eRecord: new search engine tool and Study Monitor changes

Changes to External Study Monitor eRecord Access

Per a new eRecord policy, external Study Monitor eRecord accounts will be deactivated between visits.  Any study monitor visits, we now need to be notified a few days before the visit, so we can reactivate their accounts. Deactivating study monitor (ePartner) accounts in between visits aligns the external monitor protocol with the internal study monitor protocol. This is noted on the NEW study monitor request form attached and at the erecord site, under “Research”, ‘external study’: Please note that with the new form the Principal Investigator and Program Admin will need to sign off on the request. To reactivate the external Study Monitor access, the study team’s internal contact will need to email “erecord external reviewer request” at eRecordExternalReviewerRequest@URMC.Rochester.edu at least 3 days prior to the visit and include: Study name (include CTO#), Study monitor name(s) and dates of visit /access. New request forms are need for new studies and new study monitors for an existing studies. If you have any questions please contact ResearchHelp@URMC.Rochester.edu

Find Patient Information Faster with Chart Search

A powerful new search engine lets researchers enter a keyword or keywords to search the patient chart for problems, progress notes, medications, labs, and other orders from one search bar. Users can also find and open Synopsis views, notes, and other available Hyperspace activities through this search—without needing to remember the necessary menu paths.  Click here for more information on what you can search and how it works.

CTSI and Public Health Sciences Announce New Certificate Program in Biomedical Data Science

The Clinical and Translational Science Institute and Department of Public Health Sciences are excited to announce that a new Certificate of Advanced Study in Biomedical Data Science (CAS-BDS) has been submitted for approval to the New York State Department of Education.

The program, centered around a two-semester analytic project, prepares researchers to conduct “big data” analytics for health services, clinical, and public health research. This program prepares researchers for careers in data analytics, data wrangling, and clinical and health services research using large complex datasets.

Tim Dye, Ph.D.

Tim Dye, Ph.D.

“We consulted with people from industry and in academia, and looked at the state-of-the-art in terms of what people were teaching,” said Tim Dye, Ph.D., director of biomedical informatics at the CTSI. “We created this Certificate specifically to fit with all that.”

The CAS-BDS is a stackable data analytic credential for researchers and analysts with biomedical, computer science, statistical, or health service backgrounds. The curriculum draws on a range of courses that cover the fundamentals of disease biology, health care systems, and big data management and analytics.

Coursework begins with an intensive summer session that will give researchers a solid background in data science, data management, human biology, and team science. About a half dozen courses are new, having been created specifically for CAS-BDS.

“It’s pretty intense — starting with a summer Boot Camp this July,” said Dye, who worked with faculty in the Institute for Data Science and elsewhere to make sure the Certificate complements other university data science offerings. “But we thought all these topics were required to have a good foundation in data science applied to the biomedical area.”

Several possibilities exist for the two-semester mentored project, which can have a basis in basic science, clinical work, health services, population health, or other fields. Projects will include attention to specific aim formulation, background, analytic plan development, database creation, data analysis, and reporting.

University officials expect state approval in the coming months. For more information on the CAS-BDS, contact tim_dye@urmc.rochester.edu.

Scholar Spotlight: Vankee Lin

CTSI KL2 scholar Vankee Lin, Ph.D., R.N., assistant professor in the School of Nursing and Department of Psychiatry, shares her research on Alzheimer’s Disease and memory in aging adults.

The KL2 Mentored Career Development program provides 2 years of support for new investigators interested in a career in clinical or translational research. The program is designed to support the career development of those who wish to pursue research careers in multidisciplinary clinical and translational science.

Read more about the KL2 program, and check out a list of our current and past scholars.

Director’s Update — April 2015

Every month, the CTSI Stories Blog will post excerpts from ongoing conversations with the institute’s co-directors.

Below, Karl Kieburtz talks about how the leadership is preparing for the Clinical and Translational Science Award renewals.Karl Kieburtz, M.D., M.P.H.

The new leadership structure has been in place for three months now. How are things going?

One of the great things about the change in leadership structure is it allows each of us to direct ourselves with more emphasis toward specific areas, and one of the things I’ve focused on is trying to understand what’s happening lately at NCATS. Right now, they’re very focused on the development of new methodologies and new technologies to increase the efficiency of clinical and translational research.

