Original Article Clinical and Applied Thrombosis/Hemostasis Real-Time Dissemination of Aggregate Volume 26: 1-5 ª The Author(s) 2020 Data on Presentation and Outcomes of DOI: 10.1177/1076029620931200 journals.sagepub.com/home/cat Patients With Venous Thromboembolism: The RIETE Infographics Project Alfonso Tafur, MD, MS1,2, Behnood Bikdeli, MD, MS3,4,5, Ido Weinberg, MD6, David Jimenez, MD, PhD7, Annia Monreal8, Raquel Barba, MD9, Enrique Mira, MD10, Victor Macrinici, MD2, Harlan M. Krumholz, MD, SM5,10, Mayra Hawkins, PhD8, Manuel Monreal, MD, PhD11, and the RIETE Investigators Abstract In the current era of patient empowerment and precision medicine, access to timely information is critical to decision-making. Unfortunately, we currently lack patient-specific, real-time data about clinical presentation, risk of thrombotic or hemorrhagic events, key risk factors, and adverse outcomes in patients with venous thromboembolism (VTE). Accordingly, the Registro Informatizado Enfermedad TromboEmbólica (RIETE) investigators developed a tool to provide an open-source, real-time graphic representation of VTE-related data derived from over 90 000 patients with confirmed VTE. This information is intended to facilitate discussion in the informed decision-making process. The current article describes the aims, rationale, methods, and ongoing and future efforts of the real-time VTE infographics developed by the RIETE registry collaborators. Keywords thrombosis, pulmonary embolism, risk assessment Date received: 15 March 2020; revised: 28 April 2020; accepted: 11 May 2020. 1 Introduction Medicine, Vascular Medicine, North Shore University Health System, Evan- ston, IL, USA 2 Venous thromboembolism (VTE), including deep vein throm- University of Chicago, Pritzker School of Medicine, IL, USA 3 bosis (DVT) and pulmonary embolism, is a common, danger- NewYork-Presbyterian Hospital/Columbia University Irving Medical Center, New York, USA ous, and, often, preventable cause of death and disability.1,2 4 Clinical Trials Center, Cardiovascular Research Foundation, New York, USA The management of patients with VTE is complex, with a 5 Center for Outcomes Research and Evaluation (CORE), Yale School of myriad of options for short- and long-term treatment. However, Medicine, Connecticut, USA 6 we lack timely data about clinical presentation, risk of throm- Vascular Medicine, Division of Cardiology, Fireman Vascular Center, Massa- botic or hemorrhagic events, and key risk factors or adverse chusetts General Hospital, Boston, MA, USA 7 Department of Respiratory, Hospital Ramon y Cajal, Universidad de Alcala outcomes in patients with VTE. Estimates of risk (of both (IRYCIS), Madrid, Spain recurrence and treatment-related adverse events) are important 8 RIETE Registry Coordinating Center, S&H Medical Science Service, Madrid, to decision-making about preventive, diagnostic, and therapeu- Spain 9 tic strategies. Department of Internal Medicine, Hospital Universitario Rey Juan Carlos, Madrid, Spain The Registro Informatizado Enfermedad TromboEmbólica 10 Department of Internal Medicine, Hospital Universitario Virgen de la (RIETE) registry is ideally positioned to provide information Arrixaca, Murcia, Spain about VTE. This is a global registry with over 200 participating 11 Department of Internal Medicine, Hospital Germans Trias i Pujol, Uni- centers in 20 countries. At the time of writing this manuscript, versidad Autonoma de Barcelona, Badalona, Barcelona, Spain the registry includes data from over 90 000 patients. This reg- Corresponding Author: istry is poised to offer real-time patient-centric information that Alfonso Tafur, Medicine, Vascular Medicine, NorthShore University Health- can be constantly updated. Thus, the RIETE investigators have System, Evanston, IL, USA. developed an infographics platform for the purpose of real-time Email: fonz.tafur@gmail.com Creative Commons CC BY: This article is distributed under the terms of the Creative Commons Attribution 4.0 License (https://creativecommons.org/licenses/by/4.0/) which permits any use, reproduction and distribution of the work without further permission provided the original work is attributed as specified on the SAGE and Open Access pages (https://us.sagepub.com/en-us/nam/ open-access-at-sage). 