly used to further validate or investigate the diagnosis of laryngeal reflux in the order of 1 to 12, with 1 being the most commonly obtained and 12 the least commonly obtained, with options presented including, “None. I do not order tests,” barium esophagram, esophagogastroduodenoscopy, transnasal esophagoscopy, esophageal manometry, pH probe: pharyngeal testing (Restech), pH probe: esophageal, single probe, wired, pH probe: esophageal, single probe, wireless (Bravo), pH probe: dual probe (pharyngeal and esophageal), pH probe: dual probe (proximal and distal esophageal), pH probe: dual probe with impedance, and other (with respondents specifying as a free text). Then, respondents were asked to indicate in order from 1 to 10 with 1 being the most sensitive/specific and 10 being the least sensitive/specific for the diagnosis of LPR among the following options: barium esophagram, esophagogastroduodenoscopy, transnasal esophagoscopy, esophageal manometry, pH probe: pharyngeal testing (Restech), pH probe: esophageal, single probe,
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wired, pH probe: esophageal, single probe, wireless (Bravo), pH probe: dual probe (pharyngeal and esophageal), pH probe: dual probe (proximal and distal esophageal), pH probe: dual probe with impedance, and other (with respondents specifying as a free text). Respondents were then asked to indicate yes or no if they performed the following tests as part of their own practice without referral to a gastroenterologist: barium esophagram, esophagogastroduodenoscopy, transnasal esophagoscopy, esophageal manometry, pH probe: pharyngeal testing (Restech), pH probe: esophageal, single probe, wired, pH probe: esophageal, single probe, wireless (Bravo), pH probe: dual probe (pharyngeal and esophageal), pH probe: dual probe (proximal and distal esophageal), pH probe: dual probe with impedance, and other (with respondents specifying as a free text). Next, respondents were asked to indicate the barriers that have kept them from performing their own pH probe testing as part of their own practice, ranking a list of options from 1 to 7, with 1 being the most important barrier and 7 the least important barrier, with options presented including concern for cost, concern for patient scheduling/convenience, concern for patient tolerance, do not believe it adds meaningfully to patient care, not enough time, unclear on appropriate indications, and unfamiliar with interpretation. Next, respondents were asked to indicate the barriers that have kept them from performing transnasal esophagoscopy as part of their own practice, ranking a list of options from 1 to 7, with 1 being the most important barrier and 7 the least important barrier, with options presented including concern for cost, concern for patient scheduling/ convenience, concern for patient tolerance, do not believe it adds meaningfully to patient care, not enough time, unclear on appropriate indications, and unfamiliar with interpretation. Next, respondents were asked how often they treated empirically for a patient with presumed laryngopharyngeal reflux without first obtaining any further testing, with options presented as 0%-20%, 21%-40%, 41%-60%, 61%-80%, and 81%-100%. Respondents were then asked which options they most often recommend for an empiric treatment trial in addition to lifestyle modifications, with choices presented including H2 receptor antagonist alone, once daily low-dose proton pump inhibitor (PPI), once daily high-dose PPI, twice daily PPI, once daily high-dose PPI and H2 receptor antagonist, twice daily PPI and H2 receptor antagonist, and other (with respondents specifying as a free text). Respondents were then asked, if they were treating a patient empirically, what was the duration of their initial empiric trial, with options given as < 1 month, 1 month, 2 months, 3 months, > 4 months, or other (with respondents specifying as a free text). Next, they were asked, for patients who were treated empirically for laryngopharyngeal reflux, what was the proportion of patients who responded to the specified treatment in their practice, with options presented as 0%-20%, 21%40%, 41%-60%, 61%-80%, and 81%-100%. Then, respondents were asked, for patients who do not respond to an
empiric trial of treatment for presumed laryngopharyngeal reflux, what would be the following next step, with options presented including continue empiric treatment, with increased dose of PPI, continue empiric treatment, with stable dose but increased length of trial, obtain further testing, refer the patient to a gastroenterologist for further evaluation and management, and other (with respondents specifying as a free text). Last, respondents were asked what further testing they would order for a patient who did not respond to an empiric trial of treatment for presumed laryngopharyngeal reflux on a scale of 1 to 9, with 1 being the most commonly ordered test and 9 being the least commonly ordered test, with options presented including barium esophagram, esophagogastroduodenoscopy, transnasal esophagoscopy, esophageal manometry, pH probe: pharyngeal testing (Restech), pH probe: esophageal, single probe, wired, pH probe: esophageal, single probe, wireless (Bravo), pH probe: dual probe (pharyngeal and esophageal), pH probe: dual probe (proximal and distal esophageal), pH probe: dual probe with impedance, and other (with respondents specifying as a free text). Declaration of Conflicting Interests The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.
Funding The author(s) received no financial support for the research, authorship, and/or publication of this article.
