Stepwise Design and Evaluation of a Values-Oriented Ambient Intelligence Healthcare Monitoring Platform.

OBJECTIVES: The majority of all developed digital health technologies do not reach successful implementation. A discrepancy among technology design, the context of use, and user needs and values is identified as the main reason for this failure. Value-sensitive design (VSD) is a design method enabling to align design with user values by embedding values in technology, yet the method is lacking clear heuristics for practical application. To improve the successful design and implementation of digital health, we propose and evaluate a stepwise approach to VSD. METHODS: The approach consists of the phases: experiment, demonstrate, and validate. Experiment takes place in an office to create makeshift solutions. Demonstrate takes place in a mock-up environment and aims to optimize design requirements through user feedback. The validate phase takes place in an authentic care situation and studies how the novel technology affects current workflows. RESULTS: We applied the stepwise VSD approach to the design of a hospital-based ambient intelligence solution for remotely and continuously monitoring quality and safety of patient care. We particularly focused on embodiment of the values of safety, privacy, and inclusiveness in the design. Design activities of the experiment and demonstrate phase are discussed. CONCLUSIONS: A stepwise approach to VSD enables a design to optimally meet the values of all users involved, while aligning the design process with the practical limitations of healthcare institutions. We discuss some benefits and challenges related to VSD and the potential for transfer of this approach to other digital health solutions.

From Digital Health to Digital Well-being: Systematic Scoping Review.

BACKGROUND: Digital health refers to the proper use of technology for improving the health and well-being of people and enhancing the care of patients through the intelligent processing of clinical and genetic data. Despite increasing interest in well-being in both health care and technology, there is no clear understanding of what constitutes well-being, which leads to uncertainty in how to create well-being through digital health. In an effort to clarify this uncertainty, Brey developed a framework to define problems in technology for well-being using the following four categories: epistemological problem, scope problem, specification problem, and aggregation problem. OBJECTIVE: This systematic scoping review aims to gain insights into how to define and address well-being in digital health. METHODS: We followed the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews) checklist. Papers were identified from 6 databases and included if they addressed the design or evaluation of digital health and reported the enhancement of patient well-being as their purpose. These papers were divided into design and evaluation papers. We studied how the 4 problems in technology for well-being are considered per paper. RESULTS: A total of 117 studies were eligible for analysis (n=46, 39.3% design papers and n=71, 60.7% evaluation papers). For the epistemological problem, the thematic analysis resulted in various definitions of well-being, which were grouped into the following seven values: healthy body, functional me, healthy mind, happy me, social me, self-managing me, and external conditions. Design papers mostly considered well-being as healthy body and self-managing me, whereas evaluation papers considered the values of healthy mind and happy me. Users were rarely involved in defining well-being. For the scope problem, patients with chronic care needs were commonly considered as the main users. Design papers also regularly involved other users, such as caregivers and relatives. These users were often not involved in evaluation papers. For the specification problem, most design and evaluation papers focused on the provision of care support through a digital platform. Design papers used numerous design methods, whereas evaluation papers mostly considered pre-post measurements and randomized controlled trials. For the aggregation problem, value conflicts were rarely described. CONCLUSIONS: Current practice has found pragmatic ways of circumventing or dealing with the problems of digital health for well-being. Major differences exist between the design and evaluation of digital health, particularly regarding their conceptualization of well-being and the types of users studied. In addition, we found that current methodologies for designing and evaluating digital health can be improved. For optimal digital health for well-being, multidisciplinary collaborations that move beyond the common dichotomy of design and evaluation are needed.

Action Opportunities to Pursue Responsible Digital Care for People With Intellectual Disabilities: Qualitative Study.

