Evidence map›Paper›PMID 30269245›Full record

ReviewDrug safety2019

The Role of European Healthcare Databases for Post-Marketing Drug Effectiveness, Safety and Value Evaluation: Where Does Italy Stand?

Gianluca Trifirò, Rosa Gini, Francesco Barone-Adesi, Ettore Beghi, Anna Cantarutti, Annalisa Capuano, Carla Carnovale, Antonio Clavenna, Mirosa Dellagiovanna, Carmen Ferrajolo and 19 more

Abstract readReview
PubMed Publisher
In one paragraph

Review in Drug safety, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 53 papers.

0numbers the graph read from it
0cells of the map it votes in
53citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

53 citing papers in PubMed.

  1. Article
  2. Review
  3. State sequence analysis for a deeper understanding of treatment adherence patterns in fragility fracture patients.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2026
    Observational
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

29 authors.

Gianluca TrifiròDepartment of Biomedical and Dental Sciences and Morpho-functional Imaging, University of Messina, Messina, Italy. trifirog@unime.it.ORCID 0000-0003-1147-7296
Rosa GiniAgenzia Regionale di Sanità della Toscana, Florence, Italy.
Francesco Barone-AdesiDepartment of Pharmaceutical Sciences, University of Eastern Piedmont, Novara, Italy.
Ettore BeghiDepartment of Neuroscience, IRCCS-Mario Negri Pharmacology Research Institute, Milan, Italy.
Anna CantaruttiLaboratory of Pharmacoepidemiology and Healthcare Research, Unit of Biostatistics Epidemiology and Public Health, Department of Statistics and Quantitative Methods, University of Milano-Bicocca, Milan, Italy.
Annalisa CapuanoDepartment of Experimental Medicine, Section of Pharmacology "L. Donatelli", Second University of Naples, Naples, Italy.
Carla CarnovaleUnit of Clinical Pharmacology Department of Biomedical and Clinical Sciences L. Sacco, Luigi Sacco University Hospital, University of Milan, Milan, Italy.
Antonio ClavennaPharmacoepidemiology Unit, Department of Public Health, IRCCS, Mario Negri Pharmacology Research Institute, Milan, Italy.
Mirosa DellagiovannaRegional Centre for Pharmacovigilance, Lombardy Region, Milan, Italy.
Carmen FerrajoloDepartment of Experimental Medicine, Section of Pharmacology "L. Donatelli", Second University of Naples, Naples, Italy.
Matteo FranchiLaboratory of Pharmacoepidemiology and Healthcare Research, Unit of Biostatistics Epidemiology and Public Health, Department of Statistics and Quantitative Methods, University of Milano-Bicocca, Milan, Italy.
Ylenia IngrasciottaDepartment of Biomedical and Dental Sciences and Morpho-functional Imaging, University of Messina, Messina, Italy.
Ursula KirchmayerDepartment of Epidemiology, Lazio Regional Health Service, Rome, Italy.
Francesco LapiHealth Search, Italian College of General Practitioners and Primary Care, Florence, Italy.
Roberto LeoneDepartment of Diagnostics and Public Health, Section of Pharmacology, University of Verona, Verona, Italy.
Olivia LeoniRegional Centre for Pharmacovigilance, Lombardy Region, Milan, Italy.
Ersilia LucenteforteDepartment of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy.
Ugo MorettiDepartment of Diagnostics and Public Health, Section of Pharmacology, University of Verona, Verona, Italy.
Alessandro MugelliDepartment of Neurosciences, Psychology, Pharmacology and Child Health (NEUROFARBA), University of Florence, Florence, Italy.
Luigi NaldiCentro Studi Gruppo Italiano Studi Epidemiologici in Dermatologia (GISED), Bergamo, Italy.
Elisabetta PoluzziDepartment of Medical and Surgical Sciences DIMEC, University of Bologna, Bologna, Italy.
Concita RafanielloDepartment of Experimental Medicine, Section of Pharmacology "L. Donatelli", Second University of Naples, Naples, Italy.
Federico ReaLaboratory of Pharmacoepidemiology and Healthcare Research, Unit of Biostatistics Epidemiology and Public Health, Department of Statistics and Quantitative Methods, University of Milano-Bicocca, Milan, Italy.
Janet SultanaDepartment of Biomedical and Dental Sciences and Morpho-functional Imaging, University of Messina, Messina, Italy.
Mauro TettamantiDepartment of Geriatric Neuropsychiatry, Mario Negri Pharmacology Research Institute, Milan, Italy.
Giuseppe TraversaPharmacoepidemiology Unit, National Centre for Epidemiology, National Institute of Health, Rome, Italy.
Alfredo VannacciDepartment of Neurosciences, Psychology, Pharmacology and Child Health (NEUROFARBA), University of Florence, Florence, Italy.
Lorenzo MantovaniResearch Centre on Public Health (CESP), University of Milan-Bicocca, Monza, Italy.
Giovanni CorraoLaboratory of Pharmacoepidemiology and Healthcare Research, Unit of Biostatistics Epidemiology and Public Health, Department of Statistics and Quantitative Methods, University of Milano-Bicocca, Milan, Italy.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Enormous progress has been made globally in the use of evidence derived from patients' clinical information as they access their routine medical care. The value of real-world data lies in their complementary nature compared with data from randomised controlled trials: less detailed information on drug efficacy but longer observational periods and larger, more heterogeneous study populations reflecting clinical practice because individuals are included who would not usually be recruited in trials. Real-world data can be collected in various types of electronic sources, such as electronic health records, claims databases and drug or disease registries. These data sources vary in nature from country to country, according to national healthcare system structures and national policies. In Italy, a growing number of healthcare databases have been used to evaluate post-marketing drug utilisation and safety in the last two decades. The aim of this narrative review is to describe the available Italian sources of real-world data and their contribution to generating post-marketing evidence on drug use and safety. We also discuss the strengths and limitations of the most commonly used Italian healthcare databases in addressing various research questions concerning drug utilisation, comparative effectiveness and safety studies, as well as health technology assessment and other areas.

Indexed as

Databases, FactualDrug-Related Side Effects and Adverse ReactionsDrug Utilization ReviewElectronic Health RecordsInformation Storage and RetrievalItalyNational Health ProgramsProduct Surveillance, Postmarketing

Identifiers

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.