Enhancing Stewardship of Community-Engaged Research Through Governance

Objectives. We explored the relationship of community-engaged research final approval type (tribal government, health board, or public health office (TG/HB); agency staff or advisory board; or individual or no community approval) with governance processes, productivity, and perceived outcomes.Methods. We identified 294 federally funded community-engaged research projects in 2009 from the National Institutes of Health’s Research Portfolio Online Reporting Tools, Centers for Disease Control and Prevention’s Prevention Research Centers, and Native American Research Centers for Health databases. Two hundred (68.0%) investigators completed a survey about governance processes and productivity measures; 312 partners (77.2% of 404 invited) and 138 investigators (69.0% of 200 invited) completed a survey about perceived outcomes.Results. Projects with TG/HB approval had increased likelihood of community control of resources (odds ratios [ORs] ≥ 4.80). Projects with other approvals had decreased likelihood of development or revision of institutional review board policies (ORs ≤ 0.37), having written agreements (ORs ≤ 0.17), and agreements about publishing (ORs ≤ 0.28), data use (ORs ≤ 0.17), and publishing approval (ORs ≤ 0.14).Conclusions. Community-engaged research projects with TG/HB approval had strong stewardship of project resources and agreements. Governance as stewardship protects community interests; thus, is an ethical imperative for communities, especially native communities, to adopt.Researchers working with native communities (American Indian, Alaska Native, and Native Hawaiian peoples), other racial/ethnic minority communities, or other communities facing disparities that experience similar mistrust for past research issues, health inequities (e.g., gays and lesbians or people with disabilities), or both, have advocated the use of participatory research to enhance community health.1–6 Such approaches include tribal participatory research, community-based participatory research, and participatory action research and are generally grouped as community-engaged research (CEnR). There is a continuum of engagement,7 but CEnR that involves collaborative partnership and shared leadership between community members and (academic) researchers in all phases of the research can build capacity of all partners, create research that benefits the community, and enhance translation of research findings to the community.8–13 These approaches have attraction because they can advance cocreation of the research, contribute culturally centered methods, and foster research capacity.1,2,14,15Although CEnR approaches have appeal, they still require governance to provide protection, oversight, guidance, legitimacy, and community benefit. Governance over CEnR is complex and involves numerous practices and policies.16,17 Historically, oversight responsibilities have been held by institutional review boards (IRBs) that uphold federal standards established by the Office for Human Research Protections.18,19 Use of IRBs (e.g., university IRBs or Indian Health Service IRBs) for research oversight characterizes governance as regulation as the focus is on balancing the needs of protection of individuals from harm while trying to foster scientific innovation. However, when research partners consider other functions of governance alongside legal regulation (e.g., use of tribal governments or community-based review boards), the quality of research can be strengthened and more attention paid to the benefits and harm of the research for the community.20–22In recent years, policymakers, CEnR researchers, and community organizations have advocated a broader perspective of governance, one that can be characterized as stewardship of research. Governance as stewardship enhances protection of the community, helps to foster research partnerships and appropriate access to and approval of research by community bodies, ensures benefit for the community, provides legitimacy of the research, shares responsibility for the research, provides community control, and builds research capacity in communities.20–23 For example, when native communities steward research, new patterns emerge between academic and community partners that might involve (1) community and academic partners requiring and committing to oversight by a tribal council or community board, (2) review boards or tribal governments insisting the that project demonstrate benefits to the community (not just individuals), (3) all partners committing to tribal ownership of the data, and (4) all partners working to use data and disseminate findings following tribal review.2,24–27Although nontribal communities do not have a tribal council for formal governance, they establish various governance mechanisms such as oversight by faith-based networks or leaders, health boards or public health offices, project advisory boards, or community partner boards.21,28–30 Stewardship by these governing entities may involve (1) academic partners that engage in collaboration with the community to produce the research, (2) projects that use culturally relevant research designs and instruments to enhance the quality of the research, (3) projects that hire community members on research projects to build research capacity, and (4) academic partners that encourage community engagement and participation.2–4,21,28 In both native and nonnative communities, stewardship practices lead to enhanced trust of the research process by community partners, relationships that balance community and academic institutional power, IRB processes that reflect community interests and not just biomedical interests, inclusion of cultural frameworks that fit the community, and academic members committed to community engagement.21,28,31Enhancing stewardship of research through governance has focused on several activities. First, increasingly, native and nonnative communities are asserting their roles in overseeing research by developing community IRBs and other forms of research oversight.23,32,33 Second, research review can protect community knowledge by establishing protocols for oversight and can affirm tribal or community authority to approve and guide research that will benefit the community.21,22,28–30,33,34 Third, the National Congress of American Indians35–37 asserts that tribes, as sovereign nations, have regulatory authority over research that takes place on tribal lands and with tribal citizens. Several tribes have exercised governance by establishing research codes, research review boards, and formal agreements with research institutions, and some intertribal entities have established research oversight in urban and cross-tribal regions.33,38Despite the expanded view of ethical issues within CEnR projects and an upsurge in community governance expectations from communities and some funders, there has been little research that has examined the role of governance in research specifically, as well as concerns that these processes might inhibit research. Some researchers and policy analysts suggest that tribal research review is perceived as slowing or blocking research development and dissemination.25,35 A tension related to data ownership to ensure risks and benefits are considered for communities, individual research participants, and research funders also exists.What has been lacking in these discussions to date has been research about the associations of governance with agreements, control of resources, productivity, and perceived outcomes of CEnR. Agreements are the accepted standards or protocols for the research partnership such as mission and objectives, group dynamics, and dissemination.12,39 Control of resources is whether the community, academic institution, or both hire personnel and manage project resources.12,40 Research productivity measures include garnering funding, disseminating scholarship, developing new measures centered in cultural or community perspectives, and establishing new research regulation.3,23,28,30 These measures are important as the need to generate, disseminate, and regulate new knowledge and practices are core goals of funding agencies and, to a lesser extent, communities.Perceived outcomes of CEnR focus on the contributions to health, and encompass changes in power relations, sustainability, community transformation, improved health of the community, and capacity building for individuals and agencies.12 These outcomes are important as they are health outcomes or factors that enhance public health. Ultimately, the success of a CEnR project is determined by research productivity and improvement of health outcomes.The notion of governance also has often been a source of mystery and conflict in research partnerships. We sought to foster understanding and provide context around governance as “stewardship” in research partnerships in both native and nonnative communities by focusing on the type of final approval of CEnR—the body or individual who endorsed and approved the project on behalf of the community and allowed it to continue. This approval is a key factor for legitimacy, community involvement, oversight, and guidance of the project.26,35 Furthermore, the type of approval has not been studied, whereas the general oversight of research ethics through community or tribal IRBs has garnered recent research focus.21,33,38 Examining the type of approval allows an exploration of how governance as stewardship balances needs for authority and accountability, control and capacity building, and protection and benefits.     

