title: A study of the pattern of hospital admissions in a specialist Phase I oncology trials unit: unplanned admissions as an early indicator of patient attrition.
abstract: BACKGROUND
  Unplanned hospital admissions (UHAs) in the context of oncology Phase I trials are important, yet rarely reported.
  
  
  METHODS
  All patients admitted to the Royal Marsden Hospital Phase I clinical trials unit during February and March of 2005-2007 were included. The patient-, admission- and trial-related variables were collected. Correlations were sought between the occurrence of UHAs and the baseline patient/trial-related characteristics.
  
  
  RESULTS
  Of the 308 admissions involving 177 patients, UHAs constituted 21% of all the admissions and 38% of the total bed occupancy. The majority of UHAs were cancer related (78%) and their occurrence was associated with a significant early patient attrition. Using multivariate analysis, the factors significantly associated with UHAs included age >60 years (RR 2.32, confidence interval (CI)-95% 1.12-4.81), ≥3 metastatic sites (RR 3.26, CI-95% 1.54-6.90) and LDH>ULN (RR 2.18, CI-95% 1.06-4.46), with albumin <35 g/dL trending to significance (p=0.052). The trials that contained cytotoxic chemotherapy incurred disproportionately higher rates of admissions (69.5%) than the trials that did not.
  
  
  CONCLUSIONS
  UHAs constitute a substantial workload and impact on the speed and cost of, as well as resource allocation in Phase I oncology trials. The majority of UHAs are cancer rather than treatment related. The risk stratification to guide patient selection may help reduce the incidence of UHAs.
authors.affiliation: Drug Development Unit, The Royal Marsden NHS Foundation Trust and The Institute of Cancer Research, Sutton, UK.
authors.forename: Andre T
authors.initials: AT
authors.lastname: Brunetto
authors.forename: Joo Ern
authors.initials: JE
authors.lastname: Ang
authors.forename: David
authors.initials: D
authors.lastname: Olmos
authors.forename: Daniel
authors.initials: D
authors.lastname: Tan
authors.forename: Jorge
authors.initials: J
authors.lastname: Barriuso
authors.forename: Hendrik-Tobias
authors.initials: HT
authors.lastname: Arkenau
authors.forename: Timothy A
authors.initials: TA
authors.lastname: Yap
authors.forename: L Rhoda
authors.initials: LR
authors.lastname: Molife
authors.forename: Udai
authors.initials: U
authors.lastname: Banerji
authors.forename: Johann
authors.initials: J
authors.lastname: de Bono
authors.forename: Ian
authors.initials: I
authors.lastname: Judson
authors.forename: Stan
authors.initials: S
authors.lastname: Kaye
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001509:Bed Occupancy / Q000706:statistics & numerical data; D017321:Clinical Trials, Phase I as Topic / Q000706:statistics & numerical data*; D005260:Female; D006801:Humans; D007902:Length of Stay / Q000706:statistics & numerical data; D008131:London / Q000453:epidemiology; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000453:epidemiology* / Q000628:therapy; D010343:Patient Admission / Q000706:statistics & numerical data*; D010347:Patient Care Planning / Q000706:statistics & numerical data; D018570:Risk Assessment; D012307:Risk Factors; D055815:Young Adult