BACKGROUND: Responsible digital care refers to any intentional systematic effort designed to increase the likelihood of a digital care technology developed through ethical decision-making, being socially responsible and aligned with the values and well-being of those impacted by it. OBJECTIVE: We aimed to present examples of action opportunities for (1) designing "technology"; (2) shaping the "context" of use; and (3) adjusting the behavior of "users" to guide responsible digital care for people with intellectual disabilities. METHODS: Three cases were considered: (1) design of a web application to support the preparation of meals for groups of people with intellectual disabilities, (2) implementation of an app to help people with intellectual disabilities regulate their stress independently, and (3) implementation of a social robot to stimulate interaction and physical activity among people with intellectual disabilities. Overall, 26 stakeholders participated in 3 multistakeholder workshops (case 1: 10/26, 38%; case 2: 10/26, 38%; case 3: 6/26, 23%) based on the "guidance ethics approach." We identified stakeholders' values based on bottom-up exploration of experienced and expected effects of using the technology, and we formulated action opportunities for these values in the specific context of use. Qualitative data were analyzed thematically. RESULTS: Overall, 232 effects, 33 values, and 156 action opportunities were collected. General and case-specific themes were identified. Important stakeholder values included quality of care, autonomy, efficiency, health, enjoyment, reliability, and privacy. Both positive and negative effects could underlie stakeholders' values and influence the development of action opportunities. Action opportunities comprised the following: (1) technology: development of the technology (eg, user experience and customization), technology input (eg, recipes for meals, intervention options for reducing stress, and activities), and technology output (eg, storage and use of data); (2) context: guidelines, training and support, policy or agreements, and adjusting the physical environment in which the technology is used; and (3) users: integrating the technology into daily care practice, by diminishing (eg, "letting go" to increase the autonomy of people with intellectual disabilities), retaining (eg, face-to-face contact), and adding (eg, evaluation moments) certain behaviors of care professionals. CONCLUSIONS: This is the first study to provide insight into responsible digital care for people with intellectual disabilities by means of bottom-up exploration of action opportunities to take account of stakeholders' values in designing technology, shaping the context of use, and adjusting the behavior of users. Although part of the findings may be generalized, case-specific insights and a complementary top-down approach (eg, predefined ethical frameworks) are essential. The findings represent a part of an ethical discourse that requires follow-up to meet the dynamism of stakeholders' values and further develop and implement action opportunities to achieve socially desirable, ethically acceptable, and sustainable digital care that improves the lives of people with intellectual disabilities.

Virtual reality for postsurgical pain management: An explorative randomized controlled study.

BACKGROUND: Virtual reality (VR) is a promising tool in a multimodal analgesic approach; however, evidence regarding virtual reality for postsurgical pain is limited. This study investigates the initial effectiveness and feasibility of self-administered virtual reality in postsurgical pain management. METHODS: Patients reporting a postsurgical pain score ≥4 were randomized for control or VR, stratified for 3 interventions with varying levels of immersion and interaction. Subjects were instructed to use virtual reality as add-on treatment at least 3 times a day for 10 minutes on days 2 till 4 postoperatively. Primary outcome was the mean daily pain intensity. Results of pain scores were related to patient and intervention characteristics, to explore which characteristics interact with virtual reality effects. Secondary outcomes were analgesic use, anxiety, stress, and feasibility. RESULTS: One hundred patients were included in the analyses: 37 in the control group and 63 for VR. VR did not demonstrate a significant effect on self-reported pain scores (P = .43), nor were specific patient or intervention characteristics associated with greater VR effects. Analgesic usage did not differ between groups. However, there was a trend toward greater cumulative percentages of patients achieving a 30% pain reduction, and significantly lower daily experienced stress (P = .01) and anxiety (P = .03) levels in VR intervention groups. VR was used less than prescribed, mainly because of illness and pain. Adverse events included disorientation, nausea, and fatigue. CONCLUSIONS: This explorative study did not demonstrate initial effectiveness of VR as add-on pain treatment regarding pain and analgesic use; however, VR positively affected stress and anxiety. VR is safe and suitable for a wide target audience, and feasibility differed between interventions. Personalizing and improving VR technology may enhance its effectiveness.

Designing a video consultation area for hybrid care delivery: the Garden Room with a view.

Introduction: Accelerated by the coronavirus pandemic, the healthcare landscape is rapidly evolving, with a shift towards hybrid care models combining in-person and online care. To support this shift, the Radboudumc, an academic hospital in the Netherlands, decided to redesign an existing space facilitating the conduction of video consultations. Method: The design process involved participation of end-users to ensure that the physical space met their needs. The look and feel of the area was based on evidence-based design guidelines. Two prototype setups were built and tested, and the feedback informed the final design of the Garden Room. Results: Identified end-user needs were divided into 3 major categories entailing consultation room setup, optimal use of technology and practical issues involving room availability. Combined with the look and feel of the hospital, final design requirements were developed. The Garden Room consists of 18 video consultation rooms, 4 shared workspaces, relaxation area with kitchen, and meeting rooms. Specific attention is given to the ergonomics, technology and privacy in the rooms to facilitate optimal video conversations between patients and healthcare providers. In the Garden Room, natural elements and an open design supports working in a healing environment. Discussion: Next challenge will be optimizing the use of the Garden Room, which may be hindered by various barriers like resistance to change, existing work processes, and lack of skills training. To address these barriers and support use of the Garden Room, the hospital should focus on the implementation of education, changes in work processes, and the presence of advocates for telehealth.

Self-Administered Virtual Reality for Postsurgical Pain Management: A Qualitative Study of Hospital Patients' Reported Experiences.

Virtual Reality (VR) has been shown to effectively reduce pain in patients with various pain conditions. However, questions arise on the use of VR in multimodal postsurgical pain management. Optimizing VR for pain management requires an understanding of intervention- and context-specific factors, based on patients' needs and expectations after major surgery. This substudy is part of a randomized controlled trial investigating the effects of three VR interventions as an add-on, self-administered treatment for postsurgical pain. Semi-structured interviews were conducted to evaluate VR effects, software, hardware, prescriptions, and factors affecting the implementation of VR. Experiences across interventions were compared to identify relevant factors for successful implementation. Patients benefitted from self-administered VR in postsurgical pain management in various aspects and without serious drawbacks. Participants preferred an intuitive, 3D, 360-degree VR device with a large choice of applications matching their interests. The preferred frequency and duration of VR use was 2-3 sessions a day for 10-15 min each. Adjusting the VR use to individuals' needs and contexts was reported to be key for successful implementation, with attention paid to improving the awareness of VR as a non-pharmacological means of promoting postsurgical recovery among patients and healthcare professionals.

Effect of a Behavioral Therapy-Based Virtual Reality Application on Quality of Life in Chronic Low Back Pain.

OBJECTIVES: Low back pain is the leading cause of years lived with disability with a large impact on quality of life and resistance to a broad array of current treatments. This study aimed to investigate the effect of a novel self-administered behavioral therapy-based virtual reality (VR) application on the quality of life of patients with nonspecific chronic low back pain (CLBP). METHODS: A pilot randomized controlled trial was conducted in adults with nonspecific CLBP with moderate to severe pain, waiting for treatment in a teaching hospital-based pain clinic. The intervention group used a self-administered behavioral therapy-based VR application for at least 10 minutes daily for 4 weeks. The control group received standard care. The primary outcome was quality of life at 4 weeks measured by the short form-12 physical and mental scores. Secondary outcomes were daily worst and least pain, pain coping strategies, activities of daily living, positive health, anxiety, and depression. Discontinuation of therapy and adverse events were analyzed as well. RESULTS: Forty-one patients were included. One patient withdrew due to personal reasons. No significant treatment effect was found for the short form-12 physical score (mean difference: 2.6 points; 95% CI: -5.60 to 0.48) and mental score (-1.75; -6.04 to 2.53) at 4 weeks. There was a significant treatment effect for daily "worst pain score" ( F [1, 91.425] = 33.3, P < 0.001) and "least pain score" ( F [1, 30.069] = 11.5, P = 0.002). Three patients reported mild and temporary dizziness. DISCUSSION: Four weeks of self-administered VR for CLBP does not improve quality of life, however, it may positively affect daily pain experience.

Evaluating value mediation in patients with chronic low-back pain using virtual reality: contributions for empirical research in Value Sensitive Design.

Value Sensitive Design (VSD) is the most well-known method to consider values in design. It consists of three iterative phases of investigation: conceptual, empirical, and technical. Although the approach is promising, the role of empirical research remains unclear. We address two opportunities for extending the role of empirical research in VSD. First, we argue that empirical research enables us to identify values in context. Second, we explain that empirical research enables us to anticipate how technology mediates the values of users. We make our point by means of an empirical study in a real-life controlled experimental context into the value mediation of virtual reality (VR) in patients with chronic low-back pain. Using value-oriented semi-structured interviews with twenty patients, we first analyze what values these patients consider important, and how the values are experienced. The second set of interviews held after all patients used VR four weeks at home, aims to provide insight into value changes as mediated by VR. We end the article by a comparison of our empirical results with previous, often speculative, literature into values in VR. We show that empirical research benefits the VSD process by providing in-depth insight into the effects of context and technology on values and the ability to translate these insights into recommendations for more responsible design and implementation of the technology. Supplementary information: The online version contains supplementary material available at 10.1007/s12553-022-00671-w.

