Teaming up with the IRB: The Power of Collaboration.
Ontology highlight
ABSTRACT:
SUBMITTER: Wells RE
PROVIDER: S-EPMC8385691 | biostudies-literature | 2021
REPOSITORIES: biostudies-literature
Publications
Teaming up with the IRB: The Power of Collaboration.
Narrative inquiry in bioethics 20210101 1
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Project description:ObjectiveIncreased demand for quality primary care and value-based payment has prompted interest in implementing primary care teams. Evidence-based recommendations for implementing teams will be critical to successful PA participation. This study sought to describe how primary care providers (PCPs) define team membership boundaries and coordinate tasks.MethodsThis mixed-methods study included 28 PCPs from a primary care network. We analyzed survey data using descriptive statistics and interview data using content analysis.ResultsNinety-six percent of PCPs reported team membership. Team models fell into one of five categories. The predominant coordination mechanism differed by whether coordination was required in a visit or between visits.ConclusionsTeam-based primary care is a strategy for improving access to quality primary care. Most PCPs define team membership based on within-visit task interdependencies. Our findings suggest that team-based interventions can focus on clarifying team membership, increasing interaction between clinicians, and enhancing the electronic health record to facilitate between-visit coordination.
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Project description:Patient-centered outcomes research (PCOR) is becoming increasingly common. However, there is little evidence regarding what novel ethical challenges, if any, are posed by PCOR with relevance to institutional review board (IRB) oversight and human subjects protections. This article reports the results of a national survey of all IRB chairpersons from research-intensive institutions in the United States. Findings address the responsibilities of IRBs and the challenges associated with PCOR review and oversight. IRB chairpersons varied in their judgment of PCOR's overall value to the scientific enterprise and to research at their institution. Furthermore, 27% of respondents considered patients serving in nontraditional roles to be research subjects even when they are not enrolled in research. There was also variation in the training and safeguards their IRBs require for patient partners. Our results suggest that guidance should be developed around ethical and regulatory issues associated with PCOR oversight.
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Project description:Power analysis currently dominates sample size determination for experiments, particularly in grant and ethics applications. Yet, this focus could paradoxically result in suboptimal study design because publication biases towards studies with the largest effects can lead to the overestimation of effect sizes. In this Essay, we propose a paradigm shift towards better study designs that focus less on statistical power. We also advocate for (pre)registration and obligatory reporting of all results (regardless of statistical significance), better facilitation of team science and multi-institutional collaboration that incorporates heterogenization, and the use of prospective and living meta-analyses to generate generalizable results. Such changes could make science more effective and, potentially, more equitable, helping to cultivate better collaborations.
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Project description:Multi-site Institutional Review Board (IRB) review of clinical research projects is an important but complex and time-consuming activity that is hampered by disparate non-interoperable computer systems for management of IRB applications. This paper describes our work toward harmonizing the workflow and data model of IRB applications through the development of a software-as-a-service shared-IRB platform for five institutions in South Carolina. Several commonalities and differences were recognized across institutions and a core data model that included the data elements necessary for IRB applications across all institutions was identified. We extended and modified the system to support collaborative reviews of IRB proposals within routine workflows of participating IRBs. Overall about 80% of IRB application content was harmonized across all institutions, establishing the foundation for a streamlined cooperative review and reliance. Since going live in 2011, 49 applications that underwent cooperative reviews over a three year period were approved, with the majority involving 2 out of 5 institutions. We believe this effort will inform future work on a common IRB data model that will allow interoperability through a federated approach for sharing IRB reviews and decisions with the goal of promoting reliance across institutions in the translational research community at large.
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Project description:Inflammatory chemo- and cytokines and matrix-degrading proteases underlie the progression of osteoarthritis (OA). Aiming to define upstream regulators for these disease markers, we pursued initial evidence for an upregulation of members of the adhesion/growth-regulatory galectin family. Immunohistochemical localization of galectin-3 (Gal-3) in sections of human cartilage with increasing levels of degeneration revealed a linear correlation reaching a chondrocyte positivity of 60%. Presence in situ was cytoplasmic, in OA chondrocyte cultures the lectin was secreted and binding of Gal-3 yielded lactose-inhibitable surface staining. Exposure of cells to the lectin led to enhanced gene expression and secretion of functional disease markers. Genome-wide transcriptomic analysis broadened this insight to reveal a pro-degradative/inflammatory gene signature under the control of NF-κB. Fittingly, targeting this route of activation by inhibitors impaired the unfavourable response to Gal-3 binding, as also seen by shortening the lectin’s collagen-like repeat region. Gal-3’s activation profile overlaps with that of homodimeric galectin-1 (Gal-1) and also has distinctive (supplementing) features. Tested at subsaturating concentrations in a mixture, we found cooperation between the two galectins, apparently able to team up as driving forces in OA pathogenesis. In summary, our results suggest that a network of endogenous lectins acts as upstream master regulator in OA.
