MedStar NRH Study Finds that Innovative Devices Did Not Provide Better Outcomes for Knee Replacement Patients Undergoing Outpatient Rehabilitation

Researchers from MedStar National Rehabilitation Hospital and MedStar Health Physical Therapy were a part of a large multi-center randomized clinical trial that found that newer and more expensive devices, increasingly seen in outpatient physical therapy centers, did not enhance outcomes for patients following their knee replacement relative to conventional care.

Study findings appear in  a recent issue of the Journal of Arthroplasty, one of the nation’s three leading orthopedic surgery journals and in  JAMA Network Open, JAMA’s on-line journal.

In the U.S., upwards of 1.0 million people obtain a primary total knee arthroplasty (TKA) per year. Most go on to use outpatient physical therapy—soon after discharge or following a stay at home or another facility. As part of a typical outpatient visit, the patient will initially participate in a warm-up exercise using a recumbent bike designed to increase blood flow and tissue pliability.

The trial compared 4 exercise interventions: (1) a recumbent bike (which is usual care) compared to the three newer exercise interventions: (2) a bodyweight-adjustable treadmill, (3) a patterned electrical neurostimulation (PENS) devise used with a recumbent bike, and (4) a PENS device used with a bodyweight-adjustable treadmill.

The study compared intervention outcomes using (1) walking speed, a performance-based measure, and (2) the Knee Injury and Osteoarthritis Outcome Score or KOOS, the most common patient-report measure used to evaluate TKA outcomes.

The study enrolled 363 patients with more than 90 participants in each of the study’s four arms across 15 MedStar Physical Therapy outpatient rehabilitation centers. Altogether 19 MedStar orthopedic surgeons referred patients to the study.

Jean Hsieh, PhD, of MedStar NRH’s research program served as the study’s principal investigator. Dr. Hsieh was assisted by Gerben DeJong, PhD as co-principal investigator. Michele Vita, DPT served as the chief clinical services coordinator with able assistance from Linda Briggs, EdD, AVP for the MedStar National Rehabilitation Network. Biostatistical support for the study came from Alexander Zeymo and Sameer Desale of the MedStar Health Research Institute. The study could not have succeeded without the strong support of John Brickley, VP, MedStar National Rehabilitation Network and John Rockwood, its president.

The study was funded internally by the MedStar National Rehabilitation Network with support from several outside sources including the company’s whose devices were evaluated.

Journal of Arthroplasty, Vol. 35 (08), 2054-2065. DOI: 10.1016/j.arth.2020.03.048






MedStar Health Research Evaluates Diabetes Survival Skills Education for Behavioral Health Inpatients

Researchers from across MedStar Health sought to adapt Diabetes to Go (D2Go), a diabetes survival skills education (DSSE) program for delivery on inpatient behavioral health units (BHU) and to evaluate the feasibility of implementing D2Go-BHU within nursing unit workflow. “Diabetes Education for Behavioral Health Inpatients: Challenges and Opportunities” was published in the Journal of the American Psychiatric Nurses Association. The study assessed the need for diabetes survival skills education to help patients with self-care during their transition from the hospital.

The study team used the practical robust implementation and sustainability model implementation science framework to conduct the research. There were 1989 patient admissions observed, among which 264 were discharged with a diagnosis of type 2 diabetes. Interviews, focus groups and feedback were provided from support staff and nurses to design various adaptations for the D2Go-BHU program. Adaptions to the program included (a) delivering education through facilitated group learning sessions, (b) providing paper surveys and a hard copy D2Go survival skills education booklet, (c) and developing videos which were delivered using a secure DVD versus a tablet.

During the study period, two psychiatry behavioral health units conducted a total of 9 group sessions. The primary diagnosis at hospital discharge was obtained for 29 patients and included suicide attempt (n = 10; 35%), depression (n = 7; 24%), schizophrenia (n = 5; 17%), psychosis (n = 7; 17%), bipolar (n = 3; 10%), posttraumatic stress disorder (n = 1; 3%), delusion (n = 1; 3%), homicidal (n = 1;3%), and other (n = 2; 7%). After completing assessment surveys, the results showed that those with diabetes had lower ASK12 scores compared with those without diabetes. Persons with diabetes answered most items related to what to eat correctly, but less than 33% correctly answered items related to target blood glucose (BG) after a meal, need for checking BG, symptoms of high BG, and where to store oral medicines.

The study team identified multiple barriers to implementation including lack of standardization of education content by nurse facilitators and difficulty engaging patients for the time required for completion of surveys plus group education. Both nurses and patients preferred a book as it relates to educational materials.  Further research would be needed to determine if individual diabetes education alone or a model which combines individual and group sessions is preferable for this population.

