适用于获得性脑损伤患者的疼痛行为指标量表的效度和信度：ESCID-DC研究方案

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

作者信息

López-López Candelas, Latorre-Marco Ignacio, Pérez-Pérez Teresa, Sarabia-Cobo Carmen María, Solís-Muñoz Montserrat, Sánchez-Sánchez María Del Mar, Arranz-Esteban Antonio, Frade-Mera María Jesús, Temprano-Vázquez Susana, Robleda-Font Gemma

机构信息

Emergency and Trauma Intensive Care Unit, Hospital Universitario 12 de OctubreMadrid, Madrid, Spain.

Care Research Group (InveCuid), Instituto de Investigación Sanitaria 12 de Octubre University Hospital (imas12), Madrid, Spain.

出版信息

J Adv Nurs. 2025 Aug;81(8):5143-5150. doi: 10.1111/jan.16983. Epub 2025 Apr 18.

DOI:10.1111/jan.16983

PMID:40249752

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.

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.

摘要

目的

调整并验证疼痛行为指标量表（ESCID），用于无法自我报告的获得性脑损伤且有人工气道的重症患者（ESCID-DC）。

设计

对脑损伤疼痛行为指标量表（ESCID-DC）进行多中心、前瞻性、观察性验证研究。

方法

该研究将分三个阶段进行，具体如下：（1）由一组专家通过德尔菲技术进行内容开发和内容效度评估。通过预试验评估表面效度；（2）在西班牙17家医院对大量患者（≥300例）进行新量表（ESCID-DC）的多中心验证研究。每个中心的两名盲法观察者将使用ESCID-DC和参考量表NCS-R-I（适用于插管患者的修订版伤害性昏迷量表）评估疼痛行为。将在三个时间点评估疼痛：进行疼痛和非疼痛操作前5分钟、操作期间和操作后15分钟；（3）量表的心理测量评估将包括信度分析、效度分析（结构效度、收敛效度和区分效度）以及变化敏感性分析。