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BACKGROUND: In Europe, more than 15 million people live with heart failure (HF). It imposes an enormous social, organizational and economic burden. As a reaction to impending impact on healthcare provision, different country-specific structures for HF-care have been established. The aim of this report is to provide an overview and compare the HF-care approaches of Germany, Ireland, the Netherlands and the UK, and to open the possibility of learning from each other's experience. METHODS: A mixed methods approach was implemented that included a literature analysis, interviews and questionnaires with HF-patients and caregivers, and expert interviews with representatives from healthcare, health service research and medical informatics. RESULTS: The models of HF-care in all countries analyzed are based on the European Society of Cardiology guidelines for diagnosis and treatment of HF. Even though the HF-models differed in design and implementation in practice, key challenges were similar: (i) unequal distribution of care between urban and rural areas, (ii) long waiting times, (iii) unequal access to and provision of healthcare services, (iv) information and communication gaps and (v) inadequate implementation and financing of digital applications. CONCLUSION: Although promising approaches exist to structure and improve HF-care, across the four countries, implementation was reluctant to embrace novel methods. A lack of financial resources and insufficient digitalization making it difficult to adopt new concepts. Integration of HF-nurses seems to be an effective way of improving current models of HF-care. Digital solutions offer further opportunities to overcome communication and coordination gaps and to strengthen self-management skills.
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Atenção à Saúde , Insuficiência Cardíaca , Humanos , Europa (Continente) , Alemanha , Insuficiência Cardíaca/terapia , Países BaixosRESUMO
BACKGROUND: Adherence and motivation are key factors for successful treatment of patients with chronic diseases, especially in long-term care processes like rehabilitation. However, only a few patients achieve good treatment adherence. The causes are manifold. Adherence-influencing factors vary depending on indications, therapies, and individuals. Positive and negative effects are rarely confirmed or even contradictory. An ontology seems to be convenient to represent existing knowledge in this domain and to make it available for information retrieval. METHODS: First, a manual data extraction of current knowledge in the domain of treatment adherence in rehabilitation was conducted. Data was retrieved from various sources, including basic literature, scientific publications, and health behavior models. Second, all adherence and motivation factors identified were formalized according to the ontology development methodology METHONTOLOGY. This comprises the specification, conceptualization, formalization, and implementation of the ontology "Ontology for factors influencing therapy adherence to rehabilitation" (OnTARi) in Protégé. A taxonomy-oriented evaluation was conducted by two domain experts. RESULTS: OnTARi includes 281 classes implemented in ontology web language, ten object properties, 22 data properties, 1440 logical axioms, 244 individuals, and 1023 annotations. Six higher-level classes are differentiated: (1) Adherence, (2) AdherenceFactors, (3) AdherenceFactorCategory, (4) Rehabilitation, (5) RehabilitationForm, and (6) RehabilitationType. By means of the class AdherenceFactors 227 adherence factors, thereof 49 hard factors, are represented. Each factor involves a proper description, synonyms, possibly existing acronyms, and a German translation. OnTARi illustrates links between adherence factors through 160 influences-relations. Description logic queries implemented in Protégé allow multiple targeted requests, e.g., for the extraction of adherence factors in a specific rehabilitation area. CONCLUSIONS: With OnTARi, a generic reference model was built to represent potential adherence and motivation factors and their interrelations in rehabilitation of patients with chronic diseases. In terms of information retrieval, this formalization can serve as a basis for implementation and adaptation of conventional rehabilitative measures, taking into account (patient-specific) adherence factors. OnTARi also enables the development of medical assistance systems to increase motivation and adherence in rehabilitation processes.
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Motivação , Cooperação do Paciente , Comportamentos Relacionados com a Saúde , Humanos , Armazenamento e Recuperação da Informação , IdiomaRESUMO
One main challenge of health care systems in future will be the care and treatment of dementia patients. To their advanced age, dementia patients do not only have limitations in cognition, perception, and articulation, but also suffer from several other diseases (multimorbidity). These patients have sophisticated needs for assistance, care, and treatment relying on different health care sectors. Well-known communication and coordination deficits between sectors are intensified in the case of dementia, to the above described limitations. Coordination processes concerning the transition of patients from hospitals to inpatient or outpatient aftercare pose particularly difficult. To show a possible future direction for improving intersectoral care of dementia patients, we developed the web-based case management system CASEPLUS-SimPat as part of the project SimPat "Securing Integrated Care for Multi-morbid Patients with Dementia using an IT-based Service Concept". CASEPLUS-SimPat allows health care professionals, hospital employees and general practitioners, to jointly access patient data and exchange information about the treatment of patients. The case management system was implemented in a three-tier architecture with a role-based authorization concept. A portal for relatives complements the system. By providing precise information and e-learning services, caring relatives are integrated into the care process. In a pilot test, CASEPLUS-SimPat shows a good usability. Adapting aspects, such as keywords used to structure entries will make it easier to find required information, and thus will increase usability. Next steps comprise integration of further health care professionals and care facilities as well as real-life testing in terms of feasibility and effectiveness.
