Evidence map›Paper›PMID 36327961›Full record

ArticlePsychiatry investigation2022

Clinical Data Interchange Standards in Clinical Trials on Alzheimer's Disease.

Riyoung Na, Jong Bin Bae, Sue Hyun Jung, Ki Woong Kim

Open access · diamondAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Psychiatry investigation, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact, top 82% 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

0 citing papers in PubMed, 0 citations in OpenAlex.

No citing paper in PubMed yet.

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

4 authors at 3 institutions in 1 country.

Riyoung NaRepublic of Korea National Institute of Dementia, Seoul, Republic of Korea.
Jong Bin BaeDepartment of Neuropsychiatry, Seoul National University Bundang Hospital, Seongnam, Republic of Korea.
Sue Hyun JungDepartment of Neuropsychiatry, Seoul National University Bundang Hospital, Seongnam, Republic of Korea.
Ki Woong KimRepublic of Korea National Institute of Dementia, Seoul, Republic of Korea.
Seoul National University Bundang Hospital · KRConvergence Research Center for Diagnosis Treatment and Care System of Dementia · KRSeoul National University · KR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveThe Clinical Data Interchange Standards Consortium (CDISC) proposed outcome measures for clinical trials on Alzheimer's disease (AD) in the Therapeutic Area User Guide for AD (TAUG-AD). To investigate how well the clinical trials on AD registered in the ClinicalTrials.gov complied with the recommendations on outcome measures by the CDISC.

methodsWe compared the outcome measures proposed in the TAUG-AD version 2.0.1 with those employed in the protocols of clinical trials on AD registered in ClinicalTrials.gov.

resultsWe analyzed 101 outcome measures from 305 protocols. The TAUG-AD listed ten scales for outcome measures of clinical trials on AD. The scales for cognition, activities of daily living, behavioral and psychological symptoms of dementia, and global severity listed in TAUG-AD were most frequently employed in the clinical trials on AD. However, TAUG-AD did not include any scale on quality of life. Also, several scales such as Montreal Cognitive Assessment, Alzheimer's Disease Cooperative Study-Activities of Daily Living, and Cohen- Mansfield Agitation Inventory not listed in the TAUG-AD were commonly employed in the clinical trials on AD and changed over time.

conclusionTo properly standardize the data from clinical trials on AD, the gap between the TAUG-AD and the measures employed in real-world clinical trials should be filled.

Indexed as

Alzheimer’s diseaseClinical Data Interchange Standards ConsortiumClinical trialsOutcome measures

Identifiers

PMID36327961
PMCPMC9633174
OpenAlexW4307113369

What OpenQuestion holds

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LicenceCC BY-NC
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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.