Ascertainment of acute liver injury in two European primary care databases

Ruigómez, Ana; Brauer, Ruth; Rodrı́guez, Luis A. Garcı́a; Huerta, Consuelo; Requena, Gema; Gil, Miguel; Abajo, Francisco de; Downey, Gerard; Bate, Andrew; Tepie, Maurille Feudjo; Groot, Mark de; Schlienger, Raymond G.; Reynolds, Robert F.; Klungel, Olaf H.

doi:10.1007/s00228-014-1721-y

Cited by 32 publications

(46 citation statements)

References 30 publications

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“…Although the objective behind the development of this database was to facilitate pharmacoepidemiological studies, its potential is greater. With appropriate methods and after overcoming complex validation tests, BIFAP data can be used to calculate incidence and prevalence of diseases from thousands of patients, and to investigate risk factors and associated prognostic factors [19, 20]. This research is a population-based study, which could determine accurately the incidence and prevalence of risk factors of CAP in Spain, and demonstrates the utility of BIFAP as a resource to estimate the prevalence and incidence of disease.…”

Section: Discussionmentioning

confidence: 99%

Incidence and risk factor prevalence of community-acquired pneumonia in adults in primary care in Spain (NEUMO-ES-RISK project)

Rivero‐Calle

Pardo-Seco²,

Aldaz³

et al. 2016

BMC Infect Dis

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BackgroundCommunity-acquired pneumonia (CAP) is a major cause of morbidity and mortality in adults even in developed countries. Several lifestyle factors and comorbidities have been linked to an increased risk, although their prevalence has not been well documented in the primary care setting. The aim of this study is to assess the incidence, risk factor and comorbid conditions distribution of CAP in adults in primary care in Spain.MethodsRetrospective observational study in adults (>18 years-old) with CAP diagnosed and attended at primary care in Spain between 2009 and 2013, using the Computerized Database for Pharmacoepidemiological Studies in Primary Care (BIFAP).ResultsTwenty-eight thousand four hundred thirteen patient records were retrieved and analyzed. Mean age (standard deviation): 60.5 (20.3) years, 51.7 % males. Global incidence of CAP in adults was estimated at 4.63 per 1000 persons/year. CAP incidence increased progressively with age, ranging from a 1.98 at 18–20 years of age to 23.74 in patients over 90 years of age. According to sex, global CAP incidence was slightly higher in males (5.04) than females (4.26); CAP incidence from 18 to 65 year-olds up was comparable between males (range: 2.18–5.75) and females (range: 1.47–5.21), whereas from 65 years of age, CAP incidence was noticeable higher in males (range: 7.06–36.93) than in females (range: 5.43–19.62). Average prevalence of risk factors was 71.3 %, which increased with age, doubling the risk in males by the age of 75 (females 20 % vs males 40 %). From 55 years of age, at least one risk factor was identified in 85.7 % of cases: one risk factor (23.8 %), two risk factors (23.4 %), three or more risk factors (38.5 %). Major risk factors were: metabolic disease (27.4 %), cardiovascular disease (17.8 %) and diabetes (15.5 %).ConclusionsThe annual incidence of CAP in primary care adults in Spain is high, comparable between males and females up to 65 years of age, but clearly increasing in males from that age. CAP risk increases with age and doubles in males older than 75 years. The majority of CAP cases in patients over 55 years of age is associated to at least one risk factor. The main risk factors associated were metabolic disease, cardiovascular disease, and diabetes.Electronic supplementary materialThe online version of this article (doi:10.1186/s12879-016-1974-4) contains supplementary material, which is available to authorized users.

