Portal de Periódicos da CAPES

Lone Star Stroke Consortium

2020; Lippincott Williams & Wilkins; Volume: 51; Issue: 12 Linguagem: Inglês

10.1161/strokeaha.120.031547

1524-4628

James C. Grotta, Jane Anderson, Robin L. Brey, Thomas A. Kent, Patricia D. Hurn, Mark P. Goldberg, Sean I. Savitz, Salvador Cruz‐Flores, Steven Warach,

Cerebrovascular and Carotid Artery Diseases

HomeStrokeVol. 51, No. 12Lone Star Stroke Consortium Free AccessReview ArticlePDF/EPUBAboutView PDFView EPUBSections ToolsAdd to favoritesDownload citationsTrack citationsPermissions ShareShare onFacebookTwitterLinked InMendeleyRedditDiggEmail Jump toSupplementary MaterialsFree AccessReview ArticlePDF/EPUBLone Star Stroke ConsortiumA Collaborative State-Funded Model for Research James C. Grotta, MD Jane A. Anderson, RN Robin L. Brey, MD Thomas A. Kent, MD Patricia D. Hurn, PhD Mark P. Goldberg, MD Sean I. Savitz, MD Salvador Cruz-Flores, MD Steven J. WarachMD James C. GrottaJames C. Grotta Correspondence to: James C. Grotta, MD, Memorial Hermann Hospital-Texas Medical Center, 641 Fannin St, Ste 1423, Houston, TX 77030. Email E-mail Address: [email protected] https://orcid.org/0000-0002-3667-4248 Clinical Innovation and Research Institute and Mobile Stroke Unit, Memorial Hermann Hospital-Texas Medical Center, Houston (J.C.G.). , Jane A. AndersonJane A. Anderson Office of Specialty Care Services, Houston Veterans Administration Hospital, Baylor College of Medicine, TX (J.A.A.). , Robin L. BreyRobin L. Brey Department of Neurology, UT Health San Antonio, TX (R.L.B.). , Thomas A. KentThomas A. Kent https://orcid.org/0000-0002-9877-7584 Institute of Biosciences and Technology, Texas A&M Health Science Center-Houston (T.A.K.). Department of Neurology, Houston Methodist Hospital, TX (T.A.K.). Department of Chemistry, Rice University, Houston, TX (T.A.K.). , Patricia D. HurnPatricia D. Hurn Department of Molecular, Cellular & Developmental Biology, School of Nursing, University of Michigan School of Nursing, Ann Arbor (P.D.H.). , Mark P. GoldbergMark P. Goldberg Department of Neurology, UT Southwestern Medical Center, Dallas, TX (M.P.G.). , Sean I. SavitzSean I. Savitz Institute for Stroke and Cerebrovascular Disease and Department of Neurology, UTHealth, Houston, TX (S.I.S.). , Salvador Cruz-FloresSalvador Cruz-Flores https://orcid.org/0000-0003-4998-1471 Department of Neurology, Texas Tech University Health Sciences Center El Paso (S.C.-F.). , Steven J. WarachSteven J. Warach https://orcid.org/0000-0003-3125-7979 Department of Neurology, Dell Medical School, The University of Texas at Austin (S.J.W.). Originally published29 Oct 2020https://doi.org/10.1161/STROKEAHA.120.031547Stroke. 2020;51:3778–3786Novel approaches to supporting and conducting multicenter clinical research in stroke are needed. The Lone Star Stroke Consortium (LSSC) was established by stroke leadership at the state's academic hubs to extend clinical trial expertise and recruitment to distant Texas spokes using telemedicine. Continuous funding was obtained from the Texas state legislature since 2013. LSSC has subsequently conducted 16 studies in acute stroke treatment, prevention, imaging, and rehabilitation, involving 20 000 patients, and stimulating the research careers of 29 young investigators. The LSSC might be a model for funding and conducting multicenter clinical research in other states.Single-center clinical research is often handicapped by limited sample size, resources, expertise, and generalizability. This is particularly true in stroke where clinical effects may be small, budgets and experience in conducting clinical research sparse, and outcome substantially affected by patient demographics.Multicenter trials are a solution to this problem. However, the traditional pathways to mount and fund an investigator-initiated multicenter trial are daunting and often reach a dead end for many bright ideas. The main source for funding such large trials is the Federal Government, through the National Institutes of Health (NIH), Patient-Centered Outcomes Research Institute, and Veterans Administration. NIH StrokeNet helps accelerate approved multicenter stroke trials, but few proposed studies eventually survive NIH long filtering process. Other sources of research support all have limitations. Large foundations such as the American Heart Association generally have focused research priorities or limited budgets. Industry-sponsored large clinical trials are generally restricted to commercializable agents. Finally, philanthropic support rarely is open-ended enough to fund a large clinical trial. Furthermore, aside from StrokeNet, it is up to the investigator and sponsor to enlist and vet a new set of participating centers for each trial. Hence, the road for obtaining support and carrying out clinical stroke trials is extremely difficult and discourages individual investigators to nimbly test their ideas.A statewide research network may provide a novel pathway for mounting and funding investigator-initiated multicenter clinical