Clinical trial NCT02179879: Development and Validation of Metrics Lumbar Labor Epidural Catheter Placement
Official title: Protocol for Development and Validation of Metrics for Conventional Lumbar Epidural Catheter Placement for Labor Analgesia in Obstetric Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Labor Pain
Keywords: labor,epidural,analgesia
Lead sponsor: Cork University Hospital
Sponsor class: OTHER
First posted: 2014-07-02
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Expertes and novice anaesthetist perfoming labor epidural analgesia

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.

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.

Eligibility 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

Primary outcomes:
measure: Construct validitiy
timeFrame: WIthin 12 months post recording epidural procedure video
Secondary outcomes:
measure: Concurrrent validity
timeFrame: within 12 months following completion of epidural video recording
measure: Interrater reliability
timeFrame: 12 months from time of aquiring the epidural video
Other outcomes:
Locations:
city: Cork,Ireland
country: Ireland
facility: Cork University Hospital
Study officials:
affiliation: Cork University Hospital
name: Karthikeyan Kallidaikurichi Srinivasan, FCARCSI,MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kallidaikurichi Srinivasan K, Gallagher A, O'Brien N, Sudir V, Barrett N, O'Connor R, Holt F, Lee P, O'Donnell B, Shorten G. Proficiency-based progression training: an 'end to end' model for decreasing error applied to achievement of effective epidural analgesia during labour: a randomised control study. BMJ Open. 2018 Oct 15;8(10):e020099. doi: 10.1136/bmjopen-2017-020099.