scholarly journals 4042 Enhancing Scientific Rigor, Reproducibility, and Reporting in Translational Science Training and Practice

2020 ◽  
Vol 4 (s1) ◽  
pp. 130-130
Author(s):  
Roger Vaughan ◽  
Matthew Covey ◽  
Michelle Romanick ◽  
Anthony Carvalloza ◽  
Barry S. Coller

OBJECTIVES/GOALS: Irreproducible and incompletely reported research lead to misallocated resources, wasted effort in pursing inappropriate avenues of investigation, and loss of public trust. To address this challenge, we employed a Team Science approach to create a multi-modal program to support Rigor, Reproducibility, and Reporting in Translational Science. METHODS/STUDY POPULATION: We conducted literature searches to reveal sources of irreproducibility and recommended corrective actions, invited leaders in the field to give lectures on opportunities to support reproducible science, and worked with the Rockefeller team science leadership group to instill an overarching rigor approach, infused into all training efforts. This multifaceted program was labeled R3 (R-cubed) for Enhancing Scientific Rigor, Reproducibility, and Reporting. RESULTS/ANTICIPATED RESULTS: Didactic Courses: Introduction to Biostatistics and Critical Thinking – focus on pitfalls in inferential statistics, consequences of poor research, and errors in published research.Scientific Writing – teaches methods and procedures in writing to ensure reproducibility. Lecture SeriesEstablished nine lectures on topics related to R3, including Data Management, Statistical Methods, Genomic Analyses, Data Repositories, Data Sharing, Pharmacy Formulation, and e-lab notebooks. WebsiteCreating a comprehensive website as repository for research, methods, programs, updates, and improvements related to R3. KL2 Clinical Scholars Seminars and NavigationScholars participate in seminars and tutorials to discuss opportunities to improve R3 across the research life-course.DISCUSSION/SIGNIFICANCE OF IMPACT: Striving for research reproducibility takes focused energy, discipline, and vigilance, but the effort is worthwhile as rigorous and reproducible science is the prerequisite for successful translation of great discoveries into improved health. CONFLICT OF INTEREST DESCRIPTION: none

2020 ◽  
Vol 4 (s1) ◽  
pp. 116-117
Author(s):  
Roger Vaughan ◽  
Michelle Romanick ◽  
Donna Brassil ◽  
Rhonda G Kost ◽  
Sarah Schlesinger ◽  
...  

OBJECTIVES/GOALS: There is universal recognition of the importance of team science and team leadership. We have developed a semi-quantitative translational science specific team leadership competency assessment tool and have begun implementation studies to assess the impact of personalized feedback on the team science leadership skills of KL2 Clinical Scholars. METHODS/STUDY POPULATION: To create the instrument, we employed a modified Delphi approach by conducting a thorough literature review on Leadership to concretize the relevant constructs, then used these extracted constructs as a springboard for the Rockefeller Team Science Educators (TSE’s) to discuss and refine the leadership domain areas, collectively create domain-specific survey items. Further discussion helped refined the number, grouping, and wording. Scholars also contributed feedback in item development. We piloted the Leadership Survey by having all of the Rockefeller TSEs rate Clinical Scholars, and having each Scholar rate themselves. Each item was answered using a six-point Likert scale where a low score indicated poor expression and a high score represented excellent expression of the specific leadership attribute. RESULTS/ANTICIPATED RESULTS: Incorporation into a REDCap data base made consenting and rating process by TSE’s and the Scholars straightforward. The a priori domains (Foundational Leadership Competencies, Professionalism, Team Building and Team Sustainability, Appropriate Resource Use and Study Execution, and Regulatory Accountability) had high internal validity and good internal factor structure. The congruence between TSE and Scholar self-ratings were uniformly high, and discordance was often a function of “confidence” and “modesty” on the part of the scholar, rather than deficiency. Supporting comments were informative about performance barriers and mechanisms for improvement. Return of results allowed for the exploration of training gaps. Scholars were surveyed to gauge their reaction to the formal feedback. DISCUSSION/SIGNIFICANCE OF IMPACT: This quantification of team science leadership constructs has allowed for A)- the articulation of constructs essential for successful Translational Scientists to acquire during their training, B)- identification of gaps in that training and skill set, and C)- mechanisms for bolstering any identified gaps in these essential leadership constructs. CONFLICT OF INTEREST DESCRIPTION: None


