Strengthening decision-making capacity in the Spanish Health System through living evidence: An innovative framework
Creators: name: Reyes, María Ximena Rojas
name: Ibargoyen-Roteta, Nora
name: Rada, Gabriel
name: De Val, María Soledad Isern
name: Galnares-Cordero, Lorea
name: Urrutia, Gerard
name: Gutierrez, Iñaki
name: Benavent, Patricia Gavín
name: Rispau, Ariadna Auladell
Publisher: name: OSF Registries
Year: 2024
Subjects: subject: Medical Sciences
subject: Medicine and Health Sciences
subject: Other Medical Sciences
subject: Building capacity
subject: Decision-makers
subject: LE-IHD
subject: decision-making
subject: knowledge transfer
subject: living evidence

description: Presentation

The Strengthening decision-making capacity in the Spanish Health System through living evidence: An innovative framework is a project proposed under the Living Evidence to Inform Hath Decisions Program, which follows the Horizon 2020 Data Management Plan (DMP) guidance and requirements for projects that produce, collect or process research data. 
This DMP describes both the principles and the strategies that will be carried out to collect the necessary information for the fulfillment of the study objectives. This plan also includes a first approach to the free access publications of the products that will be generated as part of the project. 
The Living Evidence to Inform Health Decisions Program, is part of the Extension of Open Research Data (ORD) Pilot program running by the European Commission. The ORD pilot aims to improve and maximize access to and re-use of research data generated by Horizon 2020 projects and takes into account the need to balance openness and protection of scientific information, commercialization and Intellectual Property Rights (IPR), privacy concerns, security as well as data management and preservation questions.
The ORD applies primarily to the data needed to validate the results presented in scientific publications. Other data can also be provided by the beneficiaries on a voluntary basis, as stated in their Data Management Plans. 
Following this principles, this document briefly presents the study protocol for the project “Strengthening decision-making capacity in the Spanish Health System through living evidence: An innovative framework” that allows understanding the origin of the data and their purpose for meeting the study objectives, and the first version of the DMP that has been developed as part of the study development.

1. Project presentation (protocol summaary)

1.1. Research team

María Ximena Rojas-Reyes. MSc.Ph.D. Sant Pau’s Hospital Institute of Health Research. Department of Clinical Epidemiology and Public Health. Barcelona, Spain.

Gerard Urrutia Cuchí MD.Ph.D Sant Pau’s Hospital Institute of Health Research. Department of Clinical Epidemiology and Public Health. Barcelona,Spain. Iberoamerican Cochrane Center. Barcelona, Spain.

Ariadna Auladell-Rispau PhD (cand). Sant Pau’s Hospital Institute of Health Research. Department of Clinical Epidemiology and Public Health.

Iván Solà Arnau PhD (cand). Iberoamerican Cochrane Center. Barcelona, Spain.

Iñaki Gutierrez Ibarluzea. Innovation of the Basque Foundation for Health Innovation and Research (BIOEF) . Osteba, Basque Office for HTA. 

Patricia Gavín, MD. PhD Institute for Health Sciences in Aragon (IACS). SCPG-program of the Spanish National Health System (GuíaSalud), Ministry of Health. Spain.

María Soledad Isern de Val, Biochemistry. MSc. PhD in Biomedicine, Institute for Health Sciences in Aragon (IACS). Zaragoza, Spain

Nora Ibargoyen Roteta. PhD in Health Science. Basque Foundation for Health Innovation and Research (BIOEF). Bilbao, Spain.

Lorea Galnares MSc in Bioinformatics. Basque Foundation for Health Innovation and Research (BIOEF). Bilbao, Spain

