首页 > 最新文献

Pain Medicine最新文献

英文 中文
The Q2-Approach for Percutaneous Peripheral Neuromodulation Stimulator Implant Targeting C2 Dorsal Root Ganglion at C2 Lamina for Treating Intractable Headache: A Technical Note. 针对 C2 背根神经节的经皮外周神经调控刺激器植入治疗顽固性头痛的 Q2 方法:技术说明。
IF 2.9 3区 医学 Q1 ANESTHESIOLOGY Pub Date : 2024-11-09 DOI: 10.1093/pm/pnae113
QiLiang Chen, Xiang Qian

Objectives: Despite significant medical treatment advancements, interventional treatments for intractable headache disorders are limited. This study's objective is to detail a novel percutaneous approach ("Q2-approach") and its technical considerations for implanting peripheral neuromodulation stimulators (PNS) to the C2 dorsal root ganglion (C2-DRG) at C2 lamina, a previously unattempted target, as a treatment for intractable headache.

Design and methods: In an outpatient setting, PNS electrodes could be percutaneously implanted at C2-DRG in patients under moderate sedation using combined ultrasound and fluoroscopic guidance. The final electrode position was determined by intraoperative patient feedback to ensure optimal stimulation. Four patients were included to demonstrate technical parameters and feasibility. Follow-ups were conducted on postoperative days 10, 30, 60, and 100-120.

Results: The Q2-approach allows safe C2-DRG PNS implants in an outpatient setting. Average operative duration was <60 minutes. All four patients achieved >50% pain relief during the 60-day implant period and 3/4 demonstrated sustained benefit beyond the implant period. No complications (e.g., lead migration or infection) were observed.

Conclusions: The current technical note demonstrated the feasibility of a novel, safe, minimally invasive approach to access C2-DRG at the C2 lamina for the treatment of intractable headaches. The utilization of PNS on C2-DRG fills an important gap in headache management as it provides an alternative neuromodulation treatment modality to the existing destruction/denervation-based techniques.

目的:尽管在医学治疗方面取得了重大进展,但针对顽固性头痛疾病的介入治疗方法仍然有限。本研究的目的是详细介绍一种新型经皮方法("Q2-方法")及其技术考虑因素,用于将外周神经调控刺激器(PNS)植入 C2 背根神经节(C2-DRG)的 C2 层,这是一种以前从未尝试过的治疗顽固性头痛的靶点:在门诊环境中,利用超声波和透视联合引导,可在患者中度镇静状态下经皮将 PNS 电极植入 C2-DRG。电极的最终位置由术中患者反馈决定,以确保最佳刺激效果。共纳入了四名患者,以展示技术参数和可行性。术后第 10、30、60 和 100-120 天进行了随访:结果:Q2-方法允许在门诊环境中安全植入C2-DRG PNS。在 60 天的植入期间,平均手术持续时间为疼痛缓解 50%,3/4 的患者在植入期后仍能持续获益。未观察到并发症(如导线移位或感染):目前的技术说明证明了一种新型、安全、微创方法的可行性,即在 C2 层接入 C2-DRG 治疗顽固性头痛。在 C2-DRG 上使用 PNS 填补了头痛治疗中的一个重要空白,因为它为现有的基于破坏/神经支配的技术提供了另一种神经调节治疗模式。
{"title":"The Q2-Approach for Percutaneous Peripheral Neuromodulation Stimulator Implant Targeting C2 Dorsal Root Ganglion at C2 Lamina for Treating Intractable Headache: A Technical Note.","authors":"QiLiang Chen, Xiang Qian","doi":"10.1093/pm/pnae113","DOIUrl":"https://doi.org/10.1093/pm/pnae113","url":null,"abstract":"<p><strong>Objectives: </strong>Despite significant medical treatment advancements, interventional treatments for intractable headache disorders are limited. This study's objective is to detail a novel percutaneous approach (\"Q2-approach\") and its technical considerations for implanting peripheral neuromodulation stimulators (PNS) to the C2 dorsal root ganglion (C2-DRG) at C2 lamina, a previously unattempted target, as a treatment for intractable headache.</p><p><strong>Design and methods: </strong>In an outpatient setting, PNS electrodes could be percutaneously implanted at C2-DRG in patients under moderate sedation using combined ultrasound and fluoroscopic guidance. The final electrode position was determined by intraoperative patient feedback to ensure optimal stimulation. Four patients were included to demonstrate technical parameters and feasibility. Follow-ups were conducted on postoperative days 10, 30, 60, and 100-120.</p><p><strong>Results: </strong>The Q2-approach allows safe C2-DRG PNS implants in an outpatient setting. Average operative duration was <60 minutes. All four patients achieved >50% pain relief during the 60-day implant period and 3/4 demonstrated sustained benefit beyond the implant period. No complications (e.g., lead migration or infection) were observed.</p><p><strong>Conclusions: </strong>The current technical note demonstrated the feasibility of a novel, safe, minimally invasive approach to access C2-DRG at the C2 lamina for the treatment of intractable headaches. The utilization of PNS on C2-DRG fills an important gap in headache management as it provides an alternative neuromodulation treatment modality to the existing destruction/denervation-based techniques.</p>","PeriodicalId":19744,"journal":{"name":"Pain Medicine","volume":" ","pages":""},"PeriodicalIF":2.9,"publicationDate":"2024-11-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142625674","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
The Intersectionality of Chronic Pain Stigma and Racial Discrimination in Black and White Adults with Chronic Low Back Pain. 患有慢性腰痛的黑人和白人成年人的慢性疼痛耻辱感与种族歧视的交叉性》(The Intersectionality of Chronic Pain Stigma and Racial Discrimination in Black and White Adults with Chronic Low Back Pain.
IF 2.9 3区 医学 Q1 ANESTHESIOLOGY Pub Date : 2024-11-09 DOI: 10.1093/pm/pnae114
Jenna M Wilson, Staja Q Booker, Burel R Goodin, Pavithra A Thomas, Robert E Sorge, Tammie L Quinn, Matthew C Morris, Edwin N Aroke, Samantha M Meints

