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J Clin Pathol doi:10.1136/jclinpath-2011-200587
  • Original article

Application of the UK NHS Improvement Anticoagulation Commissioning Support Document for ‘safety indicators’ in atrial fibrillation. Results of the European Action on Anticoagulation study

  1. Saied A Ibrahim6
  1. 1European Action on Anticoagulation (EAA) Central Facility, Faculty of Life Sciences, University of Manchester, Manchester, UK
  2. 2Department of Clinical Biochemistry, Hospital of South West Denmark, Esbjerg and Department for Thrombosis Research, Institute of Public Health, University of Southern Denmark, Esbjerg, Denmark
  3. 3Cardiology Department, Leeds General Infirmary, Leeds, UK
  4. 4Department of Haematology, Addenbrooke's NHS Trust, Cambridge, UK
  5. 5NHS Improvement, Leicester, UK
  6. 6Research Statistician, EAA Central Facility, Faculty of Life Sciences, University of Manchester, Manchester, UK
  1. Correspondence to Professor Leon Poller, EAA Central Facility, The University of Manchester, Faculty of Life Sciences, Manchester M13 9PT, UK; ecaa{at}manchester.ac.uk
  1. Contributors LP, CC and JG were authors of the NHS Improvement Document. LP was the project leader of the EAA clinical study. SAI was the statistician responsible for the analysis of the data. JJ was the chairman of the EAA group responsible for the clinical study. TB was the author of the British Committee for Standards in Haematology and National Patient Safety Agency recommendations and advised on this submission.

  • Accepted 11 January 2012
  • Published Online First 31 January 2012

Abstract

Introduction 'Safety indicators' in the anticoagulant management of atrial fibrillation (AF) are listed in the UK NHS Improvement Document, ‘Anticoagulation for AF’, aiming to promote quality services. Acceptable clinical event rates are not quantified in the document.

Objective To provide clinical evaluation of the relevant safety indicators using data from a recent large European Action on Anticoagulation (EAA) study.

Results 469 clinical events were recorded in 5839 outpatients in the EAA study. The safety indicators listed in the NHS Improvement Document were related to these patients with AF. The relevance of the ‘safety indicators’ is confirmed by the EAA study for patients starting oral anticoagulation and for those already receiving oral anticoagulation, and quantified.

Conclusion The EAA clinical study provides a quantitative basis for the safety indicators' in AF listed in the NHS Commissioning Support Document and emphasises the importance of the document.

Footnotes

  • EAA International Sensitivity Index Calibration Studies. AMHP van den Besselaar, Leiden University Medical Centre, Leiden. EAA External Quality Assessment Studies. A Tripodi, University and IRCCS Maggiore Hospital, Mangiagalli and Regina Elena Foundation, Milan, Italy.

  • Competing interests None.

  • Provenance and peer review Not commissioned; externally peer reviewed.

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