In research, there’s a very long window from discoveries in the lab to treatments in humans and actually influencing the health of the population. That’s often measured in decades. Can we get that down to a sub-decade measure by improving the tools we use? That’s NCATS’s big focus, and they’re demonstrating that focus by targeting their funding toward the new methodologies and technologies.

How are they targeting the funding?

The RFA for renewals for the CTSAs is coming out again soon, but they’re also having RFAs for three new structures. One is called a Recruitment Innovation Center (RIC), one is called a Trial Innovation Center (TIC), and the third is a Collaborative Innovation Network.

So the CTSA awards are the base awards, and they’re going to be reduced on the high end for institutions that had very large awards. Fortunately, we’re already among the smaller centers, so that shouldn’t affect us as much. But they’re likely going to use that reduction to pay for these new awards, and the way you grow your base award is by applying for one or more of these new structured grants.

Can you describe what they’re looking for in terms of RICs, TICs, and Collaborative Innovation Networks?

A RIC is responsible for new or more efficient ways to drive recruitment. Here, for example, through the National Center for Deaf Health Research, we’ve done a lot with the deaf community. So we’re thinking about whether that could be used as a model to recruit and engage with underserved communities, or communities with health disparities.

For the TIC, one example that would apply here is the work that Ray Dorsey has been doing with mobile technology. The mPower app, which is the Apple app that was highlighted recently, allows you to record your medications, record memory activities, there’s a voice activity, a measured gait activity. And that kind of tool is exactly the kind of methodology they’re looking for in terms of clinical trials, because it’s much more efficient than having people come into their research visits once a month.

For something like mPower, you can arrive at estimates of benefits faster. A lot of trials go on for a long period of time and are bigger because of there’s a lot variability of the data. But if you can get more data from fewer people, you can run trials faster, and you’re more efficient because there isn’t so much inter-individual variability. You often hear about certain advancements in research costing X billion dollars, but the reason for that cost is you’re actually amortizing all the failures in addition to the success. For every success, you might have 100 failures or 200 failures. But those 200 failures don’t happen early. They happen over the course of a trial or late in a trial. So one of my hopes is that by getting more accurate data early, you can fail earlier. It seems counterintuitive, but if you can cut off a line of study and save costs on something that’s ultimately going to fail, you can learn faster with more reliability. You can stop that trial and then put your energy into other things.

And then the Collaborative Innovation Network is when three or more CTSA hubs act collaboratively to develop something innovative which will improve the efficiency of trials.

mPower is a great example – what other strengths do we already possess here that could apply to the RFA?

Well what you said is important, because we want to be prepared to respond for this without chasing after something we’re not good at, or that we don’t have strong interest in, or that doesn’t tie in with our strategic aims.

But we already have an emphasis in technology and methodology as demonstrated by our clinical trial methodology pillar. We didn’t know they were going to have RICs and TICs, but we have a pre-existing emphasis on that, so that’s a big advantage.

On community engagement, which fits into the RIC side, we are ahead of the game because of the Center for Community Health and our Community Advisory Group and the efforts we’ve put in to community engagement. And structurally, we’re in a great place to look at what’s happening in the community, because we have a relatively simple and contained health care system, with two major providers, and one regional health database. Most communities aren’t that centralized.

We recently joined a large network called NIPTE where producing drugs or interventional agents can be done from basic synthesis all the way out to packaging and delivering. So that’s an additional strength.

Phil Ng and Adam Tatro have developed a tool that uses i2b2 to extract from the EMR and put into a REDcap database. They just presented that recently and it got a lot of attention because most centers don’t have that, so that could be part of an application, because we’re already developing new biomedical informatics tools to help assist in making trials more efficient.

So I think we’re going to be able to tap a few strategic domains, because they resonate well with what we’ve already been doing and what we want to improve on. And there are more that I haven’t mentioned, but that’s what Martin and Nana and I are thinking about right now: Where we are well placed to apply as a center – a RIC or a TIC – or if there’s something we should apply in to be part of an Collaborative Innovation Network.


