Validation of the PILL-5: A 5-Item Patient Reported Outcome Measure for Pill Dysphagia

Nogah Nativ-Zeltzer, Ahmed Bayoumi, Van Pierre Mandin, Matthew Kaufman, Indulaxmi Seeni, Maggie Kuhn, Peter C Belafsky

Research output: Contribution to journalArticle

Abstract

Objectives: Pill dysphagia is common and costly with a significant risk of pill retention, caustic injury, and poor medication compliance. The purpose of this investigation was to determine the validity and reliability of the PILL-5, a self-administered patient reported outcome measure (PROM) to quantify the degree of pill (tablet and capsule) dysphagia. The PILL-5 is a 5-item questionnaire with a maximum symptom score of 20. Methods: The PILL-5 was administered to 190 patients with dysphagia referred for videofluoroscopic esophagography (VFE). Construct validity was assessed by comparing PILL-5 composite scores to delayed barium tablet transit on VFE. Normative data was obtained by administering the instrument to a cohort of healthy community based volunteers. Internal consistency was assessed with the Cronbach alpha. Test/retest reliability was determined by administering the instrument to the same cohort of patients at two time points. Results: The mean PILL-5 was 5.6 (±4.9) for persons with dysphagia and 1.6 (±2.7) for healthy volunteers (p < 0.001). The internal consistency of the instrument was high (Cronbach alpha = 0.85). The mean PILL-5 was 4.3 (±4.1) for patients with normal transit and 7.6 (±5.3) for patients with delayed barium tablet transit on esophagography, indicating excellent criterion based validity (p < 0.001). Reproducibility was high with an intraclass correlation coefficient of 0.83 (p < 0.001). Conclusions: Healthy individuals report some degree of swallowing difficulty with pills. Normative data suggest that a PILL-5 > 6 is abnormal (mean + 2 SD). The instrument demonstrated excellent criterion based validity and reliability. The PILL-5 is the first validated patient reported outcome measure for pill dysphagia.

Original languageEnglish (US)
Article number43
JournalFrontiers in Surgery
Volume6
DOIs
StatePublished - Jul 24 2019

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Deglutition Disorders
Reproducibility of Results
Tablets
Caustics
Medication Adherence
Barium
Capsules
Volunteers
Healthy Volunteers
Patient Reported Outcome Measures
Wounds and Injuries

Keywords

  • outcome measure
  • pill dysphagia
  • questionnaire
  • swallowing
  • tablet

ASJC Scopus subject areas

  • Surgery

Cite this

Validation of the PILL-5 : A 5-Item Patient Reported Outcome Measure for Pill Dysphagia. / Nativ-Zeltzer, Nogah; Bayoumi, Ahmed; Mandin, Van Pierre; Kaufman, Matthew; Seeni, Indulaxmi; Kuhn, Maggie; Belafsky, Peter C.

In: Frontiers in Surgery, Vol. 6, 43, 24.07.2019.

Research output: Contribution to journalArticle

Nativ-Zeltzer, Nogah ; Bayoumi, Ahmed ; Mandin, Van Pierre ; Kaufman, Matthew ; Seeni, Indulaxmi ; Kuhn, Maggie ; Belafsky, Peter C. / Validation of the PILL-5 : A 5-Item Patient Reported Outcome Measure for Pill Dysphagia. In: Frontiers in Surgery. 2019 ; Vol. 6.
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abstract = "Objectives: Pill dysphagia is common and costly with a significant risk of pill retention, caustic injury, and poor medication compliance. The purpose of this investigation was to determine the validity and reliability of the PILL-5, a self-administered patient reported outcome measure (PROM) to quantify the degree of pill (tablet and capsule) dysphagia. The PILL-5 is a 5-item questionnaire with a maximum symptom score of 20. Methods: The PILL-5 was administered to 190 patients with dysphagia referred for videofluoroscopic esophagography (VFE). Construct validity was assessed by comparing PILL-5 composite scores to delayed barium tablet transit on VFE. Normative data was obtained by administering the instrument to a cohort of healthy community based volunteers. Internal consistency was assessed with the Cronbach alpha. Test/retest reliability was determined by administering the instrument to the same cohort of patients at two time points. Results: The mean PILL-5 was 5.6 (±4.9) for persons with dysphagia and 1.6 (±2.7) for healthy volunteers (p < 0.001). The internal consistency of the instrument was high (Cronbach alpha = 0.85). The mean PILL-5 was 4.3 (±4.1) for patients with normal transit and 7.6 (±5.3) for patients with delayed barium tablet transit on esophagography, indicating excellent criterion based validity (p < 0.001). Reproducibility was high with an intraclass correlation coefficient of 0.83 (p < 0.001). Conclusions: Healthy individuals report some degree of swallowing difficulty with pills. Normative data suggest that a PILL-5 > 6 is abnormal (mean + 2 SD). The instrument demonstrated excellent criterion based validity and reliability. The PILL-5 is the first validated patient reported outcome measure for pill dysphagia.",
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