Cargando…
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
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...
Autores principales: | , , , , , , , , |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
MDPI
2022
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9139373/ https://www.ncbi.nlm.nih.gov/pubmed/35624960 http://dx.doi.org/10.3390/brainsci12050573 |
_version_ | 1784714844477325312 |
---|---|
author | Scuteri, Damiana Contrada, Marianna Loria, Teresa Tonin, Paolo Sandrini, Giorgio Tamburin, Stefano Nicotera, Pierluigi Bagetta, Giacinto Corasaniti, Maria Tiziana |
author_facet | Scuteri, Damiana Contrada, Marianna Loria, Teresa Tonin, Paolo Sandrini, Giorgio Tamburin, Stefano Nicotera, Pierluigi Bagetta, Giacinto Corasaniti, Maria Tiziana |
author_sort | Scuteri, Damiana |
collection | PubMed |
description | 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. |
format | Online Article Text |
id | pubmed-9139373 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | MDPI |
record_format | MEDLINE/PubMed |
spelling | pubmed-91393732022-05-28 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 Scuteri, Damiana Contrada, Marianna Loria, Teresa Tonin, Paolo Sandrini, Giorgio Tamburin, Stefano Nicotera, Pierluigi Bagetta, Giacinto Corasaniti, Maria Tiziana Brain Sci Study Protocol 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. MDPI 2022-04-29 /pmc/articles/PMC9139373/ /pubmed/35624960 http://dx.doi.org/10.3390/brainsci12050573 Text en © 2022 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/). |
spellingShingle | Study Protocol Scuteri, Damiana Contrada, Marianna Loria, Teresa Tonin, Paolo Sandrini, Giorgio Tamburin, Stefano Nicotera, Pierluigi Bagetta, Giacinto Corasaniti, Maria Tiziana 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 |
title | 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 |
title_full | 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 |
title_fullStr | 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 |
title_full_unstemmed | 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 |
title_short | 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 |
title_sort | 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 |
topic | Study Protocol |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9139373/ https://www.ncbi.nlm.nih.gov/pubmed/35624960 http://dx.doi.org/10.3390/brainsci12050573 |
work_keys_str_mv | AT scuteridamiana pharmacologicaltreatmentofpainandagitationinseveredementiaandresponsivenesstochangeoftheitalianmobilizationobservationbehaviorintensitydementiaimobid2painscalestudyprotocol AT contradamarianna pharmacologicaltreatmentofpainandagitationinseveredementiaandresponsivenesstochangeoftheitalianmobilizationobservationbehaviorintensitydementiaimobid2painscalestudyprotocol AT loriateresa pharmacologicaltreatmentofpainandagitationinseveredementiaandresponsivenesstochangeoftheitalianmobilizationobservationbehaviorintensitydementiaimobid2painscalestudyprotocol AT toninpaolo pharmacologicaltreatmentofpainandagitationinseveredementiaandresponsivenesstochangeoftheitalianmobilizationobservationbehaviorintensitydementiaimobid2painscalestudyprotocol AT sandrinigiorgio pharmacologicaltreatmentofpainandagitationinseveredementiaandresponsivenesstochangeoftheitalianmobilizationobservationbehaviorintensitydementiaimobid2painscalestudyprotocol AT tamburinstefano pharmacologicaltreatmentofpainandagitationinseveredementiaandresponsivenesstochangeoftheitalianmobilizationobservationbehaviorintensitydementiaimobid2painscalestudyprotocol AT nicoterapierluigi pharmacologicaltreatmentofpainandagitationinseveredementiaandresponsivenesstochangeoftheitalianmobilizationobservationbehaviorintensitydementiaimobid2painscalestudyprotocol AT bagettagiacinto pharmacologicaltreatmentofpainandagitationinseveredementiaandresponsivenesstochangeoftheitalianmobilizationobservationbehaviorintensitydementiaimobid2painscalestudyprotocol AT corasanitimariatiziana pharmacologicaltreatmentofpainandagitationinseveredementiaandresponsivenesstochangeoftheitalianmobilizationobservationbehaviorintensitydementiaimobid2painscalestudyprotocol |