2 Clinical and Applied Thrombosis/Hemostasis data analysis and information sharing intended both for patients Table 1. Present Aspects and Future Directions of the RIETE Info- and for health care professionals. Herein, we describe the meth- graphics Project. odology, advantages, and limitations for the design and use of Present Future this infographics platform. Involving, informing, and receiving feedback from Yes Yes patients Methods Involving, informing, and receiving feedback from Yes Yes RIETE investigators Overview Involving, informing, and receiving feedback from Yes Yes The RIETE is a large prospective multinational ongoing reg- non-RIETE investigators istry of consecutive patients with objectively confirmed VTE Involving, informing, and receiving feedback from No Yes policymakers (ClinicalTrials.gov identifier: NCT02832245). The RIETE has Conducting research based on the infographics No Yes helped characterize the risk factors, pattern of presentation, and platform clinical outcomes of patients with VTE, including in the afore- Designing quality improvement initiatives based on No Yes mentioned understudied subgroups: cancer, renal insufficiency, the infographics platform liver cirrhosis, recent major bleeding, very elderly patients, or Abbreviation: RIETE, Registro Informatizado Enfermedad TromboEmbólica. pregnancy.3-8 The RIETE has recently expanded to collect long-term outcomes data and has broadened its inclusion cri- teria to enroll other forms of venous thrombosis (such as cere- probability, post thrombotic syndrome, and so on. At present, bral, splanchnic, superficial, or retinal vein thrombosis). The the infographics are optimized to color coding of frequency RIETE platform is also being used to conduct pragmatic com- data. The platform is built to be interactive and responds to parative effectiveness studies, including randomized controlled multiple options of query personalization. Current and trials (RCTs). expected capabilities of the platform are summarized in Table 1. All enrolled patients provide written or verbal informed Goals of the Real-Time Infographics Software consent according to the local ethics protocols. Our overarching goal is to provide real-time information col- lected during real-life VTE care in a format designed to help Definitions patients, health care providers, scholars, and policymakers with relevant and timely information from a large ongoing A comprehensive list of the main methods and definitions in prospective multinational registry. We hope our platform will RIETE has been published.9 The main outcomes presented in become an instrument to facilitate shared decision-making, the infographics are initially limited to all-cause mortality, especially for patients with characteristics underrepresented recurrent VTE, major bleeding, and clinically relevant nonma- in clinical trials. jor bleeding. Data elements are collected for a minimum of 3 months, and there is ongoing centralized quality control of the data. Platform Development The website www.trombo.info allows patients, clinicians, and/ or investigators to communicate their concerns or questions. Examples The website has over 1.5 million visits per year. Classification Currently, there are 6 interactive infographics available. The of the first 1500 questions submitted from April 2015 to following are examples: December 2018 by RIETE investigators (MM, AM, DJ, MH, and others) led to selection of the most frequent queries: (1) How often do symptoms persist after a DVT? (48% of ques- tions); (2) What could I do to prevent a VTE? (30%); and (3) Risk Factors for VTE What is the risk for recurrences? (12%). Accurate identification of at-risk patients may help to increase Additionally, questions arising from the RIETE Network of awareness about early signs and symptoms of VTE. Therefore, 200 active institutions globally served as guide for clinical and also in response to patient queries, a real-time infographic scenario development. Thus, search for occult cancer after a that presents the frequency data of conventional risk factors VTE event was a selected query. We have formed a RIETE stratified by age or gender was created. For instance, in RIETE, Real-Time Infographics steering committee (AT, BB, IW, and 50% of men but only 40% of women had unprovoked VTE MM) to organize prospective query selection and dissemina- (Figure 1). Hence, there is potential to prevent 50% of VTE in tion strategy. men and 60% of VTE in women with improved prophylaxis. The RIETE data are queried for quality control every week, When applying the filter for only women aged <35 years, we and the real-time analysis platform is updated on a monthly show that over 50% of them were using hormonal therapy, 10% basis. Infographics already available