Ascertainment and validation of major bleeding events in a primary care database

Ruigómez, Ana; Brobert, Gunnar; Suzart-Woischnik, Kiliana; Rodrı́guez, Luis A. Garcı́a

doi:10.1002/pds.4580

Cited by 12 publications

(15 citation statements)

References 31 publications

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“…Lastly, Delate et al recommended a manual chart review to validate warfarin-related bleeding events from administrative data [13]. Ruigomez et al also advocated additional information to prevent misclassification as regards major GI or urogenital bleeding events [14]. Our findings are in line with these previous results and have highlighted differential measures of accuracy between ICH and GI.…”

Section: Discussionsupporting

confidence: 87%

Sensitivity and specificity of an algorithm based on medico-administrative data to identify hospitalized patients with major bleeding presenting to an emergency department

Oger¹,

Botrel²,

Juchault

et al. 2019

BMC Med Res Methodol

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Background Validation studies on an ICD-10-based algorithm to identify major bleeding events are scarce, and mostly focused on positive predictive values. Objective To evaluate the sensitivity and specificity of an ICD-10-based algorithm in adult patients referred to hospital. Methods This was a cross-sectional, retrospective analysis. Among all hospital stays of adult patients referred to Rennes University Hospital, France, through the emergency ward in 2014, we identified major bleeding events according to an index test based on a list of ICD-10 diagnoses. As a reference, a two-step process was applied: firstly, a computerized request for electronic health records from the emergency ward, using several hemorrhage-related diagnostic codes and specific emergency therapies so as to discard stays with a very low probability of bleeding; secondly, a chart review of selected records was conducted by a medical expert blinded to the index test results and each hospital stay was classified into one of two exclusive categories: major bleeding or no major bleeding, according to pre-specified criteria. Results Out of 16,012 hospital stays, the reference identified 736 major bleeding events and left 15,276 stays considered as without the target condition. The index test identified 637 bleeding events: 293 intracranial hemorrhages, 197 gastrointestinal hemorrhages and 147 other bleeding events. Overall, sensitivity was 65% (95%CI, 62 to 69), and specificity was 99.0%. We observed differential sensitivity and specificity across bleeding types, with the highest values for intracranial hemorrhage. Positive predictive values ranged from 59% for “other” bleeding events, to 71% (95%CI, 65 to 78) for gastrointestinal hemorrhage, and 96% for intracranial hemorrhage. Conclusions Low sensitivity and differential measures of accuracy across bleeding types support the need for specific data collection and medical validation rather than using an ICD-10-based algorithm for assessing the incidence of major bleeding.

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Section: Discussionsupporting

confidence: 87%

Sensitivity and specificity of an algorithm based on medico-administrative data to identify hospitalized patients with major bleeding presenting to an emergency department

Oger¹,

Botrel²,

Juchault

et al. 2019

BMC Med Res Methodol

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“…Such an approach authorizes a more accurate estimate of haemorrhagic risk. A recent study showed that the manual medical record review was a necessary step especially for gastrointestinal and urogenital bleeds, improving the true estimated incidence rates; in comparison, the codes used alone in database overestimated the incidence rates. Furthermore, such a medical review overcomes the classification bias related to retrospective analysis of data based on hospital discharge diagnosis (ICD‐10 codes) without medical validation .…”

Section: Discussionmentioning

confidence: 99%

Major bleeding with antithrombotic agents: a 2012–2015 study using the French nationwide Health Insurance database linked to emergency department records within five areas – rationale and design of SACHA study

