title: A randomised controlled trial of Outpatient versus inpatient Polyp Treatment (OPT) for abnormal uterine bleeding.
abstract: BACKGROUND
  Uterine polyps cause abnormal bleeding in women and conventional practice is to remove them in hospital under general anaesthetic. Advances in technology make it possible to perform polypectomy in an outpatient setting, yet evidence of effectiveness is limited.
  
  
  OBJECTIVE
  To test the hypothesis that in women with abnormal uterine bleeding (AUB) associated with benign uterine polyp(s), outpatient polyp treatment achieved as good, or no more than 25% worse, alleviation of bleeding symptoms at 6 months compared with standard inpatient treatment. The hypothesis that response to uterine polyp treatment differed according to the pattern of AUB, menopausal status and longer-term follow-up was tested. The cost-effectiveness and acceptability of outpatient polypectomy was examined.
  
  
  METHODS
  A multicentre, non-inferiority, randomised controlled trial, incorporating a cost-effectiveness analysis and supplemented by a parallel patient preference study. Patient acceptability was evaluated by interview in a qualitative study.
  
  
  METHODS
  Outpatient hysteroscopy clinics and inpatient gynaecology departments within UK NHS hospitals.
  
  
  METHODS
  Women with AUB - defined as heavy menstrual bleeding (formerly known as menorrhagia) (HMB), intermenstrual bleeding or postmenopausal bleeding - and hysteroscopically diagnosed uterine polyps.
  
  
  METHODS
  We randomly assigned 507 women, using a minimisation algorithm, to outpatient polypectomy compared with conventional inpatient polypectomy as a day case in hospital under general anaesthesia.
  
  
  METHODS
  The primary outcome was successful treatment at 6 months, determined by the woman's assessment of her bleeding. Secondary outcomes included quality of life, procedure feasibility, acceptability and cost per quality-adjusted life-year (QALY) gained.
  
  
  RESULTS
  At 6 months, 73% (166/228) of women who underwent outpatient polypectomy were successfully treated compared with 80% (168/211) following inpatient polypectomy [relative risk (RR) 0.91, 95% confidence interval (CI) 0.82 to 1.02]. The lower end of the CIs showed that outpatient polypectomy was at most 18% worse, in relative terms, than inpatient treatment, within the 25% margin of non-inferiority set at the outset of the study. By 1 and 2 years the corresponding proportions were similar producing RRs close to unity. There was no evidence that the treatment effect differed according to any of the predefined subgroups when treatments by variable interaction parameters were examined. Failure to completely remove polyps was higher (19% vs. 7%; RR 2.5, 95% CI 1.5 to 4.1) with outpatient polypectomy. Procedure acceptability was reduced with outpatient compared with inpatient polyp treatment (83% vs. 92%; RR 0.90, 95% CI 0.84 to 0.97). There were no significant differences in quality of life. The incremental cost-effectiveness ratios at 6 and 12 months for inpatient treatment were £1,099,167 and £668,800 per additional QALY, respectively.
  
  
  CONCLUSIONS
  When treating women with AUB associated with uterine polyps, outpatient polypectomy was non-inferior to inpatient polypectomy at 6 and 12 months, and relatively cost-effective. However, patients need to be aware that failure to remove a polyp is more likely with outpatient polypectomy and procedure acceptability lower.
  
  
  BACKGROUND
  Current Controlled Trials ISRCTN 65868569.
  
  
  BACKGROUND
  This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 19, No. 61. See the NIHR Journals Library website for further project information.
authors.affiliation: Birmingham Women's Hospital NHS Foundation Trust, Edgbaston, Birmingham, UK.|School of Clinical and Experimental Medicine, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK.
authors.forename: T Justin
authors.initials: TJ
authors.lastname: Clark
authors.affiliation: Birmingham Clinical Trials Unit, University of Birmingham, Birmingham, UK.
authors.forename: Lee J
authors.initials: LJ
authors.lastname: Middleton
authors.affiliation: Women's Health Research Unit, The Blizard Institute, Queen Mary University of London, London, UK.
authors.forename: Natalie Am
authors.initials: NA
authors.lastname: Cooper
authors.affiliation: Health Economics Unit, School of Health and Population Sciences, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK.
authors.forename: Lavanya
authors.initials: L
authors.lastname: Diwakar
authors.affiliation: Centre for Health and Social Care Research, Faculty of Health, Birmingham City University, Edgbaston, Birmingham, UK.
authors.forename: Elaine
authors.initials: E
authors.lastname: Denny
authors.affiliation: Birmingham Women's Hospital NHS Foundation Trust, Edgbaston, Birmingham, UK.|School of Clinical and Experimental Medicine, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK.
authors.forename: Paul
authors.initials: P
authors.lastname: Smith
authors.affiliation: Birmingham Clinical Trials Unit, University of Birmingham, Birmingham, UK.
authors.forename: Laura
authors.initials: L
authors.lastname: Gennard
authors.affiliation: Centre for Health and Social Care Research, Faculty of Health, Birmingham City University, Edgbaston, Birmingham, UK.
authors.forename: Lynda
authors.initials: L
authors.lastname: Stobert
authors.affiliation: Health Economics Unit, School of Health and Population Sciences, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK.
authors.forename: Tracy E
authors.initials: TE
authors.lastname: Roberts
authors.affiliation: Birmingham Clinical Trials Unit, University of Birmingham, Birmingham, UK.
authors.forename: Versha
authors.initials: V
authors.lastname: Cheed
authors.affiliation: Birmingham Women's Hospital NHS Foundation Trust, Edgbaston, Birmingham, UK.
authors.forename: Tracey
authors.initials: T
authors.lastname: Bingham
authors.affiliation: Health Economics Unit, School of Health and Population Sciences, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK.
authors.forename: Sue
authors.initials: S
authors.lastname: Jowett
authors.affiliation: Birmingham Clinical Trials Unit, University of Birmingham, Birmingham, UK.
authors.forename: Elizabeth
authors.initials: E
authors.lastname: Brettell
authors.affiliation: Jessop Wing, Sheffield Teaching Hospitals NHS Trust, Sheffield, UK.
authors.forename: Mary
authors.initials: M
authors.lastname: Connor
authors.affiliation: Bradford Teaching Hospitals NHS Foundation Trust, Bradford, UK.
authors.forename: Sian E
authors.initials: SE
authors.lastname: Jones
authors.affiliation: School of Clinical and Experimental Medicine, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK.|Birmingham Clinical Trials Unit, University of Birmingham, Birmingham, UK.
authors.forename: Jane P
authors.initials: JP
authors.lastname: Daniels
mesh_terms: D000553:Ambulatory Care / Q000191:economics* / Q000706:statistics & numerical data; D057186:Comparative Effectiveness Research; D003365:Costs and Cost Analysis; D005260:Female; D013509:Gynecologic Surgical Procedures / Q000009:adverse effects / Q000191:economics / Q000379:methods*; D006760:Hospitalization / Q000191:economics* / Q000706:statistics & numerical data; D006801:Humans; D007407:Interviews as Topic; D008875:Middle Aged; D010043:Outcome and Process Assessment, Health Care / Q000706:statistics & numerical data; D057240:Patient Preference / Q000523:psychology* / Q000706:statistics & numerical data; D011127:Polyps / Q000150:complications / Q000191:economics / Q000601:surgery*; D036301:Qualitative Research; D019057:Quality-Adjusted Life Years; D013222:State Medicine / Q000191:economics; D006113:United Kingdom; D014592:Uterine Hemorrhage / Q000191:economics / Q000209:etiology / Q000601:surgery*