Demonstrating Methods for Handling Missing Patient Reported Outcome (Pro) Data in Clinical Trial Data Analysis.

PRM165 ExtERnal Validity of thE WEll-BEing RElatEd to food QuEstionnaiRE (WEll-BfQ©): VaRiations accoRding to thE suBjEcts’ nutRitional status Allaert FA1, Ginon E2, Rogeaux M3, Urdapilleta I4, Capuron L5, Dupuy A6, Layé S7, Lecerf J8, Prost M9, Guillemin I10, Marrel A10, Arnould B10 1CEN Biotech/CEN Nutriment, Dijon, France, 2Laboratory for Experimentation in Social Sciences and Behavioral Analysis (LESSAC) ESC, Dijon, France, 3DANONE Nutricia Research, Palaiseau, France, 4Social Psychology Laboratory of Paris (LAPPS EA 4386), Saint-Denis, France, 5Laboratory of Nutrition and Integrative Neurobiology NutriNeuro; INRA UMR 1286, Bordeaux, France, 6CERTOP UMR CNRS 5044, Toulouse, France, 7INRA UMR 1286, Bordeaux, France, 8Institut Pasteur de Lille, Lille, France, 9LARA SPIRAL, Couternon, France, 10Patient-Centered Outcomes Mapi, Lyon, France Objectives: To document the external validation of the Well-Being related to Food Questionnaire (Well-BFQ) by studying variations of scores according to subjects’ nutritional status. The Well-BFQ was developed after conducting interviews with healthy subjects and subjects with digestive, joint or immunity complaints. Its structure was determined using principal component analyses and confirmed using factor analyses with multi-trait analyses. MethOds: The Well-BFQ has a modular backbone with sub-dimensions measuring pleasure, security, relaxation, digestion and satiety, energy and psychology, health (ageing, bowel movement, immunity and mobility) and food behaviour. Each sub-dimension is rated from 0 to 100; distributions were compared according to the nutritional status of the subjects using variance analyses. Nutritional status was evaluated according to the PNNS questionnaire (French National Health Nutritional Program). Results: Subjects (N= 444) were aged 42±15 years and 71.6% women; 18.1% had a balanced diet (BD), 14.7% a non-balanced diet (NBD) and 67.1% a standard diet (SD). The majority of the dimensions assessed with the Well-BFQ were significantly higher (i.e. better food-related well-being) in subjects with a BD than in those with a NBD; even the dimensions assessing commensality (eating as a group) and behavioural attitudes toward buying and cooking food. In particular, the security dimension was rated 67.9±19.5 in BD compared with 56.9±25.2 in NBD and 61.1±21.3 in SD (p< 0.01) and health benefit was rated 67.4±12.4 in BD compared with 55.9 ±13.9 in NBD and 64.6±12.8 in SD (p< 0.0001). cOnclusiOns: This study contributes to the external validity of Well-BFQ by demonstrating the expected positive correlation of the well-being it measures and the quality of the diet of the subjects. Its ability to measure well-being differences according eating habits makes it a promising tool for epidemiological surveys and experimental trials.