References 1. Book DT, Rhee JS, Toohill RJ, Smith TL. Perspectives in laryngopharyngeal reflux: an international survey. Laryngoscope. 2002;112(8, pt 1):1399-1406. 2. Kahrilas PJ, Shaheen NJ, Vaezi MF, et al. American Gastroenterological Association Medical Position Statement on the management of gastroesophageal reflux disease. Gastroenterology. 2008;135(4):1383-1391. 3. Schwartz SR, Cohen SM, Dailey SH, et al. Clinical practice guideline: hoarseness (dysphonia). Otolaryngol Head Neck Surg. 2009;141(3)(suppl 2):S1-S31. 4. Belfasky PC, Postma GN, Koufman JA. Validity and reliability of the reflux symptom index (RSI). J Voice. 2002;16(2):274-277. 5. Belfasky PC, Postma GN, Koufman JA. The validity and reliability of the reflux finding score (RFS). Laryngoscope. 2001;111(8):1313-1317. 6. Koufman JA, Aviv JE, Casiano RR, Shaw GY. Laryngopharyngeal reflux: position statement of the committee on speech, voice, and swallowing disorders of the American Academy of Otolaryngology–Head and Neck Surgery. Otolaryngol Head Neck Surgery. 2002;127(1): 32-35. 7. Amin MR, Postma GN, Setzen M, Koufman JA. Transnasal esophagoscopy: a position statement from the American
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Gooi et al Bronchoesophagological Association (ABEA). Otolaryngol Head Neck Surg. 2008;138(4):411-414. 8. Eller R, Ginsburg M, Lurie D, Heman-Ackah Y, Lyons K, Sataloff R. Flexible laryngoscopy: a comparison of fiber optic and distal chip technologies—part 2: laryngopharyngeal reflux. J Voice. 2009;23(3):389-395. 9. Yanagisawa E, Yanagisawa K. Stroboscopic videolaryngoscopy: a comparison of fiberoptic and telescopic documentation. Ann Otol Rhinol Laryngol. 1993;102(4, pt 1):255-265. 10. Milstein CF, Charbel S, Hicks DM, Abelson TI, Richter JE, Vaezi MF. Prevalence of laryngeal irritation signs associated with reflux in asymptomatic volunteers: impact of endoscopic
technique (rigid vs. flexible laryngoscope). Laryngoscope. 2005;115(12):2256-2261. 11. Vavricka SR, Storck CA, Wildi SM, et al. Limited diagnostic value of laryngopharyngeal lesions in patients with gastroesophageal reflux during routine upper gastrointestinal endoscopy. Am J Gastroenterol. 2007;102(4):716-722. 12. Harrell SP, Koopman J, Woosley S, Wo JM. Exclusion of pH artifacts is essential for hypopharyngeal pH monitoring. Laryngoscope. 2007;117(3):470-474. 13. Altman KW, Prufer N, Vaezi MF. A review of clinical practice guidelines for reflux disease: toward creating a clinical protocol for the otolaryngologist. Laryngoscope. 2011;121(4):717-723.
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Laryngopharyngeal Reflux: Paradigms for Evaluation, Diagnosis, and Treatment Zhen Gooi, Stacey L. Ishman, Jonathan M. Bock, Joel H. Blumin and Lee M. Akst Ann Otol Rhinol Laryngol published online 1 May 2014 DOI: 10.1177/0003489414532777 The online version of this article can be found at: http://aor.sagepub.com/content/early/2014/05/01/0003489414532777
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research-article2014
AORXXX10.1177/0003489414532777Annals of Otology, Rhinology & LaryngologyGooi et al
Article
Laryngopharyngeal Reflux: Paradigms for Evaluation, Diagnosis, and Treatment
Annals of Otology, Rhinology & Laryngology 1–9 © The Author(s) 2014 Reprints and permissions: sagepub.com/journalsPermissions.nav DOI: 10.1177/0003489414532777 aor.sagepub.com
Zhen Gooi, MBBS1, Stacey L. Ishman, MD, MPH2, Jonathan M. Bock, MD3, Joel H. Blumin, MD3, and Lee M. Akst, MD1
Abstract Objective: This study aimed to describe current patterns for diagnosis and treatment of laryngopharyngeal reflux (LPR) and analyze differences between laryngologists and non-laryngologists. Methods: American Academy of Otolaryngology–Head and Neck Surgery and American Broncho-Esophagological Association members were invited to complete an online survey regarding evaluation, diagnosis, and treatment of LPR. Subgroup analysis was performed to identify differences between respondents who completed laryngology fellowships (LF) and those who did not (NL). Results: Of 159 respondents, 40 were LF. Video documentation of laryngopharyngeal exams was almost universal among LF (97% vs 38%, P < .0001). Use of rigid (100%, P = .002) and flexible distal-chip technologies (94%, P = .004) was more common among LF. Diagnostic criteria were similar between the groups, with symptoms of heartburn, globus, and throat clearing thought most suggestive of LPR. Adjunctive tests most commonly used were barium esophagram and dual-probe pH testing with impedance. Laryngology fellowship-trained respondents used dual pH probes with impedance more often (P = .004). They were more likely to prescribe twice daily proton pump inhibitors with concurrent H2-blocker medication initially (P = .004) and to treat for longer than 4 weeks (P = .0003). Conclusion: Otolaryngologists are in agreement on symptoms and physical features of LPR; however, significant differences exist between laryngologists and non-laryngologists on the use of adjunctive testing and treatment strategies. Keywords laryngopharyngeal reflux, symptoms and signs, treatment, diagnosis
Introduction Laryngopharyngeal reflux (LPR) is recognized as the extraesophageal manifestation of reflux and is a commonly treated condition in the field of otolaryngology. Although efforts have been made to develop diagnostic criteria for this clinical entity, no universally accepted system currently exists. Variations in use of diagnostic investigations and treatment also differ between practicing otolaryngologists. In a survey of American Broncho-Esophagological Association (ABEA) members in 2002, Book et al1 sought to elicit respondents’ views on symptoms, physical findings, and diagnostic tests pertaining to laryngopharyngeal reflux. Respondents to this survey identified throat clearing, persistent cough, heartburn, and voice quality change as symptoms most indicative of reflux. Respondents broadly agreed that physical signs of LPR are arytenoid erythema, arytenoid edema, vocal cord erythema, and posterior commissure hypertrophy.1 The respondents to the 2002 survey also considered flexible fiberoptic laryngoscopy to be the
