title: Willingness to participate in complementary and alternative medicine clinical trials among patients with craniofacial disorders.
abstract: OBJECTIVE
  The Oregon Center for Complementary and Alternative Medicine (OCCAM) conducted focus groups with participants to determine willingness to join a complementary and alternative medicine (CAM) research study, and to aid in the design of three clinical randomized controlled trials (RCTs) of CAM and craniofacial disorders.
  
  
  METHODS
  Center for Health Research, Kaiser Permanente, in Portland, Oregon.
  
  
  METHODS
  Kaiser Permanente health plan members meeting RCT inclusion criteria.
  
  
  METHODS
  Twelve (12) focus groups were conducted with a total of 85 participants. Six (6) of the focus groups were with members who self-identified as users of CAM therapies. Focus groups explored participants' experiences of CAM for temporomandibular disorder (TMD) and periodontal disease, and their reactions to proposed aspects of the trials. Trained facilitators led the focus groups, which lasted approximately 2 hours and were audiotaped for future transcription. Researchers then coded the transcripts to identify responses to specific questions and to capture emergent themes.
  
  
  RESULTS
  Acupuncture, chiropractic, and massage were most frequently accessed and reported as helpful by participants. Participants who had not used CAM treatments for their condition expressed interest and openness to experiencing CAM treatments through a research study. In general, participants expressed willingness to be randomly assigned to (rather than choose) a CAM treatment arm. Travel to practitioners' offices and frequent (> 1 per week) visits were acceptable to most participants, if there was flexibility in appointment scheduling.
  
  
  CONCLUSIONS
  Findings indicate considerable willingness to engage in CAM trials, even among individuals who have not used CAM. Participants' willingness to engage in CAM studies was influenced by the nature of their condition, their prior experiences with conventional and CAM treatments, and the possibility of experiencing CAM "for free" through participation in the trial. Their acceptance also was tempered by concerns about particular modalities and the possibility of having to give up aspects of their current health routine. Researchers engaging in CAM studies should take these factors into consideration as they design studies.
authors.affiliation: Center for Health Research, Kaiser Permanente Northwest, Oregon Center for Complementary and Alternative Medicine in Craniofacial Disorders, Portland, OR, USA.
authors.forename: Jennifer
authors.initials: J
authors.lastname: Schneider
authors.forename: Nancy
authors.initials: N
authors.lastname: Vuckovic
authors.forename: Lynn
authors.initials: L
authors.lastname: DeBar
mesh_terms: D000328:Adult; D000368:Aged; D001294:Attitude to Health; D000529:Complementary Therapies / Q000523:psychology*; D019465:Craniofacial Abnormalities / Q000523:psychology* / Q000628:therapy; D005260:Female; D017144:Focus Groups; D006801:Humans; D008297:Male; D008875:Middle Aged; D009922:Oregon; D010342:Patient Acceptance of Health Care; D017060:Patient Satisfaction; D016032:Randomized Controlled Trials as Topic / Q000592:standards; D012107:Research Design; D011795:Surveys and Questionnaires