articles+ search results

Female, Humans, Medical Informatics, Pelvic Organ Prolapse diagnosis, Pilot Projects, Decision Making, Decision Support Techniques, Health Personnel psychology, Patient Participation methods, Patient Preference, and Pelvic Organ Prolapse therapy

Background: Female patients with pelvic organ prolapse and clinicians need to take decisions regarding treatment that are often unpredictable in relation to how they impact the future everyday lives of the patients. This study formed the developmental phase of a larger study to develop and test an online tool to support shared decision-making.
Methods: Patients, health care professionals and other stakeholders participated in the development and evaluation process of this tool. The collected data was generated from observational studies, exploratory interviews with prompt cards and workshops with end users from four Danish gynecology outpatient clinics.
Results: Content analysis led to important themes. For the patients three themes emerged: 1) how the impact of symptoms on everyday life affected the need for relief, 2) their bodily perception and sex life and 3) their worries about the future. For clinicians the different symptoms and their severity was a main theme.
Conclusions: This article provides an overall description and discussion of the development methodology. It demonstrates how user involvement informed the prototyping process and how patients' preferences were included in the final prototype. Whether the tool actually increases SDM, remains to be tested in a pilot feasibility study.

Humans, Surveys and Questionnaires, Mobile Applications, and Telemedicine

Background: For a stress-management app to be persuasive and impactful, designers and developers should obtain a clear perspective of the value proposition according to key stakeholders before development. However, this is often not the case. In order to increase the chance of creating an impact by means of the Resilience Navigator app, this study aims to identify key stakeholders and work with them to gain an in-depth understanding of the value proposition of this stress-management app.
Methods: The approach used in this study builds on the approaches taken by Van Limburg et al. and Van Woezik et al. An initial list of stakeholders was identified by means of a literature scan. Stakeholders on this initial list took an online survey to identify key stakeholders with a ranking system. Semi-structured interviews were conducted with a subset of key stakeholders to identify the value proposition using the value proposition canvas as a framework for data collection. Finally, the value proposition was validated by key stakeholders during focus groups.
Results: The key stakeholders identified included employees, employers, participation councils within organisations, HR advisors, product owners, company doctors, and business analysts. The interviews produced a list of approximately one hundred values from which fifteen core values were distilled. One example is to take into account time constraints experienced by users during stress periods. In general, the Resilience Navigator app's main goal is to increase awareness of personal stress levels and causes of stress. In addition, the sub-goal is to increase skills for effective stress management. The focus groups validated the idea that the most important values were reflected in the value proposition and had been appropriately translated into design elements, according to key stakeholders.
Conclusions: A thorough, bottom-up identification and validation of the value proposition for the Resilience Navigator app was obtained, reflecting key stakeholders' varying ideas on this piece of eHealth technology. The results will facilitate the continued development of the Resilience Navigator app from the value specification phase to the design phase. In the design phase, the remaining assumptions regarding the app's value proposition should be tested using rapid prototyping.

Decision Making, Humans, Antirheumatic Agents therapeutic use, Decision Support Techniques, Internet, and Software Design

Background: A main element of patient-centred care, Patient Decision Aids (PtDAs) facilitate shared decision-making (SDM). A recent update of the International Patient Decision Aids Standards (IPDAS) emphasised patient involvement during PtDA development, but omitted a methodology for doing so. This article reports on the value of user-centred design (UCD) methods for the development of a PtDA that aims to support inflammatory arthritis patients in their choice between disease modifying anti-rheumatic drugs (DMARDs).
Methods: The IPDAS development process model in combination with UCD methods were applied. The process was overseen by an eight-member multidisciplinary steering group. Patients and health professionals were iteratively consulted. Qualitative in-depth interviews combined with rapid prototyping were conducted with patients to assess their needs for specific functionality, content and design of the PtDA. Group meetings with health professionals were organized to assess patients' needs and to determine how the PtDA should be integrated into patient pathways. The current literature was reviewed to determine the clinical evidence to include in the PtDA. To evaluate usability among patients, they were observed using the PtDA while thinking aloud and then interviewed.
Results: The combination of patient interviews with rapid prototyping revealed that patients wanted to compare multiple DMARDs both for their clinical aspects and implications for daily life. Health professionals mainly wanted to refer patients to a reliable, easily adjustable source of information about DMARDs. A web-based PtDA was constructed consisting of four parts: 1) general information about SDM, inflammatory arthritis and DMARDs; 2) an application to compare particular DMARDs; 3) value clarification exercises; and 4) a printed summary of patients' notes, preferences, worries and questions that they could bring to discuss with their rheumatologist.
Conclusions: The study demonstrated that UCD methods can be of great value for the development of PtDAs. The early, iterative involvement of patients and health professionals was helpful in developing a novel user-friendly PtDA that allowed patients to choose between DMARDs. The PtDA fits the values of all stakeholders and easily integrates with the patient pathway and daily workflow of health professionals. This collaborative designed PtDA may improve SDM and patient participation in arthritis care.

