Arabic Eating-10 Assessment Tool Validation Using Fiber-Optic Endoscopic Evaluation Of Swallowing (FEES) As An Imperfect Gold Standard: A Prospective Follow-up Cohort Study.

doi:10.21203/rs.3.rs-3562299/v1

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Arabic Eating-10 Assessment Tool Validation Using Fiber-Optic Endoscopic Evaluation Of Swallowing (FEES) As An Imperfect Gold Standard: A Prospective Follow-up Cohort Study.

https://doi.org/10.21203/rs.3.rs-3562299/v1

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Head and neck cancer treatments, such as radiotherapy, chemotherapy, and surgery, have diverse effects on patients, leading to dysphagia as a significant post-treatment issue. This study aims to validate the Arabic version of the EAT-10 questionnaire (A-EAT-10) using Fiber-Optic Endoscopic Evaluation of Swallowing (FEES) as an imperfect gold standard. Additionally, we seek to establish a correlation between A-EAT-10 and PEG tube insertion in head and neck cancer (HNC) patients.Our sample comprised 130 head and neck cancer patients with varying cancer types at King Hussein Cancer Center (KHCC). We followed these patients throughout their distinct treatment plans up to one month after their final treatment session. During follow-up visits, we administered the A-Eat-10 questionnaire to monitor dysphagia. FEES were conducted at the initial and concluding visits to compare results with A-EAT-10 scores. The results in our tests, assuming independence or dependence, demonstrated excellent agreement. A-EAT-10 exhibited outstanding predictive capabilities with an AUC ranging from 93–97%. A-EAT-10 tended to slightly overestimate dysphagia at later treatment stages by approximately 20% compared to FEES, with an RR of 1.2 (95% CI: 0.91, 1.56, p-value = 0.21), indicating statistical insignificance.

In conclusion, A-EAT-10 exhibits excellent properties, making it a non-invasive, simple, and cost-effective alternative to FEES in dysphagia evaluation, and it can assist in predicting whether a patient requires PEG tube insertion before treatment initiation at first visits.

Biological sciences/Cancer

Health sciences/Health care

Health sciences/Oncology

Head and neck squamous cell carcinoma (HNC) is indeed one of the most common cancers among the Jordanian population, affecting approximately 11% of men and 2.5% of women.[1] The primary treatment options for HNC, including surgery, radiotherapy, and chemotherapy, frequently lead to long-lasting physical, social, and psychological challenges due to the resulting debilitating side effects.[2] Despite the development of treatment plans, notable complications can arise from all types of treatment. Consequently, one of the most commonly reported symptoms in patients following HNC treatment is oropharyngeal dysphagia (OD). OD occurs due to changes in the normal sensory-motor swallowing process, and (HNC) can disrupt various aspects of this physiological function. These disruptions can occur in different phases of swallowing, including the oral phase, the pharyngeal phase or laryngeal elevation.[3] The nature and degree of OD depend on the site and size of the primary tumour.[4] The main symptoms of (OD) include oropharyngeal mucositis, dysgeusia (altered taste perception), xerostomia (dry mouth), and fatigue. These symptoms often lead to issues such as dehydration and significant weight loss. OD can also lead to silent aspiration, a more severe expression of the condition, which has been reported in up to 45% of patients and is associated with a higher risk of serious complications such as aspiration pneumonia, malnutrition and even death.[5] These symptoms are typically chronic and can impact the swallowing function in many patients, affecting 23–100% of individuals.[6] Its often lead to significant concerns for both patients and their caregivers. They fear malnutrition and severe weight loss during treatment, which, in turn, results in more frequent visits to the emergency room.[7] These visits can impact the treatment plan, and sometimes, the substantial weight loss necessitates changes in the chemotherapy protocol or even delays in surgery.[7] As a solution, using feeding tubes, such as Percutaneous Endoscopic Gastrostomy (PEG) tubes, is considered the most effective option before, during, or after head and neck cancer treatment.[7] At King Hussein Cancer Center (KHCC), the criteria were conducted to use PEG tubes for HNC patients deponds on medical clinical judgment, patient and family preferences, weight, swallowing and nutrition assessments most commonly guide PEG tube insertion[10]. However, these decisions may vary significantly depending on the practice setting.[8] For instance, a PEG tube may be inserted in a patient diagnosed with (HNC) who shows no signs of swallowing disorders and is not at risk of aspiration. However, this decision is influenced by the patient’s health condition and cancer staging, such as being classified as T3, making PEG tube insertion a prerequisite before initiating any treatment plan as a proactive prophylactic in anticipation of a patient needing nutritional support or reactive when nutritional compromise becomes apparent. There are clinical indications for enteral feeding.[9]

