Informed consent for participation in studies with human subjects is a critically important aspect of clinical research, but research has shown that many potential subjects do not understand information relevant to their participation. A better understanding of factors related to participant understanding of study-related information is thus important. As part of a study to develop a new measure of health literacy, participants viewed a 50 second video in their preferred language (Spanish or English) of a clinician presenting informed consent information. They then responded to six questions about it. In progressively more complicated regression models, we evaluated the relation of demographic variables, general cognitive ability, and health literacy to participants' recall of the information. In a model that only included demographic variables, Spanish language, black race and older age were associated with poorer performance. In a model that included the effects of general cognitive ability and health literacy as well as demographics, education and health literacy were related to performance. Informed consent interventions that take potential research subjects' levels of health literacy into account may result in better understanding of research-related information that can inform their decision to participate.
HIV disease progression is associated with declining quality of life and overall health status, although most research in this domain has been conducted among Western populations where B is the infecting clade. This study sought to determine the effects of early-stage clade-C HIV infection (CD4 count ≥400 cells/mm3) on neurocognitive functioning, cognitive depression, and fatigue by comparing a matched sample of HIV-positive and HIV-negative Northern Indians. This study also examined the impact of these factors on quality of life within the HIV-positive individuals. HIV-positive participants demonstrated reduced cognitive functioning, increased fatigue, and lower quality of life. Fatigue and cognitive impairment interacted to negatively impact quality of life. Results suggest that early-stage HIV clade-C-infected individuals may experience subclinical symptoms, and further research is needed to explore the benefit of therapeutic interventions to ensure optimal clinical outcomes and maintain quality of life in this vulnerable population.
We sought to examine the course of adherence and cognition in HIV-infected individuals with either cocaine or heroin dependence and investigate independent predictors of cognition change. A prospective study over six months was undertaken in which adherence was measured by monthly electronic pill cap monitoring (Medication Event Monitoring System), while a comprehensive neuropsychological battery resulting in a composite score (NPZ8) was performed at baseline and six months. Multivariable regression models were performed in order to determine independent associations with change in cognition. There were 101 subjects at baseline, of whom 62% were male and 83% were non-Hispanic black. 46.6% of subjects at baseline had completed high school, 36.6% reported active cocaine use during the course of the study, and 0% reported active heroin use during the course of the study. 66 subjects completed the final cognitive assessment at six months. Subjects had markedly impaired cognitive function at baseline (NPZ8 -1.49) which persisted at six months (NPZ8 -1.47) in the group of study completers. There was an average monthly decrease in adherence of -2.91% overall (p = 0.008). In the multivariable model, each of the following variables: baseline cognition (R 2 change = 0.121, p = 0.006), cocaine use during the study (R 2 change = 0.059, p = 0.046), and monthly adherence change (R 2 change = 0.078, p = 0.018) independently contributed to NPZ8 change with an overall R 2 change = 0.219 (p = 0.001). This study shows an overall decrease in adherence over time in this population of subjects with a history of drug dependence. Active cocaine use, baseline cognition, and temporal adherence changes independently contributed to changes in cognition. Further study on enhancing adherence, cognition, and limiting drug abuse are warranted in this subgroup of HIV-infected individuals.
Given the high prevalence of HIV-associated neurocognitive disorders (HAND), we examined the performance of a novel computerized cognitive assessment device (NCAD) for the evaluation of neurocognitive impairment in the setting of HIV. In addition to a standard 8-test neuropsychological battery, each participant underwent testing with the NCAD, which requires approximately 20 min and has been shown to accurately measure neurocognition in elderly individuals. The NCAD yields seven subtest scores in addition to an overall predictive score that is calculated based on subtest results. Thirty-nine HIV-infected participants were included in this study; the majority of which (71.8 %) had undetectable plasma HIV RNA levels and a history of significant immunocompromise (median nadir CD4+ count 34 cells/μl). The mean composite neuropsychological score (NPT-8) was 46.07, and mean global deficit score (GDS) was 0.59. NCAD total subtest accuracy correlated significantly with NPT-8 (Pearson correlation r = 0.59, p & #lt; 0.0001) as well as GDS (Spearman’s rho = −0.36, p = 0.02). NCAD predictive score also correlated significantly with NPT-8 (Spearman’s rho = −0.5601, p = 0.0016) and GDS (Spearman’s rho = 0.45, p = 0.0144). When using the most recent nosology of HAND criteria for neurocognitive impairment, the area under the curve (AUC) for NCAD total subtest accuracy was 0.7562 (p = 0.012), while the AUC for the HIV dementia scale was 0.508 (p = 0.930). While not as comprehensive as a full neuropsychological battery, the NCAD shows promise as a rapid screening tool for HIV-infected individuals, and additional research of this device is indicated.
