CTSI Services

The Clinical and Translational Science Institute (CTSI) offers up to 4 hours of free consultation per project (maximum of 2 projects per year per investigator) in biostatistical and epidemiological methodologies, study design, data management and analysis, provided to you by a team of biostatisticians from University Park and Penn State College of Medicine.

Eligibility

• We limit consultation and support to Penn State investigators or staff/students who are supporting an investigator.
• BERD provides consultation for the development of clinical and translational science research proposals and consultations for institute-funded pilot projects. K and T scholars receive free consultations.
• Medical students are eligible as long as their mentor/advisor is present for the consultation meeting.

Consultations may include

• Design and analysis strategies for research proposals
• Sample size and power calculations for research proposals
• Advice on the selection and implementation of appropriate statistical methods for research data
• Advice on table and figure construction
• Advice on data management
• Statistical review of grant proposals, protocols and manuscripts

Cost

• Maximum of 4 free consultation hours per project. This 4 hour free limit per project is subject to annual review and may be adjusted in the future.
• Maximum of 2 projects per year per investigator
• Projects requiring more than four hours (or >2 project consultation requests per year) would require funding. Billing rates for additional collaboration will be discussed at that time.
• For grant proposals where BERD personnel will be written into the grant for funded effort, additional free hours may be negotiated to prepare the grant submission.

Medical Student Research (MSR) Projects

• Eligibility for the 4 free consultation hours requires the presence of the mentor/advisor along with the student for the consultation meeting.
• Students are typically expected to analyze their own data for their MSR project based on the consultant’s recommendations. Therefore, studies requiring complex statistical methods are usually not considered appropriate for a MSR project.

Data Considerations

• Hands-on assistance with data analysis is generally not provided without funding because these projects are usually beyond the scope of the four free hours.
• Any data provided for hands-on analysis that involves human subjects must be from an IRB approved protocol and must be de-identified by not containing any of the private health information (PHI) identifiers. A list of the PHI identifiers may be found on the Penn State Office of the Vice President for Research’s website.

Authorship

• Decisions regarding authorship for faculty or staff should be considered independently of funding.
• Co-authorship should be offered to anyone who has clearly made a material contribution to the project.
• For details, please see Penn State Policy IP02 on co-authorship.

Grant Citation Requirements

• Any hands-on data analysis performed by BERD consultants using the free hours are considered as use of CTSI resources. Therefore presentations, abstracts, and publications must appropriately cite the CTSI grant.
• For proper citation, please see Citing the Institute.

Deadlines

• To receive proper attention, requests should be submitted well ahead of any deadline.
• Within two business days of receiving your submitted Request Form, the faculty or staff consultant handling your project will contact you to schedule an initial consultation meeting.
• In cases of emergency, and subject to the availability of personnel, limited assistance may be provided on short notice.
• There is no guarantee that every requested deadline will be honored.
• Projects may be triaged based on the priorities of the Clinical and Translational Science Institute.

Seminars

For those interested in learning more on this topic, the Biostatistics, Epidemiology and Research Design (BERD) Recent Topics in Research Methods seminar series takes place during the academic year. Lectures on fundamental research methods are given in the fall semester, with more advanced topics presented in the spring semester. Statisticians and methodologists from multiple Penn State departments present these seminars.

Upcoming seminars are listed here. Click any event to register or add it to your Outlook calendar.

Penn State Clinical and Translational Science Institute provides communication consultations. How research is communicated to different audiences is important for both volunteer recruitment and for dissemination of results.

Consultations include:

• Identifying audiences and appropriate messaging for each
• Lay summary assistance
• Recruitment material review (in partnership with the institute’s Recruitment and Retention Project Manager)
• Advertising strategy for recruitment (in partnership with the institute’s Recruitment and Retention Project Manager)
• Media training (in partnership with Penn State Health’s Office of Marketing and Communications)
• Study recruitment poster templates (in partnership with institute’s Recruitment and Retention Project Manager)
• Online visibility enhancement suggestions

Eligibility

Consultations are open to members of the Penn State community.

Cost

Communication consultations are free.

