Validazione qualitativa con metodologia Thinking Aloud dello “Spiritual Needs Questionnaire” e dell’ “Interpretation of Illness Questionnaire” nei pazienti con malattie infiammatorie croniche intestinali

Background: Inflammatory bowel disease (IBD) is a chronic, relapsing condition that imposes substantial physical and psychosocial burden: fatigue, anxiety, and depression with marked impacts on quality of life and functioning. Spirituality, encompassing meaning, connection, hope, and transcendence, is a key but often under assessed determinant of health, and the spiritual needs of people with IBD remain insufficiently explored in routine care. The Spiritual Needs Questionnaire (SpNQ) and the Interpretation of Illness Questionnaire (IIQ) are established tools to assess spiritual and existential dimensions yet require cross cultural adaptation and content validation for use within the Italian IBD context. Objectives: Validate and adapt the SpNQ and the IIQ questionnaire for the IBD context using a think-aloud cognitive interviewing approach, assessing clarity, relevance, and cultural adequacy. Methods: This was a qualitative instrument validation study conducted to evaluate the content validity, comprehension, and interpretability of the adaptations of the SpNQ-EV and the IIQ in individuals with IBD. Semi-structured interviews were conducted with IBD patients and healthcare professionals across two hospitals in Northeast Italy, employing the TA protocol (concurrent and retrospective probing). Sampling proceeded until data saturation was achieved. Verbal data were transcribed verbatim and analysed using a combined qualitative coding system (predefined and emergent categories). Analysis was supported by Artificial Intelligence (ChatGPT-5.0) assisted coding, and the reliability was assessed through inter-coder agreement (Cohen's Kappa). Item revision was systematically guided by the frequency of cognitive issues identified, using a threshold of at least 15% of participants as the criterion for necessary modification. Results: Both instruments were generally comprehensible. For SpNQ-EV-ITA, 596 segments were coded: 523 showed no issues, 49 questioned item sensibleness content, and 24 were comments. At the item level (n=33), 17 required no change, 8 required minor revision, and 8 underwent major revision, with 2 items eliminated. For IIQ-ITA, 136 segments were coded: 102 showed no issues, 27 questioned sensibleness content, and 7 were comments. At the item level (n=8), 6 required no change and 2 underwent major revision, with 1 item eliminated. Conclusion: Using a think-aloud cognitive interviewing approach, the study showed that the SpNQ-EV-ITA and IIQ-ITA are generally comprehensible to both patients and healthcare professionals. Nevertheless, a small subset of items, specifically those addressing end-of-life themes, appeared misaligned with the IBD context. On this basis, we proposed a revised version of the SpNQ-EV-ITA and minor adaptations of the IIQ-ITA, which we hypothesize to be suitable not only for IBD but also for other chronic conditions. The proposed instruments will require subsequent validation.