Evidence map›Paper›PMID 34092001›Full record

ReviewPharmacoepidemiology and drug safety2021

A review of the sampling methodology used in studies evaluating the effectiveness of risk minimisation measures in Europe.

Laurence Sophie Jouaville, Tulika Paul, Mariana Ferreira Almas

Abstract readReview
In one paragraph

Review in Pharmacoepidemiology and drug safety, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing 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

5 citing papers in PubMed.

  1. Review
  2. Review
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  5. Review
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

3 authors.

Laurence Sophie JouavilleIQVIA Real World Solutions, La Defense, France.ORCID 0000-0003-1027-0322
Tulika PaulIQVIA Real World Solutions, Gurugram, Haryana, India.ORCID 0000-0002-4981-1301
Mariana Ferreira AlmasIQVIA Real World Solutions, Porto Salvo, Portugal.ORCID 0000-0001-5608-9452

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeThis review aims to describe the sampling methodology used in studies assessing effectiveness of risk minimisation measures (RMMs) in the European Union.

methodsThe European Union electronic Register of Post-Authorization Studies (EU PAS Register) was searched to identify studies that assessed the effectiveness of RMMs and recruited a target population of healthcare professionals (HCPs), sites or patients. Studies with both protocol and report were included and data was extracted from these documents to describe study characteristics and variables involved in the sampling methodology.

resultsOut of 1092 studies finalised between June 2017 and May 2019, 17 studies were eligible for review. Thirteen were surveys, three chart reviews and one combined both methodologies. All the 17 studies recruited HCPs/sites and 8 of them also recruited patients. The most common rationale for country sampling was market uptake (10/17), while for HCP/site sampling, it was representativeness of the prescribing practices (14/17). Only a minority of the studies (4/17) provided supporting evidence to inform this theoretical framework. HCP/site sampling frames were mainly network of physicians (5/17) or HCP databases (5/17), with only one study providing a detailed description of the sampling frame. HCPs were selected mainly using probabilistic sampling (10/17) and patients using non-probabilistic sampling (6/8). Only a few studies compared participating with non-participating HCPs/sites (5/17) and patients (3/8). Eight studies reported that their results were generalisable.

conclusionsOverall, the study documents provided insufficient details to understand the rationale behind the sampling decisions. More standardisation and guidance in reporting the sampling strategy and operational considerations applicable to these types of studies would support transparency and facilitate the evaluation of representativeness of the study results.

Indexed as

Health PersonnelEuropeEuropean UnionHumansSurveys and QuestionnairesEU PAS registerpharmacoepidemiologypost-authorisation safety studyrepresentativenessrisk minimisation measuressampling methodology

Identifiers

PMID34092001
PMCPMC8453956

What OpenQuestion holds

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LicenceCC BY-NC-ND
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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.