Request a Communications consultation

Penn State Clinical and Translational Science Institute provides community-centered translational science infrastructure that builds on existing networks of community engagement already in place at Penn State, including the Penn State Cooperative Extension and Outreach system, and focuses on the development, implementation, evaluation and diffusion of evidence-based interventions.

Penn State views the community as our principal “customer and partner,” whose needs we strive to meet and whose collective capabilities we seek to engage. The community is where health problems arise, disease-promoting conditions prevail, and disease can be predicted, prevented and treated. Therefore, it is critical that we establish and nurture trust among people, organizations and the translational research community through transparency, utmost ethical conduct and demonstrated commitment toward the common good.

Consultations include:

• • Assistance establishing a research project in the community
  • Assistance to identify stakeholders who can provide input at all stages of research, from conceptualization and discovery to dissemination

Guidance in selection of approaches for community-engaged health research (CEHR) that promote trust and benefit all parties

• Research project design involving interdisciplinary teams and community partners
• Community-based research approaches and protocols that effectively engage stakeholders in urban and rural settings
• Support coordination among community members, health care providers and research scientists
• Identification of needs and priorities for health-related research in Central Pennsylvania communities
• Tools for increasing diversity of community member participation in health research through awareness and involving community members in the development of effective recruitment, retention and dissemination strategies
• Assistance with patient and stakeholder engagement for Patient Centered Outcomes Research Institute – also known as PCORI – applications

Eligibility

Consultations are open to members of the Penn State community. Consultations are required for all CTSI pilot funding recipients.

Cost

Community engagement consultations are free.

Request a Community Engagement consultation

Penn State Clinical and Translational Science Institute offers health policy impact consultations to support policy-relevant research and promote its translation between researchers and regulators. These consultations are open-ended and can be tailored to specific questions.

The following are examples of how previous investigators have used consultations:

• Identifying policy objectives of relevant regulatory agencies
• Supporting researchers in increasing the policy relevance of proposed projects
• Discussing policy-relevant dissemination opportunities
• Providing education and educational opportunities on legal and regulatory issues related to health policy
• Reviewing grant applications to identify ways to enhance policy relevance

Eligibility

Health policy impact consultations are open to members of the Penn State community.

Cost

Health policy impact consultations are free.

Request a Health Policy Impact consultation

Penn State Clinical and Translational Science Institute provides implementation science consultations to Penn State investigators and trainees to improve research and evaluation of intervention implementation efforts. Implementation science is an emerging field that focuses on integrating evidence-based interventions into real-world public health and clinical practices. Our consultations are available to inform existing projects, research ideas, grant applications, manuscripts, and abstract submissions.

Consultations include:

• Guidance selecting implementation science-oriented theories, models, or frameworks
• Identification of implementation strategies to test alongside interventions
• Identification of implementation measures and the creation of data collection tool(s)
• Grant and manuscript writing support
• Assistance identifying external funding opportunities
• Assistance identifying collaborators and community partners to conduct projects]

ELIGIBILITY

Consultations are open to members of the Penn State community. We especially welcome consultation requests from faculty and postdocs. Doctoral-level students (MD, PhD, DrPH) are also eligible for this service.

COST

An initial one-hour consultation and follow-up (up to 4 hours/year total) are provided free of charge, after which the faculty or staff handling your project can discuss the billing rates for additional services.

Request an Implementation Science consultation

Penn State Clinical and Translational Science Institute is engaged in standardizing and integrating disparate data sets that include electronic health records, environmental, socioeconomic and other data to develop novel methods and artifacts for predictive analytics that solve real-world health problems.

Consultations include:

• Integration of informatics in translational research activities
• User training and education
• Integration of electronic health records with genomic, contextual (environmental and socioeconomic) and wearable sensor data, etc.
• Design, implementation and deployment of advanced data analytics

Eligibility

Informatics consultations are open to members of the Penn State community.

Cost

Informatics consultations are free.