research. Few statewide networks exist for carrying out clinical research despite the fact that most states have several academic centers capable of initiating and conducting clinical trials.1–5 Statewide networks might benefit from common political and regional support for perceived public health problems, especially as they might be addressed outside of the traditional academic hubs. Furthermore, state money is another source of funding in an era of limited federal funds for research. Collaboration might be threatened by market or academic competition between neighboring centers, but this generally can be overcome if state funding is available based on cooperative efforts.In this article, we describe a statewide research network that we have successfully developed in Texas, the LSSC (http://www.lonestarstroke.com/). We believe that the LSSC can be a model for investigators in other states or regions.MethodsTexas and its academic stroke centers have a tradition of leadership in the conduct of clinical trials in stroke. In 2005, Texas state legislation established the Texas Council on Cardiovascular Disease and Stroke (TCCDS), which in turn established and coordinated one of the nation's first statewide stroke center networks. The TCCDS coordinates activities among the states' stroke centers and other agencies to improve access to stroke treatment.The germination of the idea for LSSC derived from the University of Texas Houston Stroke Program telemedicine network that had begun to use its hub and spoke model to leverage centralized telemedicine-based expertise to oversee remote enrollment of patients into clinical research protocols at its spoke emergency departments throughout southeast Texas.6 At the same time, new stroke clinical research leadership recruited to the state's academic stroke programs ignited a sense of joint mission to consider pooling expertise and institutional resources to facilitate the start-up of new local investigator-initiated clinical research initiatives and to increase the robustness of our contribution to national multicenter studies.In 2013, Texas academic leaders chartered the LSSC (Appendix I in the Data Supplement, Lone Star Stroke Consortium Charter). To accomplish its goals, the intention was for LSSC to leverage existing resources at each institution and seek funding from the Texas state legislature to support its efforts.The administration of LSSC was aided by the University of Texas System Office of Health Affairs Executive Vice Chancellor for Research and Innovation. Legislative support was sought from State Representative John Zerwas, MD, who represented the Houston suburbs and agreed to sponsor the legislation to fund LSSC. LSSC utilized University of Texas System office of governmental relations to keep documents flowing from LSSC leaders to legislative staff. The local American Heart Association also supported LSSC legislative efforts. This process was patterned on state funding for Cancer Prevention and Research Institute of Texas7 and the Texas Alzheimer Disease Research and Care Consortium.The objective of LSSC was to establish a network for stroke patient-centered research and therapeutic trials with the adults and children of Texas, linking academic health institutions with proven expertise in stroke research to community stroke centers. The network would initially employ dedicated research personnel at up to 20 regional centers throughout the state, linked by telemedicine to hub academic comprehensive stroke centers that were actively conducting stroke clinical research. This would create the infrastructure for performing clinical stroke trials and epidemiological studies with economies of scale and at the same time create a platform for quickly disseminating important advances in clinical stroke care throughout the state. We also hoped that this coordinated approach would attract new industry-sponsored clinical stroke research to Texas, in addition to allowing for competitive applications for government and foundation funding. Finally, this program would support existing Texas technology, promote new technology development, and create jobs in community hospitals throughout the state.LSSC Specific GoalsConduct patient-centered clinical stroke research via a statewide network aimed at improving the health of Texans.Identify and invite organizations that have the capability for carrying out clinical stroke research to join and build the LSSC.Promote innovation and technology development that would lead to faster diagnosis and more effective treatments for patients with stroke. A specific focus would be on promoting Texas-based industries.Support development of new systems of stroke management that would improve statewide access and reduce disparities in care.Develop and disseminate evidence-based guidelines for safe, high-quality, and cost-effective stroke care in Texas.Increase the workforce of physicians and health professionals available to provide stroke care in Texas, through recruitment and training.Leverage the