HF-OCAQ: Oral comfort assessment in heart failure patients

Oral discomfort is common among patients with heart failure (HF), with the potential to compromise nutritional intake, communication, and health-related quality of life. Existing oral assessment tools are predominantly clinician-administered and focused on objective pathology, thus failing to adequately capture patients' subjective experiences of oral comfort. A patient-reported instrument specifically designed for HF populations is lacking. To develop and preliminarily validate a novel PROM, the HF Patients' Oral Comfort Assessment Questionnaire (HF-OCAQ), designed to multidimensionally assess perceived oral comfort in hospitalized patients with HF. An initial item pool was generated through literature review, qualitative patient interviews, and expert consultation, guided by Kolcaba's Comfort Theory. Content validity was evaluated using a two-round Delphi process. A pretest was conducted to assess feasibility and clarity. The questionnaire was then administered to hospitalized patients with HF from three general hospitals between June and September 2020. Psychometric comprised assessments of content validity indices, internal consistency reliability, criterion-related validity against the Beck Oral Assessment Scale (BOAS) using Pearson's correlation, and structural validity via exploratory factor analysis (EFA) using a common-factor model. A total of 190 valid questionnaires were included in the final analysis. The final HF-OCAQ consisted of 24 items. Content validity indices were high (I-CVI range: 0.833-1.000; S-CVI/UA: 0.875; S-CVI/Ave: 0.979). Internal consistency was acceptable (Cronbach's α = 0.810). Criterion-related validity showed a weak but statistically significant correlation with BOAS scores (r = 0.233, p < 0.05), consistent with the conceptual distinction between subjective comfort and objective oral status. Exploratory factor analysis supported a four-factor structure that was theoretically coherent and aligned with the proposed multidimensional construct of oral comfort. The HF-OCAQ was developed and preliminarily validated as a patient-reported instrument for assessing perceived oral comfort in hospitalized patients with HF. The findings provide initial evidence supporting its content validity, internal consistency, and structural validity. Further studies, including confirmatory factor analysis, test-retest reliability, and assessment of responsiveness to clinical change, are warranted before broader clinical and research application.