most sensitive and specific diagnostic test for LPR and regarded dual pH probe studies as the most valuable adjunctive test.1 In the decade since that study was published, new knowledge and new technologies have influenced how LPR is diagnosed and managed. An increasing body of evidence documents potential harm from prolonged proton pump inhibitor (PPI) use even as the potential benefit of PPI in 1
Department of Otolaryngology–Head and Neck Surgery, Johns Hopkins University, Baltimore, Maryland, USA 2 Department of Otolaryngology–Head and Neck Surgery, Cincinnati Children’s Medical Center, Cincinnati, Ohio, USA 3 Department of Otolaryngology & Communication Sciences, Medical College of Wisconsin, Milwaukee, Wisconsin, USA Corresponding Author: Lee M. Akst, MD, Johns Hopkins Outpatient Center, Department of Otolaryngology–Head and Neck Surgery, 601 N. Caroline Street, Baltimore, MD 21287, USA. Email: [email protected]
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Table 1. Symptoms in Terms of Their Relationship to Reflux.a Please rate each of the following symptoms in terms of their relationship to reflux (Scale: 1 to 5, where 1 = highly related, 3 = somewhat related, 5 = not related). Answer Option Dysphagia Choking episodes Persistent cough Change in voice quality Pain with phonation Globus sensation Throat clearing Heartburn/dyspepsia Postnasal drip Nasal obstruction
1
2
3
4
5
13.0 15.6 29.1 21.1 33.4 48.3 50.0 53.1 6.2 0.7
35.6 38.8 47.3 38.8 11.7 34.0 36.5 20.0 26.7 1.4
39 31.3 18.9 26.5 33.1 11.6 9.5 15.9 28.8 21.9
8.9 9.5 4.1 10.9 35.9 2.7 2.0 9.0 27.4 41.1
3.4 4.8 0.7 2.7 15.9 3.4 2.0 2.1 11.0 34.9
a
All values are percentages.
LPR has been called into question.2,3 At the same time, pH probe testing and transnasal esophagoscopy (TNE) have entered more widespread practice. With these changes in mind, the aim of this study was to characterize current patterns in the diagnosis and treatment of LPR within the broader otolaryngologic community, with particular attention to the role that has been adopted for use of new technologies in reflux care. A second aim was to examine any significant differences between those with subspecialty training in laryngology and other otolaryngologists in approaches to LPR diagnosis, testing, and treatment.
Methods This study was reviewed by the Johns Hopkins Medicine Institutional Review Board and was granted exempt status. A link to an online survey was published in an October 2012 edition of American Academy of Otolaryngology–Head and Neck Surgery (AAO-HNS) The News, a weekly newsletter emailed to members of the AAO-HNS. At that same time, an email link was sent to ABEA members. Respondents were directed to an online survey and were asked to answer a series of multiple-choice questions related to their training, views on signs and symptoms of LPR, and patterns for diagnosis and treatment of LPR. All questions were optional and consent for participation was obtained at the beginning of the survey. During analysis of those signs or symptoms, which were most highly related to particular aspects of reflux care, answers were stratified by the proportion of respondents selecting “1–highly related” or “2” on the 5-point Likert-type scale. Similarly, those answer choices that garnered the highest proportion of “4” or “5–not related” were considered to be least related to a particular aspect of reflux care. Tests were placed in rank order in terms of utility for care, diagnosis, and treatment of reflux
patients based on these Likert-scale responses. Twosample t tests were used to assess for statistically significant differences, defined as P < .05 between laryngology fellowship-trained respondents (LF) and non-laryngology fellowship-trained respondents (NL). The complete survey is listed as an appendix.
Results There was a total of 161 survey respondents; 2 were excluded from the final analysis, as they were not practicing otolaryngologists. Thirty-five percent of respondents were in academic practice, 53% were community based, and 11% classified their practices as a combination of academic and community based. Forty respondents (26%) indicated that they had completed laryngology fellowships, 146 respondents (90%) indicated that they were AAO-HNS members, and 64 were ABEA members (41%). Fifty percent of respondents completed their training before 1993. Overall, NL respondents had been practicing longer than LF respondents (mean, 19.6 vs 11.4 years; P = .0001). Seventy-one percent of respondents indicated that < 50% of their practice is devoted to laryngology/bronchoesophagology; 62% of respondents also indicated that < 50% of their laryngobronchoesophagology patients present with chief complaints that are directly attributable to LPR. When asked about the prevalence of LPR in respondents’ laryngobronchoesophagology patients, 54% reported diagnosing LPR in ≤ 50%, 33% in 51% to 75%, and 13% in > 75% of their patients. The ratings of LPR-related patient symptoms are shown in Table 1. The 4 most frequently selected symptoms were throat clearing (87%), globus sensation (82%), persistent cough (76%), and heartburn/dyspepsia (73%). The 4 symptoms thought to be least related to reflux were nasal obstruction (76%), pain with phonation
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Gooi et al Table 2. Physical Exam Findings in Terms of Their Relationship to Reflux.a
Please rate each of the following physical exam findings in terms of their relationship to reflux (Scale: 1 to 5, where 1 = highly related, 3 = somewhat related, 5 = not related). Answer Option Pachydermia laryngis Vocal cord paralysis/paresis Vocal cord polyp Vocal cord nodule Laryngotracheal stenosis Laryngeal carcinoma Vocal cord erythema Vocal cord edema Ventricular obliteration Posterior commissure hypertrophy Arytenoid erythema Arytenoid edema Arytenoid blood vessel obliteration Subcordal edema
1
2
3
4
5
41.7 0 2.1 2.0 11.5 2.1 17.0 23.6 16.2 45.6 43.2 46.6 9.4 15.5
26.4 1.4 15.2 15.0 14.9 9.7 42.9 39.2 29.1 32.0 32.9 33.8 21.7 27.0
22.9 7.5 29.7 33.3 37.8 29.2 25.9 25.7 29.7 15.6 17.8 14.2 46.4 35.8
5.6 20.4 27.6 25.2 23.6 42.4 8.2 9.5 18.2 4.8 17.8 4.1 14.5 16.2
3.5 70.7 25.5 24.5 12.2 16.7 6.1 2.0 6.8 2.0 2.1 1.4 8.0 5.4
a
All values are percentages.