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Cuidadores/educação , Demência/enfermagem , Intervenção Baseada em Internet , Telemedicina/organização & administração , Humanos , Avaliação de Resultados em Cuidados de Saúde , Equipe de Assistência ao Paciente/organização & administração , Desenvolvimento de Programas/métodosRESUMO
INTRODUCTION: The integration of Patient-Reported Experience Measures (PREM) alongside traditional clinical outcomes is crucial for improving quality of care. Although PREMs are frequently measured in inpatient treatment settings, they are rarely employed in digitally supported care processes or longitudinal assessment of care pathways. METHODS: To gain an overview of PREMs used to cover patients' experiences with digitally supported care processes in heart failure (HF), a scoping review was conducted in Medline. RESULTS: Out of 538 publications, 29 were identified that focus on PREMs in digitally supported care processes across 9 unspecific and 14 disease-specific groups, with 5 manuscripts focusing on HF. PREMs were mostly assessed using self-developed, study-specific questionnaires lacking standardization and validity. In total, 9 PREM dimensions and 25 sub-dimensions were identified. This included care delivery, privacy, physician-patient relationship, involvement, administration, information, knowledge, technology, and experiences in general. CONCLUSION: The findings suggest that the relevance of different dimensions assessed depends largely on the type of care rather than the underlying chronic disease.
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Insuficiência Cardíaca , Medidas de Resultados Relatados pelo Paciente , Insuficiência Cardíaca/terapia , Humanos , Satisfação do Paciente , TelemedicinaRESUMO
BACKGROUND: As telemedical structures continues to be developed in the German healthcare system, remote monitoring is becoming increasingly important to ensure comprehensive, outpatient, and tailored care. The national quality assurance measure "DOQUVIDE-Documentation of quality in the assessment of vital parameters by implanted devices" is used to provide insight into everyday care for patients with telemedicine-enabled devices in Germany. METHODS: DOQUVIDE is a measuring instrument for recording outpatient remote monitoring for patients with implanted pacemaker, implantable cardioverter defibrillator (ICD), cardiac resynchronization therapy with a pacemaker (CRT-P), CRT defibrillator (CRT-D) devices and event recorder. DOQUVIDE records telemedically measured vital signs as well as cardiac events and the associated procedures initiated by cardiologists using standardized forms. RESULTS: In 74 practices/clinics in 14 federal states, 6687 patients received telemedical care in 2022; 937 were newly enrolled. These (60% male) were on average 77.8 years old, mainly with New York Heart Association (NYHA) class II (62.6%). A total of 5801 electronic records were generated as a result of telecardiology events, of which 3590 were due to pathological atrial fibrillation and 1812 due to ventricular high-frequency episodes. 295 events were triggered by event recorders and 95 by device therapies. The main measures taken were telephone contacts or outpatient visits. CONCLUSION: Remote monitoring has become a reality in German healthcare. Standardized processes and the establishment of quality assurance measures enable the definition of common quality standards and the identification of the potential for further development and simplify implementation in day-to-day care for practices.
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Desfibriladores Implantáveis , Telemedicina , Humanos , Alemanha , Idoso , Masculino , Feminino , Marca-Passo Artificial , Idoso de 80 Anos ou mais , Garantia da Qualidade dos Cuidados de Saúde , Pessoa de Meia-IdadeRESUMO
Health-enabling technologies (HET) have high potential in rehabilitation to support patients performing their home exercises. The modeling of human movements as well as the modelling of quality criteria of an exercise performance remains challenging when implementing HETs. A combination of data-driven approaches and knowledge-based methods may deliver new insights. This requires structured quality assessments of concrete exercise performances from a therapists' point of view. Therefore, a structured, easy to use questionnaire to assess home exercise performances is developed and implemented. The questionnaire consists of eight items in three categories: (1-4) overall assessment of quality and quantity, (5-7) need for correction, and (8) correction hints. The collected data will be the basis for mathematical modeling of home exercise performance assessment as foundation for the development of patient supporting HETs.