All patients at KHCC centre underwent standardized examinations based on guidelines regularly employed in clinical practice. [10] These guidelines consist of several steps for diagnosing new HNC patients. In all cases, which may differ based on the type of HNC, a Speech-Language Pathologist (SLP) is responsible for assessing the patient’s swallowing, speech, and voice. Consequently, an SLP conducted a Fiber-Optic Endoscopic Evaluation of Swallowing (FEES) to assess swallowing and voice before, during, and after treatment. Several studies showed the FEES to be a ‘Gold-Standard’ in diagnosing swallowing disorders and that it can predict if there is an aspiration risk.[11] The FEES involves inserting a flexible endoscope through the patient’s nose and into the pharynx to view the pharyngeal and laryngeal structures during swallowing.[12] This procedure provides a direct visualization of the pharyngeal phase of swallowing. The interpretation of FEES plays a pivotal role in the diagnostic process. It involves scrutinizing the recorded images and observing anatomical structures captured during the procedure. This analysis aims to identify any abnormalities or indicators of swallowing difficulties, equipping healthcare professionals with the information needed to make well-informed decisions regarding treatment and management strategies. [13] FEES scoring tools provide clinicians with a standardized method to observe and measure various aspects of swallowing function during the FEES evaluation. The two most commonly used scales are The Yale Pharyngeal Residue Severity Rating Scale and The Penetration Aspiration Scale (PAS).[13] The PAS is an 8-point scale to quantify the aspirated materials during FEES. The scale points explain the pharyngeal and laryngeal areas, comparing food passage.[13] However, interpretations of the score need experience in anatomical and physiological larynx areas to diagnose the aspiration risk. The FEES is a safe, reliable and well-tolerated procedure, making it an essential tool in diagnosing and managing dysphagia. [14, 15] Still, the most challenging aspect of this evaluation is that it can sometimes cause discomfort for the patient due to the nasal entry.

Another swallowing assessment tool used at the speech clinic at KHCC is the Arabic Eating Assessment Tool (A-EAT-10), a self-administered survey validated in 2016 to allow patients to assess their dysphagia subjectively. It is a self-reported questionnaire documenting specific (OD) symptoms[16]. It was designed to assess the initial severity of dysphagia by evaluating clinically relevant symptoms and is often utilized to monitor treatment response in patients with various dysphagia caused by conditions such as HNC, oesophagal disorders or Neurodegenerative Disease.[5] The A-EAT-10 questionnaire consists of 10 questions, with the answers scaled from 0 to 4, where 0 corresponds to ‘no problem’ and 4 to a ‘severe problem’; a score > 3 indicates abnormality.[16]

We have observed several key points during our work at the speech clinic. Firstly, (HNC) patients can be broadly categorized into two major groups. The first group consists of patients who suffer from dysphagia, and their condition is confirmed by assessments like A-EAT-10 and FEES, often in line with the severity of their disease staging. The second group of patients did not exhibit any signs of dysphagia, as confirmed by A-EAT-10 and FEES assessments. Patients from both groups underwent PEG tube insertion, either as a preventive measure (prophylactic) or in response to specific needs (reactive).[9]

The second observation is that there is no specific timeframe for PEG tube removal. For some patients, the feeding tube persists for a year after returning to regular oral feeding. It sometimes exists for a month after treatment, as the PEG tubes positively affect feeding and nutritional support. Still, they can also harm a patient’s quality of life when 5–6% become dependent on tube feeding.[6] Prolonged PEG tube usage can increase the risk of minor complications, such as inflammation, or major difficulties can also arise, including severe peristomal wound infections and aspiration pneumonia.[17] One study emphasizes the significance of predicting the need for PEG tube insertion before treatment.[18] However, no global or local studies definitively determine the ideal duration for retaining PEG tubes, especially in patients diagnosed with early cancer stages.

This study explored the correlation between patient-reported (OD) symptoms, assessed using the A-EAT-10 questionnaire, and swallowing function as evaluated through the standardized FEES protocol in (HNC) patients. The successful achievement of this correlation will mitigate the discomfort associated with FEES assessments and offer an alternative approach for cases where FEES cannot be utilized due to a patient’s health condition. Furthermore, if the A-EAT-10 tool proves effective, it may assist physicians in monitoring the timing of PEG tube insertion and removal during and after treatment.

