title: Consultation within the nephroblastoma trial SIOP 2001/GPOH as part of the workload in the trial office.
abstract: BACKGROUND
  More than 90% of children with cancer are treated in prospective clinical trials and studies in Germany. Consultations are part of the daily work in every study centre. Nevertheless little is known about the kind of requests, the time needed to handle these, and the effect on outcome due to an optimized treatment.
  
  
  METHODS
  763 consultations were carried out in 257 patients between the 1st of January 2003 and the 31st of December 2005. 237 of these patients were enrolled in the nephroblastoma trials SIOP 93-01/GPOH (33) and SIOP 2001/GPOH. 20 patients were not registered in any trial at the time of consultation.
  
  
  RESULTS
  61% of all newly diagnosed patients had a consultation by the trial centre during the three year period. The number of consultations per patient was higher in non-university hospitals compared to university hospitals. The mean duration for a consultation was 27 min with a standard deviation of 53.5 min. Most of the requests were related to chemotherapy, 36% to the general management of patients and 15% of all consultations concerned relapsed patients. A highly significant improved 5 year overall survival rate was found for relapsed patients with consultation (65 vs. 10%). This difference may be partly explained by other risk factors for relapse.
  
  
  CONCLUSIONS
  Trial centres are competence centres for a specific disease. Consultations are an important task and help to increase the quality of care for patients enrolled in clinical trials and studies. For consultation purposes about 25% of a person month was needed for every 100 new patients enrolled in the SIOP 2001/GPOH trial and study. We estimate this effort to be comparable to other studies.
authors.affiliation: Klinik für Pädiatrische Onkologie und Hämatologie, Universität des Saarlandes, Homburg.
authors.forename: K
authors.initials: K
authors.lastname: Zils
authors.forename: R
authors.initials: R
authors.lastname: Furtwängler
authors.forename: H
authors.initials: H
authors.lastname: Reinhard
authors.forename: M
authors.initials: M
authors.lastname: Alkassar
authors.forename: N
authors.initials: N
authors.lastname: Graf
mesh_terms: D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000627:therapeutic use*; D002648:Child; D003609:Dactinomycin / Q000008:administration & dosage; D005858:Germany; D006785:Hospitals, University; D006801:Humans; D007680:Kidney Neoplasms / Q000175:diagnosis / Q000188:drug therapy* / Q000401:mortality; D008130:Lomustine / Q000008:administration & dosage; D015337:Multicenter Studies as Topic; D009364:Neoplasm Recurrence, Local / Q000175:diagnosis / Q000188:drug therapy; D016032:Randomized Controlled Trials as Topic; D012017:Referral and Consultation / Q000706:statistics & numerical data*; D013996:Time and Motion Studies; D014600:Utilization Review / Q000706:statistics & numerical data; D014750:Vincristine / Q000008:administration & dosage; D009396:Wilms Tumor / Q000175:diagnosis / Q000188:drug therapy* / Q000401:mortality; D016526:Workload / Q000706:statistics & numerical data*
chemical_list: D003609:Dactinomycin; D014750:Vincristine; D008130:Lomustine