Protocol for an economic analysis of the randomised controlled trial of Improving the Well-being of people with Opioid Treated CHronic pain: I-WOTCH Study.
Protocol for an economic analysis of the randomised controlled trial of Improving the Well-being of people with Opioid Treated CHronic pain: I-WOTCH Study.
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DOI：
10.1136/bmjopen-2020-037243
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发表时间：
2020-11-20
期刊：
影响因子：
2.9
通讯作者：
I-WOTCH team
中科院分区：
文献类型：
--
作者：
Manchira Krishnan S;Gc VS;Sandhu HK;Underwood M;Eldabe S;Manca A;Iglesias Urrutia CP;I-WOTCH team
在过去的二十年里，尽管缺乏证据表明阿片类药物在缓解疼痛方面的长期有效性以及重大的、有充分记录的身体和精神不良事件，但在英国，用于治疗慢性疼痛的阿片类药物的使用稳步增加。指南建议在弊大于利的情况下逐步减少，但阿片类药物的成瘾性质阻碍了简单的剂量减少策略。改善阿片类药物治疗慢性疼痛患者的幸福感(I-WOTCH)试验测试一种旨在帮助慢性非恶性疼痛患者逐渐减少阿片类药物剂量的多成分自我管理干预措施。本文概述了I-wotch干预与最好的常规护理相比较的经济分析方法。与I-Wotch研究一起进行的经济评估，预期旨在确定、衡量和评估关键的医疗资源使用情况和正在比较的治疗策略产生的结果。将从英国国家卫生服务和个人社会服务的角度进行试验内成本-后果分析和基于模型的长期成本-效果分析。前者将量化关键参数，以填充马尔科夫模型，该模型旨在估计I-Wotch干预相对于最佳常规护理的长期成本和质量调整后的生命年。回归方程将用于估计与模型的状态和事件相关的参数，如转移概率、效用和成本。概率敏感性分析将用于评估参数不确定性对预测成本和健康结果的影响，以及由此产生的I-Wotch干预措施的物有所值评估。约克郡和亨伯-南约克郡研究伦理委员会于2016年9月13日批准了全面的伦理审查(16/YH/0325)。现行议定书：V.1.7，日期：2019年7月31日。研究结果将在同行评议的期刊、科学会议、时事通讯和网站上传播。国际标准随机对照试验编号(49 470 934)；结果前。
Over the last two decades, the use of opioids for the treatment of chronic pain in England has steadily increased despite lack of evidence of both long-term effectiveness in pain relief and significant, well-documented physical and mental adverse events. Guidelines recommend tapering when harms outweigh benefits, but the addictive nature of opioids hinders simple dose-reduction strategies. Improving the Well-being of people with Opioid Treated CHronic pain (I-WOTCH) trial tests a multicomponent self-management intervention aimed to help patients with chronic non-malignant pain taper opioid doses. This paper outlines the methods to be used for the economic analysis of the I-WOTCH intervention compared with the best usual care. Economic evaluation alongside the I-WOTCH study, prospectively designed to identify, measure and value key healthcare resource use and outcomes arising from the treatment strategies being compared. A within-trial cost-consequences analysis and a model-based long-term cost-effectiveness analysis will be conducted from the National Health Service and Personal Social Service perspective in England. The former will quantify key parameters to populate a Markov model designed to estimate the long-term cost and quality-adjusted life years of the I-WOTCH intervention against best usual care. Regression equations will be used to estimate parameters such as transition probabilities, utilities, and costs associated with the model’s states and events. Probabilistic sensitivity analysis will be used to assess the impact of parameter uncertainty onto the predicted costs and health outcomes, and the resulting value for money assessment of the I-WOTCH intervention. Full ethics approval was granted by Yorkshire & The Humber—South Yorkshire Research Ethics Committee on 13 September 2016 (16/YH/0325). Current protocol: V.1.7, date 31 July 2019. Findings will be disseminated in peer-reviewed journals, scientific conferences, newsletters and websites. International Standard Randomised Controlled Trial Number (49 470 934); Pre-result.
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影响因子：
64.3
作者：
Curtis, Helen J.;Croker, Richard;Goldacre, Ben
通讯作者：
Goldacre, Ben
影响因子：
2.4
作者：
Ikenberg, Robert;Hertel, Nadine;Liedgens, Hiltrud
通讯作者：
Liedgens, Hiltrud
CDC规定慢性疼痛的阿片类药物的指南 - 美国，2016年。
DOI：
10.1001/jama.2016.1464
发表时间：
2016-04-19
期刊：
JAMA
影响因子：
--
作者：
Dowell D;Haegerich TM;Chou R
通讯作者：
Chou R
影响因子：
3.5
作者：
Herdman, M.;Gudex, C.;Lloyd, A.;Janssen, M. F.;Kind, P.;Parkin, D.;Bonsel, G.;Badia, X.
通讯作者：
Badia, X.
影响因子：
4.4
作者：
Faria, Rita;Gomes, Manuel;Epstein, David;White, Ian R.
通讯作者：
White, Ian R.