ABSTRACT
Objective
Modified barium swallow studies (MBSS) are one of two gold‐standard assessments for oropharyngeal swallowing. It is unclear how many patients referred for outpatient MBSS have normal swallowing despite a subjective complaint of dysphagia. This study examined the rate, referral diagnoses, and referral patterns of outpatient MBSS.
Methods
A retrospective descriptive case series was conducted of outpatient adult MBSS between January 1, 2019 and December 31, 2019. Normal MBSS were identified and stratified by present/absent history of neurological disease or head and neck cancer (HNC). Referral sources and diagnoses were tracked.
Results
Six hundred fifteen patients were referred for MBSS. 285 (46%) studies were normal; of these, 209 (73% of normal MBSS; 34% of total MBSS) had no history of neurological disease or HNC and were predominately female (female 128, 61%, male 81, 39%). The primary referral diagnoses for MBSS are: Dysphagia, unspecified (48, 23.0%), Dysphagia, other (6, 2.9%), Dysphagia, pharyngeal (8, 3.8%), Dysphagia, esophageal (14, 6.7%), Dysphagia, oropharyngeal (43, 20.6%), Dysphagia, pharyngoesophageal (12, 5.7%), GERD/LPR (7, 3.3%), Chronic cough (11, 5.3%), Chronic throat clearing (2, 1.0%), Other (including Zenker's diverticulum 58, 27.8%). The primary referral sources were: ENT (72, 34.4%), Gastroenterology (57, 27.3%), PCP: (23, 11.0%).
Conclusion
Nearly half of all patients referred for MBSS were judged to have normal oropharyngeal swallowing. There may be a discrepancy between patient complaint and evaluation results necessitating revision of referral patterns and evaluation methods and consideration of transient or poorly understood presentations of dysphagia.
Levels of Evidence
4
Keywords: case series, dysphagia, modified barium swallow, normal swallowing, swallowing
1. Introduction
Modified barium swallow studies (MBSS), also known as videofluoroscopic swallow studies (VFSS), are one of two gold‐standard instrumental assessments for swallowing. MBSS are radiographic examinations that primarily utilize barium sulfate in various consistencies including thin and thick liquids, as well as semisolids and solids to simulate and visualize the swallowing of these various consistencies. In the United States, the studies are performed by a speech‐language pathologist (SLP) in radiology with an attending radiologist and a radiologic technologist/radiographer, while in many other countries a radiologist is not present. MBSS are requested by an order from a referring physician of any specialty, including, but not limited to otolaryngology, gastroenterology, and internal medicine.
The purpose of the MBS is to directly visualize swallowing anatomy and physiology, to assess the safety and efficiency of the swallow, and to test the impact of therapeutic maneuvers which may facilitate the least restrictive diet [1, 2]. The reason for obtaining an MBS may vary based upon setting (inpatient/acute care, inpatient rehab, outpatient, and skilled nursing facilities).
It is unclear how many outpatients who are referred for an MBS study receive a clinical impression of normal swallowing based on the exam. In 1997, at Saint Joseph's Hospital of Atlanta, Martin‐Harris et al. [3] and colleagues tracked all inpatient and outpatient MBSS using the Penetration‐Aspiration Scale [4] as a measure of swallowing function. Their results showed 10.4% of the MBSS were classified as normal. While they did specify that 60% of the total MBSS performed were outpatient, sub‐analysis was not performed on this group exclusively, as inpatients and outpatients were included together in the same dataset in that study [3].
Since then, additional assessment tools have been developed including the Davis Score [5], the Dynamic Image Grade of Swallowing Toxicity (DIGEST) [6] and the standardized protocol of the Modified Barium Swallow Impairment Profile (MBSImP) [7]. Additionally, recent advances in instrumentation to quantify swallowing problems include surface electromyography [8, 9], high resolution pharyngeal manometry [10, 11], and ultrasound [12, 13]. The 1997 clinical utility study [3] clearly demonstrates the scientific merit of analyzing a hospital's MBSS to determine understanding of diagnostic yields, application of swallowing maneuvers/strategies on MBSS, and changes in diet which may guide the management of patients with dysphagia; however, this study grouped inpatient and outpatient MBSS together. It is foundational research to discern which pathologies receive the most MBSS and how the proportion of normal MBSS is relevant to the underlying pathology.
While MBSS are relatively safe, they do expose the patient to risk of aspirating contrast material and radiation exposure [14]. It may be valuable to understand which patients are unlikely to show pathologic swallowing on MBSS as it may offer a window for quality improvement to reduce unnecessary risk. In 2023 the American Broncho‐Esophagological Association (ABEA) published a position statement on swallowing fluoroscopy, including expert consensus statements regarding patient selection, choice of fluoroscopic study (MBSS/VFSS, esophagram), radiation safety, required team members and their training, MBSS/VFSS technique, esophagram technique, and MBSS/VFSS and esophagram interpretation [14]. In this paper, the expert panel asserts that challenges in differentiating normal from disordered swallowing limit accurate interpretation. This may be due to limited training on and exposure to normal MBSS [15, 16, 17].
