Ethical research involving human subjects mandates that individual informed consent be obtained from research participants or from surrogates when participants are not able to consent for themselves. The existing requirements for informed consent assume that all study participants have personal autonomy; fully comprehend the purpose, risks, and benefits of the research; and volunteer for projects that disclose all relevant information. Yet contemporary examples of lapses in the individual informed consent process have been reported. The authors propose the use of community advisory boards, which can facilitate research by providing advice about the informed consent process and the design and implementation of research protocols. These activities could help reduce the number of individual informed consent lapses, benefiting study participants and the scientific integrity of the research in question.

Objective. To compare short-term and long-term effectiveness of the Arthritis Self-Help Course (ASHC) and the Chronic Disease Self-Management Program (CDSMP) for persons with arthritis concerning health care use, health-related quality of life, health behaviors, and arthritis self-efficacy. Methods. Forty-eight workshops were randomized to the ASHC (n ‫؍‬ 26) or CDSMP (n ‫؍‬ 22). A total of 416 individuals, including 365 African Americans, participated. The mean age for each group was 64 years, mean years of education was 11.7, mean number of chronic conditions was 4, and 75-80% of participants in each group were female. Multivariate statistical tests were used to assess effectiveness within and between programs for all workshop participants and African Americans. Results. At 4 months all ASHC participants including African Americans, had significant improvements (P < 0.05) in self-efficacy, stretching and strengthening exercises, aerobic exercises, and general health. All CDSMP participants had statistically significant improvements in self-efficacy, disability, pain, and general health. African American CDSMP participants showed statistically significant improvements in general health. Trends toward improvement (P ‫؍‬ 0.051-0.100) were shown in 5 variables among African American CDSMP participants and in 4 variables among all CDSMP participants. Statistically significant differences between the 2 programs at 4 months were seen in pain and disability in both groups. The CDSMP produced stronger results. Significant results at 1 year within and between programs were minimal for both groups. Conclusion. When populations with arthritis and multiple comorbid conditions are targeted, the CDSMP may be most cost effective.

We examined the effectiveness of 2 models of arthritis self-care intervention, the home study model and the small group model. The effects of disease diagnosis and duration, self-care behavior, perceived helplessness, social support, treatment choice, and formal education level on outcomes among persons with arthritis who participated in these programs were evaluated. A pretest-posttest control group design was utilized in the initial experimental study; comparison group designs were used in the longitudinal studies. Three hundred seventy-four subjects completed the interventions and 12 months of research followup. We found that the intervention models had a statistically significant positive impact on arthritis knowledge, selfcare behavior, perceived helplessness, and pain. These findings did not vary when the effects of education level, disease diagnosis and duration, informal social support, and treatment choice were controlled.

Objective. To determine the effectiveness of an intervention Tool Kit of arthritis self-management materials to be sent once through the mail, and to describe the populations reached. Methods. Spanish speakers (n ‫؍‬ 335), non-Hispanic English-speaking African Americans (n ‫؍‬ 156), and other nonHispanic English speakers (n ‫؍‬ 404) were recruited separately and randomized within each of the 3 ethnic/racial categories to immediately receive the intervention Tool Kit (n ‫؍‬ 458) or to a 4-month wait-list control status (n ‫؍‬ 463). At the end of 4 months, controls were sent the Tool Kit. All subjects were followed in a longitudinal study for 9 months. Self-administered measures included health status, health behavior, arthritis self-efficacy, medical care utilization, and demographic variables. Using analyses of covariance and t-tests, analyses were conducted for all participants and for Spanish-and English-language groups. Results. At 4 months, comparing all intervention subjects with randomized wait-list controls, there were significant (P < 0.01) benefits in all outcomes except medical care utilization and self-rated health. The results were maintained at 9 months compared with baseline. On average, the Tool Kit reached persons ages 50 -56 years with 12-15 years of schooling. There were few differences between English-and Spanish-language participants in either the effectiveness or reach variables. Conclusion. A mailed Arthritis Self-Management Tool Kit proved effective in improving health status, health behavior, and self-efficacy variables for up to 9 months. It also reached younger persons in both English-and Spanish-language groups and Spanish speakers with higher education levels than previous studies of the small-group Arthritis SelfManagement Program.

No abstract