Seasonal changes in prescribing of long-acting beta-2-agonists-containing drugs

Rottenkolber, Marietta; Voogd, Eef; Dijk, Liset van; Primatesta, Paola; Becker, Claudia; Groot, M. C. de; Plana, Estel; Álvarez, Yolanda; Durand, Julie; Slattery, Jim; Afonso, Ana; Requena, Gema; Huerta, Consuelo; Alvarez, Alicia; Abajo, Francisco J. de; Tauscher, Martin; Hasford, Joerg; Fischer, Rainald; Reynolds, Robert F.; Schmiedl, Sven

doi:10.1016/j.rmed.2015.01.010

Cited by 3 publications

(3 citation statements)

References 31 publications

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“…However, the supplement also includes descriptive and outcome validation studies and two assessments of the use of instrumental variables as a method for control of confounding. Several manuscripts from the PROTECT project were published prior to the development of this supplement …”

Section: Protect's Organizational Structure and Goalsmentioning

confidence: 99%

“…For all databases, we described the pattern of exposure to the drugs of interest. For those databases with sufficient information on diagnoses, we have described the prevalence and incidence of the outcomes of interest . For the drug–adverse event association studies we implemented a blinding procedure with central results management.…”

Section: Protect Work Package 2 and Work Package 6 Proceduresmentioning

confidence: 99%

“…For those databases with sufficient information on diagnoses, we have described the prevalence and incidence of the outcomes of interest. [57][58][59][60][61][62] For the drugadverse event association studies we implemented a blinding procedure with central results management. Results for each design were un-blinded only after project teams submitted adjusted association measures to the coordinating center at Utrecht University.…”

Section: Study Document Process Analytic Approach and Management Ofmentioning

confidence: 99%

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The IMI PROTECT project: purpose, organizational structure, and procedures

Reynolds

Kurz²,

Groot

et al. 2016

Pharmacoepidemiology and Drug

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The Pharmacoepidemiological Research on Outcomes of Therapeutics by a European ConsorTium (PROTECT) initiative was a collaborative European project that sought to address limitations of current methods in the field of pharmacoepidemiology and pharmacovigilance. Initiated in 2009 and ending in 2015, PROTECT was part of the Innovative Medicines Initiative, a joint undertaking by the European Union and pharmaceutical industry. Thirty-five partners including academics, regulators, small and medium enterprises, and European Federation of Pharmaceuticals Industries and Associations companies contributed to PROTECT. Two work packages within PROTECT implemented research examining the extent to which differences in the study design, methodology, and choice of data source can contribute to producing discrepant results from observational studies on drug safety. To evaluate the effect of these differences, the project applied different designs and analytic methodology for six drug-adverse event pairs across several electronic healthcare databases and registries. This papers introduces the organizational structure and procedures of PROTECT, including how drug-adverse event and data sources were selected, study design and analyses documents were developed, and results managed centrally.

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Section: Protect's Organizational Structure and Goalsmentioning

confidence: 99%

Section: Protect Work Package 2 and Work Package 6 Proceduresmentioning

confidence: 99%

Section: Study Document Process Analytic Approach and Management Ofmentioning

confidence: 99%

See 1 more Smart Citation

The IMI PROTECT project: purpose, organizational structure, and procedures

Reynolds

Kurz²,

Groot

et al. 2016

Pharmacoepidemiology and Drug

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Base de Datos para la Investigación Farmacoepidemiológica en Atención Primaria (BIFAP): A data resource for pharmacoepidemiology in Spain

Maciá-Martínez

Gil

Huerta

et al. 2020

Pharmacoepidemiology and Drug

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Primaria (BIFAP) is a population based database administered by the AEMPS (Spanish Agency for Medicines) of longitudinal electronic medical records (EMR) of patients attended in primary care. Its main purpose is to serve as source of information for independent studies on drug safety and support of medicines regulation activities. This article aim is to describe the characteristics of BIFAP, how to access the database and a summary of its potential for research. Methods: Health problems are registered by primary care physicians as episodes of care and include socio-demographic data, results of diagnostic procedures, lifestyle data, general data, and interventions. A proportion of data on hospitalizations and specialist care are currently available through linkage with other data sources. EMRs

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