Presenting Research Risks and Benefits to Parents: Does Format Matter?

BACKGROUND: Several studies suggest that many parents and research participants have poor understanding of the elements of consent, particularly the risks and benefits. However, some data suggest that the format and framing of research risks and benefits may be an important determinant of subject understanding. We examined the effect of tabular and graphical presentation of risks and benefits on parents' understanding of a research study. METHODS: Parents of children scheduled to undergo an elective surgical procedure (n = 408) were randomized to receive information about the risks and benefits of a sham study of postoperative pain control using text, tables, or pictographs and then completed a questionnaire to examine their gist (essential) and verbatim (actual) understanding of the information. Parent demographics were recorded and their literacy and numeracy skills measured. RESULTS: Parents randomized to receive information using tables or pictographs had significantly (P < 0.025) greater gist and verbatim understanding than did parents who received the information using standard text. Tables and pictographs were also superior to text in promoting understanding among parents with low numeracy and literacy skills. CONCLUSIONS: Many parents and patients have difficulty in assimilating and interpreting risk/benefit information for both research and treatment. This is due, in part, to the manner in which risks and benefits are communicated and to the literacy and numeracy abilities of the individual. The results of this study suggest a simple and practical method for enhancing understanding of risk/benefit statistics for parents with varying numeracy and literacy skills.

[1]  Victor H. Vroom,et al.  Predicting Leader behavior from a Measure of behavioral Intent , 1978 .

[2]  J. Cacioppo,et al.  The need for cognition. , 1982 .

[3]  C. F. Kao,et al.  The efficient assessment of need for cognition. , 1984, Journal of personality assessment.

[4]  David K. Simkin,et al.  An Information-Processing Analysis of Graph Perception , 1987 .

[5]  P. A. Kelly,et al.  Readability of pediatric biomedical research informed consent forms. , 1990, Pediatrics.

[6]  Improvement,et al.  Adult literacy in America : a first look at the results of the National Adult Literacy Survey , 1993 .

[7]  S. Inglis,et al.  The Effects of Providing Preoperative Statistical Anaesthetic-Risk Information , 1993, Anaesthesia and intensive care.

[8]  E. J. Mayeaux,et al.  Rapid estimate of adult literacy in medicine: a shortened screening instrument. , 1993, Family medicine.

[9]  Lisa M. Schwartz,et al.  The Role of Numeracy in Understanding the Benefit of Screening Mammography , 1997, Annals of Internal Medicine.

[10]  Ian Spence,et al.  Judging Proportion with Graphs: The Summation Model , 1998 .

[11]  J. G. Hollands,et al.  The visual communication of risk. , 1999, Journal of the National Cancer Institute. Monographs.

[12]  P. Slovic,et al.  Violence Risk Assessment and Risk Communication: The Effects of Using Actual Cases, Providing Instruction, and Employing Probability Versus Frequency Formats , 2000, Law and human behavior.

[13]  Michael D. Robinson,et al.  Simulation, Scenarios, and Emotional Appraisal: Testing the Convergence of Real and Imagined Reactions to Emotional Stimuli , 2001 .

[14]  B. Rimer,et al.  General Performance on a Numeracy Scale among Highly Educated Samples , 2001, Medical decision making : an international journal of the Society for Medical Decision Making.

[15]  Michael Theil,et al.  The role of translations of verbal into numerical probability expressions in risk management: a meta-analysis , 2002 .

[16]  Michael S Lauer,et al.  Readability of informed-consent forms. , 2003, The New England journal of medicine.

[17]  Terri Voepel-Lewis,et al.  Do They Understand? (Part I): Parental Consent for Children Participating in Clinical Anesthesia and Surgery Research , 2003, Anesthesiology.

[18]  T. Voepel-Lewis,et al.  Factors that influence parents' assessments of the risks and benefits of research involving their children. , 2004, Pediatrics.

[19]  J. Burkell,et al.  What are the chances? Evaluating risk and benefit information in consumer health materials. , 2004, Journal of the Medical Library Association : JMLA.

[20]  Roseann Barrett,et al.  Quality of informed consent: measuring understanding among participants in oncology clinical trials. , 2005, Oncology nursing forum.

[21]  D Feldman-Stewart,et al.  Communicating quality of life information to cancer patients: a study of six presentation formats. , 2005, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[22]  E. Winer,et al.  Understanding the decisions of cancer clinical trial participants to enter research studies: factors associated with informed consent, patient satisfaction, and decisional regret. , 2006, Patient education and counseling.

[23]  P. Ubel,et al.  Measuring Numeracy without a Math Test: Development of the Subjective Numeracy Scale , 2007, Medical decision making : an international journal of the Society for Medical Decision Making.

[24]  P. Ubel,et al.  Validation of the Subjective Numeracy Scale: Effects of Low Numeracy on Comprehension of Risk Communications and Utility Elicitations , 2007, Medical decision making : an international journal of the Society for Medical Decision Making.

[25]  P. Slovic,et al.  Numeracy skill and the communication, comprehension, and use of risk-benefit information. , 2007, Health affairs.

[26]  M. Brundage,et al.  Further Insight into the Perception of Quantitative Information: Judgments of Gist in Treatment Decisions , 2007, Medical decision making : an international journal of the Society for Medical Decision Making.

[27]  P. Ubel,et al.  The impact of the format of graphical presentation on health-related knowledge and treatment choices. , 2008, Patient education and counseling.

[28]  Robert Levine,et al.  Patient comprehension of an interactive, computer-based information program for cardiac catheterization: a comparison with standard information. , 2009, Archives of internal medicine.

[29]  B. Zikmund‐Fisher,et al.  The Effect of Format on Parents' Understanding of the Risks and Benefits of Clinical Research: A Comparison Between Text, Tables, and Graphics , 2010, Journal of health communication.