Health technology assessment (HTA) frameworks appraise the value of technologies – be they drugs, devices, procedures or services – to inform policy decision-making and resource allocation amongst alternatives within publicly funded health systems. The prevailing principles and metrics by which HTA is conducted were designed with adult health conditions and treatments in mind. The evidentiary and normative dimensions of HTA frameworks may have unique repercussions for drug policy and coverage decisions in children, but their relevance to child health has received almost no critical scrutiny in either academic or policy circles. Approaches to paediatric drug coverage approval and access currently lack child-specific data on social values and priorities, a core component of HTA in most countries with public drug funding programs, including Canada. This thesis presents a mixed methods study of social values relevant to child HTA and drug policymaking in publicly funded health systems, comprised of three original scientific contributions. The first of these is a critical interpretive synthesis (CIS) of the academic literature on the moral dimensions of child health and social policymaking across a range of disciplines and policy domains. The second is a grounded theory analysis of qualitative interviews with diverse health system stakeholders on the social values and health system factors relevant to child HTA and drug funding policy in Canada. The third is a stated preference survey of the general public that assesses societal preferences for health resource allocation to children as compared to adults, to generate evidence for priority setting on health technologies within Canada’s publicly funded health system. Together, these studies yield specific knowledge about the policy landscape for child health technologies in Canada, broad conceptual insights into the normative and methodological dimensions of child HTA, and a foundational understanding of the social values relevant to drug policy decisions for children. / Thesis / Doctor of Philosophy (PhD) / Drug research, development and policy have historically excluded children. One area of persistent neglect is public policy on funding for paediatric medicines. In most publicly funded health systems, including Canada’s, decisions about which drugs to cover are made through a formal process called health technology assessment (HTA). This dissertation examines the role and challenges of HTA as applied to child health technologies, with a focus on the social values that inform drug policy for children. It addresses existing gaps in knowledge through the integration of insights from: 1) a comprehensive review of the academic literature on the moral dimensions of child health and social policymaking; 2) in-depth qualitative analysis of the HTA and drug policy environments for children in Canada, employing Ontario as a case study; and 3) a survey of the Canadian public on health system resource allocation for children. Together, these studies generate a detailed picture of the Canadian policy landscape for child health technologies, insights into the fit of current HTA approaches to the realities of child health and illness, and a foundational understanding of the social values relevant to drug policy decisions for children.

BACKGROUND & OBJECTIVES Overarching and decision-making frameworks may be used to facilitate the evaluation of prescription drug technologies to enable Health Technology Assessment (HTA) agency’s reassessment recommendations. The objectives of this thesis were to; 1) identify overarching and qualitative decision-making reassessment framework challenges and methodological gaps and; 2) develop and/or modify a framework to address challenges/gaps. The focus was on Canadian public prescription drug reimbursement with the hope that the findings may inform other jurisdictions. METHODS The first paper systematically identified drug disinvestment frameworks to describe framework components, challenges and solutions. A qualitative descriptive study was conducted in the second paper to explore whether a qualitative benefit-risk framework (Universal Methodology for Benefit-Risk Assessment (UMBRA)) could be used or modified to further enable Health Technology Reassessment (HTR) recommendations. The last research paper assessed the Canadian Agency for Drugs and Technologies in Health’s (CADTH’s) Therapeutic Review Process. Enhancements to this process were developed based on previous research and published frameworks. RESULTS Qualitative framework components were identified, disinvestment terms captured and challenges and solutions to drug disinvestment were compiled in Chapter 2. The participants interviewed in chapter 3 recognized that the Therapeutic Review assessment process did not include a qualitative deliberative framework. However, participants did not consider that all steps of the UMBRA framework were transferable to the assessment phase of HTR. Assessment of CADTH’s Therapeutic Review process, conducted in Chapter 4, found three areas for process enhancement: Therapeutic Review topic prioritization criteria; a qualitative assessment framework, and; publically accessible mechanisms for decision monitoring and performance measurement. CONCLUSION This thesis has identified reassessment framework enhancements that are hypothesized to address HTR challenges and specific solutions to enhance CADTH’s Therapeutic Review Framework. Next steps include further evaluation and pilot testing of these proposed enhancements to enable additional Canadian stakeholder feedback. / Thesis / Doctor of Philosophy (PhD) / This thesis focuses on overarching and decision-making assessment frameworks whose purpose is to aid policy-makers in recommending which prescription drugs should continue to be government-funded and/or if modifications to funding should occur. The goal of this work is to; 1) identify challenges and gaps in these frameworks and 2) develop or modify a framework to address findings. This thesis focuses on the Canadian public prescription drug reimbursement environment. Results identified Canadian reassessment framework enhancements which could address challenges to ultimately aid in maintaining financial and institutional stability of public health care systems.

