Abstract: 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.

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