Recruitment, retention, and adherence of family caregivers: Lessons from a multisite trial / Reclutamiento, retención y adherencia de los cuidadores familiares: Lecciones de un ensayo clínico multi-sitio / Recrutamento, retenção e adesão de cuidadores familiares: lições de um estudo clínico multi-site

Objective. To describe the recruitment, retention of family caregivers, and adherence to a telephone based intervention evaluated in a multi-site trial and provide recommendations for the design of future studies. Methods.A descriptive study based on a secondary analysis of a multi-site clinical development in Colombia and Brazil. Recruitment was measured by the number of participants eligible and consented. Retention was assessed by the percentage of participants with outcomes data at two follow-ups. The intervention adherence was measured by the percentage of the caregiver who received the intervention. Results. Of the family caregivers assessed, 63% were eligible, and 32.9% declined to be in the study for time restriction or no interest. In Colombia, the total retention rate of caregivers was 63.4% at the first follow-up and 48% at the second follow-up, while in Brazil was Invest Educ Enferm. 2023; 41(2): e04Recruitment, retention, and adherence of family caregivers:Lessons from a multisite trialde 52.8% and 46.2%, respectively. At the end of the study, the sample comprised 28 and 70 caregivers in the intervention and control groups, respectively, for a retention rate of 47%. Of 104 family caregivers allocated to the intervention group, 42 (40.3%) received five sessions. Most reported not completing the Caregiver's Activity Diary. Conclusion.The recruitment of family caregivers, participant retention, and adherence to the telephone intervention was unsuccessful. Future studies should apply an assessment tool during the recruitment of family caregivers and replace the term "caregiver" with "care provider" in the material involved in the research; define a retention protocol before starting the study and involve family caregivers in the design of the interventions

Objetivo. Describir el reclutamiento, la retención y la adherencia de los cuidadores familiares en una intervención educativa telefónica evaluada en un ensayo multi-sitio y ofrecer recomendaciones para el diseño de futuros estudios. Métodos. Estudio descriptivo basado en un análisis secundario de un desarrollo clínico multicéntrico en Colombia y Brasil. El reclutamiento se midió por el número de participantes elegibles y que dieron su consentimiento. La retención se evaluó por el porcentaje de participantes con datos de resultados en dos seguimientos. La adherencia a la intervención se determinó por el porcentaje de cuidadores que recibieron la intervención. Resultados. De los cuidadores familiares evaluados, 63% fueron elegibles, y 32.9% declinaron participar en el estudio por restricción de tiempo o falta de interés. En Colombia, la tasa de retención total de cuidadores fue de 63.4% en el primer seguimiento y de 48% en el segundo, mientras que en Brasil fue de 52.8% y 46.2%, respectivamente. Al final del estudio, la muestra comprendía 28 y 70 cuidadores en los grupos de intervención y control, respectivamente, para una tasa de retención del 47%. De los 104 cuidadores familiares asignados al grupo de intervención, 42 (40,3%) recibieron cinco sesiones. La mayoría no completó el diario de actividades del cuidador.Conclusión. El reclutamiento de cuidadores familiares, la retención de participantes y la adherencia a la intervención telefónica no tuvieron éxito. Los estudios futuros deberían aplicar una herramienta de evaluación durante Invest Educ Enferm. 2023; 41(2): e04Leidy Johanna Rueda Díaz • Erika de Souza GuedesDiná de Almeida Lopes Monteiro da Cruzel reclutamiento de los cuidadores familiares y sustituir el término "cuidador" por "proveedor de cuidados" en el material empleado en la investigación; definir un protocolo de retención antes de iniciar el estudio e involucrar a los cuidadores familiares en el diseño de las intervenciones

