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• W2955102521 abstract "As part of the Standardized Outcomes in Nephrology-Hemodialysis program of work, to establish a core outcomes set for all trials in hemodialysis, fatigue was identified as one of the five core outcomes. However, although fatigue is common and debilitating for patients on hemodialysis, it is infrequently and inconsistently reported in clinical trials in this setting. Through a four-phase process we aimed to establish a core outcome measure for fatigue to facilitate standardized and accurate assessment of this outcome in all hemodialysis trials. We conducted 1) a systematic review of studies to assess the range, validity and frequency of fatigue measures used, 2) an international survey with patients and health professionals to identify the most important dimensions to assess in a fatigue measure among the varying content of existing measures identified in the review, 3) a consensus workshop including patients and health professionals including nephrologists, researchers, and policy makers to discuss content validity, feasibility and implementation, and 4) a pilot of the proposed outcome measure using cognitive interviews assessing comprehension, retrieval, judgement and response In the systematic review, we identified 43 different measures across 123 included studies with widely varying content, response scale, length, and cost. In total, 658 participants (313 [48%] patients and caregivers and 345 [52%] health professionals) from 60 countries completed the survey. Life participation (impact of fatigue on the ability to participate in usual activities) was identified as the most important dimension of fatigue. Themes from the consensus workshop indicated that life participation, along with tiredness and level of energy, would form relevant and meaningful content for the proposed outcome measure. Participants emphasized that the measure had to be simple, short, without imposing additional burden given the high level of fatigue in this population. Integrating these findings, the resulting 3-item measure was designed to assess life participation, tiredness and level of energy. All three items are on a 4-point Likert scale indicating severity. As recommended, a recall period of a week was chosen for this measure. The full measure can be seen in Figure 1. In the pilot study, the proposed outcome measure was deemed relevant and acceptable in all four aspects of the cognitive interview framework Patients and health professionals support the need for a simple, short and meaningful core patient-reported outcome measure that assesses level of energy, tiredness and impact of fatigue on the ability to participate in life activities. These aspects were integrated in the development of the proposed outcome measure for fatigue, to enable a valid and patient-centered assessment of this critical outcome" @default.
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• W2955102521 date "2019-07-01" @default.
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• W2955102521 title "SUN-096 STANDARDIZED OUTCOMES IN NEPHROLOGY-HEMODIALYSIS (SONG-HD): DEVELOPING A CORE OUTCOME MEASURE FOR FATIGUE IN HEMODIALYSIS" @default.
• W2955102521 doi "https://doi.org/10.1016/j.ekir.2019.05.493" @default.
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