title: Assessment of a personalized and distributed patient guidance system.
abstract: The MobiGuide project aimed to establish a ubiquitous, user-friendly, patient-centered mobile decision-support system for patients and for their care providers, based on the continuous application of clinical guidelines and on semantically integrated electronic health records. Patients would be empowered by the system, which would enable them to lead their normal daily lives in their regular environment, while feeling safe, because their health state would be continuously monitored using mobile sensors and self-reporting of symptoms. When conditions occur that require medical attention, patients would be notified as to what they need to do, based on evidence-based guidelines, while their medical team would be informed appropriately, in parallel. We wanted to assess the system's feasibility and potential effects on patients and care providers in two different clinical domains.
  
  
  
  We describe MobiGuide's architecture, which embodies these objectives. Our novel methodologies include a ubiquitous architecture, encompassing a knowledge elicitation process for parallel coordinated workflows for patients and care providers; the customization of computer-interpretable guidelines (CIGs) by secondary contexts affecting remote management and distributed decision-making; a mechanism for episodic, on demand projection of the relevant portions of CIGs from a centralized, backend decision-support system (DSS), to a local, mobile DSS, which continuously delivers the actual recommendations to the patient; shared decision-making that embodies patient preferences; semantic data integration; and patient and care provider notification services. MobiGuide has been implemented and assessed in a preliminary fashion in two domains: atrial fibrillation (AF), and gestational diabetes Mellitus (GDM). Ten AF patients used the AF MobiGuide system in Italy and 19 GDM patients used the GDM MobiGuide system in Spain. The evaluation of the MobiGuide system focused on patient and care providers' compliance to CIG recommendations and their satisfaction and quality of life.
  
  
  
  Our evaluation has demonstrated the system's capability for supporting distributed decision-making and its use by patients and clinicians. The results show that compliance of GDM patients to the most important monitoring targets - blood glucose levels (performance of four measurements a day: 0.87±0.11; measurement according to the recommended frequency of every day or twice a week: 0.99±0.03), ketonuria (0.98±0.03), and blood pressure (0.82±0.24) - was high in most GDM patients, while compliance of AF patients to the most important targets was quite high, considering the required ECG measurements (0.65±0.28) and blood-pressure measurements (0.75±1.33). This outcome was viewed by the clinicians as a major potential benefit of the system, and the patients have demonstrated that they are capable of self-monitoring - something that they had not experienced before. In addition, the system caused the clinicians managing the AF patients to change their diagnosis and subsequent treatment for two of the ten AF patients, and caused the clinicians managing the GDM patients to start insulin therapy earlier in two of the 19 patients, based on system's recommendations. Based on the end-of-study questionnaires, the sense of safety that the system has provided to the patients was its greatest asset. Analysis of the patients' quality of life (QoL) questionnaires for the AF patients was inconclusive, because while most patients reported an improvement in their quality of life in the EuroQoL questionnaire, most AF patients reported a deterioration in the AFEQT questionnaire.
  
  
  
  Feasibility and some of the potential benefits of an evidence-based distributed patient-guidance system were demonstrated in both clinical domains. The potential application of MobiGuide to other medical domains is supported by its standards-based patient health record with multiple electronic medical record linking capabilities, generic data insertion methods, generic medical knowledge representation and application methods, and the ability to communicate with a wide range of sensors. Future larger scale evaluations can assess the impact of such a system on clinical outcomes.
  
  
  
