Parenting, child development and primary care - 'Crescer em Grande!' intervention (CeG!) based on the Touchpoints approach: a cluster-randomised controlled trial protocol

Introduction Despite support for parenting being already recognised as a priority, there remains a paucity of evidence on how to facilitate its adoption in regular visits of maternal and child health primary care (PC). We describe the protocol for a study to assess the effect of an innovative universal Touchpoints-based intervention - 'Crescer em Grande!' (CeG!) - when supporting the process of transition to parenthood and early infancy, at multiple PC units. Methods and analysis A cluster-randomised trial will be conducted in 12 PC units (clusters) from the Lisbon metropolitan area, Portugal. Participants will be a minimum of three family physicians and one nurse/unit, as well as 216 expecting parents and future babies until 18 months who are using the PC services. Sites will be randomised to either the CeG! or usual care. The CeG! will consist of: (1) the integration of the Touchpoints approach in PC maternal and well-child visits, with the support of 28 leaflets for parents to file in a folder; plus (2) training for PC providers on how to perform the CeG! into existing practice. Parents will be required to fill in questionnaires at point throughout their child's 18-month, mostly online. The primary outcome will be the self-perception of parental competence (Parenting Sense of Competence Scale). Other outcomes include: family functioning, couple dynamics, mental health, well-being/quality of life, psychological experience of pregnancy, attachment, child development. Acceptability, satisfaction and feasibility of CeG! will also be obtained from providers' and parents' perspectives. Costs associated with delivering the CeG! will be calculated. Study analyses will be under the principle of intention-to-treat. Ethics and dissemination Approval was obtained from the Ethics Committee of the Regional Health Administration. The results will be shared with participants and disseminated via peer-reviewed published papers, presentations at scientific and professional conferences. Trial registration number ISRCTN90692907info:eu-repo/semantics/publishedVersio

'Space to talk': a Portuguese focus group study of parents' experiences, needs and preferences in parenting support during prenatal and well-child care

OBJECTIVE: To explore the experiences, needs and preferences of a group of parents regarding the parenting support received during prenatal and well-child care in the Portuguese National Health Service. DESIGN AND SETTING: We undertook descriptive-interpretive qualitative research running multiple focus groups in Porto, Northern Portugal. PARTICIPANTS, DATA COLLECTION AND ANALYSIS: Purposive sampling was used between April and November 2018. Focus groups were conducted with 11 parents of a 0-3 years old with well-child visits done in primary care units. Thematic analysis was performed in a broadly inductive coding strategy and findings are reported in accordance with Consolidated Criteria for Reporting Qualitative Research guidelines. RESULTS: Three main themes were identified to describe parents' experience when participating in their children's healthcare: (1) logistics/delivery matter, including accessibility, organisation and provision of healthcare activities, unit setting and available equipment; (2) prenatal and well-child care: a relational place to communicate, with parents valuing a tripartite space for the baby, the family and the parent himself, where an available and caring health provider plays a major role and (3) parenting is challenging and looks for support, based on key points for providers to watch for and ask about, carefully explained and consensual among health providers. CONCLUSION: This study provides insight into parents' needs and healthcare practices that affect the parenting experience. To meet parents' preferences, sensitive health providers should guarantee a relational place to communicate and person-centredness, accounting for the whole family system to support healthy parenting collaboratively. Future studies are warranted to further strengthen the knowledge in the field of a population-based approach for parenting support.info:eu-repo/semantics/publishedVersio