1.2. Introduction

In countries like Spain, with a national health system with universal coverage, the current economic situation imposes the need to increase efforts for achieving greater efficiency in allocating healthcare resources that guarantee the sustainability and the quality of the system. Investment in strategies to easily incorporate reliable and updated evidence on which to base decisions, both public and clinical, increasing the value of care and of available resources, has become an urgent need. Building capacity is one of these strategies; it is believed to contribute directly to improving performance in the health sector and is thought to play an important role in sustaining adequate performance over time,. “Capacity” represents the potential for using resources effectively and maintaining gains in performance with gradually reduced levels of external support”. 
With the aim of enhancing and sustaining individual and organizational capacity to based decisions in up to date and reliable evidence, the research program led by our principal investigator (MX Rojas), who was a beneficiary of an individual fellowship Marie Curie Actions of the H2020 (2019), relies on a large knowledge transfer (KT) and capacity building project involving the design and evaluation of a model strategy to development of capacity for the production and use of reliable, friendly and updated health evidence synthesis. As part of the research program, authors developed and tested a framework (the Living Evidence to inform health decisions framework [LE-IHD framework]) that aims to guide organizations that develop evidence synthesis to inform decisions in health, on the process of incorporating the living evidence approach as part of the development of the KT products that they usually develop to support decision makers (e.g. HTA reports and CPG recommendations. 
The LE-IHD framework was developed following an iterative process which involved literature review, expert consultation and user testing to refine its different versions. The framework guides users in applying appropriate criteria to circumvent all the steps involved in the production and maintenance of living evidence synthesis, and whether to incorporate the new evidence to the recommendations and conclusions of the KT-products already developed (i.e. CPG recommendations or HTA reports). Nevertheless, it is desirable that the final version of the LE-IHD framework be included or migrated to a user-friendly tool in order to be applied in a greater number of cases (i.e. KT products developed by other organizations and research groups) and be able to assess its performance and usability as well as improving and adjusting it to the real world needs, making it really useful for the health sector organizations (and groups within these organizations) to incorporate living evidence synthesis in their usual processes.
Being able to make an adequate use and further assessment of the LE-IHD framework, it is necessary for its potential users to know the rationale of LE synthesis to apply it properly. Developing LE synthesis involves not only the integration of innovative tools that support the identification and selection of emerging new evidence; in addition to the basic concepts of the evidence based practice there are more complex concepts and methods, some of them very recent and still evolving, that support the application and contextualization of emerging new evidence in decision making. 
This project involves both, the evaluation of the framework to incorporate living evidence in decision-making, preceded by a strategy aimed at building the capacity to perform this task among the members of the organizations that are currently working to produce evidence synthesis to support decision-making in health. 

1.3. General Objective

Our project aims at strengthening the abilities of health system stakeholders, to generate living evidence syntheses based on novel methodologies that enable the constant update of knowledge transfer products that they usually develop for supporting their own decisions and/or to support decision-makers. 

1.4. Specific objectives related to the development and evaluation of a capacity -building strategy 

 To develop and apply an effective strategy that allows members of health system organizations to obtain, improve, and retain knowledge, and develop new skills for incorporating the “Living evidence” methodological approach” in their current evidence synthesis process aimed to inform health care decisions. 
To build the capacity among members of health system organizations to use innovative and effective tools (Epistemonikos-L.OVE project) for supporting the production of evidence synthesis and maintaining living evidence.
To design and test a capacity -building monitoring and evaluation plan that outlines a systematic approach to measuring capacity and assessing the result of the capacity building interventions for including the living evidence methodological approach in the health sector decision processes 

1.5. Specific objectives related to the assessment of the "Living evidence to inform health decisions" framework 
 
To evaluate and validate a framework-based tool for the incorporation of living evidence synthesis in the development of knowledge transfer products, such as health technology evaluation reports (HTA) and CPG recommendations, aimed at problems in which the evidence evolves rapidly or constantly.
To assess the effectiveness and usability of the L.OVE platform as a tool to keep the living evidence process in the development and update of different products regularly used to inform decision in the health care sector (i.e. HTA, CPGs and evidence summaries or briefs)

1.6. Methods

1.6.1. Study population

The project targets Spanish National Health System organisations in charge of developing knowledge transfer products to inform their own health decisions or to support decision- makers. Therefore, our study population will include technical staff in charge of developing evidence synthesis and KT products at three different settings from Spain: 1) Spanish Biomedical Research Network Consortiums (CIBER); 2) health technology assessment [HTA] agencies; 3) clinical practice guideline [CPG] developers.

1.6.2. Design

This is a knowledge transfer and capacity building research. The project has organized its empirical work around two complementary projects (work packages [WPs]) to support better decision-making in healthcare. Both WP1 and WP2 will be running simultaneously.
WP1 Assessment of the Living evidence to inform health decision framework. This Study 1 seeks to apply the Living Evidence to Inform Health Decision Framework base tool (LE-IHD framework) to real life diverse situations in order to assess its usability and performance. 
WP2. Capacity-building for incorporating living evidence synthesis to inform health decisions among different actors of the Spanish health sector. This study (WP 2) includes two main actions: 1a. the development of a capacity building strategy to provide support for producing and incorporating living evidence synthesis in different KT-products and, 2a. To develop a capacity building monitoring and evaluation (M&amp;E) plan to assess whether the capacity building strategy has improved “capacity”.
Figure 1 (Please see document attached) shows the path of the participating organizations (and their members) through the project, and the activities to be completed at each step of the process, which will be detailed in a Standardized Operating Procedures (SOP) Manual that will guide them during their participation in the study.