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Terapia por Exercício , Exercício Físico , Terapia por Exercício/métodos , Humanos , Movimento , Inquéritos e QuestionáriosRESUMO
Especially in chronic diseases, such as shoulder impingement syndrome (SIS), good self-management is important for patients to take personal responsibility for their treatment and make informed decisions in rehabilitation processes. Mobile apps integrating game design elements have great potential to increase patients self-management skills. A total of 21 functionalities for a self-management app were derived from semi-structured interviews with six patients and three therapists. Thereby, welcome messages, a personalized home-screen, and training plans are rated as particular useful. Ten of these functionalities could be implemented in a first prototype of SISco: your shoulder impingement syndrome companion. SISco provides possibilities for creating and executing training programs, learning about SIS, checking daily challenges, and making diary entries. Thereby, SISco motivates patients via progress bars, collecting XP, unlocking content and Dr. SISco the virtual therapist. Future work includes the implementation of further functionalities and the evaluation of SISco for usability and user acceptance.
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Aplicativos Móveis , Autogestão , Síndrome de Colisão do Ombro , Telemedicina , Doença Crônica , Humanos , Síndrome de Colisão do Ombro/terapiaRESUMO
Designing health-enabling technologies (HETs) to support individualized physiotherapeutic exercises requires comprehensive knowledge of bio-psycho-social factors to be considered. Therefore, this review identified factors for individualization of therapeutic exercises in patients with musculoskeletal shoulder disorders in peer-reviewed articles searched in MEDLINE. The final full-text analysis included 16 of 335 search results and extracted nineteen main categories of individualization factors. The most frequently identified main categories include progression of exercises, exercise framework, and assessment. An iterative approach with constant reassessments represents the key principle for the process of individualization. Categories that are difficult to standardize were rarely mentioned, but should also be considered. The identified factors can improve the design-process of HETs by sensitizing developers, enable further formal modelling, and support communication between developers, physiotherapists, and patients.
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Doenças Musculoesqueléticas , Fisioterapeutas , Terapia por Exercício , Humanos , Ombro , Extremidade SuperiorRESUMO
Rehabilitation of musculoskeletal diseases (MSD) of the shoulder is a multifaceted long-term process, which is often not transparent to affected patients. Mobile health applications (apps) have the potential to support this complex process by improving patients' self-management skills. However, there seems to be a lack of apps providing a holistic approach to motivate and guide patients during the whole rehabilitation process. Therefore, a systematic analysis of apps on Google Play Store was conducted by two independent reviewers. A total of 3227 apps were identified, of which 64 met the eligibility criteria for the qualitative analysis. The majority of analyzed apps were developed generally for patients with MSD of the shoulder, rarely for specific diseases (individual needs of patients). The majority of apps focus on the provision of information, exercise training, and alternative medicine. Apps for diagnostics, inpatient treatment, and self-management, especially for multiple rehabilitation phases, are rare or even not existent. Game design elements are seldom used. If there are any, then simple to implement ones, e.g. messages and progress bars. The (psychological) effects of individual game design elements on patients seem to be neglected, when selecting and implementing game-components.