Objective: We examined the intersection between chronic pain stigma and racial discrimination, separately among Black and White U.S. adults with chronic low back pain.

Methods: Participants completed measures of chronic pain stigma, lifetime experiences of racial discrimination, pain severity and interference. A composite variable representing the intersectionality of stigma and discrimination was created, and Black and White participants were separately categorized into 4 groups. Black participants were categorized as: 1) high discrimination/high stigma, 2) high discrimination/low stigma, 3) low discrimination/high stigma, and 4) low discrimination/low stigma. White participants were categorized as: 1) any discrimination/high stigma, 2) any discrimination/low stigma, 3) no discrimination/high stigma, and 4) no discrimination/low stigma.

Results: Black participants reported more frequent experiences of racial discrimination than White participants (p<.05), but there was not a racial difference in chronic pain stigma (p>.05). Among Black participants, those in the high discrimination/high stigma and low discrimination/high stigma groups reported greater pain severity and interference than those in the high discrimination/low stigma and low discrimination/low stigma groups (p<.05). Among White participants, those in the any discrimination/high stigma group reported greater pain severity and interference than those in the no discrimination/low stigma group (p<.05), but there were no differences in pain severity or interference between the any discrimination/no stigma and no discrimination/high stigma groups (p>.05).

Conclusion: Our findings suggest that the relationship of intersectional chronic pain stigma and racial discrimination with pain is nuanced and differs across racial groups.

目的我们分别研究了患有慢性腰背痛的美国黑人和白人成年人的慢性疼痛耻辱感与种族歧视之间的交叉关系:受试者完成了对慢性疼痛耻辱感、一生遭受种族歧视的经历、疼痛严重程度和干扰程度的测量。我们创建了一个代表耻辱感和歧视交叉性的综合变量,并将黑人和白人参与者分别分为 4 组。黑人参与者被分为1)高歧视/高耻辱化;2)高歧视/低耻辱化;3)低歧视/高耻辱化;4)低歧视/低耻辱化。白人参与者被分为1) 任何歧视/高度成见,2) 任何歧视/低度成见,3) 无歧视/高度成见,4) 无歧视/低度成见:黑人参与者比白人参与者更频繁地遭受种族歧视(P.05)。在黑人参与者中,高歧视/高成见组和低歧视/高成见组的参与者比高歧视/低成见组和低歧视/低成见组的参与者报告的疼痛严重程度和干扰程度更高(P.05):我们的研究结果表明,交叉性慢性疼痛烙印和种族歧视与疼痛的关系是微妙的,并且在不同种族群体之间存在差异。
{"title":"The Intersectionality of Chronic Pain Stigma and Racial Discrimination in Black and White Adults with Chronic Low Back Pain.","authors":"Jenna M Wilson, Staja Q Booker, Burel R Goodin, Pavithra A Thomas, Robert E Sorge, Tammie L Quinn, Matthew C Morris, Edwin N Aroke, Samantha M Meints","doi":"10.1093/pm/pnae114","DOIUrl":"https://doi.org/10.1093/pm/pnae114","url":null,"abstract":"<p><strong>Objective: </strong>We examined the intersection between chronic pain stigma and racial discrimination, separately among Black and White U.S. adults with chronic low back pain.</p><p><strong>Methods: </strong>Participants completed measures of chronic pain stigma, lifetime experiences of racial discrimination, pain severity and interference. A composite variable representing the intersectionality of stigma and discrimination was created, and Black and White participants were separately categorized into 4 groups. Black participants were categorized as: 1) high discrimination/high stigma, 2) high discrimination/low stigma, 3) low discrimination/high stigma, and 4) low discrimination/low stigma. White participants were categorized as: 1) any discrimination/high stigma, 2) any discrimination/low stigma, 3) no discrimination/high stigma, and 4) no discrimination/low stigma.</p><p><strong>Results: </strong>Black participants reported more frequent experiences of racial discrimination than White participants (p<.05), but there was not a racial difference in chronic pain stigma (p>.05). Among Black participants, those in the high discrimination/high stigma and low discrimination/high stigma groups reported greater pain severity and interference than those in the high discrimination/low stigma and low discrimination/low stigma groups (p<.05). Among White participants, those in the any discrimination/high stigma group reported greater pain severity and interference than those in the no discrimination/low stigma group (p<.05), but there were no differences in pain severity or interference between the any discrimination/no stigma and no discrimination/high stigma groups (p>.05).</p><p><strong>Conclusion: </strong>Our findings suggest that the relationship of intersectional chronic pain stigma and racial discrimination with pain is nuanced and differs across racial groups.</p>","PeriodicalId":19744,"journal":{"name":"Pain Medicine","volume":" ","pages":""},"PeriodicalIF":2.9,"publicationDate":"2024-11-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142625672","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Evaluation of a novel nerve ablation technique to relieve lower back pain: A cadaveric feasibility pilot study. 评估缓解下背痛的新型神经消融技术:尸体可行性试验研究。
IF 2.9 3区 医学 Q1 ANESTHESIOLOGY Pub Date : 2024-11-06 DOI: 10.1093/pm/pnae112
Charlotte Jones-Whitehead, John Tran, Timothy D Wilson, Eldon Loh

Introduction: Radiofrequency ablation is a treatment for facetogenic low back pain that targets medial branches of lumbar dorsal rami to denervate facet joints. Clinical outcomes vary; optimizing cannula placement to better capture the medial branch may improve clinical outcomes. A novel parasagittal technique was proposed from an anatomical model; this technique was proposed to optimize capture of the medial branch. The anatomical feasibility of the novel technique has not been evaluated.

Objective: To simulate and evaluate the proposed parasagittal technique in its ability to achieve proper cannula placement, and proximity of uninsulated cannula tips to the medial branches of the dorsal rami in cadaveric specimens.

Materials and methods: Under fluoroscopic guidance, 14 cannulae were placed using the parasagittal technique targeting the lumbar medial branches of two cadavers. Meticulous dissection was undertaken to assess cannula alignment and measure proximities to target nerves using a digital caliper.

Results: The novel parasagittal technique was successfully performed in a cadaveric model in 12/14 attempts. The technique achieved close proximity of cannula tips to medial branches (0.8 ± 1.1 mm). In two instances cannulae were placed unsuccessfully, where one cannula was too far anterior, the other too far retracted.

Conclusion: In this cadaveric simulation study, the feasibility of performing the parasagittal technique for lumbar radiofrequency ablation was evaluated. This study suggests the parasagittal technique is a feasible option for lumbar medial branch radiofrequency ablation.

简介射频消融术是一种治疗面源性腰痛的方法,它以腰椎背侧肌内侧支为靶点,使面神经关节失去支配。临床疗效各不相同;优化插管位置以更好地捕捉内侧分支可能会改善临床疗效。根据解剖模型提出了一种新颖的矢状面技术;该技术旨在优化对内侧支的捕捉。尚未对该新型技术的解剖可行性进行评估:目的:模拟并评估拟议的副矢状位技术在尸体标本中实现正确插管位置以及未绝缘插管尖端接近背侧嵴内侧支的能力:在荧光透视引导下,针对两具尸体的腰椎内侧支,使用矢状体技术放置了 14 个插管。进行了细致的解剖,以评估插管的对齐情况,并使用数字卡尺测量目标神经的近端:结果:新颖的矢状旁技术在尸体模型上成功实施了 12/14 次。该技术实现了插管尖端与内侧分支的接近(0.8 ± 1.1 毫米)。有两次插管放置不成功,其中一个插管太靠前,另一个太靠后:在这项尸体模拟研究中,对腰椎射频消融术中采用矢状旁技术的可行性进行了评估。这项研究表明,椎旁技术是腰椎内侧支射频消融术的可行方案。
{"title":"Evaluation of a novel nerve ablation technique to relieve lower back pain: A cadaveric feasibility pilot study.","authors":"Charlotte Jones-Whitehead, John Tran, Timothy D Wilson, Eldon Loh","doi":"10.1093/pm/pnae112","DOIUrl":"https://doi.org/10.1093/pm/pnae112","url":null,"abstract":"<p><strong>Introduction: </strong>Radiofrequency ablation is a treatment for facetogenic low back pain that targets medial branches of lumbar dorsal rami to denervate facet joints. Clinical outcomes vary; optimizing cannula placement to better capture the medial branch may improve clinical outcomes. A novel parasagittal technique was proposed from an anatomical model; this technique was proposed to optimize capture of the medial branch. The anatomical feasibility of the novel technique has not been evaluated.</p><p><strong>Objective: </strong>To simulate and evaluate the proposed parasagittal technique in its ability to achieve proper cannula placement, and proximity of uninsulated cannula tips to the medial branches of the dorsal rami in cadaveric specimens.</p><p><strong>Materials and methods: </strong>Under fluoroscopic guidance, 14 cannulae were placed using the parasagittal technique targeting the lumbar medial branches of two cadavers. Meticulous dissection was undertaken to assess cannula alignment and measure proximities to target nerves using a digital caliper.</p><p><strong>Results: </strong>The novel parasagittal technique was successfully performed in a cadaveric model in 12/14 attempts. The technique achieved close proximity of cannula tips to medial branches (0.8 ± 1.1 mm). In two instances cannulae were placed unsuccessfully, where one cannula was too far anterior, the other too far retracted.</p><p><strong>Conclusion: </strong>In this cadaveric simulation study, the feasibility of performing the parasagittal technique for lumbar radiofrequency ablation was evaluated. This study suggests the parasagittal technique is a feasible option for lumbar medial branch radiofrequency ablation.</p>","PeriodicalId":19744,"journal":{"name":"Pain Medicine","volume":" ","pages":""},"PeriodicalIF":2.9,"publicationDate":"2024-11-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142590714","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Single Arm Feasibility Trial of a Mobile Application for Adolescent Migraine Management. 青少年偏头痛管理移动应用单臂可行性试验
IF 2.9 3区 医学 Q1 ANESTHESIOLOGY Pub Date : 2024-11-05 DOI: 10.1093/pm/pnae111
Amy E Noser, Abigail S Robbertz, James Peugh, Marielle Kabbouche, Joanne Kacperski, Scott W Powers, Andrew D Hershey, Kevin A Hommel
{"title":"Single Arm Feasibility Trial of a Mobile Application for Adolescent Migraine Management.","authors":"Amy E Noser, Abigail S Robbertz, James Peugh, Marielle Kabbouche, Joanne Kacperski, Scott W Powers, Andrew D Hershey, Kevin A Hommel","doi":"10.1093/pm/pnae111","DOIUrl":"https://doi.org/10.1093/pm/pnae111","url":null,"abstract":"","PeriodicalId":19744,"journal":{"name":"Pain Medicine","volume":" ","pages":""},"PeriodicalIF":2.9,"publicationDate":"2024-11-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142581895","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
The NIH Pain Common Data Elements: A Great Start but a Long Way to the Finish Line. 美国国立卫生研究院疼痛通用数据元素:良好的开端,但距离终点还有很长的路要走。
IF 2.9 3区 医学 Q1 ANESTHESIOLOGY Pub Date : 2024-11-04 DOI: 10.1093/pm/pnae110
Meredith C B Adams, Afton L Hassett, Daniel J Clauw, Robert W Hurley

