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JAMA Pediatr. 2013 Jul;167(7):640-6. doi: 10.1001/jamapediatrics.2013.1385.

Informing the uninformed: optimizing the consent message using a fractional factorial design.

Author information

1
Department of Anesthesiology, University of Michigan, Ann Arbor, MI 48109, USA. atait@umich.edu

Abstract

IMPORTANCE:

Research information should be presented in a manner that promotes understanding. However, many parents and research subjects have difficulty understanding and making informed decisions.

OBJECTIVE:

To examine the effect of different communication strategies on parental understanding of research information.

DESIGN:

Observational study from January 2010 to June 2012 using a fractional factorial design.

SETTING:

Large tertiary care children's hospital.

PARTICIPANTS:

Six hundred forty parents of children scheduled for elective surgery.

INTERVENTIONS:

Parents 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.

RESULTS:

Main 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.

Comment in

PMID:
23700028
PMCID:
PMC3700595
DOI:
10.1001/jamapediatrics.2013.1385
[Indexed for MEDLINE]
Free PMC Article
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