Bouget¹,

Balusson²,

Scailteux³

et al. 2019

Fundamemntal Clinical Pharma

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Bleeding represents the most recognized and feared complications of antithrombotic drugs including oral anticoagulants. Previous studies showed inconsistent results on the safety profile. Among explanations, bleeding definition could vary and classification bias exists related to the lack of medical evaluation. To quantify the risk of major haemorrhagic event and event‐free survival associated with antithrombotic drugs (vitamin K antagonist [VKA], non‐VKA anticoagulant [NOAC], antiplatelet agent, parenteral anticoagulant) in 2012–2015, we linked the French nationwide Health Insurance database (SNIIRAM) with a local ‘emergency database’ (clinical and biological data collected in clinical records). In the VKA‐NOAC comparison, a Cox regression analysis will be used to estimate the hazard ratio of major haemorrhagic event adjusted on gender, modified HAS‐BLED score and comorbidities. A distinction on the type of major haemorrhagic event (intracranial, gastrointestinal and other haemorrhagic events) was made. We present here the study protocol and the database linkage results. Using six linkage keys, among 3 837 557 hospital visits identified in SNIIRAM, 5264 have been matched with a major haemorrhagic event identified in the ‘emergency database’, thus clinically confirmed. The 1090 unmatched haemorrhagic events could be explained by the fact that patients were not extracted in the SNIIRAM database (patients living in accommodation establishment with internal use of pharmacy, military people with specific insurance…). We showed the value of SNIIRAM enrichment with a clinical database, a necessary step to categorize haemorrhagic events by a clinically relevant definition and medical validation; it will allow to estimate more accuracy each type of haemorrhagic event.

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“…To validate outcomes in THIN, anonymized patient profiles, including any free-text comments related to the event, are manually reviewed. The necessity and added value of this approach have been demonstrated in a previous validation study, which identified that major gastrointestinal and urogenital bleeding rates are overestimated in the absence of manual review [24]. For the Swedish nationwide health registries, a prior validation study has demonstrated high sensitivity (85.5%) and specificity (95.9%) for the detection of major bleeding events associated with hospitalization [25].…”

Section: Safety and Effectiveness Outcomesmentioning

confidence: 99%

Rationale and design of a European epidemiological post-authorization safety study (PASS) program: rivaroxaban use in routine clinical practice

Rodrı́guez

Wallander

Friberg

et al. 2020

Expert Opinion on Drug Safety

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Background: Rivaroxaban is a highly selective factor Xa inhibitor approved for use in Europe for multiple indications. Study design and methods: The European rivaroxaban epidemiological post-authorization safety study (PASS) program consists of seven complementary observational studies. For four of the studies, data are obtained from health-care databases in the UK, the Netherlands, Germany, and Sweden. These database studies describe patterns of rivaroxaban use and patient characteristics over time, and investigate safety and effectiveness outcomes in new users of rivaroxaban using a cohort analysis and nested case-control analysis. To put these results in context, safety outcomes are also analyzed in new users of standard of care. In addition, a modified prescription event monitoring study conducted in the early post-launch phase in primary care, and two specialist cohort event monitoring studies that investigated rivaroxaban use in the secondary care hospital setting, systematically collected drug utilization and safety data via questionnaires completed by health-care professionals in the UK. Discussion: The European rivaroxaban epidemiological PASS is a comprehensive program of complementary studies generating evidence from patients treated in routine clinical practice that will expand our understanding of the risk-benefit profile of rivaroxaban.

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Ascertainment and validation of major bleeding events in a primary care database

Abstract: Major GI and UG bleeding events ascertained from THIN using read codes require validation using additional information to prevent outcome misclassification. The absence of validation may lead to overestimated incidence rates of major bleeding for GI and UG bleeds.

Cited by 12 publications

References 31 publications

Sensitivity and specificity of an algorithm based on medico-administrative data to identify hospitalized patients with major bleeding presenting to an emergency department

Sensitivity and specificity of an algorithm based on medico-administrative data to identify hospitalized patients with major bleeding presenting to an emergency department

Major bleeding with antithrombotic agents: a 2012–2015 study using the French nationwide Health Insurance database linked to emergency department records within five areas – rationale and design of SACHA study

Rationale and design of a European epidemiological post-authorization safety study (PASS) program: rivaroxaban use in routine clinical practice

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