caa a22 4500 606179011 CHVBK 20210128100759.0 cr unu---uuuuu 210128e20151201xx s 000 0 eng 10.1007/s11136-015-1023-6 doi (NATIONALLICENCE)springer-10.1007/s11136-015-1023-6 Assessing the impact of non-severe hypoglycemic events and treatment in adults: development of theTreatment-Related Impact Measure—Non-severe Hypoglycemic Events (TRIM-HYPO) [Elektronische Daten] [Meryl Brod, Lise Højbjerre, Donald Bushnell, Charlotte Hansen] Purpose: Non-severe hypoglycemic events (NSHEs) are commonly experienced by diabetes patients, particularly among insulin users, and can have serious impacts on daily functioning, emotional well-being, sleep, work productivity, and treatment adherence. Currently, no PRO measures are available to assess the impacts of non-severe hypoglycemia. To address this gap, the Treatment-Related Impact Measure-Non-severe Hypoglycemic Events (TRIM-HYPO) was developed. This paper describes the TRIM-HYPO development and validation. Methods: The creation of the TRIM-HYPO followed FDA's guideline for PRO development. Concept elicitation data were gathered from literature review, clinical expert interviews, and focus groups of patients with Type 1 or 2 diabetes in four countries. Based on the qualitative analysis, draft items were generated and cognitively debriefed. Psychometric validation included factor analysis, item response theory analysis, and assessment of psychometric characteristics for the TRIM-HYPO. Results: Eight clinical experts and 167 patients participated in concept elicitation. The validation study included 407 patients. Thirteen of the 46 items from the preliminary measure were dropped due to ceiling/floor effects and high correlations between conceptually similar items. Factor analysis confirmed five domains in the TRIM-HYPO: daily function, emotional well-being, diabetes management, sleep disruption, and work productivity. All scores were internally consistent (0.86-0.95) and reproducible with a test-retest range of 0.75-0.98. All but one a priori hypothesized associations for validity were confirmed. Conclusions: Study findings demonstrate that the final, 33-item TRIM-HYPO is reliable and valid and may be useful for assessing impacts related to NSHEs in research and clinical practice. Springer International Publishing Switzerland, 2015 Non-severe hypoglycemia nationallicence Adult functioning and well-being nationallicence Diabetes management nationallicence Productivity nationallicence Patient-reported outcomes nationallicence Psychometrics nationallicence Brod Meryl The Brod Group, 219 Julia Avenue, 94941, Mill Valley, CA, USA aut Højbjerre Lise Novo Nordisk A/S, Global Development, Søborg, Denmark aut Bushnell Donald Health Research Associates, Inc., Mountlake Terrace, WA, USA aut Hansen Charlotte Novo Nordisk A/S, Global Development, Søborg, Denmark aut Quality of Life Research Springer International Publishing 24/12(2015-12-01), 2971-2984 0962-9343 24:12<2971 2015 24 11136 https://doi.org/10.1007/s11136-015-1023-6 text/html Onlinezugriff via DOI BK010053 XK010053 XK010000 Metadata rights reserved Springer special CC-BY-NC licence nationallicence 1 research-article jats NATIONALLICENCE NATIONALLICENCE NL-springer NATIONALLICENCE 856 40 https://doi.org/10.1007/s11136-015-1023-6 text/html Onlinezugriff via DOI NATIONALLICENCE 700 1- Brod Meryl The Brod Group, 219 Julia Avenue, 94941, Mill Valley, CA, USA aut NATIONALLICENCE 700 1- Højbjerre Lise Novo Nordisk A/S, Global Development, Søborg, Denmark aut NATIONALLICENCE 700 1- Bushnell Donald Health Research Associates, Inc., Mountlake Terrace, WA, USA aut NATIONALLICENCE 700 1- Hansen Charlotte Novo Nordisk A/S, Global Development, Søborg, Denmark aut NATIONALLICENCE 773 0- Quality of Life Research Springer International Publishing 24/12(2015-12-01), 2971-2984 0962-9343 24:12<2971 2015 24 11136