(52%), postnasal drip (38%), and choking episodes (14%). The ratings of reflux-related physical exam findings are shown in Table 2. Respondents most highly ranked arytenoid edema (80%), posterior commissure hypertrophy (77%), arytenoid erythema (76%), and pachydermia laryngis (68%). Conversely, the physical exam findings thought to be least related to LPR were vocal cord paralysis/paresis (91%), laryngeal carcinoma (59%), vocal cord polyp (53%), and vocal cord nodule (50%). There were no significant differences in the selection of LPR-related symptoms and physical signs between LF and NL respondents. Fifty-three percent of respondents routinely video-documented their laryngeal examinations. There was a significant difference in the video documentation of laryngopharyngeal exams between LF (97%) and NL (38%, P < .0001). Rigid laryngeal endoscopy, flexible fiberoptic transnasal endoscopy, and distal-chip transnasal endoscopy were available to 100%, 84.4%, and 94% of LF respondents, respectively, whereas among NL respondents, these diagnostic adjuncts were available to 78.4%, 95.2%, and 62.9%, respectively. The availability of rigid laryngeal endoscopy (P = .002) and distal-chip transnasal endoscopy (P = .004) was significantly higher among the LF compared to the NL group. Table 3 shows the most commonly obtained adjunctive diagnostic tests for LPR. Eighty percent of LF and 69.4% of NL indicated that they most commonly did not order any further adjunctive diagnostic tests (P = .481). Review of the survey tool in the appendix makes clear that several different types of pH probe were available for selection by respondents; the survey allowed for the separate selection of pharyngeal and esophageal probes with or without
impedance testing. The most popular adjunctive diagnostic tests were esophagogastroduodenoscopy (EGD), barium esophagram, and dual pH probe with impedance. Laryngology fellowship-trained respondents were more likely to list dual pH probe with impedance among their top 3 choices for testing than were NL respondents (85.0% LF vs 36.4% NL, P = .004). The least commonly ordered adjunctive diagnostic tests were pharyngeal pH probe testing, esophageal manometry, and wired single esophageal pH probe. When asked which tests were most sensitive and specific for diagnosis of LPR, dual pH probe with impedance was selected most often, with dual pH probe (pharyngeal and esophageal) and pharyngeal pH probe testing being the next 2 most commonly selected tests. Tests thought least sensitive or specific were wired or wireless (Bravo) single esophageal pH probe, TNE, and EGD. No statistically significant differences existed between LF and NL in their interpretation of the sensitivity and specificity of these tests. The full results for ranking of perceived sensitivity/specificity of diagnostic tools are shown in Table 4. When respondents were asked what adjunctive tests they obtained themselves without referral to a gastroenterologist, barium esophagram (67%) and TNE (47%) were the tests most commonly listed by respondents. However, LF respondents were significantly more likely to use TNE without making a referral to a gastroenterologist compared to NL respondents (80% vs 33.3%, P < .0001). Greater than 80% of respondents overall referred patients to a gastroenterologist for pH probe studies, esophageal manometry, and EGD. Respondents offered a wide variety of explanations when identifying barriers to
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Table 3. Adjunctive Diagnostic Tests Most Commonly Obtained to Further Validate or Investigate the Diagnosis of Laryngopharyngeal Reflux.a Which of the following adjunctive diagnostic tests do you most commonly obtain to further validate or investigate your diagnosis of laryngopharyngeal reflux? (Rank as many tests as you obtain, starting with 1 being the most commonly obtained and 12 being the least commonly obtained; please stop numbering when you have finished listing all of the tests you order. You do not have to rank every test.) Answer Option “None. I do not order other tests.” Barium esophagram Endoscopy: esophagogastroduodenoscopy Endoscopy: transnasal esophagoscopy Esophageal manometry pH probe: pharyngeal testing (Restech) pH probe: esophageal, single-probe, wired pH probe: esophageal, single-probe, wireless (Bravo) pH probe: dual probe (pharyngeal and esophageal) pH probe: dual probe (proximal and distal esophageal) pH probe: dual probe with impedance Other
1
2
3
4
5
6
7
8
9
11
12
73.2 35.6 11.1 13.6 0.0 10.8 0.0 2.6 2.9 0.0 28.3 15.4
5.4 18.9 39.5 20.3 6.4 2.7 6.5 7.9 11.4 7.9 17.4 15.4
5.4 12.2 16.0 10.2 19.1 10.8 0.0 18.4 22.9 23.7 10.9 0.0
3.6 8.9 13.6 13.6 10.6 8.1 9.7 5.3 5.7 15.8 2.2 23.1
0.0 7.8 8.6 11.9 12.8 16.2 6.5 5.3 5.7 2.6 8.7 0.0
0.0 2.2 4.9 6.8 10.6 21.6 12.9 15.8 2.9 7.9 0.0 0.0
0.0 2.2 2.5 8.5 6.4 2.7 19.4 10.5 11.4 10.5 0.0 0.0
0.0 3.3 3.7 0.0 8.5 2.7 6.5 21.1 17.1 2.6 2.2 0.0
0.0 4.4 0.0 3.4 12.8 5.4 12.9 5.3 14.3 7.9 6.5 0.0
7.1 3.3 0.0 1.7 6.4 8.1 6.5 5.3 0.0 21.1 8.7 15.4
5.4 1.1 0.0 10.2 6.4 10.8 19.4 2.6 5.7 0.0 15.2 30.8
a
All values are percentages.