include queries on VTE were pregnant, and 8% were postpartum, while in 15% there risk factors, cancer-associated thrombosis, occult cancer was no known risk factor (Figure 1). Tafur et al 3 Figure 1. Real-time risk factor Registro Informatizado Enfermedad TromboEmbólica (RIETE) infographic. Query October 2019. Figure 2. Real-time Registro Informatizado Enfermedad TromboEmbólica (RIETE) infographic on surgery type as VTE risk factor. Query October 2019. Venous thromboembolism after surgery. The following figure a patient education tool. Also, we plan to test the possibility of illustrates the most common surgical interventions for the affecting physician behavior and their degree of confidence in whole cohort of patients. As with all the infographics, users practicing according to published standards of care after being can filter the data (Figure 2). For instance, among 742 women exposed to data that represents a more narrow demographic (ie, aged >85 years, hip or knee surgery (either elective or for hip more similar to their patients), when compared to RCTs. More- fracture) accounted for over half of the interventions. Among over, acknowledging that the visualized data might affect 501 women aged <35 years, cesarean delivery accounted for patient–physician behavior while also respecting freedom of 23.8% of the most frequent interventions leading to VTE, fol- choice,10,11 we will not generate specific therapy recommen- lowed by genitourinary surgery (17.4%). dations, and the platform will remain as an informative tool rather than an alternative to medical advice. Ethics and Future Research We realize that forward-looking presentations of the aggregate Discussion data may influence decision-making. Thus, we are constructing As we have demonstrated, a free to access, constantly updated, a parallel study to quantify the effectiveness of this platform as real-life platform has been created based on an international 4 Clinical and Applied Thrombosis/Hemostasis Table 2. The RIETE Real-Time VTE Infographic Shared Decision- focused groups, and in consultation with behavioral scientists Making Validation. and a marketing specialist, we will generate an infographic opti- Phase 1. Framework optimization mized for a shared decision-making process. In phase 2 of our Qualitative research research, we will test the hypothesis that the format of data – Focus group interviews of patients and relatives of patients presentation to the physician may alter the degree of confidence with history of VTE. Query preferences of information in, and perception of, VTE management priorities. To this end, facilitation formats and hierarchy of content. we will test data presentation options to physicians in the RIETE – Focus group of physicians. Query perceived areas of higher network and cross validate the findings outside of RIETE. A communication uncertainty with the patients. primary strength of the RIETE network is that we will be able – Discourse analysis of focus groups. Generate visually optimized real-time infographics in response to patient–physician to test our assumptions in multiple countries and cultural back- communication needs grounds. To stress transparency of the data, the infographic Phase 2. Confidence measure webpage clarifies the date of the aggregate and patients included, Quantitative, survey research which are rigorously submitted to the same quality control as the – Query RIETE network participants. We will present in a case rest of the RIETE registry.9 The presentation and development format, common, or underrepresented patient populations in of the second-generation RIETE real-time infographics will be VTE literature and measure the degree of confidence in designed within the framework of libertarian paternalism, management. Then, we will requery management confidence after presentation of RIETE-generated scenario-specific acknowledging that the visualized data might affect patient–phy- infographic. sician behavior while also respecting freedom of choice.10,11 We Phase 3. Testing will hone our efforts to expose existing gaps of knowledge where Quantitative, randomized controlled trial there is paucity of RCT data and clearly defined guideline direc- – To measure patient-satisfaction among patients with VTE tives. Finally, the third segment of our research will measure diagnosis. The intervention will be real-time infographic- patient satisfaction scores in a cluster samples RCT using the facilitated shared decision-making using RIETE data. RIETE Network, in which