Phase IV international prospective validation of the EORTC patient satisfaction core questionnaire (EORTC PATSAT-C33) and outpatient module (EORTC OUT-PATSAT7)

<title>Abstract</title> Background Advances in cancer care require ongoing monitoring of patient satisfaction using rigorous questionnaires. The EORTC Quality of Life Group has cross-culturally developed a patient satisfaction core questionnaire (PATSAT-C33) to be used in any hospital cancer care settings and an outpatient satisfaction module (OUT-PATSAT7) to address specific aspects of ambulatory care. This multi-center international prospective study aimed to validate the PATSAT-C33 and OUT-PATSAT7, including assessing its acceptability. Methods Patients (N = 690) affected by any cancer site or stage equally distributed by age and gender, were enrolled in in- and out-patient cancer settings from 20 institutions, 12 countries and 5 geographic/cultural areas. Among them, 675 completed the PATSAT-C33 alongside the EORTC QLQ-C30, Oberst’s perception of care quality 5-item, and ‘ <italic>intention to recommend the hospital’</italic> 1-item. Among the 532 outpatients, 526 also completed the OUT-PATSAT7. A subset completed a two-week retest (N = 120 & 96 for the PATSAT-C33 & OUT-PATSAT7, respectively) or one-year responsiveness-to-change assessment (RCA) (N = 166 & 155). Comprehensive psychometric testing was performed. Results Full item completion was high (85% & 88%), 83% of patients took ≤ 20 minutes to complete both questionnaires (40 items); 5% of patients required help with understanding questionnaire items. Confirmatory factor analyses evidenced satisfactory fit on the eleven PATSAT-C33 and two OUT-PATSAT7 multi-item scales (CFI/TLI > 0.90; RMSEA < 0.10 and = 0.108, respectively). Internal consistency was good to excellent (all ≥ 0.80); test-retest reliability was fair (0.48, 1 scale), good (0.60–0.74, 11 scales) to excellent (≥ 0.75, 7 scales). Convergent validity was supported by correlations of ≥ 0.40 with related Oberst’s scales and < 0.30 with unrelated QLQ-C30 scales. Known-groups differences was shown for comorbidity, toxicity, global health, care expectations and intention to recommend the hospital. Change over time was captured in groups defined based on change in global health, cancer care setting, and the receipt of supportive care over the past year. Conclusions This study supports the psychometric robustness of the EORTC PATSAT-C33 and OUT-PATSAT7 and their promising usefulness in monitoring cancer care within and across cancer care settings from different cultures and cancer patient populations. Trial registration ClinicalTrials.gov ID NCT05989191, released August 2, 2023.