title: Role of composite endpoints as an outcome assessment tool in urogenital prolapse.
abstract: Our aim was to assess the role of composite endpoints as outcome assessment tools in urogenital prolapse. Women undergoing surgery for urogenital prolapse were recruited and followed-up over 1 year. 'Cure' following surgery was defined as: (1)
  
  
  OBJECTIVE
  POP-Q ordinal = 0 (pelvic organ prolapse quantification system); (2) Subjective: PGI-I = 1 or 2 (patient global impression of improvement); (3) Composite endpoint of cure: POP-Q ordinal = zero and patient goal achievement = 60%. Our results showed 'Composite cure' of POP was in 88.7%, while objective and subjective cure were 85.3% and 95.5%, respectively. Defining 'success' or 'failures' based on PGI-I scores was most discriminatory. Quality of life (QoL) was similar in treatment success or failure groups, where cure was measured objectively or using the composite endpoint. Composite endpoints should accurately represent cure as they combine objective measures and patient goals. However, these were not demonstrated as valid methods in defining success of prolapse surgery.
authors.affiliation: Department of Urogynaecology, King's College Hospital, Denmark Hill, London, UK. sushmasrikrishna@hotmail.com
authors.forename: S
authors.initials: S
authors.lastname: Srikrishna
authors.forename: D
authors.initials: D
authors.lastname: Robinson
authors.forename: L
authors.initials: L
authors.lastname: Cardozo
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007045:Hysterectomy, Vaginal; D008875:Middle Aged; D017773:Pelvic Floor / Q000601:surgery*; D056887:Pelvic Organ Prolapse / Q000601:surgery*; D011446:Prospective Studies; D011788:Quality of Life; D011795:Surveys and Questionnaires; D016896:Treatment Outcome