title: Assessment of data quality in an international multi-centre randomised trial of coronary artery surgery.
abstract: BACKGROUND
  ART is a multi-centre randomised trial of cardiac surgery which provided a unique opportunity to evaluate the data from a large number of centres from a variety of countries. We attempted to assess data quality, including recruitment rates, timeliness and completeness of the data obtained from the centres in different socio-economic strata.
  
  
  METHODS
  The analysis was based on the 2-page CRF completed at the 6 week follow-up. CRF pages were categorised into "clean" (no edit query) and "dirty" (any incomplete, inconsistent or illegible data). The timelines were assessed on the basis of the time interval from the visit and receipt of complete CRF. Data quality was defined as the number of data queries (in percent) and time delay (in days) between visit and receipt of correct data. Analyses were stratified according to the World Bank definitions into: "Developing" countries (Poland, Brazil and India) and "Developed" (Italy, UK, Austria and Australia).
  
  
  RESULTS
  There were 18 centres in the "Developed" and 10 centres in the "Developing" countries. The rate of enrolment did not differ significantly by economic level ("Developing":4.1 persons/month, "Developed":3.7 persons/month). The time interval for the receipt of data was longer for "Developing" countries (median:37 days) compared to "Developed" ones (median:11 days) (p < 0.001). The median number of data queries was 23% in "Developed" countries compared to 19% in "Developing" ones (p = ns).
  
  
  CONCLUSIONS
  In this study we showed that data quality was comparable between centres from "Developed" and "Developing" countries. Data was received in a less timely fashion from Developing countries and appropriate systems should be instigated to minimize any delays. Close attention should be paid to the training of centres and to the central management of data quality.
  
  
  BACKGROUND
  ISRCTN46552265.
authors.affiliation: Clinical Trials and Evaluation Unit, Royal Brompton and Harefield NHS Foundation Trust, London, UK. l.krzych@wp.pl
authors.forename: Lukasz J
authors.initials: LJ
authors.lastname: Krzych
authors.forename: Belinda
authors.initials: B
authors.lastname: Lees
authors.forename: Fiona
authors.initials: F
authors.lastname: Nugara
authors.forename: Winston
authors.initials: W
authors.lastname: Banya
authors.forename: Andrzej
authors.initials: A
authors.lastname: Bochenek
authors.forename: Jo
authors.initials: J
authors.lastname: Cook
authors.forename: David
authors.initials: D
authors.lastname: Taggart
authors.forename: Marcus D
authors.initials: MD
authors.lastname: Flather
mesh_terms: D003627:Data Interpretation, Statistical; D006801:Humans; D007387:Internal Mammary-Coronary Artery Anastomosis / Q000379:methods*