The rationale and design of public involvement in health-funding decision making: focus groups with the Canadian public.

BACKGROUND: Worldwide, governments employ health technology assessment (HTA) in healthcare funding decision making. Requests to include public perspectives in this are increasing, with the idea being that the public can identify social values to guide policy development, increasing the transparency and accountability of government decision making. OBJECTIVE: To understand the perspectives of the Canadian public on the rationale and design of public involvement in HTA. DESIGN: A demographically representative sample of residents of a Canadian province was selected to take part in two sets of two focus groups (sixteen people for the first set and twenty for the second set). RESULTS: Participants were suspicious of the interests driving various stakeholders involved in HTA. They saw the public as uniquely impartial though also lacking knowledge about health technologies. Participants were also suspicious of personal biases and commended mechanisms to reduce their impact. Participants suggested various involvement methods, such as focus groups, citizens' juries and surveys, noting advantages and disadvantages belonging to each and commending a combination. DISCUSSION AND CONCLUSIONS: We identified a lack of public understanding of how decisions are made and distrust concerning whose interests and values are being considered. Public involvement was seen as a way of providing information to the public and ascertaining their views and values. Participants suggested that public involvement should employ a mixed-methods strategy to support informed debate and participation of a large number of people.

Defining the role of the public in Health Technology Assessment (HTA) and HTA-informed decision-making processes.

OBJECTIVES: The terminology used to describe community participation in Health Technology Assessment (HTA) is contested and frequently confusing. The terms patients, consumers, public, lay members, customers, users, citizens, and others have been variously used, sometimes interchangeably. Clarity in the use of terms and goals for including the different groups is needed to mitigate existing inconsistencies in the application of patient and public involvement (PPI) across HTA processes around the world. METHODS: We drew from a range of literature sources in order to conceptualize (i) an operational definition for the "public" and other stakeholders in the context of HTA and (ii) possible goals for their involvement. Draft definitions were tested and refined in an iterative consensus-building process with stakeholders from around the world. RESULTS: The goals, terminology, interests, and roles for PPI in HTA processes were clarified. The research provides rationales for why the role of the public should be distinguished from that of patients, their families, and caregivers. A definition for the public in the context of HTA was developed: A community member who holds the public interest and has no commercial, personal, or professional interest in the HTA process. CONCLUSIONS: There are two distinct aspects to the interests held by the public which should be explicitly included in the HTA process: the first lies in ensuring democratic accountability and the second in recognising the importance of including public values in decision making.

Involving patients in health technology funding decisions: stakeholder perspectives on processes used in Australia.

BACKGROUND: Governments use a variety of processes to incorporate public perspectives into policymaking, but few studies have evaluated these processes from participants' point of view. OBJECTIVE: The objective of this study was twofold: to understand the perspectives of selected stakeholders with regard to involvement processes used by Australian Advisory Committees to engage the public and patients; and to identify barriers and facilitators to participation. DESIGN: Twelve semi-structured interviews were conducted with representatives of different stakeholder groups involved in health technology funding decisions in Australia. Data were collected and analysed using a theoretical framework created by Rowe and Frewer, but adapted to more fully acknowledge issues of power and influence. RESULTS: Stakeholder groups disagreed as to what constitutes effective and inclusive patient involvement. Barriers reported by interviewees included poor communication, a lack of transparency, unworkable deadlines, and inadequate representativeness. Also described were problems associated with defining the task for patients and their advocates and with the timing of patient input in the decision-making process. Interviewees suggested that patient participation could be improved by increasing the number of patient organizations engaged in processes and including those organizations at different stages of decision making, especially earlier. CONCLUSIONS: The different evaluations made by stakeholder groups appear to be underpinned by contrasting conceptions of public involvement and its value, in line with Graham Martin's work which distinguishes between 'technocratic' and 'democratic' public involvement. Understanding stakeholders' perspectives and the contrasting conceptions of public involvement could foster future agreement on which processes should be used to involve the public in decision making.

Australian researchers' perceptions and experiences with stem cell registration.