Objetivo. Descrever o recrutamento, retenção e adesão de cuidadores familiares em uma intervenção telefônica avaliada num estudo clínico multi-site e oferecer recomendações para o desenho de estudos futuros. Métodos. Estudo descritivo baseado em análise secundária de um desenvolvimento clínico multicêntrico na Colômbia e no Brasil. O recrutamento foi medido pelo número de participantes elegíveis e que deram consentimento. A retenção foi avaliada pela porcentagem de participantes com dados de resultado em dois acompanhamentos. A adesão à intervenção foi determinada pela porcentagem de cuidadores que receberam a intervenção. Resultados. Dos cuidadores familiares avaliados, 63% eram elegíveis, e 32.9% se recusaram a participar do estudo por limitação de tempo ou falta de interesse. Na Colômbia, a taxa de retenção total dos cuidadores foi de 63.4% no primeiro acompanhamento e 48% no segundo, enquanto no Brasil foi de 52.8% e 46.2%, respectivamente. Ao final do estudo, a amostra foi composta por 28 e 70 cuidadores nos grupos intervenção e controle, respectivamente, para uma taxa de retenção de 47%. Dos 104 cuidadores familiares designados para o grupo de intervenção, 42 (40.3%) receberam cinco sessões. A maioria não preencheu o diário de atividades do cuidador. Conclusão. Recrutamento de cuidadores familiares, retenção de participantes e adesão à intervenção telefônica não tiveram sucesso. Estudos futuros devem aplicar uma ferramenta de avaliação durante o recrutamento de cuidadores familiares e substituir o termo 'cuidador' por 'fornecedor de cuidados' em material de pesquisa; definir um protocolo de retenção antes de iniciar o estudo e envolver os cuidadores familiares no desenho das intervenções.Descritores: caregivers; enfermagem; doença crónica; telefone; cooperação e adesão ao tratamento.

Using 2-mSv Appendiceal CT in Usual Practice for Adolescents and Young Adults: Willingness Survey of 579 Radiologists, Emergency Physicians, and Surgeons from 20 Hospitals

Trastorno de la comunicación social (pragmático) (TCS f80. 82) / Disorder of social communication (pragmatic) (TCS f80. 82)

Resumen Autores: Dra. Myriam M. Velarde IncháusteguI 1 Dr. Jorge A. Vattuone Echevarría 2 Dra.Myriam E. Gómez Velarde 3 99 La pragmática estudia el lenguaje en su relación con los usuarios y las circunstancias de la comunicación. Se hace un recuento histórico desde el Síndrome Semántico Pragmático de Rapin y Allen (1980), pasando por Bishop (2000), Trastorno Pragmático del Lenguaje (TPL), hasta el Manual Estadístico de Enfermedades Mentales, DSM-5, (2013) donde aparece una nueva categoría tipi cada como Trastorno de la Comunicación Social (Pragmático) TCS, incluida dentro de los Trastornos de la Comunicación. La DSM-5 da cuatro criterios diagnósticos para la TCS: A. Dificultades en el uso de la comunicación verbal y no verbal. B. Dificultades que causan limitaciones funcionales en la comunicación. C. Los síntomas se manifiestan en edades tempranas. D. No es atribuible a déficit sensorial, motor o neurológico. Se hace diagnóstico diferencial con otras entidades que tienen compromiso pragmático: el Trastorno por Déficit de Atención/Hiperactividad (TDAH) no muestra déficit en "relaciones sociales" ni en "comunicación no verbal". Con el Trastorno de Aprendizaje no verbal o Procedimental (TAP), el déficit pragmático es común en ambos grupos, pero en el TCS es más grave y "coherencia y comprensión" se ven más afectados. Con el Trastorno del Espectro Autista (TEA) la diferencia es que los autistas manifiestan intereses restringidos y conductas motoras estereotipadas. Se revisan las pruebas más comunes donde la prueba Children's Communication Checklist (CCC) de Bishop es una prueba útil para valorar la pragmática en los escolares, ya adaptada y validada al idioma español.

Abstract Pragmatics studies how language relates with its users and the circumstances of communication. This study is a historical account from the Pragmatic Semantic Syndrome of Rapin and Allen (1980), through Bishop (2000), Pragmatic Language Disorder (PLD), to the Statistical Manual of Mental Illnesses, DSM-5, (2013) where a new category appears and is categorized as Social (Pragmatic) Communication Disorder SCD and is included in Communication Disorders. The DSM-5 provides four diagnostic criteria for the SCD: A. Difficulties in the use of verbal and non-verbal communication. B. Difficulties that cause functional limitations in e ective communication. C. Symptoms shown at early age. D. Not attributable to sensory, motor or neurological deficit; illness, intellectual disability. Differential diagnosis with other entities that have pragmatic commitment, such as Attention Deficit Hyperactivity Disorder (ADHD), do not show a de cit in 'social relations' or in 'non-verbal communication' factors. With non-verbal or Procedural Learning Disorder (PLD), pragmatic deficit is common in both groups, but in SCD it is more severe and 'coherence and understanding' are more affected. The main difference with Autism Spectrum Disorder (ASD) is that autistic individuals exhibit restricted interests and stereotyped motor behaviors. Finally, the most common tests are reviewed where the Bishop's Children's Communication Checklist (CCC) is a useful test to evaluate pragmatics in schoolchildren, which is already adapted and validated in Spanish.

