Dysphagia Risk in Rheumatic Diseases

Condition(s) studied

Study summary

This study aims to evaluate the impact of dysphagia on eating and swallowing functions, gastrointestinal symptoms, and related clinical findings in individuals with inflammatory rheumatic diseases. Additionally, the study aims to identify differences between individuals with and without dysphagia.

Eligibility

Primary outcome measure(s)

• Eating Assessment Tool (EAT-10) — at baseline
  The primary outcome is the risk of dysphagia in patients with inflammatory rheumatic diseases, measured using a validated questionnaire administered once to each participant. The swallowing function was assessed using the Eating Assessment Tool-10 (EAT-10). The scale consists of 10 items, with a total score ranging from 0 to 40. Higher scores indicate a greater severity of swallowing impairment (a score of ≥3 is considered indicative of dysphagia)
• Fonseca Anamnestic Questionnaire — at baseline
  The severity of temporomandibular disorders was assessed using the Fonseca Anamnestic Index (FAI). The index consists of 10 items with a total score ranging from 0 to 100. Higher scores indicate a greater severity of temporomandibular dysfunction
• Gastrointestinal Symptom Rating Scale (GSRS) — at baseline
  Gastrointestinal symptoms were evaluated using the Gastrointestinal Symptom Rating Scale (GSRS). The scale consists of 15 items scored on a 7-point Likert scale ranging from 1 to 7. Total and subscale scores are calculated, where higher scores indicate greater symptom severity and a worse clinical condition.
• Functional Oral Intake Scale (FOIS) — at baseline
  The patient's functional level of oral intake was assessed using the Functional Oral Intake Scale (FOIS). The scale is a 7-point ordinal scale with scores ranging from 1 to 7. Unlike many other clinical tools, higher scores on the FOIS indicate better functional oral intake, with a score of 1 representing total tube dependency and a score of 7 representing total oral intake with no restrictions.
• Mediterranean Diet Quality Index (KIDMED) — at baseline
  Nutritional habits and adherence to the Mediterranean diet were evaluated using the Mediterranean Diet Quality Index (KIDMED). The index is based on a 16-item questionnaire with total scores ranging from -4 to 12. Higher scores indicate better adherence to the Mediterranean diet and higher dietary quality.
• Reflux Symptom Index (RSI) — at baseline
  The severity of laryngopharyngeal reflux symptoms was assessed using the Reflux Symptom Index (RSI). The index is a 9-item self-reported questionnaire with a total score ranging from 0 to 45. Higher scores indicate a greater severity of symptoms, with a score of 13 or higher typically considered as clinically significant for reflux.
• Malnutrition Inflammation Score — at baseline
  Nutritional status and inflammation levels were assessed using the Malnutrition-Inflammation Score (MIS). The score consists of 10 components, including clinical history, physical examination, body mass index, and laboratory parameters (serum albumin and total iron-binding capacity). Each component is scored from 0 to 3, with total scores ranging from 0 to 30. Higher scores indicate a greater severity of malnutrition and inflammation.

Trial sites (1)

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