title: Totally implantable venous access ports systems for patients receiving chemotherapy for solid tissue malignancies: A randomized controlled clinical trial examining the safety, efficacy, costs, and impact on quality of life.
abstract: OBJECTIVE
  To examine the safety, efficacy, costs, and impact on quality of life of venous access ports implanted at the outset of a course of intravenous cancer chemotherapy.
  
  
  METHODS
  Adults beginning a course of intravenous chemotherapy at two university-affiliated hospitals were randomly allocated to have venous access using a surgically implanted venous access port (Port-a-Cath; Pharmacia, Canada Inc, Montreal, Québec, Canada) or using standard peripheral venous access. All accesses were documented by number, route, purpose, and procedure duration. Outcome measurements included port complications, access strategy failure, access-related anxiety and pain, quality of life (Functional Living Index-Cancer [FLI-C]), and costs.
  
  
  RESULTS
  Port complication rates were low (0.23/1,000 days). Failure occurred in two (3.4%) of 59 port subjects and 16 (26.7%) of 60 controls (P =. 0004) at a median period of 26 days after randomization (95% confidence interval, 8 to 92). Peripheral accesses in port subjects took less time, had less access-related anxiety and pain, and were less costly to perform than in controls. Allocation had no effect on FLI-C scores. Peripheral access failure correlated with allocation to the control group (P =.007), higher pain scores with intravenous (IV) starts (P =.003), and anxiety with IV starts (P =.01). Venous accessing overall in port patients was four times more costly than that in controls ($2,178/patient v $530/patient, respectively).
  
  
  CONCLUSIONS
  Ports were safe and effective but had no detectable impact on functional quality of life, despite less access-related anxiety, pain, and discomfort. Because only approximately one quarter of control patients ultimately required central venous access, economic considerations suggest that port-use policies should be based upon defined criteria of need.
authors.affiliation: Departments of Medicine and Medical Microbiology, University of Manitoba, Winnipeg, Canada. ebow@hsc.mb.ca
authors.forename: E J
authors.initials: EJ
authors.lastname: Bow
authors.forename: M G
authors.initials: MG
authors.lastname: Kilpatrick
authors.forename: J J
authors.initials: JJ
authors.lastname: Clinch
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000704:Analysis of Variance; D000970:Antineoplastic Agents / Q000008:administration & dosage*; D002408:Catheters, Indwelling / Q000009:adverse effects / Q000191:economics; D016009:Chi-Square Distribution; D003365:Costs and Cost Analysis; D018592:Cross-Over Studies; D004868:Equipment Failure; D004869:Equipment Safety; D005260:Female; D006801:Humans; D016014:Linear Models; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000188:drug therapy*; D011446:Prospective Studies; D011788:Quality of Life
chemical_list: D000970:Antineoplastic Agents