Global Analysis of Methylation Profiles From High Resolution CpG Data

New high throughput technologies are now enabling simultaneous epigenetic profiling of DNA methylation at hundreds of thousands of CpGs across the genome. A problem of considerable practical interest is identification of large scale, global changes in methylation that are associated with environmental variables, clinical outcomes, or other experimental conditions. However, there has been little statistical research on methods for global methylation analysis using technologies with individual CpG resolution. To address this critical gap in the literature, we develop a new strategy for global analysis of methylation profiles using a functional regression approach wherein we approximate either the density or the cumulative distribution function (CDF) of the methylation values for each individual using B‐spline basis functions. The spline coefficients for each individual are allowed to summarize the individual's overall methylation profile. We then test for association between the overall distribution and a continuous or dichotomous outcome variable using a variance component score test that naturally accommodates the correlation between spline coefficients. Simulations indicate that our proposed approach has desirable power while protecting type I error. The method was applied to detect methylation differences, both genome wide and at LINE1 elements, between the blood samples from rheumatoid arthritis patients and healthy controls and to detect the epigenetic changes of human hepatocarcinogenesis in the context of alcohol abuse and hepatitis C virus infection. A free implementation of our methods in the R language is available in the Global Analysis of Methylation Profiles (GAMP) package at http://research.fhcrc.org/wu/en.html .     

Post-acute care referral and inpatient rehabilitation admission criteria for persons with brain injury across two Canadian provinces

Purpose: Investigate health care providers’ perceptions of referral and admission criteria to brain injury inpatient rehabilitation in two Canadian provinces.

Methods: Health care providers (n?=?345) from brain injury programs (13 acute care and 16 rehabilitation facilities) participated in a cross-sectional web-based survey. The participants rated the likelihood of patients (traumatic brain injury and cerebral hypoxia) to be referred/admitted to rehabilitation and the influence of 19 additional factors (e.g., tracheostomy). The participants reported the perceived usefulness of referral/admission policies and assessment tools used.

Results: Ninety-one percent acute care and 98% rehabilitation participants reported the person with traumatic brain injury would likely or very likely be referred/admitted to rehabilitation compared to respectively 43% and 53% for the patient with hypoxia. Two additional factors significantly decreased the likelihood of referral/admission: older age and the combined presence of minimal learning ability, memory impairment and physical aggression. Some significant inter-provincial variations in the perceived referral/admission procedure were observed. Most participants reported policies were helpful. Similar assessment tools were used in acute care and rehabilitation.

Conclusions: Health care providers appear to consider various factors when making decisions regarding referral and admission to rehabilitation. Variations in the perceived likelihood of referral/admission suggest a need for standardized referral/admission practices.

• Implications for Rehabilitation

• Various patient characteristics influence clinicians’ decisions when selecting appropriate candidates for inpatient rehabilitation.

• In this study, acute care clinicians were less likely to refer patients that their rehabilitation counter parts would likely have admitted and a patient with hypoxic brain injury was less likely to be referred or admitted in rehabilitation than a patient with a traumatic brain injury.

• Such discrepancies suggest that policy-makers, managers and clinicians should work together to develop and implement more standardized referral practices and more specific admission criteria in order to ensure equitable access to brain injury rehabilitation services.