Patient Decision Aid, Shared Decision-Making, International Patient Decision Aids Standards, User-centred design, Computer applications to medicine. Medical informatics, and R858-859.7

Abstract Background A main element of patient-centred care, Patient Decision Aids (PtDAs) facilitate shared decision-making (SDM). A recent update of the International Patient Decision Aids Standards (IPDAS) emphasised patient involvement during PtDA development, but omitted a methodology for doing so. This article reports on the value of user-centred design (UCD) methods for the development of a PtDA that aims to support inflammatory arthritis patients in their choice between disease modifying anti-rheumatic drugs (DMARDs). Methods The IPDAS development process model in combination with UCD methods were applied. The process was overseen by an eight-member multidisciplinary steering group. Patients and health professionals were iteratively consulted. Qualitative in-depth interviews combined with rapid prototyping were conducted with patients to assess their needs for specific functionality, content and design of the PtDA. Group meetings with health professionals were organized to assess patients’ needs and to determine how the PtDA should be integrated into patient pathways. The current literature was reviewed to determine the clinical evidence to include in the PtDA. To evaluate usability among patients, they were observed using the PtDA while thinking aloud and then interviewed. Results The combination of patient interviews with rapid prototyping revealed that patients wanted to compare multiple DMARDs both for their clinical aspects and implications for daily life. Health professionals mainly wanted to refer patients to a reliable, easily adjustable source of information about DMARDs. A web-based PtDA was constructed consisting of four parts: 1) general information about SDM, inflammatory arthritis and DMARDs; 2) an application to compare particular DMARDs; 3) value clarification exercises; and 4) a printed summary of patients’ notes, preferences, worries and questions that they could bring to discuss with their rheumatologist. Conclusions The study demonstrated that UCD methods can be of great value for the development of PtDAs. The early, iterative involvement of patients and health professionals was helpful in developing a novel user-friendly PtDA that allowed patients to choose between DMARDs. The PtDA fits the values of all stakeholders and easily integrates with the patient pathway and daily workflow of health professionals. This collaborative designed PtDA may improve SDM and patient participation in arthritis care.

Shared decision making, Preference-sensitive decisions, Pelvic organ prolapse, User involvement, Computer applications to medicine. Medical informatics, and R858-859.7

Abstract Background Female patients with pelvic organ prolapse and clinicians need to take decisions regarding treatment that are often unpredictable in relation to how they impact the future everyday lives of the patients. This study formed the developmental phase of a larger study to develop and test an online tool to support shared decision-making. Methods Patients, health care professionals and other stakeholders participated in the development and evaluation process of this tool. The collected data was generated from observational studies, exploratory interviews with prompt cards and workshops with end users from four Danish gynecology outpatient clinics. Results Content analysis led to important themes. For the patients three themes emerged: 1) how the impact of symptoms on everyday life affected the need for relief, 2) their bodily perception and sex life and 3) their worries about the future. For clinicians the different symptoms and their severity was a main theme. Conclusions This article provides an overall description and discussion of the development methodology. It demonstrates how user involvement informed the prototyping process and how patients’ preferences were included in the final prototype. Whether the tool actually increases SDM, remains to be tested in a pilot feasibility study.

eHealth development, Stress management, Value specification, Stakeholder involvement, Value proposition design, Computer applications to medicine. Medical informatics, and R858-859.7