Aspectos bioéticos de la farmacogenómica en la fase clínica de desarrollo de medicamentos / Bioethical aspects of pharmacogenomics in the clinical phase of drug development

La fase clínica de desarrollo de medicamentos para el tratamiento de enfermedades multifactoriales es larga y costosa. La farmacogenómica ayuda ese proceso mediante un mejor diseño de los ensayos clínicos y la selección de los pacientes con mayor probabilidad de responder con efectividad y menos reacciones adversas a los candidatos terapéuticos. Los objetivo de la presente revisión bibliográfica es exponer las ventajas de las pruebas farmacogenómicas en los ensayos clínicos de desarrollo de medicamentos, explicar las consecuencias éticas, legales y psicosociales de su aplicación y proponer algunas medidas para contrarrestar los riesgos psicosociales. Las pruebas farmacogenómicas fueron evaluada de manera simple, múltiple y combinada y cumplieron varios objetivos y funciones en las diferentes de fases de los ensayos clínicos de medicamentos. La realización del consentimiento informado de los sujetos participantes en los ensayos clínicos y su evaluación por los Comité de Ética y Revisión, las acciones de las autoridades regulatorias nacionales, el cumplimiento de las regulaciones ministeriales en salud pública, la aplicación de los principios bioéticos internacionales y el análisis de cada dilema ético según sus particularidades, son medidas que buscaron favorecer el respeto a la dignidad, la autonomía e intimidad de los sujetos de investigación y facilitar la aplicación de la farmacogenómica en los ensayos clínicos de medicamentos.

The clinical phase in the development of drugs for the treatment of multifactorial diseases is both lengthy and costly. Pharmacogenomics aids this process by providing a better design of clinical trials as well as a selection of patients with a greater probability to effectively respond and fewer adverse reactions to therapeutic candidates. The present bibliographic review is intended to reveal the advantages of pharmacogenomic tests in clinical trials for drug development, explain the ethical, legal and psychosocial consequences of their application, and propose some measures to counteract psychosocial risks. Pharmacogenomic tests were evaluated in a simple, multiple and combined manner, and fulfilled several objectives and functions at the various phases of clinical trials of drugs. Informed consent from the subjects participating in the clinical trials and their evaluation by the Ethical Review Board, actions taken by national regulatory authorities, compliance with public health ministerial regulations, application of international bioethical principles, and analysis of each ethical dilemma according to its specific characteristics, are all measures aimed at enhancing respect for dignity, autonomy and privacy of research subjects and facilitating the application of pharmacogenomics to clinical trials of drugs.

Post-trial access to medication: an approach based on different knowledge / Acesso pós-teste à medicação: uma abordagem baseada em diferentes conhecimentos

This article approaches clinical trials to test medication in Brazil, and its goal is to analize the issue of post-trial access to drugs that have proven to be beneficial to the research participants from the ethical, sanitary, legal and of the human rights perspectives. In order to do so, a revision was conducted of the main national and international norms, including the normative documents related to human rights and judicial rulings pronounced by the national Courts. It is concluded that there have been important advances in this field, shown by the consensus that the research participants must have total access to the benefits explained in the project and, in Brazil, these benefits are particularly supported by Resolution No 466/2012 of the National Health Council, by the Resolution of the Board of Directors No 38/2013 of the National Health Surveillance Agency and by judicial rulings. Moreover, from the perspective of the human rights, it is established that denying the post-trial drug access represents a violation of the human right to health.

O presente artigo versa sobre ensaios clínicos para teste de medicamentos no Brasil, tendo como objetivo analisar o tema do acesso à droga pós-estudo que se mostrou benéfica aos participantes das pesquisas sob a perspectiva ética, sanitária, jurídica e dos direitos humanos. Para tanto, foi feita uma revisão das principais normas pertinentes nacionais e internacionais, incluindo as normativas de direitos humanos e das decisões judiciais proferidas pelos Tribunais nacionais. Conclui-se que ocorreram avanços expressivos neste campo, revelado pelo consenso de que os participantes do estudo devem ter acesso total aos benefícios explicitados no projeto. No Brasil, os participantes estão amparados, sobretudo, na Resolução No 466/2012 do Conselho Nacional de Saúde, na Resolução de Diretoria Colegiada No 38/2013 da Agência Nacional de Vigilância Sanitária e em decisões judiciais. Ainda, à luz dos direitos humanos, constata-se que a negativa do acesso à droga pós-estudo representa violação ao direito humano à saúde.