Asymptomatic carotid bruit

Cerebrovascular events are responsible for high morbidity and mortality, and carotid atherosclerosis with vascular stenosis is a major etiological factor in cerebrovascular disease. Carotid bruit is an important marker of generalized atherosclerosis. On the basis of good quality studies, we can conclude that it indicates an increased risk of cerebrovascular events and acute myocardial infarction, with the degree of carotid stenosis and presence of ischemic heart disease as the most important predictive factors. Management can be medical (risk factor modification and antiplatelet therapy) or surgical (endarterectomy). In this review article we briefly discuss the management of asymptomatic carotid bruit based on the main studies published in the last few years addressing cardiovascular event prevention in carotid atherosclerosis.Os eventos cerebrovasculares são responsáveis por elevada morbilidade e mortalidade e a aterosclerose carotídea com estenose constitui uma etiologia major neste contexto. O sopro carotídeo revela-se como um importante marcador de doença aterosclerótica generalizada. Baseados em estudos de boa qualidade, é possível concluir que existe um aumento do risco de eventos cerebrovasculares e de enfarte agudo do miocárdio em indivíduos com sopro carotídeo assintomático, sendo os factores preditivos mais importantes a gravidade da estenose carotídea e a presença de doença cardíaca isquémica concomitante. A abordagem pode ser médica (modulação de factores de risco e terapêutica anti-agregante plaquetária) ou cirúrgica (endarterectomia). Neste artigo de revisão discutimos brevemente a abordagem prática no sopro carotídeo, utilizando os estudos mais importantes publicados nos últimos anos sobre a prevenção de eventos cardiovasculares na aterosclerose carotídea.info:eu-repo/semantics/publishedVersio

Generalization of the results of clinical studies through the analysis of subgroups

Copyright © Ordem dos Médicos 2012Subgroup analysis in clinical trials are usually performed to define the potential heterogeneity of treatment effect in relation with the baseline risk, physiopathology, practical application of therapy or the under-utilization in clinical practice of effective interventions due to uncertainties of its benefit/risk ratio. When appropriately planned, subgroup analysis are a valid methodology the define benefits in subgroups of patients, thus providing good quality evidence to support clinical decision making. However, in order to be correct, subgroup analysis should be defined a priori, done in small numbers, should be fully reported and, most important, must endure statistical tests for interaction. In this paper we present an example of the treatment of post-menopausal osteoporosis, in which the benefits of an intervention (the higher the fracture risk is, the better the benefit is) with a specific agent (bazedoxifene) was only disclosed after a post-hoc analysis of the initial global trial sample.As análises de subgrupos em ensaios clínicos são habitualmente efectuadas para definir a potencial heterogeneidade do efeito do tratamento relacionado com o risco de base ou da fisiopatologia, com a aplicação prática da terapêutica ou ainda da subutilização da terapêutica na prática clínica de rotina devido a incerteza do benefício/risco desta. Quando apropriadamente planeadas, as análises de subgrupos são metodologias válidas para discernir benefícios terapêuticos em subgrupos de doentes, fornecendo desta maneira evidência de boa qualidade de suporte à decisão clínica. No entanto, para a sua realização ser correcta devem ser indicadas a priori no protocolo inicial, devem restringir-se ao outcome primário, devem ser feitos em número limitado, devem ser todas reportadas e, mais importante, devem ser submetidas a testes estatísticos de interacção. Neste artigo apresentamos um exemplo no tratamento da osteoporose pós-menopáusica, em que o benefício de uma intervenção (quanto mais elevado o risco de fractura, maior o benefício do tratamento) com um agente específico (o bazedoxifeno) só foi esclarecido com uma análise posthoc de toda a amostra do estudo inicial.info:eu-repo/semantics/publishedVersio

Prescrição off-label : análise científica tendo como exemplo a utilização de Bevacizumab em oftalmologia

Off-label prescribing poses specific technical/scientific, professional and ethical problems. In this study we carry out a technical and scientific analysis of the off-label prescribing using a current, clinical and economically relevant example: the paradigmatic case of the use of bevacizumab in ophthalmologic pathologies for which it has no formal indication. We conducted a systematic review of the literature on the efficacy and safety of this drug, as well as ranibizumab - which has approved ophthalmologic indications, in order to qualitatively analyze the available evidence on the two interventions. This is a typical case for technical and scientific analysis of the off-label prescribing problems. According to the results of the systematic review, the use of bevacizumab in this context has in fact scientific evidence of appreciable size, including clinical trials head-to-head with ranibizumab. However, the identified safety issues raise the question of the use of this drug in ophthalmologic pathologies. The different players involved in the treatment decisions (physicians, patients and institutional decision makers) should be adequately informed about the existing evidence that supports off-label prescribing which, by definition, must always be on an exceptional basis and properly justified.info:eu-repo/semantics/publishedVersio

Children's emotional understanding of death: response to Silva et al paper

info:eu-repo/semantics/publishedVersio

Off-label prescribing : scientific analysis taking the use of bevacizumab in ophthalmology as an example

