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International trials can be challenging to operationalise due to incompatibilities between country-specific policies and infrastructures. The aim of this systematic review was to identify the operational complexities of conducting international trials and identify potential solutions for overcoming them.
Systematic review.
Medline, Embase and Health Management Information Consortium were searched from 2006 to 30 January 2023.
All studies reporting operational challenges (eg, site selection, trial management, intervention management, data management) of conducting international trials were included.
Search results were independently screened by at least two reviewers and data were extracted into a proforma.
38 studies (35 RCTs, 2 reports and 1 qualitative study) fulfilled the inclusion criteria. The median sample size was 1202 (IQR 332–4056) and median number of sites was 40 (IQR 13–78). 88.6% of studies had an academic sponsor and 80% were funded through government sources. Operational complexities were particularly reported during trial set-up due to lack of harmonisation in regulatory approvals and in relation to sponsorship structure, with associated budgetary impacts. Additional challenges included site selection, staff training, lengthy contract negotiations, site monitoring, communication, trial oversight, recruitment, data management, drug procurement and distribution, pharmacy involvement and biospecimen processing and transport.
International collaborative trials are valuable in cases where recruitment may be difficult, diversifying participation and applicability. However, multiple operational and regulatory challenges are encountered when implementing a trial in multiple countries. Careful planning and communication between trials units and investigators, with an emphasis on establishing adequately resourced cross-border sponsorship structures and regulatory approvals, may help to overcome these barriers and realise the benefits of the approach.
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Malnutrition, sedentary lifestyle, cognitive dysfunction and poor psychological well-being are often reported in patients on haemodialysis (HD).
We aimed to explore needs, barriers and facilitators—as perceived by patients, their carers, and healthcare professionals (HCPs) for increasing the adherence to the diet, to physical activity and cognition and psychological well-being.
This is an observational cross-sectional study following the STROBE statement. This study is part of an ERASMUS+ project, GoodRENal—aiming to develop digital tools as an educational approach to patients on HD. For that, the GoodRENal comprises HD centers located in four Belgium, Greece, Spain and Sweden. Exploratory questionnaires were developed regarding the perceived needs, barriers and facilitators regarding the diet, physical activity, cognition and psychological well-being from the perspective of patients, their carers and HCPs.
In total, 38 patients, 34 carers and 38 HCPs were included. Nutrition: For patients and carers, the main needs to adhere to the diet included learning more about nutrients and minerals. For patients, the main barrier was not being able to eat what they like. Physical activity: As needs it was reported information about type of appropriate physical activity, while fatigue was listed as the main barrier. For Cognitive and emotional state, it was perceived as positive for patients and carers perception but not for HCPs. The HCPs identified as needs working as a team, having access to specialised HCP and being able to talk to patients in private.
Patients and their carers listed as needs guidance regarding nutrition and physical activity but were positive with their cognitive and emotional state. The HCPs corroborated these needs and emphasised the importance of teamwork and expert support.
Se presenta el caso clínico de una recién nacida de 3 días de vida que acude a la consulta enfermera de pediatría de Atención Primaria para realizar la primera visita, incluida en el Programa de Salud del Niño Sano. En ella, la madre describe que, durante su ingreso en la maternidad, tras el parto, manifestó su deseo de no lactar, por tanto, se prescribió Cabergolina como fármaco inhibidor. Sin embargo, actualmente, desearía reiniciar la lactancia materna. Tras realizar la valoración enfermera por patrones funcionales de Marjory Gordon, se detectaron dos patrones alterados y se estableció un plan de cuidados individualizado, utilizando la taxonomina NANDA-NOC-NIC.
Paciente de 5 años con diagnóstico de neuroblastoma abdominal metastásico de alto grado desde 2022, acude a la unidad de trasplante infantil para someterse a megaterapia con Busulfan y Melfalan como tratamiento mieloabrasivo, con posterior rescate mediante trasplante autólogo de progenitores hematopoyético (TPH). Tras realizar la valoración enfermera por patrones de M. Gordon en dos momentos, al ingreso y tras el trasplante, se detectó la alteración de 6 patrones y se estableció un plan de cuidados individualizado, que incluye al paciente y a la cuidadora principal, empleándola taxonomía NANDA-NOC-NIC.
Las fases avanzadas de insuficiencia renal crónica adquieren criterios de enfermedad terminal, siendo necesario tratamiento sustitutivo renal.
Objetivo: Analizar el impacto de la hemodiálisis en la calidad de vida de los pacientes con Insuficiencia Renal Crónica. Metodología: Estudio descriptivo transversal de calidad de vida en 102 pacientes del servicio de hemodiálisis del Hospital San Juan de Dios de Zaragoza a través de los cuestionarios SF-36 y KDQOL. Resultados: Existe un detrimento de calidad vida en las dimensiones de rol físico, salud general, rol emocional, función cognitiva, relaciones sociales y situación laboral. Conclusión: Los pacientes en tratamiento de hemodiálisis ven modificada su calidad de vida en relación a las variables sociodemográficas (sexo, edad, situación laboral y estado civil) y clínicas (tipo de acceso vascular, duración del tratamiento, tiempo con el tratamiento y presencia de comorbilidades).
Objetivo principal: Comprobar la existencia de evidencia científica que avale o rechace el uso de sedantes/hipnoticos en pacientes que sufren apnea del sueño y usan una máquina de presión positiva continua en la vía aérea (CPAP) domiciliaria. Metodología: Revisión bibliográfica. Resultados principales: No existen estudios actuales con un buen nivel de evidencia que demuestren que el uso de hipnoticos/sedantes perjudique a los pacientes que usan CPAP. Conclusión principal: Sería beneficioso recomendar a los pacientes usuarios de CPAP que presenten problemas de insomnio el uso de hipnoticos/sedantes, siempre bajo prescripción médica y tras valoración del resto de patologías.
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