Background: The NIH Pain Common Data Elements (CDEs) provide a standardized framework for pain research, but their implementation and interpretation present challenges.

Objectives: To review the NIH CDE Program's selected pain domains, provide best practices for implementing required questions, and offer a checklist for appropriate CDE use in clinical trials and secondary data analysis.

Methods: This work analyzed the ten core pain research domains selected by the NIH CDE Program and discuss their limitations and considerations for use.

Results: The manuscript provides an overview of the ten core pain research domains, including pain intensity, interference, physical function, sleep, catastrophizing, depression, anxiety, global impression of change, substance use screening, and quality of life. It offers sample scenarios for implementing required questions and presents a checklist to guide researchers in using pain CDEs effectively for clinical trials and secondary data analysis.

Discussion: Key challenges identified include contextual variability, lack of validation across all pain conditions and populations, and potential misuse or misinterpretation of measures. This work proposes solutions such as supplementary measures, context-specific guidance, comprehensive training programs, and ongoing refinement of the CDE framework.

Conclusion: While NIH Pain CDEs are valuable tools for standardizing pain assessment in research, addressing challenges in their implementation and interpretation is crucial for improving the consistency, validity, and interpretability of pain research data, ultimately advancing the field and enhancing patient care.

背景:美国国立卫生研究院(NIH)疼痛通用数据元素(CDE)为疼痛研究提供了一个标准化框架,但其实施和解释却面临挑战:回顾美国国立卫生研究院 CDE 计划选定的疼痛领域,提供实施所需问题的最佳实践,并提供一份在临床试验和二次数据分析中适当使用 CDE 的核对表:这项工作分析了美国国立卫生研究院 CDE 计划选定的十个核心疼痛研究领域,并讨论了其局限性和使用时的注意事项:手稿概述了十个核心疼痛研究领域,包括疼痛强度、干扰、身体功能、睡眠、灾难化、抑郁、焦虑、总体变化印象、药物使用筛查和生活质量。该报告提供了实施所需问题的示例方案,并提供了一份核对表,以指导研究人员在临床试验和二次数据分析中有效使用疼痛 CDE:讨论:已确定的主要挑战包括环境的可变性、缺乏对所有疼痛状况和人群的验证,以及对测量方法的潜在误用或误解。这项工作提出了一些解决方案,如补充措施、针对具体情况的指导、综合培训计划以及 CDE 框架的不断完善:尽管 NIH 疼痛 CDE 是研究中标准化疼痛评估的宝贵工具,但解决其实施和解释中的挑战对于提高疼痛研究数据的一致性、有效性和可解释性至关重要,最终将推动该领域的发展并加强对患者的护理。
{"title":"The NIH Pain Common Data Elements: A Great Start but a Long Way to the Finish Line.","authors":"Meredith C B Adams, Afton L Hassett, Daniel J Clauw, Robert W Hurley","doi":"10.1093/pm/pnae110","DOIUrl":"https://doi.org/10.1093/pm/pnae110","url":null,"abstract":"<p><strong>Background: </strong>The NIH Pain Common Data Elements (CDEs) provide a standardized framework for pain research, but their implementation and interpretation present challenges.</p><p><strong>Objectives: </strong>To review the NIH CDE Program's selected pain domains, provide best practices for implementing required questions, and offer a checklist for appropriate CDE use in clinical trials and secondary data analysis.</p><p><strong>Methods: </strong>This work analyzed the ten core pain research domains selected by the NIH CDE Program and discuss their limitations and considerations for use.</p><p><strong>Results: </strong>The manuscript provides an overview of the ten core pain research domains, including pain intensity, interference, physical function, sleep, catastrophizing, depression, anxiety, global impression of change, substance use screening, and quality of life. It offers sample scenarios for implementing required questions and presents a checklist to guide researchers in using pain CDEs effectively for clinical trials and secondary data analysis.</p><p><strong>Discussion: </strong>Key challenges identified include contextual variability, lack of validation across all pain conditions and populations, and potential misuse or misinterpretation of measures. This work proposes solutions such as supplementary measures, context-specific guidance, comprehensive training programs, and ongoing refinement of the CDE framework.</p><p><strong>Conclusion: </strong>While NIH Pain CDEs are valuable tools for standardizing pain assessment in research, addressing challenges in their implementation and interpretation is crucial for improving the consistency, validity, and interpretability of pain research data, ultimately advancing the field and enhancing patient care.</p>","PeriodicalId":19744,"journal":{"name":"Pain Medicine","volume":" ","pages":""},"PeriodicalIF":2.9,"publicationDate":"2024-11-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142569227","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Utility of the PICOTS framework to assess clinical trial disruptions: monitoring the impact of COVID-19 in the Pain Management Collaboratory. 评估临床试验中断的 PICOTS 框架的实用性:监测 COVID-19 在疼痛管理合作组织中的影响。
IF 2.9 3区 医学 Q1 ANESTHESIOLOGY Pub Date : 2024-11-01 DOI: 10.1093/pm/pnae078
Peter Peduzzi, Cynthia Brandt, Christopher L Dearth, James Dziura, Shawn Farrokhi, Steven Z George, Tassos C Kyriakides, Cynthia R Long, Edward J Mascha, Charity G Patterson, Daniel I Rhon, Robert D Kerns

Objective: Despite careful design of clinical trials, unforeseen disruptions can arise. The PICOTS (Patient population, Intervention, Comparator, Outcomes, Timepoints, Setting) framework was used to assess disruptions in pain management research imposed by coronavirus disease 2019 (COVID-19) within the Pain Management Collaboratory.

Methods: Rapid qualitative methods were employed to identify trial disruptions due to COVID-19 in 11 pragmatic clinical trials of nonpharmacological approaches for pain management. The PICOTS framework was applied by investigators of 4 Collaboratory trials selected to cover 4 types of trial designs (individually randomized, stepped-wedge, cluster, sequential multiple assignment randomized trial-SMART). Interviews with the lead investigators of these trials were completed, and findings were presented/discussed on video calls over a 6-month period (March-August 2021) from which themes/lessons learned were identified and consensus reached.

Results: Investigators indicated that patient populations remained generally stable. A major COVID-19 trial disruption was moving from in-person to virtual care affecting delivery of interventions/comparators and outcome assessments. The resultant mixed-mode of care delivery created issues with intervention fidelity posing analytic challenges. COVID-19 also induced ongoing/intermittent delays and other barriers to accessing primary and specialty care at some facilities, creating research capacity issues affecting delivery of experimental interventions requiring sustained, reliable participation of clinical partners. Study designs most affected by COVID-19 were stepped-wedge (intervention/comparator changing over time), cluster (increased site variability inflating intracluster correlation), and SMART (second-stage randomizations disrupted); stratified individually-randomized trials were less vulnerable because of individual-level randomization.

Conclusions: PICOTS provides a framework for assessing the impact of trial disruptions in a structured manner. Given the COVID-19 experience, it is important for researchers to consider the potential impact of future trial disruptions during study planning.