1.6.3. Data collection and analysis

Information necessary to evaluate the training workshops, the capacity building strategy, the LE-IHD framework-based tool, and the use of the Epistemonikos database and L.OVE platform for keeping the evidence “living”, will be collected through the whole process. The results of these evaluations will allow the capacity building strategy and the framework to be redefined and improved as a tool to incorporate and maintain living evidence in the KT-products that the participating organizations regularly produce. Figure 2 (please see document attached) presents the timeframe when evaluations will take place.

1.7. Results

Our aim is that the capacity building strategy and the LE-IHD framework-based tool, can be applicable to any country or region, increasing the impact of health research, reducing the costs and time consuming related to KT-products development and updating processes.
According to these purposes, this project will generate different types of results: 
- Results related to the assessment of the capacity building strategy used to implement the living evidence methodological approach in the development of KT products.
- Results related to the assessment of the effectiveness and usability of the Epistemonikos-L.OVE platform as a tool for keeping the living evidence process, as part of the development and updating of the different KT products that are regularly used to inform health decisions (GPC, ETS, SES).
- Results related to the clinical topics for which the new evidence synthesis or structured evidence summaries will be developed (i.e., 
- Results directly related to the evidence syntheses completed by the project participants).
- A capacity monitoring and evaluation (M&amp;E) plan for health sectors incorporates living evidence in the development of KT-products, increasing the impact of health research in the countries’ decision making in health.
- An already tested capacity-building strategy for health system organizations to use “Living evidence synthesis” in the development of KT products aimed at informing decisions on health problems in which the evidence is highly changing. 


Data management plan (version 0.1- May 2023)
LE-IHD_FortCapSpain project

1. Data Summary

The following presents the “Strengthening decision-making capacity in the Spanish Health System through living evidence: An innovative framework” data summary, which has been organized in accordance with the objectives the study seeks to achieve.

2.1. To assess the capacity-building strategy for health system organizations in charge of developing KT products to inform health decisions, to use innovative and effective tools to generate living evidence synthesis.

Taking into account that we will work with organizations that regularly develop evidence synthesis to inform health decisions as part of their work, so their members have previous knowledge and skills in the application of evidence synthesis methods, the capacity building strategy will be focused on how to implement the necessary methodology and tools to incorporate living evidence methodological approach in the usual evidence synthesis developed for KT products. Figure 3 (Please see document attached) shows the components of the capacity building strategy.

2.1.1. Assessment of training course and workshops

After finished each training session (workshop) participants will be asked to answer anonymous online surveys to assess the workshops materials (i.e. learning guide and objectives; support instructions and tutorials) as well as the skills of the teacher who led the session and the presentation that he/she used to present the key points. information and training activities; as well as to complete specific questionnaires to evaluate acquired knowledge and application of the main concepts.
The online survey will ask the participants to indicate his/her level of agreement (from strongly agree to strongly disagree), using a 5 points Likert scale, with a series of statements that will allow us to evaluate the relevance and appropriateness of the most relevant aspects of the training workshop listed above. 
Data obtained from these surveys will be analyzed using summary measures (e.g. proportion of participants who answer each of the 5 Likert scale options). 
The expected size of the data collected for assessing workshops will be given by the number of participants who join the project for each organization. Each participating organization may contribute a maximum of 5 participants. The planned training program includes 6 workshops on the Epistemonikos tools and the L.OVE platform, followed by two training sessions for the generation of structured summaries of evidence.
These data will be useful for the Epistemonikos Foundation and the teachers who are in charge of the trainings as well as for the research group, since based on these data the training strategy will be refined and different aspects of the training workshops can be re-evaluated

