Pain Medicine最新文献

{"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}

{"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}

{"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}

{"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}

{"title":"Varying definitions of long-term opioid therapy: examining prevalence, prescription patterns, and substance-related adverse outcomes.","authors":"Patrick D Quinn, Olena Mazurenko, Richard Meraz, Zheng Chang, Toyya A Pujol, Adam T Hirsh, Arvid Sjölander, Kurt Kroenke, Brian M D'Onofrio","doi":"10.1093/pm/pnae051","DOIUrl":"10.1093/pm/pnae051","url":null,"abstract":"","PeriodicalId":19744,"journal":{"name":"Pain Medicine","volume":" ","pages":"687-689"},"PeriodicalIF":2.9,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11532629/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141432517","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}

{"title":"How initial perceptions of the effectiveness of mind and body complementary and integrative health therapies influence long-term adherence in a pragmatic trial.","authors":"Steven B Zeliadt, Scott Coggeshall, Xiaoyi Zhang, Ethan W Rosser, David E Reed Ii, A Rani Elwy, Barbara G Bokhour, Joy A Toyama, Stephanie L Taylor","doi":"10.1093/pm/pnae070","DOIUrl":"10.1093/pm/pnae070","url":null,"abstract":"<p><strong>Objective: </strong>Beliefs and perceptions about pain intervention effectiveness when initiating a therapy may influence long-term engagement. This study examines how early perceived effectiveness of complementary and integrative health therapies impacts long-term engagement in a pragmatic trial context.</p><p><strong>Participants: </strong>Veterans with chronic musculoskeletal pain participating in a pragmatic trial of provider-delivered complementary and integrative health therapies (acupuncture, chiropractic care, or massage therapy) used alone compared to combining those therapies with self-care therapies (yoga, Tai Chi/Qigong, or meditation). This analysis focuses on 1713 participants using self-care therapies at baseline.</p><p><strong>Setting: </strong>18 Veterans Healthcare Administration Medical Facilities.</p><p><strong>Design: </strong>Prospective cohort study.</p><p><strong>Methods: </strong>Predictors of total self-care complementary and integrative health therapy sessions over a 6-month assessment period were assessed using linear regression to determine how strongly perceptions of initial therapy effectiveness was associated with total utilization. Perception of initial therapy effectiveness was assessed at study entry across four domains (pain, mental health, fatigue, and general well-being).</p><p><strong>Results: </strong>In total, 56% (1032/1713) of Veterans reported a positive perceived effectiveness of their recent complementary and integrative health therapy use at study initiation. Older individuals and those using meditation were more likely to report early positive perceptions. Mean number of therapy sessions over the 6-month study was 11 (range 1 to 168). Early positive perceptions had a small effect on overall use, increasing mean sessions by 2.5 (1.3 to 3.6). Other factors such as recent physical therapy use and distance to primary care explained more variation in total utilization.</p><p><strong>Conclusions: </strong>Pragmatic pain trials should examine factors associated with engagement across assigned treatment protocols, especially if any of the treatment protocols being tested are sensitive to long-term engagement.</p>","PeriodicalId":19744,"journal":{"name":"Pain Medicine","volume":"25 Supplement_1","pages":"S54-S63"},"PeriodicalIF":2.9,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11548863/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142605883","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}

{"title":"Analgesic effects of intraperitoneal lidocaine in adults undergoing surgery: a systematic review and meta-analysis with trial sequential analysis.","authors":"Ka Ting Ng, Wei En Lim, Wan Yi Teoh, Mohd Fitry Bin Zainal Abidin","doi":"10.1093/pm/pnae052","DOIUrl":"10.1093/pm/pnae052","url":null,"abstract":"<p><strong>Objective: </strong>The administration of local anesthesia in intraperitoneal space as part of the multi-modal analgesic regimen has shown to be effective in reducing postoperative pain. Recent studies demonstrated that intraperitoneal lidocaine may provide analgesic effects. Primary objective was to determine the impact of intraperitoneal lidocaine on postoperative pain scores at rest.</p><p><strong>Design: </strong>We carried out a systematic review and meta-analysis according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA).</p><p><strong>Methods: </strong>Databases of MEDLINE, EMBASE, and CENTRAL were searched from their inception date until May 2023. Randomized clinical trials (RCT) comparing intraperitoneal lidocaine and placebo in adults undergoing surgery were included.</p><p><strong>Results: </strong>Our systematic review included 24 RCTs (n = 1824). The intraperitoneal lidocaine group was significantly associated with lower postoperative pain scores at rest (MD, -0.87, 95% CI, -1.04 to -0.69) and at movement (MD, -0.50, 95% CI, -0.93 to -0.08) among adult patients after surgery. Its administration also significantly decreased morphine consumption (MD, -6.42 mg, 95% CI, -11.56 to -1.27) and lowered the incidence of needing analgesia (OR, 0.22, 95% CI, 0.14 to 0.35). Intraperitoneal lidocaine statistically reduced time to resume regular diet (MD, 0.16 days; 95% CI, -0.31 to -0.01) and lowered postoperative incidence of nausea and vomiting (OR, 0.54, 95% CI, 0.39 to 0.75).</p><p><strong>Conclusions: </strong>In this review, our findings should be interpreted with caution. Future studies are warranted to determine the optimal dose of administering intraperitoneal lidocaine among adult patients undergoing surgery.</p>","PeriodicalId":19744,"journal":{"name":"Pain Medicine","volume":" ","pages":"651-663"},"PeriodicalIF":2.9,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141446612","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}

