Relational practices for meaningful inclusion in health research: Results of a deliberative dialogue study.

INTRODUCTION: The importance of including people affected by research (e.g., community members, citizens or patient partners) is increasingly recognized across the breadth of institutions involved in connecting research with action. Yet, the increasing rhetoric of inclusion remains situated in research systems that tend to reward traditional dissemination and uphold power dynamics in ways that centre particular (privileged) voices over others. In research explicitly interested in doing research with those most affected by the issue or outcomes, research teams need to know how to advance meaningful inclusion. This study focused on listening to voices often excluded from research processes to understand what meaningful inclusion looks and feels like, and asked what contributes to being or feeling tokenized. METHODS: In this deliberative dialogue study, 16 participants with experience of navigating social exclusions and contributing to research activities reflected on what makes for meaningful experiences of inclusion. Using a co-production approach, with a diversely representative research team of 15 that included patient and community partners, we used critically reflective dialogue to guide an inclusive process to study design and implementation, from conceptualization of research questions through to writing. RESULTS: We heard that: research practices, partnerships and systems all contribute to experiences of inclusion or exclusion; the insufficiency or absence of standards for accountability amplifies the experience of exclusion; and inclusive practices require intention, planning, reflection and resources. CONCLUSIONS: We offer evidence-informed recommendations for the deeply relational work and practices for inclusivity, focused on promising practices for cultivating welcoming systems, spaces and relationships. PATIENT OR PUBLIC CONTRIBUTION: This work reflects a co-production approach, where people who use and are affected by research results actively partnered in the research process, including study design, data-generating activities, analysis and interpretation, and writing. Several of these partners are authors of this manuscript.

Brazilian breast cancer patient-reported outcomes: What really matters for these women.

Introduction: Patient-Reported Outcomes (PRO) are directly reported by the patient without interpretation of the patient's response by a clinician or anyone else and pertains to the patient's health, quality of life, or functional status associated with health care or treatment. It can provide patients' perspectives regarding treatment benefit and harm beyond survival and are often the outcomes of most importance to patients. This study aims to describe and analyze outcomes reported by Brazilian women diagnosed with breast cancer and rank the most important attributes for these patients. Methods: Observational descriptive study composed of exploratory interviews followed by online questionnaires applied to a convenience sample of women diagnosed with breast cancer. Results: Twelve women were interviewed to explore the main outcomes and preferences about their treatments, such as the most common side effects and the most impacted aspects of life after diagnosis and BC treatment. Psychological, emotional, and sexual impacts were frequently described as impacted aspects. Fifty-three women, from all the five Brazilian regions, answered the online questionnaire. Following an order of importance ranking, the following outcomes were chosen, respectively: overall survival, progression-free survival; and quality of life. The treatment effects that were considered less important, among this sample, were pain and adverse events. Conclusions: Thinking about expanding the therapeutic quality of users, it is essential to take into account the experiences of patients. PRO is a trend in current research to achieve this goal, in order to influence the decisions of HTA agencies about the importance of valuing outcomes that affect patients' lives.

O papel da sociedade civil na inovação e incorporação de dispositivos médicos no Brasil / The role of civil society in the innovation and incorporation of medical devices in Brazil

Objetivo: Abordar o contexto normativo quanto aos processos de participação social nas fases de Pesquisa, Desenvolvimento e Inovação (PD&I) e aos processos de regulação sanitária e de avaliação para incorporação de tecnologias no Sistema Único de Saúde (SUS). Métodos: Pesquisa exploratória descritiva com revisão dos referenciais normativos e análise documental: i) nos marcos regulatórios de inovação brasileiros; ii) na regulação sanitária pela Agência Nacional de Vigilância Sanitária (Anvisa); e iii) na avaliação e incorporação de dispositivos médicos na Comissão Nacional de Incorporação de Tecnologias em Saúde no SUS (Conitec). Resultados: Nos sites das instituições governamentais de fomento à Ciência, Tecnologia e Inovação (CT&I) vinculadas ao Ministério da Ciência, Tecnologia e Inovações (MCTI), observaram-se mecanismos de participação social estabelecidos na legislação. No contexto regulatório, a participação social se insere desde a construção dos regulamentos até etapas-chave do ciclo de vida da tecnologia. Na avaliação de tecnologias, verificou-se ampliação das estratégias de participação, a exemplo da "perspectiva do paciente" na plenária. Entre 64 chamadas públicas realizadas, cinco foram sobre dispositivos médicos. Conclusão: Evidenciou-se a importância da participação social em todas etapas do ciclo de vida dos dispositivos médicos, tendo em vista as especificidades dessas tecnologias. A Anvisa e a Conitec têm ampliado os mecanismos de participação para além dos preconizados em lei. Já nas etapas de PD&I, as iniciativas são incipientes, sendo localizadas ações conforme previsão legal. A ampliação de mecanismos de participação efetiva favorece a construção de soluções para minimizar os desafios de saúde, além de promover maior transparência, valor para a sociedade e confiança nas decisões em saúde brasileira.

