Normative Value For The Laryngopharyngeal Measure Of Perceived Sensation

Abstract

Objectives:

The Laryngopharyngeal Measure of Perceived Sensation (LUMP) is a recently validated patient-reported outcome measure (PROM) aimed at evaluating the symptom severity of patients with globus pharyngeus. The objective of this study was to define the normative values for the LUMP questionnaire.

Methods:

The LUMP questionnaire was completed by eighty-eight subjects. Individuals without throat related symptoms such as dysphagia, dysphonia, or cough were provided LUMP. The results of the eight-item questionnaire were analyzed for standard error of the mean (SEM), mean and standard deviation (SD).

Results:

Review of the eighty-eight LUMP questionnaires elucidated a mean of 0.42 (SEM = 0.10, SD = 0.96) in the normative population. By gender, the female (n=50) mean was 0.24, SD = 0.66, SEM = 0.09; for males (n=38), the mean was 0.66, SD = 1.21, SEM = 0.20.

Conclusion:

This study provides normative data for the LUMP, a recently established PROM useful in patients with globus pharyngeus. A LUMP score greater than, or equal to 3 should be considered abnormal, and warrants additional attention.

Introduction

Globus pharyngeus (GP) is a diagnosis that has been described for millennia^[1]. In that time, GP has undergone change in nomenclature and proposed etiology. Defined as a persistent foreign body sensation in the throat with an absence of clinical findings, GP was initially thought to be a psychosomatic disorder^[2]. It is now appreciated that GP may be associated with a variety of aerodigestive aberrations including gastroesophageal reflux disease (GERD), laryngopharyngeal reflux (LPR), esophageal dysmotility, and upper esophageal sphincter dysfunction^[1–3]. Representing 3–4% of new patient otolaryngology visits and affecting approximately 22–46% of the population, GP is frequently encountered by head and neck specialists^{[2, 4]}. Despite advancement in the understanding of this clinical entity, lack of pathognomonic clinical signs or conclusive testing has left GP difficult to objectively identify, and monitor.

The goal of objectifying subjective results in otolaryngology is not an uncommon one. A number of patient-reported outcome measures (PROMs) have been developed to assist in identifying diagnoses and trending treatment outcomes. Frequently used examples of such PROMs include the Eating Assessment Tool-10, the Voice Related Quality of Life measure, and the Reflux Symptom Index^[5–7]. In 1995 the Glasgow-Edinburgh Throat Scale was developed as an instrument to characterize the severity and nature of globus pharyngeus^[8]. This 12-item questionnaire inherently possessed three subscales relating to swallowing, painful throat and GP. Additionally, two of the 12 questions resulted in a separate score attempting to capture the somatic distress related to the patient’s diagnosis^[8]. This somewhat intricate scoring system, paired with verbiage above the level of the general public has likely resulted in the limited use of this PROM. In an effort to address the need for a practical, patient accessible, and modernized PROM to better evaluate GP, Melancon et al developed the Laryngopharyngeal Measure of Perceived Sensation (LUMP) questionnaire^[9]. This 8-item survey (Table 1) was created through the collaborative efforts of fellowship trained laryngologists and speech language pathologists following principle tenants described by Francis et al in the effective creation and validation of PROMs^[10]. The resultant LUMP questionnaire is a concise and effective symptom-specific outcome measure helpful in the evaluation of GP. The aim of this study is to establish a normative value for the LUMP questionnaire.

Table 1.

Eight-item Laryngopharyngeal Measure of Perceived Sensation

To what degree are the following statements true. Circle an answer between 0 and 4			0 = No problem 4 = significant problem
1. I feel like I have a lump in my throat	0	1	2	3	4
2. I feel like I have something stuck in my throat	0	1	2	3	4
3. I feel like my throat is closing off	0	1	2	3	4
4. I feel like my throat is swollen	0	1	2	3	4
5. I often feel like I am choking	0	1	2	3	4
6. I feel like my throat is tight	0	1	2	3	4
7. I feel like I need to swallow all of the time	0	1	2	3	4
8. My throat symptoms are very distressing to me	0	1	2	3	4

Materials and Methods

Approval was obtained from the Wake Forest Baptist Medical Center Institutional Review Board (IRB00062878) prior to initiation of this investigation. The LUMP questionnaire was offered to patients visiting the Otolaryngology - Head and Neck Surgery Clinic at Wake Forest Baptist Medical Center with chief complaints not related to concerns of the airway or swallowing. This distinction was made at the time of evaluation by the otolaryngology provider. Examples of such complaints included historical facial trauma, otologic and benign salivary pathology. Individuals visiting clinic as patient guests were also invited to participate. Residents and students participating in otolaryngology rotations were also provided the opportunity to contribute. Individuals who voiced disinterest in participating, or any history of aerodigestive complaints were excluded. 88 participants completed the provided survey after verifying a lack of prior esophageal or laryngeal testing and/or surgical procedures. The number of questionnaires collected was verified as sufficient in concluding a normative value with adequate strength. This was confirmed by a margin around the mean within 0.09 of a standard deviation when considering a reliability of 0.80. Additionally, final results demonstrated the ability to detect statistical significance reflecting an adequate sample size. All participants were asked to complete the LUMP questionnaire privately and without assistance. Only individuals greater than 18 years of age with English as their primary language were included in this study.

