Scribd Logo
Upload

Welcome to Scribd!

  • Pone.0071090 1..12 - Enhanced Reader

    Uploaded by

    Andi Tiara S. Adam
    7 views12 pages

    Original Title

    pone.0071090 1..12 _ Enhanced Reader

    Copyright

    © © All Rights Reserved

    Available Formats

    PDF or read online from Scribd

    Did you find this document useful?

    Is this content inappropriate?

    Report this Document

    Copyright:

    © All Rights Reserved
    Download as PDF or read online from Scribd
    Flag for inappropriate content
    7 views12 pages

    Pone.0071090 1..12 - Enhanced Reader

    Uploaded by

    Andi Tiara S. Adam

    Copyright:

    © All Rights Reserved
    Download as PDF or read online from Scribd
    Flag for inappropriate content
    of 12
    LOS | on (OPEN ACCESS Freely available online Glocal Clinical Registries: Pacemaker Registry Design and Implementation for Global and Local Integration - Methodology and Case Study Katia Regina da Silva’, Roberto Costa*, Elizabeth Sartori Crevelari®, Marianna Sobral Lacerda’, Caio Marcos de Moraes Albertini’, Martino Martinelli Filho’, José Eduardo Santana®, Joao Ricardo Nickenig Vissoci®”*, Ricardo Pietrobon®, Jacson V. Barros"? 1 Yer istate nC] ~ Cres Hospital ofthe Unies f Ske Paulo Medical School, Sto Pal, Sal, 2Dspartent of Surgery, Duke Unersty Medial Center, Durham, Norn Carolina, United States of Amaia, 3 Department of Carovatu Sirgen, Heo isthe ion ~ Cs Hostal ofthe Urry of 80 Plo Mecca ‘thot, So Paul, Sra, ADepartment of Caley, Heart Instute (Co) ~ Clea Hosp of the Unvety of Seo Paulo Nea School, Sse Pao, Ba, ‘Computing nse of the Federal Unies oF Alsons. Algo, rr 6 Research Fellow - Deparment of Anesthesiogy Duke nerity Mei Cente, Duta, Nort Cana United States of Amaia, 7 Ponte Cao Univenity of Seo Paso, Sao Paulo, Bai, BMedcine Oxpartment, Faculdade Ings Marna, Braz ‘Deparment of Seger, Duke Uniersty Mca Center, Duron Nth Cli, Unies Soe of Ameri, YC Hosp ofthe Unicity of Sto Fae ede Abstract Background: The ablty to apply standard and interoperable solutions for implementing and managing medical registries as well as aggregate, reproduce, and access datasets from legacy formats and platforms to advanced standard formats and ‘operating systems are crucial for both clinical healthcare and biomedical research settings. Purpose: Our study describes a reproducible, highly scalable, standard framework for 3 device registry implementation addressing both local data quality components and global inking problems. Methods and Results: We developed a device registry framework involving the following steps: (1) Data standards defniton and representation ofthe research workflow, (2) Development of electronic case report forms using REDCap (Research Electronic Data Capture), (3) Data collection according t0 the clinical research workllow and, (4) Data augmentation by enriching the registry database with local electronic health records, governmental database and inked pen data collections, (5) Data quality contol and (6) Data dissemination through the regisuy Web site. Our regsty adopted all applicable standardized data elements proposed by American College Carciology / American Heat Association nical Data Standards, as wel as variables derived from cardiac devices randomized Wals and Clinical Data Interchange Standards Consortium, Local interoperability was performed between REDCap and data derived from Electronic Health Record system, The orginal data set was also augmented by incorporating the reimbursed valves paid by the Brazilan Government during a hospitalization for pacemaker implantation. By inking our regity to the open data collection Fepostory Linked Clinical Tals LinkedCT) we found 130 clinical als which are potentally corelated with our pacemaker registry Conclusion: This study demonstrates how standard and reproducible solutions can be applied inthe implementation of medical registries to constitute a re-usable framework. Such approach has the potential to facilitate data integration between healthcare and research settings, also being a useful framework to be used in other biomedical registries, Cation: da Sha KR, Cort R Cree ES, Lacerda MS, de Mores Abetin CM, e a. 2012) loa Cina Regt: Pacemaker Regsty Design and Irplemention for Clb and Leal