The present prospective cohort study was conducted following the Declaration of Helsinki.[67] The KHCC Institution review board approved the study with IRB number 19 KHCC 127.

Participants

Participants underwent a thorough swallowing and speech assessment and were diagnosed with any type of HNC according to criteria proposed by the Head and Neck KHCC Guidelines.[8] All (HNC) patients who underwent a (FEES) examination at the Speech and Swallowing Outpatient Clinic between 2020 and 2022 were included in the study. This study’s total clinical data set consisted of 130 patients, with 108 males and 22 females. These patients were selected from those seen at a routine speech outpatient clinic. They were invited to participate if they met the following inclusion criteria: being above the age of 18, being newly diagnosed with any HNC (including laryngeal cancer, nasopharyngeal cancer, oropharyngeal cancer, hypopharyngeal cancer, thyroid cancer, or neck cancer), and having cancer at any stage (T1, T2, T3, or T4).

Exclusion criteria included a medical history of gastroenterological, respiratory, rheumatologic, metabolic, or hematologic disorders and any previous completion of radiotherapy, chemoradiotherapy, or multimodality treatment treatments. Patients who had undergone surgery, such as total laryngectomy, tracheostomy, or PEG tube insertion, were also excluded from the study.

Informed consent was obtained from all patients during regular outpatient speech and swallow clinic visits.

Swallowing Protocol.

In the dysphagia outpatient clinic, a standardized examination protocol was implemented for regular healthcare assessment. The protocol encompassed a clinical ear, nose, and throat examination conducted by a laryngologist to assess the integrity of cranial nerves. The A-EAT-10 assessment tool was also administered, a validated tool for measuring patients’ perception of their swallowing problems.[16] This tool is widely employed in daily clinical practice at the outpatient clinic for patients with or without dysphagia, which includes various etiologies, not limited to (HNC). Many patients self-reported dysphagia, but their swallowing function appeared within the normal range upon assessment. Their complaints seemed to vary compared to their pre-cancer experiences, such as xerostomia or loss of appetite. On the other hand, the assessment revealed dysphagia and weight loss before treatment, significantly affecting the patient’s nutritional status.

The A-EAT-10 is a self-administered, symptom-specific outcome instrument for dysphagia. It comprises ten statements patients rate on a scale of 0 to 4, with 0 indicating no problem and 4 signifying a severe problem. During their regular visits to the speech clinic, any patients with or without dysphagia who met the inclusion criteria were asked to complete the A-EAT-10 questionnaire by themselves. For patients who required assistance due to literacy issues, a (SLP) facilitated the process by verbally presenting the questions and recording their responses. The A-EAT-10 offers an overall assessment of dysphagia and its associated symptoms.[16] A senior SLP and ENT physician performed the standardized fibre optic endoscopic evaluation of swallowing (FEES) examination. An OtoPront PES PILOT HDpro stroboscope flexible endoscope with a 2.7 mm diameter, equipped with Video Nasopharyngoscopes VN-S and VN-P (CHIP-ON-THE-TIP) and an automatic switching system from Berlin, Germany, was utilized. All recorded videos were processed using the PILOT system and stored in an anonymous format.[19] Each FEES examination adhered to the clinical practice guidelines for fibre optic examination in the adult population.[20] Patients were comfortably seated in a chair reclined between 75 and 90 degrees, with their arms resting on the armrests and their heads in a neutral position, ensuring the best posture for the examination. Local anaesthetic drugs, such as lidocaine spray, were not used to avoid altering pharyngolaryngeal sensibility.[21] The endoscope was introduced into the most expansive nasal cavity and maintained just below the uvula to maximize the field of view, including the larynx, the glossoepiglottic valleculae, and the pyriform sinuses.[21] During the FEES examination, three different food textures were administered to evaluate swallowing safety and efficiency:

Liquid

Thin liquid at room temperature (IDDSI Level 0) was used for thin liquid trials. [22]

Moderate thick liquid

Room temperature yoghurt (IDDSI Level 4) was employed for moderate thick liquid trials. [22]

Solid

A quarter and half of an 8-gram piece of dry bread (4 grams per trial; IDDSI Level 7) were used for solid trials. [22]

Some food bolus consistencies were not administered to all patients for safety reasons and to minimize the risk of severe aspiration. Consequently, the study included only subjects who had undergone at least one trial with thin or moderate thick liquid consistencies.