2.1.2. Assessment of the learning by doing accompaniment strategy 

Following the “learning by doing” methodology which is based on “doing things” with accompaniment, looking for answers and resolutions of doubts during the application process. Our project will support participating organizations in the process of identifying the guideline questions that benefit from a living process, up to the generation of updated evidence summaries to inform the decision makers on the new evidence. Figure 4 (Please see document attached) shows the living evidence synthesis process participating organizations will develop as part of the project.
An online survey will be conducted at 6 months after the evidence surveillance period has started (i.e. once the initial evidence synthesis process has been completed and the monitoring of new evidence is going on) to assess the accompaniment strategy used in the study. All members involved in the evidence synthesis development from participant organizations will be invited to respond to the online survey that will collect information about the appropriateness of the activities planned as part of the accompaniment strategy. Among others, the survey will include questions related to:
- Clarity, relevance and timeliness of weekly messages sent to participants informing tasks and procedures
- Clarity, completeness and utility of the Manual of instructions
- Clarity and timeliness of the support given by the liaison researcher assigned to the group
- The timely of responses to doubts and difficulties from the research team and coordinating group.
- Satisfaction with results obtained (as individual and as organization group) by developing the living evidence synthesis under the learning by doing methodology.

The online survey will ask the participants to indicate his/her level of agreement (from strongly agree to strongly disagree), using a 5-points Likert scale, with a series of statements that will allow us to evaluate the above described aspects of the learning by doing methodology used as part of the capacity building strategy. 
Data obtained from this survey will be analyzed using summary measures (e.g. proportion of participants who answer each of the 5 Likert scale options).
The expected size of the data collected for assessing the learning by doing methodology used as part of the capacity building strategy will be given by the number of participants who join the project for each organization. Each organization may contribute a maximum of 5 participants.
These data will be useful for the research group to evaluate the accompaniment strategy in the learning by doing methodology used as part of the capacity building strategy, in order to incorporate corrections or new actions for improvement the process and participants' experience. This data will be also useful for audiences working on capacity building Monitoring and evaluation (M&amp;E) plans in the health sector. 

2.1.3. Assessment of the effectiveness of the strategy on building capacity

As said before, by applying the “learning by doing” methodology based on an accompaniment strategy, we will be able of evaluating and monitoring the capacity building process, which according to the authors of the Measure Evaluation Project, is the best approach for ensuring capacity building in the health sector. Monitoring and evaluation (M&amp;E) the process not only helps to answer the question about the capacity as an outcome (whether the capacity building has improved capacity) but also to understand the effectiveness and efficiency of the capacity building intervention during its implementation and enables a periodic look at the program to make strategic decisions related to capacity building or in the operation of the organization that can benefit the production and application of the capacities formed. 
In this sense, all the previous evaluation activities will contribute to the periodic evaluation and improvement of the capacity building strategy that is being developed. However, a final evaluation is planned to know whether the strategy has improved the capacity within the participating organizations, for them to integrate the "living" evidence methods and tools in their usual evidence syntheses tasks. This final evaluation is currently being designed and will be presented as part of the next update of this DMP. 

2.2.To evaluate the LE implementation framework and its effectiveness to guide the incorporation of living evidence synthesis in the development of KT products.
2.3.To assess the effectiveness and usability of the Epistemonikos-L.OVE platform as a tool for keeping the living evidence process, as part of the development and updating KT products.

To achieve these objectives, two complementary approaches will be used for collecting data; online surveys and in-depth interviews. 
Two online surveys will take place during the study. The first survey one will be conducted once the initial evidence synthesis process has been completed and a second one will be conducted at the end of the follow up period within the study (end of the 12-month monitoring process). All members of technical teams and task forces taking part of the study will be invited to respond to the online surveys. The survey will be anonymous but will collect information about the individuals' demographic characteristics and background (academic degree, level of training and time of experience) as well as the experience in evidence-based medicine and knowledge translation related activities (e.g. development of systematic reviews, evidence-based recommendations, CPG, HTA reports and use of the GRADE approach). Two types of questionnaires will be developed, one for organizations technical team members and the other for organization’s group leader. 
-Technical teams' questionnaire: This questionnaire will have three sets of questions: 1) questions specifically address the experience of participants applying the LE-IHD framework and processing the living evidence synthesis; 2) questions for assessing the ability of the user manual to guide the process. 3) Questions to assess the usability and performance of the L.OVE platform as a tool for evidence identification, screening and maintenance of the living evidence process. 
- Group leader’s questionnaire: This questionnaire will address the comprehension of the framework and its “usability” as a strategy for incorporating living evidence synthesis in the current process of the organization. We will include questions to evaluate how developers are taking into account the information and guidelines presented in the LE-IHD framework and/or following the pathway for guiding the inclusion of the new evidence in the already existing KT products. 

