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Impact of individualized pharmaceutical care on efficacy and safety of opioid-tolerant outpatients with cancer pain: a multicenter randomized controlled trial

BACKGROUND: Managing cancer pain is a growing challenge. Individualized pharmaceutical care is particularly important for opioid-tolerant outpatients due to variation in terms of their knowledge about pain, treatment adherence, and risk of experiencing inadequate analgesia and severe adverse events....

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Autores principales: Ding, Haiying, Song, Yu, Wu, Nan, Zheng, Xiaowei, Wei, Qing, Sun, Yancai, Xie, Ruixiang, Zhai, Qing, Xu, Silu, Qi, Yajun, Wang, Yinghong, Li, Hui, Yang, Lin, Fan, Qing, Zhao, Qiuling, Chen, Juan, Shi, Jing, Duan, Cunxian, Du, Qiong, Zhang, Yiwen, Song, Zhengbo, Fu, Shuang, Cai, Yunfang, Huang, Xianhong, Fang, Luo, Liu, Yuguo, Huang, Ping
Formato: Online Artículo Texto
Lenguaje:English
Publicado: AME Publishing Company 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9577747/
https://www.ncbi.nlm.nih.gov/pubmed/36267757
http://dx.doi.org/10.21037/atm-22-4091
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author Ding, Haiying
Song, Yu
Wu, Nan
Zheng, Xiaowei
Wei, Qing
Sun, Yancai
Xie, Ruixiang
Zhai, Qing
Xu, Silu
Qi, Yajun
Wang, Yinghong
Li, Hui
Yang, Lin
Fan, Qing
Zhao, Qiuling
Chen, Juan
Shi, Jing
Duan, Cunxian
Du, Qiong
Zhang, Yiwen
Song, Zhengbo
Fu, Shuang
Cai, Yunfang
Huang, Xianhong
Fang, Luo
Liu, Yuguo
Huang, Ping
author_facet Ding, Haiying
Song, Yu
Wu, Nan
Zheng, Xiaowei
Wei, Qing
Sun, Yancai
Xie, Ruixiang
Zhai, Qing
Xu, Silu
Qi, Yajun
Wang, Yinghong
Li, Hui
Yang, Lin
Fan, Qing
Zhao, Qiuling
Chen, Juan
Shi, Jing
Duan, Cunxian
Du, Qiong
Zhang, Yiwen
Song, Zhengbo
Fu, Shuang
Cai, Yunfang
Huang, Xianhong
Fang, Luo
Liu, Yuguo
Huang, Ping
author_sort Ding, Haiying
collection PubMed
description BACKGROUND: Managing cancer pain is a growing challenge. Individualized pharmaceutical care is particularly important for opioid-tolerant outpatients due to variation in terms of their knowledge about pain, treatment adherence, and risk of experiencing inadequate analgesia and severe adverse events. This study aimed to determine the influence of individualized pharmaceutical care on outcomes in opioid-tolerant outpatients with cancer pain. METHODS: A multicenter, open-label, randomized, controlled study was carried out. Opioid-tolerant outpatients experiencing chronic cancer pain and receiving sustained-release opioids were randomly assigned to the intervention group and the control group with a 1:1 ratio. The intervention group received individualized pharmaceutical care, while the control group received conventional care during 4-week period. The primary endpoint was medication adherence on the intention-to-treat (ITT) population. Secondary outcomes included the patients’ knowledge of cancer pain and pain medications, pain score, frequency of breakthrough pain, quality of life (QoL) which were assessed on the ITT population. Adverse events were evaluated according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Event (CTCAE) version 4.0 on the per-protocol (PP) population. RESULTS: A total of 118 patients were enrolled, and 102 patients (51 in each group) completed the 30-day follow-up from six oncology centers in China. The proportion of patients adhering to opioid medication increased to similar levels in the two groups during the 4 weeks (P=0.149). The intervention group had a significantly lower pain score at 4 weeks compared to the control group (P=0.015), and the proportion of participants without breakthrough pain was significantly higher at 4 weeks than at baseline in the intervention group (P=0.029), but not in the control group (P=0.322). The two groups did not differ significantly in terms of QoL or adverse events. CONCLUSIONS: Our results suggest that individualized pharmaceutical care can markedly reduce patient-related problems and significantly improve pain control in opioid-tolerant outpatients. These findings validate the recommendations to include clinical pharmacists in the management of cancer pain. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT03439904.