FEES examinations were rated independently by three operators using the video files. Two of them were speech and language therapists (SLPs and one Senior ENT physician.), all three with at least five years of experience in FEES examinations. SLPs and ENTs were blind to each other and participants’ data, since videos were stored anonymously. Two independent SLPs rated the videos using validated ordinal scales for swallowing safety and efficiency; inter-rater reliability between the two raters was analyzed. In case a difference > 1 level at each FEES rating scale occurred between the two raters, a 3rd SLP assessed the videos and decided on both ratings.[27]

The parameter used to analyze the FEES is safety impairment (Penetration/aspiration). The severity of penetration/aspiration was rated using the Penetration Aspiration Scale (PAS).[23] The PAS is an 8-point scale ranging from 1 (materials do not enter the airway) to 8 (materials enter the airway, pass below the vocal folds, and no effort is made to eject). [21] Penetration was defined as the bolus entering the laryngeal vestibule over the rim of the larynx (PAS score from 2 to 5). Aspiration was defined as the bolus passing below the true vocal folds (PAS score six or above). The swallowing safety was also evaluated, similar to Tabor et al.’s study. [24] In particular, based on the PAS score, each swallow was classified as unsafe if the material entered the laryngeal vestibule (PAS ≥ 3). In addition, to analyze the timing of unsafe swallows, each event was classified as “before”, “during”, or “after” the swallow. The worst PAS score for each consistency and each subject was considered for statistical analyses.

The table in the supplemantray file (table S1) illustrates the data collection of A-EAT-10 and the timing of the FEES application. All patients attended regular follow-up visits throughout treatment, and each received ongoing support from an SLP. The SLP’s role includes maintaining, educating, and offering counselling concerning dysphagia symptoms, providing guidance on PEG tube utilization (if applicable), and administering swallowing exercises.

Statistical Analysis

This analysis works towards validating A-EAT-10 as a diagnostic tool for dysphagia compared with the traditional FEES test on 130 HNC patients at our hospital’s speech and swallow clinic. The sample size is calculated based on Cohen’s kappa coefficient for the agreement between two raters.[25] The sample size calculation assumed a minimum acceptable kappa (\({\kappa }_{0}\)) of 0.61 (moderate to substantial agreement), and an alternative expected kappa (\({\kappa }_{1}\)) to be 0.4 (fair agreement). The expected prevalence of dysphagia is 30% among the participants. The power of the test is 80%, with a type I error equal to 0.05. These assumptions resulted in an estimated required sample size of 132 patients. At the beginning of the study, we recruited 143 participants. However, we ended up with 130 who completed the study.[2] The reasons for dropouts and attrition included ten patients who had undergone tracheostomy and PEG tube insertion before the start of treatment, following KHCC guidelines. Additionally, two patients unfortunately passed away during the follow-up period, and one was referred to palliative care. Based on our adopted protocol, the kappa coefficient test requires the largest sample size. Therefore, this sample size is sufficient for the other tests used in the analysis.[26]

The analysis’s general theme is measuring agreement between diagnostic tools under the imperfection of the gold standard and latent class analysis. The methods in this area are somewhat confusing because of many issues related to the theory. The number of alternatives and lack of consistency in the literature are significant sources of confusion even for statisticians. [27–30] We developed a simple protocol to identify the ‘best’ method(s) we can employ for the dataset in hand, considering the nature of the data.[27, 31]

The first consideration is to identify the aim of this comparison, as mentioned earlier, to validate the A-EAT-10 (self-report-based questionnaire) Arabic version using a traditional diagnostic tool as a benchmark, i.e., the FEES test. The established traditional method does not always reflect the truth, and there is some inaccuracy (error). Hence, considering FEES a ‘gold standard,’ i.e., not to have measurement errors, will be inappropriate because even this method does not produce accurate results.[32]

The second consideration is the dependency issue. Since the two tests are performed on the same patient, there is a risk of dependency. We will discuss several methods in the protocol developed under the independence assumption.[33, 34] However, such an assumption can lead to biased or unrealistic results.[33, 35] The advantage of the correction methods that assume the tests’ independence is that they are computationally less demanding. Relaxing the assumption of dependence leads to direct approaches to calculations.[36–38] This approach is not the case when the conditional independence assumption is not satisfied, which is the case in most situations.[35]

Given these considerations, we considered using measures of the agreement. Additionally, we used sensitivity and specificity to assess the validity of A-EAT-10 given the imperfection of the gold standard, i.e., the FEES test and the data dependency. The protocol for analyzing the agreement is attached as a supplementary file, but we can summarize it as follows:

Weighted and unweighted kappa, as we assessed having dysphagia as being higher in value in both tests than not having dysphagia. Cohen’s kappa measurement of agreement can measure the agreement between categorical variables. Kappa can be used to assess the agreement between alternative methods of categorical agreement, as in our case.[25, 39] This test is mainly developed for nominal classification. However, the weighted version uses linear, quadratic, and other weights for ordinal data.[40] As mentioned above, we tried to test both nominal processes’ classification using unweighted kappa versus weighted kappa by considering dysphagia as a higher order because it is associated with a higher score on the A- EAT-10 test. However, since we only have two outcomes (dysphagia vs normal), both methods produced identical results.[41, 42] The agreement cut-off points are subjective. There is no standard way to assess the strength of the agreement.[43, 44] (See table S3 and S4 in supplementary file for the criteria).

Intra-class correlation test (ICC) with a single random effect.[45] The advantage here over the kappa coefficient is the different randomness parts introduced in the model. As in our case, the single random effect (mixed effect) assumes the patients’ randomness only, and the two assessment methods are fixed.[46] In other words, it assumes that our patients are taken randomly from a population of patients, which is the case. However, it assumes that the classification methods are the only fixed ones. In other instances, when the classification methods are chosen from a population of methods (different available tests), ICC will be two-way random. The interpretation of ICC is like kappa. (See table S2 in supplemantary file for the criteria).

The traditional sensitivity-specificity analysis will include the receiver operator curve (ROC) and the area under the curve (AUC). However, this approach will be adjusted to account for the imperfection of the gold standard, i.e., the FEES test.[32] This imperfection means that a straightforward comparison will lead to certain biases in the results.[33] Corrections with prevalence rates between 0.1 and 0.9 show similar results in detecting reality, with superior results under conditional independence between the tests for Staquet et al. correction.[33] Thus, we will consider Staquet et al. [36] correction as explained in the supplementary file. The correction for the imperfection required the establishment of the imperfect gold standard sensitivity and specificity from previous studies or a test group.[33, 36] Previous studies show that FEES has approximately 80–87% sensitivity and 81–100% specificity in detecting dysphagia.[32, 47] We are correcting based on these levels. There is no established sensitivity-specificity regarding our search for HNC patients. Therefore, we will use the studies’ lowest and highest reported levels as our thresholds for the imperfect gold standard: sensitivity (80% and 87%) and specificity (81% and 100%). Alternating between different levels of sensitivity and specificity will act as a sensitivity analysis. This process will provide an upper and lower bound for the EAT-10 test’s specifications.

Random Effects Latent Class Analysis (RE-LCA) is employed under the assumption of conditional dependence.[48] This approach assumes two latent classes (with and without the condition): dysphagia vs normal. The condition’s actual status (dysphagia vs normal) is unknown, and the best reference test, FEES, indicates the status. This test is referred to as an imperfect gold standard. Therefore, the actual status of the condition is ‘latent’. Like the previous point, the sensitivity and specificity of FEES are assumed to be known.

The analysis was conducted using R version 4.2.1.[49] The packages used in the analysis are "irr",[50] "psych",[51] "vcd",[52] "DescTools",[53] "gpubr",[54] "tidyverse",[55] "pROC",[56] "rstatix",[57] and "randomLCA"[58].

The patients’ characteristics are described in Table 1. The average age of the patients is 56 years, with the majority being males (82.3%), Jordanians (97%), and smokers (73.1%).

