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Development and evaluation of screening dysphagia tools for observational studies and routine care in cancer patients.

Background and aims: Dysphagia can be associated with significant morbidity in cancer patients. We aimed to develop and evaluate dysphagia screener tools for use in observational studies (phase 1) and for routine symptom monitoring in clinical care (phase 2).

Methods: Various dysphagia or odynophagia screening questions, selected after an expert panel reviewed the content, criterion, and construct validity, were compared with either functional assessment of cancer therapy - esophageal cancer (FACT-E) Swallowing Index Cut-Off Values or to questions adapted from the Patient Reported Outcomes for Common Terminology Criteria for Adverse Events. Sensitivity, specificity, and patient acceptability were assessed.

Results: In Phase 1 (n = 178 esophageal cancer patients), the screening question "How are you currently eating?" had the highest sensitivities and specificities against various Swallowing Index Cut-Off Value cut-offs, with the best optimal cutoff associated with weight loss (80% sensitivity and 75% specificity). In phase 2 (255 head and neck, gastro-esophageal, and thoracic cancer patients), a single question screener ("Do you experience any difficulty or pain upon swallowing?") versus a Patient Reported Outcomes for Common Terminology Criteria for Adverse Events-like gold standard generated sensitivities between 86% and 94% and specificities between 93% and 100%. This screening question (+/- follow-up questions) had a median completion time of under 2 minutes, and >90% of patients were willing to complete the survey electronically, did not feel that survey made clinic visit more difficult, and did not find the questions upsetting or distressful.

Conclusion: Our results demonstrate that these screener tools ("How are you currently eating?", "Do you experience any difficulty or pain upon swallowing?") can effectively screen dysphagia symptoms without increasing cancer outpatient clinic burden, both in observational studies and for routine clinical monitoring.

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