ArticleHealthcare (Basel, Switzerland)2021
Written Informed Consent-Translating into Plain Language. A Pilot Study.
Article in Healthcare (Basel, Switzerland), 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.
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
3 citing papers in PubMed.
- Understanding Informed Consent: A Cross-Sectional Study of Objective and Self-Perceived Comprehension in Romania.Healthcare (Basel, Switzerland) · 2026Article
- Literacy and Language Barriers to Overcome in Laboratory Medicine.Clinics in laboratory medicine · 2024Review
- Judicial and legislative practice and related suggestions on off-label drug use in China.BMC health services research · 2023Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundInformed consent is important in clinical practice, as a person's written consent is required prior to many medical interventions. Many informed consent forms fail to communicate simply and clearly. The aim of our study was to create an easy-to-understand form.
methodsOur assessment of a Polish-language plastic surgery informed consent form used the Polish-language comprehension analysis program (jasnopis.pl, SWPS University) to assess the readability of texts written for people of various education levels; and this enabled us to modify the form by shortening sentences and simplifying words. The form was re-assessed with the same software and subsequently given to 160 adult volunteers to assess the revised form's degree of difficulty or readability.
resultsThe first software analysis found the language was suitable for people with a university degree or higher education, and after revision and re-assessment became suitable for persons with 4-6 years of primary school education and above. Most study participants also assessed the form as completely comprehensible.
conclusionsThere are significant benefits possible for patients and practitioners by improving the comprehensibility of written informed consent forms.
Indexed as
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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.