The soluble membrane attack complex (sMAC) represents the terminal product of the complement cascade. We enrolled 47 HIV + adults (12 of whom underwent a second visit at least 24 weeks after starting therapy) as well as 11 HIV negative controls. At baseline, cerebrospinal fluid (CSF) sMAC was detectable in 27.7% of HIV + individuals. CSF sMAC correlated with CSF HIV RNA levels and was more likely to be detectable in HIV + individuals on cART compared to HIV negative controls. In HIV + participants, there were negative association trends between sMAC and neurocognitive performance but these did not reach statistical significance.
by
Gayle G. Page;
Elizabeth Corwin;
Susan G. Dorsey;
Nancy S. Redeker;
Donna Jo McCloskey;
Joan K. Austin;
Barbara J. Guthrie;
Shirley M. Moore;
Debra Barton;
Miyong T. Kim;
Sharron L. Docherty;
Drenna Waldrop-Valverde;
Donald E. Bailey,Jr.;
Rachel F. Schiffman;
Angela Starkweather;
Teresa M. Ward;
Suzanne Bakken;
Kathleen T. Hickey;
Cynthia L. Renn;
Patricia Grady
Purpose: Biomarkers as common data elements (CDEs) are important for the characterization of biobehavioral symptoms given that once a biologic moderator or mediator is identified, biologically based strategies can be investigated for treatment efforts. Just as a symptom inventory reflects a symptom experience, a biomarker is an indicator of the symptom, though not the symptom per se. The purposes of this position paper are to (a) identify a “minimum set” of biomarkers for consideration as CDEs in symptom and self-management science, specifically biochemical biomarkers; (b) evaluate the benefits and limitations of such a limited array of biomarkers with implications for symptom science; (c) propose a strategy for the collection of the endorsed minimum set of biologic samples to be employed as CDEs for symptom science; and (d) conceptualize this minimum set of biomarkers consistent with National Institute of Nursing Research (NINR) symptoms of fatigue, depression, cognition, pain, and sleep disturbance.
Design and Methods: From May 2016 through January 2017, a working group consisting of a subset of the Directors of the NINR Centers of Excellence funded by P20 or P30 mechanisms and NINR staff met bimonthly via telephone to develop this position paper suggesting the addition of biomarkers as CDEs. The full group of Directors reviewed drafts, provided critiques and suggestions, recommended the minimum set of biomarkers, and approved the completed document. Best practices for selecting, identifying, and using biological CDEs as well as challenges to the use of biological CDEs for symptom and self-management science are described. Current platforms for sample outcome sharing are presented. Finally, biological CDEs for symptom and self-management science are proposed along with implications for future research and use of CDEs in these areas.
Findings: The recommended minimum set of biomarker CDEs include pro- and anti-inflammatory cytokines, a hypothalamic-pituitary-adrenal axis marker, cortisol, the neuropeptide brain-derived neurotrophic factor, and DNA polymorphisms. Conclusions: It is anticipated that this minimum set of biomarker CDEs will be refined as knowledge regarding biologic mechanisms underlying symptom and self-management science further develop. The incorporation of biological CDEs may provide insights into mechanisms of symptoms, effectiveness of proposed interventions, and applicability of chosen theoretical frameworks. Similarly, as for the previously suggested NINR CDEs for behavioral symptoms and self-management of chronic conditions, biological CDEs offer the potential for collaborative efforts that will strengthen symptom and self-management science.
Clinical Relevance: The use of biomarker CDEs in biobehavioral symptoms research will facilitate the reproducibility and generalizability of research findings and benefit symptom and self-management science.
In Argentina, providers' response to motivational interviewing (MI) to improve engagement and retention in care among challenging patients with HIV was evaluated. Twelve HIV care physicians participated, and their video recordings pre- and post-MI training were also obtained. One week post-training, 11 of the 12 participants were committed to using MI strategies during consult session. Of the 12 participants, 9 demonstrated appropriate utilization of MI techniques and change in HIV education provided during consultation (Z = -2.375, P =.018). Motivational interviewing appears to be a viable strategy to enhance engagement and retention in challenging HIV-positive patients.
Purpose: Chronic illness and low levels of health literacy affect health outcomes for many individuals, particularly older adults and racial/ethnic minorities. This study sought to understand the knowledge, strengths, and areas of need regarding self-management of chronic illness in order to lay the groundwork for content development of an intervention to increase health literacy and maximize patient engagement in chronic disease self-care.
Patients and methods: In-depth, qualitative interviews were conducted in Spanish and English with 25 older adults with various chronic illnesses. Topics included knowledge and understanding of chronic conditions, medications, and disease self-management skills. Qualitative data were coded by searching text and conducting cross-case analysis. An inductive analysis was then employed to allow for the patterns and themes to emerge.
Results: Emerged themes included 1) social support, 2) coping strategies, 3) spirituality, 4) chronic disease health literacy, 5) anger, and 6) depression. While participants had a general overall knowledge of chronic illness, they had deficits in knowledge regarding their own illnesses and medications.
Conclusion: Chronic illness self-management is a complex and dynamic behavioral process. This study identified themes that leverage patient motivation to engage in self-care in a personalized manner. This information will guide the development of an intervention to promote health literacy and optimal disease self-management.