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spelling pubmed-95777472022-10-19 Impact of individualized pharmaceutical care on efficacy and safety of opioid-tolerant outpatients with cancer pain: a multicenter randomized controlled trial Ding, Haiying Song, Yu Wu, Nan Zheng, Xiaowei Wei, Qing Sun, Yancai Xie, Ruixiang Zhai, Qing Xu, Silu Qi, Yajun Wang, Yinghong Li, Hui Yang, Lin Fan, Qing Zhao, Qiuling Chen, Juan Shi, Jing Duan, Cunxian Du, Qiong Zhang, Yiwen Song, Zhengbo Fu, Shuang Cai, Yunfang Huang, Xianhong Fang, Luo Liu, Yuguo Huang, Ping Ann Transl Med Original Article BACKGROUND: Managing cancer pain is a growing challenge. Individualized pharmaceutical care is particularly important for opioid-tolerant outpatients due to variation in terms of their knowledge about pain, treatment adherence, and risk of experiencing inadequate analgesia and severe adverse events. This study aimed to determine the influence of individualized pharmaceutical care on outcomes in opioid-tolerant outpatients with cancer pain. METHODS: A multicenter, open-label, randomized, controlled study was carried out. Opioid-tolerant outpatients experiencing chronic cancer pain and receiving sustained-release opioids were randomly assigned to the intervention group and the control group with a 1:1 ratio. The intervention group received individualized pharmaceutical care, while the control group received conventional care during 4-week period. The primary endpoint was medication adherence on the intention-to-treat (ITT) population. Secondary outcomes included the patients’ knowledge of cancer pain and pain medications, pain score, frequency of breakthrough pain, quality of life (QoL) which were assessed on the ITT population. Adverse events were evaluated according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Event (CTCAE) version 4.0 on the per-protocol (PP) population. RESULTS: A total of 118 patients were enrolled, and 102 patients (51 in each group) completed the 30-day follow-up from six oncology centers in China. The proportion of patients adhering to opioid medication increased to similar levels in the two groups during the 4 weeks (P=0.149). The intervention group had a significantly lower pain score at 4 weeks compared to the control group (P=0.015), and the proportion of participants without breakthrough pain was significantly higher at 4 weeks than at baseline in the intervention group (P=0.029), but not in the control group (P=0.322). The two groups did not differ significantly in terms of QoL or adverse events. CONCLUSIONS: Our results suggest that individualized pharmaceutical care can markedly reduce patient-related problems and significantly improve pain control in opioid-tolerant outpatients. These findings validate the recommendations to include clinical pharmacists in the management of cancer pain. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT03439904. AME Publishing Company 2022-09 /pmc/articles/PMC9577747/ /pubmed/36267757 http://dx.doi.org/10.21037/atm-22-4091 Text en 2022 Annals of Translational Medicine. All rights reserved. https://creativecommons.org/licenses/by-nc-nd/4.0/Open Access Statement: This is an Open Access article distributed in accordance with the Creative Commons Attribution-NonCommercial-NoDerivs 4.0 International License (CC BY-NC-ND 4.0), which permits the non-commercial replication and distribution of the article with the strict proviso that no changes or edits are made and the original work is properly cited (including links to both the formal publication through the relevant DOI and the license). See: https://creativecommons.org/licenses/by-nc-nd/4.0 (https://creativecommons.org/licenses/by-nc-nd/4.0/) .
spellingShingle Original Article
Ding, Haiying
Song, Yu
Wu, Nan
Zheng, Xiaowei
Wei, Qing
Sun, Yancai
Xie, Ruixiang
Zhai, Qing
Xu, Silu
Qi, Yajun
Wang, Yinghong
Li, Hui
Yang, Lin
Fan, Qing
Zhao, Qiuling
Chen, Juan
Shi, Jing
Duan, Cunxian
Du, Qiong
Zhang, Yiwen
Song, Zhengbo
Fu, Shuang
Cai, Yunfang
Huang, Xianhong
Fang, Luo
Liu, Yuguo
Huang, Ping
Impact of individualized pharmaceutical care on efficacy and safety of opioid-tolerant outpatients with cancer pain: a multicenter randomized controlled trial
title Impact of individualized pharmaceutical care on efficacy and safety of opioid-tolerant outpatients with cancer pain: a multicenter randomized controlled trial
title_full Impact of individualized pharmaceutical care on efficacy and safety of opioid-tolerant outpatients with cancer pain: a multicenter randomized controlled trial
title_fullStr Impact of individualized pharmaceutical care on efficacy and safety of opioid-tolerant outpatients with cancer pain: a multicenter randomized controlled trial
title_full_unstemmed Impact of individualized pharmaceutical care on efficacy and safety of opioid-tolerant outpatients with cancer pain: a multicenter randomized controlled trial
title_short Impact of individualized pharmaceutical care on efficacy and safety of opioid-tolerant outpatients with cancer pain: a multicenter randomized controlled trial
title_sort impact of individualized pharmaceutical care on efficacy and safety of opioid-tolerant outpatients with cancer pain: a multicenter randomized controlled trial
topic Original Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9577747/
https://www.ncbi.nlm.nih.gov/pubmed/36267757
http://dx.doi.org/10.21037/atm-22-4091
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