2021 ◽  
Vol 6 (1) ◽  
Author(s):  
Elizabeth Wager ◽  
◽  
Sabine Kleinert

Abstract Background Inaccurate, false or incomplete research publications may mislead readers including researchers and decision-makers. It is therefore important that such problems are identified and rectified promptly. This usually involves collaboration between the research institutions and academic journals involved, but these interactions can be problematic. Methods These recommendations were developed following discussions at World Conferences on Research Integrity in 2013 and 2017, and at a specially convened 3-day workshop in 2016 involving participants from 7 countries with expertise in publication ethics and research integrity. The recommendations aim to address issues surrounding cooperation and liaison between institutions (e.g. universities) and journals about possible and actual problems with the integrity of reported research arising before and after publication. Results The main recommendations are that research institutions should: develop mechanisms for assessing the integrity of reported research (if concerns are raised) that are distinct from processes to determine whether individual researchers have committed misconduct; release relevant sections of reports of research integrity or misconduct investigations to all journals that have published research that was investigated; take responsibility for research performed under their auspices regardless of whether the researcher still works at that institution or how long ago the work was done; work with funders to ensure essential research data is retained for at least 10 years. Journals should: respond to institutions about research integrity cases in a timely manner; have criteria for determining whether, and what type of, information and evidence relating to the integrity of research reports should be passed on to institutions; pass on research integrity concerns to institutions, regardless of whether they intend to accept the work for publication; retain peer review records for at least 10 years to enable the investigation of peer review manipulation or other inappropriate behaviour by authors or reviewers. Conclusions Various difficulties can prevent effective cooperation between academic journals and research institutions about research integrity concerns and hinder the correction of the research record if problems are discovered. While the issues and their solutions may vary across different settings, we encourage research institutions, journals and funders to consider how they might improve future collaboration and cooperation on research integrity cases.


Author(s):  
Emily Slade ◽  
Linda P. Dwoskin ◽  
Guo-Qiang Zhang ◽  
Jeffery C. Talbert ◽  
Jin Chen ◽  
...  

Abstract The availability of large healthcare datasets offers the opportunity for researchers to navigate the traditional clinical and translational science research stages in a nonlinear manner. In particular, data scientists can harness the power of large healthcare datasets to bridge from preclinical discoveries (T0) directly to assessing population-level health impact (T4). A successful bridge from T0 to T4 does not bypass the other stages entirely; rather, effective team science makes a direct progression from T0 to T4 impactful by incorporating the perspectives of researchers from every stage of the clinical and translational science research spectrum. In this exemplar, we demonstrate how effective team science overcame challenges and, ultimately, ensured success when a diverse team of researchers worked together, using healthcare big data to test population-level substance use disorder (SUD) hypotheses generated from preclinical rodent studies. This project, called Advancing Substance use disorder Knowledge using Big Data (ASK Big Data), highlights the critical roles that data science expertise and effective team science play in quickly translating preclinical research into public health impact.


2020 ◽  
Vol 4 (s1) ◽  
pp. 137-138
Author(s):  
Martha-Conley Ingram ◽  
Yao Tian ◽  
Sanjay Mehrotra ◽  
Dan Apley ◽  
Mehul V Raval

OBJECTIVES/GOALS: Designed sampling from databases (DSD) methods have been used to cross-check electronic medical records for errors, structure study design, and, we hypothesize, can be used to make data collection for surgical quality metrics more efficient, particularly within national databases. We plan to apply statistical and DSD methods to accomplish the following aims: 1.Identify the most important elements in managing post-operative pain2.Identify the most informative procedure or population-based targets to focus collection of additional, labor-intense detail surrounding adequacy of pain control (i.e., Patient Reported Outcome Measures (PROMs)).METHODS/STUDY POPULATION: Our study population includes all children, ages 1-18 years, captured in the National Surgical Quality Improvement Project-Pediatric (NSQIP-P) from 2019 to 2021. We plan to apply statistical (regression modeling) and DSD methods to accomplish the aims listed above. RESULTS/ANTICIPATED RESULTS: For Aim 1, we expect to identify patient, procedure, and perioperative pain management practices that influence postoperative pain. For Aim 2, we will focus on outcomes such as PROMs that are challenging to obtain. By applying DSD methods, we will identify specific procedure and/or population-based cohorts to capture PROMs and decrease data collection burdens, while maintaining power, as the project is scaled nationally to all of NSQIP-P. DISCUSSION/SIGNIFICANCE OF IMPACT: Data from this study will inform expansion of NSQIP-P to collect novel outcomes of clinical and societal importance without prohibitively increasing data collection burden.