Abstract Background For a stress-management app to be persuasive and impactful, designers and developers should obtain a clear perspective of the value proposition according to key stakeholders before development. However, this is often not the case. In order to increase the chance of creating an impact by means of the Resilience Navigator app, this study aims to identify key stakeholders and work with them to gain an in-depth understanding of the value proposition of this stress-management app. Methods The approach used in this study builds on the approaches taken by Van Limburg et al. and Van Woezik et al. An initial list of stakeholders was identified by means of a literature scan. Stakeholders on this initial list took an online survey to identify key stakeholders with a ranking system. Semi-structured interviews were conducted with a subset of key stakeholders to identify the value proposition using the value proposition canvas as a framework for data collection. Finally, the value proposition was validated by key stakeholders during focus groups. Results The key stakeholders identified included employees, employers, participation councils within organisations, HR advisors, product owners, company doctors, and business analysts. The interviews produced a list of approximately one hundred values from which fifteen core values were distilled. One example is to take into account time constraints experienced by users during stress periods. In general, the Resilience Navigator app’s main goal is to increase awareness of personal stress levels and causes of stress. In addition, the sub-goal is to increase skills for effective stress management. The focus groups validated the idea that the most important values were reflected in the value proposition and had been appropriately translated into design elements, according to key stakeholders. Conclusions A thorough, bottom-up identification and validation of the value proposition for the Resilience Navigator app was obtained, reflecting key stakeholders’ varying ideas on this piece of eHealth technology. The results will facilitate the continued development of the Resilience Navigator app from the value specification phase to the design phase. In the design phase, the remaining assumptions regarding the app’s value proposition should be tested using rapid prototyping.

Developing Countries, Humans, Reproducibility of Results, Software Design, Early Diagnosis, Mobile Applications, Renal Insufficiency, Chronic diagnosis, Renal Insufficiency, Chronic therapy, Self Care, and Telemedicine

Background: The chronic kidney disease (CKD) is a worldwide critical problem, especially in developing countries. CKD patients usually begin their treatment in advanced stages, which requires dialysis and kidney transplantation, and consequently, affects mortality rates. This issue is faced by a mobile health (mHealth) application (app) that aims to assist the early diagnosis and self-monitoring of the disease progression.
Methods: A user-centered design (UCD) approach involving health professionals (nurse and nephrologists) and target users guided the development process of the app between 2012 and 2016. In-depth interviews and prototyping were conducted along with healthcare professionals throughout the requirements elicitation process. Elicited requirements were translated into a native mHealth app targeting the Android platform. Afterward, the Cohen's Kappa coefficient statistics was applied to evaluate the agreement between the app and three nephrologists who analyzed test results collected from 60 medical records. Finally, eight users tested the app and were interviewed about usability and user perceptions.
Results: A mHealth app was designed to assist the CKD early diagnosis and self-monitoring considering quality attributes such as safety, effectiveness, and usability. A global Kappa value of 0.7119 showed a substantial degree of agreement between the app and three nephrologists. Results of face-to-face interviews with target users indicated a good user satisfaction. However, the task of CKD self-monitoring proved difficult because most of the users did not fully understand the meaning of specific biomarkers (e.g., creatinine).
Conclusion: The UCD approach provided mechanisms to develop the app based on the real needs of users. Even with no perfect Kappa degree of agreement, results are satisfactory because it aims to refer patients to nephrologists in early stages, where they may confirm the CKD diagnosis.

Bipolar Disorder diagnosis, Feasibility Studies, Humans, Quality Improvement, Bipolar Disorder therapy, Clinical Decision-Making, Decision Making, Decision Support Techniques, Medical Informatics Applications, and Telemedicine