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Aplicativos Móveis , Doenças Musculoesqueléticas , Autogestão , Telemedicina , Humanos , Doenças Musculoesqueléticas/terapia , OmbroRESUMO
BACKGROUND: Health-enabling technologies (HETs) are information and communication technologies that promote individual health and well-being. An important application of HETs is telerehabilitation for patients with musculoskeletal shoulder disorders. Currently, there is no overview of HETs that assist patients with musculoskeletal shoulder disorders when exercising at home. OBJECTIVE: This scoping review provides a broad overview of HETs that assist patients with musculoskeletal shoulder disorders when exercising at home. It focuses on concepts and components of HETs, exercise program strategies, development phases, and reported outcomes. METHODS: The search strategy used Medical Subject Headings and text words related to the terms upper extremity, exercises, and information and communication technologies. The MEDLINE, Embase, IEEE Xplore, CINAHL, PEDro, and Scopus databases were searched. Two reviewers independently screened titles and abstracts and then full texts against predefined inclusion and exclusion criteria. A systematic narrative synthesis was performed. Overall, 8988 records published between 1997 and 2019 were screened. Finally, 70 articles introducing 56 HETs were included. RESULTS: Identified HETs range from simple videoconferencing systems to mobile apps with video instructions to complex sensor-based technologies. Various software, sensor hardware, and hardware for output are in use. The most common hardware for output are PC displays (in 34 HETs). Microsoft Kinect cameras in connection with related software are frequently used as sensor hardware (in 27 HETs). The identified HETs provide direct or indirect instruction, monitoring, correction, assessment, information, or a reminder to exercise. Common parameters for exercise instructions are a patient's range of motion (in 43 HETs), starting and final position (in 32 HETs), and exercise intensity (in 20 HETs). In total, 48 HETs provide visual instructions for the exercises; 29 HETs report on telerehabilitation aspects; 34 HETs only report on prototypes; and 15 HETs are evaluated for technical feasibility, acceptance, or usability, using different assessment instruments. Efficacy or effectiveness is demonstrated for only 8 HETs. In total, 18 articles report on patients' evaluations. An interdisciplinary contribution to the development of technologies is found in 17 HETs. CONCLUSIONS: There are various HETs, ranging from simple videoconferencing systems to complex sensor-based technologies for telerehabilitation, that assist patients with musculoskeletal shoulder disorders when exercising at home. Most HETs are not ready for practical use. Comparability is complicated by varying prototype status, different measurement instruments, missing telerehabilitation aspects, and few efficacy studies. Consequently, choosing an HET for daily use is difficult for health care professionals and decision makers. Prototype testing, usability, and acceptance tests with the later target group under real-life conditions as well as efficacy or effectiveness studies with patient-relevant core outcomes for every promising HET are required. Furthermore, health care professionals and patients should be more involved in the product design cycle to consider relevant practical aspects.
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Exercise therapy aims to restore normal musculoskeletal function or to reduce pain in patients with musculoskeletal shoulder disorders. Especially during long-term treatments, patients perform unsupervised exercises at home. Harmful movement deviations should be identified and avoided. Assistive technologies based on physical therapists' knowledge can support patients. In this paper, we present our approach to minimize the complexity of a physical therapists' quality assessment of a shoulder exercise performance. Four experienced physical therapists assessed the quality of 13 exercise performances shown as video recordings with a visual analogue scale and explained their ratings as free text. In some cases, the resulting assessments differed widely depending on the respective therapeutic goals. The therapists had difficulties to reduce the performances quality to a single value. Despite the existing consensus on exercises' descriptions, a more than one-dimensional scale is needed to evaluate exercises. Therefore, rating categories have to be identified for more detailed assessments.
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Fisioterapeutas , Terapia por Exercício , Humanos , Movimento , Ombro , Gravação em VídeoRESUMO
INTRODUCTION: Shoulder lesions rank among the top 15 diagnoses accounting for days of incapacity to work. Inpatient or full-day outpatient rehabilitation are some of the standard therapies. For sustainable rehabilitation, continuation of rehabilitation after discharge from a rehabilitation centre is vital. Besides medical exercise therapy (MET), home-based physical exercise programmes are used. To monitor exercise quantity and quality, AGT-Reha, a health-enabling technology for home rehabilitation, has been developed and evaluated in a pilot study for technical feasibility and acceptance. To integrate the digital therapeutic AGT-Reha into regular healthcare processes, an efficacy evaluation is required. METHODS AND ANALYSIS: AGT-Reha-WK is a prospective, monocentric, non-randomised, unblinded non-inferiority trial. Primary objective is to investigate whether AGT-Reha enhanced home-based exercise training is non-inferior to MET as standard aftercare. Secondary objective is to compare the costs of both therapies. Efficacy as medical success (primary outcome) is examined with regard to ability to work, return to work and sustainability of training (secondary outcomes). The outcome measure for non-inferiority is shoulder function (pain and disability) assessed by the standardised Shoulder Pain and Disability Index (SPADI). The non-inferiority margin is set to 10 points on SPADI score using a 95% CI. Subjects will be recruited at the Rehabilitation Center Bad Pyrmont, Germany. The total number of subjects should be 84 (42 per group). Treatment takes 6 months per patient. Subjects will be assessed at four time points: pre-baseline (admission to rehabilitation centre), baseline (discharge from rehabilitation centre), post-therapy and follow-up (3 months post-therapy). ETHICS AND DISSEMINATION: Ethics approval was granted by the Ethics Committee of Hannover Medical School (ethics approval no: 7313). Results of the trial are planned to be published in a peer-reviewed journal. TRIAL REGISTRATION NUMBER: German Clinical Trials Register DRKS00011596. Registered 2 June 2017. Recruitment started on 3 March 2017, and it is expected to continue until December 2020. PROTOCOL VERSION: V2.0, 23 May 2018, Amendment 01: improved risk analysis, clarification of exclusion criteria to increase reproducibility, additional documentation with OpenClinica; these changes have no effect on structural equality.
