title: A pragmatic randomised controlled trial of the cost-effectiveness of palliative therapies for patients with inoperable oesophageal cancer.
abstract: OBJECTIVE
  To compare whether treatment with self-expanding metal stents (SEMS) is more cost-effective than treatment with conventional modalities in patients with inoperable oesophageal cancer. Quality of life effects were also considered.
  
  
  METHODS
  A multicentre pragmatic, randomised controlled trial with health economic analysis.
  
  
  METHODS
  Seven NHS hospitals selected to represent a cross-section of UK hospitals in terms of facilities and staffing.
  
  
  METHODS
  All patients attending the centres with oesophageal cancer deemed unsuitable for surgery were assessed for inclusion in the main trial; 217 patients were randomised. A health state utilities substudy was also performed in 71 patients who had previously received curative surgery for oesophageal cancer.
  
  
  METHODS
  Eligible patients were randomised to one of four treatment groups within two study arms. Assessments were performed at enrolment, 1 week following treatment and thereafter at 6-weekly intervals until death, with prospective data collection on complications and survival. Structured interviews to elicit patient preferences to health states and treatments were performed in a substudy.
  
  
  METHODS
  Dysphagia grade and quality of life were examined at 6 weeks. Survival, resources consumed from randomisation to death and quality-adjusted life-years were also considered.
  
  
  RESULTS
  There was no difference in cost or effectiveness between SEMS and non-SEMS therapies, and 18-mm SEMS had equal effectiveness to, but less associated pain than, 24-mm SEMS. Rigid intubation was associated with a worse quality of swallowing and increased late morbidity. Bipolar electrocoagulation and ethanol tumour necrosis were poor in primary palliation. A survival advantage was found for non-stent therapies, but there was a significant delay to treatment. The length of stay accounts for the majority of the cost to the NHS. Patients were found to have distinct individual treatment preferences.
  
  
  CONCLUSIONS
  It was suggested that rigid tubes and 24-mm SEMS should no longer be recommended and bipolar electrocoagulation and ethanol tumour necrosis should not be used for primary palliation. The choice in palliation would between non-stent and 18-mm SEMS treatments, with non-stent therapies being made more available and accessible to reduce delay. A multidisciplinary team approach to palliation is also suggested. A randomised controlled clinical trial of 18-mm SEMS versus non-stent therapies with survival and quality of life end-points would be helpful, as would an audit of palliative patient admissions to determine the reasons and need for inpatient hospital care, with a view to implementing cycle-associated change to reduce inpatient stay. A study of delays in palliative radiotherapy treatment is also suggested, with a view to implementing cycle-associated change to reduce waiting time.
authors.affiliation: Northern Oesophago-Gastric Unit, Royal Victoria Infirmary, Newcastle upon Tyne, UK.
authors.forename: J
authors.initials: J
authors.lastname: Shenfine
authors.forename: P
authors.initials: P
authors.lastname: McNamee
authors.forename: N
authors.initials: N
authors.lastname: Steen
authors.forename: J
authors.initials: J
authors.lastname: Bond
authors.forename: S M
authors.initials: SM
authors.lastname: Griffin
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D003362:Cost-Benefit Analysis; D004938:Esophageal Neoplasms / Q000503:physiopathology / Q000628:therapy*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010166:Palliative Care / Q000191:economics* / Q000592:standards*; D019057:Quality-Adjusted Life Years; D013222:State Medicine; D006113:United Kingdom