The team included Joan K. Bardsley MBA, RN, CDE, FAADE, from MedStar Health Research Institute, Michelle F. Magee, MD, from MedStar Diabetes Institute and Georgetown University; Kelly M. Baker, MA, and Kelly M. Smith, Msc, PhD, from MedStar Institute for Quality and Safety.

The study was funded by the National Institutes of Health, National Institute for Diabetes, Digestive, and Kidney Diseases (Grant Number R34-DK-109503).

Journal of the American Psychiatric Nurses Association, DOI: 10.1177/1078390319878781






October Peer-Reviewed Publications from MedStar Health

Congratulations to all MedStar researchers who had articles published in October 2020. 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 Management of Gout in Patients with Cardiovascular Disease and Heart Failure
    American Journal of Cardiovascular Drugs, 2020. DOI: 10.1007/s40256-020-00400-6
    Mouradjian MT, Plazak ME, Gale SE, Noel ZR, Watson K, Devabhakthuni S

  2. Externally Validated Prediction Model of Vaginal Delivery After Preterm Induction With Unfavorable Cervix
    Obstetrics & Gynecology, 2020. DOI: 10.1097/AOG.0000000000004039
    Kawakita T, Reddy UM, Huang JC, Auguste TC, Bauer D, Overcash RT.

  3. Galectin-1 production is elevated in hypertrophic scar
    Wound Repair and Regeneration, 2020. DOI: 10.1111/wrr.12869
    Kirkpatrick LD, Shupp JW, Smith RD, Alkhalil A, Moffatt LT, Carney BC.

  4. Micropuncture technique for femoral access is associated with lower vascular complications compared to standard needleCatheter Cardiovasc Interv, 2020. DOI: 10.1002/ccd.29330
    Ben-Dor I, Sharma A, Rogers T, Yerasi C, Case BC, Chezar-Azerrad C, Musallam A, Forrestal BJ, Zhang C, Hashim H, Bernardo N, Satler LF, Waksman R.

  5. Management of recurrent granulosa cell tumor of the ovary: Contemporary literature review and a proposal of hyperthermic intraperitoneal chemotherapy as novel therapeutic option
    The Journal of Obsetrics and Gynaecology Research, 2020. DOI: 10.1111/jog.14494

       
       

      The Time is Now. Enroll in Your Benefits.

      Annual Enrollment is the time to assess your healthcare options for next year and select the coverage that best meets your needs. You have until Nov. 16 to make your selections during 2021 Annual Enrollment. Visit myHR from StarPort or myHRMedStar.net from any computer or mobile device.

      If you wish to keep your current benefits coverage for 2021, you do not need to enroll online. Your 2020 benefit selections and eligible dependents will roll over to 2021, except for Flexible Spending Accounts (FSAs)—you must enroll each year to participate.

      FSAs allow you to set aside pre-tax dollars from your paycheck to use for out-of-pocket expenses, such as eligible medical, dental and vision costs, as well as child care and adult day care services.

      Contact the HR Solution Center at 855-674-myHR (6947), select option 4, for questions about your benefits offerings.


      Save $360 on your medical premium

      Complete the MyHealth Questionnaire at MedStarMyHealth.org by Nov. 30 and save approximately $360 a year on your MedStar Select or CareFirst medical premium for 2021.

      Exempt Human Subjects Research: Pathway to Approval

      Oftentimes, there is confusion surrounding with Exempt research and the requirements for IRB or institutional review. This is perfectly understandable, particularly given that the Common Rule has been revised in recent years and more research involving human subjects may fall into an exempt category.

      Although federal regulations do not require IRB review of exempt research, federal agencies have issued guidance recommending that exempt determinations should be made by an individual that is not otherwise affiliated with the research. In other words, institutions should not permit study investigators to make exempt determination for their own projects.

      To ensure that exempt determinations are issued by individuals that are not directly involved with the research, MedStar Health Research Institute policy states that exempt determinations must be made by either an IRB member or qualified / trained / designated members of the ORI staff.

      In order to make these determinations, a formal submission is required through the Huron system. As with all other Human Subjects Research projects the formal determination must be issued before any research activities may begin.

      If you have any questions regarding this process, please contact MHRI’s ORI Director, Jim Boscoe, at [email protected].

      Research Grand Rounds: An Alternative to Target-Based Drug Discovery-Optimizing Mitochondrial Bioenergetics to Combat Noncommunicable Diseases—November 6, 2020

      Research Grand Rounds are sponsored by the Georgetown-Howard Universities Center for Clinical and Translational Science (GHUCCTS) and MedStar Health Research Institute to bring together our diverse clinical and research communities to share research that spans disciplines and stages of translation to improve individual and community health.

