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• W2343950725 abstract "There is a paucity of evidence regarding a well-defined, reliable, and feasible method for measuring efficacy outcomes from a patient perspective in Community-Acquired Bacterial Pneumonia (CABP) trials. Most CABP studies evaluate treatment efficacy on the basis of clinical outcomes; however, there is no patient-reported outcome (PRO) to capture additional symptoms of how patients feel, function, or survive. The goal of this study was to explore CABP symptoms as reported by patients, and to develop a draft PRO instrument designed to comprehensively assess these symptoms. Concept elicitation was conducted by telephone interviews with patients within 10 days of CABP diagnosis. Data was analyzed using an iterative process to identify themes and concepts and was recorded in a saturation grid. Saturation was monitored according to the FDA PRO guidance. Using this qualitative data, a draft PRO instrument was prepared. Cognitive debriefing interviews were conducted to assess item readability, relevance, comprehensiveness, and content validity. Twenty patients participated in concept elicitation interviews. Mean age of the patients was 59.5 years (SD = 18.8, range: 29-90); 45% were female. The most common symptoms reported included a lack of energy or tiredness (n=18), cough (n=16), and shortness of breath (n=16). Nearly half the patients also reported fever, chest pain and general aches/pain as well as significant impacts on their social (n=10) and physical functioning (n=17) related to the skin infection. Subsequent cognitive debriefing in 9 patients and 3 clinical experts demonstrated that the items were understandable, relevant, and interpreted as intended. Qualitative data from patients and input from experts formed the basis of the CABP PRO structure and item pool. These patient-reported CABP symptoms were shown to demonstrate content saturation and concept validity and provide unique information important for both comprehensive evaluation of individuals with CABP and evaluation of new antibacterial treatments." @default.
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• W2343950725 date "2015-05-01" @default.
• W2343950725 modified "2023-10-16" @default.
• W2343950725 title "Community-Acquired Bacterial Pneumonia (Cabp): Development of A New Patient-Reported Outcome (Pro) FNIH Biomarkers Consortium CABP ABSSSI Project Team ‘3" @default.
• W2343950725 doi "https://doi.org/10.1016/j.jval.2015.03.1408" @default.
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