Background: People with bipolar disorder often experience ill health and have considerably reduced life expectancies. Suboptimal treatment is common and includes a lack of effective medicines, overtreatment, and non-adherence to medical interventions and lifestyle measures. E- and m-health applications support patients in optimizing their treatment but often exhibit conceptual and technical shortcomings. The objective of this work was to develop and test the usability of a system targeting suboptimal treatment and compare the service to other genres and strategies.
Methods: Based on the frameworks of shared decision-making, multi-criteria decision analysis, and single-subject research design, we interviewed potential users, reviewed research and current approaches, and created a first version using a rapid prototyping framework. We then iteratively improved and expanded the service based on formative usability testing with patients, healthcare providers, and laypeople from Norway, the UK, and Ukraine. The evidence-based health-optimization system was developed using systematic methods. The System Usability Scale and a questionnaire were administered in formative and summative tests. A comparison of the system to current standards for clinical practice guidelines and patient decision aids was performed.
Results: Seventy-eight potential users identified 82 issues. Driven by user feedback, the limited first version was developed into a more comprehensive system. The current version encompasses 21 integrated core features, supporting 6 health-optimization strategies. One crucial feature enables patients and clinicians to explore the likely value of treatments based on mathematical integration of self-reported and research data and the patient's preferences. The mean ± SD (median) system usability score of the patient-oriented subsystem was 71 ± 18 (73). The mean ± SD (median) system usability score in the summative usability testing was 78 ± 18 (75), well above the norm score of 68. Feedback from the questionnaire was generally positive. Eighteen out of 23 components in the system are not required in international standards for patient decision aids and clinical practice guidelines.
Conclusion: We have developed the first evidence-based health-optimization system enabling patients, clinicians, and caregivers to collaborate in optimizing the patient's health on a shared platform. User tests indicate that the feasibility of the system is acceptable.

Gene Frequency genetics, Humans, Data Interpretation, Statistical, Databases, Genetic standards, Genetic Privacy standards, and Genome-Wide Association Study standards

Background: The biomedical community benefits from the increasing availability of genomic data to support meaningful scientific research, e.g., Genome-Wide Association Studies (GWAS). However, high quality GWAS usually requires a large amount of samples, which can grow beyond the capability of a single institution. Federated genomic data analysis holds the promise of enabling cross-institution collaboration for effective GWAS, but it raises concerns about patient privacy and medical information confidentiality (as data are being exchanged across institutional boundaries), which becomes an inhibiting factor for the practical use.
Methods: We present a privacy-preserving GWAS framework on federated genomic datasets. Our method is to layer the GWAS computations on top of secure multi-party computation (MPC) systems. This approach allows two parties in a distributed system to mutually perform secure GWAS computations, but without exposing their private data outside.
Results: We demonstrate our technique by implementing a framework for minor allele frequency counting and χ2 statistics calculation, one of typical computations used in GWAS. For efficient prototyping, we use a state-of-the-art MPC framework, i.e., Portable Circuit Format (PCF) 1. Our experimental results show promise in realizing both efficient and secure cross-institution GWAS computations.

Chronic kidney disease, Self-monitoring, Mobile application, mHealth, User-centered design, Computer applications to medicine. Medical informatics, and R858-859.7

Abstract Background The chronic kidney disease (CKD) is a worldwide critical problem, especially in developing countries. CKD patients usually begin their treatment in advanced stages, which requires dialysis and kidney transplantation, and consequently, affects mortality rates. This issue is faced by a mobile health (mHealth) application (app) that aims to assist the early diagnosis and self-monitoring of the disease progression. Methods A user-centered design (UCD) approach involving health professionals (nurse and nephrologists) and target users guided the development process of the app between 2012 and 2016. In-depth interviews and prototyping were conducted along with healthcare professionals throughout the requirements elicitation process. Elicited requirements were translated into a native mHealth app targeting the Android platform. Afterward, the Cohen’s Kappa coefficient statistics was applied to evaluate the agreement between the app and three nephrologists who analyzed test results collected from 60 medical records. Finally, eight users tested the app and were interviewed about usability and user perceptions. Results A mHealth app was designed to assist the CKD early diagnosis and self-monitoring considering quality attributes such as safety, effectiveness, and usability. A global Kappa value of 0.7119 showed a substantial degree of agreement between the app and three nephrologists. Results of face-to-face interviews with target users indicated a good user satisfaction. However, the task of CKD self-monitoring proved difficult because most of the users did not fully understand the meaning of specific biomarkers (e.g., creatinine). Conclusion The UCD approach provided mechanisms to develop the app based on the real needs of users. Even with no perfect Kappa degree of agreement, results are satisfactory because it aims to refer patients to nephrologists in early stages, where they may confirm the CKD diagnosis.

