title: Effect of intensive glycemic lowering on health-related quality of life in type 2 diabetes: ACCORD trial.
abstract: OBJECTIVE
  To compare the effect of intensive versus standard glycemic control strategies on health-related quality of life (HRQL) in a substudy of the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial.
  
  
  METHODS
  A randomly selected subsample of 2,053 ACCORD participants enrolled in the HRQL substudy was assessed at baseline and 12-, 36-, and 48-month visits. HRQL assessment included general health status (the 36-Item Short Form Health Survey [SF-36]), diabetes symptoms (the Diabetes Symptom Distress Checklist), depression (Patient Health Questionnaire [PHQ]-9), and treatment satisfaction (Diabetes Treatment Satisfaction Questionnaire [DTSQ]). Repeated-measures ANOVA models were used to estimate change in HRQL outcomes by treatment group over 48 months adjusting for model covariates. The effects of early discontinuation of the ACCORD intensive glycemic control arm on study results were explored.
  
  
  RESULTS
  A total of 1,956 (95%) completed the self-report HRQL instrument(s) at baseline. The intensive arm had a larger decrease in SF-36 physical health component score than the standard arm (-1.6 vs. -1.1, P = 0.0345). Treatment satisfaction (DTSQ) showed larger improvement with intensive than standard (P = 0.0004). There were no differences in mean scores of the Diabetes Symptom Checklist and PHQ-9. Effects of participant transition following discontinuation of the intensive arm on HRQL were not significant.
  
  
  CONCLUSIONS
  The ACCORD trial strategy of intensive glycemic control did not lead to benefits in HRQL and was associated with modest improvement in diabetes treatment satisfaction. Thus patient acceptability was apparently not compromised with intensive and complex interventions such as those used in ACCORD.
authors.affiliation: Department of Public Health Sciences, Pennsylvania State University College of Medicine, Hershey, Pennsylvania, USA. rtanders@psu.edu
authors.forename: Roger T
authors.initials: RT
authors.lastname: Anderson
authors.forename: K M Venkat
authors.initials: KM
authors.lastname: Narayan
authors.forename: Patricia
authors.initials: P
authors.lastname: Feeney
authors.forename: David
authors.initials: D
authors.lastname: Goff
authors.forename: Mohammed K
authors.initials: MK
authors.lastname: Ali
authors.forename: Debra L
authors.initials: DL
authors.lastname: Simmons
authors.forename: Jo-Ann
authors.initials: JA
authors.lastname: Sperl-Hillen
authors.forename: Thomas
authors.initials: T
authors.lastname: Bigger
authors.forename: Robert
authors.initials: R
authors.lastname: Cuddihy
authors.forename: Patrick J
authors.initials: PJ
authors.lastname: O'Conner
authors.forename: Ajay
authors.initials: A
authors.lastname: Sood
authors.forename: Ping
authors.initials: P
authors.lastname: Zhang
authors.forename: Mark D
authors.initials: MD
authors.lastname: Sullivan
mesh_terms: D000368:Aged; D001786:Blood Glucose / Q000187:drug effects; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy* / Q000523:psychology*; D005260:Female; D006442:Glycated Hemoglobin / Q000378:metabolism; D006304:Health Status; D006801:Humans; D007004:Hypoglycemic Agents / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D017060:Patient Satisfaction; D011788:Quality of Life; D016896:Treatment Outcome
chemical_list: D001786:Blood Glucose; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents