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MedStar Health Publishes Collaborative Research to Explore the Prevalence of Inflammatory Heart Disease Among Professional Athletes With Prior COVID-19 Infection

Recently published collaborative research evaluated the prevalence of detectable inflammatory heart disease in professional athletes with prior COVID-19 infection, using current return-to-play screening recommendations. The major North American professional sports leagues were among the first to return to full-scale sport activity during the COVID-19 pandemic. Each of these professional sports leagues (MLS, MLB, NHL, NFL, and the men’s and women’s NBA) implemented a program for all players who had tested positive for COVID-19 prior to resumption of team-organized sports activities. “Prevalence of Inflammatory Heart Disease Among Professional Athletes With Prior COVID-19 Infection Who Received Systemic Return-To-Play Cardiac Screening” was published in JAMA Cardiology.

The goal of the study is to assess the prevalence of clinically detectable and relevant cardiac injury in athletes testing positive for COVID-19 and the efficacy of consensus screening recommendations in achieving a safe return to competitive sports. This cross-sectional study reviewed return-to-play cardiac testing performed between May and October 2020 on professional athletes who had tested positive for COVID-19. Troponin testing, electrocardiography (ECG), and resting echocardiography were performed after a positive COVID-19 test result. Those with abnormal screening test results were referred for additional testing, including cardiac magnetic resonance imaging and/or stress echocardiography.

The study included 789 professional athletes. The results show a total of 460 athletes had prior symptomatic COVID-19 illness and 329 were asymptomatic or minimally symptomatic but had tested positive for the virus. Using the return-to-play cardiac screening algorithm, 6 athletes had an abnormal troponin level, 10 athletes had ECG abnormalities warranting further cardiac evaluation, and 20 athletes had an echocardiographic finding necessitating additional testing to exclude acute cardiac injury. No adverse cardiac events occurred in athletes who underwent cardiac screening and resumed professional sport participation.

The study team concluded “while long-term follow-up is ongoing, few cases of inflammatory heart disease have been detected, and a safe return to professional sports activity has thus far been achieved.” Further research is needed to understand whether there may be long-term cardiac effects among athletes infected with COVID-19, whether or not they were symptomatic.

This study was co-authored by Dr. Andrew Tucker, Medical Director of MedStar Union Memorial Hospital Sports Medicine and. Dr. Tucker also serves on the US National Football League General Medical Committee.

Jama Cardiology, 2021. DOI: 10.1001/jamacardio.2021.0565

MedStar Health Researchers Investigate the Effects of Headgear in High School Girls’ Lacrosse

A collaborative investigation was undertaken to evaluate potential differences in rates, extent, and game-play characteristics of impacts among players with and without headgear during high-school girl’s lacrosse competition. “The Effects of Headgear in High School Girls’ Lacrosse” was published in The Orthopaedic Journal of Sports Medicine. The research was completed in collaboration with the Sports Medicine Assessment, Research & Testing (SMART) Laboratory at George Mason University in Manassas, VA.

The goals of this study were to determine whether differences in the rates and magnitudes of impacts to the head and other areas of the body occurred in players with and without headgear during competition, along with determine if the distribution of impact mechanisms and penalties called for impacts were different with the introduction of headgear. With the growing popularity of girls’ lacrosse among high schools in the US, the reporting of head injuries has also increased. Recent studies have incorporated sensor technology and video surveillance to characterize head impacts and head injuries.

The study included a cohort of 49 girls from a single high school lacrosse team during the 2016 season (no headgear; 18 games) and 2017 (headgear; 15 games). In 2017, a performance standard (ASTM F3137) for girls’ lacrosse headgear became commercially available. Each participant was assigned a wearable sensor affixed behind their ear. All game-related impacts recorded by the sensors were verified on video. Data was collected to describe game-play characteristics among players with and without headgear.

The study recorded 649 sensor-instrumented player-games and 204 impacts ≥20g were verified as game-related impacts using video analysis. The results show that most impacts were imparted to the player’s body (74.5%), rather than to the player’s head (25.5%). Impact rates per player-game did not vary between the no headgear and headgear conditions. No game-related concussions were reported during this study.

The research team concluded that lacrosse headgear use was associated with a reduction in the magnitude of overall impacts but not a significant change in the rate of impacts, how they occur, or how penalties were administered for impacts sustained during competition. Further research is needed with a larger sample and different levels of play to evaluate the consequences of headgear use in girls’ lacrosse.

