Validity and reliability of Italian version of the Non-Communicating Children's Pain Checklist: revised version.

Background: The Non-Communicating Children Pain Check List-Revised (NCCPC-R) is a clinical assessment tool used to assess and measure pain in children aged 3 to 18 years, with mental and intellectual disabilities, incapable to speak.
Aim: Aim of our study was to test the validity and reliability of the Italian version of the NCCPC-R in children with cognitive impairment, in order to obtain a valid tool for pain assessment in these children.
Design: Prospective observational study.
Setting: Pediatric Outpatient of Physical and Rehabilitative Medicine Department, and Pediatrics, Child Neurology and Psychiatry Department, Sapienza University, Rome.
Population: 55 non-communicating children, with severe intellectual disability, aged 3-18 years.
Methods: The guidelines for "translation, adaptation, and validation of instruments or scales for cross-cultural healthcare research" were used to translate the scale, which was administered by the parents/caregivers twice for 2 consecutive days, in association with NRS (Numerical Rating Scale). The reliability of the scale was evaluated using the intra and inter-class correlation coefficient (ICCs); Cronbach alpha coefficient was used to test the internal validity of the scale; "Receiver Operating Characteristic" (ROC) curves were used to compare pain-free scores with pain scores, determining threshold scores; Pearson correlation between NCCPC-R and NRS values was measured.
Results: The InterCC between the first and the second interviewer at T0 was 0,97, the IntraCC of the first interviewer at T0-T1 was 0,89, showing a high correlation; the Cronbach alpha coefficient at T0 was 0,97, showing a high scale's validity. Pearson correlation between NRS and NCCPC-R values at T0 was 0,54 showing a medium level of agreement (P<0,0001). AUC (area under the curve) obtained by ROC curve at T0 was 0,807 (P=0,001), with sensitivity 95,2 and specificity 55,6, while a T1 AUC was 0,814 (P<0,001), with sensitivity 86,49, specificity 78,57.
Conclusions: The Italian version of NCCPC-R scale could be used to asses pain in non-communicating patients with mental and intellectual disabilities, showing a good correlation when compared to the NRS.
Clinical Rehabilitation Impact: The use of NCCPC-R scale in daily life made parents/caregivers able to discriminate the presence/absence of pain in non-communicating children, based on the scores obtained with the questionnaire.