SCORE Half-Day Seminar: A Minds-On Practice

The Study Coordinators Organization for Research & Education (SCORE) recently held its 8th annual Half-Day Seminar. This year, the seminar included lectures on self-determination theory, standard operating procedures, and mindful practice, and also focused on root cause analysis, a method of reviewing adverse events that occur in clinical research in order to prevent recurrence.

SCORE, which is part of the Clinical and Translational Science Institute, provides support and networking opportunities for research coordinators and staff across the University of Rochester. With recent changes in Food and Drug Administration guidelines for investigation of adverse events in clinical trials, some of the burden of root cause analysis has fallen to study coordinators and research nurses.

Multi-Cultural Office Staff Sitting Having Meeting TogetherThat is why the Seminar Planning Committee, according to Nancy Needler, Manager, CTSI Research Coordinator Program decided to include a hands-on and “minds-on” root cause analysis practice in breakout sessions this year – a first for the SCORE Half-Day Seminar.

The hands-on practice was kicked off with a lecture on root cause analysis by Michael Leonard M.D. M.S., associate professor of Pediatrics and associate chief quality officer for UR Medicine. During his lecture, Leonard and a group of actors introduced a hypothetical scenario of an adverse event in clinical research. In the scenario, a teenaged participant in a clinical trial for a depression medication was sent to the emergency department after overdosing on the study drug.

According to Needler, key information was purposefully left out of the scenario introduction, “because you never have all of the information from an event in normal life situations.”

Seminar participants had the opportunity to gather more information by asking the actors questions prior to breaking into groups for discussions with trained facilitators. The seminar participants divided into six groups to review the facts and find areas or policies that could be changed to prevent this adverse event from happening again.

“What I thought was wonderful from all of the teams,” says Needler, “was that none said ‘it was so-and-so’s fault’. They all examined the process; not the person.”

That is key in root cause analysis. The goal is to identify the sources of error in a systematic process and to develop approaches that address the root of the issue.  The seminar’s scenario reflects the reality that research teams plan and manage study activities with the utmost focus on ensuring participant safety and maintaining data integrity.

The presentation that followed the root cause analysis activity was an orientation to the development of Standard Operating Procedures (SOPs), which are a set detailed instructions for each process used in a clinical study. Root cause analysis often leads to development or modification of SOPs in order to prevent future adverse effects or breaches of protocol.

Closing the Half-Day, attendees participated in a mindful exercise guided by Ronald Epstein MD, professor of Family Medicine, Psychiatry and Oncology at URMC.   Attendees were introduced to the concepts of mindfulness, to promote resilience and well-being in the workplace.

The seminar was well-attended with 123 participants from 9 institutions, with over 30 University of Rochester departments represented.

Clinical Trials Day: A History of Fostering Clinical Research

Today is Clinical Trials Day, an international day of recognition for the scientists, study teams, and volunteers that make new health care discoveries possible. Clinical Trials Day is celebrated on May 20th each year in honor of the start of what is largely regarded as the first clinical trial.

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British warship similar to the one on which James Lind conducted the first clinical trial.

On May 20, 1747, a surgeon in the British Royal Navy, James Lind, randomly assigned 6 pairs of sailors afflicted with scurvy to a variety of dietary regimens. Scurvy, a vitamin C deficiency, is characterized by fatigue and bleeding gums and was common among sailors, who had little access to fresh fruit on long voyages. After 6 days on their special diets, only the sailors who were given oranges and lemons showed drastic improvement.

The idea to use citrus fruit for treatment of scurvy came from centuries of prior knowledge – dating back to Vasco De Gama’s expedition to India in 1497. However, the British Royal Navy didn’t adopt the use of citrus juice on ships as common practice, until 40 years after Lind published his results.

The story of Lind and the history of scurvy demonstrates the many roadblocks between scientific discovery and improving the health of a population. Some of these same roadblocks exist today – though, thankfully, to a lesser degree. While it may no longer take centuries to develop new ideas into life-saving therapies, it still can take several decades.