The recently issued ISSCR standards in stem cell research recommend registration of human pluripotent stem cell lines (hPSCs). Registration is critical to establishing stem cell provenance and connecting cell lines to data derived on those lines. In this study, we sought to understand common barriers to registration by conducting interviews with forty-eight Australian stem cell stakeholders, including researchers, clinicians, and industry professionals. Australian stem cell researchers do not routinely register their lines, and only a third of those Australian lines captured by an international registry have fully completed the registration process. Most registered Australian cell lines lack complete information about their ethical provenance or key pluripotency characteristics. Incomplete registration is poorly aligned with the goals of open science on which registries are founded. Users also expressed concerns about the quality of the incomplete information provided to the resource. Registration was considered negatively, for instance as a hurdle or barrier to publication, which impacted on user perceptions of usefulness of registration and lowered the likelihood that they would engage with registries to find resources. Broader adoption of registration by journals, and continued advocacy by stem cell societies, will be important levers for awareness and engagement with registration. Although the Australian community represents a small fraction of potential registry users, the results of this study suggest ways for journals, registries, funders, and the international stem cell community to improve registration compliance.

Understanding Canadian Health Technology Assessment through a systems lens.

OBJECTIVE: Governments around the world face challenges in maintaining sustainable, high-quality healthcare systems. Health Technology Assessment (HTA) is widely used as a method to assist in funding decisions. However, the scope and influence of HTA is still limited. We examined how policymakers can improve the usefulness of HTA. METHODS: We used Systems Thinking as a theoretical framework to examine HTA as a system. We purposely sampled stakeholders involved in Canadian HTA at a national or provincial level. We conducted 22 semi-structured interviews in September-December 2016. Data were analysed using NVivo10 and findings are presented as a concept map with explanatory text. FINDINGS: The HTA system is influenced by stakeholder interactions. Such interactions are, in turn, affected by stakeholders' worldviews and environmental factors. Stakeholders' worldviews includes individual's or groups' values and affect the exchange of information, and interpretation of events. External factors, such as changes to government structures, also affect the system. CONCLUSION: Most stakeholder groups are supportive of the system. However, participants identified a need for change, though the exact changes being recommended differed. Some interactions were praised (formal, inclusive collaborations to provide government with policy guidance on both broad and technology-specific matters), while other interactions were criticised (two-party alliances formed around purposes other than the common good, and lacklustre patient and industry engagement on the part of provincial government).

Supporting youth wellbeing with a focus on eating well and being active: views from an Aboriginal community deliberative forum.

OBJECTIVE: Including and prioritising community voice in policy development means policy is more likely to reflect community values and priorities. This project trialled and evaluated a storyboard approach in a deliberative community forum to engage Australian Aboriginal people in health policy priority setting. METHODS: The forum was co-constructed with two Aboriginal community-controlled organisations. A circle storyboard was used to centre Aboriginal community knowledge and values and encourage the group to engage with broader perspectives and evidence. The forum asked a diverse (descriptively representative) group of Aboriginal people in a rural town what governments should do to support the wellbeing of children and youth, particularly to encourage them to eat well and be active. RESULTS: The storyboard provided a tactile device to allow shared stories and identification of community issues. The group identified policies they believed governments should prioritise, including strategies to combat racism and provide local supports and outlets for young people. CONCLUSIONS: An informed deliberative storyboard approach offers a novel way of engaging with Aboriginal communities in a culturally appropriate and inclusive manner. Implications for public health: The identification of racism as a major issue of concern in preventing children from living healthy lifestyles highlights the need for policy responses in this area.

Vulnerabilidade e Declínio Funcional em pessoas idosas da Atenção Primária à Saúde: estudo longitudinal / Vulnerability and Functional Decline in older people in Primary Health Care: a longitudinal study