Table 4. Tests Regarded as Most Sensitive and Specific for the Diagnosis of Laryngopharyngeal Reflux.a Of the possible tests listed, which do you feel is most sensitive and specific for the diagnosis of laryngopharyngeal reflux? (Please rank on a scale of 1 to 10, with 1 as the most sensitive/specific and 10 as the least sensitive/specific.) Answer Option Barium esophagram Endoscopy: esophagogastroduodenoscopy Endoscopy: transnasal esophagoscopy Esophageal manometry pH probe: pharyngeal testing (Restech) pH probe: esophageal, single-probe, wired or wireless (Bravo) pH probe: dual probe (pharyngeal and esophageal) pH probe: dual probe (proximal and distal esophageal) pH probe: dual probe with impedance Other
1
2
3
4
5
6
7
8
9
10
2.8 10.0 10.7 1.9 26.3 2.0 32.4 10.5 65.7 30.0
9.9 11.4 5.4 9.6 10.5 7.8 36.8 28.1 9.0 10.0
9.9 10.0 14.3 7.7 14.0 5.9 16.2 29.8 6.0 0.0
2.8 8.6 10.7 7.7 8.8 31.1 7.4 8.8 9.0 0.0
7.0 4.3 3.6 3.8 22.8 29.4 4.4 12.3 3.0 10.0
8.5 14.3 8.9 15.4 12.3 15.7 0.0 3.5 1.5 0.0
7.0 18.6 26.8 9.6 3.5 0.0 2.9 1.8 3.0 0.0
19.7 14.3 12.5 11.5 1.8 5.9 0.0 1.8 1.5 0.0
19.7 7.1 3.6 30.8 0.0 0.0 0.0 3.5 1.5 0
12.7 1.4 3.6 1.9 0.0 2.0 0.0 0.0 0.0 50.0
a
All values are percentages.
performing pH probe testing as part of their practice (Table 5). The most commonly selected options for “most important barrier” were not enough time (33%), do not believe it adds meaningfully to patient care (25%), and concern for cost (22%). An almost equal number of respondents indicated concern for patient tolerance (20%) and being unfamiliar with interpretation (18%) as the most important barrier for not performing pH probe testing. A greater proportion of LF respondents indicated “not enough time” as the most important barrier compared with NL, whereas “concern for cost” was cited by a greater proportion of NL as the most important barrier (P = .08). When asked to identify the most important
barriers that prevented respondents from incorporating TNE as part of their practice, concern for cost (49%), unfamiliarity with interpretation (20%), concern for patient tolerance (20%), and not enough time (17%) were the most popular choices, as shown in Table 6. A majority (82%) of respondents indicated that they would treat presumed LPR empirically without further testing more than 60% of the time. The most popular empiric treatment options selected were twice daily PPI (39%), once daily high-dose PPI (29%), and once daily low-dose PPI (21%). Laryngology fellowship-trained respondents were significantly more likely to prescribe twice daily PPI with concurrent H2-blocker medication
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Gooi et al Table 5. Barriers Toward pH Probe Testing.a If you do NOT currently perform your own pH probe testing as part of your practice, what are the barriers that have kept you from doing so? Please rank in order of importance, from 1 to 7 (1 = most important barrier, 8 = least important barrier). If you do perform your own pH probe testing, please skip this question. Answer Option Concern for cost Concern for patient scheduling/convenience Concern for patient tolerance Do not believe it adds meaningfully to patient care Not enough time Unclear on appropriate indications Unfamiliar with interpretation
1
2
3
4
5
6
21.9 8.8 19.7 25.0 32.9 4.5 18.4
28.8 25.0 15.2 10.0 5.7 17.9 14.5
13.7 23.5 21.2 10.0 17.1 6.0 14.5
16.4 13.2 18.2 8.3 15.7 11.9 13.2
8.2 14.7 7.6 5.0 8.6 28.4 10.5
5.5 10.3 13.6 13.3 5.7 19.4 14.5
7 5.5 4.4 4.5 28.3 14.3 11.9 14.5
a
All values are percentages.