Established literature describes the components of normal swallowing [18, 19, 20, 21, 22, 23] with acknowledgement of wide variability of normal parameters throughout a person's lifespan [24, 25]. Within the literature, normal MBSS are determined by a variety of factors including an absence of aspiration, effective bolus transit of the barium contrast, complete clearance of the contrast from the oropharynx post‐swallow, and coordinated muscular and structural movement during swallowing, including lip closure, palate elevation, laryngeal elevation, and pharyngeal contraction. The combination of these factors leads speech‐language pathologists to assign MBSS as normal [2]. Currently, there is a new body of research outlining diagnostic pathways for outpatients with subjective swallowing complaints who have normal instrumental exams including treatment for muscle tension and laryngeal hypersensitivity [26, 27, 28]. Clinically, these patients often represent significant challenges as their reported symptoms are not validated by available MBS testing and scoring systems. In Kang et al., all patients had a complaint of difficulty swallowing, a normal MBS, and 90% of patients improved with therapy by an SLP which focused on unloading muscle tension [27]. The purpose of this study is to determine the rate of outpatient MBS referrals resulting in normal oropharyngeal swallow function over one calendar year at a major academic medical center. The second aim of this study is to examine the demographics, referral diagnoses, and referral patterns of those normal MBSS.
2. Materials and Methods
Cleveland Clinic Institutional Review Board Approval was obtained: IRB #19‐454 for a retrospective case series. A retrospective chart review was conducted of outpatient MBSS in adults between January 1, 2019 and December 31, 2019 by a team of speech‐language pathologists at a large academic medical center. The average number of years of experience performing MBSS was 24.17 years without including clinical fellows and 18.96 years when including clinical fellows. In 2019, the MBSS were determined to be normal by the clinical judgment of the assessing SLP at time of MBS by the absence of aspiration, effective bolus transit of the barium contrast, complete clearance of the contrast from the oropharynx post‐swallow, and coordinated muscular and structural movement during swallowing, including lip closure, palate elevation, base of tongue retraction, laryngeal elevation, and pharyngeal contraction. The Penetration‐Aspiration Scale (PAS) [4] was utilized to describe swallowing on MBSS. In 2020 and beyond, MBSS were completed using the MBSImp and DIGEST (as appropriate) in addition to the PAS, however, these were not utilized with this data. Data was gathered via chart review analysis of the radiographic interpretation for the MBSS for each patient. The normal MBSS were then stratified by present/absent history of neurological disease (e.g., stroke, TBI) or head and neck cancer (HNC). Referral sources, age, diagnoses, and diet recommendations were recorded. Descriptive statistics were conducted. Two‐tailed student's T‐tests and chi‐squared testing were applied to continuous and categorical variables when appropriate when comparing referral source and diet recommendation and when comparing age of patient and diet recommendation. An alpha value of 0.05 was used when determining significance. No adjustment was made for multiple testing as statistics were primarily descriptive. JMP 17.2 (SAS Institute Inc., Cary, NC, 1989–2023) was used for all statistical analyses. The data was collected from the calendar year 2019 a pre‐COVID‐19 pandemic time frame, to avoid introducing the coronavirus pandemic as a confounding variable. As this is a cohort from one academic medical center, bias could be introduced due to the subjective nature of the instrumental assessment itself and that the population studied at our center may not represent “normal” in other areas or regions.