network to solicit extramural funding for clinical research, that is, funding outside of funding provided by the Texas Legislature.LSSC Administrative StructureAs a recipient of Texas state funds, LSSC was organized with emphasis on transparent governance and external review. The LSSC charter and bylaws are reviewed annually.Member organizations: the LSSC is composed of member organizations and their research partners. Founding organizations included the University of Texas Southwestern Medical Center, University of Texas Health Sciences Center San Antonio, The University of Texas Health Science Center at Houston, Baylor College of Medicine, and Seton Healthcare Family (now Dell Medical Center/Ascension Seton). New organizations could be added by unanimous vote of the Executive Committee (EC).EC: the EC was initially comprised of 1 member from each founding organization. The EC now also includes a representative from the University of Texas (fiduciary agent), a community representative, and a member at large. New EC members can be added by unanimous vote of the existing EC. The EC meets no less frequently than monthly by teleconference. The EC appoints an External Advisory Committee (EAC), approves additional hub and spoke sites, and selects network projects and studies.Stroke Research Network: a hub and spoke structure was used to implement the goals of LSSC. This initially included the 5 aforementioned academic hubs. Each hub had responsibility for selecting and guiding implementation of clinical trials in at least 4 spoke institutions. To assure readiness to participate in the stroke network, a spoke was a Texas hospital that had been designated as a primary or comprehensive stroke center by the state or had achieved or was actively seeking certification as a primary stroke center by The Joint Commission, Healthcare Facilities Accreditation Program, Det Norske Veritas, or other organization authorized by the Centers for Medicare and Medicaid Services as an organization for stroke center accreditation. Other selection factors for the spoke hospital initially included willingness to permit clinical trial enrollment via telemedicine, a commitment to screen all eligible patients for study, the ability to enter a collaborative agreement with the hub facility and initiate research protocols in a timely fashion, and prior experience of the hospital and its personnel in clinical trial participation. Nominations of spoke centers were brought to the EC for discussion and approval.Spoke performance was monitored by its hub on an ongoing basis and with an annual evaluation. Each research protocol provided an estimate of expected target number of patients screened and enrolled in studies. Spoke centers could be replaced for failure to meet screening and recruitment targets, protocol violations, inadequate record keeping, or other considerations including patient protection, data quality, research integrity, availability of funds to support the spoke research activities, or changes in hospital operations that rendered the spoke a nonproductive research site.Administrative core: an administrative core group at Dell Medical Center helped coordinate the work of the EC and the financial staff at the University of Texas Office of Health System Affairs. LSSC has one staff member who operates the web site and maintains social media notices.Annual meeting and report: LSSC meets annually in a public, open access meeting in Austin, TX. An annual progress report is prepared and reported to the TCCDS.EAC: a group of 4 non-Texas residents and leaders in clinical stroke research form an EAC to evaluate proposed studies from LSSC members and recommend budgets. Proposed studies are submitted in a proscribed template for EAC approval, revision, or rejection. The EAC provides guidance on the merit of new projects and a review of study metrics and milestones for existing projects. Guidance from the EAC may also be sought on optimizing performance of individual hubs and their relationship with spokes, difficulties with executing existing studies, ideas for new projects suitable for the LSSC, strategies for working with industry partners, and interacting with legislative officials. The EC meets with the EAC by video conference yearly, at which time the yearly progress report is reviewed. When new projects need to be evaluated by the EAC (generally once a year), these are provided to them electronically by the LSSC administrative staff. The EAC rates each project using criteria currently used by NIH for proposal review.LSSC OperationsClinical ResearchThe initial concept was for each site to build its own telemedicine network and use these networks to recruit patients into acute stroke therapy trials performed by LSSC. For acute treatment trials, each hub and its respective spoke hospitals would use telemedicine to permit remote evaluation and enrollment of patients. The creation of a stroke network linked by telemedicine provides a platform for remote spoke sites to consult with stroke experts at the hub center and an opportunity to screen, enroll, and collect data for clinical research studies. During the process of evaluating a patient at the spoke site, either the spoke physician or the hub telemedicine physician identifies the patient as a possible study candidate and sends out a page to the hub research team notifying them of a possible study patient at the spoke telemedicine site. After doing so, the hub telemedicine physician and the spoke Emergency Department team carry out standard management, including intravenous tPA (tissue-type plasminogen activator) if indicated. A member of the hub research team and the local spoke stroke coordinator obtain informed consent via telemedicine from the patient or surrogate. The informed consent is signed with the Emergency Department nurse, spoke stroke coordinator, or emergency physician as the witness. Then the spoke stroke coordinator or emergency physician proceeds with study-specific preparatory steps while the hub research team determines and communicates the treatment assignment (if randomized allocation is applicable).The patient then receives the study-specific intervention (or control) per protocol at the spoke, and the hub telemedicine physician performs the follow-up examinations per protocol over telemedicine. If the patient is subsequently transferred to the hub, the spoke nurses make copies of all the paperwork to be transferred with the patient.Later, as spoke sites increased their expertise and capabilities, telemedicine was no longer required for their effective participation, and clinical trials in stroke prevention, patient education, and other aspects of management were approved. The requirement to utilize telemedicine was relaxed as long as the hub and spoke concept for patient recruitment was retained. This change occurred as LSSC leadership recognized the value of a number of proposed studies in stroke management, treatment, and prevention that did not require the use of telemedicine.Network Procedure for Selecting Research ProtocolsStudies can be proposed by hubs or spokes. The selection process of studies includes consideration of the following principles:Quality and impact of the study in the field of stroke.Feasibility of conducting the study when taking into consideration other studies to which the LSSC has already made a commitment.Whether the study under consideration can be conducted successfully considering complexity of design, anticipated time commitment, and the required resources relative to the capacity of LSSC collaborators.Study ManagementGenerally, each study is run by the hub Principle Investigator and hub institution.Institutional review board: there is no central institutional review board.Data safety: each study appoints its own data safety board as needed.Data monitoring: there is no LSSC contract research organization. Each study Principle Investigator is responsible for coordinating the monitoring of spoke sites in each study.Data core: to date, a centralized database and data repository have not been established.Data availability statement: deidentified participant data are shared on request to the study Principle Investigator.ResultsFundingThe EC constructed a budget. A rider to the annual state appropriation to the TCCDS was proposed, and on May 13, 2013, the 83rd Texas Legislature appropriated $4.5 million for fiscal year 2014–2015 (2-year biennium) to implement the LSSC. This funding has been renewed every biennium since 2016 to 2017, 2018 to 2019, and 2020 to 2021.Initially, funds flowed to LSSC through the TCCDS. Currently, the University of Texas System serves as the fiduciary agent for LSSC. The University of Texas System Office of Health Affairs manages all of the funds transferred from the legislature assuring appropriate allocation and use. Contracts were established with each receiving institution for the period of total funding, which specified how much each would receive and the mechanics of accounting.Since its inception, LSSC has added one new hub, at the Texas Tech University Health Sciences Center, El Paso. The 6 existing hubs are associated with a total of 50 spoke centers, including most of the major health care organizations in the state. As seen in the Figure, the spokes still do not cover a substantial part of the state, though all urban and exurban regions are covered.Download figureDownload PowerPointFigure. Map of Lone Star Stroke hubs and spokes.Research PerformedTo date, LSSC has performed 2 trials in acute stroke treatment (581 patients), 5 trials in stroke prevention (1451 patients), 1 trial in stroke rehabilitation (28 patients), 6 observational or imaging studies (2063 patients), a telemedicine registry (13 012 patients), and a statewide telemedicine research mapping project (Table). In addition to the two acute treatment trials where patients were enrolled at the spokes, the LSSC telemedicine network has facilitated identification of spoke patients for transfer to hubs for at least 7 other multicenter acute stroke treatment trials