Table 1

Patients’ characteristics (n = 130)
Characteristic	Mean ± SD*	Number (%)
Age	56 ± 12.1
Gender Female Male Total		23 (17.7) 107 (82.3) 130 (100)
Height	1.69 ± 0.1
Weight	74.9 ± 16.9
BMI**	26.1 ± 5.3
Nationality Jordanian Non-Jordanian Total		126 (97) 4 (3) 130 (100)
Smoking status Smokers (including ex-smokers of less than one year) Ex-smokers (ex-smokers of more than one year) Non-smoker (Never smoked or ex-smokers of ten years or more) Total		95 (73.1) 14 (10.8) 21 (16.1) 130 (100)
Tumour Location Larynx Nasopharynx Multilocation Thyroid Maxillary Sinus Oral Cavity/Tongue Oropharyngeal Total		71 (54.6) 33 (25.4) 6 (4.6) 5 (3.8) 4 (3.1) 4 (3.1) 7 (5.4) 130 (100)
* SD: Standard Deviation ** BMI: Body Mass Index

The participating patients reported their swallowing sensation on their first clinic visit (self-reporting dysphagia). Also, they underwent two tests (FEES and A-EAT-10). Both tests were repeated at the final visit (one month after finishing treatment). At the fifth visit, the patients received A-EAT-10 and were diagnosed again with dysphagia without a FEES test. PEG tube insertion was measured per the patients’ treatment protocol. The numbers and percentages for each category are summarized in Table 2 and Fig. 1.

Table 2

Dysphagia among patients either as self-reported, FEES or A-EAT-10 diagnosis and patients who underwent PEG tube insertion per the treatment protocol (n = 130)
	Yes – Dysphagia (%)	Normal (%)	Total
Self-reported dysphagia	43 (33%)	87 (67%)	130 (100%)
FEES first visit	37 (28%)	93 (78%)	130 (100%)
A-EAT-10 first visit	42 (32%)	88 (68%)	130 (100%)
A-EAT-10 fifth visit	50 (38%)	80 (62%)	130 (100%)
FEES final visit	53 (41%)	77 (59%)	130 (100%)
A-EAT-10 final visit	67 (48%)	63 (52%)	130 (100%)
PEG tube insertion per protocol	41 (32%)	89 (68%)	130 (100%)

The analytical protocol described in the methods part is explained below. The first step in the protocol is using Cohen’s kappa of measures agreement. The results compared the agreement in diagnosing dysphagia at the first and final visits by the patients. Since the weighted and unweighted results are identical, we only report the result as a kappa value (Table 2). The results suggest approximately perfect agreement between the two methods on the first visit. However, over time and one month of treatment, the 95% confidence interval for kappa of the final visit suggests a good to a near-perfect agreement.

Table 3

kappa coefficient of agreement test at different visits between FEES test and A- EAT-10 (n = 130)
		95% confidence interval of kappa (κ)
Visit	kappa value (κ)	Lower Bound	Upper Bound
First	0.91	0.83	0.99
Final	0.82	0.72	0.91

The results of the agreement are reported in Table 3. And the (Table 4) below shows the results for ICC are identical to kappa, with the only exception of narrower confidence intervals. The agreement is almost perfect at the beginning of the treatment cycle and slightly decreasing at the end. The one-way ICC is also employed similarly to the first and final visits of the patients.

Table 4

Intra Class Correlation (ICC) agreement at different visits between the FEES test and A-EAT-10 (n = 130)
		95% confidence interval of ICC
Visit	ICC	Lower Bound	Upper Bound
First	0.91	0.88	0.94
Final	0.82	0.75	0.88

Under Independence Assumption

Alternating between the lower and upper sensitivity of the FEES test and using Staquet et al. correction, the sensitivity of the A-EAT-10 is 88–91%, and the specificity is 97–100%. The area under the curve ranged between 92% and 97%. Figure 2 shows the lower and upper bounds of the AUC.

The best results are obtained on the first visit. At the first visit, the minimum sensitivity obtained was 90%, and the maximum was 91%. At the same time, the specificity equalled 100%. The final visit produced the lower bounds.

Under Dependence Assumption

Under dependence, we used the RE-LCA model to fit a random model with two classes. This process was employed for the first and final visits. The results in the first visit (FEES v1 vs A- EAT-10 v1) show, under this model, 93% sensitivity of A-EAT-10 compared to FEES. The specificity is approximately 97%. On the final visit, these numbers decreased. The sensitivity decreased to 87%, and the specificity decreased to 91%. The marginal probability shows that FEES has a 28.5% probability of diagnosing dysphagia at the first visit. A -EAT-10 has a higher probability of 32.3%. In the final visit, FEES has a marginal probability of 40.8% of diagnosing dysphagia, and A-EAT-10 has 48.5%; the Relative Risk (RR) = 1.19, with a confidence interval (0.91, 1.56), and p-value = 0.21.

