title: Impact of disclosure of individual imaging results in a multi-center Parkinson clinical trial.
abstract: BACKGROUND
  Little is known about the impact of providing individual research results to clinical trial participants or the impact of sharing such data.
  
  
  OBJECTIVE
  The objective of this follow-up study was to evaluate the desire of participants for learning their imaging results and the impact of this information on their perception of their PD diagnosis and care.
  
  
  METHODS
  The Parkinson Research Examination of CEP-1347 Trial (PRECEPT) evaluated the experimental treatment CEP-1347 obtaining dopamine transporter imaging at baseline and 22 months as a secondary outcome. Dopamine transporter imaging and results were categorized as 'dopamine transporter deficit', 'no dopamine transporter deficit' or 'indeterminate.' Self-administered surveys were provided on three occasions to subjects who chose to learn their dopamine transporter imaging results: prior to receiving imaging data, immediately following receipt of imaging information, and three months following image disclosure.
  
  
  RESULTS
  656/777 subjects (84.4%) consented to receive their individual imaging data, comprising overall result categories of 86.3% 'dopamine transporter deficit', 10.4% 'no dopamine transporter deficit', and 3.4% 'indeterminate.' 99.6% of subjects believed their decision to receive data was correct. Following disclosure of imaging results, 97% of the 'dopamine transporter deficit' and 'indeterminate' subjects believed they had Parkinson disease compared with 34% of 'no dopamine transporter deficit' subjects. About 45% of participants reported that learning individual imaging data resulted in improved understanding of their diagnosis.
  
  
  CONCLUSIONS
  The majority of research participants chose to learn their individual dopamine transporter imaging results and were satisfied with their decision. Disclosure of imaging information resulted in improved understanding of parkinsonian symptoms in nearly half of subjects, and less belief among 'no dopamine transporter deficit' subjects that they had a diagnosis of Parkinson disease.
authors: Institute for Neurodegenerative Disorders, New Haven, CT, USA.
authors: Danna
authors: D
authors: Jennings
authors: Department of Biostatistics and Computational Biology, University of Rochester, Rochester, NY, USA.
authors: Shirley
authors: S
authors: Eberly
authors: Department of Biostatistics and Computational Biology, University of Rochester, Rochester, NY, USA.
authors: David
authors: D
authors: Oakes
authors: Institute for Neurodegenerative Disorders, New Haven, CT, USA.
authors: John
authors: J
authors: Seibyl
authors: Institute for Neurodegenerative Disorders, New Haven, CT, USA.
authors: Ken
authors: K
authors: Marek
authors: Program for Regulatory Science & Medicine (PRSM), Georgetown University, Washington, D.C., USA.
authors: Ira
authors: I
authors: Shoulson
mesh_terms: D014150:Antipsychotic Agents / Q000627:therapeutic use*; D002227:Carbazoles / Q000627:therapeutic use*; D003042:Cocaine / Q000031:analogs & derivatives; D050483:Dopamine Plasma Membrane Transport Proteins / Q000378:metabolism*; D005260:Female; D006306:Health Surveys; D006801:Humans; D008137:Longitudinal Studies; D008297:Male; D010300:Parkinson Disease / Q000000981:diagnostic imaging* / Q000188:drug therapy*; D019275:Radiopharmaceuticals; D012189:Retrospective Studies; D015899:Tomography, Emission-Computed, Single-Photon; D016896:Treatment Outcome
chemical_list: D014150:Antipsychotic Agents; D002227:Carbazoles; D050483:Dopamine Plasma Membrane Transport Proteins; D019275:Radiopharmaceuticals; C106592:3,9-bis((ethylthio)methyl)-K-252a; C069723:2beta-carbomethoxy-3beta-(4-iodophenyl)tropane; D003042:Cocaine
keywords: Dopamine transporter; Parkinson's disease; single photo emission-computed tomography