To obtain these solutions available in the public health system calls for a rigorous multidimensional evaluation that, as a complete and valid approach, is developed through the implementation of the Health Technology Assessment (HTA) methodology. However, the route to integrate patients’ perspectives of evaluation, considered essential from this standpoint, is still much debated (see, for instance, [
2]). Moreover, the multidimensional evaluation framework can be applied at different stages of the development of a technology, ranging from the very first conceptualizations (with the early assessment approach) to existing prototypes virtually ready for introduction and testing in the market and in the healthcare system.
The aim of the present paper is, therefore, to illustrate how the Smart&TouchID (STID) model addresses the need to incorporate patients’ evaluations into a multidimensional technology assessment framework by presenting a feasibility study of model application with regard to rehabilitation experiences of people living with NCDs.
Although the STID model operates to optimize the co-design and development of innovative solutions for rehabilitation care for NCDs, in the present paper the focus is not on specific technologies as outputs of the STID multidimensional evaluation flow. Rather, the attention is drawn to the processes that the STID model enables in order to integrate the standpoints (action and attitudes) of the various stakeholders to obtain technology optimization. This way, the paper targets the feasibility testing of the STID model as a tool in national/regional governance strategies aimed at tuning the agenda-setting of innovation in rehabilitation care through a participatory methodology.
After detailing how technological innovation can address the growing need for rehabilitation of people with NCDs, an overview of the STID model will be illustrated, showing how it models the development of health technologies for people with NCDs into a flow that embeds the evaluation of digital solutions from the very first stages of their development and from the perspectives of different stakeholders including patients. Then, as a feasibility study in running the STID model with regard to the embedding of patients’ and citizens’ evaluations in technological development, preliminary evidence from the collection of patients’ and citizens’ experiences on rehabilitation will be described and discussed.
1.1. Technological Innovation to Meet the Need for Rehabilitation for People with Non-Communicable Diseases
In the last thirty years, the need for rehabilitation for people with Non-Communicable Diseases (NCDs) has increased to involve up to 2.41 billion people. Innovative technologies for remote rehabilitation care can help reach all those in need.
According to the estimates of the Global Burden of Diseases, Injuries, and Risk Factors Study [
3], NCDs have, since 1990, become responsible for a notable proportion of the burden due to Years of Life lived with Disability (YLDs). In 2019, together with those connected with injury, YLDs due to NCDs accounted for over 50% of all disease burdens in 11 countries. Drawing on this evidence, the landmark study by Cieza and colleagues [
4] estimated that one-third of the world’s population lives with a health condition that would benefit from rehabilitation. This need has increased by 63% in the last thirty years, going from 1.48 billion to 2.41 billion people. The impact on public health expenditure is considerable: just in Europe, for instance, healthcare costs for NCDs are estimated at around 700 billion euros per year [
5]. However, so far, rehabilitation is still construed as a very specialized and expensive service, mostly directed at severe disabilities. This way, it cannot guarantee timed and intensive access to people in the early to medium stages of the disease, when, as documented in the literature, early intervention can load on the cognitive reserve and residual skills, with documented slow-down clinical outcomes [
6,
7,
8].
Digital healthcare technologies, conceived as new means for addressing the big healthcare challenges of the 21st century [
5] can provide rehabilitation interventions that through telecommunication and information technologies, guarantee the continuity-of-care for NCDs outside the hospital settings [
9,
10]. These remote rehabilitation interventions, defined as telerehabilitation (TR), require a “double-loop” communication between the clinic and the patient’s home to be in line with face-to-face treatment and to warrant the fundamental clinical actions: assessment, monitoring, and feedback to the patient [
11]. While in TR synchronous models, usually delivered through video conferencing devices, the 1:1 setting is the same as in face-to-face interventions, in asynchronous models the clinician’s actions and the patient’s actions are temporally decoupled. The asynchronous modeling option, therefore, moves beyond the conventional 1:1 setting, enabling a one-to-many simultaneous delivery of rehabilitation treatments. Evidence on the efficiency and efficacy of TR is accumulating, both as directed to people with NCDs [
11,
12,
13] and documenting its non-inferiority, with respect to conventional face-to-face treatments [
1,
11]. Along this line, tech-enabled rehabilitation care can be conceived as the ideal candidate to scale up rehabilitation to reach all people with NCDs in need, providing accessibility to continuity of care outside the hospital through its integration into the health system. The target is to strengthen rehabilitation services at the primary care level, as advocated by Cieza and colleagues [
4].
To reach the aim of making tech-enabled rehabilitation a widespread service, ensuring accessibility and quality home-based management of chronic conditions requires rigorous and evidence-based evaluation regarding its safety, efficacy, and sustainability balance. The Health Technology Assessment (HTA) methodology provides a more complete and valid approach for evaluating if and how in a health system, new technologies can promote equitable and quality care with available healthcare resources. However, in the last ten years, HTA agencies have strongly highlighted that the assessment of new technologies should not only include the technical and financial dimensions of new treatments, but also patients’ perspectives on usability, acceptability, and their full impact on everyday care routines. That is, an expansion in breadth and depth of the HTA approach is called for to include in the evaluation process the evidence on the impact of new technologies both on patients’ health and on their well-being and quality of life [
2]. Several mechanisms have been identified for this aim (e.g., the meaningful patient involvement approach, [
14]), which encompasses the alignment of commitment of stakeholders (including patients besides clinicians, industries and experts) to shared goals, together with in-depth accounts of patients’ lived experiences to add up to organizational evaluations [
15]. Notwithstanding the great variability and an absence of comprehensive, robust practices for patient engagement, the mechanisms identified in the literature essentially call for a change in the way patient evaluations can be embedded, and transform the organizational setup (when, what, and how) of evaluations of all relevant stakeholders.
