Desenvolvimento de um novo instrumento de qualidade de vida relacionada à saúde para pacientes em nutrição enteral domiciliar pela percepção do cuidador: NEDQV- C

Abstract

The use of instruments to assess the Health-Related Quality of Life (HRQOL) of patients using Home Enteral Nutrition (HEN) is important to investigate the positive and negative impacts of the therapy. However, users in HEN, unable to judge their health and well- being, are prevalent, especially neurological patients in advanced stages. Since this epidemiological profile, specific instruments are needed to assess the quality of life that caregivers can complete, which, to date, is unknown in the literature. In this context, this study aimed to develop a specific instrument to assess the HRQoL of users in HEN to be completed by the caregiver. It was a methodological study with the association of qualitative and quantitative methods. The domains and items of the instrument was defined after the initial steps (literature review, focus group, and semi-structured interview), the content was validated by a committee of nine experts, by the Delphi method and using the Content Validity Index with a rate of ≥ 0.78. After content validation, a semantic assessment was performed with a subsample of formal (n=5) and informal (n=5) caregivers. In the pilot study, Item Response Theory and Classical Testing Theory were used to reduce the instrument, being analyzed: item adjustment, Differential Item Function (DIF), ordering of polytomous categories, the function of information power associated with reliability of internal consistency (Cronbach's alpha and item-total correlation). Once the initial steps were completed, the instrument consisted of nine domains and 56 items. After four Delphi rounds, the instrument content was validated. In the semantic analysis, there was good understanding without the need for change. For the pilot study, 66 interviews were carried out with caregivers. Good internal consistency was achieved (α=0.84), the information function of each item and the corrected item-total correlation coefficient ranged from 0.99 - 3.99 and -0.04 - 0.60, respectively, indicating low suitability of some items. Three items with null variance and one item with DIF were also identified. In total, 16 items and three domains did not fit the cutoff points of the information function for the test, but they did not affect the internal consistency, so they were maintained. Once this instrument development process was completed, its content was considered valid and reliable, to suitable for future validation studies.