A pragmatic randomized trial comparing tablet computer informed consent to traditional paper-based methods for an osteoporosis study.

OBJECTIVE: Methods 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. METHODS: Nine 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. RESULTS: The 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]. CONCLUSIONS: Although, 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.

Barriers and benefits to leisure-time physical activity among older Mexican Americans.

OBJECTIVE: To identify the perceived barriers to and benefits of leisure-time physical activity among older Mexican Americans (MA) and European Americans (EA). DESIGN: Cross-sectional survey using in-home interviews of subjects. SETTING: Subjects recruited from 10 family practice offices in South Texas that are part of a practice-based research network. PARTICIPANTS: Two hundred ten MA and EA adults, aged 60 years and older, interviewed between April 1994 and April 1996. MEASUREMENTS: The perceived benefits and barriers summary score from the San Diego Health and Exercise Questionnaire, the Minnesota Leisure Time Physical Activity Questionnaire, body mass index, chronic diseases, depressive symptoms, and demographics. MAIN RESULTS: Older MA reported greater perceived benefits to physical activity and fewer perceived barriers than older MA while having lower levels of habitual physical activity. Lower levels of education, male sex, higher body mass index, and older age were also associated with lower levels of habitual physical activity. CONCLUSIONS: Although MA reported lower levels of physical activity, they perceived greater benefits and fewer barriers to physical activity. These attitudes about physical activity held by older MA may present an opportunity to encourage greater levels of physical activity throughout this population.

Body fatness and increased injury rates in high school football linemen.

OBJECTIVE: To determine whether associations exist between body fatness and injury rates in high school football linemen. DESIGN: Prospective, injury surveillance study during a 2-week preseason and 10-week regular season. SETTING: 10 public high schools in Texas. PARTICIPANTS: Two hundred fifteen varsity and junior varsity high school football linemen. MAIN OUTCOME MEASURES: Injury rates (injuries per 1000 hours of playing time) for groups of players above a given body fat level and at or below a given body fat level. Rates were computed as the number of injuries per group divided by the group's aggregate playing time (practice + game time). The null hypothesis was that there is no difference in injury rates between players above a given level of body fat and those at or below that level of body fat. Body fat was determined from chest, abdomen, and thigh skinfold measurements using standard conversion equations. Body mass index (BMI) (kg/m2) was also calculated for each player. RESULTS: The overall injury rate was 5.66 injuries per 1000 hours of playing time. Percent body fat ranged from 9.3% to 40.2%. BMI ranged from 19.9 to 46.6 kg/m2. Sixty-seven players sustained 86 injuries, the most common of which were ankle sprains and medial collateral ligament sprains. No difference in overall injury rates between higher and lower fat groups was seen at any body fat level. Players in higher body fat groups, however, had significantly greater lower extremity injury rates than did players in lower fat groups between 18% and 27% body fat and again 32% to 33%, but not at intermediate levels or >33%. Players in higher BMI groups had significantly greater lower extremity injury rates than did players in lower BMI groups throughout the range from 24 to 36 kg/m2, except at 34 kg/m2. CONCLUSION: Both higher body fatness and BMI were associated with increased rates of lower extremity injury among high school football linemen. BMI appears to be associated more consistently with increased lower extremity injury rates than is body fat.