Request an Informatics consultation

The CTSI Informatics Core empowers researchers in several ways. Not only do researchers get access to the Penn State instance of OMOP for pilot studies and access to the TriNetX system, they also can receive:

1. Help with study design, feasibility analysis.
2. Help with cohort definition and data extraction.
3. Support for data preparation
4. Support for analysis of large data sets (characterization, prediction, effect estimation)
5. Support for model interpretation, interrogation, deployment, and inference
6. AI/ML support for research proposal development
7. Help with AI/ML-based analyses of EHR, claims, or other large clinical data sets.

Watch Our Recent Webinar

Study Examples Using Big Data and Artificial Intelligence and Machine Learning Support from the CTSI Informatics Core

Project HERA

Project HERA – Health Equity Research Assessment uses the multi-site OHDSI system. The investigators sought to advance knowledge of health disparities to ultimately reduce them on a large scale. With OHDSI community’s input with phenotyping and adding databases to this project, HERA was able to generate hypotheses across a wide range phenotypes and subgroups, identify conditions under which subgroup differences must be mitigated when building predictive models and causal inference analyses, and detangled biological differences from implicit healthcare biases.

Investigators used HERA to ask: Are there systematic patterns of diagnosis coding prevalence for Black and white patients across a network of observational health datasets and across all diagnoses? In this retrospective observational study of 8.3 million American patients across nine databases, investigators discovered that Black and white patients receive diagnoses at different prevalences. We focus on neoplasm conditions and find that Black patients are more likely to be diagnosed with genital and lower body neoplasms, while white patients are more likely to be diagnosed with skin and soft tissue neoplasms. These findings persist across geographical sites and types of insurance.

This question, and the data it yields, shows that large-scale characterizations across heterogenous institutions, populations, and insurance coverage types allow the identification of persistent and generalizable trends in diagnosis disparity. The HERA dashboard and visualizations can be used to further investigate health disparities and generate novel hypotheses.

Predicting Cancer-specific Mortality with Machine Learning

Another study that leveraged big data sets sought to ask: Can the cause of death for newly diagnosed cancer patients be predicted? Cancer is one of the leading causes of death in the US. While current oncology guidelines recommend treatment options for a particular cancer, they do not account for competing risks of death, which can influence follow-up decisions to prevent mortality from specific causes. This study created a pan-cancer analysis to predict cancer-specific mortality via machine learning.

Using data points of 1,415,109 patients extracted from a US national cancer database, this study utilized a random forest algorithm to create accurate models to predict 1, 5, and 10-year probabilities of alive, death due to cancer, and death due to non-cancer causes. Patients were sub-stratified into low-, intermediate-, and high-risk groups of cancer specific mortality. This model had an overall accuracy of 77.4% versus a baseline of 33.3%, with 10-year area under the curve of 0.88.

Accurate models such as this can help cancer patients, care givers, and families tailor follow-up care decisions and survivorship guidelines by identifying patients at risk of death from specific causes.

Peripheral Artery Disease + COVID-19 Health Outcomes

Using the TriNetX system, investigators sought to build a model that predicted 30-day clinical outcomes for patients with COVID-19, with and without peripheral artery disease (PAD). The goals were to determine the “best” performing machine learning model and to compare the results to a classical statistics approach (standard logistic regression model).

The primary goal with this study was to investigate the relationship between input features and outcomes prediction. The outcomes demonstrate that there is general agreement between the logistic regression and the machine learning analysis; in addition, the study determined which features are important for the best performing models, as well as which impact the model the most. For instance, smoking as an input feature presented as particularly important when it comes to a hospitalization outcome within 30 days.

Maternal and Infant Outcomes

Using the PaTH to Health data repository, the Penn State College of Medicine received a $4 million to study the health impacts of COVID on pregnancy. Serving as a lead site, the investigators from the Penn State College of Medicine compile existing electronic health record data that are standardized and harmonized across four PCORnet clinical sites in Pennsylvania (Penn State, UPMC, Geisinger, and Temple) to examine retrospectively the impacts on pregnancy for both maternal and child health outcomes across diverse communities in Pennsylvania. Based on the existing EHR data repository, the study utilizes clustering sampling strategies to identify 3,000 pregnant women for intensive survey follow-ups. The survey results will be linked to the electronic health records. Machine learning models will be developed to gain insights of the overall impact of the pandemic on pregnancy, and how different communities cope with the stress of COVID and associated with different health outcomes.

