title: Assessing the impact of non-severe hypoglycemic events and treatment in adults: development of the Treatment-Related Impact Measure-Non-severe Hypoglycemic Events (TRIM-HYPO).
abstract: OBJECTIVE
  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.
authors.affiliation: The Brod Group, 219 Julia Avenue, Mill Valley, CA, 94941, USA. mbrod@thebrodgroup.net.
authors.forename: Meryl
authors.initials: M
authors.lastname: Brod
authors.affiliation: Novo Nordisk A/S, Global Development, Søborg, Denmark.
authors.forename: Lise
authors.initials: L
authors.lastname: Højbjerre
authors.affiliation: Health Research Associates, Inc., Mountlake Terrace, WA, USA.
authors.forename: Donald M
authors.initials: DM
authors.lastname: Bushnell
authors.affiliation: Novo Nordisk A/S, Global Development, Søborg, Denmark.
authors.forename: Charlotte Thim
authors.initials: CT
authors.lastname: Hansen
mesh_terms: D000328:Adult; D000368:Aged; D048909:Diabetes Complications / Q000628:therapy*; D005260:Female; D006801:Humans; D007003:Hypoglycemia / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D011594:Psychometrics / Q000379:methods*; D011788:Quality of Life / Q000523:psychology*; D011795:Surveys and Questionnaires / Q000706:statistics & numerical data*; D016896:Treatment Outcome; D055815:Young Adult
keywords: Adult functioning and well-being; Diabetes management; Non-severe hypoglycemia; Patient-reported outcomes; Productivity; Psychometrics