Table 6. Barriers Toward Transnasal Esophagoscopy.a If you do NOT currently perform transnasal esophagoscopy (TNE) as part of your practice, what are the barriers that have kept you from doing so? Please rank in order of importance, from 1 to 7 (1 = most important barrier, 7 = least important barrier). If you do perform TNE as part of your practice, then do not answer this question and skip to question 18. Answer Option Concern for cost Concern for patient scheduling/convenience Concern for patient tolerance Do not believe it adds meaningfully to patient care Not enough time Unclear on appropriate indications Unfamiliar with interpretation
1
2
3
4
5
6
7
48.9 7.1 19.6 12.2 17.4 7.1 20.4
17.0 19.0 30.4 4.9 19.6 11.9 14.8
6.4 26.2 19.6 12.2 17.4 11.9 13.0
12.8 19.0 15.2 7.3 15.2 9.5 13.0
6.4 14.3 8.7 12.2 6.5 23.8 14.8
4.3 11.9 6.5 7.3 4.3 31.0 14.8
4.3 2.4 0.0 43.9 19.6 4.8 9.3
a
All values are percentages.
initially (P = .004). The most common responses for duration of this empiric treatment trial were 2 months (43%), 3 months (34%), and 1 month (18%). Laryngology fellowship-trained respondents were significantly more likely to use empiric treatment duration of greater than 1 month compared to NL respondents (P = .0003). When asked what they would do for a patient who failed empiric treatment for LPR, 37% of respondents indicated that they would obtain further testing, 30% would refer to a gastroenterologist for further evaluation and management, 25% would continue empiric treatment with an increased PPI dose, and 5% indicated that they would prolong empiric treatment with the same medication regimen. A greater proportion of LF respondents chose further testing compared to NL (51% vs 31%, P = .053), whereas NL more commonly chose “refer to gastroenterologist for further evaluation and management” (30% vs 18%, P = .115). When respondents were asked their most commonly ordered diagnostic test for a patient who failed an empiric treatment trial for LPR, the top 3 overall selections were EGD, barium esophagram, and esophageal dual pH probe with impedance.
Discussion The current study examines practice patterns of otolaryngologists in the diagnosis, adjunct testing, and treatment of LPR. Overall, diagnosis and management of LPR remain frustrating, without true gold standards against which to measure current practice patterns. Regarding diagnosis of LPR, strategies vary from clinical diagnosis based on history and examination alone to diagnosis based on response to empiric treatment and on pH testing. Laryngology fellowship-trained and NL respondents demonstrated broad agreement in which patient complaints and exam findings they thought to be most related to LPR. Heartburn, throat clearing, globus sensation, and persistent cough were thought by respondents to correlate with LPR. This symptom complex mirrors those symptoms included on the reflux symptom index.4 Similarly, physical findings thought to be highly related to LPR by respondents mirror those included in the reflux finding score and include arytenoid edema, posterior commissure hypertrophy, pachydermia laryngis, and arytenoid erythema.5 Despite this broad agreement on signs and symptoms, there are
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statistically significant differences in practice patterns between NL and LF respondents, particularly related to use of diagnostic adjuncts and treatment strategies for LPR. As knowledge evolves, recommendations have evolved as well. It used to be that the recommended treatment for suspected LPR was twice daily PPI for at least 2 months.6 With more recent concerns about the efficacy of PPI in treatment of isolated LPR symptoms (in the absence of heartburn) and with concern for PPI side effects, a more recent recommendation from the gastroenterology and otolaryngology communities has been to restrict empiric treatment of possible LPR without some further indication based on signs or symptoms that reflux is indeed present; otolaryngology position statements support laryngeal exam as being able to document reflux, whereas the most recent gastroenterology guidelines do not consider flexible laryngoscopy as a credible tool for LPR diagnosis.2,3 In this changing environment, an understanding of current practice patterns in the diagnosis, evaluation, and treatment of reflux takes on practical significance as current paradigms must be understood before care can be optimized. The finding that the vast majority of LF video- documented their laryngeal examinations and that there is increased availability of rigid laryngeal endoscopy and distal-chip transnasal endoscopy in LF practices in comparison with NL practices is likely due to a combination of factors. These include the cost of this equipment, emphasis on video documentation, and need in any particular practice for laryngeal stroboscopy, which would bring with it the necessity of video documentation and increase the likelihood of rigid endoscope and distal-chip technology availability. These perceived cost–benefit considerations may reduce the likelihood that NL practices will invest in distal-chip equipment and they fit with the finding of the current study that concern for cost was the most commonly identified barrier among NL practitioners not performing TNE as part of their practice. There is evidence to show that TNE has reduced overall patient costs compared to conventional esophagoscopy due to the avoidance of anesthetic and operating room charges.7 When weighing the costs and benefits of distal-chip technology, it is important to recognize that both distal-chip technology and rigid laryngeal exam may offer improved visualization of the larynx over flexible fiberoptic exam.8,9 Although potentially meaningful with regard to laryngeal lesions, the differences between these technologies as applied to reflux are more uncertain. Flexible exam may more often find signs of laryngeal tissue irritation in asymptomatic patients than rigid exam,10 perhaps suggesting reduced diagnostic specificity of flexible laryngoscopy in diagnosis of LPR; however, regardless of technique, there is a question as to whether laryngopharyngeal exam findings correlate with presence or absence of reflux in the first place.11
