Evidence map›Paper›PMID 34457159›Full record

ArticleAMIA Joint Summits on Translational Science proceedings. AMIA Joint Summits on Translational Science

CONSIDER Statement: Consolidated Recommendations for Sharing Individual Participant Data from Human Clinical Studies.

Craig S Mayer, Nick Williams, Vojtech Huser

Abstract read
In one paragraph

Article in AMIA Joint Summits on Translational Science proceedings. AMIA Joint Summits on Translational Science. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–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

2 citing papers in PubMed.

  1. Article
  2. Review
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

3 authors.

Craig S MayerLister Hill National Center for Biomedical Communication, National Library of Medicine, NIH Bethesda, MD.
Nick WilliamsLister Hill National Center for Biomedical Communication, National Library of Medicine, NIH Bethesda, MD.
Vojtech HuserLister Hill National Center for Biomedical Communication, National Library of Medicine, NIH Bethesda, MD.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Many research sponsors require sharing of data from human clinical trials. We created the CONSIDER statement, a set of recommendations to improve data sharing practices and increase the availability and re-usability of individual participant data from clinical trials. We developed the recommendations by reviewing shared individual participant data and study artifacts from a set of completed studies, as well as study data deposited on ClinicalTrials.gov and on several data sharing platforms. The CONSIDER statement is comprised of seven sections including: format, data sharing, study design, case report forms, data dictionary, data de-identification and choice of data sharing platform. We developed several different forms of CONSIDER which includes a brief form (the checklist), a full form (detailed descriptions and examples), and a scoring methodology. The checklist can be used to evaluate adherence to various progressive data sharing recommendations. We are currently in Phase 2 of collecting feedback on the CONSIDER statement.

Indexed as

Information DisseminationResearch DesignChecklistHumans

Identifiers

PMID34457159
PMCPMC8378623

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.