     

Bioelectrical impedance analysis and other hydration parameters as risk factors for delirium in rural nursing home residents

BACKGROUND: The study investigators conducted a vigorous screening protocol for delirium in rural long-term care (LTC) facilities for a period of 28 days focusing on Bioelectrical Impedance Analysis (BIA) and other hydration parameters as risk factors. METHODS: A two-stage cluster sampling procedure was used to randomly select participants (n = 313) from 13 LTC facilities located in southeastern Iowa, stratified on facility bed size. BIA was used to estimate intracellular water (ICW), extracellular water (ECW), and total body water (TBW) on four occasions--baseline and follow-up days 7, 14, and 28. Volume estimates were calculated as a percent of body weight (%WT). Serum electrolytes and hematology were also measured. Delirium was measured with four strict criteria: a NEECHAM Confusion Scale score < 25, Vigilance "A" score > 2, a Mini-Mental Status Examination < baseline, and a positive Confusion Assessment Method score. RESULTS: There were n = 69 delirium cases (22.0%). Blood urea nitrogen/creatinine ratios greater than 21:1 (odds ratio = 1.76, 95% confidence interval 1.02-3.06). No significant risk for delirium was associated with ICW, ECW, or TBW as a percent of body weight. CONCLUSIONS: Some changes were observed with a slight decrease in ICW between day 7 and day 14 of follow-up that tended to follow an increase in delirium events, but in general the BIA measures did not predict delirium events.     

A meta-analysis of genome-wide linkage scans for hypertension: the National Heart,Lung and Blood Institute Family Blood Pressure Program

bACKGROUND: Four multicenter Networks (GenNet, GENOA, HyperGEN, SAPPHIRe) form the National Heart, Lung and Blood Institute Family Blood Pressure Program (FBPP), to search for hypertension/blood pressure (BP) genes. The networks used different family designs and targeted multiple ethnic groups, using standardized protocols and definitions. Linkage genome scans were done on samples within each network (N = 6245 relatives). METHODS: The evidence was synthesized using meta-analysis. RESULTS: Combining ethnic groups, no region reached LOD >2, but several small peaks were identified, including chromosome 2p where two other recent reports find hypertension linkage. CONCLUSIONS: No regions show uniformly large effects on BP/hypertension in all populations.     

An analysis of an older driver evaluation program

OBJECTIVES: To identify elements of an older driver evaluation program that predict driving performance in older adults. SETTING: Outpatient medical clinic in an academic medical center. DESIGN: A retrospective analysis. PARTICIPANTS: Six hundred sixty-four older adults who were referred to an older driver evaluation program. MEASUREMENTS: A physician trained in geriatric medicine and a clinical geriatric nurse specialist oversaw an experienced driving evaluator and an occupational therapist who conducted assessments of older persons' functional status; reaction time; driving skills; and cognitive, hearing, and vision abilities. Self-report data along with a medical history submitted by patients' primary care physicians supplemented the clinical assessments. RESULTS: A multinomial logistic regression revealed that the Mini-Mental State Examination (MMSE), cues needed with the Trail Making Test, Part B, grip strength, and an interaction effect between the MMSE and reaction time constituted the most parsimonious model for predicting on-the-road performance. A receiver operating characteristic analysis indicated that this index had good sensitivity but low specificity. A binomial regression comparing imperfect and perfect drivers demonstrated the significance of the Traffic Sign and Visual Perception tests. CONCLUSION: Clinicians should employ a multilevel screening process that includes initial cognitive tests, such as the MMSE and the Trail Making Test, Part B, although more studies of driving evaluation programs in medical settings that include random samples of older drivers are needed.     

Salivary alpha‐amylase during pregnancy: Diurnal course and associations with obstetric history,maternal demographics,and mood

Diurnal patterns of salivary alpha amylase (sAA) in pregnant women have not previously been described. The current study employed ecological momentary assessment to examine the association between the diurnal sAA, obstetric history, maternal demographics, and mood during pregnancy. Saliva was self‐collected by 83 pregnant women (89% White, age 25.3–43.0 years; mean gestational age 21.9 weeks, range 6–37 weeks; gravida 1–6) at home over three days. Results indicated that current pregnancy (gestational age and fetal sex) and maternal demographics were not related to diurnal sAA. In contrast, a history of previous miscarriage (Parameter = ?.17; SE = .05; p < .05) was associated with an atypical diurnal pattern. Even after accounting for obstetric history, trait anxiety (Parameter = .16; SE = .04; p < .001) was associated with increased sAA over the day while chronic levels of fatigue (Parameter = ?.06; SE = .03; p < .05) were associated with decreased sAA. In a separate model, we also tested the time varying covariation of sAA and mood. The effects of momentary mood were in contrast to those for trait mood. Both momentary depression (Parameter = .22; SE = .09; p < .01) and vigour/positive mood (Parameter = .12; SE = .04; p < .001) were associated with momentary increases in sAA while momentary anxiety and fatigue were not related to sAA. The findings suggest that basal sAA during pregnancy is sensitive to emotional arousal. Evaluating diurnal patterns of sAA holds promise for advancing understanding of how emotional arousal during pregnancy may affect fetal development. © 2012 Wiley Periodicals, Inc. Dev Psychobiol 55: 156–167, 2013