Validity and Reliability of the Behavioural Indicators of Pain Scale Adapted to Patients With Acquired Brain Injury: ESCID-DC Study Protocol.

AIM: To adapt and validate the Behavioural Indicators of Pain Scale (ESCID) for use in critically ill patients with acquired brain injury and artificial airway who are unable to self-report (ESCID-DC).

DESIGN

Multicentre, prospective, observational validation study of the Behavioural Indicators of Pain Scale-Brain Injury (ESCID-DC).

METHODS

The study will be carried out in three phases, as follows: (1) Content development and evaluation of content validity by a group of experts (Delphi technique). Face validity will be assessed through a pilot study; (2) multicentre validation study of the new scale (ESCID-DC) in a large sample of patients (≥ 300) at 17 hospitals in Spain. Two blinded observers at each centre will assess painful behaviours using the ESCID-DC and a reference scale, the NCS-R-I (Nociception Coma Scale-Revised-adapted for Intubated patients). Pain will be assessed at three time points: 5 min before, during and 15 min after the performance of painful and non-painful procedures; (3) the psychometric evaluation of the scale will consist of a reliability analysis, a validity analysis (construct, convergent and discriminant), and a sensitivity to change analysis.

DISCUSSION: The ESCID-DC scale will provide specific, adapted behavioural indicators to detect the presence of pain in this patient population.

IMPACT: Given the high prevalence of pain in critically ill patients, the availability of a new instrument to detect and monitor pain behaviours associated with routine ICU procedures will allow clinicians to reliably assess pain and implement preventive strategies in a highly vulnerable patient population.

REPORTING METHOD: The report of this study protocol followed the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement guidelines and Consensus-based Standards for the selection of health Measurement Instruments (COSMIN) guidelines and standards.

PATIENT OR PUBLIC CONTRIBUTION: This study did not receive any patient or public contributions.

TRIAL REGISTRATION: The protocol is registered with ClinicalTrials.gov: NCT04898491, available at: https://classic.

CLINICALTRIALS: gov/ct2/show/NCT04898491.