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Section: Discussionmentioning

confidence: 99%

Incidence and risk factor prevalence of community-acquired pneumonia in adults in primary care in Spain (NEUMO-ES-RISK project)

Rivero‐Calle

Pardo-Seco²,

Aldaz³

et al. 2016

BMC Infect Dis

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“…In another study among 128 patients with ALT > 3ULN 7 cases were validated with DILI (5%) . In a study identifying ALI cases in primary care databases in Spain and the United Kingdom using the same restrictive algorithm including both diagnostic codes and laboratory measurements, PPVs of, respectively, 24% (43/179) and 63% (64/101) were found …”

Section: Discussionmentioning

confidence: 98%

Validity of diagnostic codes and laboratory measurements to identify patients with idiopathic acute liver injury in a hospital database

Udo

Zee

Egberts

et al. 2015

Pharmacoepidemiology and Drug

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Purpose The development and validation of algorithms to identify cases of idiopathic acute liver injury (ALI) are essential to facilitate epidemiologic studies on drug-induced liver injury. The aim of this study is to determine the ability of diagnostic codes and laboratory measurements to identify idiopathic ALI cases. Results A total of 707 cases of ALI were identified. After medical review 194 (27%) patients had confirmed idiopathic ALI. The PPV for (I) algorithms with an ICD-9-CM code as well as abnormal tests ranged from 32% (13/41) to 48% (43/90) with the highest PPV found with ALT > 2ULN. The PPV for (II) algorithms with liver test abnormalities was maximally 26% (150/571). Conclusions The algorithm based on ICD-9-CM codes indicative of ALI combined with abnormal liver-related laboratory tests is the most efficient algorithm for identifying idiopathic ALI cases. However, cases were missed using this algorithm, because not all ALI cases had been assigned the relevant diagnostic codes in daily practice.

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“…The validity of the algorithms that were used in the PROTECT case–control studies was assessed in the BIFAP and UPOD databases. In BIFAP the narrow definition resulted in a higher proportion of valid ALI cases compared to the broader definition (35% versus 20%) . In UPOD the stricter criteria of inclusion (diagnostic codes plus laboratory abnormalities) showed a positive predictive value (PPV) of 47%, whereas the PPV in the broader algorithm (based on laboratory results only) was only 26% .…”

Section: Discussionmentioning

confidence: 98%

“…Only validated ALI cases were used in the statistical analyses. Details about the algorithms and utilized diagnostic codes (READ codes in CPRD and International Classification of Primary Care (ICPC) codes in BIFAP) are described in the PROTECT case ascertainment study in CPRD and BIFAP …”

Section: Methodsmentioning

confidence: 99%

The risk of acute liver injury associated with the use of antibiotics—evaluating robustness of results in the pharmacoepidemiological research on outcomes of therapeutics by a European consortium (PROTECT) project.

Udo

Tcherny-Lessenot

Brauer

et al. 2015

Pharmacoepidemiology and Drug

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Purpose To examine the robustness of findings of case-control studies on the association between acute liver injury (ALI) and antibiotic use in the following different situations: (i) Replication of a protocol in different databases, with different data types, as well as replication in the same database, but performed by a different research team. (ii) Varying algorithms to identify cases, with and without manual case validation. (iii) Different exposure windows for time at risk. Methods Five case-control studies in four different databases were performed with a common study protocol as starting point to harmonize study outcome definitions, exposure definitions and statistical analyses. Results All five studies showed an increased risk of ALI associated with antibiotic use ranging from OR 2.6 (95% CI 1.3-5.4) to 7.7 (95% CI 2.0-29.3). Comparable trends could be observed in the five studies: (i) without manual validation the use of the narrowest definition for ALI showed higher risk estimates, (ii) narrow and broad algorithm definitions followed by manual validation of cases resulted in similar risk estimates, and (iii) the use of a larger window (30 days vs 14 days) to define time at risk led to a decrease in risk estimates. Conclusions Reproduction of a study using a predefined protocol in different database settings is feasible, although assumptions had to be made and amendments in the protocol were inevitable. Despite differences, the strength of association was comparable between the studies. In addition, the impact of varying outcome definitions and time windows showed similar trends within the data sources.

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Ascertainment of acute liver injury in two European primary care databases

Cited by 32 publications

References 30 publications

Incidence and risk factor prevalence of community-acquired pneumonia in adults in primary care in Spain (NEUMO-ES-RISK project)

Incidence and risk factor prevalence of community-acquired pneumonia in adults in primary care in Spain (NEUMO-ES-RISK project)

Validity of diagnostic codes and laboratory measurements to identify patients with idiopathic acute liver injury in a hospital database

The risk of acute liver injury associated with the use of antibiotics—evaluating robustness of results in the pharmacoepidemiological research on outcomes of therapeutics by a European consortium (PROTECT) project.

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