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Background <p>Diabetic autonomic neuropathy (DAN) is a significant complication of diabetes. The Composite Autonomic Symptom Score-31 (COMPASS-31) is a widely used and validated instrument to assess autonomic dysfunction, yet no validation of its use exists in the Arabic language. In this study, we aimed to develop and validate an Arabic language version of the COMPASS-31 (A-COMPASS-31) in a cohort of Egyptian patients with DAN.</p> Methods <p>We enrolled 20 diabetic subjects with DAN and 20 age- and sex-matched diabetic subjects without DAN. Following International Society for Pharmacoeconomics and Outcomes Research (ISPOR)-guided adaptation, the A-COMPASS-31 was developed and subsequently administered twice (four weeks apart) for test-retest reliability. Convergent validity was evaluated against the Ewing battery of autonomic tests, sympathetic skin response (SSR), the neuropathic pain scale (NPS), somatic neuropathy (The Utah Early Neuropathy Scale (UENS)), and quality of life (EuroQol-5 Dimensions-5 Levels (EQ-5D-5&#xa0;L)) measures. Receiver operating characteristic (ROC) analysis determined diagnostic accuracy.</p> Results <p>A-COMPASS-31 demonstrated excellent reliability (Cronbach’s α = 0.841; ICC = 0.992). It significantly correlated with the UENS (r<sub>s</sub>=0.517, <i>p</i> = 0.001), NPS (r<sub>s</sub>=0.495, <i>p</i> = 0.001), and EQ-5D-5L (r<sub>s</sub>=-0.539, <i>p</i> = 0.001). ROC analysis yielded fair diagnostic accuracy (AUC = 0.742, 95% CI 0.580–0.867, <i>p</i> = 0.003) with an optimal cut-off of 28.43 (sensitivity 80%, specificity 65%).</p> Conclusion <p>The A-COMPASS-31 is a reliable and valid instrument for assessing autonomic symptoms in Arabic-speaking diabetic patients. Its strong correlation with neuropathy severity scales and quality of life measures supports its utility as a first-line clinical screening tool. Due to its modest specificity, initial screening should be followed by objective autonomic testing for definitive diagnosis.</p>

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Validation of the Arabic version of the composite autonomic symptom score 31 questionnaire in diabetic autonomic neuropathy

  • 期刊论文

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  • 发表日期：

    2026年3月27日

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  • Ahmed S. Alkotami,
  • Asmaa Aboelfath,
  • Aya E. Zhran,
  • Amro M. Stino,
  • Ahmed M. Eldokla

摘要

Background

Diabetic autonomic neuropathy (DAN) is a significant complication of diabetes. The Composite Autonomic Symptom Score-31 (COMPASS-31) is a widely used and validated instrument to assess autonomic dysfunction, yet no validation of its use exists in the Arabic language. In this study, we aimed to develop and validate an Arabic language version of the COMPASS-31 (A-COMPASS-31) in a cohort of Egyptian patients with DAN.

Methods

We enrolled 20 diabetic subjects with DAN and 20 age- and sex-matched diabetic subjects without DAN. Following International Society for Pharmacoeconomics and Outcomes Research (ISPOR)-guided adaptation, the A-COMPASS-31 was developed and subsequently administered twice (four weeks apart) for test-retest reliability. Convergent validity was evaluated against the Ewing battery of autonomic tests, sympathetic skin response (SSR), the neuropathic pain scale (NPS), somatic neuropathy (The Utah Early Neuropathy Scale (UENS)), and quality of life (EuroQol-5 Dimensions-5 Levels (EQ-5D-5 L)) measures. Receiver operating characteristic (ROC) analysis determined diagnostic accuracy.

Results

A-COMPASS-31 demonstrated excellent reliability (Cronbach’s α = 0.841; ICC = 0.992). It significantly correlated with the UENS (rs=0.517, p = 0.001), NPS (rs=0.495, p = 0.001), and EQ-5D-5L (rs=-0.539, p = 0.001). ROC analysis yielded fair diagnostic accuracy (AUC = 0.742, 95% CI 0.580–0.867, p = 0.003) with an optimal cut-off of 28.43 (sensitivity 80%, specificity 65%).

Conclusion

The A-COMPASS-31 is a reliable and valid instrument for assessing autonomic symptoms in Arabic-speaking diabetic patients. Its strong correlation with neuropathy severity scales and quality of life measures supports its utility as a first-line clinical screening tool. Due to its modest specificity, initial screening should be followed by objective autonomic testing for definitive diagnosis.