Under-recording of hospital bleeding events in UK primary care: a linked Clinical Practice Research Datalink and Hospital Episode Statistics study

Laura McDonald,1,* Cormac J Sammon,2,* Mihail Samnaliev,2 Sreeram Ramagopalan1 1Centre for Observational Research and Data Sciences, Bristol-Myers Squibb, Uxbridge, UK; 2PHMR, Berkeley Works, London, UK *These authors contributed equally to this work Background: Primary care databases represent a rich source of data for health care research; however, the quality of recording of secondary care events in these databases is uncertain. This study sought to investigate the completeness of recording of hospital admissions for bleeds in primary care records and explore the impact of incomplete recording on estimates of bleeding risk associated with antithrombotic treatment.Methods: The study population consisted of adults with non-valvular atrial fibrillation who had at least one bleed recorded in either the Clinical Practice Research Datalink (CPRD) or Hospital Episode Statistics (HES) while receiving prescriptions for an oral anticoagulant. The proportion of bleeds recorded in HES that had a corresponding bleed recorded in the subsequent 12 weeks in CPRD was calculated, and factors associated with having a corresponding record were identified. Cox proportional hazards analyses investigating the hazard of subsequent bleeding associated with antithrombotic treatment were carried out using linked CPRD-HES data and using CPRD only data, and the results were compared.Results: Less than 20% of the 14,361 bleeds recorded in the HES data had a corresponding bleed coded in the CPRD in the subsequent 12 weeks. This proportion varied by bleed characteristics, calendar time, day of week of admission (weekday vs weekend) and oral anticoagulant treatment at the time of the bleed. The hazard of subsequent bleeding associated with vitamin K antagonists (VKAs) and antiplatelet agents (APAs) relative to no antithrombotic treatment were similar using the linked primary and secondary care dataset (VKA HRadj 1.06 CI95 0.96–1.16; APA HRadj 1.08 CI95 0.96–1.21) and the unlinked primary care data (VKA HRadj 1.12 CI95 1.01–1.24; APA HRadj 1.06 CI95 0.95–1.20).Conclusion: Secondary care bleeding events are not completely recorded in primary care records and under-recording may be differential with respect to a variety of factors, including antithrombotic treatment. While the impact of under-recording on estimates of the comparative safety of antithrombotic drugs was limited, the extent of the under-recording suggests its potential impact should be considered, and ideally evaluated in future studies utilizing stand-alone primary care data. Keywords: real-world data, data linkage, comparative effectiveness, secondary care, atrial fibrillation