The CTSI is built around breaking through those roadblocks and facilitating scientists in moving their work forward. The institute offers services and guidance all along the spectrum of research, including the design and implementation of clinical trials, which are much more complicated and sophisticated than Lind’s rudimentary trial.

“It’s great that we have a chance at the University of Rochester to go from the inception of the idea to actually have patients coming to be evaluated [in a clinical trial],” says Giovanni Schifitto, MD, MS, Director of the Clinical Research Center and professor of Neurology at the University of Rochester Medical Center. “It’s a full circle.”

The Clinical Research Center (CRC) is an essential resource for the implementation of clinical trials offered by the CTSI. The CRC offers a safe and comfortable place for patients and study volunteers to receive treatments and employs a dedicated, knowledgeable staff that is vital to its success.

“Clinical research is very important and the research nurse is at the forefront of the process,” says Ann Miller, RN, MS, CCRC, nurse manager of the CRC. “The CRC nurses have skill sets that range from neonate to geriatric experience. In conjunction with the Bionutrition staff, Imaging Sciences, and Health Project Coordinator we benefit, and enhance, each other’s knowledge base and I think that’s been very helpful.”

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Richard Moxley, MD utilizing the Clinical Research Center.

In addition to traditional nurse training for the hospital, the nurses of the CRC are required to undergo continual specialized training to keep them up-to-date on best practices in clinical research and to give them a solid understanding of each of the studies they facilitate. Each investigator that wishes to utilize the CRC must give an inservice training to explain the science behind the study as well as detailed information about what the CRC staff will need to do, when, and why, with the overall goal of making the CRC an integral part of the investigating team.

 

The CRC commonly carries over 100 studies at once. Right now, they are implementing around 80 clinical trials that aim to cure, prevent, or better diagnose 35 different diseases. From understanding the cause of cognitive decline in HIV patients to testing new drugs for rare, debilitating diseases like Duchenne Muscular Dystrophy, the CRC staff is integral to a process that offers hope not only to their study participants, but to millions of people suffering with these diseases around the world.

“We are lucky,” Schifitto says, “to have a resource like the CRC. There are institutions that don’t have such a resource and therefore cannot do certain studies.”

Schifitto also points out that the CRC is just one clinical trial resource offered by the CTSI. While the CRC aids with the implementation phase of a trial, the CTSI also offers help with designing trials, developing helpful collaborations, navigating regulatory processes, recruiting the required amount of participants – especially from populations that are typically under-represented in clinical research, training and providing study personnel, and the collection and management of clinical data.

The CTSI is also affiliated with the Center for Human Experimental Therapeutics (CHET), which was established to conduct rigorous initial investigations of new therapies for musculoskeletal, cardiovascular, neurologic, infectious/immunologic disorders and cancer. CHET facilitates initial clinical trials from many disciplines around the URMC – from vaccines being produced by the infectious disease program to innovative therapies for cancer being tested in the Wilmot Cancer Institute.

All of the resources provided by the CTSI help researchers take their ideas from the laboratory to the clinic and help put URMC at the forefront of biomedical research.  With these resources, our dedicated researchers strive to cure debilitating diseases and improve the lives of the millions of people suffering around the world.

Practice Root Cause Analysis at SCORE Half Day Seminar

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The registration deadline to attend the 8th Annual Study Coordinators Organization for Research and Education (SCORE) Half Day Seminar is quickly approaching.  This year’s seminar will feature a simulation of root cause analysis, a methodology to review adverse events, identify key causes and contributing factors and implement system-based solutions. Recent changes to guidelines for investigation and prevention of non-compliance in clinical trials require sponsors and often research teams (study coordinators and research nurses) to be able to perform root cause analysis.

Clinical trial protocols are designed to examine specific scientific questions while minimizing risks to patient safety and maintaining data integrity.  Clinical trials have become increasingly large and complex over the past few decades. It is not uncommon for a trial to have many sites that span the nation or the globe and study teams that may change in personnel during the trial. This increased complexity leads to greater risk of errors and non-compliance, resulting in deviations from the protocol.

