title: Outcomes toolbox for head and neck cancer research.
abstract: BACKGROUND
  Clinical research in head and neck cancer traditionally focused on tumor control. As survival improves, it is increasingly recognized that the side-effects of multimodality treatment can be profound and enduring. Thus, clinical trials require patient-reported and functional outcomes.
  
  
  METHODS
  A subcommittee of the Previously Untreated, Locally Advanced (PULA) Task Force of the Head and Neck Steering Committee of the Coordinating Centre for Clinical Trials at the National Cancer Institute (NCI) was convened to identify a set of instruments suitable for widespread application in the conduct of clinical trials for head and neck cancer.
  
  
  RESULTS
  Based on existing literature and expert opinion, 18 main areas of concern were identified. For each, measures suitable for use in multicenter clinical trials were recommended on the basis of validity, feasibility, and clinical acceptance.
  
  
  CONCLUSIONS
  Suitable instruments exist for most head and neck cancer concerns, but gaps require further development. Future efforts should be made to harmonize measurement across trials.
authors: Department of Radiation Oncology and Institute of Health Policy, Management and Evaluation, The Princess Margaret Cancer Centre and The University of Toronto, Toronto, Canada.
authors: Jolie
authors: J
authors: Ringash
authors: Lori J
authors: LJ
authors: Bernstein
authors: David
authors: D
authors: Cella
authors: Jerilynn
authors: J
authors: Logemann
authors: Benjamin
authors: B
authors: Movsas
authors: Barbara
authors: B
authors: Murphy
authors: Andrea
authors: A
authors: Trotti
authors: Nancy
authors: N
authors: Wells
authors: Bevan
authors: B
authors: Yueh
authors: John
authors: J
authors: Ridge
mesh_terms: D035843:Biomedical Research; D005260:Female; D006258:Head and Neck Neoplasms / Q000175:diagnosis / Q000401:mortality / Q000628:therapy*; D006801:Humans; D008297:Male; D063868:Patient Outcome Assessment; D017410:Practice Guidelines as Topic; D011788:Quality of Life; D018570:Risk Assessment; D017741:Survivors
keywords: clinical trials; head and neck neoplasms; outcomes; quality of life; questionnaires