Introduction to the Principles and Practice of Clinical Research (IPPCR)

MedStar Health is proud to be participating in The Introduction to the Principles and Practice of Clinical Research (IPPCR) course established by the National Institutes of Health (NIH). The program provides training in designing a successful clinical trial by focusing on biostatistical and epidemiologic methods, study design, protocol preparation, patient monitoring, quality assurance, ethical and legal issues, and much more. Other areas covered include data management and ethical issues, including protection of human subjects. This course will be of interest to resident and fellow physicians, as well as junior level faculty, wishing to enhance their understanding and expertise in clinical research.

The course will be conducted entirely online in a self-paced format. However, it is recommended that participants view 1 to 2 lectures per week to give themselves ample time to understand the theoretical and practical aspects of the content and to prepare for the final examination. The course is comprised of approximately 40 lectures, and participants should plan approximately 50 hours to watch the video-archived lectures, and additional time for course readings, discussion board participation, and the on-line multiple choice final examination.

This course is being offered as a certificate program. Registration is required in order for you to be eligible to take the examination and receive certification. You must receive a grade of 75% to receive a certificate of completion. The final exam will be available on the course website starting January 2nd and closing on June 30th.

Textbook:  The course textbook, Principles and Practice of Clinical Research, Fourth Edition, is available online through the Georgetown School of Medicine Dahlgren Library. You will need your GU Net ID to access this.

Course Objectives:

  • Provide an overview of basic biostatistical and epidemiologic methods involved in conducting clinical research
  • Describe the principles involved in the ethical, legal, and regulatory issues in clinical human subjects research, including the role of Institutional Review Boards (IRBs)
  • Describe principles and issues involved in monitoring patient-oriented research
  • Describe the infrastructure required in performing clinical research and the steps involved in developing and funding research studies

The 2019-2020 Course Schedule, Syllabus and additional registration information is available online:

MedStar Investigator Orientation—January 23, 2020

The MedStar Health Research Institute (MHRI) is offering a one-day orientation session on Thursday, January 23, focused on conducting research at MedStar Health. This orientation session is for both early-career investigators as well as experienced investigators who recently moved to MedStar who wish to learn more about the services and resources available for every stage of the research lifecycle.

This 1-day orientation helps both experienced and early-career investigators learn to successfully conduct research within the MedStar system and access the research support services available from MedStar Health Research Institute (MHRI). Topics include:

  • An overview of the core business and research support services available to you
  • Tips and tools for finding funding and research collaborators
  • Research informatics and statistical support
  • The IRB process
  • An overview of study contracting mechanisms and financial management procedures
  • Answers to the most frequently asked compliance questions
  • Best practices for effective proposal preparation and submission

Thursday, January 23
8:00am – 4:00pm
MHRI Administrative Offices at University Town Center
6525 Belcrest Road, Suite 700
Hyattsville, MD 20782

Please email [email protected] to RSVP.
Note: breakfast and lunch will be provided.

November Peer-Reviewed Publications from MedStar Health

Congratulations to all MedStar researchers who had articles published in November 2019. The selected articles and link to PubMed provided below represent the body of work completed by MedStar Health investigators, physicians, and associates and published in peer-reviewed journals last month. The list is compiled from PubMed for any author using “MedStar” in the author affiliation. Congratulations to this month’s authors. We look forward to seeing your future research.

View the full list of publications on here.

Selected research:

  1. Silent Myocardial Infarction and Sudden Cardiac Death—Finding the Culprit
    Jama Cardiology, 2019. DOI:
    Kuku KO, Olatunji-Bello T, Garcia-Garcia HM.
  1. Neurogenic Stunned Myocardium in Severe Neurological Injury
    Current Neurology and Neuroscience Reports, DOI:10.1007/s11910-019-0999-7
    Kenigsberg BB, Barnett CF, Mai JC, Chang JJ.
  1. Evaluation of Risk-Assessment Tools for Severe Postpartum Hemorrhage in Women Undergoing Cesarean Delivery.
    Obstetrics & Gynecology, 2019. DOI: 10.1097/AOG.0000000000003574
    Kawakita T, Mokhtari N, Huang JC, Landy HJ.
  1. Bariatric Surgery Among Vulnerable Populations: The Effect of the Affordable Care Act's Medicaid Expansion
    Surgery: Official Journal of the Society of University Surgeons, Central Surgical Association, and the American Association of Endocrine Surgeons, 2019. DOI: 10.1016/j.surg.2019.05.005
    Gould KM, Zeymo A, Chan KS, DeLeire T, Shara N, Shope TR, Al-Refaie WB.
  1. Does a Care Bundle Reduce Racial Disparities in Postcesarean Surgical Site Infections?
    American Journal of Perinatology, 2019. DOI: 10.1055/s-0039-1688822
    Kawakita T, Umans JG.