Machine Learning Prediction of 1-year Mortality and Recurrence after Ischemic Stroke

Using the Penn State PaTH to Health data linking to Geisinger’s EHRs, the Penn State College of Medicine is rewarded a $3.2 million from the NIH to study factors predicting the inpatient readmission among ischemic stroke patients. The study will use standardized EHR-based data across two health care centers (Penn State and Geisinger) to identify clusters of ischemic stroke patients with common traits. The Penn State investigators will develop machine learning models to predict 1-year mortality and recurrence. Finally, the investigators will validate the models prospectively using electronic health records from the same sources.

Developing and validating EHR-integrated readmission risk prediction models for hospitalized patients with diabetes

Lead by collaborators at the Temple College of Medicine, the study aims to use the existing standardized/harmonized electronic health records, including Penn State’s PaTH to Health data, to develop and prospectively validate a risk model to predict unplanned 30-day all-cause hospital readmission among all patients with diabetes. The study team also aims to develop an automated model tool integrated with electronic health record systems.

Adult PCORnet-PASC (RECOVER)

This study is led by Cornell University with funding support from the NIH. The Penn State College of Medicine uses the PaTH to Health data infrastructure to participate in a national multi-site study to examine factors characterizing the Post-acute Sequelae SARS-CoV-2 infection (PASC or the long COVID), and predicting the treatment outcomes. 

Strengthening public health systems and services through national partnerships to improve and protect the national health

Penn State receives CDC’s funding to join the continued surveillance, such as characteristics of adults and children infected with COVID-19. Bi-weekly, the Penn State investigators respond to the “standard data query” to report patient characteristics, complications, long-term sequelae of infection, and use of COVID-19 treatments over time as a part of national public health surveillance data.

Project ECHO is a model with the power to rapidly transfer knowledge and exponentially increase capacity to deliver best-practice care to underserved populations. The ECHO model’s “all teach, all learn” approach is the infrastructure for knowledge-sharing in rural and underserved communities around the world. The heart of the ECHO model is its hub-and-spoke knowledge-sharing networks, led by expert specialist teams (hub), mentoring multiple community providers (spokes) via teleconferencing. The ECHO model is not “telemedicine” where specialists assume the care of the patient; it is a guided model aimed at practice improvement, in which providers retain responsibility for patients, and operate with increasing independence as skills, confidence and self-efficacy grow. Unlike traditional learning, Project ECHO facilitates rapid dissemination of medical knowledge and increased capacity to deliver best-practice care by utilizing case-based, collaborative learning to support discussion of learners’ challenges and barriers to guideline implementation.

The ECHO model was designed to address the unique challenges faced by rural and underserved communities. Only about 10 percent of physicians practice in rural areas of the country despite nearly one-fourth of the population living in these areas. Rural areas have higher rates of some chronic diseases and face many challenges, including transportation, connectivity and isolation. Further, it can be difficult to recruit healthcare providers to work in rural and underserved areas, and opportunities for professional development and support in these areas can be difficult. The goal of Project ECHO is to provide the same level of healthcare to rural patients with chronic diseases as can be obtained in an urban setting. A secondary goal is to provide rural healthcare practitioners with a level of interaction and support commensurate with their urban counterparts to enhance their technical competence and decrease their feelings of professional isolation.

Consultations include:

• Guidance on whether Project ECHO is right for your needs
• Determining what an ECHO series might look like based on your needs
• Grant writing support
• Assistance in identifying external funding opportunities
• Assistance in identifying specialists, collaborators and community partners

Eligibility

Consultations are open to anyone interested in writing the Project ECHO model into their grants or research plans. Doctoral-level students (MD, PhD, DrPH) are also eligible for this service.

Cost

An initial one-hour consultation and follow-up are provided free of charge.

Request a Project ECHO consultation

ECHO Sessions

For those interested in observing an ECHO session in action, a list of upcoming ECHO sessions is provided below. Click any event for more information.

