title: Attitudes toward clinical trials among patients with sickle cell disease.
abstract: Background A substantial number of planned clinical trials for sickle cell disease (SCD) have terminated early due to insufficient patient enrollment. Purpose To describe attitudes toward clinical trials among a sample of adults with SCD and identify patient-level factors associated with these attitudes. Methods Our data came from a sample (N = 291) of primarily adults with SCD participating in the Improving Patient Outcomes with Respect and Trust (IMPORT) study, which is a federally funded observational study of SCD patient experiences in seeking healthcare. Attitudes toward clinical trials were assessed using items from the Perceptions of Participation in Clinical Research instrument. Patient factors examined as potential correlates of clinical trial attitudes were demographics, disease severity, engagement in self-care, trust, healthcare experience ratings, and prior history of participation in clinical trials. Multiple regression analyses were used to identify patient-level correlates of clinical trial attitudes. Results Our sample of SCD patients expressed overwhelmingly favorable attitudes about clinical trials, with 77%-92% of our sample expressing agreement with a series of positive statements about clinical trials in general. Demographics, engagement in self-care, healthcare experience ratings, and prior trial participation each explained significant portions of the variability in clinical trial attitudes. Limitations The generalizability of our results to the entire SCD population may be of concern as the study participants were all receiving care at comprehensive sickle cell centers and already participating in clinical research. Conclusion Our results suggest that, in principle, adults with SCD enrolled in an observational study express very positive general attitudes about clinical trial participation and that specific factors attached to particular clinical trial opportunities may play a greater role in a SCD patient's decision to participate than a general unwillingness to participate.
authors.affiliation: a Department of Medicine, The Johns Hopkins School of Medicine, Baltimore, MD, USA.
authors.forename: Carlton
authors.initials: C
authors.lastname: Haywood
authors.affiliation: a Department of Medicine, The Johns Hopkins School of Medicine, Baltimore, MD, USA.
authors.forename: Sophie
authors.initials: S
authors.lastname: Lanzkron
authors.affiliation: b Department of Biostatistics, The Johns Hopkins Bloomberg School of Public Health, Baltimore MD, USA.
authors.forename: Marie
authors.initials: M
authors.lastname: Diener-West
authors.affiliation: c Psychiatry and Behavioral Sciences, The Johns Hopkins School of Medicine, Baltimore, MD, USA.
authors.forename: Jennifer
authors.initials: J
authors.lastname: Haythornthwaite
authors.affiliation: d Department of Pediatrics, The Johns Hopkins School of Medicine, Baltimore, MD, USA.
authors.forename: John J
authors.initials: JJ
authors.lastname: Strouse
authors.affiliation: e Department of Psychology, The University of Maryland Baltimore County, Baltimore MD, USA.
authors.forename: Shawn
authors.initials: S
authors.lastname: Bediako
authors.affiliation: f Department of Medicine, The Howard University Hospital, Washington, DC, USA.
authors.forename: Gladys
authors.initials: G
authors.lastname: Onojobi
authors.affiliation: a Department of Medicine, The Johns Hopkins School of Medicine, Baltimore, MD, USA.
authors.forename: Mary Catherine
authors.initials: MC
authors.lastname: Beach
mesh_terms: D000328:Adult; D000755:Anemia, Sickle Cell / Q000628:therapy*; D002986:Clinical Trials as Topic; D005260:Female; D007722:Health Knowledge, Attitudes, Practice; D006801:Humans; D008297:Male; D008875:Middle Aged; D010817:Physician-Patient Relations; D035842:Research Subjects / Q000523:psychology*