Implementation Science: Time and Motion Research to Improve Inpatient Diabetes Education at MedStar

Recently published research evaluated nurse and patient care technician workflow to identify opportunities for providing education to patients during care. The study sought to examine the feasibility of implementing a diabetes education program on a tablet computer in the hospital setting within existing nursing workflow with existing staff.

“Understanding Nursing Workflow for Inpatient Education Delivery: Time and Motion Study” was published in the Journal of Nursing Care Quality. The collaborative research team included Kelley M. Baker, MA and Kelly M. Smith, MSc, PhD from the MedStar Institute for Quality and Safety and MedStar Health Research Institute; and Michelle Magee, MD from the MedStar Diabetes Institute, MedStar Health Research Institute and the School of Medicine and Healthcare Sciences at Georgetown University.

The researchers conducted a time and motion study of nurses and patient care technicians on three medical-surgical units within a 912-bed tertiary care medical center. Two units were standard medical-surgical units and the third unit was a cardiac care unit. Five trained observers conducted observations in 2-hour blocks. During the observation block, one observer shadowed a nurse and one observer shadowed a patient care technician and recorded tasks, locations, and their durations using a web-based time and motion data collection tool.

The results of this observation study show that nurses spent approximately one-third of their time in direct patient care and 60% on the unit but not in a patient room. Patient care technicians spent 42% of their time in direct patient care, compared with nurses. Patient care technicians averaged 18.2 tasks per hour, while nurses averaged 16.2. On average, the amount of time spent for a direct patient care session was 3:42 minutes for nurses and 3:02 minutes for patient care technicians. For nurses, 56% of task durations were 2 minutes or less and 38% were 1 minute or less. For patient care technicians, 62% of task durations were 2 minutes or less and 44% were 1 minutes or less. Nurses visited 5.3 patient rooms per hour, while patient care technicians visited 9.4 patient rooms per hour.

The research team concluded that within the existing workflow of nurses and patient care technicians, constantly in and out of patient rooms, it is possible to deliver a tablet to the patient to provide diabetes education. However, the short duration of direct patient care sessions could potentially limit the ability of the nurses and patient care technicians to spend much time with each patient on instruction for use of the technology platform or in answering questions about the content. Diabetes self-management education and support is beneficial for persons living with diabetes. Future research should identify ways to implement technology to support education delivery in the hospital within the existing workflow for nurses and patient care technicians.

This research was funded by the National Institutes of Diabetes and Digestive and Kidney Diseases (R34DK109503). Dr. Smith also received funding from the National Center for Advancing Translational Sciences of the National Institutes of Health under Award Number UL1TR001409.

JMIR Nursing, 2019. DOI: 10.2196/15658

KL2 Junior Faculty Scholars Program: Now Accepting Applications

Georgetown-Howard Universities Center for Clinical and Translational Science (GHUCCTS) is now accepting applications for its KL2 Junior Faculty Scholars Program. Projects that are novel, inter- or multi-disciplinary and collaborative will be favored. The KL2 scholars will be awarded up to $90, 000 salary support and $40,000 project support per year (for up to three years).

Who is eligible: Junior Faculty with a full-time or equivalent appointment at a GHUCCTS institution (Georgetown University, Howard University, or MedStar Health) at the time of award activation. Scholars must devote 75% effort to the program for three yearsscholars must be US Citizens, Non-citizen Nationals, or Permanent Residents. Individuals who were, or currently are Principal Investigator of NIH R01, P01 or P50 subprojects, or individual K (e.g., K01, K08, K22, K23) grant ARE NOT eligible; current/former PIs of non-NIH peer reviewed research grants >$100k annual direct costs are ineligible.