About Qualitative and Mixed Methods Consultation (QMMC) support

The Clinical and Translational Science Institute (CTSI) offers up to 4 hours of free consultation per project (maximum of 2 projects per year per investigator) in qualitative and mixed methods research methodologies, study design, and training on interviewing, coding and analysis.  This provided by a faculty member with expertise at Penn State College of Medicine.

Who is eligible for free consultation?

• QMMC provides consultation for investigators who would like short-term assistance with project design, grant writing, interview guide development, codebook development, or access to training materials.
• QMMC provides consultation for investigators who need long-term collaboration for funded projects.  In this case, investigators are required to have two staff members or students on their team (i.e., research assistants, medical/grad students, project managers) to implement the work.  Implementation means being trained to interview, facilitate transcription to an outside vendor, and code the transcripts.
• Medical students and graduate students are eligible as long as their mentor/advisor is present for the consultation meeting.

What can I expect?

Consultations may include:

• Design and analysis strategies for research projects and grant proposals
• Develop a clear focus for the research question and subsequent individual and/or focus group interview guide development
• Advice on the selection and implementation of appropriate methods for research data
• Recommendations for further training on conducting interviews, transcribing interviews to an outside vendor, and/or coding and coding software.
• Advice on data analysis
• Methodological review of grant proposals, protocols and manuscripts

Funding

• Maximum of 4 free consultation hours per project. This 4 hour free limit per project is subject to annual review and may be adjusted in the future.
• Maximum of 2 projects per year per investigator
• Projects requiring more than four hours (or more than 2 project consultation requests per year) would require funding. Billing rates for additional collaboration will be discussed at that time.
• For grant proposals where QMMC personnel will be written into the grant for funded effort, additional free hours may be negotiated to prepare the grant submission.

Medical Student Research (MSR) Projects

• Eligibility for the 4 free consultation hours requires the presence of the mentor/advisor along with the student for the consultation meeting.
• Students are expected to analyze their own data for their MSR project based on the consultant’s recommendations. Therefore, studies requiring complex methods are usually not considered appropriate for a MSR project.

Data Considerations

• Hands-on assistance with data analysis is generally not provided without funding because these projects are usually beyond the scope of the four free hours.
• Any data provided for hands-on analysis that involves human subjects must be from an IRB approved protocol and must be de-identified by not containing any of the private health information (PHI) identifiers. A list of the PHI identifiers may be found at the IRB website.

Authorship

• Decisions regarding authorship for faculty or staff should be considered independently of funding.
• Co-authorship should be offered to anyone who has clearly made a material contribution to the project.
• For details, please see Penn State Policy IP02 on co-authorship.

Grant Citation Requirements

• Any hands-on data analysis performed by QMMC consultants using the free hours are considered as use of CTSI resources. Therefore presentations, abstracts, and publications must appropriately cite the CTSI grant.
• For proper citation, please see the citing the CTSI page.

Deadlines

• To receive proper attention, requests should be submitted well ahead of any deadline.
• Within two business days of receiving your submitted Request Form, the faculty or staff consultant handling your project will contact you to schedule an initial consultation meeting.
• In cases of emergency, and subject to the availability of personnel, limited assistance may be provided on short notice.
• There is no guarantee that every requested deadline will be honored.
• Projects may be triaged based on the priorities of the Clinical and Translational Science Institute.

Penn State Clinical and Translational Science Institute provides recruitment and retention consultations. Recruitment and retention is an integral part of research studies, yet it can be one of the most challenging aspects of an investigation.

Individualized support for researchers and their study teams includes:

• Developing a customized recruitment and retention strategy for any Penn State human subjects research study
• Providing support and training for institute recruitment tools, including Studyfinder, ResearchMatch and TriNetX
• Reviewing and providing feedback about recruitment materials, including recruitment flyers and letters
• Providing feedback relating to study design
• Helping to develop a study recruitment budget

Eligibility

Consultations are open to members of the Penn State community.

Cost

Recruitment and retention consultations are free.

Request a Recruitment and Retention consultation

About REDCap support

In collaboration with the Survey Research Center (SRC) at University Park and the College of Medicine, the Clinical and Translational Science Institute offers up to 10 hours of free consultation for data management, database development and for REDCap implementation, provided to you by a team of programmers and analysts.

