Validation of the Laryngeal Cognitive-Affective Tool in a Taiwanese Population

Summary:

Background and Aim

The laryngeal cognitive-affective tool (LCAT) was recently validated in the US to assess laryngeal-specific hypervigilance and anxiety. The aim of this study was to examine LCAT validity in the Taiwanese population.

Methods

This prospective single-center study enrolled adults from Hualien Tzu Chi Hospital with laryngeal symptoms for >6 months.

Results

104 patients included: Mean age 49.5 years (SD 13.3), 69% female, mean BMI 25.3 kg/m² (5.8), and mean LCAT 25.9 (15.2). The LCAT had excellent internal consistency (α=0.969) and split-half reliability (Guttman=0.925).

Conclusions

The LCAT is newly validated in the Taiwanese population and assess laryngeal-specific cognitive-affective processes in patients with chronic laryngeal symptoms.

Introduction

Laryngopharyngeal symptoms such as throat clearing, cough, dysphonia, globus sensation, or sore throat are commonly attributed to gastro-esophageal reflux disease (GERD); however, pathologic evidence of GERD is often not seen in these patients.¹ As a result of this discrepancy, guidelines currently recommend up-front reflux testing in patients presenting with isolated laryngopharyngeal symptoms, to better identify patients that may respond to acid-suppressive therapies.^1-3 However, symptomatic patients, with and without findings of pathologic GERD, often report elevated symptom-specific hypervigilance and anxiety, as well as higher rates of quality of life impairment, depression, and anxiety.^4-7 These cognitive-affective processes can further complicate evaluation, as many with pathologic GERD will not respond to traditional acid-suppressive therapies, and instead require adjunctive treatment, such as behavioral therapy or speech therapy, to fully address symptoms, highlighting the important role for multidisciplinary care of these patients.⁸ Up until now, there are limited tools to assess for these often comorbid cognitive-affective processes and most studies have utilized the esophageal hypervigilance and anxiety scale (EHAS).⁹ Though useful for assessing esophageal symptoms, a similar tool to evaluate cognitive-affective processes in patients with laryngeal symptoms is lacking. Due to this need, the laryngeal cognitive-affective tool (LCAT) was recently established and validated in the United States to assess for laryngeal-specific hypervigilance and symptom-specific anxiety.¹⁰ In the validation study, the LCAT was found to have good internal consistency (α=0.942) and split-half reliability (Guttman=0.853), and a score of 33 or more was defined as elevated.¹⁰ The aim of the present investigation was to examine the validity of the LCAT in an external international (Taiwanese) population.

Methods

This prospective single-center study enrolled patients from January to September 2023. Adult patients were recruited from Hualien Tzu Chi Hospital. Patients were eligible for inclusion if they were between 20 and 69 years old and had been experiencing laryngeal symptoms for more than six months, with a Reflux Symptom Index (RSI) score of over 13. They were excluded if they were unable to provide consent. After providing informed consent, participants, with the assistance of researchers, completed a series of questionnaires that were professionally translated into Taiwanese Mandarin by Ulatus, a translation company, and demographic data were collected. The study was approved by Research Ethical Committee of Hualien Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation. Data Use Agreements were obtained, and de-identified data were provided to University of California San Diego (UCSD), where analyses were conducted. The following questionnaires were provided to patients: Gastroesophageal Reflux Disease Questionnaire (GerdQ), RSI, Voice Handicap Index (VHI), Illness Cognition Questionnaire (ICQ), Northwestern Esophageal Quality of Life Questionnaire (NEQOL), and NIH Patient Reported Outcomes Measurement Information System (PROMIS) for Anxiety and Depression.¹⁰ The primary objective was to assess the psychometric properties of the LCAT and to assess the reliability of the score by measuring Cronbach α and split-half reliability (Guttman statistic). Construct validity was assessed through Pearson’s correlations with previously validated questionnaires. Inter-item correlations were assessed via Pearson’s correlations between questions. Finally, LCAT subscale structure was evaluated through principal component factor analysis with varimax rotation. Details of these methods have been previously published.¹⁰ Analyses were carried out via SPSS v28 for Macintosh (Chicago, IL) and R v4.2.2 (Vienna, Austria).

Results

Baseline Demographics

A total of 104 individuals were included in analyses: Mean age 49.5 (SD 13.3) years, 72 (69%) female, and mean BMI 25.3 (5.8) kg/m² (Table 1).

