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Do people prefer to take part in a clinical trial from home or come to site? A discrete choice experiment in type 2 diabetes mellitus

Por: Kopanz · J. · Lagerwaard · B. · Veldwijk · J. · Mader · J. K. · Tews · D. · van Sloten · T. T. · Grobbee · D. E. · Zuidgeest · M. G. P. · on behalf of the Trials@Home consortium
Objectives

To determine what drives participation in clinical trials with decentralised elements and to estimate trial participation probabilities for trials with different degrees of decentralisation.

Design

Patient preference study using a discrete choice experiment.

Setting

Recruitment in primary, secondary, tertiary care and other settings in the Netherlands (NL), Austria (AT) and Germany (DE).

Participants

People with type 2 diabetes mellitus (T2DM) aged ≥18 years. A total of 787 people (NL n=276, AT n=265, DE n=246) participated in the study.

Main outcome measures

Preferences for participation in clinical trials with different options for location and type of contact with the study team, activities to perform by participant, use of digital technologies by participant, number of scheduled contacts, trial duration, known safety and efficacy of the drug.

Results

How much was known about the safety and efficacy of the drug was the most important element in the decision whether to participate in a clinical trial in all countries. The trial duration, location and type of contact with the study team, and number of scheduled contacts were other important elements. Participation probabilities for hypothetical trial scenarios differed between countries, with the highest rates for a decentralised trial involving video contact (NL: 89%; AT: 99%; DE: 84%).

Conclusions

People with T2DM prefer to take part in clinical trials with decentralised approaches. Information on preferences can help trialists and protocol developers to design and plan future trials that integrate patients’ needs and thus reduce barriers to participation.

Mapping the global implementation of parent-focused infant-centred and family-centred developmental care (IFCDC) principles: a scoping review protocol

Por: Düzenli · A. · Kemper · R. · Grüger · J. · Hoffmann · J. · Hummler · H. · Mader · S. · Tischer · C.
Introduction and objectives

Infant-centred and family-centred developmental care (IFCDC) within the frame of special intensive care prioritises a holistic approach to caring for infants by addressing their developmental and emotional needs. A key principle of IFCDC is the active involvement of parents in care, which promotes better long-term outcomes for both the infant and their caregivers. This scoping review aims to examine parental satisfaction and the challenges associated with their involvement in infant care by assessing the global implementation of the IFCDC principle of parental involvement in specialised intensive care settings.

Methods and analysis

The scoping review will follow the methodological framework outlined by Khalil et al and the Joanna Briggs Institute methodology. Literature from 2014 to 2025 will be searched for relevant papers across PubMed (MEDLINE). Two reviewers will independently screen titles, abstracts and full texts, with a third reviewer resolving conflicts. Key findings and results from eligible papers will be analysed and summarised in line with the scoping review’s objectives.

Ethics and dissemination

No ethical approval is needed. We intend to submit the paper for publication and thus to present the results in a peer-reviewed journal. This scoping review is registered at OSFREGISTRIES (https://osf.io/h94qr/?view_only=a08b30a5eb3a4a3d97aeda7c6d7e157d).

Antibody development after three mRNA SARS-CoV-2 vaccinations in patients with systemic autoimmune rheumatic disease with and without treatment: an observational cohort study

Por: Simader · E. · Kartnig · F. · Tobudic · S. · Mrak · D. · Deimel · T. · Karonitsch · T. · Haslacher · H. · Perkmann · T. · Mitter · G. · Winkler · S. · Aletaha · D. · Blueml · S. · Mandl · P.
Objectives and design

To further elucidate the effects of rare systemic autoimmune rheumatic diseases (SARD) and their treatment on antibody development after vaccination against SARS-CoV-2, we compared patients with and without immunosuppressive therapy to healthy controls in an observational cohort study.

Participants and setting

We enrolled 52 patients with SARD and 72 healthy subjects in a prospective, observational study at the Medical University of Vienna and measured the humoral response 6 months after two mRNA vaccinations and 2–6 weeks after a third dose.

Results

Patients with vasculitis showed significantly (p=0.02) lower antibody titres 6 months after vaccination (median 247 BAU/mL, IQR [185–437]), as compared with healthy controls (median 514 BAU/mL, [185–437], IQR 323; 928, vasculitis patients: 247, IQR [185; 437], p

Conclusions

Patients with SARD displayed lower antibody development after booster vaccination, even if antibody levels after two immunisations were comparable to healthy controls. Our data may be limited due to sample size, but it provides pointers for a more individualised, antibody-titre-oriented approach and earlier booster vaccination in patients with SARD.

Monitorización con Índice biespectral para reducción de complicaciones asociadas a sobresedación en adultos: revisión sistemática

Objetivo: Demostrar mediante la monitorización con el índice biespectral la reducción de complicaciones asociadas a sobresedación en paciente con ventilación mecánica. Metodología: Enfermería basada en evidencia. Traducción a lenguaje científico DeCS y MeSH. Fuentes documentales: Epistemonikos, PUBMED, ELSEVIER, DOAJ y Google académico. Operador booleano AND, OR y NOT. Lectura critica mediante FLC 3.0. Jerarquización con Scottish Intercollegiate Guidelines Network (SIGN). Resultados: Ocho de 10 artículos demuestran reducción de eventos adversos, 5 de 10 artículos indican reducción de dosis empleadas y administradas de sedantes, también una fuerte evidencia de la precisión para valorar el nivel de sedación y reducción de la incidencia de la sedación. Se necesitan más estudios. Conclusión: La monitorización con índice Biespectral tiene un índice de especificidad más objetivo que escalas de sedación comúnmente usadas y demostró que reduce complicaciones asociadas a la sobresedación. Se requieren más estudios.

Terapia de masaje como adyuvante en el tratamiento con fototerapia para disminuir la bilirrubina neonatal

Objetivo principal: Analizar la evidencia científica sobre la fototerapia convencional vs la fototerapia con terapia de masaje para la disminución de los niveles de bilirrubina en neonatos a término (37 a 42 SDG) con hiperbilirrubinemia > 5 mg/dL en la terapia intensiva neonatal. Metodología: Enfermería Basada en Evidencia. Bases de datos consultadas: Google académico, PubMed. Elaboración de tablas con los Descriptores en Ciencias de la Salud (DeCS). La lectura crítica se realizó usando CASPe y el nivel de evidencia de acuerdo al Centre for Evidence-Based Medicine, Oxford. Resultados principales: Doce artículos describen que la terapia de masaje aumenta la actividad vagal, dando como resultado una mayor motilidad gástrica y una disminución más rápida de los niveles de bilirrubina. Conclusión principal: la terapia de masaje es una intervención complementaria efectiva durante la fototerapia para reducir los niveles de bilirrubina neonatal.

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