How Digital Therapeutics Are Urging the Need for a Paradigm Shift: From Evidence-Based Health Care to Evidence-Based Well-being.

A scientific paradigm consists of a set of shared rules, beliefs, values, methods, and instruments for addressing scientific problems. Currently, health care embraces the paradigm of evidence-based health care (EBH). This paradigm prompts health care institutions to base decisions on the best available evidence, which is commonly generated in large-scale randomized controlled trials. We illustrate the application of EBH via the evaluation of drugs. We show how EBH is challenged when it is applied to the evaluation of digital therapeutics, which refers to technology and data to prevent, manage, or treat a medical disorder or disease. We conclude that amid the growing application of digital therapeutics, the paradigm of EBH is challenged in four domains: population, intervention, comparison, outcome. In the second part of this viewpoint, we argue for a paradigm shift in health care so we can optimally evaluate and implement digital therapeutics, and we sketch out the contours of this novel paradigm. We address the need for considering design in health care and evaluation processes, studying user values so that health care can move from a focus on health to well-being, focusing on individual experiences rather than the average, addressing the need for evaluation in authentic use contexts, and stressing the need for continuous evaluation of the dynamic relations between users, context, and digital therapeutics. We conclude that the transition from EBH toward evidence-based well-being would improve the successful implementation of digital technologies in health care.

Feasibility of Virtual Reality Exercises at Home for Post-COVID-19 Condition: Cohort Study.

BACKGROUND: Between 30% to 76% of COVID-19 patients have persistent physical and mental symptoms, sometimes up to 9 months after acute COVID-19. Current rehabilitation is mostly focused on the physical symptoms, whereas experts have agreed on the need for a biopsychosocial approach. A novel approach such as virtual reality (VR) rehabilitation at home might benefit patients and therapists, especially considering the expected rush of patients with post-COVID-19 condition needing rehabilitation. OBJECTIVE: The aim of this study was to investigate the feasibility of self-administered VR exercises at home for post-COVID-19 condition. METHODS: This was a single-arm feasibility study in an outpatient care setting. Patients who needed physiotherapy because of post-COVID-19 condition were included as determined by the treating physiotherapist. Participants performed VR physical exercises at home for a period of 6 weeks and were allowed to perform VR mental exercise through applications available on the VR platform to reduce stress and anxiety and promote cognitive functioning. The main outcomes were related to feasibility (ie, duration and frequency of VR use), safety (ie, adverse events), patient satisfaction, and reasons to withdraw. Physical performance, daily activities, cognitive functioning, anxiety and depression, and the quality of life were measured before and after. RESULTS: In total, 48 patients were included; 1 (2%) patient did not start VR, and 7 (15%) patients withdrew, mostly due to dizziness. Almost 70% (33/47) of participants reported experiencing any adverse event during VR exercising. However, only 25% (9/36) recalled these events at the end of the intervention period. The majority (27/36, 75%) of the patients described VR as having a positive influence on their recovery, and the global satisfaction score was 67%. The average VR use was 30 minutes per session, 3-4 times a week for 3-6 weeks. The overall use of VR applications was almost equally distributed over the 3 sets of VR exercises (physical, relaxing, and cognitive). However, the use frequency of physical exercises seemed to decrease over time, whereas the use of cognitive and relaxation exercises remained stable. Physical performance and quality of life outcomes were significantly improved after 6 weeks. CONCLUSIONS: VR physical exercises at home is feasible and safe with good acceptance in a significant percentage of patient with post-COVID-19 condition. TRIAL REGISTRATION: ClinicalTrials.gov NCT04505761; https://clinicaltrials.gov/ct2/show/NCT04505761.

Do Simulated Hospital Admissions Reflect Reality? A Qualitative Study of Volunteer Well-Being During a 24-Hr Simulated Hospitalization.

OBJECTIVES: This study aims to delineate if and how healthy volunteers admitted to simulated care can aid in understanding real well-being experiences of in-hospital surgical patients. BACKGROUND: Scientific research is necessary to understand the mediating effect of healthcare design on patient outcomes. Studies with patients are, however, difficult to conduct as they require substantial funding, time, and research capacity, and recovering patients are often not willing or able to participate. If studies conducted with volunteers provide similar findings, such studies might serve as fruitful alternatives for future research. METHOD: A multimethod study was conducted between July 2017 and December 2017 with 17 volunteers who underwent a 24-hr simulated inpatient postsurgical care protocol. Data on value experiences, norms, and design requirements for an optimal healing environment were collected via diaries and semi-structured value-oriented interviews, focused on the values of spatial comfort, privacy, autonomy, sensory comfort, safety and security, and social comfort. Volunteers' outcomes were compared to prior literature on similar patients' outcomes. RESULTS: Volunteers seem to experience their healing environment similarly to patients with regard to the values of spatial comfort, privacy, autonomy, sensory comfort, and social comfort related to contact with personnel and relatives. Less valuable insights were gained on the values of safety and security, and social comfort related to interaction with other patients, most probably due to the study design and because the participants did not truly experience a diseased bodily state. CONCLUSION: Simulated hospital admissions with volunteers provide a satisfactory alternative for studying real patient outcomes.

Could Virtual Reality play a role in the rehabilitation after COVID-19 infection?

Post-COVID-19 patients, particularly those who needed high care, are expected to have high needs for physical, psychological and cognitive rehabilitation. Yet, the resources needed to provide rehabilitation treatment are expected to be inadequate because healthcare systems faced a shortage of high-quality treatment of these symptoms already before the COVID-19 crisis emerged in patients with comparable needs. In this viewpoint, we discuss the potential of Virtual Reality (VR) administering fast, tailor-made rehabilitation at a distance, and offering a solution for the impending surge of demand for rehabilitation after COVID-19. VR consists of a head-mounted display (HMD) that can bring the user by computer-generated visuals into an immersive, realistic multi-sensory environment. Several studies on VR show its potential for rehabilitation and suggest VR to be beneficial in post-COVID-19. The immersion of VR may increase therapy adherence and may distract the patient from experienced fatigue and anxiety. Barriers still have to be overcome to easily implement VR in healthcare. We argue that embedding VR in virtual care platforms would assist in overcoming these barriers and would stimulate the spread of VR therapy, both for post-COVID-19 patients in the present and possibly for other patients with similar rehabilitation needs in the future.

Environmental Needs, Barriers, and Facilitators for Optimal Healing in the Postoperative Process: A Qualitative Study of Patients' Lived Experiences and Perceptions.

OBJECTIVES: Gaining an understanding of postoperative patients' environmental needs, barriers, and facilitators for optimal healing. BACKGROUND: An optimal hospital environment (the "healing environment") can enhance patients' postoperative recovery and shorten length of stay. However, insights lack into patients' lived environmental needs for optimal healing after surgery and how these needs are being met. METHOD: A qualitative study was conducted between August 2016 and August 2017 with 21 patients who underwent elective major abdominal surgery in a Dutch university hospital. Data were collected through context-mapping exercises and interviews to capture patients' lived experiences and explore the meaning of these experiences. Data were systematically analyzed according to the principles of thematic content analysis. RESULTS: Three themes were identified. First, participants want a sense of control over their treatment, ambient features, privacy, nutrition, and help requests. Participants described the need for positive distractions: personalizing the room, connecting with the external environment, and the ability to undertake activities. Finally, participants expressed the importance of functional, practical, and emotional support from professionals, peers, and relatives. According to participants, the hospital environment often does not meet their healing needs while being hospitalized. CONCLUSION: The hospital environment often does not meet patients' needs. Needs fulfillment can be improved by practical adjustments to the physical and interpersonal environment and considering patient's individual preferences and changing needs during recovery. Patient narratives, pictures, and drawings are valuable sources for hospital managers in their efforts to design evidence-based environments that anticipate to patient-specific needs for achieving early recovery.