Table 1:

Baseline Demographics

	Symptomatic Patients (n=104)
Age (years)	49.5 (13.3)
Sex (female)	72 (69%)
Body Mass Index (kg/m2)	25.3 (5.8)
Total LCAT Score	25.9 (15.2)
LCAT Symptom-specific Anxiety Subscale (Q1-9)	15.3 (9.1)
LCAT Hypervigilance Subscale (Q10-15)	10.6 (6.6)
LCAT ≥ 33	35 (34%)
GerdQ	8.9 (3.0)
ICQ Helplessness Subscale	9.5 (4.0)
ICQ Acceptance Subscale	17.3 (4.5)
ICQ Perceived Benefits Subscale	17.9 (3.6)
NEQOL	39.8 (12.0)
PROMIS Anxiety	13.6 (7.6)
PROMIS Depression	11.5 (5.9)
VHI	14.9 (21.0)
RSI	18.5 (5.3)

Questionnaire Scores

Mean total LCAT scores were 25.9 (15.2) and a total LCAT of ≥ 33 (defined as elevated in the prior validation study)¹⁰ was found in 35 (34%). Other questionnaire scores are found in Table 1.

LCAT Score Validation

The LCAT had excellent internal consistency (α=0.969) and split-half reliability (Guttman=0.925). Construct validity is supported by moderate relationship with RSI (r=0.41), VHI (r=0.53), NEQOL (r=−0.44), ICQ-helplessness (r=0.53), ICQ-acceptance (r=−0.47), and weak relationships between PROMIS-depression (r=0.30), PROMIS-anxiety (r=0.30), and ICQ-perceived benefits (r=−0.23) (all p-values <0.05). There was no relationship between GerdQ (r=−0.03, p=0.78) (Table 2).

Table 2:

Pearson’s Correlations

	LCAT Total	LCAT Symptom- Specific Anxiety	LCAT Hypervigilance
LCAT Total	--	--	--
LCAT Symptom-Specific Anxiety	0.98*	--	--
LCAT Hypervigilance	0.96*	0.88*	--
GerdQ	−0.03 p=0.78	−0.04 p=0.69	−0.01 p=0.93
ICQ Helplessness	0.53*	0.56*	0.45*
ICQ Acceptance	−0.47*	−0.50*	−0.40*
ICQ Perceived Benefits	−0.23 p=0.02	−0.27*	−0.16 p=0.11
NEQOL	−0.44*	−0.45*	−0.38*
PROMIS Anxiety	0.30*	0.34*	0.24 p=0.02
PROMIS Depression	0.30*	0.31*	0.27*
VHI	0.53*	0.54*	0.48*
RSI	0.41*	0.40*	0.39*

^*p<0.01

Differences from validation study highlighted in grey

Subscale Identification

The principal component factor analysis yielded 2 components (Table 3). Two questions loaded differently than the original LCAT. Question 9, which was part of the symptom-specific anxiety subscale instead loaded into the hypervigilance subscale; and question 15, which was part of the hypervigilance sub-scale instead loaded into the symptom-specific anxiety subscale (Table 3).

Table 3:

Rotated Component Matrix with Factor Loading for LCAT Consistent with Two Subscales

Laryngeal Cognitive-Affective Tool	Factor 1 (Symptom- specific Anxiety)	Factor 2 (Symptom- specific Hypervigilance)
Symptom Specific Anxiety Questions (1-9)
1) Can’t keep my throat symptoms out of my mind.	0.742
2) Hard time enjoying myself because I cannot get my mind off throat symptoms.	0.884
3) Throat symptoms are overwhelming.	0.895
4) As soon as I awake, I worry that I will have throat discomfort	0.866
5) I often worry about my throat.	0.891
6) My throat symptoms are terrible and never going to get better.	0.868
7) Nothing I can do to reduce my throat symptoms.	0.818
8) Discomfort in my throat scares me.	0.876
9) Anxiously want throat symptoms to go away.	0.757	0.905 †
Symptom-Specific Hypervigilance Questions (10-15)
10) Quick to notice changes in my throat symptoms.		0.852
11) Focus on my throat symptoms in social situations.		0.934
12) Notice throat symptoms even if I am busy		0.920
13) I focus on my throat.		0.901
14) Very sensitive to my throat		0.854
15) Keep track of my throat symptoms.	0.720 †	0.637

Notes: Items are paraphrased for Copyright Restrictions. Questionnaire prompt indicates for patients to answer if they agree with the following statements based on their experience with throat symptoms over the past month.

