In 2017, a Patient Involvement Interest Group (PIIG) was created in the Spanish Network for Health Technology Assessment of the National Health System (RedETS) to facilitate and promote Patient Involvement (PI) in Health Technology Assessment (HTA). The PIIG proposed a decisional flowchart to guide researchers’ in decisions regarding PI methods in HTA. The flowchart proposed a combination of direct involvement and incorporation of patient-based evidence depending on the scope and the aims of the assessment.

This work aims to present the flowchart and the results of the evaluation of the latest experiences in PI in HTA in RedETS (2018–2020), including direct-involvement and patient-based evidence.

A survey was sent to the HTA researchers who implemented PI initiatives in RedETS assessments. The survey asked to describe their experiences, lessons learned, challenges and added value regarding the use of direct-involvement, systematic reviews (SR) and primary studies. A descriptive analysis was performed and the results were discussed in an online PIIG workshop.

Thirty-two assessments included direct PI, twenty-one SR synthesized qualitative and quantitative studies about patient experiences, values and preferences and eight included primary studies, mainly of qualitative design. Recruitment and the lack of methodological resources were the main barriers both for direct PI and primary studies. Relevance of the included studies was the main barrier for SR. Added value was found in all PI methods. Direct-involvement had an impact on the project plan and PICO definition, outcomes relevance, information about the health condition and treatments. SR contributed with relevant patient-based evidence, deeper assessment of patient experiences, values and preferences and implementation factors. Primary studies developed new or contextualized knowledge directly applicable to decision-making.

The PI flowchart has served to facilitate the incorporation of patient input in HTA reports. The different approaches implemented have allowed to provide relevant and well-grounded data in each report to inform decision-making in patient-centered healthcare provision, but it is necessary that specific training and resources are provided to enable adequate and timely implementation.

The management of the COVID-19 pandemic is a challenge for Health Technology Assessment (HTA) methodology due to the need to formulate evidence-based recommendations in times of uncertainty in minimal time - for a large number of publications and with changing or even contradictory information. Living systematic reviews (LSRs) are systematic reviews that are continually updated, incorporating relevant new evidence as it becomes available. Since the COVID-19 pandemic fits all criteria to perform LSRs: (i) the Review question is a particular priority for decision-making, (ii) there is an high level of uncertainty about the existing evidence, and (iii) there is likely to be emerging evidence that will impact on the conclusions of the LSR, the aim of which is to analyze the role of LSRs as an innovative approach to HTA in recent years, and its impact on the management of the pandemic.

A systematic search of LSRs (published or protocols) was run on the main biomedical databases (Medline, Embase and Cochrane Library) in November 2020 and it was rerun in June 2021 without time limit. The results will be analyzed and classified by year and category (epidemiology, treatment, prognosis, symptoms, diagnosis and vaccines).

The literature research has returned a total of 187 publications. The LSR concept emerged in 2014, from which some LSRs began to be published, but an exponential increase has been observed in 2020 with 76 references of which 66 percent were focused on the SARS-CoV-2. By category, 81.8 percent were focused on treatment, 41.8 percent on epidemiology, 20.9 percent on rehabilitation, 15.1 percent on diagnosis, 10.2 percent on prognosis and 2.2 percent on symptoms until June 2021. There wasn't any LSR for vaccines and 28 percent was focused on other fields.

LSRs are particularly important during the COVID-19 pandemic, with research evidence emerging rapidly, current evidence being uncertain, and new research changing policy or decisions on health. The majority of LSRs published up to June 2021 were focused on the treatment of COVID-19.

This paper aims to describe the development of a flowchart to guide the decisions of researchers in the Spanish Network for Health Technology Assessment of the National Health System (RedETS) regarding patient involvement (PI) in Health Technology Assessment (HTA). By doing so, it reflects on current methodological challenges in PI in the HTA field: how best to combine PI methods and what is the role of patient-based evidence.

A decisional flowchart for PI in HTA was developed between March and April 2019 following an iterative process, reviewed by the members of the PI Interest Group and other RedETS members and validated during an online deliberative meeting. The development of the flowchart was based on a previous methodological framework assessed in a pilot study.

The guidelines on how to involve patients in HTA in the RedETS were graphically represented in a flowchart. PI must be included in all HTA reports, except those that assess technologies with no relevant impact on patients’ experiences, values, and preferences. Patient organizations or expert patients related to the topic of the HTA report must be identified and invited. These patients can participate in protocol development, outcomes' identification, assessment process, and report review. When the technology assessed affects in a relevant way patient experiences, values, and preferences, patient-based evidence should be included through a systematic literature review or a primary study.

The decisional flowchart for PI in HTA contributes to the current methodological challenges by proposing a combination of direct involvement and patient-based evidence.

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.

In the past decades the community-based participatory research method known as PhotoVoice has gained relevance, but there are few published studies on its application in the field of health technology assessment (HTA) and clinical practice guidelines (CPGs). The aim of this presentation was to describe a PhotoVoice project linked to a CPG on major depression in children and adolescents.

The design of the study was adapted to the main objective, which was to enhance the understanding of major depression and improve clinical practice with the contributions of clinicians, methodologists, and patients. Seven adolescents and ten of their family members participated in the study through PhotoVoice sessions and focus groups. The audio recordings of all sessions were transcribed verbatim and coded, and a thematic analysis was undertaken.