Computer Simulation, Humans, Systems Integration, Electronic Health Records, and Software

Background: The openEHR project and the closely related ISO 13606 standard have defined structures supporting the content of Electronic Health Records (EHRs). However, there is not yet any finalized openEHR specification of a service interface to aid application developers in creating, accessing, and storing the EHR content.The aim of this paper is to explore how the Representational State Transfer (REST) architectural style can be used as a basis for a platform-independent, HTTP-based openEHR service interface. Associated benefits and tradeoffs of such a design are also explored.
Results: The main contribution is the formalization of the openEHR storage, retrieval, and version-handling semantics and related services into an implementable HTTP-based service interface. The modular design makes it possible to prototype, test, replicate, distribute, cache, and load-balance the system using ordinary web technology. Other contributions are approaches to query and retrieval of the EHR content that takes caching, logging, and distribution into account. Triggering on EHR change events is also explored.A final contribution is an open source openEHR implementation using the above-mentioned approaches to create LiU EEE, an educational EHR environment intended to help newcomers and developers experiment with and learn about the archetype-based EHR approach and enable rapid prototyping.
Conclusions: Using REST addressed many architectural concerns in a successful way, but an additional messaging component was needed to address some architectural aspects. Many of our approaches are likely of value to other archetype-based EHR implementations and may contribute to associated service model specifications.

Adult, Female, Humans, Male, Middle Aged, Needs Assessment, Program Development, Depression prevention control, Internet, and Telemedicine organization administration

Background: To reduce the large public health burden of the high prevalence of depression, preventive interventions targeted at people at risk are essential and can be cost-effective. Web-based interventions are able to provide this care, but there is no agreement on how to best develop these applications and often the technology is seen as a given. This seems to be one of the main reasons that web-based interventions do not reach their full potential. The current study describes the development of a web-based intervention for the indicated prevention of depression, employing the CeHRes (Center for eHealth Research and Disease Management) roadmap. The goals are to create a user-friendly application which fits the values of the stakeholders and to evaluate the process of development.
Methods: The employed methods are a literature scan and discussion in the contextual inquiry; interviews, rapid prototyping and a requirement session in the value specification stage; and user-based usability evaluation, expert-based usability inspection and a requirement session in the design stage.
Results: The contextual inquiry indicated that there is a need for easily accessible interventions for the indicated prevention of depression and web-based interventions are seen as potentially meeting this need. The value specification stage yielded expected needs of potential participants, comments on the usefulness of the proposed features and comments on two proposed designs of the web-based intervention. The design stage yielded valuable comments on the system, content and service of the web-based intervention.
Conclusions: Overall, we found that by developing the technology, we successfully (re)designed the system, content and service of the web-based intervention to match the values of stakeholders. This study has shown the importance of a structured development process of a web-based intervention for the indicated prevention of depression because: (1) it allows the development team to clarify the needs that have to be met for the intervention to be of use to the target audience; and (2) it yields feedback on the design of the application that is broader than color and buttons, but encompasses comments on the quality of the service that the application offers.

Shared decision-making, Patient decision aid, Clinical decision support system, Patient participation tool, Compliance, Adherence, Computer applications to medicine. Medical informatics, and R858-859.7

Abstract Background People with bipolar disorder often experience ill health and have considerably reduced life expectancies. Suboptimal treatment is common and includes a lack of effective medicines, overtreatment, and non-adherence to medical interventions and lifestyle measures. E- and m-health applications support patients in optimizing their treatment but often exhibit conceptual and technical shortcomings. The objective of this work was to develop and test the usability of a system targeting suboptimal treatment and compare the service to other genres and strategies. Methods Based on the frameworks of shared decision-making, multi-criteria decision analysis, and single-subject research design, we interviewed potential users, reviewed research and current approaches, and created a first version using a rapid prototyping framework. We then iteratively improved and expanded the service based on formative usability testing with patients, healthcare providers, and laypeople from Norway, the UK, and Ukraine. The evidence-based health-optimization system was developed using systematic methods. The System Usability Scale and a questionnaire were administered in formative and summative tests. A comparison of the system to current standards for clinical practice guidelines and patient decision aids was performed. Results Seventy-eight potential users identified 82 issues. Driven by user feedback, the limited first version was developed into a more comprehensive system. The current version encompasses 21 integrated core features, supporting 6 health-optimization strategies. One crucial feature enables patients and clinicians to explore the likely value of treatments based on mathematical integration of self-reported and research data and the patient’s preferences. The mean ± SD (median) system usability score of the patient-oriented subsystem was 71 ± 18 (73). The mean ± SD (median) system usability score in the summative usability testing was 78 ± 18 (75), well above the norm score of 68. Feedback from the questionnaire was generally positive. Eighteen out of 23 components in the system are not required in international standards for patient decision aids and clinical practice guidelines. Conclusion We have developed the first evidence-based health-optimization system enabling patients, clinicians, and caregivers to collaborate in optimizing the patient’s health on a shared platform. User tests indicate that the feasibility of the system is acceptable.

