Evidence map›Paper›PMID 29105853›Full record

SynthesisBritish journal of clinical pharmacology2018

Measuring the impact of medicines regulatory interventions - Systematic review and methodological considerations.

Thomas Goedecke, Daniel R Morales, Alexandra Pacurariu, Xavier Kurz

Abstract readSystematic Review
PubMed Full text at PMC Publisher
In one paragraph

Synthesis 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 41 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
41citing papers in PubMed, 4 pooled it
–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

41 citing papers in PubMed, 4 syntheses or guidelines pooled it.

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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

4 authors.

Thomas GoedeckePharmacovigilance and Epidemiology Department, Inspections Human Medicines Pharmacovigilance and Committees Division, European Medicines Agency (EMA), London, E14 5EU, UK.ORCID 0000-0002-0141-4518
Daniel R MoralesPharmacovigilance and Epidemiology Department, Inspections Human Medicines Pharmacovigilance and Committees Division, European Medicines Agency (EMA), London, E14 5EU, UK.
Alexandra PacurariuPharmacovigilance and Epidemiology Department, Inspections Human Medicines Pharmacovigilance and Committees Division, European Medicines Agency (EMA), London, E14 5EU, UK.
Xavier KurzPharmacovigilance and Epidemiology Department, Inspections Human Medicines Pharmacovigilance and Committees Division, European Medicines Agency (EMA), London, E14 5EU, UK.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsEvaluating the public health impact of regulatory interventions is important but there is currently no common methodological approach to guide this evaluation. This systematic review provides a descriptive overview of the analytical methods for impact research.

methodsWe searched MEDLINE and EMBASE for articles with an empirical analysis evaluating the impact of European Union or non-European Union regulatory actions to safeguard public health published until March 2017. References from systematic reviews and articles from other known sources were added. Regulatory interventions, data sources, outcomes of interest, methodology and key findings were extracted.

resultsFrom 1246 screened articles, 229 were eligible for full-text review and 153 articles in English language were included in the descriptive analysis. Over a third of articles studied analgesics and antidepressants. Interventions most frequently evaluated are regulatory safety communications (28.8%), black box warnings (23.5%) and direct healthcare professional communications (10.5%); 55% of studies measured changes in drug utilization patterns, 27% evaluated health outcomes, and 18% targeted knowledge, behaviour or changes in clinical practice. Unintended consequences like switching therapies or spill-over effects were rarely evaluated. Two-thirds used before-after time series and 15.7% before-after cross-sectional study designs. Various analytical approaches were applied including interrupted time series regression (31.4%), simple descriptive analysis (28.8%) and descriptive analysis with significance tests (23.5%).

conclusionWhilst impact evaluation of pharmacovigilance and product-specific regulatory interventions is increasing, the marked heterogeneity in study conduct and reporting highlights the need for scientific guidance to ensure robust methodologies are applied and systematic dissemination of results occurs.

Indexed as

Drug and Narcotic ControlPharmacovigilanceHumansResearch Designanalytic methodbefore-after study designimpact evaluationinterrupted time seriespharmacovigilancereal-world effectivenessregulatory interventions

Identifiers

PMID29105853
PMCPMC5809349

What Socratic holds

Textmetadata
LicenceCC BY-NC-ND
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 Socratic graph.