title: Coordination and management of multisite complementary and alternative medicine (CAM) therapies: experience from a multisite reflexology intervention trial.
abstract: BACKGROUND
  Multisite randomized clinical trials allow for increased research collaboration among investigators and expedite data collection efforts. As a result, government funding agencies typically look favorably upon this approach. As the field of complementary and alternative medicine (CAM) continues to evolve, so do increased calls for the use of more rigorous study design and trial methodologies, which can present challenges for investigators.
  
  
  OBJECTIVE
  To describe the processes involved in the coordination and management of a multisite randomized clinical trial of a CAM intervention.
  
  
  METHODS
  Key aspects related to the coordination and management of a multisite CAM randomized clinical trial are presented, including organizational and site selection considerations, recruitment concerns and issues related to data collection and randomization to treatment groups. Management and monitoring of data, as well as quality assurance procedures are described. Finally, a real world perspective is shared from a recently conducted multisite randomized clinical trial of reflexology for women diagnosed with advanced breast cancer.
  
  
  RESULTS
  The use of multiple sites in the conduct of CAM-based randomized clinical trials can provide an efficient, collaborative and robust approach to study coordination and data collection that maximizes efficiency and ensures the quality of results.
  
  
  CONCLUSIONS
  Multisite randomized clinical trial designs can offer the field of CAM research a more standardized and efficient approach to examine the effectiveness of novel therapies and treatments. Special attention must be given to intervention fidelity, consistent data collection and ensuring data quality. Assessment and reporting of quantitative indicators of data quality should be required.
authors.affiliation: Epidemiology and Biostatistics, The University of Texas School of Public Health at Houston, Houston, TX 77030, United States. Mohammad.H.Rahbar@uth.tmc.edu
authors.forename: Mohammad H
authors.initials: MH
authors.lastname: Rahbar
authors.forename: Gwen
authors.initials: G
authors.lastname: Wyatt
authors.forename: Alla
authors.initials: A
authors.lastname: Sikorskii
authors.forename: David
authors.initials: D
authors.lastname: Victorson
authors.forename: Manouchehr
authors.initials: M
authors.lastname: Ardjomand-Hessabi
mesh_terms: D001943:Breast Neoplasms / Q000188:drug therapy*; D016009:Chi-Square Distribution; D002986:Clinical Trials as Topic; D000529:Complementary Therapies; D005260:Female; D006801:Humans; D033181:Information Dissemination / Q000379:methods; D008405:Massage; D015337:Multicenter Studies as Topic; D012107:Research Design