Spinal cord atrophy (SMA) affects one in every 1,000 live births in Spain. Cerebral palsy (CP) is the most common cause of chronic motor disability in children, affecting two to three in every 1,000 live births. The Atlas 2030 exoskeleton is the first portable robotic pediatric exoskeleton aimed at facilitating walking in these children. It is used as a complement to other therapies.

We aimed to compare the efficacy and safety of the ATLAS 2030 exoskeleton with conventional physiotherapy in children aged between four and 12 years with SMA or CP. We conducted a literature search to identify clinical trials and systematic reviews in the PubMed, Embase, Web of Science, and Cochrane Library databases, finding 201 original articles published between 2017 and 2022. No controlled studies were found on the ATLAS 2030 or any other portable device, even after expanding the searches to any robot-assisted gait devices.

Although systematic reviews evaluating the efficacy and safety of robotic orthoses in general were found, there were no specific controlled studies on the ATLAS 2030. The five studies found (two on CP and three on SMA) were of low quality and did not show conclusive results in terms of efficacy and safety. However, some of them suggested that this technology could provide significant improvements in acceptability, range of motion, and spasticity. With respect to safety there appeared to be no evidence of serious adverse effects from its use, reinforcing the developer’s initial hypothesis that the technology is safe.

Although the available evidence is very limited, the ATLAS 2030 appears to show efficacy in some gait-related outcomes without serious adverse effects. To demonstrate safety and efficacy, randomized controlled trials are required that compare the ATLAS 2030 with conventional physiotherapy, with more participants and a longer duration, and are conducted by independent expert groups without conflicts of interest.

Patient involvement (PI) has become a key priority to the Spanish Network of Agencies for Assessing National Health System Technologies and Performance (RedETS). As part of the national strategy to promote PI, an interest group was created in 2017 to share knowledge, develop methodologies and standardize PI processes. The aim of this work is to analyze the main activities of the Patient Interest Group 5 years after its launch and to reflect on possible needs and challenges.

Narrative description and an in-depth analysis of the main activities of the Interest Group from 2017 to the present.

The group is composed of HTA researchers from the 8 regional agencies in Spain and is supported by the Ministry of Health and the RedETS council. It currently has the participation of 26 researchers, organized into different working subgroups. The initial lines of work were the analysis of the situation, the development of procedures, and the initiation of training materials for patients on HTA. At present, the main projects are the development of metrics for evaluating the impact of patient participation, the development of procedural materials to promote methodological process standardizaton (e.g., a flowchart with the main process steps, checklists, templates), and the design and piloting of virtual training for patients in HTA. New lines include the analysis of the ethical challenges of PI and the feasibility of setting up an HTA patient registration system and a patient forum to facilitate participation. In addition, the interest group has promoted the exchange of relevant information for PI and the organization of capacity building activities.

The RedETS Patient Interest Group is encouraging the development of activities, reflection on collective experiences, and tools that facilitate PI in Spain. Among the main challenges are the need to ensure the quality and applicability of PI and to analyze the views of patients who have actively participated in HTAs.

Patients have knowledge, perspectives and experiences that are unique and can make an essential contribution to Health Technology Assessment (HTA). However, in order for their participation to be effective, they need to be able to understand how HTA reports are generated and the decision-making processes that they inform. The aim is to describe the development and virtualization of training materials for patients, as well as to their implementation in a pilot study.

A working group from Spanish Network of Agencies for Assessing National Health System Technologies and Performance (RedETS) agencies was created to develop educational materials in collaboration with patients. The content was based on international initiatives and feedback from the working group. The project was initiated in November 2020. The team consisted of HTA researchers, technicians with experience in training and virtualization and patients. The final version was obtained after an iterative process and refinement of the content and design.

The materials were published in complete and summary versions, and they were translated into Catalan, Basque and Galician. The online course was designed in an e-learning platform (Moodle) with the aim of being implemented by each of the agencies. The materials include relevant and summarized information on HTA processes, current framework at national and European level, and the role of patients in HTA. Health research and the importance of qualitative and quantitative methods are also addressed. The course also includes a module of practical aspects of patient and citizen participation for achieving an effective contribution to HTA. The course is being piloted with patients in different regions in Spain. The objective of the pilot is to evaluate the usefulness and satisfaction with the course, and it has been designed with the purpose of incorporating the pertinent modifications in the course.

The online training course is intended to facilitate the acquisition of knowledge related to the processes and tools of HTA for patients, as well as to inform them in what phases and in what way they can participate. The pilot will provide relevant information on its use in practice. It is expected that the course will favor capacity building and patient involvement.

The Spanish Network of Agencies for Assessing National Health System Technologies and Performance (RedETS) defined a patient involvement (PI) framework for health technology assessment (HTA) activities in 2016. The aim of this study is to evaluate the process and impact of those PI initiatives that were implemented in the first year following the publication of this new framework.

A survey was sent to those HTA researchers who implemented PI in RedETS projects. Responses were reviewed by two authors. An adapted thematic analysis was performed and the results were later discussed by all authors.

Six responses from six agencies/units were analyzed. The objectives of PI initiatives were the following: inclusion of patient perspectives, preferences and values; elicitation of important health outcomes measures; and barriers, facilitators, or suggestions for implementation. Different methods were used for PI: surveys, focus groups, in depth interviews, and participation in an expert panel. Five main themes emerged: (i) challenges with the recruitment process, (ii) needs identified, (iii) impact of PI, (iv) lessons learned, and (v) suggestions for the future.

PI initiatives within the RedETS framework were tailored to each HTA project, its specific goals and the individual needs and resources of each HTA agency. The results also pointed out how PI has a relevant impact that has enriched RedETS products providing key information on experiences, values, and preferences of patients, contributions that benefit the HTA and the process of drawing up recommendations. The main challenges were related to recruitment processes and capacity building.