Pre-Applications are due DECEMBER 13, 2019
Final Applications are due FEBRUARY 19, 2020

Online Informational Sessions:
November 22nd - 2:00PM
November 25th - 5:30PM
December 2nd – 3:00PM
December 4th- 2:00PM

To register for the sessions, e-mail [email protected]

Learn more on the GHUCCTS website

QUESTIONS? Contact the Executive Committee:
Jason G. Umans, MD, PhD [email protected]
Dexter L. Lee, PhD [email protected]
Kathryn Sandberg, PhD [email protected]

MedStar Investigator Receives the ‘Women Advancing Thyroid Research’ Award

Join us in congratulating Cristiane Gomes-Lima, MD, on her 2019 Women Advancing Thyroid Research (WATR) award from the American Thyroid Association (ATA). The WATR is a new award from the American Thyroid Association that recognizes and celebrates the work of women that are leading outstanding thyroid research. The WATR Award is sponsored by Mary Ann Liebert, Inc. through the Rosalind Franklin Society.

Dr. Gomes-Lima presented her award-winning work, “Do Molecular Profiles of Primary versus Metastatic Radioiodine Refractory Differentiated Thyroid Cancer Differ?” as a highlighted oral presentation at the ATA conference in late October. Her work was recognized at the Women in Thyroid meeting of the ATA.

The research focused on patients with advanced differentiated thyroid cancer. The research team sought to understand the molecular biology of the primary tumor and its metastases. They leveraged a bioinformatics approach to explore the interconnections of abnormal cancer genes in the context of thyroid physiology. In the era of precision medicine, this knowledge is essential to offer optimal treatment choices for our patients. “This award reassures my commitment to advance health through research,” said Dr. Gomes-Lima.

Dr. Cristiane Gomes-Lima graduated in Medicine from the University of Brasilia, Brazil. She completed her Internal Medicine residency, followed by Endocrinology fellowship and a master’s degree in Health Sciences. After working in clinical practice, she pursued a post-graduate research fellowship in thyroid cancer. She is currently a research fellow at MedStar Health Research Institute, in Washington, DC, and a guest researcher at the National Institutes of Health in Bethesda, Maryland.

In addition to Dr. Gomes-Lima, there were three other recipients of the award: Drs. Mariella Tutter, Silvia Ippolito, and Rosa Falcone. The ATA press release can be viewed here.

Master’s Degree in Health Informatics & Data Science at Georgetown University

The Master's in Health Informatics & Data Science (HIDS) at Georgetown University is an industry-driven program, focused on current and emerging technologies that will inform healthcare. Students will gain core competency in data science, big data analytics, artificial intelligence, and machine learning applications to achieve Precision Medicine and Value-based healthcare. The program curriculum aligns with the core competencies for training in the field of medical informatics by the American Medical Informatics Association (AMIA).

Georgetown University’s graduate and professional programs are among the most rigorous and respected around the world. The program offers students access to Georgetown’s distinguished faculty and unique opportunities in the nation’s capital.

If you are a prospective student and desire more information about the program, visit here.


MedStar Researchers Evaluate Coffee and Tea Consumption in Relation to Risk of Rheumatoid Arthritis

Recently published collaborative research evaluated whether tea or coffee consumption is associated with an increased risk of incident rheumatoid arthritis using the Women’s Health Initiative Observational Study. The research team included members from MedStar Washington Hospital Center, National Institute of Nursing Research, Fred Hutchinson Cancer Research Center, National Institute of Environmental Health Science, MedStar Health Research Institute and Georgetown/Howard Universities Center for Clinical and Translational Sciences.

The Women’s Health Initiative was a long-term national health study which MedStar Health Research Institute joined as a collaborating center in 1994, under the direction of Barbara Howard, PhD. The observational study includes a cohort of 93,676 postmenopausal women, age 50 to 79, whom were enrolled from 1993 to 1998. In the study, 76,853 women completed a self-administered questionnaire at baseline providing information on their daily consumption of tea and coffee.