Objective: To address the normative context regarding the processes of social participation in the phases of Research, Development and Innovation (RD&I), sanitary regulation and assessment for incorporation of technologies into SUS. Methods: Descriptive exploratory research with review of normative references and document analysis: i) in the regulatory milestones of Brazilian Innovation; ii) sanitary regulation by the National Health Surveillance Agency (Anvisa); and iii) in the assessment and incorporation of medical devices in the National Committee for Health Technology Incorporation into SUS (Conitec). Results: In the websites of government institutions that support RD&I linked to the MCTI, mechanisms of social participation established in the legislation were observed. In the regulatory context, social participation is inserted since the construction of regulations until key stages of the technology lifecycle. In the assessment of medical devices, we verified an expansion of engagement strategies, such as the "patient perspective" in the plenary meeting. From its 64 public calls, five were directed to medical devices. Conclusion: The importance of social participation in the

O papel da sociedade civil na inovação e incorporação de dispositivos médicos no Brasil / The role of civil society in the innovation and incorporation of medical devices in Brazil

Objetivo: Abordar o contexto normativo quanto aos processos de participação social nas fases de Pesquisa, Desenvolvimento e Inovação (PD&I) e aos processos de regulação sanitária e de avaliação para incorporação de tecnologias no Sistema Único de Saúde (SUS). Métodos: Pesquisa exploratória descritiva com revisão dos referenciais normativos e análise documental: i) nos marcos regulatórios de inovação brasileiros; ii) na regulação sanitária pela Agência Nacional de Vigilância Sanitária (Anvisa); e iii) na avaliação e incorporação de dispositivos médicos na Comissão Nacional de Incorporação de Tecnologias em Saúde no SUS (Conitec). Resultados: Nos sites das instituições governamentais de fomento à Ciência, Tecnologia e Inovação (CT&I) vinculadas ao Ministério da Ciência, Tecnologia e Inovações (MCTI), observaram-se mecanismos de participação social estabelecidos na legislação. No contexto regulatório, a participação social se insere desde a construção dos regulamentos até etapas-chave do ciclo de vida da tecnologia. Na avaliação de tecnologias, verificou-se ampliação das estratégias de participação, a exemplo da "perspectiva do paciente" na plenária. Entre 64 chamadas públicas realizadas, cinco foram sobre dispositivos médicos. Conclusão: Evidenciou-se a importância da participação social em todas etapas do ciclo de vida dos dispositivos médicos, tendo em vista as especificidades dessas tecnologias. A Anvisa e a Conitec têm ampliado os mecanismos de participação para além dos preconizados em lei. Já nas etapas de PD&I, as iniciativas são incipientes, sendo localizadas ações conforme previsão legal. A ampliação de mecanismos de participação efetiva favorece a construção de soluções para minimizar os desafios de saúde, além de promover maior transparência, valor para a sociedade e confiança nas decisões em saúde brasileira.

A framework for action to improve patient and public involvement in health technology assessment.

BACKGROUND: Patient and public involvement (PPI) in the Brazilian Health Technology Assessment (HTA) process occurs in response to a legislative mandate for "social participation." This resulted in some limited patient participation activities, and, therefore, a more systematic approach was needed. The study describes the development of a suggested framework for action to improve PPI in HTA. METHODS: This work used formal methodology to develop a PPI framework based on three-phase mixed-methods research with desktop review of Brazilian PPI activities in HTA; workshop, survey, and interviews with Brazilian stakeholders; and a rapid review of international practices to enact effective patient involvement. Patient partners reviewed the draft framework. RESULTS: According to patient group representatives, their involvement in the Brazilian HTA process is important but could be improved. Different stakeholders perceived barriers, identified values, and made suggestions for improvement, such as expansion of communication, capacity building, and transparency, to support more meaningful patient involvement. The international practices identified opportunities for earlier, more active, and collaborative PPI during all HTA stages, based on values and principles that are relevant for Brazilian patients and the public. These findings were synthesized to design a framework that defines and systematizes actions to support PPI in Brazil, highlighting the importance of evaluating these strategies. CONCLUSIONS: Since the publication of this framework, some of its suggestions are being implemented in the Brazilian HTA process to improve PPI. We encourage other HTA organizations to consider a systematic and planned approach with regular evaluation when pursuing or strengthening involvement practices.