IntgaionMethodsigy and Cae Stay Peas ONE 87671000 deI0 97 fpumalpone 0071050 or Gerard Pasterlamp, Unversity Medal Center Uect, The Netherands Received March 5, 20% Aecopted June 2, 2013 Published Jay 25,2013 Copyright: © 2013 da Siva eta. This san open-access ate dsubuted unde the tems of the leat Corons AtbutonLcnse, which permits Srresreted us, dation snd rproction many eum provided the oral author an sure sre ree Funding Ths sty was supped by CRPES ound, Min of auction of Ban Postdoctoral Fellowship Program 3928/10) he funders had no role Irs) dena, dt colecton ard ana, desi o publeh, er preparation ofthe mans. + eal fata regnasincorsp.be Introduction device reghtries have been essential 1o guide improvements in technology and to faitate the refinement of patient selection in Over the past few years, the worldwide volume of healthcare oper to maximize outcomes with current andl new device options and clinial research data generated. has been significantly [15,74 Studies derived from wel-designed and wellconducted expanded [13]. Data sources now encompass muliple registries yeical devices registries can provide a real-world view of clinical ans clinical trials as well as the progressive implementation of hospital administration andl electronic health record (EHR) systems [1-6]. Aca special case of data collection systems, medical practice, patient outcomes, salty, comparative effectiveness and LOS ONE | wowplosoneorg 1 July 2013 | Volume & | Issue 7 | e71090 Pacemaker Registry ~ Open Data Collection Figure 1. Registry processes representation. Lagend: ACC/AHA American Collage of Cardiology American Heart Associaton; CDISC~ Clinical, Data interchange Standards Consortium CRF= Case Report Form, HU REDCap~ Research Electronic Data Capture 440:10.1371 journal pone 007108000 cost effectiveness and may strengthen a number of evidence development and decision making provess [5,7 14] Despite its huge potential for both biomedical researc as well 8 the potential to positively ale clinical practice and healthcare polices, medical registries are frequently surrounded by process problems that substantially decrease their value [415,16]. These ineluce msg data an poor data quality shih i rate! o howe the research component of the registry is connected to clinical \workllow and how personnel involved in the data collection are trained [4]. Compatbilty problems with other health registries or publicly available data sets, which are associated with hove dats ements are structured and defined ta accomplish the registy's intended purposes are ther weakness presented in large quattity of electronic medical registries (3,17. 20} Authough welrbased electronic data capture (EDC) systems have become more prevalent across the globe, the data collection for research purposes sal a challenging process [1.20.22]. Lack fof harmonization between the clinical and research workflows is time consuming for both clinical sta? and patients [23,24]. ln aaddidon, many hospitals and healthcare faites that participate in studies present different data. capture systems for both LOS ONE | wowplosoneorg Health Level Severs NDF National Cardiovascular Data Registry, Dealtheare and research settings resuking in effort duplication, ulimately leading to data inconsistency [4,18 20) Adopting standardized data elements ‘ogy is arguably the key to fuiltate the exchange of data actoss studies nl to promote interoperability between diferent EHRs systems [4,17 20]. The objective of this study is therefore to dlesribe a reprodhcibe, highly sealable, standarel framework fora device registry implementation addressing both local data quality ‘components as well as global liking problems. In the frst section ‘of our article we set the theoretical background, while ia the second section we provides elinical ose case involin pacemaker registry implementation designed to systematically collect interpretable longer safety nda common terminol- ind outcomes daa, Methods Registry description The Pacemaker Resistry Open Data Collection i derived from the SAFE-LV PACE randomized wal (Safety and the Elles of eolated Left Ventricular Pacing in Patienss With Bradyarrhyt- nis,” Clinical Fak gow study ID NCTOI7174659), This ranean July 2013 | Volume & | Issue 7 | e71090 Pacemaker Registry ~ Open Data Collection Zire Proper | Projet Setup a i i" i Figure 2. REDCap Data Entry. Footnote: Case report forms are accesible to users who have sufficient access rights and it contains felé-speciic ‘alidation code sufficient to ensure dat Integr. ¢40:10.1371Journal pone.0071080 9002 ‘ed controlled study i being conducted to compare the fees of conventional right ventricular (RV) pacing versus left ventieular GV) pacing in patents with atrioventricular block. Our main hypenhess is that isolated LV pacing theongh the coronary sinas can he used safely and provide greater hemodynamic benefit 10 patients with atrioventricular block and normal ventricular Fiction who reqte only the cortection ofheart rte. Specifically, ‘our aims are to evaluate the safety, ellcacy and the elects of LY pacing using active-fixation coronary sinus lead — dain Starkie® Mode! 4195 OTW Lead, compared to RV pacing in patients with ‘implantation criteria for conventional pacemaker simulation In this registry we are creating large and interoperable database to report pacemaker longterm outcomes, All clinical data stored will maintain full patent confidentiality acconding Good Clinical Pracices (GCP) and the Health Insurance Portability and Accountability Act (HIPAA) [25] and will be Freely available co allow collaboration between researehersaeound the world, Main advantages of this open daa collection include the incentive for interdisiplinary and mul-instiutinal collabo. LOS ONE | wowplosoneorg rations along with the ereation of ‘mone timely manner sl and policy mesures i a Glocal registry methodology “The Institutional Review Board of the Clinies Hospital of the University of Sio Palo Medical School (S80 Paulo, Brazil) approved this study. All participating subjects provided waiten informed consent. All clements in this article comply with a reproducible research protocol [26] "The device regisry implementation comprised a group of generic procestes suecesilly applied 10 project management inching the initiation, planning, execution, monitoring and controling, and closing. ‘The sequence included (1) daca planning as wel used to define the common data standards and termine asthe representation ofthe research workflow, (2) development of ‘lectronic ease report forms using REDCap (Research Electro Data Capture), (3) the process of data collection according 10 the nical research workflow (4 the aggregation between the registry data and other systems, (9) data quality control and data analysis July 2013 | Volume & | Issue 7 | e71090 —, Pacemaker Registry ~ Open Data Collection ‘oaion T Heahrare Mom ' ‘etone nea cogs Figure 3. Pacemaker Registry Use Case Stakeholders. <4010:1371Journal pone.0671090.0003 using statistical methods and, finally (6) the data dissemination rough the regisry Web site (Figure 1) Defining Data Elements Over the last few years, the American College of Cardiology (ACO) and the American Heart Association (AHL) have started an inikatve to develop and publish clinical data standards that ca he ted ina variety of data collection flor for a range of cardiovascular conditions [27.28]. "The ACC/AHA. Writing Commitee to Develop Clinical Data Standaeds for Electrophys iology was charged with providing sandard definitions to relevant terms in the care of patients with a diagnosis of arrhythenia and implanted cardiac electronic deviees (29) Our registry adopted all applicable data elements and definitions in accordance with AGC/AHA available published dlata standards inching those developed for Electrophysiology, Awl Fibrillation, Acute Coronary Syndromes, Heart Fare, and Cardiac Imaging [29-33], Other data sources included data lements from large device clinical ils and registries, such as CTOPP (Canadian ‘Trial of Physiologic Pacing) [38], MOST (Mode Selection Trial in Sinus Node Dysfunction) [35], COM PANION (Comparison of Medical ‘Therapy, Pacing, and Def LOS ONE | wowplosoneorg bwllacon in Heart Failure) [36], REVERSE (REsynchronization reVErses Remodeling in Systolic Left vEntrieular Dystinetion) [37]. We ako reviewed case report forms, data elements, and finikons foun international data collection efforts, Examples of these data sources ineludle the ACC National Cardiovascular Data Regisry (NCDR) [38,39], Health Level Seven International (HL?) [10), Clinical Data Interchange Standards Consortim (CDIS [41] and Cancer Data Standards Registry and Repository (caDSR) [42.43]. Finally, we also included standardized definigions for clinical endpoints and adverse events in cardiovascular tial From the US Food and Drag Administration (FDA) [44] Defining the Registry Workflow ~ Clinical Activity Model Based om discussions with practicing clinicians and participatory ‘observation of the clinic by two of the authors (KRS and RC), UML (Unified Modeling Language) activity diagram models were prepared to represent the clinical registry as well as the data Collection ssorklow. A comparison of these elnical and daa collection workflow models was then conducted to ensure the detection of potential areas where the sctvities related to ds collection might not be in perfect alignment with the activites ‘executed in the daly clinical workflow, ulsimately leading to daa 4 July 2013 | Volume & | Issue 7 | e71090 Pacemaker Regisry ~ Open Data Collection A ea =e i ‘Receve suay sips Te te =a, = ra a aa | aaa crags ana aut a aa = aos jy “smear cee : a eee I ca a | |Sermee =e es nee ome one @ ; en ae f oa = ae ee! === a | a ace —_——_ (Cam Olsvomination wl soup Transmit fra data ‘ta Vk iO Figure 4. Pacemaker Registry Activity Diagram to Support Data Exchange between EHR system and REDCap. Footnote: (!) The study design is communicated to Cimeal Tal Team specticaly tothe Research Cootainator. (2) Case Report Form (CRF) i developed using the REDCap EDC tool hosted at local server within the fewall ofthe University of S30 Paul Once built the CRF, the Registy Adminstrator wil asign users tight for system access. 3) Patient is admitted to fait and the healthcare team entered demographic and cca data ino the EHR, () Research coordinators kenty elie study subjects by consulting the EHR patents records, 3) After patient enroiment, a REDCap API requests send tothe Data Work Group for retrieving and importing sociodemographic information ively fom the sources of hospital systems. (6) (7 Information is ‘exchanged between the EHR and REDCap. &) Raglety admnitator oversees al ta callaced by ressrch coordinators (9) CRF ls trnmited from the research coordinators tothe Data Work Group for data validation, data quality controle data analysis (10) Data Work Group transmits CRF and aggregated dats to the Research Team and Regisvy Administrator. {40°10.1371Journal pone0071080.g008 quality ies, rework, and other processes inelicencies. These Electronic Data Collection sfagrams were modeled according to UML version 20 [45]. All Once the absence of penal worklow dissonance was ensured activity diagrams were created using ArgoUML (version 1:54) yhrough the modeling, eleettonie ease report forms (CRE) were (16 developed using the REDCap [21] EDG tool hosted at a local server within the firewall of the University of Sto Paulo Health rable 1. Pacemaker Registry Use Case Description. Use case Contextual Deseription Bescon Ths use ase describ the steps vce nthe ata clacton and ot gareaton node to develop» comprehensive pacemaker gt) Paints Patents, Physcans Nysing sf Cia TA Team, Data Work Grou, Rely Ans, Research vests Team ier Patient presenting radyartytieis and ination o pacemaker implantation according to cuenta oy Pecandion Palen eral the study. Research coowdatrs tat the data colection proces. Post conions| ata work aroup recive the data and pero the vation apareaatin and sorane Noma Fo et erogragh hry rd clean ae cece Pte i sbited to preopertve bation a fg oe dm the laconic heath econ (nical Ti Team calles regiy specie dn at ef inthe eit potocal using REDCp. ‘Data workgroup performs data exchange bere Ef and REDCAP, daa vation, deta quo cons daa ans ata sagregatin and storage the dowd repost. Erk seni heth econ REDCap= Reseach actonc Data Cpt [doe101371Jouralpone 0710501001 LOS ONE | wowplosoneorg 5 July 2013 | Volume & | Issue 7 | e71090 Pacemaker Registry ~ Open Data Collection i a rom i ee rome | Seo, ni coma = ad fine ‘Cnc Eaton Px Progam Eeroeeagram ‘Chest Xa) ‘Aaj econ Post Procedure Aaseessment Discharge Plan Rea) Figure 5. Pacemaker Registry Activity Diagram. Footnote: Ths gure represents the alignment between clinical white fowchart and research {blue flowchart) worfiows.

    You might also like