^†Indicates items that were originally within another factor category in the prior Esophageal Hypervigilance and Anxiety Scale (EHAS)⁹ and LCAT validation studies.

Inter-item Correlations

The highest inter-item correlation was found between question 11 and 12 (0.903). Several other questions exhibited high inter-item correlation, >0.75 with all p-values <0.05 (Q2/3, Q3/4, Q2/5, Q3/5, Q3/8, Q4/5, Q5/8, Q6/7, Q9/10, Q9/11, Q9/12, Q9/13, Q10/13, Q11/13, Q12/13, and Q13/14).

Discussion

Due to the contribution of cognitive-affective processes in patients with laryngeal symptoms, a recently validated questionnaire, the LCAT, was developed. In this current study the LCAT exhibited excellent reliability and construct validity to measure laryngeal hypervigilance and symptom-specific anxiety among an external Taiwanese population. Like the LCAT Validation study, this population was predominately female (69% in this study and 71% in the original validation study).

However, some notable differences did exist. A total of 17 questions exhibited high inter-item correlation, >0.75, indicating redundancy, which is possibly due to difficulty in exactly translating the meaning of the questions from English to Chinese. In the LCAT validation study, inter-item correlations were all <0.75.¹⁰

Another difference was that question 9 loaded into the hypervigilance subscale, instead of symptom-specific anxiety subscale and question 15 into the symptom-specific anxiety instead of hypervigilance subscale. For question 9, “Anxiously want throat symptoms to go away,” this may have loaded into the hypervigilance subscale, as the direct translation of “anxiously” does not convey the same meaning in Chinese and the closest equivalent is “urgently,” which may suggest hypervigilance rather than anxiety. With regards to question 15, “Keep track of my throat symptoms”, the term “track” in Chinese denotes the act of recording and continuous monitoring of one’s symptoms. This is often perceived more of a behavior indicative of anxiety due to its association with uncertainty and worry about the future, rather than being related to constant vigilance.

A few of the Pearson’s correlations were also found to be different than the original LCAT (Table 2). Most notably, the GerdQ, which was positively and significantly correlated with LCAT total and subscales in the original validation study no longer exhibited any correlation. GerdQ scores in patients with an RSI > 13 in the original cohort were slightly higher than in the Taiwanese population (9.7 (2.8) vs. 8.9 (3.0). Other differences are noted in Table 2.

Finally, it is noteworthy that the original LCAT validation population seemed to experience higher rates of symptom-specific hypervigilance and anxiety when compared to the Taiwanese population. Total LCAT scores in patients with an RSI > 13 in the original cohort were 37.6 (11.1) versus 25.9 (15.2) in the Taiwanese population. In addition, NEQOL scores were lower in the original cohort for patients with an RSI >13 when compared to the Taiwanese population, indicating worse esophageal quality of life in the original cohort [27.8 (14.0) vs. 39.8 (12.0)].Some literature suggests that Asians may report lower rates of physical symptoms when compared to other races/ethnicities.¹¹ Literature also suggests that Asians may have a lower prevalence of anxiety disorders.¹² This could explain some of the differences observed.

Despite these variations, the LCAT score demonstrated excellent internal consistency (α=0.969) and split-half reliability (Guttman=0.925) in the Taiwanese population, although the study was underpowered. Given the lower overall LCAT scores observed, it may be worthwhile to re-evaluate what is considered elevated in this population in future studies with larger sample sizes and outcomes data.

Conclusions

In conclusion, the LCAT is a newly validated questionnaire, in both the US and Taiwanese population, that allows for improved understanding of the complex psychosocial interplay of laryngeal specific hypervigilance and symptom-specific anxiety on symptom perception and burden in patients suffering from chronic laryngeal symptoms. The use of this questionnaire in clinical practice allows providers both a means to assess laryngeal symptoms and monitor changes in scores over time with laryngeal-targeted treatments. Next steps of research include validation of the questionnaire in other languages, as well as determining how the LCAT changes with various treatment modalities for patients with laryngopharyngeal symptoms. It would also be worthwhile to determine if sex-specific differences exist.

Data Availability Statement:

The data that support the findings of this study are available from the corresponding author upon reasonable request.