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Development and Validation of Metrics Lumbar Labor Epidural Catheter Placement

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ClinicalTrials.gov Identifier: NCT02179879
Recruitment Status : Completed
First Posted : July 2, 2014
Last Update Posted : August 28, 2015
Sponsor:
Information provided by (Responsible Party):
Karthikeyan Kallidaikurichi Srinivasan, Cork University Hospital

Brief Summary:

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.


Condition or disease Intervention/treatment
Labor Pain Other: Video validation

Detailed Description:

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.

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Study Type : Observational
Actual Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Protocol for Development and Validation of Metrics for Conventional Lumbar Epidural Catheter Placement for Labor Analgesia in Obstetric Patients
Study Start Date : November 2013
Actual Primary Completion Date : July 2014
Actual Study Completion Date : July 2014

Group/Cohort Intervention/treatment
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
Other: Video validation
Video taping of anaesthetist (experts and novices) perfoming labor epidural.




Primary Outcome Measures :
  1. Construct validitiy [ Time Frame: 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


Secondary Outcome Measures :
  1. Concurrrent validity [ Time Frame: 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.

  2. Interrater reliability [ Time Frame: 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



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Expertes and novice anaesthetist perfoming labor epidural analgesia
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02179879


Locations
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Ireland
Cork University Hospital
Cork,Ireland, Ireland
Sponsors and Collaborators
Cork University Hospital
Investigators
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Principal Investigator: Karthikeyan Kallidaikurichi Srinivasan, FCARCSI,MD Cork University Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Karthikeyan Kallidaikurichi Srinivasan, Specialist Registrar,Anaesthetics,Cork University Hospital, Cork University Hospital
ClinicalTrials.gov Identifier: NCT02179879    
Other Study ID Numbers: ECM4(U)01/10/13
First Posted: July 2, 2014    Key Record Dates
Last Update Posted: August 28, 2015
Last Verified: August 2015
Keywords provided by Karthikeyan Kallidaikurichi Srinivasan, Cork University Hospital:
labor,epidural,analgesia
Additional relevant MeSH terms:
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Labor Pain
Pain
Neurologic Manifestations