Who is eligible for free consultation?

We limit consultation and support to funded Penn State investigators or staff/students who are supporting an investigator with funded research, for institute-funded pilot projects, and for K and T scholars. We do not support staff or students with unfunded projects. This service is only offered once per investigator/study team.

What can I expect?

When you submit a ticket through the REDCap support portal, you will be asked to determine what you need support with:

• Account support
• Project Support
• Learn more about REDCap

If you are looking for Account Support or to Learn more about REDCap, you will be provided with additional information, links and trainings to help guide you. If you select Project Support, our team of programmers and analysts can assist you with a wide range of tasks to help optimize your use of REDCap. We can assist you with everything from project design and set-up, to data quality assurance and reports. Additionally, we can provide guidance and support with features such as repeatable instruments and events, branching logic, alerts and notifications, surveys, and the API. We can also help with more advanced features such as the calendar/scheduling module, the randomization module, and the electronic regulatory (eReg) binder. Furthermore, our team can offer assistance with the delegation form, eConsent, mobile options (including REDCap Mobile App and MyCap), and user rights/data access groups. Regardless of type of support chosen, investigators will be limited to 10 hours only once. If future work requires additional REDCap support, researchers can work directly with the SRC to get a budget estimate for their project.

What is included in the free consultation?

During the consultation, our programmers and analysts will learn more about your project needs and help to guide you through the process of setting up the infrastructure you are looking for in REDCap. Consultation does not include our programmers and analysts building the project or database for you. If the scope of work goes beyond what we are able to support during the consultation phase, please contact SRC for a project estimate that would include billable hours.

Access the Support Form

Penn State Clinical and Translational Science Institute helps to facilitate the process by which novel research ideas are transformed into scientifically and ethically sound research study protocols that are in compliance with regulatory requirements. We involve both investigators and regulators into a partnership where values of efficiency, appropriate attention to ethical research conduct and regulatory compliance are continuously balanced.

Consultations include:

• Education and mentorship on the regulatory and ethical research
• Considerations of the regulatory and ethics implications of a research project
• Promotion of scholarship in ethical research
• Obtaining informed consent
• Addressing privacy issues in data-driven research
• Development of research questions related to specific regulatory or ethical concerns to incorporate in study design

Eligibility

Regulatory and ethics consultations are open to members of the Penn State community.

Cost

Regulatory and ethics consultations are free.

Request a regulatory and ethics consultation

Penn State Clinical and Translational Science Institute provides research ethics consultations to maximize the benefits and minimize potential harms of research to society. The institute involves both investigators and regulators where values of efficiency, appropriate attention to ethical research conduct and regulatory compliance are continuously balanced.

Consultations can help researchers and others involved in the research process identify practical solutions to ethical, policy and social challenges.

The institute also provides education through seminars and facilitated discussions on a variety of research ethics topics, including responsible conduct of research (research misconduct, informed consent, authorship), ethical and social issues around genomic research, biobanking, and privacy and confidentiality in an era of broad data sharing and data-driven research.

Research ethics consultations are part of the institute’s Research Methods Core.

Eligibility

Research ethics consultations are open to members of the Penn State community.

Cost

Ethics consultations are free.

Request a Research Ethics consultation

To request a special presentation on research ethics topics for a department or University group, email ctsi@pennstatehealth.psu.edu.

If you are looking to collaborate, begin by searching the University’s research networking tool, Pure. Further assistance is available through consultations with the Clinical and Translational Science Institute.

Consultations include:

• Assistance identifying potential collaborators
• Techniques to grow and develop effective teams
• Effective integration of knowledge, coordination and communication in team environment
• Effective management of interpersonal dynamics
• Assistance motivating a team to meet milestones
• Guidance on the science of team science
• Tracking and evaluation of team effectiveness and and team science outcomes
  mentorship for team leaders and education on the role individual factors in effective multidisciplinary research
• Assistance with team-level processes including establishing common language and conflict resolution
• Techniques to effectively manage multisite teams

Eligibility

Teams and collaboration consultations are open to members of the Penn State community.

Cost

Teams and collaboration consultations are free.

Request a teams and collaboration consultation