3. Results
In the year 2019 (Figure 1), 615 patients were referred for outpatient MBSS. 285 (46%) MBSS studies were normal; of these, 209 (73% of normal MBSS; 34% of total MBSS) had no history of neurological disease or HNC. The 209 patients were predominantly female (female 128, 61%, male 81, 39%). The median duration of patient complaint prior to normal MBSS was 9.5 months. The primary referral diagnoses for MBSS were: Dysphagia, unspecified (48, 23.0%), Dysphagia, other (6, 2.9%), Dysphagia, pharyngeal (8, 3.8%), Dysphagia, esophageal (14, 6.7%), Dysphagia, oropharyngeal (43, 20.6%), Dysphagia, pharyngoesophageal (12, 5.7%), GERD/LPR (7, 3.3%), Chronic cough (11, 5.3%), Chronic throat clearing (2, 1.0%), Other (evaluate for possible Zenker's diverticulum, 58, 27.8%). No patients had a diagnosis of Dysphagia, oral (0, 0.0%) or Dysphagia, cricopharyngeal (0, 0.0%). Other referral diagnoses (n = 58) varied widely (Figure 2). Common referring specialty sources for MBSS includes: ENT (72, 34.4%), Gastroenterology (57, 27.3%), primary care provider: (23, 11.0%) and other referral sources (28%) including psychiatry, psychology, spine, thoracic surgery, pulmonology. Of the 209 patients, 198 of them were recommended to continue consuming a regular diet. The 11 patients who were recommended a modified diet were recommended the modification regarding solid consistencies only; all 11 were recommended thin liquids. Solid modifications were recommended for 10 patients with the modification being “soft solids” correlating to the International Dysphagia Diet Standardization Initiative (IDDSI) Level 6: soft and bite sized, which is one level below IDDSI: Regular, Level 7. Only one patient was recommended a liquid‐only diet due to a dental fracture leading to nerve exposure and pain. Of the 10 patients who were recommended “soft solids,” five were edentulous, two had oral holding, two reported improvement with residues and one “preferred” soft solids. There were no statistically significant differences between the recommendation for continuing a normal diet and the MBS referral source (p = 0.11). The average age of patients with normal swallowing and a recommendation for a regular diet was 59.8 years of age (SD = 16 years, SE = 1.1 years). The average age of patients who had a normal MBS and were not recommended a regular diet was 73.5 years of age, (SD = 16.6 years, SE = 5.01 years). The age of patients with a recommendation for normal diet was significantly lower than those who had a recommendation for a modified diet (p = 0.0228). After MBSS, 39 patients (18.7%) were referred to Gastroenterology. Prior to normal MBSS (Figure 3) 75 patients had a CT scan (35.8%), 74 patients had Esophagogastroduodenoscopy (EGD) (35.4%), 71 patients had laryngoscopy (33.9%), 29 patients had an esophagram (13.8%), 28 patients had esophageal manometry (13.4%), 13 had prior MBSS (6.2%), 12 had pH probe (5.7%), 6 had MRI (2.9%), and 2 patients had a FEES evaluation (1%).
FIGURE 1.

2019 Modified barium swallow studies.
FIGURE 2.

Other referral diagnoses.
FIGURE 3.

Diagnostic tests prior to normal MBS.
For patients who received an esophagogastroduodenoscopy (EGD) prior to normal MBSS: 63.2% of patients were referred by GI, 36.4% of patients were referred by their PCP, 24.1% by other specialties, and 22.2% of patients were referred by ENT providers. For patients who received an esophagram prior to normal MBSS: 24.6% of patients were referred by GI, and 16.7% of patients were referred by ENT. The most common diagnostic tests to be ordered prior to a normal MBS included CT scans (n = 75) and EGD (n = 74) (Figure 3).
4. Discussion
The study results demonstrated that at our institution patients with a normal MBS were most likely to be female, approximately 60 years old, have an unspecified dysphagia diagnosis, be recommended a normal diet, and be referred by ENT.
Nearly half of all patients referred for an MBS had a normal oropharyngeal swallow, including many (n = 76) with neurological disease and head and neck cancer. After eliminating those patients with a normal oropharyngeal swallow and concomitant neurological disease or head and neck cancer, approximately one‐third (34%) of all patients referred for outpatient MBSS have normal oropharyngeal swallows. Given that so few patients (n = 29) had an esophagram prior to a normal MBS, this work could support obtaining an esophagram in combination with an MBS as outlined by the ABEA: “2d. An esophagram should be considered in patients with unexplained solid food dysphagia‐this includes patient with both normal and abnormal findings on VFSS.” “… a comprehensive esophagram is recommended for patients with solid food, unexplained oropharyngeal, and retrosternal dysphagia. This coincides with published esophagram indications from the ACR and American College of Gastroenterology (ACG)” [14]. Viewing the entire swallowing mechanism from lips to stomach on fluoroscopy involves two separate tests, MBS and esophagram. There may be benefits in doing these concurrently as one study [29] found that 48.4% of patients who had an unremarkable MBS study had an abnormal esophagram but does not specify which was completed first. The same study [29] found that 71.8% of patients had change in their original diagnosis after having both tests at different time points. Furthermore, this study [29] found that of the patients who had simultaneous MBS plus esophagram, 25.6% of them had no explanation for their complaint based upon those two tests concurrently.
The abundance of normal instrumental assessments posits the question as to whether the true nature of the patient's dysphagia is best captured by the MBS study and/or esophagram. It may be reasonable to continue further inquiry regarding whether the patient has sensory dysfunction/hypersensitivity (irritable larynx, laryngospasm, etc.) or possibly muscle tension in the absence of any anatomic and physiologic abnormalities. These more poorly understood mechanisms of dysphagia may be harder to assess objectively and therefore require not only a process of diagnostic elimination but additional assessment of the clinical features of the swallowing dysfunction [28]. It also posits the question as to what the best treatment course is for a patient with a subjective complaint/symptom of dysphagia in the absence of identifiable swallowing dysfunction. Therefore, there may be a mismatch between the available tests to assess dysphagia symptoms and the ability of those tests to identify the etiology of dysphagia.
