ABSTRACT
The New Drugs and Clinical Trial Rules (NDCTR) came in force in 2019, these brought in some changes, but certain earlier parts, such as Rule 122 DAB, were incorporated unchanged. A few sections of the NDCTR are problematic and need revision for the smooth conduct of clinical trials in India. Training of Ethics Committee (EC) members and other stakeholders is a very important driver for clinical research but has not been defined clearly. In addition, some processes of EC review need a relook. Compensation formulae were finalized in 2013; now, the altered economic situation has eroded the value of money. Hence, for the protection of research participants, an urgent review of the compensation formula is suggested.
ABSTRACT
Background: Schools are vital settings for overweight and obesity prevention among children and adolescents. School Committee Members (SCMs) are crucial assets to engaging students with overweight and obesity prevention programs. This study aimed to determine factors contributing to overweight and obesity among high school students in Kiribati through the perception of SCMs. Methods: This prospective qualitative study was conducted in four randomly selected senior high schools in South Tarawa, Kiribati, from August to November 2020. With a purposive selection of 20 SCMs employed at the four high schools, both male and female participants consented to participate in the study. A semi-structured open-ended questionnaire was used for data collection using focus group discussions (FGDs). Data were transcribed and analyzed using the thematic analysis method. Results: Twenty participants were involved in FGDs with equal number of SCMs (n = 5) who attended FGDs for each school and 45% of them were female participants. Six themes were identified, namely, knowledge, behaviors, perceived status toward overweight and obesity, perceived action benefits, perceived barriers to practices, and proposed strategies to overweight and obesity prevention. These themes reveal that SCMs have a broad understanding and skill set for overweight and obesity causes and effects. However, the aptitude alone is not enough to prevent the occurrence, and thus, proposed feasible plans were voiced for responsible stakeholders to include in policy developments for overweight and obesity prevention. Conclusion: This study recognized that the knowledge-behavior gap is the main reason behind the failure in preventative strategic approaches among adolescents. As role models to students, SCMs and their schools should team up in implementing the public health policies and building mutual awareness and understanding with students and other specialist stakeholders for a more momentous and viable impact.
Subject(s)
Committee Membership , Overweight , Adolescent , Child , Female , Humans , Male , Obesity/epidemiology , Overweight/epidemiology , Perception , Prospective Studies , StudentsABSTRACT
BACKGROUND: Our paper presents experiences and perceptions of beneficiaries, health service providers, and community members about a conditional cash transfer (CCT) programme piloted in Nigeria from April 2013 to May 2015 to boost demand for maternal, newborn, and child health services. METHODS: We conducted a descriptive cross-sectional retrospective study using both qualitative and quantitative methods. Personal interviews and focus group discussions (FGDs) were conducted between June and July 2015 for 314 CCT beneficiaries, 72 ward development committee (WDC) members, and 60 service providers (midwives, community health extension workers [CHEWs], and village health workers [VHWs]) including 29 officers-in-charge as key informants. Content analysis was applied to qualitative findings and grouped into themes of attitude, practices, CCT operations, payout, and perceived impact. RESULTS: Over 97% of beneficiaries affirmed that the cash incentive was very helpful and almost 70% opined that the free supply-side services were the real benefit. Majority of service providers applauded the programme though, with complaints about the increased workload. Community members applauded the scheme, with mixed feelings over some operational processes. CONCLUSION: Beneficiaries, service providers, and community members expressed deep satisfaction with the CCT programme and opined that antenatal care (ANC) and skilled birth delivery service utilization increased. Insights into some programmatic challenges are provided to enrich future CCT design and implementation.
Subject(s)
Community Health Workers , Health Services Accessibility/economics , Healthcare Financing , Maternal Health Services , Child , Community Health Workers/psychology , Cross-Sectional Studies , Female , Focus Groups , Humans , Interviews as Topic , Male , Nigeria , Pilot Projects , Qualitative Research , Retrospective StudiesABSTRACT
Trata-se de estudo metodológico, que objetivou traduzir, adaptar e validar dois instrumentos para as práticas educativas na condição crônica do diabetes no contexto cultural brasileiro. MÉTODOS: Primeira etapa: A tradução e adaptação cultural do Diabetes Empowerment Scale- Short Form foi realizada de acordo com a metodologia padrão, sendo que a avaliação realizada pelo Comitê de Juízes foi conduzida da ferramenta web e-Surv. A versão adaptada foi utilizada durante o pré-teste, aplicado via ligação telefônica, a um grupo de onze usuários com diagnóstico de Diabetes Mellitus tipo 2. Os resultados do pré-teste foram examinados por um grupo de especialistas, composto por profissionais das áreas da Saúde, Linguística Aplicada e Estatística, para obtenção de uma versão adequada do instrumento. Para análise da confiabilidade do instrumento, a Escala de Auto eficácia em Diabetes - Versão Curta foi aplicada no teste e reteste em uma amostra de 100 usuários com diagnóstico de Diabetes Mellitus tipo 2, por meio de ligação telefônica e registro das respostas dos usuários com a ferramenta e - Surv. Foi possível obter validade de face e de conteúdo do instrumento, além de suas medidas de confiabilidade e consistência interna. Segunda etapa: A tradução, adaptação e validação de conteúdo do Diabetes Medical Management Plan para o contexto brasileiro foi realizado em quatro etapas: tradução inicial, síntese da tradução inicial, retrotradução e validação de conteúdo por um Comitê de Juízes composto por 94 especialistas (29 linguistas aplicados e 65 profissionais da área da Saúde) para avaliação da versão traduzida por meio de um questionário on-line. O nível de concordância dos juízes foi calculado com base no Índice de Validade de Conteúdo. Os dados coletados foram exportados para análise estatística no ambiente R. RESULTADOS: A Escala de Auto eficácia em Diabetes -Versão Curta apresentou consistência interna aceitável, com alfa de Cronbach igual a 0,634 ...
This is a methodological study aimed to translate, adapt and validate two instruments for educational practices in chronic condition of diabetes in the Brazilian cultural context. METHODS: First step: The translation and cultural adaptation of the Diabetes Empowerment Scale- Short Form was performed according to standard methodology, and the assessment made by the Judges Committee was conducted in the web tool e-Surv. The adapted version was used during the pre-test, applied via phone call, a group of eleven users diagnosed with diabetes Mellitus type 2. Pre-test results were examined by a group of experts, composed of professionals from the fields of Health and Statistics Applied Linguistics, to obtain a suitable version of the instrument. To analyze the reliability of the instrument, the Escala de Autoeficácia em Diabetes-Versão Curta was applied to the test and retest in a sample of 100 users diagnosed with type 2 diabetes Mellitus through phone call and record the responses of users with the tool e-Surv. It was possible to face validity and content of the instrument, as well as their measures of reliability and internal consistency. Second step: The translation, adaptation and validation of the Diabetes Medical Management Plan content for the Brazilian context was conducted in four stages: initial translation, the initial translation synthesis, back-translation and content validation by an expert committee consisting of 94 experts (29 applied linguists and 65 health professionals) to evaluate the version translated through an online questionnaire. The judges' level of agreement was calculated based on the Content Validity Index. The collected data were exported to statistical analysis in the environment R. RESULTS: Escala de Autoeficácia em Dia...
Subject(s)
Humans , Diabetes Mellitus , Chronic Disease , Patient Education as Topic , Translations , Surveys and Questionnaires , Reproducibility of ResultsABSTRACT
O objetivo do estudo foi construir o perfil dos indicados pelos Comitês de Ética em Pesquisa - CEPs - para membros da Comissão Nacional de Ética em Pesquisa - CONEP, líderes no sistema de controle da ética em pesquisa no Brasil, quanto à representação de grupos sociais, formação e experiência profissional e experiência e conhecimento em ética na pesquisa. Enquanto informantes-chave, buscou-se conhecer práticas correntes no sistema, e compreensão da regulamentação. Foram aplicados questionários, via correio ou via eletrônica, aos 188 componentes da lista de 2003, obtendo-se 94 respostas válidas, que representaram 80% dos CEPs. O questionário constou de 4 partes - a parte I, de caracterização pessoal, mostrou proporção semelhante de gênero, alta qualificação acadêmica, participação em cursos de pequena duração sobre ética em pesquisa/ bioética, e sensibilidade social. Dos respondentes, 50% tinham cargos de gestão na instituição, 18% deles ligados diretamente à pesquisa, apenas 4% eram representantes de usuários, 90% participaram de pesquisas nos últimos 10 anos, sendo um terço em pesquisa clínica. A parte II correspondeu a uma auto-avaliação de sua participação como membros de CEPs, que mostrou satisfação com a relevância do trabalho, valorização de qualidades como responsabilidade, compromisso, habilidade para trabalho em equipe, sendo que 89% e 85% consideraram-se preparados e competentes respectivamente, apesar de percepção variada da representatividade e compreensão política de sua atuação. Identificaram-se áreas de maior dificuldade na análise de projetos, e encontros, seminários e discussão de casos como formas preferenciais de preparação. A parte III identificou as percepções sobre o funcionamento do sistema de avaliação ética das pesquisas no Brasil, evidenciando a utilização das diretrizes e normas do CNS na análise dos projetos. A mais efetiva participação dos representantes de usuários e o monitoramento das pesquisas são dificuldades...
The objective of the study was to analyze the profile of the persons indicated by the research ethics institutional review boards to become members of the National Commission of Research Ethics (Comissão Nacional de Ética em Pesquisa/CONEP), considered as leaders in the research ethics evaluation system in Brazil, as to their social group representation, professional experience, experience in research ethics, views about current practices in the system and relations to formal regulations. Questionnaires were sent by mail and electronically to the 188 members of IRBs indicated as candidates in 2003 for nomination as member of CONEP, with 94 answers, representing 80% of the IRB universe at that time. The questionnaire was composed of 4 parts, with part 1 dedicated to personal characterization. The results indicated equal gender proportions, high academic qualification, and frequent participation in short courses about research and bioethics. About 50% occupied institutional positions, 18% directly related to research, and only 4% were representatives of the patients. About 90% had involvement with research in the last 10 years, a third with clinical research. Part II was dedicated to their self-evaluation as members of IRBs, revealing feelings of satisfaction and gratification with their work, and valorization of attributes such as responsibility, compromise, team work capabilities, and 89% and 85% considered themselves prepared and competent for their functions, although with differing perceptions regarding representation and political understandings about their work. Some areas present more difficulties in the analysis of the projects and meetings, seminars and case discussions were mentioned as preferential mechanisms for development. Part III identified perceptions about the functioning of the national research ethics evaluation system, and the utilization of official regulations in project analysis. A more effective participation of the patient...
