Informing the Uninformed Optimizing the Consent Message Using a Fractional Factorial Design Informing the Uninformed

Tait AR, Voepel-Lewis T, Nair VN, et al. — Mon, 13 May 2013 00:00:00 GMT

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.

Violence, Crime, and Abuse Exposure in a National Sample of Children and Youth An Update National Violence, Crime, and Abuse Exposure

Finkelhor D, Turner HA, Shattuck A, et al. — Mon, 13 May 2013 00:00:00 GMT

Importance

Because exposure to violence, crime, and abuse has been shown to have serious consequences on child development, physicians and policymakers need to know the kinds of exposure that occur at various developmental stages.

Objectives

To provide updated estimates of and trends for childhood exposure to a broad range of violence, crime, and abuse victimizations.

Design

The National Survey of Children's Exposure to Violence was based on a cross-sectional, US national telephone survey conducted in 2011.

Setting

Interviews by telephone.

Participants

The experiences of 4503 children and youth aged 1 month to 17 years were assessed by interviews with caregivers and with youth in the case of those aged 10 to 17 years.

Results

Two-fifths (41.2%) of children and youth experienced a physical assault in the last year, and 1 in 10 (10.1%) experienced an assault-related injury. Two percent experienced sexual assault or sexual abuse in the last year, but the rate was 10.7% for girls aged 14 to 17 years. More than 1 in 10 (13.7%) experienced maltreatment by a caregiver, including 3.7% who experienced physical abuse. Few significant changes could be detected in rates since an equivalent survey in 2008, but declines were documented in peer flashing, school bomb threats, juvenile sibling assault, and robbery and total property victimization.

Conclusions and Relevance

The variety and scope of children's exposure to violence, crime, and abuse suggest the need for better and more comprehensive tools in clinical and research settings for identifying these experiences and their effects.

JAMA Pediatrics: Pediatrics Topic Collection

Informing the Uninformed Optimizing the Consent Message Using a Fractional Factorial Design Informing the Uninformed

Violence, Crime, and Abuse Exposure in a National Sample of Children and Youth An Update National Violence, Crime, and Abuse Exposure