The potential for private sector healthcare business in Africa has been forecasted to reach $35 billion by 2016, with South Africa being regarded as the most industrially advanced country on the continent. South Africa’s entry to modern biotechnology is fairly recent, though, with companies in the private sector still in a developmental phase, and most having limited bioproduct ranges. While considerable research has been conducted in the past to attempt to define the biotechnology environment of South Africa, as yet, a concise overview is lacking. In particular, a synopsis of the biomedical or commercial health technology environment has not been forthcoming for entrepreneurs to refer to as a ‘roadmap’. The purpose of this study was to perform a comprehensive study on the attributes that should be met for a successful, sustainable health technology venture (HTV) to be started in South Africa; while identifying the opportunities and threats that have existed in the South African market; thereby, affecting their success and sustainability to date. In this study, two phases of research were conducted. The first was a small-sampled mixed-methods (both qualitative and quantitative) study involving 21 medical devices, biogenerics, diagnostics, and contract services companies. The second was a quantitative study, involving 107 vaccines, biogenerics, therapeutics, nutraceuticals, reagents, diagnostics, medical devices, biotools, contract services and public services companies. Inferential statistical tests were conducted on the data, including Pearson’s Chi-Square, ANOVA, bivariate correlation, linear regression, logistic regression and multinomial logistic regression. From the study, the overall proportion of business sustainability for HTVs was found to be 66.7%, and at least 30% were unsustainable (or not yet at a level of sustainability). Variations were observed in the overall rate of sustainability for companies, based on their core functional classification, location, production type, size and start-up or R&D spending. By converting the observed frequencies of activity level, as an indication of sustainability, into a probability, it was possible to observe the company type that was most, and least likely to succeed in South Africa. Based on the statistical observations in this study, the HTV type most likely to succeed in South Africa, with a 63.7% probability of reaching sustainability, is a ‘vaccines’, ‘biotools’ or ‘public services’ company from Johannesburg with at least 20 employees; that has developed its goods or services internally, but manufactured externally and spent between R20 million–and–R30 million on its R&D or start-up. Conversely, least likely to succeed (3.2% probability) is a nutraceutical company from Cape Town with between six and 20 employees, that has developed and produced internally, and which has spent between R1 million–and–R10million on its start-up. / Life and Consumer Sciences / M.Sc (Life Sciences)

The potential for private sector healthcare business in Africa has been forecasted to reach $35 billion by 2016, with South Africa being regarded as the most industrially advanced country on the continent. South Africa’s entry to modern biotechnology is fairly recent, though, with companies in the private sector still in a developmental phase, and most having limited bioproduct ranges. While considerable research has been conducted in the past to attempt to define the biotechnology environment of South Africa, as yet, a concise overview is lacking. In particular, a synopsis of the biomedical or commercial health technology environment has not been forthcoming for entrepreneurs to refer to as a ‘roadmap’. The purpose of this study was to perform a comprehensive study on the attributes that should be met for a successful, sustainable health technology venture (HTV) to be started in South Africa; while identifying the opportunities and threats that have existed in the South African market; thereby, affecting their success and sustainability to date. In this study, two phases of research were conducted. The first was a small-sampled mixed-methods (both qualitative and quantitative) study involving 21 medical devices, biogenerics, diagnostics, and contract services companies. The second was a quantitative study, involving 107 vaccines, biogenerics, therapeutics, nutraceuticals, reagents, diagnostics, medical devices, biotools, contract services and public services companies. Inferential statistical tests were conducted on the data, including Pearson’s Chi-Square, ANOVA, bivariate correlation, linear regression, logistic regression and multinomial logistic regression. From the study, the overall proportion of business sustainability for HTVs was found to be 66.7%, and at least 30% were unsustainable (or not yet at a level of sustainability). Variations were observed in the overall rate of sustainability for companies, based on their core functional classification, location, production type, size and start-up or R&D spending. By converting the observed frequencies of activity level, as an indication of sustainability, into a