title: Usual and unusual care: existing practice control groups in randomized controlled trials of behavioral interventions.
abstract: OBJECTIVE
  To evaluate the use of existing practice control groups in randomized controlled trials of behavioral interventions and the role of extrinsic health care services in the design and conduct of behavioral trials.
  
  
  METHODS
  Selective qualitative review.
  
  
  RESULTS
  Extrinsic health care services, also known as nonstudy care, have important but under-recognized effects on the design and conduct of behavioral trials. Usual care, treatment-as-usual, standard of care, and other existing practice control groups pose a variety of methodological and ethical challenges, but they play a vital role in behavioral intervention research.
  
  
  CONCLUSIONS
  This review highlights the need for a scientific consensus statement on control groups in behavioral trials.
authors.affiliation: Department of Psychiatry, Washington University School of Medicine, 4320 Forest Park Ave, Suite 301, St Louis, Missouri 63108, USA. freedlak@bmc.wustl.edu
authors.forename: Kenneth E
authors.initials: KE
authors.lastname: Freedland
authors.forename: David C
authors.initials: DC
authors.lastname: Mohr
authors.forename: Karina W
authors.initials: KW
authors.lastname: Davidson
authors.forename: Joseph E
authors.initials: JE
authors.lastname: Schwartz
mesh_terms: D001521:Behavior Therapy / Q000592:standards; D035841:Behavioral Research / Q000941:ethics / Q000379:methods*; D015986:Confounding Factors, Epidemiologic; D035061:Control Groups; D019317:Evidence-Based Medicine; D006801:Humans; D016032:Randomized Controlled Trials as Topic / Q000941:ethics / Q000379:methods*; D012107:Research Design; D059039:Standard of Care