A New Method for Structured Integration of User Needs in Two Health Technology Development Projects: Action Sheets.

An early integration of users and stakeholders is needed for a successful innovation process. Nonetheless, the integration of users is often hard to realize - especially when dealing with persons with chronic diseases. In addition, patients or users in general often are not able to formulate the requirements in a technical manner. Therefore, even if user requirements are collected, it is not certain that the developers know or understand 'what is really wanted'. To overcome these 'gaps', we have developed so-called Action Sheets (AS). This article presents the use of AS in two projects: the development of health technologies for people with cancer (INFOPAT) and dementia (QuartrBack). Depending on the project context, group sessions were conducted with different stakeholders to identify the needs of (potential) users. Within the INFOPAT project, ten focus groups were conducted with patients, physicians and other healthcare professionals. In QuartrBack stakeholders like e.g. care professionals, technical assistance organizations and citizens participated in two focus groups and three world cafés. Their requirements were then 'fed' into the technology development by the use of AS. AS appear to be a promising tool to make user needs based on social values more tangible and implementable into technology development processes. In addition, it shows up that four phases seem to be necessary for transferring identified user and stakeholder needs into AS, which can therefore be seen as essential to translate non-technically formulated requirements into technically feasible ones. The case study shows as lessons learned that despite the successful integration of user needs, context-sensitive adjustments are still necessary.

Caregivers' role in using a personal electronic health record: a qualitative study of cancer patients and caregivers in Germany.

BACKGROUND: Particularly in the context of severe diseases like cancer, many patients wish to include caregivers in the planning of treatment and care. Many caregivers like to be involved but feel insufficiently enabled. This study aimed at providing insight into patients' and caregivers' perspectives on caregivers' roles in managing the patient portal of an electronic personal health record (PHR). METHODS: A descriptive qualitative study was conducted comprising two study phases: (1) Usability tests and interviews with patients with cancer and caregivers (2) additional patient interviews after a 3-month-pilot-testing of the PHR. For both study parts, a convenience sample was selected, focusing on current state of health and therapy process and basic willingness to participate and ending up with a mixed sample as well as saturation of data. All interviews were audio-recorded, pseudonymized, transcribed verbatim and qualitatively analyzed. RESULTS: Two main categories emerged from qualitative data: 'Caregivers' role' and 'Graduation of access rights' - consisting of four subcategories each. The interviewed patients (n = 22) and caregivers (n = 9) felt that the involvement of caregivers is central to foster the acceptance of a PHR for cancer patients. However, their role varied from providing technical support to representing patients, e.g. if the patient's state of health made this necessary. Heterogeneous opinions emerged regarding the question whether caregivers should receive full or graduated access on a patient's PHR. CONCLUSIONS: In order to support the patient and to participate in the care process, caregivers need up-to-date information on the patient's health and treatment. Nevertheless, some patients do not want to share all medical data with caregivers, which might strain the patient-caregiver relationship. This needs to be considered in development and implementation of personal health records. Generally, in the debate on patient portals of a personal health record, paying attention to the role of caregivers is essential. By appreciating the important relationship between patients and caregivers right from the beginning, implementation, of a PHR would be enhanced. TRIAL REGISTRATION: ISRCTN85224823 . Date of registration: 23/12/2015 (retrospectively registered).

Digitalizing Health Services by Implementing a Personal Electronic Health Record in Germany: Qualitative Analysis of Fundamental Prerequisites From the Perspective of Selected Experts.

BACKGROUND: The implementation of a personal electronic health record (PHR) is a central objective of digitalization policies in the German health care system. Corresponding legislation was passed with the 2015 Act for Secure Digital Communication and Applications in the Health Sector (eHealth Act). However, compared with other European countries, Germany still lags behind concerning the implementation of a PHR. OBJECTIVE: In order to explore potential barriers and facilitators for the adoption of a PHR in routine health care in Germany, this paper aims to identify policies, structures, and practices of the German health care system that influence the uptake and use of a PHR. METHODS: A total of 33 semistructured interviews were conducted with a purposive sample of experts: 23 interviews with different health care professionals and 10 interviews with key actors of the German health care system who were telematics, eHealth, and information technology experts (eHealth experts). The interviews were transcribed verbatim and subjected to a content analysis. RESULTS: From the expert perspective, a PHR was basically considered desirable and unavoidable. At the same time, a number of challenges for implementation in Germany have been outlined. Three crucial themes emerged: (1) documentation standards: prevailing processes of the analog bureaucratic paper world, (2) interoperability: the plurality of actors and electronic systems, and (3) political structure: the lack of clear political regulations and political incentive structures. CONCLUSIONS: With regard to the implementation of a PHR, an important precondition of a successful digitalization will be the precedent reform of the system to be digitized. Whether the recently passed Act for Faster Appointments and Better Care will be a step in the right direction remains to be seen.