Moving beyond exam findings, although an almost equal proportion of LF and NL indicated that no further adjunctive diagnostic tests were obtained to validate the diagnosis of LPR, it was noted that a statistically significantly larger cohort of LF ordered pH probe: dual probe impedance studies as a diagnostic adjunct compared to NL. This is reflected in results showing an increased likelihood of LF respondents obtaining further testing and choosing pH probe studies as the preferred testing option compared to NL in the event of empiric treatment failure. The AAO-HNS has put forward that dual pH probe studies are the gold standard for objectively documenting LPR.6 Nevertheless, it is also acknowledged that the accuracy of pH probe testing is subject to variations in interpretation subject to positioning of the probe and artifactual errors caused by the local environment of the pharynx or upper esophageal sphincter and the inability to record non-acid reflux events.12 This uncertainty in diagnostic criteria may account for NL more commonly referring their patients to gastroenterologists and not using pH probe studies themselves as diagnostic adjuncts in the event of treatment failure, even as NL respondents indicate that a pH probe: dual probe test is one of the most sensitive and specific tests for the diagnosis of LPR. In this context, it is interesting that both NL and LF respondents list concern for interpretation as one of the most common reasons for not performing their own pH probes. The variation in treatment patterns of LPR observed in the current study between LF and NL is a likely reflection of ongoing evolvement in treatment recommendations by both gastroenterological and otolaryngological professional bodies. There seems to be some agreement between gastroenterology and otolaryngology communities that empiric treatment is to be undertaken cautiously and not without further evidence that reflux is related to patient complaints; for instance, the American Gastroenterology Association recommends against empiric treatment of extra-esophageal complaints of reflux with proton pump inhibitors unless there is concomitant patient complaint of heartburn.2 In relatively recent practice guidelines for management of hoarseness, empiric treatment with PPI was not recommended unless there were symptoms of GERD or laryngeal findings of inflammation to support reflux as a contributing factor to voice complaints.3 It is unfortunate that these guidelines do not suggest alternative strategies for treatment of extra-esophageal complaints in the absence of heartburn or laryngeal findings of reflux; otolaryngologists have expressed concern that most clinical practice guidelines for reflux disease are heavily biased toward the gastroenterological literature.13 Meanwhile, even as these guidelines recommend against empiric treatment, other guidelines suggest that if LPR is to be treated, then trials of therapy should be of twice daily PPI for at least 2 months to be considered adequate.6
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Gooi et al Treatment patterns as revealed in this study do not closely follow either of the above approaches. The majority of respondents treat reflux empirically, without further testing; this study does not assess whether these physicians are seeking other evidence on history of exam such as complaint of heartburn to justify empiric treatment; it is presumed that laryngoscopy is often performed, although specificity of laryngoscopy findings for reflux may be low as noted. It is surprising that the most common NL strategy for empiric treatment seems to be once daily PPI rather than twice daily PPI, as the total for once daily high-dose and once daily low-dose therapies constitutes one-half of all treatment regimens; although 77% of respondents choose 2 or 3 months as their most common length of empiric treatment, nearly 1 in 5 respondents would treat empirically for only 1 month. The observed variation in treatment patterns for LPR refractory to an initial trial of medical therapy also indicates the current state of the field, with no agreed-upon standard for either initial empiric treatment or subsequent evaluation of patients whose complaints are refractory to empiric treatment. Similarly, the wide variation of responses on the barriers toward the performance of TNE and pH probe testing in the management of LPR is also reflective of the lack of consensus of practitioners on the indications for these tests. There is further need for well-designed studies to establish an algorithm incorporating the use of these investigative modalities in cases of diagnostic uncertainty or treatment failure. To conclude, LF and NL respondents in our survey are in broad agreement regarding the symptoms and physical signs thought to be related to LPR. Laryngology fellowship-trained respondents were more likely to videodocument their laryngeal examinations and to use TNE and pH probe: dual probe with impedance compared to NL; these differences are a likely reflection of increased exposure from subspecialty training. Barriers that have been identified among practitioners to the use of these technologies include lack of familiarity, cost, and uncertainty with interpretation of results. There exists a need to refine clinical practice guidelines for the diagnosis and treatment of LPR in collaboration with gastroenterological specialties.
Appendix Respondents were asked about the nature of their practice (academic, community, and combination of academic and community) and the year in which they completed their training. They were asked to indicate if they had fellowship training in laryngology, head and neck surgery, pediatric otolaryngology, rhinology, facial plastic and reconstructive surgery, otology, allergy, thoracic surgery, or sleep medicine. Membership status in the American Academy of Otolaryngologic Allergy, American Academy of Otolaryngology–Head and Neck Surgery, American Broncho-Esophagological Association, American Head and
Neck Society, American Laryngological Association, American Rhinologic Society, and American Society of Pediatric Otolaryngology was elicited. Respondents were then asked, “What percentage of your clinical practice is devoted to laryngology or bronchoesophagology?” with options presented (0%-25%, 26%-50%, 51%-75%, and 76%-100%). Next, they were asked, “What percentage of your laryngobronchoesophagology patients present with chief complaints that you believe are directly or mainly attributable to laryngopharyngeal reflux?” with options presented (0%-25%, 26%-50%, 51%-75%, and 76%-100%), followed by, “What percentage of your laryngobronchoesophagology patients overall have laryngopharyngeal reflux?” with options presented (0%-25%, 26%-50%, 51%75%, and 76%-100%). Respondents were then asked to rate the following symptoms of dysphagia, choking episodes, persistent cough, change in voice quality, pain with phonation, globus sensation, throat clearing, heartburn and dyspepsia, postnasal drip, and nasal obstruction in terms of their relationship to reflux