title: Utilities for treatment-related adverse events in type 2 diabetes.
abstract: OBJECTIVE
  The impact of Type 2 diabetes mellitus (T2DM) on health-related quality-of-life (HRQoL) is complex due to the burden of disease, lifelong treatment requirements, and comorbidities. This study aimed to capture UK societal utility values for health states associated with T2DM and treatment-related adverse events (AEs) to assess the burden of the disease and common AEs.
  
  
  METHODS
  Nine health state descriptions were developed (from a literature review and patient and clinician qualitative input) depicting the burden associated with T2DM and treatment-related AEs. These were mild/moderate urinary tract infection (UTI); severe UTI; mycotic infection; moderate hypoglycemic events; severe hypoglycemic events; fear of hypoglycemia; gastrointestinal symptoms; and hypovolemic events. Members of the UK general public (n = 100) valued these states using the time trade-off (TTO) methodology to elicit utility values (between 0 = dead, 1 = full health). Regression analysis was conducted to understand the influence of age and gender.
  
  
  RESULTS
  All treatment-related AEs were found to have a significant effect on utility. From the T2DM baseline state (0.92), the experience of AEs was associated with the following disutility: T2DM with hypovolemic events (0.08); T2DM with mild/moderate UTIs (0.09); T2DM with moderate hypoglycemic events (0.11); T2DM with severe hypoglycemic events (0.15); T2DM with fear of hypoglycemia (0.15); T2DM with severe UTIs (0.19); T2DM with GI symptoms (0.24); and T2DM with mycotic infection (0.25); Males consistently scored the states with significantly lower utility values, but no significant age effects emerged.
  
  
  CONCLUSIONS
  Findings suggest that adverse events in T2DM can be a burden for some individuals. The study indicates the potential importance of including information regarding AEs in economic evaluations. Although some states were rated severely in terms of utility; in reality, many of these only last a few days, therefore having a minimal quality-adjusted life year (QALY) impact.
authors.affiliation: ICON PRO , Oxford , UK.
authors.forename: S
authors.initials: S
authors.lastname: Shingler
authors.forename: B
authors.initials: B
authors.lastname: Fordham
authors.forename: M
authors.initials: M
authors.lastname: Evans
authors.forename: M
authors.initials: M
authors.lastname: Schroeder
authors.forename: G
authors.initials: G
authors.lastname: Thompson
authors.forename: S
authors.initials: S
authors.lastname: Dewilde
authors.forename: A J
authors.initials: AJ
authors.lastname: Lloyd
mesh_terms: D000328:Adult; D015897:Comorbidity; D003924:Diabetes Mellitus, Type 2 / Q000150:complications* / Q000188:drug therapy*; D005260:Female; D005767:Gastrointestinal Diseases / Q000139:chemically induced; D006304:Health Status; D006801:Humans; D007003:Hypoglycemia / Q000139:chemically induced; D007004:Hypoglycemic Agents / Q000009:adverse effects* / Q000627:therapeutic use; D020896:Hypovolemia / Q000139:chemically induced; D007407:Interviews as Topic; D008297:Male; D008875:Middle Aged; D009181:Mycoses / Q000139:chemically induced; D011788:Quality of Life; D012959:Socioeconomic Factors; D006113:United Kingdom; D014552:Urinary Tract Infections / Q000139:chemically induced
chemical_list: D007004:Hypoglycemic Agents
keywords: Co-morbidities; Quality-of-life; Type 2 diabetes; Utility