The Orthopaedic Journal of Sports Medicine., 2020. DOI: 10.1177/2325967120969685

March Peer-Reviewed Publications from MedStar Health

Congratulations to all MedStar researchers who had articles published in March 2021. 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 PubMed.gov here.

Selected research:

  1. Pharmacologic Treatments for PCOS Patients.
    Clinical Obstetrics and Gynecology, 2021. DOI: 10.1097/GRF.0000000000000597
    Kodama S, Torrealday S.

  2. Lessons Learned from Caring for Patients with COVID-19 at the End of Life.
    Journal of Palliative Medicine, 2021. DOI: 10.1089/jpm.2020.0251
    Rao A, Kelemen A.

  3. Evaluation of Maternal-Fetal Triage Index in a Tertiary Care Labor and Delivery Unit.
    American Journal of Obstetrics & Gynecology MFM, 2021. DOI: 10.1016/j.ajogmf.2021.100351
    Kodama S, Mokhtari NB, Iqbal SN, Kawakita T.

  4.  Assessing the Relationship Between Bone Density and Loss of Reduction in Nonsurgical Distal Radius Fracture Treatment.
    Journal of Hand Surgery, 2021. DOI: 10.1016/j.jhsa.2021.02.002
    Ghodasra JH, Yousaf IS, Sanghavi KK, Rozental TD, Means KR Jr, Giladi AM.

MedStar Health Proud of SPIRIT Award Recipient Allie Moses

Allie Moses was awarded the SPIRIT of Excellence Award during the MHRI Virtual Town Hall.  Allie is the Manager of the Clinical Research Systems and Recruitment Center, Chair of the MHRI Wellness Committee, and Co-Chair of MedStar Research AIDE. The award was presented by Tina Stanger, Assistant Vice President of Research Administration.

Allie was recognized not only for the work she does as a superb manager day to day but also for leading the work of the Wellness Committee for MHRI along with the work she does with AIDE to change MHRI for the better. Allie is an awesome team player and we are thankful for her “willingness to step up, speak up, and lead.”

“I wanted to make sure you knew from my perspective how incredibly valuable and valued you are to MHRI—as a colleague, manager and leader,” said Deliya Wesley.

The SPIRIT Award is given to recognize and reward one associate (management or non-management) each quarter, who excels in Service, Patient First, Integrity, Respect, Innovation, and Teamwork.

Nominations are based on submission to the MHRI Kudos program. Each quarter, the MHRI Executive Team will review the KUDOS submissions and select an associate or manager who best exemplifies all our SPIRIT values.

MedStar Health Researchers Assess Emergency Department Care Coordination Strategies Across Maryland’s Hospital System

Researchers from MedStar Health evaluated emergency department care coordination processes and their perceived effectiveness across Maryland’s hospital system, which were seeking to reduce hospital admissions due to financial considerations led by Maryland-state governance. “Emergency Department Care Coordination Strategies and Perceived Impact Under Maryland’s Hospital Payment Reforms” was published in the American Journal of Emergency Medicine. The goals of the study were to characterize the scope and variation of emergency department care coordination strategies in response to Maryland reforms and describe how physician leaders and care coordination staff perceive the effectiveness of specific strategies.

In 2014, Maryland expanded its all-payer hospital rate-setting model into a population-based global budget revenue model, which replaced fee-for-service hospital payments and introduced quality pay-for performance incentives for acute-care hospitals. The model has incentivized a shift towards non-hospital care and reduced hospital admissions. The research team conducted a total of 25 semi-structured interviews across 18 different hospital emergency departments with emergency department physician leadership (n = 14) and care coordination staff (n = 11) to examine emergency department care coordination processes and understand the focus of care coordination efforts. The interviews assessed the perceived efficacy of care coordination and identified barriers to success, as well as the influence of Maryland’s payment reform model on emergency department care coordination strategies.

The results showed that across all emergency departments, there was significant variation in the hours and types of care coordination staff coverage and the number of initiatives implemented to improve care coordination. Most participants perceived Maryland’s reform with global budgeting as having a mixed impact on emergency department care coordination and overall emergency department care. Participants perceived emergency department care coordination as effective in facilitating safer discharges, improving outpatient follow-up and addressing social determinants of health; however, adequate access to outpatient providers was a significant barrier. Emergency department physician leaders identified improved care transitions and patient care but experienced increased workloads to avoid admissions and support safe transitions among their discharged patients.