2017 ◽  
Vol 1 (S1) ◽  
pp. 47-47
Author(s):  
Gayathri Devi ◽  
Ranjan Sudan ◽  
Stephanie Freel ◽  
Laura Fish

OBJECTIVES/SPECIFIC AIMS: To improve translational research, we have developed a program called Duke Multidisciplinary Education and Research in Translational Sciences (Duke MERITS). Duke MERITS will facilitate cross-disciplinary collaboration among faculty involved in foundational, clinical and/or health care research and in turn also prepare them to train the next generation of translational researchers. METHODS/STUDY POPULATION: The program aims are (1) to define metrics and outcomes measures so faculty can track their progress and identify impact of their collaborative research in translational sciences; (2) to offer a multi-modal faculty development series to promote team science, improve didactic teaching, and incorporate innovative resources to promote interdisciplinary approach to translational research; (3) to provide module-based hands-on-training sessions in bench to bedside research and training in translational grant writing to facilitate the development of multidisciplinary research collaborations. The present study describes results from Aim 1 and includes (a) development of baseline outcome assessment tools necessary to gauge the impact of our programs on both the participating faculty and the research culture within Duke University, (b) impact of a specific course offering in Translational Medicine. In order to achieve this, we conducted multiple focus group sessions with faculty self-identified as junior-, mid-, or advanced-career, a mixed group at any career level and included a group of graduate students and postdoctoral trainees to study the impact of a graduate level course in Translational Aspects of Pathobiology. The activities during these translational science focus groups were designed to define what successful translational science is, to determine what resources support translational Science at Duke, and to decide what resources we need in order to enhance Duke’s position as a leader in research and scientific education. RESULTS/ANTICIPATED RESULTS: We identified that translational science is changing standards while incorporating leadership, teamwork, collaborations, and movement primarily focusing on the overall goal of improving all aspects of health. Participants categorized their field of study and the fields of their coparticipants most frequently as basic discovery and a combination of intervention and health services. The most frequently identified pros/benefits of performing translational science at Duke include industry connections, collaborations with other departments resulting in disciplines being bridged, improving patient care, and access to resources as well as money. The most frequently identified cons/barriers of performing translational science includes the expensiveness, silos, and lack of resources willing to absorb risks. DISCUSSION/SIGNIFICANCE OF IMPACT: The identification of these defined factors from the focus groups has allowed us to issue a comprehensive, sliding Likert scale-based anonymous survey from the secure RedCap system and is being rolled out throughout Duke University, including schools of medicine, nursing, Trinity, biomedical engineering. We envision that Duke MERITS education program will facilitate interprofessional efforts, which we define as a team science approach to identify the clinical “roadblock” and then seek an innovative approach or technology to help overcome this “roadblock”? It can facilitate institutional and departmental recognition in faculty career development. The common goal is to gain fundamental new insights that will result in significant improvement of the existing “standard of care” and meet the challenges of dwindling extramural support.


2020 ◽  
Vol 4 (s1) ◽  
pp. 61-61
Author(s):  
Celia Chao ◽  
Emma Tumilty ◽  
Celia Chao ◽  
Judith Aronson ◽  
Jonathan D. Hommel ◽  
...  

OBJECTIVES/GOALS: We aimed to explore the students’ assessments of workload distribution by comparing personal reflective commentaries and team documents defining division of labor in a team science setting. METHODS/STUDY POPULATION: The Interprofessional Research Design course models the team science experience by bringing together MD and PhD students to write a research grant. Four teams of 13 students were tasked with both individual and team-based assignments: 1) Each week, each student reported their perception of their own and their team members’ effort over the week (totalling 100%). 2) Iterative work contracts for each team were submitted at four time-points; assigned work toward project completion totalled 100%. 3) Lastly, each student submitted a short commentary reflecting on the prior week’s team dynamics and teamwork. We retrospectively performed a mixed-methods analysis of the workload data. RESULTS/ANTICIPATED RESULTS: Group-reporting in the team contracts remained static throughout the course, often stating equal distribution of workload, whereas individual reporting was more dynamic. Of 13 students, 8 rated more than 50% of the weeks as balanced. Among some students, there was a discordance of workload distribution when comparing the group document to the individual perceptions of work performed by their teammates. Reflective writing mapped more closely to individual quantitative reports. The data also revealed within team variations, where one student may report a higher proportion of their contributions, while the rest of the team attributed that student a lower percentage of the total work. DISCUSSION/SIGNIFICANCE OF IMPACT: An important aspect of team function is workload distribution. Group-based workload discussions may be a useful framework, but does not provide insight into team dynamics, whereas individually reported workload distributions and short reflections seem to more accurately inform us on team function.