on a scale of 1 to 5 (where 1 = highly related, 3 = somewhat related, and 5 = not related). Next, they were asked to rate each of the following physical exam findings of pachydermia laryngis, vocal cord paralysis/paresis, vocal cord polyp, vocal cord nodule, laryngotracheal stenosis, laryngeal carcinoma, vocal cord erythema, vocal cord edema, ventricular obliteration, posterior commissure hypertrophy, arytenoid erythema, arytenoid edema, arytenoid blood vessel obliteration, and subcordal edema in terms of their relationship toward reflux on a scale of 1 to 5 (where 1 = highly related, 3 = somewhat related, and 5 = not related). Respondents were asked if they routinely performed video documentation of their laryngeal examinations. They were asked if rigid laryngeal endoscopy, flexible fiberoptic transnasal endoscopy, and distal-chip transnasal endoscopy were available in their practice. Next, respondents ranked the adjunctive diagnostic tests most commonly used to further validate or investigate the diagnosis of laryngeal reflux in the order of 1 to 12, with 1 being the most commonly obtained and 12 the least commonly obtained, with options presented including, “None. I do not order tests,” barium esophagram, esophagogastroduodenoscopy, transnasal esophagoscopy, esophageal manometry, pH probe: pharyngeal testing (Restech), pH probe: esophageal, single probe, wired, pH probe: esophageal, single probe, wireless (Bravo), pH probe: dual probe (pharyngeal and esophageal), pH probe: dual probe (proximal and distal esophageal), pH probe: dual probe with impedance, and other (with respondents specifying as a free text). Then, respondents were asked to indicate in order from 1 to 10 with 1 being the most sensitive/specific and 10 being the least sensitive/specific for the diagnosis of LPR among the following options: barium esophagram, esophagogastroduodenoscopy, transnasal esophagoscopy, esophageal manometry, pH probe: pharyngeal testing (Restech), pH probe: esophageal, single probe,
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wired, pH probe: esophageal, single probe, wireless (Bravo), pH probe: dual probe (pharyngeal and esophageal), pH probe: dual probe (proximal and distal esophageal), pH probe: dual probe with impedance, and other (with respondents specifying as a free text). Respondents were then asked to indicate yes or no if they performed the following tests as part of their own practice without referral to a gastroenterologist: barium esophagram, esophagogastroduodenoscopy, transnasal esophagoscopy, esophageal manometry, pH probe: pharyngeal testing (Restech), pH probe: esophageal, single probe, wired, pH probe: esophageal, single probe, wireless (Bravo), pH probe: dual probe (pharyngeal and esophageal), pH probe: dual probe (proximal and distal esophageal), pH probe: dual probe with impedance, and other (with respondents specifying as a free text). Next, respondents were asked to indicate the barriers that have kept them from performing their own pH probe testing as part of their own practice, ranking a list of options from 1 to 7, with 1 being the most important barrier and 7 the least important barrier, with options presented including concern for cost, concern for patient scheduling/convenience, concern for patient tolerance, do not believe it adds meaningfully to patient care, not enough time, unclear on appropriate indications, and unfamiliar with interpretation. Next, respondents were asked to indicate the barriers that have kept them from performing transnasal esophagoscopy as part of their own practice, ranking a list of options from 1 to 7, with 1 being the most important barrier and 7 the least important barrier, with options presented including concern for cost, concern for patient scheduling/ convenience, concern for patient tolerance, do not believe it adds meaningfully to patient care, not enough time, unclear on appropriate indications, and unfamiliar with interpretation. Next, respondents were asked how often they treated empirically for a patient with presumed laryngopharyngeal reflux without first obtaining any further testing, with options presented as 0%-20%, 21%-40%, 41%-60%, 61%-80%, and 81%-100%. Respondents were then asked which options they most often recommend for an empiric treatment trial in addition to lifestyle modifications, with choices presented including H2 receptor antagonist alone, once daily low-dose proton pump inhibitor (PPI), once daily high-dose PPI, twice daily PPI, once daily high-dose PPI and H2 receptor antagonist, twice daily PPI and H2 receptor antagonist, and other (with respondents specifying as a free text). Respondents were then asked, if they were treating a patient empirically, what was the duration of their initial empiric trial, with options given as < 1 month, 1 month, 2 months, 3 months, > 4 months, or other (with respondents specifying as a free text). Next, they were asked, for patients who were treated empirically for laryngopharyngeal reflux, what was the proportion of patients who responded to the specified treatment in their practice, with options presented as 0%-20%, 21%40%, 41%-60%, 61%-80%, and 81%-100%. Then, respondents were asked, for patients who do not respond to an
empiric trial of treatment for presumed laryngopharyngeal reflux, what would be the following next step, with options presented including continue empiric treatment, with increased dose of PPI, continue empiric treatment, with stable dose but increased length of trial, obtain further testing, refer the patient to a gastroenterologist for further evaluation and management, and other (with respondents specifying as a free text). Last, respondents were asked what further testing they would order for a patient who did not respond to an empiric trial of treatment for presumed laryngopharyngeal reflux on a scale of 1 to 9, with 1 being the most commonly ordered test and 9 being the least commonly ordered test, with options presented including barium esophagram, esophagogastroduodenoscopy, transnasal esophagoscopy, esophageal manometry, pH probe: pharyngeal testing (Restech), pH probe: esophageal, single probe, wired, pH probe: esophageal, single probe, wireless (Bravo), pH probe: dual probe (pharyngeal and esophageal), pH probe: dual probe (proximal and distal esophageal), pH probe: dual probe with impedance, and other (with respondents specifying as a free text). Declaration of Conflicting Interests The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.
Funding The author(s) received no financial support for the research, authorship, and/or publication of this article.
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