1.2. Embedding Patients’ Perspective into an Operational Framework for Technological Innovation in Rehabilitation Care: The Smart&Touch-ID Approach
Smart&Touch-ID (STID) is a research project funded by the Lombardy Region as part of the HUB Research and Innovation Call (Announcement POR-FESR 2014-2020; Call for strategic research, development and innovation projects aimed at the strengthening of Lombardy ecosystems of research and innovation as hubs with international value; see also Funding section below). The main outcome of the project is the STID model, which structures the design and development of technological solutions for the home-based management of chronic disabilities. The STID model embeds patient evaluations of technology from the very first stages of its development and provides a dedicated infrastructure whereby the different stakeholders can take action as actors of the same ecosystem, not as isolated segments that act sequentially to the same aim.
The vision behind STID consists of harmonizing the health (ID) and well-being (Touch) needs of patients and citizens with the design and development (SMART) actions of Innovators’ eHealth solutions while working on the economic sustainability of the proposed innovation (Governance). This aspect of the STID model provides an answer to the unsolved gap of the patient perspective management in the technology assessment and advancement, by applying a patient-centered and co-design approach, typical of the multidimensional processes [
14].
The circular model is concretized through the definition of an operational flow that enables interaction between the involved stakeholders and empowers them to carry out their activities in line with their roles and timelines. The flow has been termed ‘circular’ because the realization of activities relevant to the needs of each stakeholder has impacts on the realization of the activities of the other stakeholders in an iterative way.
Figure 1 shows a conceptual view of the operational flow.
An operational flow originates from the launch of a challenge in response to a need. A need models the expression of a demand as perceived by the patient and/or citizen, the domain experts, and the clinicians. A challenge is the process that leads to the identification of technological solutions in response to the detected need that is validated against the ID, Touch, SMART, and Governance aspects.
The evidence about needs that the technological solutions address is collected from different sources (see the upper side of
Figure 1). The flow supports two types of challenges to integrate all the identified sources of needs: top-down and bottom-up.
In the top-down challenge, needs are identified by domain experts, on the basis of their in-depth knowledge of the domain, and by clinicians, on the basis of the information they routinely collect from patients during rehabilitation activities. This information is collected in a Register that feeds the modeling of needs in this specific modality.
In the bottom-up challenge, patients and citizens proactively communicate their experiences and attitudes through targeted and anonymous questionnaires (termed “waves”) administered on the website of the project (
https://smart-touch-id.com/en/#/home, accessed on 20 May 2023).
Once a challenge is launched, different actors may register for it with different roles. Each role corresponds to different actions that contribute to advancing the challenge. The main roles are Innovators and Citizens: the former propose solutions (prototypes or simple ideas), and the latter manifest interest in the evolution of the challenge and/or declare their interest in testing the solutions.
Innovators who propose ideas are assisted by Experts who help them turn their idea into a prototype through mentorship-dedicated sessions.
All proposed prototypes are validated against SMART, Touch, and ID criteria. If one or more criteria are not met, Experts help Innovators bring their prototypes in line with the established criteria through mentorship. Once prototypes meet all the SMART, Touch, and ID criteria required, they are evaluated for Governance aspects. Finally, prototypes supporting the needs are discussed in terms of their sustainability to identify the most promising ones also from the point of view of patients’ acceptability.
The operational flow has been implemented using PROCS (Process Oriented Development) software, version 1.1.5 [
16]. PROCS enables the management and control of complex and dynamic processes. The peculiarity of PROCS is that it allows one to “design” the implementation of each stage of the process and adapt it to the specific needs of the project.
The way STID operates is framed through multidimensional assessment tools, in line with the mainstream methodology for public health interventions. At the same time, its organizational flow takes into account the needs of multiple stakeholders to develop technological solutions that are relevant and applicable to the domain of rehabilitation care, tapping not only the clinical and economic dimensions but also the ones connected to well-being in the real-life experiences of patients [
17]. Therefore, STID not only optimizes the multi-stakeholder innovation process in rehabilitation but also enables the construction and stabilization of shared practices for this purpose, activating the process of multidimensional assessment essential to validate the technologies [
18]. Further, the definition of the operational flow described above enables the various stakeholders both to tune and perform their activities coherently with their roles and deadlines. This way, it can respond to both public health and patients’ management needs, while facilitating the process of multidimensional assessment to offer innovative and customized solutions for the rehabilitation of chronic disabilities [
19].
The designed model takes concrete form through a web portal (
https://smart-touch-id.com/en/#/home, accessed on 20 May 2023). People interested in a challenge can subscribe to the website and contribute to it in different ways according to their role (e.g., an innovator can propose an idea or a prototype).
To summarize, challenges operate as “incubators” of technological solutions, allowing the optimization of a suite of solutions that can strengthen community-based rehabilitation of chronic conditions and enhance the competitiveness of the system.
Needs are the core of the model. They can be identified by domain experts and clinicians, but also by patients and citizens. In the present manuscript, the focus is on how patients’ and citizens’ experiences and attitudes on rehabilitation care, detected through “waves”, are embedded into the operational flow of the STID model, providing preliminary evidence for its feasibility under this specific regard.
Materials, methods, and results of the wave of detection on patients’ and citizens’ experiences on rehabilitation are described below, and preliminary results are discussed.