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. 2022 Apr 29;12(5):573.
doi: 10.3390/brainsci12050573.

Pharmacological Treatment of Pain and Agitation in Severe Dementia and Responsiveness to Change of the Italian Mobilization-Observation-Behavior-Intensity-Dementia (I-MOBID2) Pain Scale: Study Protocol

Damiana Scuteri  1   2 , Marianna Contrada  2 , Teresa Loria  3 , Paolo Tonin  2 , Giorgio Sandrini  4 , Stefano Tamburin  5 , Pierluigi Nicotera  6 , Giacinto Bagetta  1 , Maria Tiziana Corasaniti  7
Affiliations

Pharmacological Treatment of Pain and Agitation in Severe Dementia and Responsiveness to Change of the Italian Mobilization-Observation-Behavior-Intensity-Dementia (I-MOBID2) Pain Scale: Study Protocol

Damiana Scuteri et al. Brain Sci. .

Abstract

Up to 80% of Alzheimer's disease (AD) patients in nursing homes experiences chronic pain and 97% develops fluctuant neuropsychiatric symptoms (NPS). Agitation, associated with unrelieved pain, is managed through antipsychotics and may increase the risk of death. Evidence is accumulating in favor of analgesia for a safer, effective therapy of agitation. The Italian version of Mobilization-Observation-Behavior-Intensity-Dementia, I-MOBID2, recently validated in the Italian setting, shows: good scale content validity index (0.89), high construct validity (Spearman rank-order correlation Rho = 0.748), reliable internal consistency (Cronbach's α coefficient = 0.751), good-excellent inter-rater (intraclass correlation coefficient, ICC = 0.778) and test-retest (ICC = 0.902) reliability, and good inter-rater and test-retest agreement (Cohen's K = 0.744) with 5.8 min completion time. This study intends to identify the responsiveness of the I-MOBID2 based on COnsensus-based Standards for the selection of health Measurement Instruments (COSMIN) recommendations, assessing the a priori hypotheses of (1) the efficacy of painkillers administered to severe AD patients after proper pain assessment and (2) the effect of reduction of the Cohen-Mansfield Agitation Inventory (CMAI) score and of agitation rescue medications. This protocol is approved by Calabria Region Ethics Committee protocol No. 31/2017 and follows the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) guidelines.

Keywords: I-MOBID2; agitation; dementia; pain; responsiveness.

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Conflict of interest statement

The authors declare no conflict of interest.

Figures

Figure 1
Figure 1
Schedule of analgesic treatment after observational pain assessment.
See this image and copyright information in PMC

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