title: Impact of DaTscan SPECT imaging on clinical management, diagnosis, confidence of diagnosis, quality of life, health resource use and safety in patients with clinically uncertain parkinsonian syndromes: a prospective 1-year follow-up of an open-label controlled study.
abstract: BACKGROUND
  This study assessed the impact of DaTscan on clinical management, diagnosis, confidence of diagnosis (CoD), quality of life (QoL), health resource use (HRU) and safety during a 1-year follow-up in patients with clinically uncertain parkinsonian syndromes (CUPS).
  
  
  METHODS
  A total of 19 university hospital centres in Europe and the USA participated in this open-label, single-dose, prospective, clinical trial in patients with CUPS who were randomised to a DaTscan imaging group or to a no-imaging (control) group. The proportion of patients with changes in clinical management, diagnosis, CoD, QoL and HRU from baseline through 1 year post-DaTscan was compared between groups.
  
  
  RESULTS
  There were 273 patients randomised (135 DaTscan, 138 control). Significantly more patients in the DaTscan imaging group had at least one change in their actual clinical management after 12 weeks (p=0.002) and after 1 year (p<0.001) compared with patients in the control group. In addition, significantly more DaTscan patients had changes in diagnosis and an increased CoD at 4 weeks, 12 weeks and 1 year (all p<0.001) compared with control patients. No significant differences in total score for QoL or HRU were observed between groups during the 1-year follow-up period. DaTscan was safe and well tolerated. One patient in the imaging group had an adverse event (headache) with suspected relationship to DaTscan post-administration.
  
  
  CONCLUSIONS
  DaTscan had a significant impact on clinical management, diagnosis and CoD in patients with CUPS. DaTscan is safe and well tolerated, and is a useful adjunct to differentiate a diagnosis of CUPS. Trial registration number http://ClinicalTrials.gov Identifier: NCT00382967.
authors.affiliation: Department of Neurology,University Medicine Berlin, Berlin, Germany.
authors.forename: Andreas R
authors.initials: AR
authors.lastname: Kupsch
authors.forename: Nin
authors.initials: N
authors.lastname: Bajaj
authors.forename: Frederick
authors.initials: F
authors.lastname: Weiland
authors.forename: Antonio
authors.initials: A
authors.lastname: Tartaglione
authors.forename: Susanne
authors.initials: S
authors.lastname: Klutmann
authors.forename: Melanie
authors.initials: M
authors.lastname: Buitendyk
authors.forename: Paul
authors.initials: P
authors.lastname: Sherwin
authors.forename: Ann
authors.initials: A
authors.lastname: Tate
authors.forename: Igor D
authors.initials: ID
authors.lastname: Grachev
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D019468:Disease Management; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007457:Iodine Radioisotopes; D008297:Male; D008875:Middle Aged; D009662:Nortropanes; D020734:Parkinsonian Disorders / Q000175:diagnosis* / Q000000981:diagnostic imaging / Q000523:psychology*; D010342:Patient Acceptance of Health Care / Q000523:psychology*; D011237:Predictive Value of Tests; D011446:Prospective Studies; D011788:Quality of Life / Q000523:psychology*; D012449:Safety / Q000706:statistics & numerical data; D015899:Tomography, Emission-Computed, Single-Photon / Q000379:methods / Q000523:psychology
chemical_list: D007457:Iodine Radioisotopes; D009662:Nortropanes; C519528:ioflupane