      On behalf of the Georgetown-Howard Universities Center for Clinical and Translational Science, and MedStar Health Research Institute, you are invited to Clinical and Translational Research Grand Rounds on Friday, November 6, 2020 from 12:00pm to 1:00pm. The speaker this month will be Hazel H. Szeto, MD, PhD who will discuss “An alternative to target-based drug discovery-Optimizing mitochondrial bioenergetics to combat noncommunicable diseases”.

      Live Stream Link: https://georgetown.zoom.us/j/527229623

      Dr. Szeto is director of research at the Social Profit Network Research Laboratory, professor emerita of Pharmacology at Weill Medical College of Cornell University, and scientific founder of Stealth Biotherapeutics. Her serendipitous discovery of a novel class of orally-active, widely-distributed mitochondrial-targeted peptide analogs with profound effects on mitochondrial structure and function has revealed bioenergetic mechanisms as key treatment targets in an almost-dizzying variety of disease models. Preclinical models suggest potential

      benefits in most all clinical domains, from ischemia-reperfusion injury to neurodegeneration, and including heart failure, muscle weakness and disuse atrophy, chemotherapy toxicities, diabetes, vision loss, orthopedic injury, acute kidney injury and progressive chronic kidney disease and a wide range of age-associated chronic diseases. Her research exemplifies widely collaborative and discipline-spanning team science focused on translating basic discoveries to therapeutic impact while revealing new pathophysiological mechanisms and basic biology.

      Research Grand Rounds are open to all members of the research team, from principal investigators to clinical and research coordinators and trainees. Topics covered in the Research Grand Rounds range from community-focused research to best practices and are intended to increase collaboration within the research community in and outside of MedStar Health.

      For more information please contact [email protected] or visit www.georgetownhowardctsa.org

      MedStar Investigators Examine Computed Tomography Pulmonary Angiography in the Emergency Department

      Recently published collaborative research examined utilization patterns and predictors of computed tomography pulmonary angiography (CTPA) results in the emergency department. “High Scan Volume with Low Positive Scan Rate in Highest Utilizers: Computed Tomography Pulmonary Angiography in the Emergency Department” was published in The Journal of Emergency Medicine. This publication was the result of the Summer Research Student program with MedStar Health investigators mentoring rising second-year medical students from the Georgetown University School of Medicine. The team included investigators from MedStar Good Samaritan Hospital, MedStar Union Memorial Hospital, MedStar Washington Hospital Center and Georgetown University.

      The overutilization of CTPA is a serious concern in the emergency department because the potential of increased risk for radiation exposure, cost, and over diagnosis bias may occur. This study reviewed all CTPA studies performed in one year across a multisite medical system and focused on data for emergency department attendings and positive CTPA scan rates (PSR). The team manually reviewed all applicable scans and classified them as positive, negative, or indeterminate.

      The results show there were 10,032 total scans from the emergency department and 6,168 of those were ordered by 153 emergency department attendings. Most attendings (123/153; 80%) ordered 60 or fewer scans, with relatively high PSR (259/2927, PSR 8.8%; 95% confidence interval 7.8–9.9%). Of the emergency department attendings, 13 (3%) ordered more than 100 scans each (1981 scans; 32% of all scans), with PSR of 5.5% (95% confidence interval 4.5–6.5%).

      Overall, the study found that most emergency department attendings were low-to mid-volume utilizers of CTPA and had a relatively high PSR. However, the small percentage of attendings who ordered more than 100 scans each accounted for a large percentage of the total number of scans and had a relatively low PSR. These findings suggest that mentoring and/or sharing of performance feedback and best practices in the highest utilizers could help to improve CTPA PSR in the emergency department. 

      Dr. David Weisman, a mentor for the Scholars program and senior author for the publication shared his thoughts on the students and the program.  “I’ve have been extremely fortunate to have had the opportunity to work with so many wonderful Georgetown medical students for the past 4 years. Each student brings to the table their individual uniqueness and talents. I’ve been thankful and impressed by the dedication of MedStar Health and Georgetown University leadership to support this program which is so vital to introduce students to research early in their career. I look forward too many more years of collaboration and mentorship.”

      The research team included Himanshu Rawal, MD; Oluwatoyosi Ipaye, MS; Amit D. Kalaria, MD; Radhika Vij, MD, FACP; Jeffrey S. Dubin, MD, MBA; Lyn Camire, MA, ELS; and David S. Weisman, DO, FACP.

      The Journal of Emergency Medicine, 2020. DOI: 10.1016/j.jemermed.2020.04.008

      September Peer-Reviewed Publications from MedStar Health

      Congratulations to all MedStar researchers who had articles published in September 2020. 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. Diabetes Education for Behavioral Health Inpatients: Challenges and Opportunities
        Journal of the American Psychiatric Nurses Association, 2020. DOI: 10.1177/1078390319878781
        Bardsley JK, Baker KM, Smith KM, Magee MF.
      2. Measurement of Outlet Pressures Favors Rib Resection for Decompression of Thoracic Outlet Syndrome
        Annals of Thoracic Surgery, 2020. DOI: 10.1016/j.athoracsur.2019.12.059
        Assi PE, Hui-Chou HG, Giladi AM, Segalman KA.

