Evidence map›Paper›PMID 35906006›Full record

ArticleEvidence-based mental health2022

Important adverse events to be evaluated in antidepressant trials and meta-analyses in depression: a large international preference study including patients and healthcare professionals.

Astrid Chevance, Anneka Tomlinson, Philippe Ravaud, Suzanne Touboul, Catherine Henshall, Viet-Thi Tran, Andrea Cipriani

Open access · hybridAbstract read
In one paragraph

Article in Evidence-based mental health, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 1 pooled it
5.6field-weighted citation impact, top 3% 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

10 citing papers in PubMed, 1 synthesis or guideline pooled it, 33 citations in OpenAlex.

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  9. What I stand for asBMJ mental health · 2023
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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 4 institutions in 3 countries.

Astrid ChevanceCRESS, INSERM, INRA, F-75004 Paris, France, University of Paris, Paris, France.ORCID 0000-0002-0852-4322
Anneka TomlinsonDepartment of Psychiatry, University of Oxford, Oxford, UK.
Philippe RavaudCRESS, INSERM, INRA, F-75004 Paris, France, University of Paris, Paris, France.
Suzanne TouboulPatient representative, University of Paris, Paris, France.
Catherine HenshallOxford Health NHS Foundation Trust, Warneford Hospital, Oxford, UK.ORCID 0000-0001-5659-3296
Viet-Thi TranCRESS, INSERM, INRA, F-75004 Paris, France, University of Paris, Paris, France.
Andrea CiprianiDepartment of Psychiatry, University of Oxford, Oxford, UK andrea.cipriani@psych.ox.ac.uk.ORCID 0000-0001-5179-8321
Inserm · FROxford Health NHS Foundation Trust · GBOxford Brookes University · GBUniversité Paris Cité · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundNon-serious adverse events (NSAEs) should be captured and reported because they can have a significant negative impact on patients and treatment adherence. However, the reporting of NSAEs in randomised controlled trials (RCTs) is limited.

objectiveTo identify the most important NSAEs of antidepressants for patients and clinicians, to be evaluated in RCTs and meta-analyses.

methodsWe conducted online international surveys in English, German and French, including (1) adults prescribed an antidepressant for a depressive episode and (2) healthcare professionals (HCPs) prescribing antidepressants. Participants ranked the 30 most frequent NSAEs reported in the scientific literature. We fitted logit models for sets of ranked items and calculated for each AE the probability to be ranked higher than the least important AE. We also identified additional patient-important AEs not included in the ranking task via open-ended questions.

findingsWe included 1631 patients from 44 different countries (1290 (79.1%) women, mean age 39.4 (SD 13), 289 (37.1%) with severe depression (PHQ-9 score ≥20)) and 281 HCPs (224 (79.7%) psychiatrists). The most important NSAEs for patients were insomnia (95.9%, 95% CI 95.2% to 96.5%), anxiety (95.2%, 95% CI 94.3% to 95.9%) and fatigue (94.6%, 95% CI 93.6% to 95.4%). The most important NSAEs for HCPs were sexual dysfunction (99.2%, 95% CI 98.5% to 99.6%), weight gain (98.9%, 95% CI 97.7% to 99.4%) and erectile problems (98.8%, 95% CI 97.7% to 99.4%). Participants reported 66 additional NSAEs, including emotional numbing (8.6%), trouble with concentration (7.6%) and irritability (6%).

conclusionsThese most important NSAEs should be systematically reported in antidepressant trials. CLINICAL IMPLICATIONS: The most important NSAEs should contribute to the core outcome set for harms in depression.

Indexed as

DepressionDepressive DisorderAdultAntidepressive AgentsAnxietyDelivery of Health CareFemaleHumansMaleAntidepressive Agentsadult psychiatrydepression & mood disorders

Identifiers

PMID35906006
PMCPMC9811084
OpenAlexW4288708859

What OpenQuestion holds

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LicenceCC BY
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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.