Clinicoepidemiological research designs in childhood allergic diseases

Clinical epidemiology is defined as a method for investigating the distribution and determinants of diseases and for applying this knowledge in their prevention, and simply means application of epidemiological methods for medical research. In evidence-based medicine, randomized controlled trials (RCT) are the gold standard for assessing efficacy and safety of the intervention, while it is commonly impractical because of many limitations, such as ethical/legal problems and weak external-validity. High internal-validity of RCT permits to assess the direct efficacy of intervention without interference with bias and confounder; however, it has less generalizability or applicability to the real-life practice. Evidence-based practical guidelines are developed for patient management and decision making in real-life practice; paradoxically, the evidence of the guidelines does not come from real life, but from strict trial life. To overcome these limitations, pragmatic clinical trials for assessing the effectiveness of intervention in real-life practice or high-quality observational studies would be the best alternatives or could add more strong evidence. This article provides an overview of clinicoepidemiological research designs in the field of childhood allergic diseases and their strength/weakness.

Análisis crítico de ensayos clínicos aleatorizados: Riesgo de sesgo / Critical analysis of randomized clinical trials: The risk of bias

Los ensayos clínicos aleatorizados (ECAs) presentan el nivel de investigación experimental más alto según los niveles de evidencia. Los resultados encontrados en ellos brindarán las pautas para la elección del mejor tratamiento clínico en los pacientes, es por ello la necesidad de conocer cuáles son las pautas para analizar críticamente los ECAs en la búsqueda de la precisión científica. El æRiesgo de SesgoÆ es una herramienta desarrollada por la ôCochrane Collaborationõ para evaluar la metodología de la evidencia científica siendo útil en revisiones sistemáticas para el análisis individual de los ECAs incluidos. La presente revisión busca desarrollar los conceptos del æRiesgo de SesgoÆ definiendo cada uno de sus componentes para el correcto análisis de los artículos científicos...

Randomized clinical trials (RCTs) represent the highest level of experimental research according to levels of evidence. The findings of RCTs provide guidelines for choosing the best clinical treatment. Reason why it is a need to critically assess their methodology in order to show the accuracy. æRisk of BiasÆ is a tool developed by the Cochrane Collaboration to determine the quality of evidence in systematic reviews to be reliable for the individual analysis of the included RCTs. The present review aims to present the concepts of risk bias defining each of its items for the proper assessment of scientific articles...

Experiencia en enfermería, ensayo clínico y atención a pacientes con cáncer de pulmón / Experience in nursing, clinical assay and care of patients with lung cancer

INTRODUCCIÓN: los ensayos clínicos con nuevas sustancias, como anticuerpos y vacunas han tenido un incremento debido a la necesidad de encontrar nuevas terapéuticas para el tratamiento del cáncer. En la aplicación del tratamiento el éxito depende del buen desempeño profesional, el nivel de preparación y capacitación que tenga el personal de enfermería, como parte del equipo de investigación al ejecutar un rol importante. OBJETIVO: evaluar la experiencia del personal de enfermería en este ensayo relacionado con la atención a pacientes con cáncer de pulmón. MÉTODOS: se realizó un estudio descriptivo con una revisión bibliográfica sobre el actuar, y la experiencia de enfermería en el ensayo clínico. Se evaluó la seguridad de CIMAvax®- EGF en pacientes avanzados con tumores del pulmón, de células no pequeñas y tratados en la asistencia primaria de salud. Para ello se realizó un análisis documental de la buena práctica clínica, y los protocolos de estudios sobre el tema. RESULTADOS: fueron incluidos 11 pacientes. El promedio de diagnóstico y tratamiento de pacientes, con cáncer de pulmón estuvo en 23 y 14 meses al respecto. CONCLUSIONES: enfermero (a) en su desempeño debe tener dominio del protocolo en su totalidad sobre el producto, propiedades farmacéuticas y dosis a administrar. Además, identificar las reacciones adversas que pueden presentarse y las medidas a tomar para de esta forma lograr evaluar la efectividad del nuevo producto en investigación y mitigar cualquier riesgo que influya en la calidad y excelencia de nuestros servicios de salud.