Academic Medical Centers economics, Biomedical Research economics, Clinical Protocols, Database Management Systems, Ethics Committees, Research, Government Regulation, Hospital Costs, Humans, Internet, North Carolina, Organizational Case Studies, Programming Languages, Surgery Department, Hospital legislation jurisprudence, Academic Medical Centers legislation jurisprudence, Biomedical Research legislation jurisprudence, Guideline Adherence economics, and Integrated Advanced Information Management Systems

Background: Although regulatory compliance in academic research is enforced by law to ensure high quality and safety to participants, its implementation is frequently hindered by cost and logistical barriers. In order to decrease these barriers, we have developed a Web-based application, Duke Surgery Research Central (DSRC), to monitor and streamline the regulatory research process.
Results: The main objective of DSRC is to streamline regulatory research processes. The application was built using a combination of paper prototyping for system requirements and Java as the primary language for the application, in conjunction with the Model-View-Controller design model. The researcher interface was designed for simplicity so that it could be used by individuals with different computer literacy levels. Analogously, the administrator interface was designed with functionality as its primary goal. DSRC facilitates the exchange of regulatory documents between researchers and research administrators, allowing for tasks to be tracked and documents to be stored in a Web environment accessible from an Intranet. Usability was evaluated using formal usability tests and field observations. Formal usability results demonstrated that DSRC presented good speed, was easy to learn and use, had a functionality that was easily understandable, and a navigation that was intuitive. Additional features implemented upon request by initial users included: extensive variable categorization (in contrast with data capture using free text), searching capabilities to improve how research administrators could search an extensive number of researcher names, warning messages before critical tasks were performed (such as deleting a task), and confirmatory e-mails for critical tasks (such as completing a regulatory task).
Conclusion: The current version of DSRC was shown to have excellent overall usability properties in handling research regulatory issues. It is hoped that its release as an open-source application will promote improved and streamlined regulatory processes for individual academic centers as well as larger research networks.

Computer applications to medicine. Medical informatics and R858-859.7

Abstract Background Although regulatory compliance in academic research is enforced by law to ensure high quality and safety to participants, its implementation is frequently hindered by cost and logistical barriers. In order to decrease these barriers, we have developed a Web-based application, Duke Surgery Research Central (DSRC), to monitor and streamline the regulatory research process. Results The main objective of DSRC is to streamline regulatory research processes. The application was built using a combination of paper prototyping for system requirements and Java as the primary language for the application, in conjunction with the Model-View-Controller design model. The researcher interface was designed for simplicity so that it could be used by individuals with different computer literacy levels. Analogously, the administrator interface was designed with functionality as its primary goal. DSRC facilitates the exchange of regulatory documents between researchers and research administrators, allowing for tasks to be tracked and documents to be stored in a Web environment accessible from an Intranet. Usability was evaluated using formal usability tests and field observations. Formal usability results demonstrated that DSRC presented good speed, was easy to learn and use, had a functionality that was easily understandable, and a navigation that was intuitive. Additional features implemented upon request by initial users included: extensive variable categorization (in contrast with data capture using free text), searching capabilities to improve how research administrators could search an extensive number of researcher names, warning messages before critical tasks were performed (such as deleting a task), and confirmatory e-mails for critical tasks (such as completing a regulatory task). Conclusion The current version of DSRC was shown to have excellent overall usability properties in handling research regulatory issues. It is hoped that its release as an open-source application will promote improved and streamlined regulatory processes for individual academic centers as well as larger research networks.