probability, it was possible to observe the company type that was most, and least likely to succeed in South Africa. Based on the statistical observations in this study, the HTV type most likely to succeed in South Africa, with a 63.7% probability of reaching sustainability, is a ‘vaccines’, ‘biotools’ or ‘public services’ company from Johannesburg with at least 20 employees; that has developed its goods or services internally, but manufactured externally and spent between R20 million–and–R30 million on its R&D or start-up. Conversely, least likely to succeed (3.2% probability) is a nutraceutical company from Cape Town with between six and 20 employees, that has developed and produced internally, and which has spent between R1 million–and–R10million on its start-up. / Life and Consumer Sciences / M. Sc. (Life Sciences)

This thesis addresses the question of the design, production and use of information graphics in health technology assessment (HTA). Drawing on previous research in both information design and health policy, it describes a comprehensive design process for creating new visual presentations that can inform health policy-makers. The thesis begins by introducing, and functionally defining the terms ‘information graphics’ and ‘health technology assessment’ in Chapter 1. It then offers a methodological discussion of how research can be performed at the intersection between these two diverse fields. This discussion forms Chapter 2 of the thesis. The context of use is surveyed in two studies, which are presented in Chapter 3. These assess the current use of information graphics in HTA, and the information needs of health policy decision-making bodies. This enables a needs-based approach to the design of 10 information graphics, that could be used in hta. These are shown in Chapter 4. Finally, two of these information graphics are empirically tested with two further research studies, forming Chapter 5 and Chapter 6. The thesis is aimed at giving practical advice to those wanting to produce graphical presentations of information in HTA, and to provide the foundation for further original research in information design and HTA. Chapter 7 draws together the research from the rest of the thesis, to make recommendations in light of the combined findings.

Les développements récents en économie du bien-être ouvrent la voie à des méthodes d’évaluations reposant sur d’autres modèles de justice sociale que l’utilitarisme. Leur faisabilité dans les pratiques quotidiennes d’évaluation des interventions de santé pose question : l’objectif de cette thèse est de contribuer d’y répondre. Pour cela nous nous sommes intéressés à trois cas pratiques. L’objectif du Chapitre I est de comparer les méthodologies d’évaluation de trois agences publiques d’évaluation, le NICE (Grande-Bretagne), l’IQWiG (Allemagne) et le KCE (Belgique), pour identifier les positions en matière de justice sociale qui en découlent. Le Chapitre II propose d’étudier le dilemme moral que suscite le phénomène d’adaptation des préférences dans l’évaluation deux dispositifs de compensation du handicap. Trois options sont avancées résoudre ce dilemme, elles s’appuient sur les théories de la justice sociale égalitaristes. Enfin, le Chapitre III démontre la faisabilité de l’approche revenu équivalent-santé, développée par Fleurabey, dans l’aide à la décision publique, au sujet des traitements antihypertenseurs en prévention primaire / Welfare economics encompasses other public choice theories besides utilitarianism, like egalitarian social justice theory. Whether these economic frameworks provide practical tools that could be used in health technology assessment is an ongoing debate, and this study aim to contribute to answer this question. The aim of the first chapter is to review health economic evaluation guidelines and compare methods from three national health technology assessment agencies - NICE (England and Wales), IQWiG (Germany) and KCE (Belgium) - and to assess what social justice principles are implied by their methodological choices. The second chapter studies the moral dilemma raised by adaptive preferences in growth hormones treatment and bilateral cochlear implants. Three options are put forward to solve this dilemma: they are grounded on egalitarian social justice theories. The objective of the third chapter is to provide evidence about the feasibility of assessment based on equivalent income approach, developed by M. Fleurbaey, in the context of public decision making. For this application case, we focussed on antihypertensive treatments in primary prevention