2017 ◽  
Vol 1 (5) ◽  
pp. 285-291 ◽  
Author(s):  
Sarah J. Schlesinger ◽  
Michelle Romanick ◽  
Jonathan N. Tobin ◽  
Donna Brassil ◽  
Rhonda G. Kost ◽  
...  

Introduction and MethodsThe Rockefeller Clinical Scholars (KL2) program began in 1976 and transitioned into a 3-year Master’s degree program in 2006 when Rockefeller joined the National Institute of Health Clinical and Translational Science Award program. The program consists of ∼15 trainees supported by the Clinical and Translational Science Award KL2 award and University funds. It is designed to provide an optimal environment for junior translational investigators to develop team science and leadership skills by designing and performing a human subjects protocol under the supervision of a distinguished senior investigator mentor and a team of content expert educators. This is complemented by a tutorial focused on important translational skills.ResultsSince 2006, 40 Clinical Scholars have graduated from the programs and gone on to careers in academia (72%), government service (5%), industry (15%), and private medical practice (3%); 2 (5%) remain in training programs; 39/40 remain in translational research careers with 23 National Institute of Health awards totaling $23 million, foundation and philanthropic support of $20.3 million, and foreign government and foundation support of $6 million. They have made wide ranging scientific discoveries and have endeavored to translate those discoveries into improved human health.ConclusionThe Rockefeller Clinical Scholars (KL2) program provides one model for translational science training.


2019 ◽  
Vol 3 (s1) ◽  
pp. 63-63
Author(s):  
Katherine Cornelius ◽  
Alexandra Joelle Greenberg-Worisek ◽  
Ryan Jimison ◽  
Jennifer Weisbrod ◽  
Karen Marie Weavers

OBJECTIVES/SPECIFIC AIMS: Scholars and faculty in the Clinical and Translational Science (CTS) track of our institution’s biomedical science graduate school reported a lack of satisfaction with our learning management system (LMS); specifically, they reported frustration with the amount of time spent locating learning assignment guidelines, course readings, and submission portals. As a result, we created a new master template to address their concerns. METHODS/STUDY POPULATION: A new template was created within the LMS based on scholar and faculty feedback. Surveys and other tools have been used to determine student and faculty satisfaction as well as measure secondary outcomes of time spent in the online learning space. Some key changes include a redesigned menu and submission portal. RESULTS/ANTICIPATED RESULTS: There was an increase in satisfaction with the new LMS template. Next steps include systematically rolling out the new template, with continued solicitation of feedback from all stakeholders. All courses in the CTS track will be converted to the new template by summer quarter 2020. DISCUSSION/SIGNIFICANCE OF IMPACT: The strengths of this project include the multidisciplinary team-based approach to improving course satisfaction and usability, as well as the use of innovative technologies. Additionally, the analytical capabilities of the LMS will be maximized in the new template, which was a shortcoming of the previously available template.


2021 ◽  
Vol 36 (Supplement_1) ◽  
Author(s):  
Bartholomeus Willigers ◽  
Mario Ouwens ◽  
Andrew Briggs ◽  
Oliver Darlington ◽  
Purav Bhatt ◽  
...  

