Walter Ling, Vijay R Nadipelli, Caitlyn T Solem, David Farabee, Naoko A Ronquest, Brian Perrochet, Susan M Learned, Chinmay G Deshpande, Christian Heidbreder
{"title":"测量阿片类药物使用障碍的恢复:治疗效果评估的临床效用和心理测量学特性。","authors":"Walter Ling, Vijay R Nadipelli, Caitlyn T Solem, David Farabee, Naoko A Ronquest, Brian Perrochet, Susan M Learned, Chinmay G Deshpande, Christian Heidbreder","doi":"10.2147/SAR.S198361","DOIUrl":null,"url":null,"abstract":"<p><p><b>Purpose:</b> The Treatment Effectiveness Assessment (TEA) is a patient-centered instrument for evaluating treatment progress and recovery from substance use disorders, including opioid use disorder (OUD). We assessed the TEA's reliability and validity and determined minimal clinically important differences (MIDs) in participants with moderate to severe OUD. <b>Patients and methods:</b> The TEA measures change in four single-item domains (substance use, health, lifestyle, community involvement) from treatment initiation across the duration of a treatment program. Self-reported responses range from 1 (\"none or not much\") to 10 (\"much better\") with items summed to a total score ranging from 4-40. We assessed floor and ceiling effects, internal consistency, test-retest reliability, known-groups validity (ANOVA stratified by current health status [36-Item Short Form Health Survey item 1]), convergent/divergent validity, and MIDs using data from a phase 3, open-label clinical trial of buprenorphine extended-release monthly injection for subcutaneous use (BUP-XR). Participants with OUD completed the TEA at screening and before monthly injections for up to 12 months. <b>Results:</b> Among 410 participants (mean age 38 years; 64% male), the mean baseline (pre-injection 1) TEA total score was 25.4 (SD 9.7), with <10% of participants at the measure floor and 10%-20% at the ceiling across domains. Internal consistency was high (Cronbach's α=0.90), with marginal test-retest reliability (intraclass correlation coefficient =0.69). Mean TEA total score consistently increased from baseline (n=410; mean 25.4 [SD 9.7]) to end of study (n=337; 35.0 [6.7]) and differentiated between current health status groups (<i>P</i><0.001); it was weakly correlated with other measures of health-related quality of life/severity. MIDs ranged from 5-8 for the TEA total score across anchor- and distribution-based approaches. <b>Conclusion:</b> The TEA exhibited acceptable reliability and validity in a cohort of participants with moderate to severe OUD treated with BUP-XR. Given its brevity and psychometric properties, the TEA is a promising tool for use in clinical practice and research.</p>","PeriodicalId":22060,"journal":{"name":"Substance Abuse and Rehabilitation","volume":"10 ","pages":"13-21"},"PeriodicalIF":5.1000,"publicationDate":"2019-06-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2147/SAR.S198361","citationCount":"2","resultStr":"{\"title\":\"Measuring recovery in opioid use disorder: clinical utility and psychometric properties of the Treatment Effectiveness Assessment.\",\"authors\":\"Walter Ling, Vijay R Nadipelli, Caitlyn T Solem, David Farabee, Naoko A Ronquest, Brian Perrochet, Susan M Learned, Chinmay G Deshpande, Christian Heidbreder\",\"doi\":\"10.2147/SAR.S198361\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><p><b>Purpose:</b> The Treatment Effectiveness Assessment (TEA) is a patient-centered instrument for evaluating treatment progress and recovery from substance use disorders, including opioid use disorder (OUD). We assessed the TEA's reliability and validity and determined minimal clinically important differences (MIDs) in participants with moderate to severe OUD. <b>Patients and methods:</b> The TEA measures change in four single-item domains (substance use, health, lifestyle, community involvement) from treatment initiation across the duration of a treatment program. Self-reported responses range from 1 (\\\"none or not much\\\") to 10 (\\\"much better\\\") with items summed to a total score ranging from 4-40. We assessed floor and ceiling effects, internal consistency, test-retest reliability, known-groups