Previous directors’ updates:

March 2015 – Martin Zand introduces himself and discusses his interest in informatics and population-based research.
February 2015 – Nana Bennett discusses the CTSI’s Seminar Series on population health.
January 2015 – Harriet Kitzman reflects on her time as a CTSI co-director.
December 2014  – Karl Kieburtz offers his takeaways from the CTSI all-hands retreat.
November 2014 – Nana Bennett speaks to the expansion of the role of the CTSI’s Community Advisory Council.
October 2014 – Harriet Kitzman discusses the science of team science.
September 2014 – Karl Kieburtz talks about why the CTSI is beefing up its informatics team.
August 2014 – Nana Bennett discusses the new Population Health pillar.
July 2014 – Harriet Kitzman offers her takeaways from the Mini Summer Research Institute.
June 2014 – Karl Kieburtz gives an overview of the CTSI’s six pillars.

URMC joins NIPTE, strengthens pharmaceutical science and engineering

The University of Rochester Medical Center has gained admission to the National Institute for Pharmaceutical Technology and Education (NIPTE), a collaborative organization dedicated to research and education in the field of pharmaceutical science and engineering.

URMC becomes the 14th member institution of NIPTE.

Cornelia Kamp, M.B.A.

Cornelia Kamp, M.B.A.

URMC’s Clinical Material Services Unit (CMSU), a core research unit of the Center for Human Experimental Therapeutics (CHET), was the key to the university’s admission. CMSU provides investigational drug and device services for many large, multi-center clinical trials conducted at URMC and elsewhere, and acts as the central pharmacy for the National Institutes of Health’s NeuroNEXT network. CMSU also works closely with the CTSI and CHET on drug development research.

“This membership in NIPTE expands the resources available to CMSU, and to researchers at the University of Rochester,” said Cornelia Kamp, M.B.A., executive director for strategic initiatives at CMSU. “A researcher can ask us a question, and if we don’t have an immediate answer, we can work on finding a solution through NIPTE.”

There is minimal overlap of expertise within the NIPTE member organizations, as each university brings something different to the table, said Kamp. Through CMSU, URMC is able to bring expertise in back-end pharmaceutical distribution — such as packaging, labeling, kitting, and drug destruction — to NIPTE. In turn, CMSU leaders hope to gain experience from other member collaborators, which could lead to gains for Rochester researchers.

Karl Kieburtz, M.D., M.P.H.

Karl Kieburtz, M.D., M.P.H.

“Through NIPTE, we have a better chance of making or procuring certain drugs that researchers might be interested in studying,” said Kamp.

The membership could also strengthen a future application that involves the Clinical and Translational Science Award program, said Karl Kieburtz, M.D., M.P.H., co-director of the CTSI, who will serve on the NIPTE Board of Directors.

“The National Center for Advancing Translational Science is developing this vision of improving the efficiency of clinical research and focusing on clinical trials,” said Kieburtz. “So we’re looking at what strengths we have that would apply towards these various centers, and CMSU’s affiliation with NIPTE is definitely one of them.”

URBEST opening enrollment for grad students, postdocs

Medical research training — for students and postdocs alike — is heavily geared towards an academic career path. But only 40 percent of Ph.D. holders go on to become professors, according to a 2012 study from the National Institutes of Health.

“There isn’t as much funding for PIs as anyone would like, and people are getting nervous as to what students and postdocs are going to be doing if there isn’t enough funding for them in academia,” said Tracey Baas, Ph.D.

Steve Dewhurst, Ph.D. (above, right) and Sarah Peyre, Ed.D., are the PIs for URBEST.

Steve Dewhurst, Ph.D. (above, right) and Sarah Peyre, Ed.D., are the PIs for URBEST.

That’s where URBEST comes in. The program, which launched in October, is one of 17 NIH-funded BEST (Broadening Experiences in Scientific Training) programs throughout the country, and provides career training to graduate students and postdocs who are considering careers outside of academia.

BEST programs differ from institution to institution, but Rochester’s program places emphasis in two main areas.

First, URBEST is designed around self-determination theory. This means the curriculum is very flexible, allowing enrollees to dip their toe into the water or dive much deeper to obtain the experience they desire. (In order to obtain a URBEST certificate, students need to accumulate 120 “points” within the program, but those points can be accumulated in a variety of ways.)

Second, URBEST places heavy emphasis on connecting students to internships, which isn’t done at every BEST program.

