Trial reportJAMA pediatrics2013
Informing the uninformed: optimizing the consent message using a fractional factorial design.
Trial report in JAMA pediatrics, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 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
10 citing papers in PubMed.
- Permission form synopses to improve parents' understanding of research: a randomized trial.Journal of perinatology : official journal of the California Perinatal Association · 2017Trial
- Improved participants' understanding of research information in real settings using the SIDCER informed consent form: a randomized-controlled informed consent study nested with eight clinical trials.European journal of clinical pharmacology · 2017Trial
- Review
- Article
- Distributive randomization: a pragmatic fractional factorial design to screen or evaluate multiple simultaneous interventions in a clinical trial.BMC medical research methodology · 2024Article
- Creating concise and readable patient information sheets for interventional studies in Australia: are we there yet?Trials · 2022Article
- Can we make informed consent forms more informative?Archives of disease in childhood. Fetal and neonatal edition · 2018Article
- Development of Plain Language Supplemental Materials for the Biobank Informed Consent Process.Journal of cancer education : the official journal of the American Association for Cancer Education · 2017Article
- Article
- Ensuring that informed consent is really an informed consent: Role of videography.Perspectives in clinical research · 2014Article
Corrections and comments
- Commented on by
Authors and funding
5 authors.
Funding
Abstract
importanceResearch information should be presented in a manner that promotes understanding. However, many parents and research subjects have difficulty understanding and making informed decisions.
objectiveTo examine the effect of different communication strategies on parental understanding of research information.
designObservational study from January 2010 to June 2012 using a fractional factorial design.
settingLarge tertiary care children's hospital.
participantsSix hundred forty parents of children scheduled for elective surgery.
interventionsParents were randomized to receive information about a hypothetical pain trial presented in 1 of 16 consent documents containing different combinations of 5 selected communication strategies (ie, length, readability, processability [formatting], graphical display, and supplemental verbal disclosure). MAIN OUTCOME AND MEASURES: Parents were interviewed to determine their understanding of the study elements (eg, protocol and alternatives) and their gist (main point) and verbatim (actual) understanding of the risks and benefits.
resultsMain effects for understanding were found for processability, readability, message length, use of graphics, and verbal discussion. Consent documents with high processability, eighth-grade reading level, and graphics resulted in significantly greater gist and verbatim understanding compared with forms without these attributes (mean difference, 0.57; 95% CI, 0.26-0.88, number of correct responses of 7 and mean difference, 0.54; 95% CI,0.20-0.88, number of correct responses of 4 for gist and verbatim, respectively). CONCLUSIONS AND RELEVANCE: Results identified several communication strategy combinations that improved parents' understanding of research information. Adoption of these active strategies by investigators, clinicians, institutional review boards, and study sponsors represents a simple, practical, and inexpensive means to optimize the consent message and enhance parental, participant, and patient understanding.
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.