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Enhancing Institutional Research Capacity: Results and Lessons from a Pilot Project Program.

ABSTRACT: The National Institutes of Health (NIH) established the Building University Infrastructure Leading to Diversity (BUILD) initiative to increase engagement and retention of undergraduates from diverse backgrounds in biomedical research. Portland State University, in partnership with ten other academic institutions, received a BUILD award and developed the BUILD EXITO (Enhancing Cross-Disciplinary Infrastructure and Training at Oregon) project. The EXITO program offers a three-year research and mentorship experience for undergraduates in biomedical, behavioral, social science, clinical, and bioengineering disciplines. The BUILD initiative also emphasizes enhancing research capacity and infrastructure through institutional change and faculty development. A key piece of EXITO's program to enhance research capacity is offering faculty an opportunity to apply for up to $50,000 of funding to carry out a one-year pilot study. We conducted two separate RFAs for this purpose, closely modeled on NIH's Small Grant Program (R03), over two years. Principal Investigators of pilot projects were encouraged to include EXITO students, or other undergraduate students, on their research teams. Students then worked on these research projects as part of EXITO's intensive mentored research program. This paper reports on methods to conduct and implement a pilot project program intended to train primarily junior faculty members to write and submit an NIH proposal and fund successful applicants to gather pilot project data to aid in applying for future proposals. We provided a step-by-step rigorous submission and review process. We provided proposal writing and revising workshops, technical support, and helped pilot project Principal Investigators (PIs) with biosketches, IRB applications, IUCUC documents, budgets, and other proposal sections. We secured at least three external (not at any BUILD EXITO institution) reviewers for each proposal. PIs revised proposals before resubmitting and receiving their final scores. Across two RFAs, we provided funds twenty PIs to conduct pilot projects; these projects included at least 21 students working on them who received mentoring in research methods and in disseminating results. This paper describes important lessons learned, including the importance of: allotting sufficient time to recruit reviewers; recruiting reviewers through a variety of sources and methods; and assisting PIs in engaging with research administration staff at Portland State University and partner institutions. Challenges included: finding an optimal timeline that was neither too compressed nor too stretched out; encouraging applicants from distant partner institutions to apply and keeping them engaged and retained through the entire process; and assisting PIs from partner institutions to efficiently utilize Portland State University's sponsored projects department if similar resources were not available at their home institutions. Our goal is to provide guidance and insights to faculty and research-administration staff at other institutions interested in replicating or adapting EXITO's program to enhance institutional research capacity.

SUBMITTER: Bienen L

PROVIDER: S-EPMC8455099 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BACKGROUND:The Korean Undiagnosed Diseases Program (KUDP) was launched in January 2017 as a one-year pilot project to address the increasing global interest in patients with undiagnosed rare diseases. The purpose of this paper is to summarize the project results and emphasize the unmet research needs among patients with undiagnosed rare diseases in Korea. RESULTS:Patient enrollment, assessment, and diagnostic processes were determined by the KUDP clinical expert consortium. Patients followed a diagnostic workflow after being categorized into one of four groups: I) insufficient clinical information or lack of standard diagnostic processes; II) undiagnosed due to low disease awareness; III) clinically diagnosed but unconfirmed genetically due to genetic heterogeneities; or IV) unknown disease due to complex, atypical clinical presentations. After excluding two patients from group I, 97 patients were enrolled, including 10 in group II, 67 in group III, and 20 in group IV. Most of them (92 of 97, 94.8%) were pediatric patients (< 18 years old) and 59 (60.8%) were male. The primary symptoms for 80 patients (82.5%) were neurologic. During the one-year pilot study, 72 patients completed a diagnostic assessment including clinical and molecular genetic analyses; some patients also underwent pathological or biochemical analysis. Twenty-eight of these patients (28/72, 38.9%) achieved molecular genetic diagnosis. Thirteen patients were diagnosed based on traditional tests, including biochemical assay, single or targeted genetic analysis, and chromosomal microarray. We performed whole exome sequencing on 52 patients, among whom 15 (28.8%, 15/52) reached a final diagnosis. One new disorder was identified via international collaboration. CONCLUSIONS:Using an efficient clinical diagnostic workflow, this KUDP pilot study resulted in a fair diagnostic success rate, improving the potential for additional diagnoses and new scientific discovery of complex and rare diseases. KUDP also satisfied unmet needs for rare diseases with multisystem involvement, highlighting the value of emerging genomic technologies for further research into rare and still-undiagnosed conditions.