Introdução: A gravidez na adolescência é um fenômeno que alimenta o ciclo de pobreza e a vulnerabilidade dos adolescentes e de seus filhos. Estudos apontam que adolescentes que engravidam têm maior dificuldade para desenvolver a parentalidade, maior risco de gravidez subsequente, maiores taxas de abandono escolar e maiores índices de inserção precária no mercado de trabalho. Método: Trata-se de um estudo metodológico de validação de aparência e de conteúdo, que teve como sujeitos enfermeiros da Atenção Básica e experts da área de Saúde Mental, Saúde Pública e Saúde Materno -Infantil. O programa de cuidado foi construído com base na literatura e encontra-se em teste piloto na pesquisa O efeito do Programa de Visitação para Jovens Gestantes sobre o Desenvolvimento Infantil. Os dados foram coletados por meio da técnica Delphi, através de instrumento de caracterização da amostra e de um questionário tipo Likert dividido em blocos temáticos e quatro pontos por item, que vão de 1. Totalmente adequado, 2. Parcialmente adequado, 3. Adequado e 4. Totalmente inadequado. O instrumento foi enviado por email, utilizando-se o google docs. Para determinar a validade de aparência e de conteúdo, foi utilizado o Índice de Validade de Conteúdo, foi considerado válido, as avaliações de juízes que obtiveram aprovação acima de 75% (IVC = 0,75). Resultados: Obteve-se a participação de onze sujeitos, entre os quais quatro eram enfermeiros (36,3%) e sete eram experts (63,6%), a maioria provenientes da região de São Paulo. Todos os enfermeiros eram do sexo feminino, tinham idade entre vinte e sete e trinta e três anos, três tinham até cinco anos de formado e um tinha tempo de graduação entre dez e quinze anos. A área de especialização dos profissionais era Saúde da Família e Saúde Mental. Todos os experts eram do sexo feminino, com idade entre 29 e 61 anos, com graduação de diferentes cursos: Enfermagem, Pedagogia, Medicina e Psicologia. O tempo de graduação predominante foi a de mais 15 anos, seguido de intervalo entre 10 e 15 anos, com tempo de experiência, em sua maioria, como mais de 15 anos. As duas áreas de atuação dos experts foram: saúde da criança e saúde mental, e os cargos eou funções que exerciam foram: docente, supervisão, coordenação técnica, psiquiatra e pesquisadora. O grupo 1 obteve IVC dentro do esperado, no entanto para o grupo 2, os valores descritivos da amostra no que diz respeito ao conteúdo indicam que quatro itens (de um total de vinte e oito) obtiveram índice de concordância abaixo do número previamente estabelecido (75%). Os valores descritivos em relação a aparência indicaram que 10 três itens (de um total de seis) não foram considerados validados pelo grupo 2. Conclusões: O programa de visitas domiciliares foi validado pelos juízes nos seus aspectos de conteúdo e de aparência. As sugestões feitas pelos juízes foram incorporadas em uma nova redação do Programa e estão disponibilizadas neste relatório. / Introduction: Teenage pregnancy is a phenomenon that feeds the cycle of poverty and vulnerability of adolescents and their children. Studies show that adolescents who become pregnant are more difficult to develop parenting, increased risk of subsequent pregnancy, higher dropout rates and higher rates precarious insertion in the labor market. Method: This is a methodological study of appearance and content validation, which had as subjects of primary care nurses and experts in the mental health area, Public Health, Child and Woman Health.The care program was built based on the literature and is in pilot research \"The effect of the visitation program for young pregnant women on child development\". Data were collected through Delphi technique using sample characterization tool and a questionnaire Likert divided into thematic blocks and four points per item, ranging from 1. Totally appropriate, 2. Partially appropriate, 3. Adequate and 4. Totally inappropriate. The instrument was sent by email, using the \"google docs\". To determine the validity of appearance and content, the Content Validity Index was used, it was considered valid, evaluations of judges who have passed above 75% (CVI = 0.75). Results: We obtained the participation of eleven subjects, among which four were nurses (36.3%) and seven were experts (63.6%), mostly from the region of São Paulo. All nurses were female, were aged from twenty-seven thirty-three years, three had up to five years and one had formed graduation time between ten and fifteen years. The area of expertise of the professionals was Family Health and Mental Health. All experts were female, aged between 29 and 61 years with different undergraduate courses: Nursing, Education, Medicine and Psychology. The predominant time of graduation was another 15 years, followed by range of 10 to 15 years, with long experience, mostly as more than 15 years. The two areas of expertise of experts were: children\'s health and mental health, and the positions and / or functions exercised were teaching, supervision, technical coordination, a psychiatrist and researcher. Group 1 received CVI as expected, but for the group 2, the descriptive values of the sample with respect to the content indicate that four items (a total of twenty-eight) obtained concordance rate below the predetermined number (75%). Descriptive values regarding the appearance indicated that three items (a total of six) were not considered validated by the group 12 2. Conclusions: The home visits program has been validated by the judges in the aspects of content and appearance. The suggestions made by the judges were incorporated into a new draft of the program and are available in this report.