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Telerreabilitação , Exercício Físico , Terapia por Exercício , Alemanha , Humanos , Projetos Piloto , Estudos Prospectivos , Reprodutibilidade dos Testes , OmbroRESUMO
BACKGROUND: Gamification has become increasingly important both in research and in practice. Particularly in long-term care processes, such as rehabilitation, playful concepts are gaining in importance to increase motivation and adherence. In addition to neurological diseases, this also affects the treatment of patients with musculoskeletal diseases such as shoulder disorders. Although it would be important to assist patients during more than one rehabilitation phase, it is hypothesized that existing systems only support a single phase. It is also unclear which game design elements are currently used in this context and how they are combined to achieve optimal positive effects on motivation. OBJECTIVE: This scoping review aims to identify and analyze information and communication technologies that use game design elements to support the rehabilitation processes of patients with musculoskeletal diseases of the shoulder. The state of the art with regard to fields of application, game design elements, and motivation concepts will be determined. METHODS: We conducted a scoping review to identify relevant application systems. The search was performed in 3 literature databases: PubMed, IEEE Xplore, and Scopus. Following the PICO (population, intervention, comparison, outcome) framework, keywords and Medical Subject Headings for shoulder, rehabilitation, and gamification were derived to define a suitable search term. Two independent reviewers, a physical therapist and a medical informatician, completed the search as specified by the search strategy. There was no restriction on year of publication. Data synthesis was done by deductive-inductive coding based on qualitative content analysis. RESULTS: A total of 1994 articles were screened; 31 articles in English, published between 2006 and 2019, were included. Within, 27 application systems that support patients with musculoskeletal diseases of the shoulder in exercising, usually at home but also in inpatient or outpatient rehabilitation clinics, were described. Only 2 application systems carried out monitoring of adherence. Almost all were based on in-house developed software. The most frequently used game components were points, tasks, and avatars. More complex game components, such as collections and teams, were rarely used. When selecting game components, patient-specific characteristics, such as age and gender, were only considered in 2 application systems. Most were described as motivating, though an evaluation of motivational effects was usually not conducted. CONCLUSIONS: There are only a few application systems supporting patients with musculoskeletal diseases of the shoulder in rehabilitation by using game design elements. Almost all application systems are exergames for supporting self-exercising. Application systems for multiple rehabilitation phases seem to be nonexistent. It is also evident that only a few complex game design elements are used. Patient-specific characteristic are generally neglected when selecting and implementing game components. Consequently, a holistic approach to enhance adherence to rehabilitation is required supporting patients during the entire rehabilitation process by providing motivational game design elements based on patient-specific characteristics.
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BACKGROUND: After discharge from a rehabilitation center the continuation of therapy is necessary to secure already achieved healing progress and sustain (re-)integration into working life. To this end, home-based exercise programs are frequently prescribed. However, many patients do not perform their exercises as frequently as prescribed or even with incorrect movements. The telerehabilitation system AGT-Reha was developed to support patients with shoulder diseases during their home-based aftercare rehabilitation. OBJECTIVES: The presented pilot study AGT-Reha-P2 evaluates the technical feasibility and user acceptance of the home-based telerehabilitation system AGT-Reha. METHODS: A nonblinded, nonrandomized exploratory feasibility study was conducted over a 2-year period in patients' homes. Twelve patients completed a 3-month telerehabilitation exercise program with AGT-Reha. Primary outcome measures are the satisfying technical functionality and user acceptance assessed by technical parameters, structured interviews, and a four-dimensional questionnaire. Secondary endpoints are the medical rehabilitation success measured by the active range of motion and the shoulder function (pain and disability) assessed by employing the Neutral-0 Method and the standardized questionnaire "Shoulder Pain and Disability Index" (SPADI), respectively. To prepare an efficacy trial, various standardized questionnaires were included in the study to measure ability to work, capacity to work, and subjective prognosis of work capacity. The participants have been assessed at three measurement points: prebaseline (admission to rehabilitation center), baseline (discharge from rehabilitation center), and posttherapy. RESULTS: Six participants used the first version of AGT-Reha, while six other patients used an improved version. Despite minor technical problems, all participants successfully trained on their own with AGT-Reha at home. On average, participants trained at least once per day during their training period. Five of the 12 participants showed clinically relevant improvements of shoulder function (improved SPADI score > 11). The work-related parameters suggested a positive impact. All participants would recommend the system, ten participants would likely reuse it, and seven participants would have wanted to continue their use after 3 months. CONCLUSION: The findings show that home-based training with AGT-Reha is feasible and well accepted. Outcomes of SPADI indicate the effectiveness of aftercare with AGT-Reha. A controlled clinical trial to test this hypothesis will be conducted with a larger number of participants.