validity (ANOVA stratified by current health status [36-Item Short Form Health Survey item 1]), convergent/divergent validity, and MIDs using data from a phase 3, open-label clinical trial of buprenorphine extended-release monthly injection for subcutaneous use (BUP-XR). Participants with OUD completed the TEA at screening and before monthly injections for up to 12 months. <b>Results:</b> Among 410 participants (mean age 38 years; 64% male), the mean baseline (pre-injection 1) TEA total score was 25.4 (SD 9.7), with <10% of participants at the measure floor and 10%-20% at the ceiling across domains. Internal consistency was high (Cronbach's α=0.90), with marginal test-retest reliability (intraclass correlation coefficient =0.69). Mean TEA total score consistently increased from baseline (n=410; mean 25.4 [SD 9.7]) to end of study (n=337; 35.0 [6.7]) and differentiated between current health status groups (<i>P</i><0.001); it was weakly correlated with other measures of health-related quality of life/severity. MIDs ranged from 5-8 for the TEA total score across anchor- and distribution-based approaches. <b>Conclusion:</b> The TEA exhibited acceptable reliability and validity in a cohort of participants with moderate to severe OUD treated with BUP-XR. 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引用次数: 2
摘要
目的:治疗效果评估(TEA)是一种以患者为中心的评估药物使用障碍(包括阿片类药物使用障碍(OUD))治疗进展和恢复的工具。我们评估了TEA的可靠性和有效性,并确定了中度至重度OUD参与者的最小临床重要差异(MIDs)。患者和方法:TEA测量从治疗开始到整个治疗过程中四个单项领域(物质使用、健康、生活方式、社区参与)的变化。自我报告的回答范围从1(“没有或不多”)到10(“好多了”),各个项目的总分在4-40之间。我们评估了地板效应和上限效应、内部一致性、测试-重测信度、已知组效度(按当前健康状况分层的方差分析[36-Item Short Form health Survey item 1])、趋同/发散效度,以及使用丁丙诺啡每月皮下注射缓释(BUP-XR)的3期开放临床试验数据的mid。患有OUD的参与者在筛查时和每月注射前完成TEA长达12个月。结果:410名参与者(平均年龄38岁;平均基线(注射前1)TEA总分为25.4 (SD 9.7), p < 0.05。结论:TEA在BUP-XR治疗的中重度OUD患者队列中显示出可接受的信度和效度。由于其简洁和心理测量的特性,TEA在临床实践和研究中是一个很有前途的工具。
Measuring recovery in opioid use disorder: clinical utility and psychometric properties of the Treatment Effectiveness Assessment.
Purpose: The Treatment Effectiveness Assessment (TEA) is a patient-centered instrument for evaluating treatment progress and recovery from substance use disorders, including opioid use disorder (OUD). We assessed the TEA's reliability and validity and determined minimal clinically important differences (MIDs) in participants with moderate to severe OUD. Patients and methods: The TEA measures change in four single-item domains (substance use, health, lifestyle, community involvement) from treatment initiation across the duration of a treatment program. Self-reported responses range from 1 ("none or not much") to 10 ("much better") with items summed to a total score ranging from 4-40. We assessed floor and ceiling effects, internal consistency, test-retest reliability, known-groups validity (ANOVA stratified by current health status [36-Item Short Form Health Survey item 1]), convergent/divergent validity, and MIDs using data from a phase 3, open-label clinical trial of buprenorphine extended-release monthly injection for subcutaneous use (BUP-XR). Participants with OUD completed the TEA at screening and before monthly injections for up to 12 months. Results: Among 410 participants (mean age 38 years; 64% male), the mean baseline (pre-injection 1) TEA total score was 25.4 (SD 9.7), with <10% of participants at the measure floor and 10%-20% at the ceiling across domains. Internal consistency was high (Cronbach's α=0.90), with marginal test-retest reliability (intraclass correlation coefficient =0.69). Mean TEA total score consistently increased from baseline (n=410; mean 25.4 [SD 9.7]) to end of study (n=337; 35.0 [6.7]) and differentiated between current health status groups (P<0.001); it was weakly correlated with other measures of health-related quality of life/severity. MIDs ranged from 5-8 for the TEA total score across anchor- and distribution-based approaches. Conclusion: The TEA exhibited acceptable reliability and validity in a cohort of participants with moderate to severe OUD treated with BUP-XR. Given its brevity and psychometric properties, the TEA is a promising tool for use in clinical practice and research.