Les dispositifs médicaux (DM) innovants offrent sans cesse de nouvelles options thérapeutiques et diagnostiques et contribuent à améliorer la prise en charge des malades à l’hôpital. Toutefois, ces innovations, potentiellement onéreuses, ne disposent pas toujours de données probantes garantissant leur efficience. Par conséquent, pour guider le choix des décideurs hospitaliers, une évaluation à l’échelle de l’hôpital est souvent nécessaire afin de lever le maximum d’incertitudes avant leur acquisition. Cette démarche, appelée évaluation des technologies de santé (ETS) en milieu hospitalier, s’est beaucoup développée à l’étranger, mais reste méconnue en France. A travers notre travail, nous avons montré que les CHU français proposaient des modèles d’organisation pour l’évaluation des DM innovants tout à fait comparables à ceux rencontrés dans d’autres pays. Parmi les modèles d’ETS en milieu hospitalier, la mini-ETS semble être le plus généralisable et pourrait concourir à l’harmonisation des pratiques entre CHU. Ce modèle en plein essor existe sous de multiples formes dans le monde. La confrontation des critères d’évaluation identifiés dans les modèles assimilables à la mini-ETS à ceux utilisés dans les CHU français nous a permis d’isoler 26 critères d’évaluation d’intérêt pour l’évaluation des DM innovants. Enfin, nous avons élaboré puis testé, en situation réelle, un outil d’aide multicritère à la décision dérivé des précédents critères identifiés. / Innovative medical devices offer solutions to medical problems. However, medical devices arriving on the European market have generally little evidence about efficiency. To manage the uncertainty surrounding the introduction of innovative medical devices, hospitals and university hospitals have developed worldwide hospital-based health technology assessment (HTA) processes to guide the selection of expensive and innovative products. Nevertheless, little is known about hospital-based HTA activities in France. We demonstrated that French models of hospital-based HTA are comparable to those found elsewhere and presented sometimes a combination of several HTA models. We also underlined that a mini-HTA like model could easily be applied to French university hospitals. Mini-HTA has become widespread in many different forms across the world. We compared criteria of different mini-HTA forms to criteria used in French university hospitals and identified 26 relevant criteria to assess innovative medical devices. Finally, we developed and tested in real conditions a multiple-criteria decision tool derived from these 26 criteria.

Aims: Untreated opioid use disorder (OUD) is associated with overdose, premature death and infectious disease, including human immunodeficiency virus (HIV) and Hepatitis C (HCV). While prior studies have shown that educational interventions are associated with improvements in HIV and HCV knowledge and reductions in risk behaviors, those examined to date have typically been time- and resource-intensive. We recently developed an HIV+HCV Education intervention which aims to improve HIV and HCV knowledge in a single visit using an automated iPad platform. In this project, we examined its ability, using a within-subject evaluation, to improve knowledge of HIV and HCV transmission and risks among adults with OUD. Methods: Participants were 25 adults with OUD who were enrolled in a 12-week randomized trial evaluating the efficacy of an Interim Buprenorphine Treatment (IBT) for reducing illicit opioid use while awaiting entry into community-based opioid treatment. Participants completed a baseline HIV+HCV knowledge assessment (Pre-Test) followed by corrective feedback, both administered via iPad. They then completed an interactive HIV flipbook and animated HCV video, also on iPad, followed by a second administration of the knowledge assessment (Post-Test). Finally, to evaluate whether any changes in knowledge persisted over time, the HIV+HCV assessment was administered again at 4 and 12 weeks following study intake. Results: At baseline (Pre-Test), participants answered 69% and 65% of items correctly on the HIV and HCV assessments, respectively. After completing the educational intervention, participants answered 86% of items correctly on both the HIV and HCV assessments (p’s<.001). These improvements in knowledge also persisted throughout the three-month study, with scores at Week 4 and 12 timepoints significantly greater than baseline (p’s<.001). Conclusion: An HIV+Hepatitis Education intervention delivered via a portable, automated iPad platform may produce significant and persistent improvements in HIV and HCV knowledge among adults with OUD. These data provide additional support for the use of mobile educational interventions for enhancing HIV and HCV knowledge in individuals at elevated risk for infectious disease. Support: This trial was supported by NIDA R34 DA3730385 (Sigmon) with additional support by NIDA T32 DA007242 (Higgins).