Project description:BACKGROUND:Community-acquired pneumonia is a leading cause of pediatric morbidity. Administrative data are often used to conduct comparative effectiveness research (CER) with sufficient sample sizes to enhance detection of important outcomes. However, such studies are prone to misclassification errors because of the variable accuracy of discharge diagnosis codes. OBJECTIVE:The aim of this study was to develop an automated, scalable, and accurate method to determine the presence or absence of pneumonia in children using chest imaging reports. METHODS:The multi-institutional PHIS+ clinical repository was developed to support pediatric CER by expanding an administrative database of children's hospitals with detailed clinical data. To develop a scalable approach to find patients with bacterial pneumonia more accurately, we developed a Natural Language Processing (NLP) application to extract relevant information from chest diagnostic imaging reports. Domain experts established a reference standard by manually annotating 282 reports to train and then test the NLP application. Findings of pleural effusion, pulmonary infiltrate, and pneumonia were automatically extracted from the reports and then used to automatically classify whether a report was consistent with bacterial pneumonia. RESULTS:Compared with the annotated diagnostic imaging reports reference standard, the most accurate implementation of machine learning algorithms in our NLP application allowed extracting relevant findings with a sensitivity of .939 and a positive predictive value of .925. It allowed classifying reports with a sensitivity of .71, a positive predictive value of .86, and a specificity of .962. When compared with each of the domain experts manually annotating these reports, the NLP application allowed for significantly higher sensitivity (.71 vs .527) and similar positive predictive value and specificity . CONCLUSIONS:NLP-based pneumonia information extraction of pediatric diagnostic imaging reports performed better than domain experts in this pilot study. NLP is an efficient method to extract information from a large collection of imaging reports to facilitate CER.

Project description:BackgroundStrengthening health research is essential to inform public health policies. However, few research training programs have systematically measured their impact on capacity building and most evaluations have been limited to reporting of individual trainee metrics. Hence, we conducted an evaluation of the impact of a five-year training program focused on building both trainee and institutional research capacity at a public medical college in India.MethodsQuantitative and qualitative methods were used to assess the individual and institutional research capacity building of a five-year HIV-TB research training program at Byramjee Jeejeebhoy Government Medical College in Pune, India, supported by the US National Institutes of Health, Fogarty International Center. In addition to documentation of the number of trainee research projects initiated, the number of research papers produced by the Fogarty Scholars (FSs) available on PubMed was calculated. The institutional impact of this program was assessed by documentation of research training activities conducted by the FSs, as well as by surveys and in-depth interviews conducted at the beginning and end of the program.ResultsTwenty-one mid-level BJGMC faculty were provided training in HIV-TB research competencies. Between 1 April 2014 and 1 April 2019, 13 of these FSs designed and implemented new IRB-approved research studies and contributed to 49 PubMed listed research papers, including 11 first-authored manuscripts. FSs also conducted 36 journal club discussions, mentored 58 student research projects and conducted 5 institutional research method workshops. Pre- and-post-program surveys and in-depth interviews documented a perceived increase in institutional research capacity, particularly in TB research (epidemiology, clinical research, laboratory research). The impact of the Fogarty Training Program on institutional scientific output was perceived to be marginally improved.ConclusionThe Fogarty Training Program had a significant impact on building individual research capacity. To sustain this impact beyond the five years of Fogarty support, additional governmental and institutional resources, the establishment of dedicated space for faculty research and protected faculty time for research are needed. These findings can inform the design and implementation of future health research capacity building initiatives.

Project description:BACKGROUND:Clinical trials management can be studied using project management theory. The CYCLE pilot randomized controlled trial (RCT) was conducted to determine the feasibility of a future rehabilitation trial of early in-bed cycling in the intensive care unit (ICU). In-bed cycling is a novel intervention, not typically available in ICUs. Implementation of this intervention requires personnel with specialized clinical expertise caring for critically ill patients and use of the in-bed cycle. Our objective was to describe the implementation and conduct of our pilot RCT using a project management approach. METHODS:We retrospectively reviewed activities, timelines, and personnel involved in the trial. We organized activities into four project management phases: initiation, planning, execution, and monitoring and controlling. Data sources included Methods Centre documents used for trial coordination and conduct, and the trial data set. We report descriptive statistics as counts and proportions and also medians and quartiles, and we summarize the lessons learned. RESULTS:Seven ICUs in Canada participated in the trial. Time from research ethics board and contracts submission to first enrolment was a median (first quartile, third quartile) of 185 (146, 209) and 162 (114, 181) days, respectively. We trained 128 personnel on the CYCLE pilot RCT protocol, and 80 (63%) completed trial-related activities. Four sites required additional training after start-up due to staff turnover and leaves of absence. Over 15?months, we screened 864 patients: 256 were eligible and 66 were enrolled. Despite an 85% consent rate, 74% (190/256) of eligible patients were not randomized, largely (80% [152/190]) due to physiotherapist availability. Thirteen percent of recruitment weeks were lost due to physiotherapist staffing shortages. We highlight five key lessons learned: (1) prepare and anticipate site needs; (2) communicate regularly; (3) proactively analyse and act on process measure data; (4) develop contingency plans; (5) express appreciation to participating sites. CONCLUSIONS:Our analysis highlights the scope of relevant activities, rigorous training and monitoring, number and types of required personnel, and time required to conduct a multicentre ICU rehabilitation intervention trial. Our lessons learned can help others interested in implementing complex intervention trials, such as rehabilitation. TRIAL REGISTRATION:ClinicalTrials.gov, NCT02377830 . Registered prospectively on 4 March 2015.

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Enhancing Institutional Research Capacity: Results and Lessons from a Pilot Project Program.

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