{"title":"Impact of the COVID-19 pandemic on participants in pragmatic clinical trials for chronic pain: implications for trial outcomes and beyond.","authors":"John J Sellinger, Kathryn Gilstad-Hayden, Christina Lazar, Karen Seal, Natalie Purcell, Diana J Burgess, Steve Martino, Alicia Heapy, Diana Higgins, Marc I Rosen","doi":"10.1093/pm/pnae060","DOIUrl":"10.1093/pm/pnae060","url":null,"abstract":"<p><strong>Objective: </strong>The COVID-19 pandemic had profound effects on society, including those living with chronic pain. This study sought to examine pandemic impacts on individuals enrolled in pragmatic clinical trials focused on nonpharmacological treatments for chronic pain.</p><p><strong>Methods: </strong>We evaluated responses to a questionnaire on COVID-19 impacts that had been administered to participants (n=2024) during study enrollment in 3 pragmatic clinical trials for chronic pain treatment. All trials were part of the National Institutes of Health (NIH)-Department of Veterans Affairs (VA)-Department of Defense (DOD) Pain Management Collaboratory. COVID-19-related impacts on access to health care, mental health, finances, ability to meet basic needs, and social support were assessed.</p><p><strong>Results: </strong>Pandemic impacts were found in all domains assessed, including access to health care, mental and emotional health, ability to meet basic needs, finances, and social support. Impacts varied by demographic and clinical characteristics. The participants most negatively impacted by the pandemic were younger, Black or Latino, female, more educated, and unemployed and had screened positive for depression. No impact differences were found with regard to alcohol use disorder screenings or a prior history of COVID-19. Higher levels of pain were associated with worse pandemic impacts, and negative impacts declined over time.</p><p><strong>Conclusions: </strong>Negative impacts of the pandemic on individuals living with chronic pain cut across aspects of life that are also central to effective pain management, including access to health care, social support, and mental and emotional health, with differential impacts found across key demographic and clinical factors. These findings should yield consideration of pandemic impacts in clinical practice and as moderating effects of treatment outcomes in clinical trials conducted during the pandemic.</p>","PeriodicalId":19744,"journal":{"name":"Pain Medicine","volume":"25 Supplement_1","pages":"S17-S27"},"PeriodicalIF":2.9,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11548862/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142605892","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}

{"title":"Initial development of a self-report survey on use of Nonpharmacological and Self-Care Approaches for Pain management (NSCAP).","authors":"Sara N Edmond, Robert D Kerns, Mary Geda, Stephen L Luther, Robert R Edwards, Stephanie L Taylor, Marc I Rosen, Julie M Fritz, Christine M Goertz, Steven B Zeliadt, Karen H Seal","doi":"10.1093/pm/pnae082","DOIUrl":"10.1093/pm/pnae082","url":null,"abstract":"","PeriodicalId":19744,"journal":{"name":"Pain Medicine","volume":" ","pages":"S14-S16"},"PeriodicalIF":2.9,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11548860/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142009191","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}

{"title":"Toward facilitating the collection and utilization of patient-reported outcomes in the Military Health System: Lessons learned from a pragmatic clinical trial on physical therapy management for low back pain.","authors":"Emma H Beisheim-Ryan, Brad D Hendershot, Timothy C Mauntel, Sara R Gorczynski, Ryan W Smith, Andrea Crunkhorn, Shawn Farrokhi, Christopher L Dearth","doi":"10.1093/pm/pnae059","DOIUrl":"https://doi.org/10.1093/pm/pnae059","url":null,"abstract":"","PeriodicalId":19744,"journal":{"name":"Pain Medicine","volume":"25 Supplement_1","pages":"S11-S13"},"PeriodicalIF":2.9,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142605947","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}