ArticleJournal of bioethical inquiry2026
Ethical and Linguistic Quality of Participant Information Sheets and Their Association with Recruitment Outcomes : An Empirical Bioethics Study of Clinical Trials.
Article in Journal of bioethical inquiry, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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
0 citing papers in PubMed.
No citing paper in PubMed yet.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
1 author.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Informed consent protects autonomy in clinical research, and it is often assumed that clearer Participant Information Sheets and Informed Consent Forms may also improve recruitment. This study examined whether the ethical and linguistic qualities of these documents are associated with accrual-related outcomes in industry-sponsored interventional trials. We conducted a retrospective analysis of ClinicalTrials.gov records with readable consent materials, operationalizing ethical clarity, linguistic comprehensibility, and cognitive burden using large language model-based extraction and quantitative text analysis. These measures were linked with trial status, enrolment, and operational duration. Across multinomial, binary, and competing risk models, none of the consent quality indicators predicted termination for poor accrual. Structural factors, particularly start year and enrolment capacity, showed much stronger associations with continuation or discontinuation. The findings suggest that recruitment failure reflects organizational and infrastructural constraints rather than shortcomings in consent communication. Ethically robust communication remains essential, but efforts to improve accrual should target structural conditions that support feasible trial delivery.
Indexed as
Identifiers
42821032What 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.