Although the observed care coordination initiatives were perceived to produce positive results, Maryland's global budgeting policies were also perceived to produce barriers to improving emergency department care. Further research is needed to determine the association of the different strategies to improve emergency department care coordination with patient outcomes to inform practice leaders and policymakers on the efficacy of the various approaches.  This research was led by Dr. Jessica Galarraga, a MedStar Health economics investigator and emergency medicine physician.

American Journal of Emergency Medicine, 2021. DOI: 1016/j.ajem.2020.12.048

MedStar Health Researchers Adapt Diabetes to Go-Inpatient Program to Implement Diabetes Survival Skills Education Within Nursing Unit Workflow

Diabetes researches from across MedStar Health sought to develop a strategy to enable hospital nursing unit staff to deliver diabetes survival skills education to adults with type 2 diabetes within their usual workflow using an adaptation of the Diabetes to Go (D2Go) program to fill the gap in education delivery on inpatient units.

Diabetes survival skills education (DSSE) focuses on core knowledge and skills necessary for safe, effective, short-term diabetes self-care. Inpatient diabetes survival skills education delivery approaches are needed. “Diabetes to Go-Inpatient: Pragmatic Lessons Learned from Implementation of Technology-Enabled Diabetes Survival Skills Education Within Nursing Unit Workflow in an Urban, Tertiary Care Hospital” was published in The Joint Commission Journal on Quality and Patient Safety. Diabetes to Go is an evidence-based diabetes survival skills education program originally designed for outpatients.

The Practical, Robust Implementation and Sustainability Model (PRISM) was used to help redesign D2Go for delivery and evaluate the feasibility of integrating a high-tech tablet computer-enabled DSSE program for hospital inpatients. The study team conducted interviews and focus groups with stakeholders to identify perceived barriers and facilitators for implementation; redesigned the D2Go program via stakeholder feedback and education and human factors principles; developed implementation design for tablet delivery and patient engagement by unit staff; and completed a prospective cohort implementation feasibility study on three medical/surgical units.

The results identified 596 adults with type 2 diabetes on three medical/surgical units, 415 (69.6%) were program eligible. Of those eligible, 59 (14.2%) received, accessed, and engaged with the platform; and among those, 43 (72.9%) completed the intervention, representing just 10.4% of those eligible. Multilevel implementation barriers were encountered: staff (receptivity, time, production pressures, culture); process (electronic health record [EHR] integration, patient identification, data tracking, bedside delivery); and patient (receptivity, acuity, availability, accessibility).

In conclusion, strategies are needed to enable effective delivery of diabetes survival skills education to inpatients with type 2 diabetes. System and staffing barriers coupled with patient and technology barriers limited successful implementation of the delivery of diabetes education at the bedside. As a result, adoption of a tablet-based diabetes survival skills e-learning program in a high-acuity care setting was limited.

The Joint Commission Journal on Quality and Patient Safety, 2021. DOI: 10.1016/j.jcjq.2020.10.007

February Peer-Reviewed Publications from MedStar Health

Congratulations to all MedStar researchers who had articles published in February 2021. 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 PubMed.gov here.

Selected research:

  1. "Innovations in Infection Prevention and Treatment"
    Surgical Infections, 2021. DOI: 10.1089/sur.2020.202
    Tejiram S, Shupp JW.

  2. "Understanding and Measuring Long-Term Outcomes of Fingertip and Nail Bed Injuries and Treatments"
    Hand Clinics. 2021.DOI: 10.1016/j.hcl.2020.09.011
    Means KR Jr, Saunders RJ.
  3. "Negative pressure wound therapy system in extremely obese women after cesarean delivery compared with standard dressing"
    The Journal of Maternal-Fetal & Neonatal Medicine, 2021. DOI: 10.1080/14767058.2019.1611774
    Kawakita T, Iqbal SN, Overcash RT. 

  4. "The STRIATE-G Technique for COVID-19 ST-Segment Elevation Myocardial Infarction"
    JACC Cardiovascular Interventions, 2021. DOI: 10.1016/j.jcin.2020.09.045
    Yerasi C, Khalid N, Khan JM, Hashim H, Waksman R, Bernardo N.