Resumo Objetivo Avaliar a associação da vulnerabilidade e o declínio funcional para Atividades Instrumentais de Vida Diária (AIVD) em pessoas idosas atendidas em unidades da Atenção Primária à Saúde (APS) no município de Várzea Grande (MT), Brasil. Método Estudo longitudinal realizado com 304 pessoas idosas, com acompanhamento de 24 meses. A variável de exposição principal, vulnerabilidade, foi mensurada na linha de base utilizando-se o Vulnerable Elders Survey (VES-13). A variável dependente foi "declínio funcional em AIVD", definido como a diminuição de pelo menos um ponto no score de capacidade funcional, avaliada pela Escala de Lawton e Brody, entre a coleta da linha de base e o follow-up. As associações entre declínio funcional em AIVD e vulnerabilidade, condições de saúde, fatores sociodemográficos, autoavaliação de saúde, estilo de vida e eventos adversos em saúde foram estimadas por meio do Odds Ratio (OR), utilizando regressão logística binária. Resultados 35,20% das pessoas idosas apresentaram declínio da capacidade funcional em AIVD. O declínio funcional se associou no modelo final com a interação entre vulnerabilidade e inatividade física (OR=3,12, IC95%, 1,42-6,86), insatisfação com a vida (OR=2,23, IC95%, 1,09-4,56) e hospitalização (OR=2,01, IC95%, 1,18-3,41). Conclusão O declínio funcional em AIVD foi maior nas pessoas idosas vulneráveis que estavam inativas fisicamente, naquelas insatisfeitas com a vida e que foram hospitalizadas durante o período de seguimento, sendo importante que essas condições sejam identificadas precocemente, para que ações de prevenção de declínio funcional sejam implementadas, além dos programas de incentivo à prática de atividade física pelas pessoas idosas.

Abstract Objective To assess the association between vulnerability and functional decline for Instrumental Activities of Daily Living (IADL) in older people treated in Primary Health Care (PHC) units in the municipality of Várzea Grande (MT), Brazil. Method A longitudinal study was carried out with 304 older people with a 24-month follow-up. The main exposure variable vulnerability was measured at baseline using the Vulnerable Elders Survey (VES-13). The dependent variable was "functional decline in IADL" defined as the decrease of at least one point in the score of functional capacity assessed by the Lawton and Brody Scale between baseline evaluation and the end of follow-up. The associations between the functional decline in IADL and vulnerability, health conditions, sociodemographic factors, self-rated health, lifestyle, and adverse health events were estimated using the Odds Ratio (OR) with binary logistic regression. Results A decline in functional capacity in IADL was observed in 35,20% of the cohort members. In the final model, functional decline was associated with the interaction between vulnerability and physical inactivity (OR = 3.12, 95%CI, 1.42-6.86), dissatisfaction with life (OR = 2.23, 95%CI, 1.09-4.56), and hospitalization (OR = 2.01, 95%CI, 1.18-3.41). Conclusion Functional decline in IADL was greater in vulnerable older people who were physically inactive, in those dissatisfied with life, and those who were hospitalized during the follow-up period. These conditions must be identified early so that actions to prevent functional decline could be implemented in addition to programs to encourage older people to exercise.

Power relations and contrasting conceptions of evidence in patient-involvement processes used to inform health funding decisions in Australia.

We collected and analysed views of key stakeholders on the processes used to involve patient organisations in health care funding decision making in Australia. We conducted 12 semi-structured interviews with patient organisation representatives and members of Advisory Committees that provide advice to the Australian Department of Health and employ Health Technology Assessment (HTA) as an evaluation framework. Using two theoretical frameworks, we analysed structural and contextual elements pertaining to the involvement processes. The findings reported in this article relate to interviewees' perspectives on contextual elements, analysed using a Foucauldian lens. These elements include: the perspectives of marginalised voices; the diversity of views on what ought to be considered valid evidence in a HTA setting; and the relationships between stakeholders, along with how these relationships impact on involvement processes and the outcomes of those processes. The findings demonstrate that the involvement processes currently used are deemed inadequate by both patient organisation representatives and Advisory Committee members, but for different reasons connected to how different stakeholders conceptualise evidence. Advisory Committee members viewed evidence as encompassing clinical outcomes and patient preferences, whereas patient organisation representatives tended to view evidence as encompassing aspects not directly related to a disease entity, such as the social and emotional aspects of patients' experiences in living with illness. Patient organisation representatives reported interacting with other stakeholders (especially industry) to increase the influence of their conception of evidence on decision making. The use of this strategy by interviewees illustrates how power struggles occur in government decision-making processes which involve both medical expertise and patients' accounts. Such struggles, and the power differentials they reflect, need to be considered by those responsible for designing and implementing meaningful public- and patient-involvement processes.

