ArticleJournal of clinical epidemiology2021
An international core outcome set for evaluating interventions to improve informed consent to clinical trials: The ELICIT Study.
Article in Journal of clinical epidemiology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers, 3 of them syntheses that pooled 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.
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.
Who cites it
9 citing papers in PubMed, 3 syntheses or guidelines pooled it.
- Operationalizing and Measuring Informed Choice in Health Care: An Umbrella Review.Medical decision making : an international journal of the Society for Medical Decision Making · 2026Pooled it
- Pooled it
- Decision aids for people considering taking part in clinical trials.The Cochrane database of systematic reviews · 2015Pooled it
- A meta-review of patient engagement, shared decision-making, and factors influencing equity-deserving populations' participation in clinical trials.Research involvement and engagement · 2026Review
- Core Measure Set for Patient Safety in Perioperative Care: A Clinical Practice-Oriented Consensus Study.International journal of public health · 2026Article
- Critical outcomes to be included in the Core Outcome Set for nutritional intervention studies in older adults with malnutrition or at risk of malnutrition: a modified Delphi Study.European journal of clinical nutrition · 2024Article
- Evaluation of CTRL: a web application for dynamic consent and engagement with individuals involved in a cardiovascular genetic disorders cohort.European journal of human genetics : EJHG · 2024Article
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Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors.
Funding
Abstract
objectiveTo develop a core outcome set for the evaluation of interventions that aim to improve how people make decisions about whether to participate in randomized controlled trials (of healthcare interventions), the ELICIT Study. STUDY
designInternational mixed-method study involving a systematic review of existing outcomes, semi-structured interviews, an online Delphi survey, and a face-to-face consensus meeting.
resultsThe literature review and stakeholder interviews (n = 25) initially identified 1045 reported outcomes that were grouped into 40 individually distinct outcomes. These 40 outcomes were scored for importance in two rounds of an online Delphi survey (n = 79), with 18 people attending the consensus meeting. Consensus was reached on 12 core outcomes: therapeutic misconception; comfort with decision; authenticity of decision; communication about the trial; empowerment; sense of altruism; equipoise; knowledge; salience of questions; understanding, how helpful the process was for decision making; and trial attrition.
conclusionThe ELICIT core outcome set is the first internationally agreed minimum set of outcomes deemed essential to be measured in all future studies evaluating interventions to improve decisions about participating in an randomized controlled trial. Use of the ELICIT core set will ensure that results from these trials are comparable and relevant to all stakeholders. REGISTRATION: COMET database - http://www.comet-initiative.org/Studies/Details/595.
Indexed as
Identifiers
What OpenQuestion holds
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.