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Terapia por Exercício , Lesões do Ombro/reabilitação , Telerreabilitação , Estudos de Viabilidade , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Projetos Piloto , Inquéritos e QuestionáriosRESUMO
Networking is a key competence, especially for young researchers in the field of medical informatics. Therefore, it is encouraged in organizations like AMIA. Since, in Europe no such networking possibility is known, concepts and ideas for the implementation shall be established and assessed with regard to their appropriateness. Demands, suggestions and attitudes of the community were collected in an online survey. Based on this, a workshop with international participants was conducted at Medical Informatics Europe 2018 in Gothenburg, Sweden. Following topics were addressed: i) communication channels, ii) activities to be carried out, iii) organizational structures and iv) acquisition of participants. The results show the relevance of such a networking platform. Furthermore, numerous requirements and realization possibilities, but also challenges were identified and assessed during the workshop. Altogether, essential ideas for the implementation of an European Young Researcher Network (EYouRNet) were collected, which can serve as a basis for the realization.
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Informática Médica , Pesquisadores , Europa (Continente) , Humanos , Rede Social , Inquéritos e Questionários , SuéciaRESUMO
Although adherence is a key factor for successful treatment of chronic diseases, only about 50% of patients achieve good adherence. However, health enabling technologies and gamification offer new possibilities to enhance patient's motivation. In physical rehabilitation, various applications exist. As these often stress a specific part of the rehabilitation process, we introduce a six-step new holistic approach to apply game design elements in the entire rehabilitation process, while focusing on patients with musculoskeletal diseases of the shoulder.
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Doenças Musculoesqueléticas , Cooperação do Paciente , Ombro , Doença Crônica , Atenção à Saúde , Comportamentos Relacionados com a Saúde , Humanos , Doenças Musculoesqueléticas/reabilitação , Jogos de VídeoRESUMO
INTRODUCTION: Systemic inflammatory response syndrome (SIRS) is one of the most critical indicators determining the clinical outcome of paediatric intensive care patients. Clinical decision support systems (CDSS) can be designed to support clinicians in detection and treatment. However, the use of such systems is highly discussed as they are often associated with accuracy problems and 'alert fatigue'. We designed a CDSS for detection of paediatric SIRS and hypothesise that a high diagnostic accuracy together with an adequate alerting will accelerate the use. Our study will (1) determine the diagnostic accuracy of the CDSS compared with gold standard decisions created by two blinded, experienced paediatricians, and (2) compare the system's diagnostic accuracy with that of routine clinical care decisions compared with the same gold standard. METHODS AND ANALYSIS: CADDIE2 is a prospective diagnostic accuracy study taking place at the Department of Pediatric Cardiology and Intensive Care Medicine at the Hannover Medical School; it represents the second step towards our vision of cross-institutional and data-driven decision-support for intensive care environments (CADDIE). The study comprises (1) recruitment of up to 300 patients (start date 1 August 2018), (2) creation of gold standard decisions (start date 1 May 2019), (3) routine SIRS assessments by physicians (starts with recruitment), (4) SIRS assessments by a CDSS (start date 1 May 2019), and (5) statistical analysis with a modified approach for determining sensitivity and specificity and comparing the accuracy results of the different diagnostic approaches (planned start date 1 July 2019). ETHICS AND DISSEMINATION: Ethics approval was obtained at the study centre (Ethics Committee of Hannover Medical School). Results of the main study will be communicated via publication in a peer-reviewed journal. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov NCT03661450; Pre-results.