title: Clinical endpoint adjudication in a contemporary all-comers coronary stent investigation: methodology and external validation.
abstract: BACKGROUND
  Globalisation in coronary stent research calls for harmonization of clinical endpoint definitions and event adjudication. Little has been published about the various processes used for event adjudication or their impact on outcome reporting.
  
  
  RESULTS
  We performed a validation of the clinical event committee (CEC) adjudication process on 100 suspected events in the RESOLUTE All-comers trial (Resolute-AC). Two experienced Clinical Research Organisations (CRO) that had already extensive internal validation processes in place, participated in the study. After initial adjudication by the primary-CEC, events were cross-adjudicated by an external-CEC using the same definitions. Major discrepancies affecting the primary end point of target-lesion failure (TLF), a composite of cardiac death, target vessel myocardial infarction (TV-MI), or clinically-indicated target-lesion revascularization (CI-TLR), were analysed by an independent oversight committee who provided recommendations for harmonization. Discordant adjudications were reconsidered by the primary CEC. Subsequently, the RAC database was interrogated for cases that based on these recommendations merited re-adjudication and these cases were also re-adjudicated by the primary CEC. Final discrepancies in adjudication of individual components of TLF occurred in 7 out of 100 events in 5 patients. Discrepancies for the (hierarchical) primary endpoint occurred in 5 events (2 cardiac deaths and 3 TV-MI). After application of harmonization recommendations to the overall RAC population (n=2292), the primary CEC adjudicated 3 additional clinical-TLRs and considered 1 TV-MI as no event.
  
  
  CONCLUSIONS
  A harmonization process provided a high level of concordance for event adjudication and improved accuracy for final event reporting. These findings suggest it is feasible to pool clinical event outcome data across clinical trials even when different CECs are responsible for event adjudication.
authors.affiliation: Cardialysis, Clinical Research Management & Core Laboratories, Rotterdam, The Netherlands. pascal.vranckx@jessazh.be
authors.forename: Pascal
authors.initials: P
authors.lastname: Vranckx
authors.forename: Eugene
authors.initials: E
authors.lastname: McFadden
authors.forename: Donald E
authors.initials: DE
authors.lastname: Cutlip
authors.forename: Roxana
authors.initials: R
authors.lastname: Mehran
authors.forename: Michael
authors.initials: M
authors.lastname: Swart
authors.forename: P P
authors.initials: PP
authors.lastname: Kint
authors.forename: Felix
authors.initials: F
authors.lastname: Zijlstra
authors.forename: Sigmund
authors.initials: S
authors.lastname: Silber
authors.forename: Stephan
authors.initials: S
authors.lastname: Windecker
authors.forename: Patrick W C J
authors.initials: PW
authors.lastname: Serruys
mesh_terms: D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000379:methods*; D003324:Coronary Artery Disease / Q000401:mortality / Q000601:surgery*; D054855:Drug-Eluting Stents; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D015994:Incidence; D008297:Male; D008875:Middle Aged; D011183:Postoperative Complications / Q000453:epidemiology; D011474:Prosthesis Design; D015996:Survival Rate / Q000639:trends; D014481:United States / Q000453:epidemiology