Guidance for Industry: Oversight of Clinical Investigations – A Risk-Based Approach to Monitoring, has set expectations that all sponsor or clinical research organization (CRO) personnel should review the monitoring plan and be prepared to perform a root cause analysis, and to implement appropriate corrective and preventative actions when deviations occur.

When things go awry in clinical research, it is essential to understand the underlying cause(s) of the error or protocol failure. Root cause analysis gets to the core of the issues, which are often related to system defects in communication, policies and processes, environment, information management and/or human resources. Depending on the root cause identified, system-based solutions are designed to reduce or eliminate the risk of the event recurring.

One thing to keep in mind is that, by their very nature, root cause analyses are not one-size-fits-all. The nature of issues and the optimal intervention will vary from site to site and from study to study. This is why it is important to do a thorough assessment of each critical issue as it arises and devise targeted solutions to prevent future issues.

To learn more about root cause analysis and the expectations for study coordinators and research nurses, register for the SCORE Half Day Seminar.

The seminar will be held on Tuesday, June 7th in the Ryan Case Method room in the URMC with live streaming available at an overflow site. Parking will be available for non-UR attendees for $6 fee.

For more information, please contact SCORE@urmc.rochester.edu.

An Eye on Global Health: The Rochester Global Health Symposium

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The CTSI recently hosted a full-day symposium to discuss current global health issues, such as the spread of the Zika virus, global cancer prevention and control, addressing global health disparities using new approaches and technologies, and more.

If you are interested in learning more about these topics, you can find a full video of the symposium here and the full agenda and additional information here.

The Rochester Global Health Symposium & UNYTE Scientific Session, which was organized by the Global Network Coordinating Center and UNYTE, featured presentations by leaders in global health research who are part of the Global and Territorial Health Research Network, or “Global Network”.

The Global Network, which was created with funding from the CDC Prevention Research Centers (PRC) Program, is an international collaborative web of academic and public health institutions and their community partners. The network strives to reduce disease burden in areas of the world that lack sufficient resources. A major strategy in achieving this is to understand lessons learned around the world in controlling and preventing diseases, and applying those solutions in under-served areas of the US and affiliated regions in a community responsive way.

The symposium included a full day of presentations with breakout discussion sessions as well as a student poster session and competition. Three students were recognized for the outstanding scientific merit and visual quality of their posters out of 27 poster presenters.

Scientific AwardClaire E. McCarthy: Dung Biomass Smoke Exposure Attenuates Immune Responses to Toll-like Receptor Ligands in Airway Epithelial Cells in Mice

Visual AwardKaren C. Chong: Relationship Between Age and ASQ-3 Scores Per Screening Interval in Peruvian Infants

Poster Presentation AwardZhishen Pan: Towards Understanding How News Coverage Affects Public Perception during Epidemic Outbreak

 

SCORE Half-day Seminar: Call for Posters!

Confident businesswoman giving a presentation at white boardResearch study coordinators and project nurses are invited to register and submit posters for the CTSI-sponsored 8th Annual Study Coordinators Organization for Research and Education (SCORE) Half-Day Seminar taking place at the URMC on Tuesday, June 7th.

The SCORE Half-Day Seminar is a morning of learning and professional development for research personnel. Researchers, study coordinators, and project nurses are encouraged to participate in discussions about autonomous motivation  and supporting psychological needs in the workplace,  learning problem-solving skills, such as root cause analysis, to address errors and reduce risk, understanding how to plan, implement, and maintain standard operating procedures and learning how “being mindful” promotes resilience and well-being.

Study team members interested in presenting a research-related poster must submit their entry by Friday, May 6 at 4pm. The poster session will kick off the seminar from 7:30 to 8:00am on Tuesday, June 7. Presenting authors must remain by their posters for the 30 minute poster session and posters will remain on display throughout the half-day seminar.

