Evidence map›Paper›PMID 25158932›Full record

ReviewTrials2014

The recording of adverse events from psychological treatments in clinical trials: evidence from a review of NIHR-funded trials.

Conor Duggan, Glenys Parry, Mary McMurran, Kate Davidson, Jane Dennis

Registry-linked trialAbstract readReview
PubMed Full text at PMC Publisher
In one paragraph

Review in Trials, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03730155 (Compassion Cultivation Training), which is not on this map. Cited by 63 papers, 10 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
63citing papers in PubMed, 10 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.

NCT03730155 nacompletednot on this mapstarted 2018, after this paper: background citation

Compassion Cultivation Training (CCT): A Preventive Intervention for Caregivers of People Who Suffer From a Mental Illness

TypeinterventionalSponsorUniversity of AarhusRan2018 to 2020Enrolled160ConditionsPsychological DistressArmsCCT intervention.
3 · Its place in the literature

Who cites it

63 citing papers in PubMed, 10 syntheses or guidelines pooled it.

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  10. Psychological therapies for treatment-resistant depression in adults.The Cochrane database of systematic reviews · 2018
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3 more citing papers are in PubMed but not listed here.

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

5 authors.

Conor DugganInstitute of Mental Health, University of Nottingham Innovation Park, Triumph Road, Nottingham NG7 2TU, UK. Conor.Duggan@Nottingham.ac.uk.
Glenys Parry
Mary McMurran
Kate Davidson
Jane Dennis

Funding

Department of Health 08/53/06Department of Health PB-PG-0408-15144
6 · The paper itself

Abstract

backgroundThere is a concern in the literature that harm from interventions is insufficiently documented in clinical trials in general, and in those assessing psychological treatments in particular. A recent decision by a trial steering committee to stop recruitment into a randomized controlled trial (RCT) of a psychological intervention for personality disorder led to an investigation of the recording of harm in trials funded by the National Institute for Health Research (NIHR).

methodsThe protocols and final reports of all 82 NIHR trials funded between 1995 and 2013 were examined for the reporting of adverse events. These were subdivided by category of intervention.

resultsNone of the psychological intervention trials mentioned the occurrence of an adverse event in their final report. Trials of drug treatments were more likely to mention adverse events in their protocols compared with those using psychological treatments. When adverse events were mentioned, the protocols of psychological interventions relied heavily on severe adverse events guidelines from the National Research Ethics Service (NRES), which were developed for drug rather than psychological interventions and so may not be appropriate for the latter.

conclusionsThis survey supported the belief that the reporting of adverse events in psychological treatments is weak and the criteria used may not be appropriate. Recommendations are made as to how current practice might be improved.

Indexed as

Clinical Trials as TopicPsychotherapyBiomedical TechnologyClinical ProtocolsHumans

Identifiers

PMID25158932
PMCPMC4152561

What OpenQuestion holds

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Registered trials

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.