ArticleJCO oncology practice2023
Digitalizing the Clinical Research Informed Consent Process: Assessing the Participant Experience in Comparison With Traditional Paper-Based Methods.
Article in JCO oncology practice, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 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
4 citing papers in PubMed.
- Quality of Informed Consent via Telemedicine Compared With In-Person for Clinical Cancer Research.JCO oncology practice · 2026Article
- Article
- Assessment of readability of informed consent forms of gynecologic cancer clinical trials: A (Potential) barrier to enrollment?Gynecologic oncology reports · 2025Article
- Integrating clinical research into electronic health record workflows to support a learning health system.JAMIA open · 2024Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
11 authors.
Funding
Abstract
purposeConsent processes are critical for clinical care and research and may benefit from incorporating digital strategies. We compared an electronic informed consent (eIC) option to paper consent across four outcomes: (1) technology burden, (2) protocol comprehension, (3) participant agency (ability to self-advocate), and (4) completion of required document fields.
methodsWe assessed participant experience with eIC processes compared with traditional paper-based consenting using surveys and compared completeness of required fields, over 3 years (2019-2021). Participants who consented to a clinical trial at a large academic cancer center via paper or eIC were invited to either pre-COVID-19 pandemic survey 1 (technology burden) or intrapandemic survey 2 (comprehension and agency). Consent document completeness was assessed via electronic health records.
resultsOn survey 1, 83% of participants (n = 777) indicated eIC was easy or very easy to use; discomfort with technology overall was not correlated with discomfort using eIC. For survey 2, eIC (n = 262) and paper consenters (n = 193) had similar comprehension scores. All participants responded favorably to at least five of six agency statements; however, eIC generated a higher proportion of positive free-text comments (
conclusionOur findings suggest that eIC when compared with paper (1) did not increase technology burden, (2) supported comparable comprehension, (3) upheld key elements of participant agency, and (4) increased completion of mandatory consent fields. The results support a broader call for organizations to offer eIC for clinical research discussions to enhance the overall participant experience and increase the completeness of the consent process.
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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.