Copyright © Ordem dos Médicos 2013Off-label prescribing poses specific technical/scientific, professional and ethical problems. In this study we carry out a technical and scientific analysis of the off-label prescribing using a current, clinical and economically relevant example: the paradigmatic case of the use of bevacizumab in ophthalmologic pathologies for which it has no formal indication. We conducted a systematic review of the literature on the efficacy and safety of this drug, as well as ranibizumab - which has approved ophthalmologic indications, in order to qualitatively analyze the available evidence on the two interventions. This is a typical case for technical and scientific analysis of the off-label prescribing problems. According to the results of the systematic review, the use of bevacizumab in this context has in fact scientific evidence of appreciable size, including clinical trials head-to-head with ranibizumab. However, the identified safety issues raise the question of the use of this drug in ophthalmologic pathologies. The different players involved in the treatment decisions (physicians, patients and institutional decision makers) should be adequately informed about the existing evidence that supports off-label prescribing which, by definition, must always be on an exceptional basis and properly justified.A prescrição off-label levanta problemas técnicos/científicos, profissionais e éticos específicos. No presente trabalho, procurámos realizar uma análise técnico-científica da prescrição off-label recorrendo a um exemplo atual, clinica e economicamente relevante: o caso paradigmático da utilização de bevacizumab em patologias do foro oftalmológico para as quais não tem indicação formal aprovada. Para tal realizámos uma revisão sistemática da literatura sobre a eficácia e segurança deste medicamento, assim como de ranibizumab – o qual tem indicações oftalmológicas aprovadas, no sentido de analisar qualitativamente a evidência científica disponível sobre as duas intervenções. Este caso é exemplar para análise técnico-científica dos problemas da prescrição off-label, já que, de acordo com os resultados da revisão sistemática realizada, o uso do bevacizumab neste contexto possui, de facto, evidência científica de dimensão apreciável, incluindo ensaios clínicos head-to-head com ranibizumab. No entanto, os problemas de segurança identificados levantam a questão da utilização deste fármaco nas patologias oftalmológicas. Os diferentes agentes que participam no processo de decisão terapêutica (médicos, doentes e decisores institucionais) devem estar adequadamente informados sobre a evidência existente que suporta a prescrição off-label, a qual, por definição, deve ser sempre de caracter excecional e devidamente justificada.info:eu-repo/semantics/publishedVersio

The Portuguese versions of the This Is ME Questionnaire and the Patient Dignity Question: tools for understanding and supporting personhood in clinical care

Background: Modern medicine can be impersonal and routinized, paying insufficient attention to issues of personhood. The Patient Dignity Question (PDQ) and This Is ME (TIME) Questionnaire are clinical tools developed with the aim of probing for personhood, reinforcing dignity and promoting health care attitudes based on looking at people for who they are and not defining them solely based on their medical condition. This study aimed to translate and validate the TIME Questionnaire and the PDQ into European Portuguese, coined as Questionário Este Sou EU (ESEU) and Pergunta da Dignidade (PD), respectively. Methods: A three-stage research design, namely: a forward and back translation process (which included an expert committee panel), collected data on a sample of 43 non-institutionalized active elderly for the validation stage and a final expert panel consultation. Inclusion criteria: being 50 years old or older; ability to provide written informed consent; ability to read, speak and understand Portuguese. Results: The original TIME authors fully endorsed the back translated version. A Portuguese version was created. Forty-three participants (response rate of 62%) were included, 53% of whom were male. The average age was 69 years old (range, 60–80 years old). The interviewed elderly strongly felt that the ESEU’s summary captured their essence as a person beyond whatever health problems they might be experiencing (6.8, SD =0.48), heightened their sense of dignity (6.1, SD =1.48), considered important that health care professionals (HCPs) have access to ESEU’s summary (6.6, SD =0.73) and that this information could affect the way HCPs see and care for them (6.4, SD =0.86), rated on a Likert scale: 1 “strongly disagree”–7 “strongly agree”. According to the experts’ evaluations, the translated ESEU Questionnaire was clear, precise, comprehensible and captured important dimensions of personhood. Conclusions: The Questionário ESEU and the PD are clear, precise, comprehensible and well-aligned in terms of measuring aspects of personhood. This measure could add additional value to the patient-healthcare provider relationship, allowing a new perspective on how healthcare professionals perceive patients in suffering, ensuring they acknowledge not just patienthood, but critical dimensions of personhood.Foundation for Science and Technology (FCT) PhD Fellow Grant number PD/BD/113664/2015 Doctoral Program in Clinical and Health Services Research (PDICSS) funded by FCT Grant number (PD/0003/2013); F Fareleira is funded by Foundation for Science and Technology (FCT) PhD Fellow Grant number PD/BD/132860/2017 Doctoral Program in Clinical and Health Services Research (PDICSS); N Correia Santos: this work has been developed under the scope of the project NORTE-01-0145-FEDER-000013, supported by the Northern Portugal Regional Operational Programme (NORTE 2020), under the Portugal 2020 Partnership Agreement, through the European Regional Development Fund (FEDER), and was co-financed by the Portuguese North Regional Operational Program (ON.2—O Novo Norte), under the National Strategic Reference Framework (QREN), through FEDER. N Correia Santos is supported by a Research Assistantship by the Portuguese Foundation for Science and Technology (FCT, Portugal) through the “FCT Investigator Programme (200 ∞ Ciência)”info:eu-repo/semantics/publishedVersio

