RESUMO
BACKGROUND: The demand for clinical trial participants is today one of the highest it has ever been and continues to increase. At the same time, subject recruitment continues to be problematic and the major reason for clinical trial premature terminations. The literature on clinical trial recruitment, which spans several decades and includes hundreds of studies, has an abundance of findings that can be synthesized by way of an overview to provide a well-informed and complete picture of the factors that determine subject participation. OBJECTIVES: An overview of the systematic reviews that report barriers and facilitators to clinical trial participation was conducted. The extracted data were synthesized, and a thematic framework of the factors that affect subject participation in clinical trials was developed. The overview extended across medical subjects and demographics. METHODS: Thirty reviews that complied with the inclusion criteria were included. These reviews covered 753 relevant primary studies and reported 881 barriers and facilitators. The barriers and facilitators were thematically synthesized and a thematic framework of 20 themes was developed. The quality of the included reviews was assessed and reported. MAIN RESULTS: Several opportunities to increase clinical trial participation, by developing interventions and changing the trial design, derived from an analysis of the thematic framework. That analysis also showed that most of the 20 themes operate mainly as a barrier or as a facilitator, and that most have an effect across medical subjects. As to the quality elements assessed, some reviews complied almost fully but most only partially.
RESUMO
The difficulty to keep our patients' skin intact combined with few articles on this topic in pediatrics led the authors to carry out a study in their Pediatrics Intensive Care Unit "UCIP" at the Central University Hospital of Asturias, HUCA. The objective of this study consisted in determining if a decrease in the appearance of bed sores in children checked into their unit after a program whose purpose was to prevent bed sores had been applied occurred. This retrospective/prospective, comparative, observational study dealt with patients checked in their UCIP from September 2004 to September 2007; patients were broken into two groups, before and after applying a protocol and comparing the following variables: the number of patients checked in during each of the periods of this study; patients who had bed sores; average time kept in this ward for each group; pathologies patients who suffered from bed sores had when checked into this ward; the site and degree of these bed sores. Although there was an increase in the number of patients checked into this unit, the number of bed sores among children in this unit decreased 24.6% during the second period after the application of the protocol. Among the study observations noted there was a reduction in the severity of lesions patients manifested, as well as important differences as to where their lesions were located. Based on the results of the authors' study, one may conclude that the measures included in the bed sore prevention protocol, as well as the use of Mepentol hyperoxygenated fatty acids, have proven effective in their UCIP leading to a decrease in the number of patients which evidenced bed sores and the severity of these lesions was much less.
Assuntos
Unidades de Terapia Intensiva Pediátrica , Úlcera por Pressão/prevenção & controle , Criança , Pré-Escolar , Feminino , Humanos , Lactente , Masculino , Avaliação de Programas e Projetos de Saúde , Estudos Prospectivos , Estudos RetrospectivosRESUMO
La dificultad para mantener íntegra la piel de nuestros pacientes y la poca literatura al respecto en pediatría nos llevó a realizar un estudio en nuestra Unidad de Cuidados Intensivos Pediátricos (UCIP) del Hospital Univer-sitario Central de Asturias (HUCA). El objetivo consiste en determinar si se produjo una disminución en la aparición de Úlceras por Presión (UPP) en los niños ingresados en nuestra unidad después de la aplicación de un programa destinado a la prevención de las mismas. Se trata de un estudio retrospectivo/prospectivo, comparativo, ob-servacional de los pacientes ingresados en el periodo comprendido entre el mes de septiembre de 2004 y septiembre de 2007, separándolos en dos grupos, antes y después de la implantación de un protocolo y comparando las siguientes variables: número de pacientes ingresados en cada uno de los dos periodos a estudio; pacientes que presentaron UPP; edad media de cada grupo; estancia media de cada grupo; patologías de ingreso de los pacientes en los que aparecen dichas heridas; localización y grado de las mismas. Aunque se produjo un aumento del número de pacientes ingresados, descendió en un 24,6% la incidencia de aparición en los niños en el segundo periodo tras la aplicación del protocolo. También se constató una disminución de la severidad de las lesiones presentes, así como diferencias importantes en cuanto a sus localizaciones. A tenor de los resultados de nuestra evaluación se puede concluir que las medidas incluidas en el protocolo de prevención como el uso de los ácidos grasos hiperoxigenados (Mepentol®), han sido efectivas en nuestra unidad, con una disminución en el número de pacientes que las presentaron y la gravedad de las lesiones fue mucho menor(AU)
The difficulty to keep our patients skin intact combined with few articles on this topic in pediatrics led the authors to carry out a study in their Pediatrics Intensive Care Unit «UCIP» at the Central University Hospital of Asturias, HUCA. The objective of this study consisted in determining if a decrease in the appearance of bed sores in children checked into their unit after a program whose purpose was to prevent bed sores had been applied occurred. This retrospective/prospective, comparative, observational study dealt with patients checked in their UCIP from September 2004 to September 2007; patients were broken into two groups, before and after applying a protocol and comparing the following variables: the number of patients checked in during each of the periods of this study; patients who had bed sores; average time kept in this ward for each group; pathologies patients who suffered from bed sores had when checked into this ward; the site and degree of these bed sores. Although there was an increase in the number of patients checked into this unit, the number of bed sores among children in this unit decreased 24.6% during the second period after the application of the protocol. Among the study observations noted there was a reduction in the severity of lesions patients manifested, as well as important differences as to where their lesions were located. Based on the results of the authors' study, one may conclude that the measures included in the bed sore prevention protocol, as well as the use of Mepentol® hyperoxygenated fatty acids, have proven effective in their UCIP leading to a decrease in the number of patients which evidenced bed sores and the severity of these lesions was much less(AU)
