Evidence map›Paper›PMID 29522255›Full record

ArticleBritish journal of clinical pharmacology2018

Does patient reporting lead to earlier detection of drug safety signals? A retrospective comparison of time to reporting between patients and healthcare professionals in a global database.

Leàn Rolfes, Florence van Hunsel, Ola Caster, Henric Taavola, Katja Taxis, Eugène van Puijenbroek

Abstract readComparative Study
In one paragraph

Article in British journal of clinical pharmacology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers.

0numbers the graph read from it
0cells of the map it votes in
14citing 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

14 citing papers in PubMed.

  1. Article
  2. Article
  3. Article
  4. Article
  5. Article
  6. Analysis of adverse drug events as a way to improve cancer patient care.European journal of hospital pharmacy : science and practice · 2023
    Observational
  7. Article
  8. Pharmacovigilance in China: Evolution and future challenges.British journal of clinical pharmacology · 2023
    Review
  9. Article
  10. Review
  11. Article
  12. Article
  13. Article
  14. 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

6 authors.

Leàn RolfesNetherlands Pharmacovigilance Centre Lareb, 's-Hertogenbosch, The Netherlands.ORCID 0000-0001-9046-1609
Florence van HunselNetherlands Pharmacovigilance Centre Lareb, 's-Hertogenbosch, The Netherlands.ORCID 0000-0001-8965-3224
Ola CasterUppsala Monitoring Centre (UMC), Box 1051, SE-751 40, Uppsala, Sweden.ORCID 0000-0002-2259-1716
Henric TaavolaUppsala Monitoring Centre (UMC), Box 1051, SE-751 40, Uppsala, Sweden.ORCID 0000-0002-2604-2810
Katja TaxisUniversity of Groningen, Groningen Research Institute of Pharmacy, Unit of PharmacoTherapy, Epidemiology & Economics, University of Groningen, Groningen, The Netherlands.ORCID 0000-0001-8539-2004
Eugène van PuijenbroekNetherlands Pharmacovigilance Centre Lareb, 's-Hertogenbosch, The Netherlands.ORCID 0000-0002-2236-1398

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsTo explore if there is a difference between patients and healthcare professionals (HCPs) in time to reporting drug-adverse drug reaction (ADR) associations that led to drug safety signals.

methodsThis was a retrospective comparison of time to reporting selected drug-ADR associations which led to drug safety signals between patients and HCPs. ADR reports were selected from the World Health Organization Global database of individual case safety reports, VigiBase. Reports were selected based on drug-ADR associations of actual drug safety signals. Primary outcome was the difference in time to reporting between patients and HCPs. The date of the first report for each individual signal was used as time zero. The difference in time between the date of the reports and time zero was calculated. Statistical differences in timing were analysed on the corresponding survival curves using a Mann-Whitney U test.

resultsIn total, 2822 reports were included, of which 52.7% were patient reports, with a median of 25% for all included signals. For all signals, median time to signal detection was 10.4 years. Overall, HCPs reported earlier than patients: median 7.0 vs. 8.3 years (P < 0.001).

conclusionsPatients contributed a large proportion of reports on drug-ADR pairs that eventually became signals. HCPs reported 1.3 year earlier than patients. These findings strengthen the evidence on the value of patient reporting in signal detection and highlight an opportunity to encourage patients to report suspected ADRs even earlier in the future.

Indexed as

PharmacovigilanceAdverse Drug Reaction Reporting SystemsDrug MonitoringHealth PersonnelHumansPatient ParticipationRetrospective StudiesTime FactorsWorld Health Organizationadverse drug reactiondrug safetypatient reportingpharmacovigilancesignal detection

Identifiers

PMID29522255
PMCPMC6005587

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Registered trials

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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.