M. Layola

Development and validation of a specific questionnaire to assess health-related quality of life in patients with home enteral nutrition: NutriQoL® development

Introduction Home enteral nutrition (HEN) is indicated in patients with a functional gastrointestinal tract but who are unable to meet their nutritional requirements with normally consumed foodstuffs. HEN allows patients to remain in their social and family environment, thus reducing complications and costs associated with hospital admission, while increasing health-related quality of life (HRQoL). HRQoL in patients with HEN is mainly evaluated by generic instruments, which are not sensitive enough to identify certain specific patient-related outcomes of HEN. Objective To develop a specific instrument to measure HRQoL in patients receiving HEN whose results allow interpretation regardless of the underlying disease and nutritional support administration route: the NutriQoL® questionnaire. Materials and methods The development of the NutriQoL entailed a literature review, focus groups with experts, semistructured interviews with patients, an assessment of face validity and feasibility, and Rasch analysis conducted on data from a sample of 141 patients and 24 caregivers. Results Of the 52 items initially proposed on the basis of the literature review, expert focus group, and semi-structured interviews with patients and caregivers, 17 items were finally selected through the development process to make up the final version of the NutriQoL, as well as a visual analog scale for global HRQoL scoring. The selected items were evaluated as adequate for frequency, importance, and clarity. Furthermore, they have been shown to be independent of the underlying condition and HEN administration route. Conclusion A new instrument for measuring the HRQoL of patients with HEN in Spain has been developed, whose results are independent of the underlying condition and administration route. The next step will be the validation of the questionnaire to ensure that the instrument is valid, reliable, and sensitive to health status changes in patients, to be used periodically in usual clinical practice.

Responsiveness and Minimal Clinically Important Difference of A Specific Health Related Quality of Life (Hrqol) Questionnaire for Home Enteral Nutrition (Hen) Patients: Nutriqol® Questionnaire.

two back translations of the English ItchRO. Cognitive interviews with five children with ALGS (patient report) and five parents (observer report) were to be performed. Key inclusion criteria were: children aged 5-9 years with cholestatic liver disease (ALGS) or progressive familial intrahepatic cholestasis (PFIC), who were also experiencing itching. Results: Recruitment was challenging and threatened to delay the clinical trial programme. Thus, recruitment was extended to include children who were 3-17 years of age, and in Spain and Germany, patients with alternative pathologies that manifested primarily with generalized pruritus were included. The final sample included: 15 with ALGS (France n= 5; Poland n= 5; Germany n= 3; Spain n= 2), 2 with PFIC (Spain), 2 with atopic dermatitis (Germany) and 1 with contact dermatitis (Spain). The ItchRO translations were well understood; there were no apparent differences in translation interpretations by disease state. ConClusions: Recruitment in linguistic validation projects in rare diseases can be a hurdle, yet patient understanding, rather than those of ‘lay people, ’ is preferable in paediatrics to ensure adequate interpretation, which can vary substantially across children. As a result patients with similar symptom and impact characteristics could be recruited if recruiting the primary population is likely to delay clinical trial research in rare diseases, where there is an urgent need for treatment.

Rasch analysis in the development of the NutriQoL® questionnaire, a specific health-related quality of life instrument for home enteral nutrition

BackgroundHome enteral nutrition (HEN) is a therapeutic method used in patients who are unable to ingest the required amounts of nutrients but retain a functional gastrointestinal tract. The objective of this study was to compose a specific questionnaire for measuring health-related quality of life (HRQoL) in HEN patients irrespective of their underlying condition and HEN route of administration.MethodsLiterature review, focus groups and semi-structured interviews were used to propose an initial version of the questionnaire which was answered by 165 participants. The responses were analyzed using the Rasch methodology. Firstly, the appropriateness of response options was assessed. Then, the differential item functioning (DIF) was evaluated. Finally, the item fit statistics, infit and outfit, were determined.ResultsRasch analysis was performed on the responses given to the 43 items included in the initial questionnaire. Four items were excluded because more than 50% of respondents answered that the situation proposed did not apply to them. Seven items that showed overlapping and disordered categories were also removed. Pairwise DIF analysis were performed in subgroups defined by underlying disease and administration route. Eleven items presented DIF and were eliminated from the questionnaire. Finally, four items were deleted after analyzing the fit statistics, three of which did not fit the Rasch model and one did not belong to either of the dimensions. The final version of NutriQoL® includes 17 items.ConclusionsNutriQoL® is a useful instrument to assess the HRQoL of HEN patients with any disease and any administration route.

Patients’ and professionals’ preferences in terms of the attributes of home enteral nutrition products in Spain. A discrete choice experiment

Background/objectivesTo elicit and compare preferences in terms of the attributes of home enteral nutrition (HEN) among patients and physicians, using a discrete choice experiment (DCE).Subjects/methodsA DCE comprising eight choice scenarios, with six HEN attributes (tolerability, adaptation to comorbidities, nutrition and calories, handling, connections and information; two levels each) was designed. The Relative Importance (RI) for patients and physicians of each attribute was estimated. Sociodemographic and clinical variables, as well as additional questions (n = 8) were compiled to analyze possible explanatory variables and other preferences.ResultsA total of 148 HEN patients (71 needing caregivers to answer on their behalf) and 114 physicians completed the DCE. The most important attributes for patients were adaptation to comorbidities (33% RI), tolerability (33% RI), and nutrition and calories (26% RI). Significantly, younger patients had stronger preferences for tolerability whereas elderly ones (≥75 years) were more concerned about handling. In comparison, physicians gave a higher RI to tolerability, and nutrition and calories compared to patients (p = 0.002). Overall, a higher percentage of physicians answered that HEN characteristics such as easy-handling bags (85.1 vs. 64.9%; p = 0.001), container material (69.3 vs. 57.1%; p = 0.003) or reusable containers (79.8 vs. 70.3%; p = 0.01) were “important” or “very important” compared to patients.ConclusionsOur findings showed that although patients and physicians have a similar perception about the relevance of different HEN attributes, the relative weight given to each one varies between them. Therefore, both points of view should be considered when choosing a HEN product in order to improve patients’ satisfaction and clinical outcomes.

SUN-P104: Preferences for the Characteristics of Home Enteral Nutrition Viatube Feeding: A Discrete-Choice Experiment

Preferencias Nutrición Enteral Domiciliaria SUN-P104 Preferences for the characteristics of home enteral nutrition via tube feeding: a discrete-choice experiment (DCE) Authors: Olveira G1, Martínez-Olmos MA2, Fernández de Bobadilla B3, Ferrer M4, Virgili N5, Vega B6, Blanco M7, Layola M7, Lizán L8, Tribaldos Causadias M8 Filiation: 1. Hospital Regional Universitario de Málaga, Málaga, Spain; 2. Hospital Universitario de Santiago, A Coruña, Spain; 3. Hospital General Universitario de Ciudad Real, Ciudad Real, Spain; 4. Hospital Universitario Clínico Virgen de la Arrixaca, Murcia, Spain; 5. Hospital Universitario de Bellvitge, Barcelona, Spain; 6. Hospital Universitario Ramón y Cajal, Madrid, Spain; 7. Nestlé Health Science, Barcelona, Spain; 8. Outcomes’10, Castellón, Spain.