Data obtained from these surveys will be analyzed descriptively using summary measures (e.g. proportion of participants answering each item option in categorical variables and median or mean with interquartile range for continuous variables). 
The expected size of the data collected for assessing workshops will be given by the number of participants who join the project for each organization. Each participating organization may contribute a maximum of 5 participants. The training program includes an initial set of self-learning modules followed by virtual workshops on the Epistemonikos tools and the L.OVE platform, and a set of two workshops aimed at training groups in the generation of structured living evidence summaries.
At the end of follow-up (i.e. the end of the 12-month monitoring process) of the PICO questions being developed by each participant organization, we will perform in-depth interviews to a randomly selected sample of participants (including technical team or taskforce members as well as team leaders). These interviews seek to obtain information about participants´ perception of the: I) the capacity building strategy and ii) the LE-implementation framework and its effectiveness to guide the incorporation of living evidence synthesis processes into their usual working tasks (either for producing KT-products or other evidence synthesis process to inform decision makers). 
The interviews will be carried out by a third-party expert in this type of interviews, with a script of questions generated by the research group. The data obtained from these interviews will be included anonymously in the NVivo® program by the same third party and analyzed as qualitative data by an expert in the subject.
There is not a sample size estimated for these interviews, however we will ensure that all participating organizations will be represented in the sample using a proportional selection strategy according to the number of participants from each organization. 
These data will be useful for the scientific community, particularly expert methodologists working on evidence synthesis development and implementation as well as for those working on knowledge transfer research in health care. 

1. FAIR data 

1.1. Making research data* findable, including provisions for metadata 

The following actions will be taken by the research team of the project “Strengthening decision-making capacity in the Spanish Health System through living evidence: An innovative framework” for making research data findable.

1.1.1.Making data produced in the project discoverable with metadata

Taking into account that metadata is data on the research data themselves and there are not discipline-specific standards for metadata in knowledge translation research or in health sector capacity-building research, we will create a metadata that enables other researchers to find our data in an online repository. We will add rich and detailed metadata for other researchers to be able to determine whether the dataset is relevant and useful for their own research. Metadata will be uploaded in a standardized form and will be kept separate from the original research data. 
As described in the project proposal, the bibliographic metadata must be in a standard format and must include all of the following:
the terms "FIS" from the Fondo de Investigación en Salud, and "ISCIII" by the Instituto Carlos III. Madrid.
the project name, acronym, and grant number (Grant PI21/01564),
the publication date and, if applicable, the length of the embargo period
a persistent identifier

1.1.2. Naming conventions and version numbers

Research data files will be versioned and structured by using a name convention consisting as follows: LE-IHD_FortCapSpain-survey[name and number of the survey starting with1…]_ YYYYMMDD_V[number of the version starting in 0.1]

1.1.3. Searching keywords

To optimize possibilities for data finding and re-use, the following keywords will be used in all its publications: living evidence; evidence synthesis; living evidence framework; health decisions; decision making; knowledge transfer; capacity building; health systems research.

2. Making data openly accessible 

As part of its planning phase, the “Strengthening decision-making capacity in the Spanish Health System through living evidence: An innovative framework” project has been included in the Open Science Framework (OSF) to effectively share the research process in the spirit of collaboration among participating organizations and with other researchers interested in this field. The OSF is an open online research data repository that complies with FAIR data principles given that: i) allows researchers to deposit both publications and data, providing tools to linking them to these through persistent identifiers and data citations, ii) facilitates the finding, accessing, re-using and inter-operating of data sets, iii) enables researchers and institutions to share research results in a wide variety of formats (e.g. text, spreadsheets, audio, video, and images), display their research results and get credited by making the research results citable.
The data associated with metadata, documentation and code will be freely available from the OSF for other researchers to be able to determine whether the dataset is relevant and useful for their own research. OSF allows performing simple and advanced search queries using the project keywords. The following tags have been added to the OSF project space so far: Livingevidence; framework; healthdecisions; decisionmaking; knowledgetransfer; capacitybuilding; heathsystemsresearch.
Research data related to the evaluation of training activities (i.e. online course and workshops), the framework-based tool and the capacity building strategy will be openly available as the default in OSF once its publication in scientific journals has been completed. Before its publication, the original research data will be available upon explicit request to researchers (contact information will be provided as part of the metadata from) and will be delivered for its re-use upon presentation of a research protocol that clearly specifies the used to be made of the information and the name and affiliation of researchers, to guarantee the proper use of the data. Provision of data access will be discussed in a regular research group meeting. 
Each database will be available in excel file for easy re-use. All variables will have an identification code. The variable dictionary will be created with the name of the variable, its code and operational definition (i.e. measure scale, range of data, among others).
Participant organizations are aware that the “Strengthening decision-making capacity in the Spanish Health System through living evidence: An innovative framework” is part of Living Evidence To Inform Health Decisions Program, which was a research funded by the Horizon 2020, and adheres to the principle of transparency and to the guidelines of the Open Research Europe initiative of the European Union. 
Therefore, the products generated by the organizations as part of the study process will be available from the freely accessible repository created at the Living Evidence Program website at https://livingevidenceframework.com/en/lesr/