[Immunization status of risk newborns and difficulties experienced by mothers]. / Situação vacinal de recém-nascidos de risco e dificuldades vivenciadas pelas mães.

Among newborns at risk, immunization becomes relevant due to its preventive characteristic. The research aimed to analyze the vaccination status of newborns at risk of Cuiabá-MT, as well as satisfaction and difficulties of mothers regarding immunization. This is descriptive study, quantitative, with 113 newborns at risk, selected by the Statement of Live Birth: 25.7% had delayed immunization, being the lack of vaccine at the Health Unit (50.0%) the reason most often reported. Of the children with delayed immunization, 65.5% had more than one vaccine late, 100% had weight less than expected, 75.9% were accompanied in their growth and development by the Health Unit, 69.0% had an episode of illness in the six first months of life, 41.4% of mothers were under 18 years. The mothers reported more difficulties to the immunization service. We emphasize the importance of strategies to improve the quality of care, structure of health services, reception and professional preparation.

Situação vacinal de recém-nascidos de risco e dificuldades vivenciadas pelas mães / Immunization status of risk newborns and difficulties experienced by mothers / Estado de vacunación de recién nacidos de riesgo y dificultades experimentadas por las madres

Entre recém-nascidos de risco, a imunização torna-se relevante em virtude do caráter preventivo. A pesquisa objetivou analisar a situação vacinal dos recém-nascidos de risco de Cuiabá-MT, bem como a satisfação e dificuldades das mães em relação à imunização. Estudo descritivo, quantitativo, com 113 recém-nascidos de risco, selecionados pela Declaração de Nascido Vivo: 25,7% apresentaram atraso vacinal, sendo a falta de vacinas na Unidade de Saúde (50,0%) o motivo mais relatado. Das crianças em atraso, 65,5% tinham mais de uma vacina atrasada, 100% apresentavam peso abaixo do esperado, 75,9% eram acompanhados em seu crescimento e desenvolvimento pela Unidade de Saúde, 69,0% apresentaram episódio de doença nos seis primeiros meses de vida, 41,4% das mães eram menores de 18 anos. As mães relataram várias dificuldades quanto ao serviço de imunização. Destaca-se a importância de estratégias que visem melhorar a qualidade no atendimento, estrutura dos serviços de saúde, acolhimento e preparo dos profissionais.

Among newborns at risk, immunization becomes relevant due to its preventive characteristic. The research aimed to analyze the vaccination status of newborns at risk of Cuiabá-MT, as well as satisfaction and difficulties of mothers regarding immunization. This is descriptive study, quantitative, with 113 newborns at risk, selected by the Statement of Live Birth: 25.7% had delayed immunization, being the lack of vaccine at the Health Unit (50.0%) the reason most often reported. Of the children with delayed immunization, 65.5% had more than one vaccine late, 100% had weight less than expected, 75.9% were accompanied in their growth and development by the Health Unit, 69.0% had an episode of illness in the six first months of life, 41.4% of mothers were under 18 years. The mothers reported more difficulties to the immunization service. We emphasize the importance of strategies to improve the quality of care, structure of health services, reception and professional preparation.

Entre los recién nacidos en situación de riesgo, la inmunización se vuelve relevante debido a su característica preventiva. Esta investigación tuvo como objetivo analizar el estado de vacunación de los recién nacidos en riesgo de Cuiabá-MT, así como la satisfacción y las dificultades de las madres con respecto a la inmunización. Este estudio descriptivo, cuantitativo, con 113 recién nacidos en riesgo, seleccionados por la Declaración de Nacimiento: 25,7% había retrasado la vacunación, siendo la falta de vacuna en la Unidad de Salud (50,0%), la razón más frecuentemente reportado. De los niños con retraso en la vacunación, 65,5% tenían más de una vacuna retrasada; 100% tenían un peso inferior a lo esperado; 75,9% fueron acompañados en su crecimiento y desarrollo en la Unidad de Salud; 69,0% tuvo un episodio de la enfermedad en los seis primeros meses de vida; y 41,4% de las madres eran menores de 18 años. Las madres reportaron varias dificultades relativas al servicio de vacunación. Destacamos la necesidad y la importancia de estrategias que mejoren la calidad de la atención, la estructura de los servicios de salud, la recepción y la preparación profesional.