The general A-EAT-10 tool is a widely used clinical screening instrument designed to evaluate swallowing difficulties, and it has demonstrated good validity and predictability.[59, 60] Numerous studies have shown the efficacy of the general EAT-10 questionnaire in predicting OD symptoms in the early stages.[61] One such study assessed 360 dysphasic patients with varying OD etiologies. A statistically significant correlation was discovered between EAT-10 scores and the risk of aspiration and extended total pharyngeal transit time.[62] Patients with EAT-10 score above 15 had 22-fold higher likelihood of aspiration. The sensitivity of EAT-10 score above 15 in the case of aspiration was 71%, while the specificity was 53%.

Our study examined 130 patients in a Speech clinic for dysphagia, demonstrating the validity of using A-EAT-10 to predict or assess OD symptoms,given the high prevalence of OD and its impact on health-related quality of life in the HNC population. Early detection is crucial to facilitate the timely implementation of swallowing rehabilitation and nutritional support. However, which patients should be monitored for OD often needs to be clarified. Systematic monitoring of the nature of OD and the nutritional status pre or during HNC treatment may help reduce OD-related complications. A reliable and easily implementable Arabic-language tool for identifying and assessing OD can facilitate the monitoring of OD in HNC patients in daily follow-up clinical visits[5]. Therfore,this work used different protocols under different assumptions to establish boundaries for the sensitivity and specificity of the A-EAT-10 test compared to the standard test such as FEES. The tests showed that A-EAT-10 approximates the FEES test on the first visit. The different approaches implemented in this work showed that at the first visit, the A-EAT-10 test has a high agreement with positively diagnosing dysphagia and approximately perfect agreement on negatively diagnosing dysphagia compared to FEES. There is a tendency of A-EAT-10 to diagnose dysphagia. This result was consistent across the visits. The RE-LCA model confirmed this result as the probability of diagnosing dysphagia was higher in A-EAT-10 on the first and final visits.

Based on the study’s findings, it’s evident that the A-EAT-10 questionnaire plays a crucial role in the early evaluation of (HNC) patients. It can assist in determining whether a PEG tube is needed proactively, as a preventive measure in anticipation of potential nutritional support, or reactively, when clinical indications for enteral feeding become apparent. Monitoring the swallowing process during follow-up appointments at the speech and swallowing clinic at KHCC, may assess the timing and necessity of tube usage. Our current study found that 41% of patients reported difficulty swallowing during the first visit, confirmed using the FEES or A-EAT-10 questionnaire. Therefore, 41% of these patients had a feeding tube inserted before the treatment started. This result means that patients who reported difficulty swallowing, and whose difficulty was confirmed during the first evaluation by A-EAT-10, had results that are consistent with their PEG tube placement, according to the protocol followed at the KHCC. Moreover, Laryngoscopy is often uncomfortable for some people because it enters through the nose to the throat, and the patient is asked to make sounds or eat something to ensure no aspiration risk[63]. The laryngoscopy procedure becomes difficult or painful for patients with advanced stage head and neck cancer. Therefore, the accuracy rate of the A-EAT-10 questionnaire is significant to us in the initial visits for assessment, as it reduces the use of invasive or uncomfortable procedures such as FEES.[63, 64]

Using a simple, swift, and reliable tool like A-EAT-10 in the early stages aids in identifying the requirement for PEG tube and has the potential to reduce the necessity for patients without dysphagia, feeding tube procedures are conducted, this valuable information guides us in making post-treatment decisions regarding the retention or removal of the PEG tube.

Various factors influence the physician’s decision to recommend inserting a feeding tube, including the patient’s anticipated radiation dose, concurrent chemotherapy with radiation, and their ability to tolerate the treatment. Nevertheless, specifying a precise timeframe for PEG tube placement may assist physicians in convincing patients to opt for the tube’s insertion, thereby alleviating the psychological stress patients often experience during their treatment phase.[48] PEG tube duration varied among patients, with a median duration of 168 days observed among head and neck cancer (HNC) cases.[65] A study found a link between long-term PEG tube dependency and poorer survival.[66] Another prospective cohort study suggested that long-term tube dependence significantly decreased when patients partially used the PEG tube while maintaining continuous oral intake.[67] In addition, dysphagia was prevalent, with 41% of patients reporting it during their initial visit in our study. A similar proportion persisted until the final sessions, where the A-EAT-10 questionnaire revealed that 48% of patients reported dysphagia. Furthermore, 32% of patients required the tube one month after the treatment. It’s important to note that the questionnaire may yield a higher percentage than FEES, as it covers a broader range of swallowing symptoms and details, including questions about appetite and saliva. Moreover, the questionnaire’s agreement with FEES decreased in later stages, especially during the final visit, which included a re-test one-month post-treatment. This decrease could be attributed to patients undergoing additional treatments, such as chemotherapy after radiation, which can exacerbate swallowing difficulties. It may also result from patients completing adjuvant radiation treatment after surgery, heightening the sensation of dysphagia even when FEES results appear normal.