      3. Biomechanical Analysis of Zone 2 Flexor Tendon Repair With a Coupler Device Versus Locking Cruciate Core Suture
        Journal of Hand Surgery, 2020. DOI: 10.1016/j.jhsa.2020.02.015
        Irwin CS, Parks BG, Means KR Jr.
      4. Bulla Formation and Tension Pneumothorax in a Patient with COVID-19
        The American Society of Tropical Medicine and Hygiene, 2020. DOI: 10.4269/ajtmh.20-0736
        Yasukawa K, Vamadevan A, Rollins R.

      Honoring SPIRIT at MHRI

      Grant Gonzalez was awarded the SPIRIT of Excellence Award during the MHRI Virtual Town Hall.  Grant is the Director of Finance Operations for the Office of Financial Management. Nominated by Ron Migues, Executive Director, MedStar Health Research Institute, the award was presented by Tina Stanger, Assistant Vice President of Research Administration.

      Grant was recognized for his willingness to work with anyone and his infectious smile.  Grant is a problem solver and is dedicated to gather all the necessary components to make something more efficient.

      “Wanted to give you a huge thank you for taking the time to work with me and my team to ensure our finances are up to date and as accurate as possible,” said Ron Migues. “Given we encompass so many areas and have the most diverse areas of research, it usually takes a small village to accomplish anything, but you have stepped forward and are leading us to become financially sound.  We really see all you do and are extremely appreciative for the support!”

      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.

      Sorting out Single IRB Review: What Investigators Need to Know at MHRI

      In recent years, there has been an increasing trend toward the use of a single IRB (sIRB) review for multi-site HSR projects funded through other sources.  Specifically, many commercial sponsors prefer single IRB review for their multi-site projects.

      The revised common rule includes a requirement for single IRB review of most federally funded multi-site non-exempt human subjects research projects. Initially, the Office of Human Research Protections (OHRP) indicated that compliance with this common rule requirement was required starting on January 20, 2020. Later, OHRP clarified that although sIRB review is required for all federally funded multi-site non-exempt HSR projects, the agency has granted an exemption for all projects approved prior to January 20, 2020. This eliminates the need to transition currently approve projects from review by multiple IRBs to sIRB review.

      For all future federally funded projects, it is strongly suggested that investigators include IRB review fees in the budget for their grant proposals. In most cases it is assumed that sIRB review will be conducted by a commercial IRB (such as WIRB or Advarra) or a larger academic/medical institution IRB. In some limited cases, the MHRI IRB may agree to serve as the IRB of record for a multi-site HSR project but this will not be the norm.

      In all cases (regardless of funding) for which a MedStar investigator intends to request the MHRI IRB serve as the IRB of record, they must submit a request to the ORI office. The request must be submitted before the investigator commits the MHRI IRB to the responsibility of serving as IRB of record for other sites and before discussing reliance with any outside institution. The request should include a copy of the research protocol, an indication of the source of funding (if any), a list of all sites that may be engaged in the project, and the scope of involvement for each site. The ORI Director will evaluate the request and in consultation with the Institutional Official determine if the request will be approved or should be declined.

      This process is similar to that for investigators requesting reliance on an external IRB. When an investigator would like to rely on an external IRB for review of their non-exempt HSR project, a request to cede review must be submitted to ORI in advance. In the case of the commercial IRBs for which there is a master reliance agreement (currently WIRB and Advarra), the investigator may simply submit an external IRB application through the Huron system. For other IRBs, a reliance agreement must be executed for each individual project. In the event that MedStar has not previously had an agreement with the intended external IRB, a request should be submitted to the ORI by email. The ORI Director will evaluate the request and in consultation with the Institutional Official determine if the request may be approved or should be declined. If approved the organization will be added to the Huron system and the investigator may submit the external IRB application for the project.

      Please note that in most cases request for reliance involving exempt HSR projects will not be approved. Generally speaking, it is more efficient for these projects to be reviewed individually by each institution and most institutions have not been willing to enter into a reliance agreement for these projects.

      In all cases, requests for reliance (either for the MHRI IRB to serve as the IRB of record or for MedStar to rely on an external IRB) will be considered with regard to the need for reliance, the feasibility of the arraignment and nature of the project. Ultimately the determination of reliance is left to the discretion of the ORI Director and the Institutional Official.

      If you have any questions regarding this process, please contact MHRI’s ORI Director, Jim Boscoe, at [email protected].