INTRODUCTION: an increase in clinical assays of new substances, such as antibodies and vaccines, has taken place in response to the need to find new cancer therapies. Success in the application of treatment depends on the good professional performance, background and training of nursing personnel, for they play an important role as research team members. OBJECTIVE: evaluate the experience of nursing personnel in an assay about the care of patients with lung cancer. METHODS: a descriptive study was conducted based on a bibliographic review of the role and experience of nurses in the clinical assay performed. The safety of CIMAvax®- EGF was evaluated in patients with advanced non-small-cell lung tumors treated at primary health care services. For this purpose a document analysis was performed about good clinical practice and study protocols about the subject. RESULTS: eleven patients were included. Average diagnosis and treatment of patients with lung cancer was 23 and 14 months, respectively. CONCLUSIONS: nurses should be thoroughly aware of the entire protocol, particularly the product, its pharmaceutical properties and the dose to administer. They should also be able to identify the potential adverse reactions and the measures to take to assess the effectiveness of the new product under research, as well as mitigate any risk affecting the quality and excellence of our health services.

Aplicabilidade do peso ideal na titulação do volume corrente em pacientes no pós-operatório imediato de cirurgia cardíaca / Applicability of ideal weight in the titration of the flow volume in immediate postoperative cardiac surgery patients

Introdução: A ventilação mecânica (VM) é indispensável nas intervençõescirúrgicas cardíacas. Porém, mesmo que por curto períodode tempo, pode causar prejuízo pulmonar, com lesões no parênquimapor excesso de pressão e/ou volume nas vias aéreas. Na titulação dovolume corrente (VC), é comum utilizar o peso real e não o pesoideal, aquele calculado baseando-se pela altura, o que poderia geraralterações gasométricas e na mecânica pulmonar. Objetivo: Comparara titulação do volume corrente pelo peso ideal e pelo peso realdurante o uso da VM no pós-operatório imediato de cirurgia cardíaca.Método: Ensaio clínico prospectivo, randomizado, realizado no períodode agosto a novembro de 2008. Pacientes de ambos os gêneros,idade entre 18 e 80 anos foram randomizados em dois grupos: peso real(PR) e peso ideal (PI) durante o pós-operatório imediato de cirurgiacardíaca, nos quais foram analisados a troca gasosa, pela gasometriarealizada no ato de admissão e 30 minutos após a mesma; e a mecânicapulmonar (pressão platô). Pacientes com acidose metabólicacom pH < 7,2 foram excluídos. A análise estatística incluiu teste denormalidade de Kolmogorov-Smirnov, teste t com p < 0,05, e testede Mann Whitney para variáveis não paramétricas. Resultados: Totalde 55 pacientes, sendo 28 no grupo PR e 25 no PI; dois pacientesexcluídos, restando 29 homens e 24 mulheres. A idade média foi de58,83 ± 11,74 anos. Os valores de pressão platô (PR: 19,29 cmH2Ovs PI: 17,12 cmH2O), pH (PR: 7,38 vs. PI: 7,32) e PCO2 (PR: 34,5mmHg vs. PI: 40,85 mmHg) foram estatisticamente significantes,com p < 0,04, p < 0,01 e p < 0,02, respectivamente. Conclusão: Usodo PR pareceu ser benéfico na população estudada quando analisadodistúrbio ácido básico; porém, o grupo PI mostrou-se melhor quantoà mecânica pulmonar.

Introduction: The mechanical ventilation (MV) is essential in cardiacsurgery. But even for a short period of time, the MV can causelung injury with parenchyma injury of pressure and/or volume inthe airways. In the titration of tidal it is common to use the actualweight rather than the ideal weight, calculated based on the height,which could generate gasometric and changes in lung mechanics.Objective: To compare the titration of the current volume by idealweight and the actual weight during the use of MV in the immediatepostoperative period of cardiac surgery. Method: Clinical prospective,randomized, carried out from August to November 2008. Patientsof both sexes, aged between 18 and 80 years, randomized into twogroups: actual weight (AW) and ideal weight (IW), in the immediatepostoperative period of cardiac surgery. The blood gas analysis wasconducted in the act of admission and 30 minutes after that. Blood gasand pressure plateau results were compared among the two groups.Patients with metabolic acidosis of pH < 7.2 were excluded. Statisticalanalysis included the test of Kolmogorov-Smirnov normality, t testwith p < 0.05, and the Mann Whitney test for non parametric variables.Results: Total 55 patients being 28 PR and 25 IP, 2 excludedpatients, 29 men and 24 women. The average age was 58.83 ± 11.74years. The values of Plateau pressure (real: 19.29 vs ideal: 17.12), pH(real: 7.38 vs ideal: 7.32) and PCO2 (real: 34.5 vs ideal: 40.85) werestatistically significant, with p < 0.04, p < 0.01 and p < 0.02, respectively.Conclusion: Using the actual weight seemed to be beneficialin the study population as compared to the ideal weight when disturbacid basic was analyzed.