title: Recommendations for enhancing clinical trials education: a review of the literature.
abstract: This study aims to apply the evidence-based practice (EBP) process to determine the factors that influence patients' understanding of, participation in, and satisfaction with clinical trials, the informed consent process, and treatment decisions and to make recommendations for improving clinical trials education. Beginning with evidence retrieval, the authors identified key search terms and searched MEDLINE--Ovid, MEDLINE--PubMed, and the Cumulative Index to Nursing and Allied Health Literature to identify articles published between July 2001 and July 2006 that highlighted clinical trials education. The articles were reviewed for clinical trials patient education information, clinician methods of communicating clinical trial information to patients, and patient satisfaction with the clinical trials process, including the informed consent process. As a result, practice changes were recommended for the patient/family, staff/community, and institution. From the literature review, 81 articles were identified. Recurring themes included decision-making, patient education, staff education, and pediatrics. Most articles focused on methods and strategies aimed at improving education at the patient/family, staff/community, and institutional levels. The issues surrounding clinical trial education are complex due to multiple variables interfering with poor patient understanding of, participation in, and satisfaction with clinical trial treatment decisions. On the basis of our findings, we recommend that clinicians involved in educating patients, families, staff, and communities about clinical trials have an awareness of and understanding for very complex issues.
authors.affiliation: Patient Education Office, The University of Texas MD Anderson Cancer Center, 1515 Holcombe Blvd, Unit 21, Houston, TX 77030, USA. kstepan@mdanderson.org
authors.forename: Karen A
authors.initials: KA
authors.lastname: Stepan
authors.forename: Amy P
authors.initials: AP
authors.lastname: Gonzalez
authors.forename: Vivian S
authors.initials: VS
authors.lastname: Dorsey
authors.forename: Debra K
authors.initials: DK
authors.lastname: Frye
authors.forename: Nita D
authors.initials: ND
authors.lastname: Pyle
authors.forename: Regina F
authors.initials: RF
authors.lastname: Smith
authors.forename: Terry A
authors.initials: TA
authors.lastname: Throckmorton
authors.forename: Louise A
authors.initials: LA
authors.lastname: Villejo
authors.forename: Scott B
authors.initials: SB
authors.lastname: Cantor
mesh_terms: D002986:Clinical Trials as Topic; D007722:Health Knowledge, Attitudes, Practice; D006801:Humans; D007258:Informed Consent; D010353:Patient Education as Topic; D010358:Patient Participation / Q000523:psychology*; D017060:Patient Satisfaction; D010817:Physician-Patient Relations