  5. Early mortality benefit with COVID-19 convalescent plasma: a matched control study"
    British Journal for Haematology, 2021. DOI: 10.1111/bjh.17272
    Shenoy AG, Hettinger AZ, Fernandez SJ, Blumenthal J, Baez V.

Vulnerable Populations in Research: A CFR Refresher for Investigators

When conducting research, some populations of research participants require special considerations. The Code of Federal Regulations (CFR 45 part 46) Protection of Human Subjects includes Subparts B, C and D, that describe special protections and criteria for inclusion of pregnant women, prisoners and children. These protections are meant to safeguard of rights, welfare, and safety of these participants but does not mean they should automatically be excluded from research.

Pregnant women, human fetuses, and neonates (Subparts B): Because research may pose additional and/or unknown risks to pregnant women, human fetuses and neonates, the regulations require additional safeguards in research. It is important to include pregnant women in research, as their exclusion from research creates a wider gap in understanding and knowledge.

Prisoners (Subparts C): Because prisoners may not be free to make a truly voluntary and uncoerced decision regarding research participation, the regulations require additional safeguards for the protection of prisoners. For example: In order for an IRB to approve research involving prisoners the membership of the Board must include one or more prisoner representatives and that representative must be involved in the review of the research.

Children (Subparts D): The CFR defines children as “persons who have not attained the legal age for consent to treatments or procedures involved in the research, under the applicable law of the jurisdiction in which the research will be conducted.” It is important to include, where appropriate, children as part of a research study. Children of all ages present different disease manifestations than adults, have different pharmacokinetics/ pharmacodynamics than adults and have a different psychology/psychiatry as part of their developing brain.
While the populations afforded special protections have traditionally been labeled “vulnerable” it should be noted that they are not specifically defined as such in Sub Parts B, C and D. The common rule does not define the term “vulnerable population”. The existence of additional protections should not specifically discourage inclusion of these populations in research. Rather, the protections are intended to guide the inclusion of these populations in such a way as to protect the rights and welfare of the individuals.

Although the regulation does not define the term vulnerable they do provide examples of research subjects “that are likely to be vulnerable to coercion or undue influence.” This is different from the special populations traditionally referred to as “vulnerable populations” description of sub parts B, C, and D. While children and prisoners are included in the current list of examples, pregnant women are no longer included as of the 2018 Revised Common Rule. The types of study populations that are likely to be vulnerable to coercion or undue influence may including but are not necessarily limited to:

• Children/minors
• Prisoners
• Employees
• Military persons and students/trainees in hierarchical organizations
• Terminally ill, comatose, physically and intellectually challenged individuals
• Institutionalized, elderly individuals
• Ethnic minorities
• Refugees
• Economically and educationally disadvantaged

When some or all participants are likely to be vulnerable to coercion or undue influence the regulations mandated that the IRB ensure “…additional safeguards have been included in the study to protect the rights and welfare of subjects.”

As previously noted, there has been an historical categorization of pregnant women and women of reproductive potential as a “vulnerable population.” While Sub Part B of the Common Rule describes special protections for pregnant women there is nothing about pregnancy, in and of itself, that renders a woman susceptible to coercion or undue influence. This categorization typically results in a tendency to exclude women, particularly pregnant women, from research. This exclusion may be intended to protect women from potential risk or may be done out of a misunderstanding of the special protection’s provision. Rather than serving to protect women from risk this broad exclusion of women from research has had a detrimental impact. Instead of shielding women and their fetuses from adverse effects, exclusion from clinical research in which they may be able to safely participate has served to limit understanding of pharmacokinetic and pharmacodynamic differences in women’s responses to treatment. Without scientific evidence this has drove the medical community to make potentially faulty assumptions about safety and efficacy of therapeutics when used with pregnant women.

While it is important to protect human subjects in research from coercion, undue influence and unjustified risks, it is equally important to ensure equitable selection of research subjects. This includes (but is not limited to) the inclusion of pregnant women and women of reproductive potential in research. Broad exclusion of any population, absent regulatory restriction or legitimate safety concerns, can serve to create a knowledge gap around the appropriate treatment modalities, appropriate dosing and the potential need to modify treatment modalities for some populations.