Utilizing a Prototype Patient-Controlled Electronic Health Record in Germany: Qualitative Analysis of User-Reported Perceptions and Perspectives.

BACKGROUND: Personal electronic health records (PHR) are considered instrumental in improving health care quality and efficiency, enhancing communication between all parties involved and strengthening the patient's role. Technical architectures, data privacy, and applicability issues have been discussed for many years. Nevertheless, nationwide implementation of a PHR is still pending in Germany despite legal regulations provided by the eHealth Act passed in 2015. Within the information technology for patient-oriented care project funded by the Federal Ministry of Education and Research (2012-2017), a Web-based personal electronic health record prototype (PEPA) was developed enabling patient-controlled information exchange across different care settings. Gastrointestinal cancer patients and general practitioners utilized PEPA during a 3-month trial period. Both patients and physicians authorized by them could view PEPA content online and upload or download files. OBJECTIVE: This paper aims to outline findings of the posttrial qualitative study carried out to evaluate user-reported experiences, perceptions, and perspectives, focusing on their interpretation of PEPA beyond technical usability and views on a future nationwide implementation. METHODS: Data were collected through semistructured guide-based interviews with 11 patients and 3 physicians (N=14). Participants were asked to share experiences, views of perceived implications, and perspectives towards nationwide implementation. Further data were generated through free-text fields in a subsequent study-specific patient questionnaire and researcher's notes. Data were pseudonymized, audiotaped, and transcribed verbatim. Content analysis was performed through the Framework Analysis approach. All qualitative data were systemized by using MAXQDA Analytics PRO 12 (Rel.12.3.1). Additionally, participant characteristics were analyzed descriptively using IBM SPSS Statistics Version 24. RESULTS: Users interpreted PEPA as a central medium containing digital chronological health-related documentation that simplifies information sharing across care settings. While patients consider the implementation of PEPA in Germany in the near future, physicians are more hesitant. Both groups believe in PEPA's concept, but share awareness of concerns about data privacy and older or impaired people's abilities to manage online records. Patients perceive benefits for involvement in treatment processes and continuity of care but worry about financing and the implementation of functionally reduced versions. Physicians consider integration into primary systems critical for interoperability but anticipate technical challenges, as well as resistance from older patients and colleagues. They omit clear positioning regarding PEPA's potential incremental value for health care organizations or the provider-patient relationship. CONCLUSIONS: Digitalization in German health care will continue to bring change, both organizational and in the physician-patient relationship. Patients endorse and expect a nationwide PEPA implementation, anticipating various benefits. Decision makers and providers need to contribute to closing modernization gaps by committing to new concepts and by invigorating transformed roles.

[Personal health records on the Internet. A narrative review of attitudes, expectations, utilization and effects on health outcomes]. / Persönliche Patientenakten im Internet. Ein narrativer Review zu Einstellungen, Erwartungen, Nutzung und Effekten.

BACKGROUND: The integration of information and communication technologies (ICT) is increasingly considered in the development of healthcare structures. This fact is also recognised in the e-Health Act. In this context, personal health records (PHR) have a specific meaning. The aim of this paper is to provide an overview on utilization, barriers and possible effects on the implementation of PHR. METHODS: This analysis is based on a literature search in Web of Science (Core Collection) (01/2000 to 12/2014) using the following terms: "personal health record", "personal medical record", "personal electronic health record", "interpersonal health record", "personally controlled health record". RESULTS: In general, patients have positive attitudes towards the electronic exchange of personal health information (PHI) on a PHR. Even the sharing of PHI with physicians, health professionals, family and friends appears to be an option for many patients. Physicians also see the potential of a PHR on the internet, but they are more critical than patients. Barriers exist towards the use of complex and non-intuitive PHR concepts along with technical faults and the lack of functionality. From the physicians' perspective, prejudices concerning the use of PHR have not been confirmed and, other than previously expected, the workload has not increased so much. However, clinical outcomes have so far been rather moderate. Stronger effects may be achieved by embedding the PHR in a broader healthcare concept. CONCLUSION: In the context of chronic disease, a connected PHR (patient-controlled, cross-sectoral, and interoperable) can be a valuable tool for organizing healthcare for patients. To take full effect, the development of such systems should focus on patients and their families as well as on physicians and other healthcare professionals. Whether the e-Health Act is a step in the right direction will have to be established by future analysis.