Six themes emerged: (i) a lack of understanding and information about depression in childhood and adolescence; (ii) the importance of support groups; (iii) the need to favor early care and access to services; (iv) the adaptation of therapeutic strategies tailored to individual needs; (v) the sensitivity of professionals; and (vi) fostering interaction between the health and education systems. Photographic exhibitions were planned to share the main results. These exhibitions were promoted to increase public awareness and reduce stigmatization, and to reach clinicians and policy makers. From a methodological point of view, the use of PhotoVoice in this study helped to effectively incorporate the lived experiences, concerns, and preferences of patients and their relatives into the CPG. The study also confirmed the value of photographs and participatory methods. The main limitations and strengths of the study, as well as suggestions for future research, are also outlined.

PhotoVoice is a flexible, effective, and innovative method of obtaining information about patients’ perspectives and experiences, and it offers the added value of being able to reach the main stakeholders, including policymakers and the public.

The specificities of non-pharmaceuticals can require adapting classical health technology assessment (HTA) methodologies and developing additional regional approaches to support decision-making processes. However, little information exists regarding the explicit approaches used in different countries. The aim of this work is to provide an overview of the role and activities of the Galician HTA agency (avalia-t, Spain) regarding assessment, appraisal and continued evaluation across the whole life cycle of non-pharmaceutical technologies.

In depth review and analysis of the activities undertaken by avalia-t during the past five years to support the introduction and appropriate use of non-pharmaceutical health care technologies at the regional level.

A multidisciplinary Commission judges the added value of new non-pharmaceuticals and establishes the indications and conditions for use. HTAs, which are mandatory for all relevant technologies, rely on the best available evidence on safety and effectiveness but also provide fit for purpose contextualized information based on organizational data and administrative registers. Interaction with multidisciplinary stakeholders is commonly needed to complement the evidence base (ad hoc working groups, face to face discussions), and post-launch studies can be implemented to analyze the utilization and results in real world practice. Performance indicators and other HTA based products can also be required to ensure the quality of health care (e.g., appropriate use indications, quality indicators, evidence based patient information). In addition, technical and scientific advice/support can be provided at different decision levels of the health organization to promote the quality of care and appropriate use of technologies (e.g., regional mental health program, suicide management strategy, bariatric surgery surveillance registry).

Rigorous, comprehensive and systematic processes for supporting non-pharmaceutical technology adoption and implementation are required. Although it is acknowledged that core information does not differ substantially within countries, contextualized information is recognized as essential for establishing the conditions for use at the regional level.

Conclusions and recommendations of health technology assessment (HTA) reports have an impact on all relevant actors involved in the health system (health authorities, administrators, health professionals, patients, citizens and industry). The involvement of all those relevant stakeholders in the HTA process facilitates making valid and informed decisions and an efficient allocation of resources. Improving communication, participation and transparency among all agents will lead to more efficient evaluation and decision-making processes.

To review key aspects of the relations between HTA agencies and health industries, two process were carried out: a narrative review of literature searched in Medline, PubMed, Embase, CINAHL and WOS (2007-2017) and a review of websites of international HTA agencies. References and webs with information on the framework, objectives, methodologies, impact or results of the relationships were included.

A total of 1961 references were located and forty-five were selected. From the synthesis of the selected references the following key aspects of the relationships between HTA and industry were identified: (i) the importance of early dialogues with industry to align HTA objectives with the generation of evidence; (ii) challenges of the bias in the evidence produced by industry; (iii) difficulties in industry engagement in HTA processes; and (iv) industry interest in HTA. The review of six agency websites provided information on industry involvement in strategic activities, early dialogues, provision of documentation, management of industry clarifications, review of the report/allegations and other forms of relationship.

Both the review of the literature and the contents of the web pages of international agencies with experience in relations with industry show that the interest is in the creation of collaborative frameworks between regulatory authorities that decide on authorization and price and reimbursement and HTA agencies, while both try to maintain an early, transparent and systematic interaction with the healthcare industry.

In December 2017, a patient involvement (PI) Interest Group was created in the Spanish Network of Agencies for Assessing National Health System Technologies and Performance (RedETS) Annual conference. It started as a voluntary group of health technology assessment (HTA) methodologists interested in PI. The objective of the Group is to promote and facilitate PI in HTA. With the support of the Spanish Ministry of Health and the RedETS Council the Interest Group grew to at least one member for each of the eight RedETS regional agencies and units. It currently has 22 members. The PI Interest Group works in periodic online meetings and an annual offline meeting to establish a space for experiences exchange and reach consensus on main issues regarding PI.

RedETS published a strategy to facilitate effective and efficient PI in HTA processes in 2017. The long-term objective is to mainstream PI in all RedETS products. This strategy was built on a literature review and a qualitative study with semi-structured interviews. The interviews detected capacity building needs for technicians and methodologist in the network to be able to actively engage patients in HTA reports.

Since the kick-off meeting the PI Interest Group has worked in a number of activities. The main lines of action since its creation were: (i) evaluation of PI process in RedETS HTA reports in 2017 and in current reports, (ii) discussion on main methodological and procedural aspects, and feasibility of different patient participation approaches, (iii) development of technical protocols and templates to facilitate PI, (iv) the creation/adaptation of educational materials for patients and (v) translation of the HTAi Glossary for patients to Spanish.

Peer-to-peer learning processes can foster technical capacity of HTA methodologist in the Spanish HTA Network and may favor the implementation of the PI strategy.