Moreover, patients who are found to have a normal instrumental swallowing exam, but a lingering complaint of subjective swallowing dysfunction may benefit from further diagnostic work up with consideration for muscle tension or laryngeal hypersensitivity [26, 27, 28]. If further diagnostic tests rule out any abnormalities, it may be reasonable to consider swallowing or voice therapy for some of these patients [26, 27]. Chalmers et al. [28] stresses that a functional dysphagia diagnosis cannot rely on exclusionary criteria alone [30] and also can co‐occur with a disorder of visible motoric swallowing dysfunction [26, 27]. However, it is unclear how many receive or seek therapy. As a corollary, patients with voice changes and or pain/discomfort with voicing and a normal videostroboscopic evaluation of the larynx with no evidence of anatomic abnormality or neurologic impairment are presumed to have muscle tension dysphonia/functional dysphonia and sent to voice therapy [30]. It certainly would be reasonable to consider a therapeutic option for patients without evidence of abnormality either after comprehensive work‐up or while comprehensive work‐up is being completed [26, 27].
Patients without prior evaluation of the esophagus and normal oropharyngeal swallow may require additional diagnostics to assess esophageal structure and function [29, 31, 32]. Given that only 13% of patients in this study had an esophagram before a normal MBS, the esophageal screening component of the MBSS by SLP may be useful to determine the next step in dysphagia diagnostics. However, there is a lack of standardization, terminology, and protocol for this screen [33], and it does not substitute for full gastroenterological assessment.
This study offers data on a commonly ordered instrumental assessment for dysphagia to determine the diagnostic yield of normal versus impaired exams. Valuable next steps would include potential studies where long‐term swallowing outcomes are measured for patients with subjective complaints of dysphagia to determine the etiology of the subjective complaint in the setting of a normal instrumental exam. It could be theorized that these patients could have a component of muscle tension or upper airway hypersensitivity (“irritable larynx”) or other nonspecific complaints which are not measured by MBSS. Additionally, longitudinal studies could determine which patients may have resolution from reassurance of a normal exam versus continuing further investigation into symptomatic complaints of dysphagia. Longitudinal data would reveal whether MBSS are failing to identify subclinical dysphagia but treatable symptoms/pathologies and how to address these issues. This study offers preliminary insight into background data regarding the efficacy of MBSS by tracking yield, referral sources, and primary pathologies.
The patients in this study were all evaluated at a single academic medical center, which is a study limitation. While this study examined which tests were conducted prior to an MBS referral, we did not have access to these test results. Other limitations include the use of retrospective data, the possibility of incomplete clinical records, and possible inconsistencies with determining a “normal” swallow. It would be useful to look at a larger volume of normal outpatient MBSS across multiple institutions to determine if the patterns seen here are unique. An additional study limitation is the lack of a formalized definition of “normal.” Lastly, data was collected prior to the start of the Covid‐19 Pandemic; this year was specifically chosen to prevent the coronavirus pandemic from becoming a variable in the dataset.
5. Conclusion
Given that nearly half of outpatient MBSS were interpreted as normal, this evaluation method has limited sensitivity to determine the cause of subjective complaints of dysphagia. In the presence of a normal outpatient MBS, clinicians should consider the specific nature of patient report and clinical signs and symptoms to guide additional testing and intervention. Future directions include tracking follow‐up visits or interventions for those patients deemed to have normal MBSS to determine pathways to resolution of subjective complaints of dysphagia.
Funding
The authors have nothing to report.
Conflicts of Interest
The authors declare no conflicts of interest.
Acknowledgments
We would like to thank the team of speech‐language pathologists who performed these MBSS: Rachel Barrocas, MS, CCC‐SLP, Kristen Berezniak, MS, CCC‐SLP, Amy Calhoun Rosneck, MA, CCC‐SLP, Emily Fitzpatrick, MS, CCC‐SLP Lauren Gurd, MA, CCC‐SLP, Brian Hedman, MA, CCC‐SLP, Beth Hohman, MS, CCC‐SLP, Joann Kmiecik, MA‐CCC‐SLP, Kim Lewin, MA, CCC‐SLP. To SLP colleagues Michelle York, MA, CCC‐SLP, Molly Smeltzer, MS, CCC‐SLP, and Rachel Barrocas, MS, CCC‐SLP, thank you for your time, attention, and peer review of this manuscript.
Data Availability Statement
Research data are not shared.
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Associated Data
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Data Availability Statement
Research data are not shared.
