Evidence map›Paper›PMID 31758215›Full record

Observational studyEuropean journal of clinical pharmacology2020

Methods for constructing treatment episodes and impact on exposure-outcome associations.

Laura Pazzagli, Lena Brandt, Marie Linder, David Myers, Panagiotis Mavros, Morten Andersen, Shahram Bahmanyar

Open access · hybridAbstract readComparative StudyObservational Study
PubMed Publisher
In one paragraph

Observational study in European journal of clinical pharmacology, 2020. 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
1.5field-weighted citation impact, top 18% of its field
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, 25 citations in OpenAlex.

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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

7 authors at 5 institutions in 3 countries.

Laura PazzagliCentre for Pharmacoepidemiology, Department of Medicine Solna, Karolinska Institutet, S-171 76, Stockholm, Sweden. laura.pazzagli@ki.se.ORCID http://orcid.org/0000-0002-1908-6073
Lena BrandtCentre for Pharmacoepidemiology, Department of Medicine Solna, Karolinska Institutet, S-171 76, Stockholm, Sweden.
Marie LinderCentre for Pharmacoepidemiology, Department of Medicine Solna, Karolinska Institutet, S-171 76, Stockholm, Sweden.
David MyersThe Janssen Pharmaceutical Companies of Johnson & Johnson, Janssen Cilag AB, Stockholm, Sweden.
Panagiotis MavrosJanssen Scientific Affairs, Titusville, NJ, USA.
Morten AndersenCentre for Pharmacoepidemiology, Department of Medicine Solna, Karolinska Institutet, S-171 76, Stockholm, Sweden.
Shahram BahmanyarCentre for Pharmacoepidemiology, Department of Medicine Solna, Karolinska Institutet, S-171 76, Stockholm, Sweden.
Karolinska Institutet · SEJanssen (United States) · USJohnson & Johnson (Sweden) · SEScience for Life Laboratory · SEUniversity of Copenhagen · DK

Funding

Novo Nordisk Foundation NNF15SA0018404public-private real world evidence collaboration between Karolinska Institutet and Janssen Pharmaceuticals 5-63/2015
6 · The paper itself

Abstract

purposeTo assess the impact on exposure time and outcome misclassifications, and consequent impact on exposure-outcome associations from treatment episode construction. We investigated the dosage assumptions of 1 unit per day, and 1 DDD per day, versus actual prescribed dosage under different handling of gaps and overlaps of prescriptions.

methodsData on mirtazapine and citalopram exposure (years 2006-2014) from the Swedish Prescribed Drug register were used. Via a within individuals design we compared method A, based on actual dosage, with methods B and C based on 1 unit of drug per day and 1 DDD per day assumptions, respectively, including consideration of gaps and overlaps. Four outcomes were used, hospitalizations and outpatient visits for all and for psychiatric causes.

resultsRelative to method A, both alternative methods lead to misclassification of exposure time. With regard to outcome misclassifications, method B overestimates the effect of the exposure on the outcome in 77% and 100% of exposure definition comparisons for mirtazapine and citalopram respectively, while 23% of the comparisons for mirtazapine results in underestimation of exposure-outcome associations. Conversely, treatment episodes based on DDD (method C) result in underestimation of the exposure-outcome association in 100% and 87.5% of exposure definition comparisons for mirtazapine and citalopram respectively, while 12.5% of the comparisons for citalopram results in overestimation of the exposure-outcome associations.

conclusionsThe study provides results that have consistent clinical relevance. We have showed that a non-accurate construction of exposure time may lead to errors on outcome detection during exposed time, and consequently affect conclusions on safety or efficacy profile of a treatment.

Indexed as

Outcome Assessment, Health CareAmbulatory CareAntidepressive AgentsCitalopramDose-Response Relationship, DrugHospitalizationHumansMirtazapineRegistriesSwedenTime FactorsAntidepressive AgentsCitalopramMirtazapineDefined daily doseGapsOverlapsPharmacoepidemiologyTreatment durationTreatment episode

Identifiers

PMID31758215
OpenAlexW2991156213

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.