that involved imaging or treatment (such as endovascular therapy) not available at the spokes. Two studies proposed by investigators were not approved by the EAC.Table. LSSC Studies Performed to DateStudyDescriptionFundingStart dateNo. of sitesEnrollment targetEnrolled, nStatusFindingsPublications directly from the studyCLOTBUST-ERWorldwide clinical trial evaluating a UT-initiated technology to assess whether ultrasound delivered into a clot improves the efficacy of tPA therapy for strokeCerevast2013367626 (5% of patients enrolled by LSSC)CompletedStopped early (unlikely to prove efficacy of primary outcome)Ann Clin Transl Neurol6Lancet Neurol8NAS-CARe*A nursing-led standardized pit-stop model for treating stroke emergencies at remote telestroke hospitalsLSSC20157876555Completed, final data analysis ongoingImplementation of ED training and standard process improved door-to-CT and door-to-provider but not door-to-needle timesV-STOP Phase I*Pilot implementation study of the V-STOP intervention to determine feasibility of using VT technology across multiple academic health care systems to deliver self-management education and stroke risk factor management to stroke survivorsLSSC201622016CompletedFeasibility of VT SM education for stroke RF management was established across LSS facilities and to patients on their private devices at home via a cloud-based bridging application. A centralized delivery model was identified for phase II open trial pilotJ Telemed Telecare9V-STOP Phase II*Phase II open trial pilot study to determine recruitment strategies and preliminary effectiveness of the V-STOP intervention using a centralized mHealth model to deliver patient self-management education and stroke risk factor management to stroke survivors at LSSC facilitiesLSSC20173300215CompletedSatisfaction with the program and mHealth delivery was high (score 4.76 of 5). Improvements from baseline to 18 wk were observed in SBP (P=0.006), stroke knowledge (P=0.000), self-efficacy (P=0.000), exercise (P=0.000), activity limitations (P=0.000), anxiety (P=0.001), and disability (P=0.009)Clinical Case Studies10Am J Disability Rehabil11V-STOP Phase III*Chart review and survey of a representative usual care sample for outcomes comparison with V-STOP phase II participants. Finding will be combined with phase II results as pilot data and recruiting strategies for a larger national grant application to the National Institute of Health and Nursing Research to investigate the benefit of using VT self-management support for improved access to follow-up care after stroke and for long-term reduction of vascular events in stroke survivorsLSSC201938060OngoingPendingLESTER*LESTER is a telestroke registry that is the first of its kind to understand how stroke care is delivered and how outcomes are achieved with the use of TM in the stateLSSC20153909813 012Ongoing registryTo improve allocation of health care resources using telestroke to treat stroke in a state with a large rural populationStroke12J Stroke Cerebrovasc Dis13Stroke14BMJ Open15J Stroke Cerebrovasc Dis16EnRICH*A prospective, observational study to determine outcomes of patients with spontaneous intracerebral hemorrhage at comprehensive vs primary stroke centersLSSC2017411401267CompletedHigh SBP variability associated with worse outcome especially in elderly, hypertensive womenBMC Neurology17Int J Stroke18Circ Cardiovasc Qual Outcomes19IAT-TiMeS*Prospective study that aims to analyze the transfer times of patients with acute stroke initially evaluated by TM at a community hospital and then transferred to a CSC for endovascular therapy evaluationLSSC20168100124Final data analysis ongoingSTART*The study is to answer the question of the safest time to start new classes of blood thinners after a strokeLSSC2017121000, revised to 20084OngoingLancet Neurol20Int J Stroke21WISHeS Retrospective*The WISHeS is a multiyear study of brain arteries and blood flow in women using noninvasive brain scans to understand why women are at greater risk from strokeLSSC20173865571OngoingWomen present with treatable ischemic stroke more often than men and have greater probability of potentially treatable imaging targetsAnn Clin Trans Neurol22WISHeS Prospective*The WISHeS is a multiyear study of brain arteries and blood flow in women using noninvasive brain scans to understand why women are at greater risk from strokeLSSC2019118542OngoingIn patients with LVO, women have better collateral circulation, smaller baseline core, and slower core growthStroke23Sci Rep24MVT-ILR*To develop and validate an optimal MRI lesion pattern as an imaging biomarker of occult atrial fibrillation that may be used in future to predict patients at high risk for recurrent stroke. Cryptogenic stroke monitored with implantable loop recordersLSSC20172185185Final data analysis ongoingMVT-AF*To develop and validate an optimal MRI lesion pattern as an imaging biomarker of occult atrial fibrillation that may be used in future to predict patients at high risk for recurrent stroke. Model development