Community engagement is increasingly becoming an integral part of research. “Community-engaged research” (CEnR) introduces new stakeholders as well as unique challenges to the protection of participants and the integrity of the research process. We—a group of representatives of CTSA-funded institutions and others who share expertise in research ethics and CEnR—have identified gaps in the literature regarding (1) ethical issues unique to CEnR; (2) the particular instructional needs of academic investigators, community research partners, and IRB members; and (3) best practices for teaching research ethics. This paper presents what we know, as well as what we still need to learn, in order to develop quality research ethics educational materials tailored to the full range of stakeholder groups in CEnR.
Objectives
Targeted Training in Illness Management (TTIM) addresses serious mental illness and diabetes (DM) concurrently and is designed to improve psychiatric symptoms, functioning, general health and DM control. This 60-week, randomized controlled trial assessed TTIM vs. treatment as usual in 200 individuals with serious mental illness and diabetes.
Methods
Clinical Global Impression (CGI), Montgomery Asberg Depression Rating Scale (MADRS) and Brief Psychiatric Rating Scale (BPRS) assessed symptoms. Global Assessment of Functioning (GAF) and Sheehan Disability Scale (SDS) assessed functioning. Short-form 36 (SF-36) assessed general health and serum glycosylated hemoglobin (HbA1c) assessed DM.
Results
Average age was 52.7±9.5 years, 54% African-American. Psychiatric diagnoses were depression (48%), schizophrenia (25%) and bipolar disorder (28%). Baseline depressive severity was substantial while psychosis severity was modest. There was greater improvement at 60-weeks in TTIM for CGI (p=<.001) and MADRS (p=.016) and no difference on BPRS. There was greater TTIM improvement on GAF (p=.003) and an improvement trend on SDS (p=.086). There were no group differences on SF-36 or HbA1c means. Diabetes knowledge was significantly improved for TTIM vs. treatment as usual. In post-hoc analyses among individuals within recommended American Diabetes Association HbA1c targets adjusted for high comorbidity at baseline (53%), TTIM had minimal HbA1c 60-week change, while treatment as usual worsened.
Conclusions
TTIM was associated with improved psychiatric symptoms, functioning, and DM knowledge compared to treatment as usual. General health and DM did not significantly differ when analyzing the whole group, although there were post-hoc analysis differences among sub-groups based upon DM control at baseline.
SummaryBackground and objectives The objective of this study was to evaluate the association between neighborhood socioeconomic status and barriers to peritoneal dialysis eligibility and choice.
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