Introdução: A gravidez na adolescência é um fenômeno que alimenta o ciclo de pobreza e a vulnerabilidade dos adolescentes e de seus filhos. Estudos apontam que adolescentes que engravidam têm maior dificuldade para desenvolver a parentalidade, maior risco de gravidez subsequente, maiores taxas de abandono escolar e maiores índices de inserção precária no mercado de trabalho. Método: Trata-se de um estudo metodológico de validação de aparência e de conteúdo, que teve como sujeitos enfermeiros da Atenção Básica e experts da área de Saúde Mental, Saúde Pública e Saúde Materno -Infantil. O programa de cuidado foi construído com base na literatura e encontra-se em teste piloto na pesquisa O efeito do Programa de Visitação para Jovens Gestantes sobre o Desenvolvimento Infantil. Os dados foram coletados por meio da técnica Delphi, através de instrumento de caracterização da amostra e de um questionário tipo Likert dividido em blocos temáticos e quatro pontos por item, que vão de 1. Totalmente adequado, 2. Parcialmente adequado, 3. Adequado e 4. Totalmente inadequado. O instrumento foi enviado por email, utilizando-se o google docs. Para determinar a validade de aparência e de conteúdo, foi utilizado o Índice de Validade de Conteúdo, foi considerado válido, as avaliações de juízes que obtiveram aprovação acima de 75% (IVC = 0,75). Resultados: Obteve-se a participação de onze sujeitos, entre os quais quatro eram enfermeiros (36,3%) e sete eram experts (63,6%), a maioria provenientes da região de São Paulo. Todos os enfermeiros eram do sexo feminino, tinham idade entre vinte e sete e trinta e três anos, três tinham até cinco anos de formado e um tinha tempo de graduação entre dez e quinze anos. A área de especialização dos profissionais era Saúde da Família e Saúde Mental. Todos os experts eram do sexo feminino, com idade entre 29 e 61 anos, com graduação de diferentes cursos: Enfermagem, Pedagogia, Medicina e Psicologia. O tempo de graduação predominante foi a de mais 15 anos, seguido de intervalo entre 10 e 15 anos, com tempo de experiência, em sua maioria, como mais de 15 anos. As duas áreas de atuação dos experts foram: saúde da criança e saúde mental, e os cargos eou funções que exerciam foram: docente, supervisão, coordenação técnica, psiquiatra e pesquisadora. O grupo 1 obteve IVC dentro do esperado, no entanto para o grupo 2, os valores descritivos da amostra no que diz respeito ao conteúdo indicam que quatro itens (de um total de vinte e oito) obtiveram índice de concordância abaixo do número previamente estabelecido (75%). Os valores descritivos em relação a aparência indicaram que 10 três itens (de um total de seis) não foram considerados validados pelo grupo 2. Conclusões: O programa de visitas domiciliares foi validado pelos juízes nos seus aspectos de conteúdo e de aparência. As sugestões feitas pelos juízes foram incorporadas em uma nova redação do Programa e estão disponibilizadas neste relatório. / Introduction: Teenage pregnancy is a phenomenon that feeds the cycle of poverty and vulnerability of adolescents and their children. Studies show that adolescents who become pregnant are more difficult to develop parenting, increased risk of subsequent pregnancy, higher dropout rates and higher rates precarious insertion in the labor market. Method: This is a methodological study of appearance and content validation, which had as subjects of primary care nurses and experts in the mental health area, Public Health, Child and Woman Health.The care program was built based on the literature and is in pilot research \"The effect of the visitation program for young pregnant women on child development\". Data were collected through Delphi technique using sample characterization tool and a questionnaire Likert divided into thematic blocks and four points per item, ranging from 1. Totally appropriate, 2. Partially appropriate, 3. Adequate and 4. Totally inappropriate. The instrument was sent by email, using the \"google docs\". To determine the validity of appearance and content, the Content Validity Index was used, it was considered valid, evaluations of judges who have passed above 75% (CVI = 0.75). Results: We obtained the participation of eleven subjects, among which four were nurses (36.3%) and seven were experts (63.6%), mostly from the region of São Paulo. All nurses were female, were aged from twenty-seven thirty-three years, three had up to five years and one had formed graduation time between ten and fifteen years. The area of expertise of the professionals was Family Health and Mental Health. All experts were female, aged between 29 and 61 years with different undergraduate courses: Nursing, Education, Medicine and Psychology. The predominant time of graduation was another 15 years, followed by range of 10 to 15 years, with long experience, mostly as more than 15 years. The two areas of expertise of experts were: children\'s health and mental health, and the positions and / or functions exercised were teaching, supervision, technical coordination, a psychiatrist and researcher. Group 1 received CVI as expected, but for the group 2, the descriptive values of the sample with respect to the content indicate that four items (a total of twenty-eight) obtained concordance rate below the predetermined number (75%). Descriptive values regarding the appearance indicated that three items (a total of six) were not considered validated by the group 12 2. Conclusions: The home visits program has been validated by the judges in the aspects of content and appearance. The suggestions made by the judges were incorporated into a new draft of the program and are available in this report.