2017-02-09 | GSE85254 | GEO
Project description:Inflammatory chemo- and cytokines and matrix-degrading proteases underlie the progression of osteoarthritis (OA). Aiming to define upstream regulators for these disease markers, we pursued initial evidence for an upregulation of members of the adhesion/growth-regulatory galectin family. Immunohistochemical localization of galectin-3 (Gal-3) in sections of human cartilage with increasing levels of degeneration revealed a linear correlation reaching a chondrocyte positivity of 60%. Presence in situ was cytoplasmic, the lectin was secreted from OA chondrocytes in culture and binding of Gal-3 yielded lactose-inhibitable surface staining. Exposure of cells to the lectin led to enhanced gene expression and secretion of functional disease markers. Genome-wide transcriptomic analysis broadened this result to reveal a pro-degradative/inflammatory gene signature under the control of NF-κB. Fittingly, targeting this route of activation by inhibitors impaired the unfavourable response to Gal-3 binding, as also seen by shortening the lectin's collagen-like repeat region. Gal-3's activation profile overlaps with that of homodimeric galectin-1 (Gal-1) and also has distinctive (supplementing) features. Tested at subsaturating concentrations in a mixture, we found cooperation between the two galectins, apparently able to team up to promote OA pathogenesis. In summary, our results suggest that a network of endogenous lectins is relevant for initiating this process cascade.
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Project description:The number of hospital beds per capita, an important measure of equity in healthcare availability and resource allocation, was found to vary across geographic areas in many countries, including the USA. The hospital service areas (HSAs) have proven to be more meaningful spatial units for studying health-seeking behaviors and health resource allocation and service utilization. However, when evaluating the geographical balance in ratios of hospital beds to population (HBtP), no existing HSA delineation methods directly consider the underlying population distribution. Using Geographic Information Systems (GIS), this study incorporated the State Inpatient Database with census data to develop a population-based HSA delineation method. The census-derived HSAs were produced for Florida and were validated by aggregating and comparing with the traditional flow-based HSAs. The difference in current ratios of HBtP between the most over- and under-served HSAs was approximately 60 times. Significant clusters of high and low ratios were found in Miami and Jacksonville metropolitan areas, respectively. Such results may be of interest to relevant stakeholders and contribute to planning and optimization of hospital resource allocation and healthcare policy-making. Furthermore, the discovery of a strong correlation between the numbers of hospital discharges and the population at ZIP code level holds a remarkable potential for affordable population estimation, especially in non-census years.
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Project description:ObjectiveClinical research involving humans is critically important, but it is a lengthy and expensive process. Most studies require institutional review board (IRB) approval. Our objective is to identify predictors of delays or accelerations in the IRB review process and apply this knowledge to inform process change in an effort to improve IRB efficiency, transparency, consistency and communication.MethodsWe analyzed timelines of protocol submissions to determine protocol or IRB characteristics associated with different processing times. Our evaluation included single variable analysis to identify significant predictors of IRB processing time and machine learning methods to predict processing times through the IRB review system. Based on initial identified predictors, changes to IRB workflow and staffing procedures were instituted and we repeated our analysis.ResultsOur analysis identified several predictors of delays in the IRB review process including type of IRB review to be conducted, whether a protocol falls under Veteran's Administration purview and specific staff in charge of a protocol's review.ConclusionsWe have identified several predictors of delays in IRB protocol review processing times using statistical and machine learning methods. Application of this knowledge to process improvement efforts in two IRBs has led to increased efficiency in protocol review. The workflow and system enhancements that are being made support our four-part goal of improving IRB efficiency, consistency, transparency, and communication.
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Project description:BackgroundParticipatory research is particularly suitable in adressing know-do gaps in health systems. There is a disparity between what is known about the benefits of social participation and home care's responsibility to provide conditions amenable to older adults' social participation, and what is accomplished in home care practice. Home care workers are a large, low-power group, whose competences should be better harnessed. We carried out a participatory action research (PAR) project with the goal of generating an improved structure for identifying and alleviating loneliness. This article aims to explore the co-creative process of designing a work model that guides home care workers in supporting social participation among older care recipients.MethodsMultimodal data from 16 PAR workshops with 14 home care workers were described and explored through the 'recursive PAR process' and the 'framework for occupational enablement for change in community practice".ResultsThe PAR process is outlined through the objectives, activities, and work model, as well as enablement strategies employed throughout the PAR process; as are its opportunities, challenges and implications. The work model describes how care workers can act as discoverers of care recipients' unmet social needs, employ intentional communication, and link to relevant professions or community services to alleviate loneliness among older home care recipients.ConclusionsThis research process included opportunities of collaborating with enthusiastic and competent home care workers, but also challenges of moving between theory and practice and maintaining active participation between workshops. The resulting work model is in step with the requirements of elderly care, is unique in its field and could comprise a first step toward a more systematic approach of assessing and addressing loneliness. The vivid delineation of the PAR process provided in this paper can aid other researchers in navigating participatory research in home care contexts.
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