The table below includes the populations used as exemplars in the common rule for subjects that “…likely to be vulnerable to coercion or undue influence…” The table includes a notation for those included as examples in the pre-2018 Common Rule (Former Common Rule) and those now listed in the 2018 Revised Common Rule.

If you have any questions or concerns, please contact MHRI’s Office of Research Integrity Director, Jim Boscoe, at [email protected].

MedStar Health Policy and Procedure Updates

MedStar Health regularly updates, revises and creates new policies and procedures for the operational efficiency of the organization.

Please be advised, the following policies and procedures are now in effect.

Effort Commitment and Certification

The Effort Commitment and Certification policy was updated to incorporate changes mandated in the Uniform Guidance to match MHRI Office of Contract & Grants processes in our current accounting system, and to provide a tool for collecting effort information for those staff employed by MedStar but external to MHRI.

There are no substantial changes to our business practices. However, one change does close the loop on a known audit gap regarding the reconciliation of the committed effort and the actual effort expending on a federal award or any award that invokes the federal regulations regarding effort commitment.

Government Inquiries

These policies have been updated as part of the three year periodic review.

Emergency Response Management

It is recommended by MedStar Health ER One Institute that ERM policies are reviewed annually. During the annual review, we work with ER One and they inform us of any MedStar Health changes. In addition, we confirm all contact information (e.g., telephone numbers) are still accurate.

Any questions regarding the new policy and procedure should be directed to [email protected].

Investigation of COVID-19 Positive Test Prior to Elective Surgeries Published from MedStar Health Team

Researchers from MedStar Health Urgent Care/MedStar Ambulatory Services, MedStar Health Research Institute and Georgetown University recently published research to determine what percentage of preoperative asymptomatic patients tested positive for COVID-19 on a hospital-based polymerase chain reaction (PCR) testing platform.  The researchers also sought to determine if there were certain demographics (ie, gender, age) which led to a higher pretest probability of an asymptomatic positive test.   

"Incidence of SARS-CoV-2 in Preoperative Patients Tested in an Urgent Care Setting" was published in the Journal of Urgent Care Medicine. The emergence of COVID brought on unique challenges for healthcare professionals.  It was essential to have the capability to identify patients with COVID-19 before they undergo a surgical procedure to ensure safety to the patient, the surgical team, and postoperative staff. Given the fact that many patients with the virus never exhibit symptoms, proactive preoperative testing in the urgent care center may lower the risk of spread and help quantify the rate of asymptomatic infection.  

As COVID began to spread more rapidly, there was higher demand in healthcare services including availability of healthcare personnel, equipment and hospital beds. To aid in conserving hospital resources and minimize exposure to COVID-19, semi-elective and elective procedures were suspended.  

The research included a total of 1,262 patients scheduled to undergo elective or semi-elective procedure presenting to a MedStar Health Urgent Care facility or urgent care testing tent for a nasopharyngeal (NP) PCR test 1–5 days prior to their scheduled surgery. After testing, patients were advised to quarantine at home to minimize any new exposures to the virus prior to their surgical date.   

The study results show that 29 (2.30%) patients tested positive for COVID-19. Patients between 20-29 years of age had the highest rate of positive cases around 6%. Patients over 80 years old or under 10 years old had no positive cases. However, the difference was not statistically significant. The data collected shows that gender is not a factor in rate of asymptomatic COVID-19 cases. As with age, our study shows that gender is not a factor in rate of asymptomatic COVID-19 cases. While females had a higher rate of positive asymptomatic tests (2.89%) compared with males (1.65%), the difference is not statistically significant.     

The research team concluded the findings from this study support the continued practice of testing for SARS-CoV-2 in all preoperative patients, with a positivity rate of over 2% in asymptomatic patients.
 
Because asymptomatic transmission is an important factor in the spread of the virus, all individuals, regardless of age and gender, should remain diligent to decrease the potential of asymptomatic transmission of the virus. Urgent care providers should take precautions prior to all patient interactions, not just patients with COVID-19 symptoms. Furthermore, these safeguards should be upheld with all patients regardless of gender or age. Additionally, these data suggest there are variables independent of gender and age that influence expression of symptoms of COVID-19.  

Journal of Urgent Care Medicine, 2020. 15(4):33-36