from patients with known AFLSSC2017211171117Final data analysis ongoingMapping*Texas Stroke Center Mapping Project (UTHealth) and Stroke Readiness Survey (UTSW)LSSC20161NANACompletedTM extended stroke expertise by 1.5 million Texas residents; similar for Blacks, Hispanics, and non-HispanicsJ Telemed Telecare25Neurology26Smartphone Pilot*Test use of smartphone in Black women with unstable hypertensionLSSC201726667CompletedImproved BP parameters with smartphone vs usual careTEAM-FS PilotTo demonstrate that telerehabilitation home visits with stroke patients after discharge from inpatient rehabilitation is feasible, and will lead to fall and secondary stroke preventionLSSC201515028ClosedFinal data analysis ongoingBMJ Open27AF indicates atrial fibrillation; BP, blood pressure; CLOTBUST-ER, Combined Lysis of Thrombus With Ultrasound and Systemic Tissue Plasminogen Activator for Emergent Revascularization in Acute Ischemic Stroke; CSC, Comprehensive Stroke Center; CT, computed tomography; ED, emergency department; EnRICH, Efficient Resource Utilization for Patients With Intra-Cerebral Hemorrhage; IAT-TiMeS, Intra-Arterial Transfer Time Metric Study; LESTER, Lone Star Stroke TeleStroke Registry; LSSC, Lone Star Stroke Consortium; LVO, large vessel occlusion; mHealth, mobile health; MRI, magnetic resonance imaging; MVT-AF, Multiple Vascular Territories – Atrial Fibrillation; NAS-CARe, Nursing-Driven Acute Stroke Care; RF, risk factor; SBP, systolic blood pressure; SM, self management; START, Optimal Delay Time to Initiate Anticoagulation After Ischemic Stroke in Atrial Fibrillation; TEAM-FS, Telemedicine Education Acceptability Model for Fall and Secondary Stroke Prevention; TM, telemedicine; tPA, tissue-type plasminogen activator; UT, University of Texas; UTSW, University of Texas Southwestern; V-STOP, Video-Teleconference Self-Management to Prevent Stroke; VT, video teleconference; and WISHeS, Women's Imaging of Stroke Hemodynamics Study.* Studies led by junior investigators.Twenty-nine young investigators have obtained experience and data from the LSSC studies listed in the Table that have helped launch their research careers. All 29 have continued in academic medicine. One of these investigators has obtained a K career development award from NIH building on her LSSC project. LSSC studies have generated 20 peer-reviewed published manuscripts to date directly emanating from LSSC projects. This number does not include several peer-reviewed abstracts presented at major scientific meetings. In addition to the one K award, LSSC studies have germinated 4 successful funded grants by LSSC investigators to expand the work started with their LSSC pilots: 1 from industry, 1 from the American Heart Association Southwest Affiliate, 1 from the Veterans Administration, and 1 from the Texas Medical Center Health Policy Institute. There are 2 NIH grant proposals currently under review. LSSC data have helped support one successful multimillion-dollar multicenter Patient-Centered Outcomes Research Institute study to one of the LSSC principal investigators, and the LSSC supported telemedicine program at one center grew to become one of the critical programs supporting a multimillion-dollar institutional endowment for their stroke center.DiscussionThe LSSC capitalized on statewide professional expertise and interinstitutional collaboration to establish a successful clinical trial network with continuous financial support from the state legislature.Most of the 7 goals of LSSC have been realized. Initially, the relatively narrow aim of LSSC was to facilitate enrollment of more patients into acute stroke treatment trials by supporting hub research infrastructure and leveraging telemedicine to enroll patients at spokes who would otherwise not have access to research protocols. Over the 4 funding cycles, the LSSC model has expanded to include research in aspects of stroke care beyond acute treatment and to build infrastructure at our spokes so that they can conduct the research without telemedicine oversight. LSSC clinical research now includes all aspects of stroke management incorporating trials in acute treatment, prevention, and rehabilitation. We have enlarged our network to include one new hub and additional spoke hospitals in underserved areas and have documented our ability to utilize telemedicine to extend treatment to these regions. Four of our studies have specifically addressed racial, ethnic, and sex disparities. LSSC research has increased the workforce of health professionals with expertise in stroke and research in the state. Hub-based nurses and young investigators have led many of our studies. At our spoke centers, personnel have trained in carrying out appropriate stroke patient management, as well as in the conduct of clinical research including patient recruitment and follow-up. One of our studies involved an innovative technology developed at one of our hubs. LSSC studies have generated one K award, multiple other grants, and preliminary data for NIH grant applications.