目的:尽管对临床试验进行了精心设计,但仍可能出现不可预见的干扰。我们采用了 PICOTS(患者人群、干预措施、比较者、结果、时间点、环境)框架来评估疼痛管理合作组织内因冠状病毒病 2019(COVID-19)而对疼痛管理研究造成的干扰:采用快速定性方法确定了 11 项疼痛管理非药物疗法实用临床试验中因 COVID-19 导致的试验中断。4 项合作试验的研究人员采用了 PICOTS 框架,这些试验涵盖了 4 种类型的试验设计(单独随机试验、阶梯式楔形试验、群组试验、连续多次分配随机试验-SMART)。对这些试验的主要研究人员进行了访谈,并在 6 个月(2021 年 3 月至 8 月)的视频通话中介绍/讨论了研究结果,从中确定了主题/经验教训,并达成了共识:研究人员表示,患者群体总体保持稳定。COVID-19 试验的一个主要干扰是从面对面护理转变为虚拟护理,这影响了干预/比较指标和结果评估的提供。由此产生的混合护理模式造成了干预忠实性问题,给分析带来了挑战。COVID-19 还导致一些机构在提供初级和专科医疗服务时出现持续/间歇性延误和其他障碍,从而产生了研究能力问题,影响了需要临床合作伙伴持续、可靠参与的实验干预措施的实施。受 COVID-19 影响最大的研究设计是阶梯式楔形设计(干预/比较者随时间而变化)、群组设计(现场变异性增加导致群组内相关性增大)和 SMART 设计(第二阶段随机化中断);分层单独随机试验由于采用了个人层面的随机化,因此受影响较小:PICOTS为以结构化的方式评估试验中断的影响提供了一个框架。鉴于 COVID-19 的经验,研究人员在制定研究计划时必须考虑到未来试验中断的潜在影响。
{"title":"Utility of the PICOTS framework to assess clinical trial disruptions: monitoring the impact of COVID-19 in the Pain Management Collaboratory.","authors":"Peter Peduzzi, Cynthia Brandt, Christopher L Dearth, James Dziura, Shawn Farrokhi, Steven Z George, Tassos C Kyriakides, Cynthia R Long, Edward J Mascha, Charity G Patterson, Daniel I Rhon, Robert D Kerns","doi":"10.1093/pm/pnae078","DOIUrl":"10.1093/pm/pnae078","url":null,"abstract":"<p><strong>Objective: </strong>Despite careful design of clinical trials, unforeseen disruptions can arise. The PICOTS (Patient population, Intervention, Comparator, Outcomes, Timepoints, Setting) framework was used to assess disruptions in pain management research imposed by coronavirus disease 2019 (COVID-19) within the Pain Management Collaboratory.</p><p><strong>Methods: </strong>Rapid qualitative methods were employed to identify trial disruptions due to COVID-19 in 11 pragmatic clinical trials of nonpharmacological approaches for pain management. The PICOTS framework was applied by investigators of 4 Collaboratory trials selected to cover 4 types of trial designs (individually randomized, stepped-wedge, cluster, sequential multiple assignment randomized trial-SMART). Interviews with the lead investigators of these trials were completed, and findings were presented/discussed on video calls over a 6-month period (March-August 2021) from which themes/lessons learned were identified and consensus reached.</p><p><strong>Results: </strong>Investigators indicated that patient populations remained generally stable. A major COVID-19 trial disruption was moving from in-person to virtual care affecting delivery of interventions/comparators and outcome assessments. The resultant mixed-mode of care delivery created issues with intervention fidelity posing analytic challenges. COVID-19 also induced ongoing/intermittent delays and other barriers to accessing primary and specialty care at some facilities, creating research capacity issues affecting delivery of experimental interventions requiring sustained, reliable participation of clinical partners. Study designs most affected by COVID-19 were stepped-wedge (intervention/comparator changing over time), cluster (increased site variability inflating intracluster correlation), and SMART (second-stage randomizations disrupted); stratified individually-randomized trials were less vulnerable because of individual-level randomization.</p><p><strong>Conclusions: </strong>PICOTS provides a framework for assessing the impact of trial disruptions in a structured manner. Given the COVID-19 experience, it is important for researchers to consider the potential impact of future trial disruptions during study planning.</p>","PeriodicalId":19744,"journal":{"name":"Pain Medicine","volume":"25 Supplement_1","pages":"S34-S40"},"PeriodicalIF":2.9,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11548861/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142605951","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Pragmatic clinical trials as hybrid effectiveness-implementation studies to shrink the evidence-to-practice gap for chronic pain management. 务实的临床试验作为效果与实施的混合研究,可缩小慢性疼痛管理从证据到实践的差距。
IF 2.9 3区 医学 Q1 ANESTHESIOLOGY Pub Date : 2024-11-01 DOI: 10.1093/pm/pnae067
Amanda M Midboe, Karen H Seal, Diana J Burgess, Marc I Rosen, Steve Martino
{"title":"Pragmatic clinical trials as hybrid effectiveness-implementation studies to shrink the evidence-to-practice gap for chronic pain management.","authors":"Amanda M Midboe, Karen H Seal, Diana J Burgess, Marc I Rosen, Steve Martino","doi":"10.1093/pm/pnae067","DOIUrl":"10.1093/pm/pnae067","url":null,"abstract":"","PeriodicalId":19744,"journal":{"name":"Pain Medicine","volume":"25 Supplement_1","pages":"S77-S79"},"PeriodicalIF":2.9,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11548854/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142605932","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Tele-collaborative outreach to rural patients with chronic pain: pragmatic effectiveness trial protocol for the CORPs study. 针对农村慢性疼痛患者的远程协作推广:CORPs 研究的实用有效性试验方案。
IF 2.9 3区 医学 Q1 ANESTHESIOLOGY Pub Date : 2024-11-01 DOI: 10.1093/pm/pnae075
Benjamin J Morasco, Natassja Pal, Sarah S Ono, Sterling M McPherson, Frances L Lynch, John F Dickerson, Steven K Dobscha, Erin E Krebs, Una E Makris, Amanda S Mixon, Patricia Maloy, Melinda M Davis, Travis I Lovejoy

Background: Despite the increased availability of evidence-based treatments for chronic pain, many patients in rural areas experience poor access to services. Patients receiving care through the VA may also need to navigate multiple systems of care.

Objective: To examine the effectiveness of a remotely delivered collaborative care intervention for improving pain interference among veterans with high-impact chronic pain living in rural areas.