Although the A-EAT-10 did not precisely specify the required duration for retaining the PEG tube after treatment, it is clear that keeping the PEG tube for at least one month post-treatment is essential to maintain good nutritional status among patients. One study has provided support for this, explaining that patients who undergo PEG tube placement after one month are able to maintain nutritional support.[65]

Despite the challenges posed by data collection during the COVID-19 pandemic, the preliminary findings of the current study suggest that the A-EAT-10 questionnaire holds promise as a valuable assessment tool for predicting dysphagia symptoms and the need for PEG tube insertion in the early stages of treatment. It was observed that keeping a PEG tube for a month after treatment completion can be beneficial, and subsequent re-evaluation helps determine whether PEG tube removal is necessary.

This study is subject to several limitations. Firstly, the sample size of enrolled patients is relatively small, although it is consistent with previous studies. This limitation arises from unforeseen complications associated with the disease and data collection during the COVID-19 pandemic. Ideally, a larger patient cohort would have been preferred to enhance the study’s statistical power. Consequently, the results presented in this study should be interpreted cautiously, especially true given the subjective nature of Penetration Aspiration Scale (PAS) effects and potential variations in score interpretations among clinicians. In light of this, an alternative gold standard should be considered to guide treatment plans and validate the accuracy of the A-EAT-10 tool.

In conclusion, A-EAT-10 showed a decreasing correlation with FEES over time. However, it maintains acceptable sensitivity and specificity even after one month. Notably, A- EAT-10 demonstrated higher sensitivity than specificity and a higher probability of diagnosis of dysphagia than FEES, making it a valuable screening tool before the expensive, somewhat painful instrumental evaluation of dysphagia (FEES). Therefore, A-EAT-10 can be a helpful screening tool for treating dysphagia in Head and Neck cancer patients.

ACKNOWLEDGMENT

The authors wish to thank Dr. Tamer Mesallam, professor of phonetics, College of Medicine at King Saud University for providing the valid Arabic-EAT-10 Questionnaire.

Author contributions statement

Ms.Da'ad Abdel-Hay, is the corresponding author and is the first author with Dr.Osama Abdelhay.

Da'ad Abdel-Hay, contributed to the idea of manuscript concept , clinical evaluation , questionnaire administration and writing of the paper.

Dr.Osama Abdelhay, contributed to the design, methodology, statistical analysis and data validation.

Dr. Hamza A. G Ghatasheh, responsible for the scientific review of the manuscript.

Mr. Sameer Al-Jarrah, overseeing the administration of A-EAT-10 assessments and help in clinical evaluation.

Dr. Suhaib Eid, providing assistance with conducting FEES.

Mr. Mutaz Al Tamimi and Mr. Ibrahim Al-Mayata, responsible for patient data collection within the hospital

All authors have reviewed and revised the final manuscript.

Ethical approval

Permission to use the Arabic-EAT-10 for the study was obtained from the Copyright holder, Dr.Tamer Mesallam. An ethical approval for study protocol was approved by King Hussein Cancer center ethical committee, approved the study with IRB NO: 19 KHCC 127. A written informed consent was obtained from all patients after explaining the objectives of the study and ensuring the freedom to refuse without affecting in daily clinical practice.

Data Availability

The datasets generated during and/ or analyzed during the current study are available from the corresponding author on reasonable request.

Conflict of interest

The author (s) declared no potential conflict of interest with respect to the research, authorship, and/or publication of this article.

Funding

close access and the author(s) received no financial support for the research, authorship,and/or publication of this article.

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Arabic Eating-10 Assessment Tool Validation Using Fiber-Optic Endoscopic Evaluation Of Swallowing (FEES) As An Imperfect Gold Standard: A Prospective Follow-up Cohort Study.

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