All attendees (nurses and non-nurses) can earn 3.83 continuing education contact hours from the University of Rochester Center for Nursing Professional Development, which is accredited as a provider of continuing nursing education by the American Nurses Credentialing Center’s Commission on Accreditation.

The seminar is presented by SCORE and the University of Rochester School of Nursing, and sponsored by the Association of Clinical Research Professionals and CTSI.

For further information about poster submissions or to register for the seminar on-line by June 2, click here.

Please contact SCORE@urmc.rochester.edu, with any questions.

 

RocHackHealth: A Path Toward New Solutions to Health Care Issues

RocHackHealth, a health care data hackathon hosted by the University of Rochester CTSI, was held this past weekend, April 8th –  10th, and was a great success. Teams of “hactivists” competed to come up with innovative big data solutions to three issues currently facing the US health care system.

The A Team, which included Alykhan Alani, Adora D’Souza, Arnab Sarkar,  Anas Abidin,  Sushant K,  won the first challenge using Medicare data to predict and prevent hospital readmissions.

The second challenge,  to examine patterns of controlled substance prescription in the US and identify potential over-prescribers was won by Team AHA members, Anthony Corbett, Hillary Lincourt, Andy Straw. In fact, Team AHA managed to identify several medical providers who are currently being investigated, or are serving sentences, for over prescribing narcotics.

Finally, Team Datalization members Giulia Paris, Hunter Johnston, Thanatcha Khunket (Kwan), Zino HuThe won the third challenge using Medicare data to identify social networks of health care providers in New York State.

For more images and information on the winners, click here.

Can Big Data Transform Health Care?

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Last night, Martin Zand, M.D., Ph.D., director of the Rochester Center for Health Informatics and co-director of the CTSI discussed the future of big data in health care at the Simon Business School New York City Seminar Series.

Big data, defined as too large or complex to be captured, analyzed, or stored by conventional data processing methods, has captured the world’s attention in recent years. The inception of many new and inexpensive ways to collect large amounts of data (think Fitbit® and genome sequencing), has unlocked new and boundless potential to inform practices in business, government, health care, and beyond.

MartinZandNEWWhen it comes to health care and medical research, data abounds. Data is collected in real time by medical devices, such as EEG, and new technological devices, such as consumer fitness monitors or wearable health monitors. Millions of clinical images, laboratory results, and electronic medical records are produced every day. Massive amounts of de-identified patient data are also available from national registries and Medicare. The human genome is itself a treasure trove of information and the Precision Medicine Initiative Cohort aims to collect and analyze one million genome sequences. All of these examples show that the US has numerous resources and a preponderance of big data that could be used to improve health care in the US … and it sure could use some improvement.

It’s no secret that the US overpays and under performs in the health care sector compared to other nations. We pump much more money – most of which comes from private sources – into health care than any other nation in the world and yet we have shorter life spans and higher infant mortality than countries who spend less on health care. According to The Commonwealth Fund Executive Rankings from 2014, although the US health care system does well in terms of safety and overall efficacy of medical care, it ranks poorly overall and in terms of health care efficiency, equity, and in the health of our daily lives.

However, the boundless potential offered by big health care data will remain untapped if data analysis methods fail to keep pace with data collection. In his talk, Zand suggested that we need to remove obstacles of data sharing and use, improve data visualization and train researchers and health care professionals on how to collect and handle data. Then we can use this data to figure out who is doing things well – in terms of health care data analysis and health care outcomes – and emulate them. Using big data, we could predict when and where adverse events might occur, and intervene before they happen. Similarly, we could predict risk of disease in patients from their genetic data and implement preventative medicine. Data science can also help us figure out why quality and cost of health care varies across the nation and how to standardize it, how to get health care to remote areas efficiently, and how to leverage networking between healthcare providers.

There are many issues in the US health care system that could be addressed using big data. Zand urges researchers to clearly identify issues needing intervention, try many different methods of analyzing the data, ensure the data is accurate and reliable, and to share their results.  That is one promising path to transforming US health care in the new era of big data.