Evidence map›Paper›PMID 38854895›Full record

ArticleClinical epidemiology2024

Development and Validation of a META-Algorithm to Identify the Indications of Use of Biological Drugs Approved for the Treatment of Immune-Mediated Inflammatory Diseases from Claims Databases: Insights from the VALORE Project.

Andrea Spini, Luca L'Abbate, Ylenia Ingrasciotta, Giorgia Pellegrini, Massimo Carollo, Valentina Ientile, Olivia Leoni, Martina Zanforlini, Domenica Ancona, Paolo Stella and 5 more

Abstract read
In one paragraph

Article in Clinical epidemiology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing 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

4 citing papers in PubMed.

  1. Article
  2. Article
  3. Article
  4. Article
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

15 authors.

Andrea SpiniDepartment of Diagnostics and Public Health, University of Verona, Verona, Italy.ORCID 0000-0001-7496-5575
Luca L'AbbateDepartment of Biomedical and Dental Sciences and Morphofunctional Imaging, University of Messina, Messina, Italy.
Ylenia IngrasciottaDepartment of Diagnostics and Public Health, University of Verona, Verona, Italy.ORCID 0000-0002-9549-6111
Giorgia PellegriniDepartment of Diagnostics and Public Health, University of Verona, Verona, Italy.
Massimo CarolloDepartment of Diagnostics and Public Health, University of Verona, Verona, Italy.ORCID 0000-0002-6523-6036
Valentina IentileDepartment of Biomedical and Dental Sciences and Morphofunctional Imaging, University of Messina, Messina, Italy.
Olivia LeoniLombardy Regional Centre of Pharmacovigilance and Regional Epidemiologic Observatory, Milan, Italy.
Martina ZanforliniAzienda Regionale per l'Innovazione e gli Acquisti, S.p.A, Milan, Italy.
Domenica AnconaApulian Regional Health Department, Bari, Italy.
Paolo StellaApulian Regional Health Department, Bari, Italy.
Anna CavazzanaAzienda Zero, Regione Veneto, Italy.
Angela ScapinAzienda Zero, Regione Veneto, Italy.
Sara LopesDepartment of Epidemiology, Lazio Regional Health Service, Rome, Italy.
Valeria BelleudiDepartment of Epidemiology, Lazio Regional Health Service, Rome, Italy.ORCID 0000-0002-8286-443X
Gianluca TrifiròDepartment of Diagnostics and Public Health, University of Verona, Verona, Italy.ORCID 0000-0003-1147-7296

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Purpose: This research aimed to develop and validate a META-algorithm combining individual immune-mediated inflammatory disease (IMID)-specific algorithms to identify the exact IMID indications for incident biological drug users from claims data within the context of the Italian VALORE project. Methods and Patients: All subjects with at least one dispensing of TNF-alpha inhibitors, anti-interleukin agents, and selective immunosuppressants approved for IMIDs were identified from claims databases of Latium region in Italy (observation period: 2010-2020). Validated coding algorithms for identifying individual IMIDs from claims databases were found from published literature and combined into a META-algorithm. Positive predictive value (PPV), sensitivity (Se), negative predictive value (NPV), specificity (Sp), and accuracy (Acc) were estimated for each indication against the electronic therapeutic plans (ETPs) of the Latium region as the reference standard. Lastly, the frequency of the indication of use across individual biologic drugs was compared with that reported in three other Italian regions (Lombardy, Apulia, and the Veneto region). Results: In total, 9755 incident biological drug users with a single IMID indication were identified. Using the newly developed META-algorithm, an indication of use was detected in 95% (n=9255) of the total cohort. The estimated Acc, Se, Sp, PPV, and NPV, against the reference standard were as follows: 0.96, 0.86, 0.97, 0.82, and 0.98 for Crohn's disease, 0.96, 0.80, 0.98, 0.85, and 0.97 for ulcerative colitis, 0.93, 0.76, 0.99, 0.95, and 0.92 for rheumatoid arthritis, 0.97, 0.75, 0.99, 0.85, and 0.98 for spondylarthritis, and 0.91, 0.92, 0.91, 0.88, and 0.94 for psoriatic arthritis/psoriasis, respectively. Additionally, no substantial difference was observed in the frequency of indication of use by active ingredient among Latium and the other three Italian regions included in the study. Conclusion: The newly developed META-algorithm demonstrated high validity estimates in the Italian claims data and was capable of discriminating with good performance among the most frequent IMID indications.

Indexed as

biological drugsclaims dataimmune-mediated inflammatory diseasesindication for useMETA-algorithmvalidation

Identifiers

PMID38854895
PMCPMC11162210

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.