Abstract Background and Aims Elevated albuminuria in patients with chronic kidney disease (CKD) is associated with increased risks of CKD progression, cardiovascular events and all-cause death. In the DAPA-CKD study, dapagliflozin significantly reduced the risk of all-cause death in patients with elevated albuminuria compared with placebo (hazard ratio: 0.69; 95% confidence interval 0.53–0.88). To assess the cost-effectiveness of new treatments, decision makers require survival estimates over a longer period than that of a typical clinical trial, usually over a lifetime time horizon. A formal elicitation process is currently underway to obtain estimates of long-term survival of patients with albuminuric CKD from clinical experts. Their responses will be used to validate extrapolations of all-cause mortality data from DAPA-CKD, which could inform cost-effectiveness analyses for dapagliflozin. Method Targeted literature searches were conducted to collate data on all-cause mortality in patients with CKD and elevated albuminuria. Clinical trials and observational studies were included if they involved non-dialysis-dependent patients with CKD aged 18 years and over, had more than 500 participants per study arm and reported incidence of all-cause death and/or all-cause mortality/survival Kaplan–Meier (KM) curves. To estimate long-term survival, KM curves were extrapolated to 20 years by calculating standard mortality ratios (SMRs) using age- and sex-adjusted general-population lifetable data. Study and patient characteristics and mortality data from relevant studies were provided to clinical experts to inform their judgements in a formal elicitation process. After receiving training on the elicitation process, six leading disease area experts were invited to complete the elicitation survey using an Excel-based tool, which consisted of 10 calibration questions, and three questions regarding the survival of patients in the placebo arm of the DAPA-CKD study at 10 and 20 years. The elicited estimates will be weighted and aggregated using Cooke’s method. Results Literature searches identified 13 relevant articles (seven clinical trials and six observational studies), with a range of 1094 to 5674 participants. Mean age varied across studies (range: 55–70 years). Where reported, median follow-up was 9–144 months, and mean estimated glomerular filtration rate (eGFR) at baseline was 22.4–56.3 mL/min/1.73 m2. Five studies exclusively included patients with type 2 diabetes (T2D). The incidence of all-cause death was reported in nine studies and was 1.5–9.4 deaths per 100 patient-years, with the highest incidence observed in a study reporting data for patients with CKD stage 4 and 5 (8.0 and 9.4 deaths per 100 patient-years, respectively). Nine studies provided KM curves; from these, estimated survival at 2 years ranged from 86% (study population mean age 67 years, eGFR < 15 mL/min/1.73 m2) to 98% (study population mean age 58 years, mean eGFR 46.2 mL/min/1.73 m2). The SMR-extrapolated survival at 10 and 20 years was 36–80% and 2–69%, respectively. The ranges defined by the expert judgements collected to date for survival at 10 and 20 years are in line with the variability of the extrapolated KM survival curves. The elicitation process is ongoing and therefore, to avoid biasing the judgements that remain to be collected, preliminary results are not reported here. Results of the expert elicitation will be presented in full at the congress. Conclusion Initial results from the survey calibration questions suggest that the expert elicitation process provides expert judgements that are both informative and precise. The elicitation of survival estimates for patients with CKD and elevated albuminuria at 10 and 20 years will provide greater insight than extrapolated data alone, and will increase the validity of long-term survival projections for dapagliflozin cost-effectiveness analyses.


2020 ◽  
Vol 4 (s1) ◽  
pp. 62-62
Author(s):  
Alexandra Joelle Greenberg-Worisek ◽  
Katherine Cornelius ◽  
Becca Gas ◽  
Carmen Silvano ◽  
Karen Marie Weavers ◽  
...  

OBJECTIVES/GOALS: The Mayo Clinic Clinical and Translational Science (CTS) Predoctoral program aims to develop independent researchers capable of leading multi-disciplinary teams to accelerate the translation of discovery to application. Here, we detail the outcomes of our graduates over the past ten years (2010-2019). METHODS/STUDY POPULATION:): A survey was fielded with all CTS graduates whose degrees were conferred since the program’s inception to 2019. Items addressed their current position, whether they were still involved in research, what type of research they were involved in, and whether they stayed involved with education. They also submitted a recent CV, from which data were collected about publications and grants. A subset were then contacted for a semi-structured interview. Items included questions addressing motivation for pursuing a PhD in CTS, whether the program prepared them for their current work, gaps they felt they had in training, and whether they felt they were making a difference in the lives of patients. RESULTS/ANTICIPATED RESULTS: Of the 41 alumni, 34 responded (83% response rate). Of these, 19 (56%) are at Mayo Clinic, 9 (26%) work for other academic institutions, and 6 (21%) do not work for an academic institution. Most have remained in research (33/34, 97%). The majority (22/33, 67%) are involved in clinical research, 30% (10/33) in basic science, and 24% (8/33) in healthcare delivery research. Most (23/34, 68%) are engaged in educational activities. When asked about changes they have led, 67% (18/27) led quality improvement projects and 44% (12/27) designed a new research method. Several hold leadership positions either in their organization (12/16, 75%) or in a professional organization (10/16, 63%). DISCUSSION/SIGNIFICANCE OF IMPACT: The CTS Predoctoral program successfully prepares scholars for careers involving clinical and translational research; furthermore, alumni remain in research-oriented careers after graduation. We will continue to gather longitudinal data alumni move forward in their careers.


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