During analysis, the study team found that previous studies have shown an increased risk of rheumatoid arthritis associated with consumption of decaffeinated coffee, but no such association with caffeinated coffee intake. Many teas such as green tea, black tea, and oolong tea have been considered as antioxidants and perhaps reducing the risk of rheumatoid arthritis. However, several studies have suggested no relationship between tea consumption and rheumatoid arthritis. Other risk factors such as age, race/ethnicity, cigarette smoking, medical history, medication use, and other lifestyle behaviors may also be associated with an increased risk of rheumatoid arthritis.

There were 185 women who self-reported incident cases of rheumatoid arthritis. The results show that women with a history of nonherbal, nondecaffeinated tea consumption of any amount had an increased risk of developing rheumatoid arthritis during the first 3 years of observation in the Women’s Health Initiative Observation Study. The study results do not show any association between coffee intake and rheumatoid arthritis but there is a minimal increased risk of incident rheumatoid arthritis with caffeinated tea consumption.

The study authors are Diman Lamichlane, MD; Christopher Collins, MD; Florina Constantinescu, MD, PhD; Brian Walitt, MD; Mary Pettinger, MS; Christine Parks, PhD, MSPH; and Barbara Howard, PhD.

Journal of Clinical Rheumatology, 2019. DOI: 10.1097/RHU.0000000000000788

Now Open: AcademyHealth Delivery System Science Fellowship

The Delivery System Science Fellowship application cycle for the 2020 cohort is NOW OPEN! The Academy Health Delivery System Science Fellowship (DSSF) provides a year-long professional development opportunity for highly qualified, doctorally-prepared individuals to gain more applied experience in a delivery system setting. MedStar Health Research Institute is one of six participating host sites. We are pleased to welcome Jason Brown, PhD, RN as our Academy Health Delivery System Science Fellow for this year. Dr. Jason Brown’s research interest include patient and provider decision support, behavioral economics, data science, clinical informatics, and healthcare disparities. Read his full bio here.

The goal of the fellowship is to provide hands-on training and professional opportunities for highly qualified researchers with a background in health services research (HSR) or related fields to enhance analytic skills and ultimately increase the capacity of the HSR workforce. Applications are now being accepted for 2020. The deadline to apply is January 1, 2020.

Submit an Intent to Apply
Once applicants submit a brief Intent to Apply form, they will receive a link to the full application.

Application Deadline: Wednesday, January 1, 2020, at 5:00 p.m. ET
Questions? Please contact DSSF staff at [email protected]

October Peer-Reviewed Publications from MedStar Health

Congratulations to all MedStar researchers who had articles published in October 2019. The selected articles and link to PubMed provided below represent the body of work completed by MedStar Health investigators, physicians, and associates and published in peer-reviewed journals last month. The list is compiled from PubMed for any author using “MedStar” in the author affiliation. Congratulations to this month’s authors. We look forward to seeing your future research.

View the full list of publications on here.

Selected research:

  1. Second-generation drug-eluting resorbable magnesium scaffold: Review of the clinical evidence
    Cardiovascular Revascularization Medicine, 2019. DOI:10.1016/j.carrev.2019.10.012
    Ozaki Y, Garcia-Garcia HM, Shlofmitz E, Hideo-Kajita A, Waksman R.
  2. Virtual reality for pain management in patients with heart failure: Study rationale and design.
    Contemporary Clinical Trials Communications, 2019. DOI:10.1016/j.conctc.2019.100470     
    Stewart D, Mete M, Groninger H.

  3. Outcomes of the Medial Femoral Trochlea Osteochondral Free Flap for Proximal Scaphoid Reconstruction.
    Journal of Hand Surgery, 2019. DOI: 10.1016/j.jhsa.2019.08.008 
    Pet MA, Assi PE, Yousaf IS, Giladi AM, Higgins JP.

  4. Diabetes Education for Behavioral Health Inpatients: Challenges and Opportunities.
    Journal of the American Psychiatric Nurses Association, 2019. DOI:10.1177/1078390319878781
    Bardsley JK, Baker KM, Smith KM, Magee MF.