the intervention will be the utilization Abbreviation: RIETE, Registro Informatizado Enfermedad TromboEmbólica; of our optimized infographic platform as a tool to facilitate the VTE, venous thromboembolism. shared decision-making process. In conclusion, the current article provides a summary of an ongoing effort to develop an infographics platform to share registry of over 90 000 patients to offer some insight into the relevant information about demographics, presentation, and products of these data. This information is not meant to be used outcomes of patients with VTE. Shared decision-making needs as medical advice nor to change the management recommen- to harmonize evidence-based medicine, physician experience, dations as defined by international guidelines. Randomized and patient preference. These constantly updated, free to trials and sophisticated observational comparative effective- access, data could be informative for patients, clinicians, and ness studies continue to have their important roles. Certainly, policy makers and may help in the generation of better knowl- at the current stage of development, the infographics are not a edge to help improve patient care. The proposed platform is platform to conduct comparative effectiveness studies or to aimed to help preserve patient autonomy while facilitating make real-time decision about comparative effectiveness or educated medical choices. Interested researchers are invited safety of treatment alternatives. However, we speculate that to join the RIETE investigators. this tool may potentially impact health literacy and will help prioritize future research questions and VTE-care policy. Advocacy for shared decision-making is gaining momentum Appendix A in health care policy.12 Yet, there is a paucity of validated tools Coordinator of the RIETE Registry: Manuel Monreal. to facilitate VTE-specific questions. In contrast, there is high- RIETE Steering Committee Members: Paolo Prandoni, Benja- level evidence that decision aids with clarification exercises min Brenner and Dominique Farge-Bancel. will improve value-based patient choices and may also improve RIETE National Coordinators: Raquel Barba (Spain), Pier- the patient–practitioner communication.13,14 Indeed, patients paolo Di Micco (Italy), Laurent Bertoletti (France), Sebastian with VTE recognize and dislike the lack of facilitated commu- Schellong (Germany), Inna Tzoran (Israel), Abilio Reis (Por- nication to establish expectations and management choices.15 tugal), Marijan Bosevski (R. Macedonia), Henri Bounameaux In its current form, the RIETE infographic project is predomi- (Switzerland), Radovan Malý (Czech Republic), Peter Ver- nantly informative (Table 1). hamme (Belgium), Joseph A. Caprini (USA), Hanh My Bui Less is known about quantification of the extent to which (Vietnam). decision aids are needed to have a positive effect. Thus, in order RIETE Registry Coordinating Center: S & H Medical Science to validate our tool, we propose a multistep project (Table 2) Service. anchored on the readily available real-time infographics. In the Members of the RIETE Group first step, we will optimize the framework of presentation of the Spain: Adarraga MD, Agud M, Aibar J, Aibar MA, Alfonso infographic data using patient and physician feedback measured J, Amado C, Arcelus JI, Baeza C, Ballaz A, Barba R, Barba- within a qualitative study. With information anchored on gelata C, Barrón M, Barrón-Andrés B, Blanco-Molina A, Tafur et al 5 Camon AM, Cañas I, Castro J, Cerdà P, Criado J, de Ancos C, Funding de Miguel J, del Toro J, Demelo-Rodrı́guez P, Dı́az-Peromingo The author(s) received no financial support for the research, author- JA, Dı́ez-Sierra J, Dı́az-Simón R, Domı́nguez IM, Encabo M, ship, and/or publication of this article. 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The authors also thank the RIETE Registry Coordinating Center, S&H Medical Science Ser- international patient decision aid standards collaboration: evolu- vice, for their quality control data, logistic and administrative support. tion of the core dimensions for assessing the quality of patient decision aids. BMC Med Inform Decis Mak. 2013;13 suppl 2:S1. Declaration of Conflicting Interests 15. Golemi I, Salazar Adum JP, Diaz Quintero L, et al. Gaps of care in The author(s) declared no potential conflicts of interest with respect to patients with venous thrombotic embolism: a qualitative study. Int the research, authorship, and/or publication of this article. Angiol. 2019;38(4):284-290.