- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02179879
Development and Validation of Metrics Lumbar Labor Epidural Catheter Placement
Protocol for Development and Validation of Metrics for Conventional Lumbar Epidural Catheter Placement for Labor Analgesia in Obstetric Patients
Procedural skills play an important role in anaesthetic expertise. More focused training and assessment of procedural skills will be needed in the future as training moves from an apprenticeship based training system to competency based assessment.
Currently various techniques exists to assess procedural skills of anaesthetist. For epidural catheter placement, task specific check list, global rating scales and cumulative sum techniques have been developed and validated. These techniques aim either for better qualitative outcome sacrificing objectivity or rely on self-reporting. A decrease in objectivity in turn hampers inter-rater reliability which is an essential component of a valid assessment model. Checklists type assessments force the developer to comprehensively characterize the procedure of interest and then validate the completed procedure characterization. This approach has been quantitatively shown to have higher assessment reliability levels compared to Likert-scale assessment.
The objective of the project is to develop and validate a comprehensive procedure characterization for labor epidural catheter placement. Another objective is to compare this new assessment tool with existing checklist and global rating scale for labor epidural to establish concurrent validity.5 A well-developed objective, validated procedure characterization serves as a master tool which has multiple applications. It helps to build a training programme for the procedure, allows providing metrics based feedback to trainees using simulator, helps to assess the performance of trainees and in future might be used as benchmark to allow competency based progression in the training.
Descripción general del estudio
Descripción detallada
Study part 1 After ethics committee approval a group of experts (n = 3 ) in conventional lumbar epidural catheter placement will be selected (an expert is defined as one who has performed more than 500 labor epidurals in preceding 5 year period). During a number of face-to-face meetings experts will identify, characterize and define the procedure. They will analyze task and identify units of behavior to be measured which constitute in a step-wise fashion how the procedure is optimally performed and deviations from optimal procedure performance as described previously. After informed consent from the patient and the anaesthetist performing the procedure, 2 video recordings of experts performing epidural and 2 video recordings of novices (defined as one who has done less than 50 epidurals) performing epidural will be recorded for detailed review during metric development meetings.
Study part 2 The developed metrics will be subjected to assessments of construct validity (a set of procedures for evaluating a testing instrument based on a degree to which the test terms identify the quality, ability or trait it was designed to measure) and concurrent validity (the evaluation in which the relationship between the test scores and the scores on the another instrument purporting to measure the same construct are related). We will also evaluated the inter-rater reliability of the metrics using i) proportion of agreement between raters, ii) correlation strength (using Pearson's Correlation Coefficient) and iii) Coefficient Alpha. After informed consent,10 experts (who are not a part of committee developing the metrics) each performing one or more lumbar epidural catheter placements for labor and 10 novices each performing one or more lumbar epidural catheter placements for labor will be video recorded. Two experts will review the video recording and score the performance based on checklist based system developed and compare with likert-scale checklists/global rating scale system.
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
-
Cork,Ireland, Irlanda
- Cork University Hospital
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- an expert is defined as one who has performed more than 500 labor epidurals in preceding 5 year period
- novice (defined as one who has done less than 50 epidurals in previous 2 years)
Exclusion Criteria:
- Non consenting anaesthetist
- Patients not consenting for video recording
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: Grupo
- Perspectivas temporales: Futuro
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
|
Video validation group
This will include video taping of experts (defined as one who has performed more than 500 labor epidurals in preceding 5 year period) and novices (defined as one who has done less than 50 epidurals in preceeding 2 years) perfoming labor epidural
|
Video taping of anaesthetist (experts and novices) perfoming labor epidural.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Construct validitiy
Periodo de tiempo: WIthin 12 months post recording epidural procedure video
|
a set of procedures for evaluating a testing instrument based on a degree to which the test terms identify the quality, ability or trait it was designed to measure.In our study we aim to see if the metrics developed will be able to differentiate between experts and novices in performing the porcedure
|
WIthin 12 months post recording epidural procedure video
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Concurrrent validity
Periodo de tiempo: within 12 months following completion of epidural video recording
|
Concurrent validity is defined as a set of procedures for evaluating a testing instrument based on a degree to which the test terms identify the quality, ability or trait it was designed to measure.We aim to compare the interrater reliability of the metrics with compare with likert-scale checklists/global rating scale system developed already for the procedure.
|
within 12 months following completion of epidural video recording
|
|
Interrater reliability
Periodo de tiempo: 12 months from time of aquiring the epidural video
|
We will evaluate the inter-rater reliability of the metrics using i) proportion of agreement between raters, ii) correlation strength (using Pearson's Correlation Coefficient) and iii) Coefficient Alpha
|
12 months from time of aquiring the epidural video
|
Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- ECM4(U)01/10/13
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
producto fabricado y exportado desde los EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .