Cynthia McRae1, Jennifer Caspari2, Daniel Russell3, Heiner Ellgring4, Chris Bezzant1, Paul Greene5, Stanley Fahn6. 1. University of Denver Denver Colorado USA. 2. VA Portland Health Care System Portland Oregon USA. 3. Iowa State University Ames Iowa USA. 4. University of Würzburg Würzburg Bavaria Germany. 5. Mt. Sinai Health System New York New York USA. 6. Neurological Institute Columbia University Medical Center New York New York USA.
Abstract
BACKGROUND: A randomized controlled double-blind sham surgery trial was conducted to determine the effectiveness of implantation of human embryonic dopamine neurons into the putamen of patients with advanced Parkinson's disease (PD). The present analyses determined whether patients viewing a video of them performing motor activities off medications at baseline would affect self-ratings 12 months later on the Global Rating Scale (GRS). OBJECTIVES: To examine changes in GRS scores pre- and post-video review for the total sample; to examine differences in scores between actual implant and sham groups, as well as perceived groups pre- and post-video review; to examine differences among four subgroups of patients based on actual and perceived treatment (i.e., actual implant/perceived implant). METHODS: Forty participants were recruited and randomly assigned to receive either neural implantation or sham surgery. The primary outcome variable was a one-item GRS ranging from -3 (much worse since surgery) to +3 (much improved since surgery). At 12 months (before the blind was lifted) patients rated themselves on the GRS before and after viewing the baseline video. RESULTS: Total sample GRS scores improved after the video (P = .001). There were no differences between the actual implant and sham groups before or after the video, but there were differences between perceived groups at both times (P < .001). Among subgroups, improvement after the video was found only in the group receiving the implant but who thought sham (P = .011). CONCLUSIONS: When self-ratings are an outcome variable, review of baseline videos is recommended before making comparative ratings.
BACKGROUND: A randomized controlled double-blind sham surgery trial was conducted to determine the effectiveness of implantation of human embryonic dopamine neurons into the putamen of patients with advanced Parkinson's disease (PD). The present analyses determined whether patients viewing a video of them performing motor activities off medications at baseline would affect self-ratings 12 months later on the Global Rating Scale (GRS). OBJECTIVES: To examine changes in GRS scores pre- and post-video review for the total sample; to examine differences in scores between actual implant and sham groups, as well as perceived groups pre- and post-video review; to examine differences among four subgroups of patients based on actual and perceived treatment (i.e., actual implant/perceived implant). METHODS: Forty participants were recruited and randomly assigned to receive either neural implantation or sham surgery. The primary outcome variable was a one-item GRS ranging from -3 (much worse since surgery) to +3 (much improved since surgery). At 12 months (before the blind was lifted) patients rated themselves on the GRS before and after viewing the baseline video. RESULTS: Total sample GRS scores improved after the video (P = .001). There were no differences between the actual implant and sham groups before or after the video, but there were differences between perceived groups at both times (P < .001). Among subgroups, improvement after the video was found only in the group receiving the implant but who thought sham (P = .011). CONCLUSIONS: When self-ratings are an outcome variable, review of baseline videos is recommended before making comparative ratings.
Entities:
Keywords:
Parkinson's disease; double‐blind; global ratings; placebo surgery; video review
Authors: C R Freed; P E Greene; R E Breeze; W Y Tsai; W DuMouchel; R Kao; S Dillon; H Winfield; S Culver; J Q Trojanowski; D Eidelberg; S Fahn Journal: N Engl J Med Date: 2001-03-08 Impact factor: 91.245
Authors: Cynthia McRae; Eva Cherin; T Gayle Yamazaki; Gretchen Diem; Alexander H Vo; Dan Russell; J Heiner Ellgring; Stanley Fahn; Paul Greene; Sandra Dillon; Hal Winfield; Kimberly B Bjugstad; Curt R Freed Journal: Arch Gen Psychiatry Date: 2004-04
Authors: C T Trott; S Fahn; P Greene; S Dillon; H Winfield; L Winfield; R Kao; D Eidelberg; C R Freed; R E Breeze; Y Stern Journal: Neurology Date: 2003-06-24 Impact factor: 9.910