  MobiGuide's feasibility was demonstrated by a working prototype for the AF and GDM domains, which is usable by patients and clinicians, achieving high compliance to self-measurement recommendations, while enhancing the satisfaction of patients and care providers.
authors.affiliation: Department of Information Systems, University of Haifa, Haifa, Israel. Electronic address: morpeleg@is.haifa.ac.il.
authors.forename: Mor
authors.initials: M
authors.lastname: Peleg
authors.affiliation: Department of Information Systems Engineering, Ben Gurion University of the Negev, Beer-Sheva, Israel.
authors.forename: Yuval
authors.initials: Y
authors.lastname: Shahar
authors.affiliation: Department of Electrical, Computer and Biomedical Engineering, University of Pavia, Italy.
authors.forename: Silvana
authors.initials: S
authors.lastname: Quaglini
authors.affiliation: MobiHealth B.V., Enschede, The Netherlands.
authors.forename: Tom
authors.initials: T
authors.lastname: Broens
authors.affiliation: IRCCS Foundation "Salvatore Maugeri", Pavia, Italy.
authors.forename: Roxana
authors.initials: R
authors.lastname: Budasu
authors.affiliation: University of Twente, 7500 AE, Enschede, The Netherlands.
authors.forename: Nick
authors.initials: N
authors.lastname: Fung
authors.affiliation: Department of Information Systems, University of Haifa, Haifa, Israel.
authors.forename: Adi
authors.initials: A
authors.lastname: Fux
authors.affiliation: Bioengineering and Telemedicine Centre, Universidad Politécnica de Madrid, and Networking Research Centre for Bioengineering, Biomaterials and Nanomedicine (CIBER-BBN), Spain.
authors.forename: Gema
authors.initials: G
authors.lastname: García-Sáez
authors.affiliation: Department of Information Systems Engineering, Ben Gurion University of the Negev, Beer-Sheva, Israel.
authors.forename: Ayelet
authors.initials: A
authors.lastname: Goldstein
authors.affiliation: Department of Information Systems, University of Haifa, Haifa, Israel.
authors.forename: Arturo
authors.initials: A
authors.lastname: González-Ferrer
authors.affiliation: University of Twente, 7500 AE, Enschede, The Netherlands.
authors.forename: Hermie
authors.initials: H
authors.lastname: Hermens
authors.affiliation: Bioengineering and Telemedicine Centre, Universidad Politécnica de Madrid, and Networking Research Centre for Bioengineering, Biomaterials and Nanomedicine (CIBER-BBN), Spain.
authors.forename: M Elena
authors.initials: ME
authors.lastname: Hernando
authors.affiliation: University of Twente, 7500 AE, Enschede, The Netherlands.
authors.forename: Val
authors.initials: V
authors.lastname: Jones
authors.affiliation: Department of Information Systems, University of Haifa, Haifa, Israel.
authors.forename: Guy
authors.initials: G
authors.lastname: Klebanov
authors.affiliation: Department of Information Systems Engineering, Ben Gurion University of the Negev, Beer-Sheva, Israel.
authors.forename: Denis
authors.initials: D
authors.lastname: Klimov
authors.affiliation: MobiHealth B.V., Enschede, The Netherlands.
authors.forename: Daniel
authors.initials: D
authors.lastname: Knoppel
authors.affiliation: University of Twente, 7500 AE, Enschede, The Netherlands.
authors.forename: Nekane
authors.initials: N
authors.lastname: Larburu
authors.affiliation: Atos Spain S.A, Madrid, Spain.
authors.forename: Carlos
authors.initials: C
authors.lastname: Marcos
authors.affiliation: Bioengineering and Telemedicine Centre, Universidad Politécnica de Madrid, and Networking Research Centre for Bioengineering, Biomaterials and Nanomedicine (CIBER-BBN), Spain.
authors.forename: Iñaki
authors.initials: I
authors.lastname: Martínez-Sarriegui
authors.affiliation: IRCCS Foundation "Salvatore Maugeri", Pavia, Italy.
authors.forename: Carlo
authors.initials: C
authors.lastname: Napolitano
authors.affiliation: Associacio de Diabetics de Catalunya,Barcelona, Spain.
authors.forename: Àngels
authors.initials: À
authors.lastname: Pallàs
authors.affiliation: Atos Spain S.A, Madrid, Spain.
authors.forename: Angel
authors.initials: A
authors.lastname: Palomares
authors.affiliation: Department of Electrical, Computer and Biomedical Engineering, University of Pavia, Italy.
authors.forename: Enea
authors.initials: E
authors.lastname: Parimbelli
authors.affiliation: Endocrinology and Nutrition Department Parc Tauli Sabadell University Hospital, Sabadell, Spain.
authors.forename: Belén
authors.initials: B
authors.lastname: Pons
authors.affiliation: Endocrinology and Nutrition Department Parc Tauli Sabadell University Hospital, Sabadell, Spain.
authors.forename: Mercedes
authors.initials: M
authors.lastname: Rigla
authors.affiliation: Department of Electrical, Computer and Biomedical Engineering, University of Pavia, Italy.
authors.forename: Lucia
authors.initials: L
authors.lastname: Sacchi
authors.affiliation: Department of Information Systems Engineering, Ben Gurion University of the Negev, Beer-Sheva, Israel.
authors.forename: Erez
authors.initials: E
authors.lastname: Shalom
authors.affiliation: Department of Information Systems, University of Haifa, Haifa, Israel.
authors.forename: Pnina
authors.initials: P
authors.lastname: Soffer
authors.affiliation: University of Twente, 7500 AE, Enschede, The Netherlands.
authors.forename: Boris
authors.initials: B
authors.lastname: van Schooten
mesh_terms: D000328:Adult; D001281:Atrial Fibrillation / Q000628:therapy*; D003195:Computer Communication Networks; D003657:Decision Making; D020000:Decision Support Systems, Clinical; D016640:Diabetes, Gestational / Q000628:therapy*; D057286:Electronic Health Records; D005260:Female; D019983:Guideline Adherence; D006801:Humans; D017410:Practice Guidelines as Topic / Q000592:standards*; D011247:Pregnancy; D011788:Quality of Life
keywords: Clinical decision-support systems; Computer-interpretable clinical guidelines; Mobile health; Patient guidance system