“But we thought the internship would make it most attractive for both the students and for future potential employers,” said Baas, executive director of URBEST.

The program allows students to pick one of three pathways, each with its own associated coursework and internship options:

The program will be accepting applications for its next cohort from April 6-17. To apply, or for more information, visit the URBEST website.

Success stories: Clinical Research Center goes “above and beyond”

The Clinical Research Center (CRC), a pillar of the CTSI, plays host to numerous research studies at the University of Rochester. Charles Kamen, Ph.D., recently used the CRC for his study of psychological distress in cancer survivors.

Kamen discussed his research, and his experience at the CRC, with CTSI Stories.

Charles Kamen, Ph.D.

Charles Kamen, Ph.D.

Tell us a little bit about your research.

I work closely with Karen Mustian, and she’s done a lot of work showing that exercise is effective in reducing side effects in people recovering from cancer. She’s shown that if you give people a home-based exercise intervention — walking regularly and increasing steps to the recommended 10,000 a day, as well as doing a resistance activity — that fatigue goes down over the course of six weeks.

I’m a clinical psychologist and I’m interested in psychological distress. So I was curious if we could use that same exercise intervention to address psychological distress in cancer survivors. I’m also interested, specifically, in psychological distress in gay and lesbian cancer survivors. There’s a lot of evidence that LGBT persons have more stress in general than heterosexual individuals do, probably because of a lifetime of discrimination and prejudice. I’ve shown in past datasets that if you look at LGBT cancer survivors, the same disparities you see in the population as a whole persist in cancer survivorship. So even in the context of cancer, which is very stressful, LGBT survivors have more stress than other cancer survivors.

So I wanted to get a group of LGBT cancer survivors, and their care partners, to come in to an intervention to see if we could study psychological stress. That’s the overall view, and that’s why I’m trying to address health disparities and psychological distress in this underserved population.

How did you come to work at the CRC?

I put together a proposal, and I got a Wilmot Cancer Center seed grant. My study is on cancer survivors and their care partners, and I’m randomizing them to have them either exercise as a pair — a dyad — or to have the survivor exercise alone. So I’m looking at whether people adhere more to an intervention when they have a partner. The thinking is that no one likes to exercise, but if you exercise with someone else, it’s going to increase the chance of you doing it. And if you exercise, that improves your immune system. So to test that, I also needed blood samples.

So there’s an exercise component, which is done in the PEAK lab, and we also need to do blood draws, and for that, one of my colleagues recommended the CRC.

What was your experience like?

The CRC went above and beyond what I expected. First, I wasn’t sure how the blood draws were going to work. I was worried that I was going to need to somehow haul the blood to a lab right away, aliquot it, and freeze it. This would’ve been tricky, because since it’s a partner study, we have two people coming in at a time. So while one person is doing the exercising with my study coordinator, I’m running the other person through the questionnaire. We would’ve needed a third person to transport, aliquot, and freeze the blood.

But the CRC was able to do all of that for me. I just brought the patient in, they drew the blood, and I took the patient down to the PEAK lab for the rest of the assessment. The CRC would spin the blood for me, aliquot it, and freeze it for me in their -20 degree freezer. Then my coordinator could come by a few days later and take it to our -80 freezer. So the convenience of that was fantastic, and I don’t know how it would’ve worked if the CRC hadn’t been able to process the blood for me.

I also knew I was going to have the participants do their physical exercises, and then I was going to have them do some questionnaires and other assessments. But I knew I was going to have to feed them before those 2 hours of other assessments, so my plan was to get yogurt and granola bars or something to offer them. But Ann Miller at the CRC told me that they have snacks there, so they could give meals to the participants. So in addition to the convenience of the blood processing, they also had meals, and we didn’t have to stock a bunch of Gogurt in the PEAK lab.

And how did the study itself go? Any results you care to share?

The LGBT population compared with heterosexuals do indeed have more psychological distress, more fatigue, and they actually report a little less support from their care partners. I didn’t expect that last part.

But over the course of the intervention, the distress for LGBT couples in the dyad comes down pretty sharply, and there’s an increase in the care partner support. Thanks to the pilot data I collected with the help of the CRC, I was able to successfully compete for a major career development award from the National Cancer Institute!