title: Evaluating single-incision slings in female stress urinary incontinence: the usefulness of the CONSORT statement criteria.
abstract: OBJECTIVE
  To evaluate the usefulness and applicability of the Consolidated Standards of Reporting Trials (CONSORT) for journal articles reporting randomized, controlled trials evaluating single-incision slings in the treatment of female stress urinary incontinence.
  
  
  METHODS
  Original articles reporting randomized, controlled trials assessing single-incision slings in the treatment of female stress urinary incontinence were searched for in the PubMed and Embase databases in 2011. Reporting quality was studied by 2 hospital pharmacists and 2 urologic surgeons. Primary outcome was the score out of 20 in the abstract CONSORT checklist. Secondary outcomes were the scores in the standard CONSORT checklist and the extension CONSORT additional items for trials assessing nonpharmacologic treatments.
  
  
  RESULTS
  Among 135 articles retrieved, 8 met the inclusion criteria and were assessed. Abstract scores ranged from 4.7-14.1. Standard scores were >10.0 out of 20 for most articles; the extension scores did not exceed 5.0 out of 10. Four reported trials were not identified as randomized in the title. The interventions were incompletely reported. Four articles reported whether blinding was achieved but lack of blinding was never discussed as a potential source of bias. Few articles reported the operators and centers characteristics and their impact on statistical analysis. The combination of the 3 checklists was considered a useful guideline to enhance and assess the reporting quality of a surgical trial.
  
  
  CONCLUSIONS
  Our results support the further use of CONSORT criteria as a basic standardized tool in all stages of clinical evaluation for any prosthetic device in female pelvic surgery.
authors.affiliation: Pharmacy Department, Hôpital Foch, Suresnes, France. stephanie.diallo@tnn.aphp.fr
authors.forename: Stéphanie
authors.initials: S
authors.lastname: Diallo
authors.forename: Florence
authors.initials: F
authors.lastname: Cour
authors.forename: Anne
authors.initials: A
authors.lastname: Josephson
authors.forename: Adrien
authors.initials: A
authors.lastname: Vidart
authors.forename: Henri
authors.initials: H
authors.lastname: Botto
authors.forename: Thierry
authors.initials: T
authors.lastname: Lebret
authors.forename: Brigitte
authors.initials: B
authors.lastname: Bonan
mesh_terms: D005260:Female; D006801:Humans; D011643:Publishing / Q000592:standards*; D016032:Randomized Controlled Trials as Topic / Q000592:standards; D058028:Research Report / Q000592:standards*; D053825:Suburethral Slings; D014550:Urinary Incontinence, Stress / Q000601:surgery*; D013520:Urologic Surgical Procedures / Q000379:methods