2.1. Making data interoperable 

As part of the project research data, we will create independent databases for each set of evaluations (e.g. for training workshops; for the learning-by-doing accompaniment strategy; for the capacity-building strategy etc.). Each database will be available in an Excel file for easy re-use. All variables will have an identification code. We will create a data coding dictionary using standard vocabularies for all data types, which will include: the name of the variable, its code; the type of variable, and its operational definition (i.e. measure scale, range, etc.).
Some data produced in the project is interoperable, as it is exchanged and re-used between participant organizations and Epistemonikos Foundation. In order to facilitate document exchange, we have created within the OSF, a workspace for each participating organization. From there, the documents that are generated by each organization as part of the participation process are exchanged with the research team from OSTEBA, IACS, and IIB Sant Pau. Using the same channel, we share documents with the evaluation results of interest to all participants.

3. Allocation of resources 

The costs associated with making data FAIR in the project are those related to hiring the people who must enter, encode and analyse the data.
There is a designated budget for this purpose; Statisticians from the Epidemiology and Public Health Service and the Cochrane Centre of the Institut de Recerca de l'hospital de la Santa Creu i Sant Pau, will provide this service.
There is no provision that allows this action to be maintained for a long term after the project execution has ended.

4. Data security 

Researchers from the Institut de Recerca de l'hospital de la Santa Creu i Sant Pau can use the repository "Dipòsit de Documentos Digitales (DDD)" of the Autonomous University of Barcelona, to store their research data. This repository meets the FAIR principles. A copy of all the datasets, deliverables and the final research results will be stored in this repository. As an initial step, only the research partners will have access to the dataset. 
Throughout the study process we will consider the following precautions to ensure data security:
Store data in at least two separate locations to avoid loss of data; 
Encrypt data if it is deemed necessary by the participating researchers;
Limit the use of USB flash drives. 
Label files in a systematically structured way in order to ensure the coherence of the final dataset. 
All project technical memories and data will be stored and shared in a Dropbox folder restricted to the project research group. 

5. Ethical aspects 

The project involves work from collaborative and interdisciplinary research groups formally established as part of academic institutions that are legally constituted according to the laws of Spain. The group “Epidemiology, public health, and healthcare service” is registered as part of the Institut de Recerca de l'hospital de la Santa Creu i Sant Pau, the OSTEBA and IACS are health technology assessment agencies legally constituted in Spain. The research group that has given life to the Epistemonikos Foundation is part of the Evidence Center of the Universidad de Católica de Chile. This project will be developed in Spain but will use the tools developed by Chile’s group that will provide guidance and technical support throughout the project’s execution. 
The project also involves organizations of the Spanish health system and developers of guidelines from other European countries who agree to collaborate, through which members of their working groups are invited as “study participants”. All partners and study participants will assure that the EU standards regarding ethics and data management are fulfilled in compliance with the ethical principles and confidentiality.
One of the most relevant aspects to consider is that which relates to “International transfers of personal data” given that throughout the study, the work group’s members and researcher’s data may be interchanged between the two countries. We have reviewed and assured that both countries have defined regulations that are protected by law for personal data processing that safeguards the rights of the people involved regarding the use of their private information. To ensure respect for the moral integrity, for the rights, and to guarantee the privacy of this study’s participants, written consent for the national and international use of contact information will be required of all participating organizations. This document considers both Chile and Spain’s data protection legislation. 
Personal data of individual members from participating organizations will not be shared; it will keep storage in a secure place with restricted access to the study coordination team. 
During the project process, we will collect information to assess the efficacy of the capacity building strategy; this information will be anonymous, therefore the information in the databases that we will share in open access repositories will not be related to the personal data of the participants.
Data controllers and processors are fully responsible for data processing operations in accordance with the General Data Protection Regulation 2016/679. Therefore, they will follow the necessary procedures to safeguard the ethical principles related to the protection of personal data and other human rights.