Design: We will conduct a four-site pragmatic effectiveness trial of remotely delivered collaborative care for high-impact chronic pain. Participants (n = 608) will be randomized to the Tele-Collaborative Outreach to Rural Patients (CORPs) intervention or to minimally enhanced usual care (MEUC). Participants randomized to CORPs will complete a biopsychosocial assessment and five follow-up sessions with a nurse care manager (NCM), who will collaborate with a consulting clinician to provide personalized recommendations and care management. CORP participants will also be invited to a virtual 6-session pain education group class. Participants randomized to MEUC will receive a one-time education session with the NCM to review available pain services. All participants will complete quarterly research assessments for one year. The primary study outcome is pain interference. This trial will oversample veterans of female birth sex and minoritized race or ethnicity to test heterogeneity of treatment effects across these patient characteristics. We will conduct an implementation process evaluation and incremental cost-effectiveness analysis.

Discussion: This pragmatic trial will test the real-world effectiveness of a remotely delivered collaborative care intervention for chronic pain. Study findings will inform future implementation efforts to support potential uptake of the intervention.

背景:尽管以证据为基础的慢性疼痛治疗方法越来越多,但农村地区的许多患者却很难获得相关服务。通过退伍军人事务部接受治疗的患者可能还需要浏览多个治疗系统:目的:研究远程协作护理干预对改善农村地区患有严重慢性疼痛的退伍军人的疼痛干扰的有效性:设计:我们将在四个地点开展一项针对高影响慢性疼痛的远程协作护理实用有效性试验。参与者(n = 608)将被随机分配到 "农村患者远程协作外展"(CORPs)干预或 "最小化增强型常规护理"(MEUC)中。被随机选中参加 CORPs 的患者将完成生物心理社会评估,并与护士护理经理 (NCM) 进行五次随访,护士护理经理将与临床顾问合作提供个性化建议和护理管理。此外,CORP 参与者还将受邀参加为期 6 个疗程的虚拟疼痛教育小组课程。被随机分配到 MEUC 的参与者将接受一次 NCM 教育课程,以了解可用的疼痛服务。所有参与者都将完成为期一年的季度研究评估。主要研究结果是疼痛干扰。本试验将对女性出生性别和少数种族或族裔的退伍军人进行超量抽样,以测试这些患者特征的治疗效果的异质性。我们将进行实施过程评估和增量成本效益分析:这项实用性试验将检验远程协作护理干预对慢性疼痛的实际效果。研究结果将为未来的实施工作提供参考,以支持干预措施的潜在应用。
{"title":"Tele-collaborative outreach to rural patients with chronic pain: pragmatic effectiveness trial protocol for the CORPs study.","authors":"Benjamin J Morasco, Natassja Pal, Sarah S Ono, Sterling M McPherson, Frances L Lynch, John F Dickerson, Steven K Dobscha, Erin E Krebs, Una E Makris, Amanda S Mixon, Patricia Maloy, Melinda M Davis, Travis I Lovejoy","doi":"10.1093/pm/pnae075","DOIUrl":"10.1093/pm/pnae075","url":null,"abstract":"<p><strong>Background: </strong>Despite the increased availability of evidence-based treatments for chronic pain, many patients in rural areas experience poor access to services. Patients receiving care through the VA may also need to navigate multiple systems of care.</p><p><strong>Objective: </strong>To examine the effectiveness of a remotely delivered collaborative care intervention for improving pain interference among veterans with high-impact chronic pain living in rural areas.</p><p><strong>Design: </strong>We will conduct a four-site pragmatic effectiveness trial of remotely delivered collaborative care for high-impact chronic pain. Participants (n = 608) will be randomized to the Tele-Collaborative Outreach to Rural Patients (CORPs) intervention or to minimally enhanced usual care (MEUC). Participants randomized to CORPs will complete a biopsychosocial assessment and five follow-up sessions with a nurse care manager (NCM), who will collaborate with a consulting clinician to provide personalized recommendations and care management. CORP participants will also be invited to a virtual 6-session pain education group class. Participants randomized to MEUC will receive a one-time education session with the NCM to review available pain services. All participants will complete quarterly research assessments for one year. The primary study outcome is pain interference. This trial will oversample veterans of female birth sex and minoritized race or ethnicity to test heterogeneity of treatment effects across these patient characteristics. We will conduct an implementation process evaluation and incremental cost-effectiveness analysis.</p><p><strong>Discussion: </strong>This pragmatic trial will test the real-world effectiveness of a remotely delivered collaborative care intervention for chronic pain. Study findings will inform future implementation efforts to support potential uptake of the intervention.</p>","PeriodicalId":19744,"journal":{"name":"Pain Medicine","volume":"25 Supplement_1","pages":"S91-S98"},"PeriodicalIF":2.9,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11548859/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142605941","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Strategies for working with pragmatic clinical trial observational data-lessons learned from the Pain Management Collaboratory. 使用实用临床试验观察数据的策略--从疼痛管理合作组织中学到的经验。