A Personal Electronic Health Record: Study Protocol of a Feasibility Study on Implementation in a Real-World Health Care Setting.

BACKGROUND: A significant potential for patient empowerment is seen in concepts aiming to give patients access to their personal health information (PHI) and to share this PHI across different care settings and health systems. Personal health records (PHRs) and the availability of information through health information exchanges are considered to be key components of effective and efficient health care. With tethered PHRs, as often used in the United States, patients' opportunities to manage their PHI are strongly restricted. Therefore, within the INFOPAT (information technology for patient oriented care) project (2012-2016) in Germany, funded by the Federal Ministry of Education and Research (BMBF), the development of a patient-controlled "personal electronic health record" (PEPA) was based on user requirements right from the beginning. OBJECTIVE: The overall objective of the study is to implement and evaluate a PEPA prototype for patients with colorectal cancer who are treated at the National Center for Tumor Diseases in Heidelberg. To achieve this aim, this study has 2 parts: a pre-implementation study (phase 1) and an implementation study (phase 2). The pre-implementation study will include a usability evaluation of the PEPA approach and the consideration of organizational preconditions for the implementation. With the implementation study, we will evaluate the process of implementation (eg, barriers or facilitators), the need for organizational change (eg, processes of communication), and the impact on outcomes (eg, self-efficacy, involvement in care). METHODS: The pre-implementation study is based on a mixed methods approach and comprises qualitative and quantitative element according to our research aim. We will use a think-aloud method for the usability analysis. Additionally, participants will be asked to evaluate their overall satisfaction based on a standardized questionnaire, the System Usability Scale. For the analysis of preconditions, we will conduct semistructured personal interviews with, for example, patients, medical assistants, and physicians. Within the implementation study the outcome evaluation is planned as a prospective, 3-month, open-label "before and after" trial. Additionally, for the analysis of processes and the need for organizational change, we will conduct interviews with the participants (eg, patients, general practitioners, physicians) of the before and after trial. RESULTS: This project is part of the INFOPAT project, which is funded (2012-2016) by the Federal Ministry of Education and Research (BMBF). The enrolment was completed in July 2016. Data analysis is currently under way and the first results are expected to be submitted for publication at end of 2017. CONCLUSIONS: Existing approaches of PHRs aim to give patients access to their treatment data. With the PEPA approach and this study, we go a step further: patients have access to their PHI and they can give other persons (eg, their general practitioner) access. With this approach, new possibilities for professional collaboration and the engagement of patients can arise.

Strengthening Interprofessional Requirements Engineering Through Action Sheets: A Pilot Study.

BACKGROUND: The importance of information and communication technology for healthcare is steadily growing. Newly developed tools are addressing different user groups: physicians, other health care professionals, social workers, patients, and family members. Since often many different actors with different expertise and perspectives are involved in the development process it can be a challenge to integrate the user-reported requirements of those heterogeneous user groups. Nevertheless, the understanding and consideration of user requirements is the prerequisite of building a feasible technical solution. In the course of the presented project it proved to be difficult to gain clear action steps and priorities for the development process out of the primary requirements compilation. Even if a regular exchange between involved teams took place there was a lack of a common language. OBJECTIVE: The objective of this paper is to show how the already existing requirements catalog was subdivided into specific, prioritized, and coherent working packages and the cooperation of multiple interprofessional teams within one development project was reorganized at the same time. In the case presented, the manner of cooperation was reorganized and a new instrument called an Action Sheet was implemented. This paper introduces the newly developed methodology which was meant to smooth the development of a user-centered software product and to restructure interprofessional cooperation. METHODS: There were 10 focus groups in which views of patients with colorectal cancer, physicians, and other health care professionals were collected in order to create a requirements catalog for developing a personal electronic health record. Data were audio- and videotaped, transcribed verbatim, and thematically analyzed. Afterwards, the requirements catalog was reorganized in the form of Action Sheets which supported the interprofessional cooperation referring to the development process of a personal electronic health record for the Rhine-Neckar region. RESULTS: In order to improve the interprofessional cooperation the idea arose to align the requirements arising from the implementation project with the method of software development applied by the technical development team. This was realized by restructuring the original requirements set in a standardized way and under continuous adjustment between both teams. As a result not only the way of displaying the user demands but also of interprofessional cooperation was steered in a new direction. CONCLUSIONS: User demands must be taken into account from the very beginning of the development process, but it is not always obvious how to bring them together with IT knowhow and knowledge of the contextual factors of the health care system. Action Sheets seem to be an effective tool for making the software development process more tangible and convertible for all connected disciplines. Furthermore, the working method turned out to support interprofessional ideas exchange.