Evidence map›Paper›PMID 28895274›Full record

GuidelineBipolar disorders2017

Methodological recommendations for cognition trials in bipolar disorder by the International Society for Bipolar Disorders Targeting Cognition Task Force.

K W Miskowiak, K E Burdick, A Martinez-Aran, C M Bonnin, C R Bowie, A F Carvalho, P Gallagher, B Lafer, C López-Jaramillo, T Sumiyoshi and 8 more

Abstract readPractice Guideline
In one paragraph

Guideline in Bipolar disorders, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 82 papers, 9 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
82citing papers in PubMed, 9 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

82 citing papers in PubMed, 9 syntheses or guidelines pooled it.

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  14. Change in prefrontal activity and executive functions after action-based cognitive remediation in bipolar disorder: a randomized controlled trial.Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology · 2021
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22 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

18 authors.

K W MiskowiakCopenhagen Affective Disorder Research Centre, Psychiatric Centre Copenhagen, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.ORCID 0000-0003-2572-1384
K E BurdickDepartment of Psychiatry, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.
A Martinez-AranClinical Institute of Neuroscience, Hospital Clinic, University of Barcelona, IDIBAPS, CIBERSAM, Barcelona, Catalonia, Spain.ORCID 0000-0002-0623-6263
C M BonninClinical Institute of Neuroscience, Hospital Clinic, University of Barcelona, IDIBAPS, CIBERSAM, Barcelona, Catalonia, Spain.
C R BowieDepartment of Psychology, Queen's University, Kingston, Canada.
A F CarvalhoDepartment of Clinical Medicine, Federal University of Ceará, Fortaleza, Brazil.ORCID 0000-0001-5593-2778
P GallagherInstitute of Neuroscience, Newcastle University, Newcastle upon Tyne, UK.
B LaferBipolar Disorder Research Program, Institute of Psychiatry, University of São Paulo Medical School, São Paulo, Brazil.
C López-JaramilloResearch Group in Psychiatry, Department of Psychiatry, Universidad de Antioquia, Medellín, Colombia.
T SumiyoshiDepartment of Clinical Epidemiology, National Center of Neurology and Psychiatry, Tokyo, Japan.
R S McIntyreMood Disorders Psychopharmacology Unit, Brain and Cognition Discovery Foundation, University of Toronto, Toronto, Canada.ORCID 0000-0003-4733-2523
A SchafferDepartment of Psychiatry, University of Toronto, Toronto, Canada.
R J PorterDepartment of Psychological Medicine, University of Otago, Christchurch, New Zealand.
I J TorresDepartment of Psychiatry, University of British Columbia, Vancouver, Canada.
L N YathamDepartment of Psychiatry, University of British Columbia, Vancouver, Canada.
A H YoungDepartment of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.
L V KessingCopenhagen Affective Disorder Research Centre, Psychiatric Centre Copenhagen, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.ORCID 0000-0001-9377-9436
E VietaClinical Institute of Neuroscience, Hospital Clinic, University of Barcelona, IDIBAPS, CIBERSAM, Barcelona, Catalonia, Spain.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesTo aid the development of treatment for cognitive impairment in bipolar disorder, the International Society for Bipolar Disorders (ISBD) convened a task force to create a consensus-based guidance paper for the methodology and design of cognition trials in bipolar disorder.

methodsThe task force was launched in September 2016, consisting of 18 international experts from nine countries. A series of methodological issues were identified based on literature review and expert opinion. The issues were discussed and expanded upon in an initial face-to-face meeting, telephone conference call and email exchanges. Based upon these exchanges, recommendations were achieved.

resultsKey methodological challenges are: lack of consensus on how to screen for entry into cognitive treatment trials, define cognitive impairment, track efficacy, assess functional implications, and manage mood symptoms and concomitant medication. Task force recommendations are to: (i) enrich trials with objectively measured cognitively impaired patients; (ii) generally select a broad cognitive composite score as the primary outcome and a functional measure as a key secondary outcome; and (iii) include remitted or partly remitted patients. It is strongly encouraged that trials exclude patients with current substance or alcohol use disorders, neurological disease or unstable medical illness, and keep non-study medications stable. Additional methodological considerations include neuroimaging assessments, targeting of treatments to illness stage and using a multimodal approach.

conclusionsThis ISBD task force guidance paper provides the first consensus-based recommendations for cognition trials in bipolar disorder. Adherence to these recommendations will likely improve the sensitivity in detecting treatment efficacy in future trials and increase comparability between studies.

Indexed as

Bipolar DisorderCognition DisordersAdvisory CommitteesClinical Trials as TopicCognitionConsensusDisease ManagementHumansResearch DesignTreatment Outcomebipolar disordercognitive impairmentmethodologyrecommendationstreatment

Identifiers

PMID28895274
PMCPMC6282834

What OpenQuestion holds

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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.