IF 2.9 3区 医学 Q1 ANESTHESIOLOGY Pub Date : 2024-11-01 DOI: 10.1093/pm/pnae093
Michael E Matheny, Cynthia Brandt, Kalyn C Jannace, William T Roddy, Michael Raffanello, Norman Silliker, Joseph Erdos
{"title":"Strategies for working with pragmatic clinical trial observational data-lessons learned from the Pain Management Collaboratory.","authors":"Michael E Matheny, Cynthia Brandt, Kalyn C Jannace, William T Roddy, Michael Raffanello, Norman Silliker, Joseph Erdos","doi":"10.1093/pm/pnae093","DOIUrl":"10.1093/pm/pnae093","url":null,"abstract":"","PeriodicalId":19744,"journal":{"name":"Pain Medicine","volume":"25 Supplement_1","pages":"S28-S30"},"PeriodicalIF":2.9,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11548852/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142605938","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Achieving two-part harmony: standardizing pain-related phenotypes and outcomes. 实现两部分和谐:疼痛相关表型和结果的标准化。
IF 2.9 3区 医学 Q1 ANESTHESIOLOGY Pub Date : 2024-11-01 DOI: 10.1093/pm/pnae069
Robert Edwards, Mary Geda, Diana J Burgess, Alison F Davis, Lynn DeBar, Natassja Pal, Peter Peduzzi, Stephanie L Taylor, Robert Wallace, Stephen L Luther
{"title":"Achieving two-part harmony: standardizing pain-related phenotypes and outcomes.","authors":"Robert Edwards, Mary Geda, Diana J Burgess, Alison F Davis, Lynn DeBar, Natassja Pal, Peter Peduzzi, Stephanie L Taylor, Robert Wallace, Stephen L Luther","doi":"10.1093/pm/pnae069","DOIUrl":"10.1093/pm/pnae069","url":null,"abstract":"","PeriodicalId":19744,"journal":{"name":"Pain Medicine","volume":"25 Supplement_1","pages":"S7-S10"},"PeriodicalIF":2.9,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11548856/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142605844","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
期刊
Pain Medicine
全部 Acc. Chem. Res. ACS Applied Bio Materials ACS Appl. Electron. Mater. ACS Appl. Energy Mater. ACS Appl. Mater. Interfaces ACS Appl. Nano Mater. ACS Appl. Polym. Mater. ACS BIOMATER-SCI ENG ACS Catal. ACS Cent. Sci. ACS Chem. Biol. ACS Chemical Health & Safety ACS Chem. Neurosci. ACS Comb. Sci. ACS Earth Space Chem. ACS Energy Lett. ACS Infect. Dis. ACS Macro Lett. ACS Mater. Lett. ACS Med. Chem. Lett. ACS Nano ACS Omega ACS Photonics ACS Sens. ACS Sustainable Chem. Eng. ACS Synth. Biol. Anal. Chem. BIOCHEMISTRY-US Bioconjugate Chem. BIOMACROMOLECULES Chem. Res. Toxicol. Chem. Rev. Chem. Mater. CRYST GROWTH DES ENERG FUEL Environ. Sci. Technol. Environ. Sci. Technol. Lett. Eur. J. Inorg. Chem. IND ENG CHEM RES Inorg. Chem. J. Agric. Food. Chem. J. Chem. Eng. Data J. Chem. Educ. J. Chem. Inf. Model. J. Chem. Theory Comput. J. Med. Chem. J. Nat. Prod. J PROTEOME RES J. Am. Chem. Soc. LANGMUIR MACROMOLECULES Mol. Pharmaceutics Nano Lett. Org. Lett. ORG PROCESS RES DEV ORGANOMETALLICS J. Org. Chem. J. Phys. Chem. J. Phys. Chem. A J. Phys. Chem. B J. Phys. Chem. C J. Phys. Chem. Lett. Analyst Anal. Methods Biomater. Sci. Catal. Sci. Technol. Chem. Commun. Chem. Soc. Rev. CHEM EDUC RES PRACT CRYSTENGCOMM Dalton Trans. Energy Environ. Sci. ENVIRON SCI-NANO ENVIRON SCI-PROC IMP ENVIRON SCI-WAT RES Faraday Discuss. Food Funct. Green Chem. Inorg. Chem. Front. Integr. Biol. J. Anal. At. Spectrom. J. Mater. Chem. A J. Mater. Chem. B J. Mater. Chem. C Lab Chip Mater. Chem. Front. Mater. Horiz. MEDCHEMCOMM Metallomics Mol. Biosyst. Mol. Syst. Des. Eng. Nanoscale Nanoscale Horiz. Nat. Prod. Rep. New J. Chem. Org. Biomol. Chem. Org. Chem. Front. PHOTOCH PHOTOBIO SCI PCCP Polym. Chem.
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
0
微信
客服QQ
Book学术公众号 扫码关注我们
反馈
×
意见反馈
请填写您的意见或建议
请填写您的手机或邮箱
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
现在去查看 取消
×
提示
确定
Book学术官方微信
Book学术文献互助
Book学术文献互助群
群 号:481959085
Book学术
文献互助 智能选刊 最新文献 互助须知 联系我们:info@booksci.cn
Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。
Copyright © 2023 Book学术 All rights reserved.
ghs 京公网安备 11010802042870号 京ICP备2023020795号-1