Dialogues with parents: a parental support and empowerment program based on the Touchpoints Model

“Dialogues with Parents-welcoming, listening, and empowering” aimed to understand the impact of an innovative approach supporting parents with identified social/emotional vulnerabilities. Program goals included the promotion of positive parenting, the expansion of parents' knowledge and skills, and the enhancement of parent–child interactions. Based on the Brazelton Touchpoints Developmental-Relational Frameworks, the program applied strength-based assumptions and relationship-based practices to underpin empathic and collaborative relationships with families, seeking to strengthen their confidence in parenting. Two modalities were offered with a modular structure from prenatal–newborn to 6 years. Both included 10 modules, one in which the same group of parents carried out the complete sequence of sessions (Continuous Group) and a second in which parents selected one Touchpoint according to their needs and “drop in” to the session(s) of their choice (Touchpoints 1 by 1 Group). Data were gathered through satisfaction questionnaires at the end of each encounter. A focus group was also held with parents from the Continuous Group. The difference between applications (248) and total participation (99) indicates that parent's interest in participating is high but only a third managed to join the groups. Nevertheless, the results were very positive, highlighting the quality of the Touchpoints approach and program implementation, namely its impact on improving parents' understanding of children's development and of their own role in parenting. Parents particularly valued the opportunity to actively participate in the encounters and, in the Continuous Group, the usefulness of the encounters for themselves as a person and as parents

Parenting, child development and primary care—‘Crescer em Grande!’ intervention (CeG!) based on the Touchpoints approach: a cluster-randomised controlled trial protocol

Introduction Despite support for parenting being already recognised as a priority, there remains a paucity of evidence on how to facilitate its adoption in regular visits of maternal and child health primary care (PC). We describe the protocol for a study to assess the effect of an innovative universal Touchpoints-based intervention—‘Crescer em Grande!’ (CeG!) - when supporting the process of transition to parenthood and early infancy, at multiple PC units.Methods and analysis A cluster-randomised trial will be conducted in 12 PC units (clusters) from the Lisbon metropolitan area, Portugal. Participants will be a minimum of three family physicians and one nurse/unit, as well as 216 expecting parents and future babies until 18 months who are using the PC services. Sites will be randomised to either the CeG! or usual care. The CeG! will consist of: (1) the integration of the Touchpoints approach in PC maternal and well-child visits, with the support of 28 leaflets for parents to file in a folder; plus (2) training for PC providers on how to perform the CeG! into existing practice. Parents will be required to fill in questionnaires at point throughout their child’s 18-month, mostly online. The primary outcome will be the self-perception of parental competence (Parenting Sense of Competence Scale). Other outcomes include: family functioning, couple dynamics, mental health, well-being/quality of life, psychological experience of pregnancy, attachment, child development. Acceptability, satisfaction and feasibility of CeG! will also be obtained from providers’ and parents’ perspectives. Costs associated with delivering the CeG! will be calculated. Study analyses will be under the principle of intention-to-treat.Ethics and dissemination Approval was obtained from the Ethics Committee of the Regional Health Administration. The results will be shared with participants and disseminated via peer-reviewed published papers, presentations at scientific and professional conferences.Trial registration number ISRCTN9069290