ArticleContemporary clinical trials communications2016
A pragmatic randomized trial comparing tablet computer informed consent to traditional paper-based methods for an osteoporosis study.
Article in Contemporary clinical trials communications, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 22 papers, 2 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
22 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Comparative Effectiveness of eConsent: Systematic Review.Journal of medical Internet research · 2023Pooled it
- Implementation of Electronic Informed Consent in Biomedical Research and Stakeholders' Perspectives: Systematic Review.Journal of medical Internet research · 2020Pooled it
- Comparing in-person and remote consent of people with dementia into a primary care-based cluster randomised controlled trial: lessons from the Dementia PersonAlised Care Team (D-PACT) feasibility study.BMC medical research methodology · 2025Trial
- Assessing the feasibility of the Effectiveness of Discontinuing Bisphosphonates trial: a pilot study.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2017Trial
- Article
- A pilot study to explore utility of electronic informed consent in a low- income setting; the case of a Controlled human infection study in Blantyre, Malawi.Wellcome open research · 2024Article
- Testing and Practical Implementation of a User-Friendly Personalized and Long-Term Electronic Informed Consent Prototype in Clinical Research: Mixed Methods Study.Journal of medical Internet research · 2023Article
- Developing a digital informed consent app: opportunities and challenges of a new format to inform and obtain consent in public health research.BMC medical ethics · 2023Article
- Patient Perspectives and Preferences for Consent in the Digital Health Context: State-of-the-art Literature Review.Journal of medical Internet research · 2023Review
- Participant comprehension and perspectives regarding the convenience, security, and satisfaction with teleconsent compared to in-person consent: A parallel-group pilot study among Danish citizens.Contemporary clinical trials communications · 2022Article
- Comparing a Multimedia Digital Informed Consent Tool With Traditional Paper-Based Methods: Randomized Controlled Trial.JMIR formative research · 2021Article
- Development of a multi-component intervention to promote participation of Black and Latinx individuals in biomedical research.Journal of clinical and translational science · 2021Article
- Electronic consenting for conducting research remotely: A review of current practice and key recommendations for using e-consenting.International journal of medical informatics · 2020Review
- Key components and IT assistance of participant management in clinical research: a scoping review.JAMIA open · 2020Article
- A REDCap-based model for electronic consent (eConsent): Moving toward a more personalized consent.Journal of clinical and translational science · 2020Article
- Replacing Paper Informed Consent with Electronic Informed Consent for Research in Academic Medical Centers: A Scoping Review.AMIA Joint Summits on Translational Science proceedings. AMIA Joint Summits on Translational Science · 2020Article
- Pragmatic Clinical Trials in Osteoporosis.Current osteoporosis reports · 2019Review
- Tools and Methods for Real-World Evidence Generation: Pragmatic Trials, Electronic Consent, and Data Linkages.Rheumatic diseases clinics of North America · 2019Review
- Improving the Informed Consent Process in Hematopoietic Cell Transplantation: Patient, Caregiver, and Provider Perspectives.Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation · 2018Article
- Personalized and longitudinal electronic informed consent in clinical trials: How to move the needle?Digital healthArticle
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
12 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveMethods to improve informed consent efficiency and effectiveness are needed for pragmatic clinical trials. We compared informed consent using a tablet computer to a paper approach to assess comprehension and satisfaction of patients and clinic staff for a future osteoporosis clinical trial.
methodsNine community-based practices identified and recruited patients to compare the informed consent processes (tablet vs. paper) in a mock osteoporosis clinical trial. The tablet informed consent included an animation summarizing the trial, complete informed consent document, and questions to assess and reinforce comprehension of the study. Participants were women age ≥55 years with ≥1 year of alendronate use. We surveyed participants to assess comprehension and satisfaction and office staff for satisfaction and perceived time demands.
resultsThe nine practices enrolled 33 participants. There was not a significant difference in comprehension between the tablet vs. paper informed consent [mean (SD) tablet: 12.2 (1.0) vs. paper: 11.4 (1.7)]. Office staff preferred the tablet to the paper informed consent for identifying potential study participants (two-sided t-test p = 0.02) despite an increased perceived time spent to complete the tablet process [tablet: 28.3 min (SD 16.3) vs. paper: 19.0 min (SD 6.9); p = 0.08].
conclusionsAlthough, there were no significant differences in participant satisfaction and comprehension with the tablet informed consent compared to a paper informed consent, patients and office staff trended towards greater satisfaction with the tablet informed consent. Larger studies are needed to further evaluate the utility of electronic informed consent in pragmatic clinical trials.
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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.