Social participation in the health technology incorporation process into Unified Health System.

OBJECTIVE: To describe the current process of social participation in the incorporation of health technologies in Brazil, within the context of the Unified Health System (SUS). METHODS: A descriptive study was conducted based on the analysis of official records of the actions of the National Committee for Health Technology Incorporation into Unified Health System and its website, from the beginning of its activities in January 2012 until December 2017. RESULTS: The findings indicate that, in Brazil, there are legal instruments related to social participation in health, including the health technology assessment (HTA) field. However, its implementation is relatively recent and has been carried out gradually. In addition to the legal instruments (National Health Council representative, public consultation and public hearing forecast), other information and transparency strategies have been shown to be allied to social participation in the incorporation of health technologies. However, activities such as legally provided public hearings have not yet been carried out. CONCLUSIONS: Several actions to foster social participation were developed over the analyzed period, but they need to be evaluated in order to maintain or improve them. In addition, there is a need for more qualified social participation in the various existing spaces, including those prescribed by law.

Stories of Patient Involvement Impact in Health Technology Assessments: A Discussion Paper.

OBJECTIVES: As more health technology assessment (HTA) bodies seek to implement patient involvement, there is a desire to learn from other HTA bodies about their experiences and understand what approaches can be used and which ones make a real difference to HTA. This is difficult, as the impact of patient involvement in HTA is not well documented. This study aims to promote further discussion about the ways in which patient involvement can impact HTAs by studying stories of impact. METHODS: In a multi-stakeholder workshop, experts leading patient involvement in four HTA bodies shared examples of HTAs where they believed patient involvement made a difference, then they reflected on these impact stories within the wider context of impact evaluation. RESULTS: The HTA bodies drew on patient input and patient-based evidence to inform their HTAs. The patient involvement was observed to elucidate patients' experiences, needs and preferences which, in turn, was observed to influence the HTA recommendations about optimal use of technologies, including taking account of issues for sub-groups, outcomes that matter to patients and educational needs. CONCLUSIONS: Personal stories of patient involvement may enable a wider understanding of different approaches to and impact of patient involvement. The examples relate to both patient input and patient-based evidence and highlight the role that patient involvement can play in reducing uncertainties and complementing the clinical and economic evidence in HTA. They suggest that impact can be seen in recommendations about how and when a technology is used.

O envolvimento do público no processo de Avaliação de Tecnologias em Saúde: experiências mundiais e proposições para sua ampliação no Brasil / Public involvement in the assessment process Health Technology: worldwide experience and proposals for its expansion in Brazil

A Avaliação de Tecnologias em Saúde (ATS) é um campo multidisciplinar deanálise de políticas, que estuda as implicações clínicas, sociais, éticas e econômicas do desenvolvimento, difusão e uso da tecnologia em saúde, levando-se em consideraçãoaspectos como eficácia, efetividade, segurança, custos, custo-efetividade, entre outros. Entretanto, os impactos éticos, legais e sociais, direcionados a perspectivas de pacientes e da sociedade, são postergados em detrimento de outros atributos clínicos eeconômicos. Com a crescente ênfase sobre o engajamento dos pacientes pelo direito aos seus próprios cuidados, há uma necessidade de determinar meios efetivos para envolver a sociedade nos processo de avaliação e de decisão.O objetivo do presente trabalho foi explorar os desafios presentes no contexto internacional e nacional para envolver a perspectiva da sociedade (pacientes, cuidadores e profissionais de saúde) nos processos de avaliação e incorporação de tecnologias noSistema Único de Saúde (SUS). Foi adotado método integrativo, composto por revisão da literatura, análise de documentos e registro oficiais do Ministério da Saúde. A análisedos resultados mostrou experiências internacionais em franco desenvolvimento, destacando-se Reino Unido e Canadá. No Brasil, existem instrumentos legais para envolver o cidadão nas políticas de saúde e de incorporação de tecnologias, mas a sua implementação prática ainda éincipiente. Os principais desafios identificados em âmbito nacional e internacional são aqueles relacionados aos aspectos culturais. Com base nos resultados foi possível apontar proposições para aprimorar os mecanismos de envolvimento da sociedade nos processos de avaliação e incorporação de tecnologias no SUS.