The individual item responses from each LUMP questionnaire were recorded into a computer spreadsheet (Microsoft® Excel 2018). Responses were then analyzed for mean, standard error of the mean (SEM), and standard deviation (SD). Outliers were defined as being greater than three standard deviations from the mean.

Results

All 88 of the LUMP questionnaires were answered in their entirety. The average age of participants, in years, was 43.4 with a range of 18 to 79. None of the questionnaires met criteria for exclusion as outliners, as all individual averages fell within three standard deviations of the overall mean. Fifty of the 88 questionnaires were answered by women and 38 were answered by men. When separated by gender, the female group mean (n = 50) was 0.24 (SD = 0.66, SEM = 0.09), the male group mean (n = 38) was 0.66 (SD = 1.21, SEM = 0.20) and collectively the results of all questionnaires had a mean of 0.42 (SD = 0.96, SEM = 0.10).

Discussion

Despite being simplified as a “lump in the throat”, globus pharygneus (GP) is often a complex and frustrating process to manage. Given this disease process is chiefly driven by subjective experiences by the patient, it is paramount to have a strong clinical tool to assist in treatment. Like other otolaryngologic complaints, GP is challenging in that there is no way to asses a “normal” amount of pharyngeal awareness and what is bothersome to one individual may not be noticeable to another. Additionally, various states of pathology can result in a shared experience or complaint of GP. For example, symptoms of GP may present similarly in a patient with GERD while another’s symptoms could be driven by esophageal dysmotility, anxiety and xerostomia^{[2, 3]}. The heterogeneity and subjectivity of this disorder makes it difficult to discern severity and track treatment response especially without a solid PROM. The Glasgow-Edinburg throat scale aimed to resolve some of these concerns but addressed multiple subscales not entirely descriptive of GP including dysphagia, and throat pain/swelling^[8]. Furthermore, a complex scoring system and jargon utilized in the survey made the PROM less attractive for both the clinician and the patient.

Melancon et al sought to address the need for a succinct and modernized PROM to be used in the management of GP. The Laryngopharyngeal Measure of Perceived Sensation (LUMP) questionnaire was thus created, relying on principles established through a review of frequently used and successful PROMs^{[9, 10]}. Some of tenets embraced in the formulation of LUMP included independence of visual scales, straightforward calculation of scores and clear and relatable language. Like other PROMs developed to address patient-reported complaints, no gold standard or pathognomonic diagnostic measure may exist for which to crosscheck diagnostic accuracy. As a result, PROMs share a limitation of strict reliance on subjective reports and outcomes. This does not underscore their utility in clinical practice, however, especially in a field largely focused on quality of life concerns. Additionally, effective tools like PROMs may expose often overlooked patients and push practitioners to proceed with further evaluation like high resolution manometry, video fluoroscopic swallowing study, or trial of medication^[3].

This study aimed to establish normative data for the LUMP questionnaire and provide a background against which patients can be compared. When separating mean values by gender, a difference in distribution of data was identified. Statistical strength and measurement stability may be sacrificed when separating and reviewing data in a gender specific manner. Additionally, utilizing a test for each gender in the clinical setting could be overly burdensome without providing additional benefit. Furthermore, this would result in a decreased power of the individual tests and therefore, a focus was placed on the cumulative mean of 0.42. This value may provide context when evaluating a patient’s responsiveness to intervention using LUMP. This normative value also allows for the defining of an abnormal score by including two standard deviations from the mean. This results in a value of 2.34 (0.42 + (2 × 0.96)). Therefore, individuals with a score of 3 or greater should be considered as having an abnormal LUMP score and warrant additional GP specific evaluation. Limitations of this study include the somewhat focused participant population represented. At Wake Forest Baptist Medical Center, the approximate western half of North Carolina is well captured. Though this is clearly not inclusive of all areas addressing otolaryngologic complaints, it is felt that this population is diverse enough to allow widespread application of LUMP and these established normative data. Though statistical significance was reached, greater focus could be placed in future studies to acquire a larger patient population with additional effort in diversifying the studied group. Further investigation is necessary to evaluate pre- and post-treatment LUMP scores and the optimal way to reflect responsiveness to treatment. We also seek to define the minimal clinically important difference as has been completed with other PROMs in otolaryngology^[11]. Additional avenues of study include organizing responsiveness to GP management based on etiology and what, if any, effect psychosomatic comorbid diagnoses have on expected responsiveness. This could provide valuable insight when creating treatment plans with patients suffering from globus pharyngeus.

Conclusion

88 individuals participated as controls for the Laryngopharyngeal Measure of Perceived Sensation. The mean in the normative group was 0.42. This established an upper limit of normal of 2.34. Since scores are reported in whole numbers, values greater than or equal to 3 should be considered pathologic. These values will assist in identifying patients with globus pharyngeus and provide a foundation onto which post-intervention symptomology can be followed.