Pain Medicine最新文献

{"title":"Recommendations for monitoring adherence and fidelity in pragmatic trials based on experience in the Pain Management Collaboratory.","authors":"James Dziura, Kathryn Gilstad-Hayden, Cynthia J Coffman, Cynthia R Long, Qilu Yu, Eugenia Buta, Scott Coggeshall, Mary Geda, Peter Peduzzi, Tassos C Kyriakides","doi":"10.1093/pm/pnae080","DOIUrl":"10.1093/pm/pnae080","url":null,"abstract":"<p><strong>Objective: </strong>Most pragmatic trials follow the PRagmatic Explanatory Continuum Indicator Summary (PRECIS-2) criteria. The criteria specify unobtrusive measurement of participants' protocol adherence and practitioners' intervention fidelity but suggest no special monitoring strategies to assure trial integrity. We present experience with adherence/fidelity monitoring in the Pain Management Collaboratory (PMC) and provide recommendations for their monitoring in pragmatic trials to preserve inferences of treatment comparisons.</p><p><strong>Methods: </strong>In November 2021, we surveyed 10 of 11 originally funded PMC pragmatic trials to determine the extent to which adherence and fidelity data were being monitored.</p><p><strong>Results: </strong>Of the 10 PMC trials, 8 track adherence/fidelity. The electronic health record is the most frequent source for monitoring adherence (7/10) and fidelity (5/10). Most adherence data are used to monitor participant engagement with the trial intervention (4/10) and are reviewed by study teams (8/10) and often with a data and safety monitoring board (DSMB) (5/10). Half of the trials (5/10) reported using fidelity data for feedback/training; such data are not shared with a DSMB (0/10). Only 2 of 10 trials reported having prespecified guidance or rules around adherence/fidelity (eg, stopping rules or thresholds for corrective action, such as retraining).</p><p><strong>Conclusions: </strong>As a best practice for pragmatic trials, we recommend early and regular adherence/fidelity monitoring to determine whether intervention delivery is as intended. We propose a 2-stage process with thresholds for intervening and triggers for conducting a formal futility analysis if adherence and fidelity are not maintained. The level of monitoring should be unobtrusive for both participants and those delivering the intervention; resulting data should be reviewed by an independent DSMB.</p>","PeriodicalId":19744,"journal":{"name":"Pain Medicine","volume":"25 Supplement_1","pages":"S41-S48"},"PeriodicalIF":2.9,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11548857/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142605934","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":"Screening, brief intervention, and referral to treatment for pain management for veterans separating from military service: study protocol of a hybrid type 2 study testing implementation facilitation versus training-as-usual.","authors":"John J Sellinger, Marc I Rosen, Christina M Lazar, Kathryn Gilstad-Hayden, James Dziura, Fang-Yong Li, Kristin Mattocks, Adrienne Weede, Michael Sullivan-Tibbs, Liam Rose, Gabriela Garcia Vassallo, Ajay Manhapra, Amos Turner, Dawne Vogt, Eva N Woodward, Christine W Hartmann, Sally G Haskell, Amir Mohammad, Steve Martino","doi":"10.1093/pm/pnae062","DOIUrl":"10.1093/pm/pnae062","url":null,"abstract":"<p><strong>Background: </strong>Veterans transitioning to civilian life often have chronic pain from service-related musculoskeletal disorders (MSD) with higher risk for substance misuse. Many seek VA (Department of Veterans Affairs) compensation for MSD. Use of Screening, Brief Intervention, and Referral to Treatment for Pain Management (SBIRT-PM) by VA Post-9/11 Military2VA (M2VA) case managers presents an opportunity to engage these veterans in VA pain care and address substance misuse. Implementation facilitation might help case managers use SBIRT-PM and engage veterans in services to improve outcomes.</p><p><strong>Design: </strong>This study is a 2-cohort multisite cluster-randomized hybrid type 2 effectiveness-implementation trial. Within 2 separate cohorts of 14 VA sites each, sites will be allocated to receive an implementation strategy through the use of a constrained randomization procedure: virtual implementation facilitation or training-as-usual. Sites and M2VA case managers will receive the assigned implementation strategy to support use of SBIRT-PM. Recently discharged veterans (n = 1848) claiming service-connected MSD will be recruited, with case managers blind to veterans' study enrollment. The proportion of participants who receive any SBIRT-PM will be the primary implementation outcome. Veteran participants will complete baseline, 12-week, and 36-week assessments, irrespective of whether case managers conduct SBIRT-PM with them (intent-to-treat). Pain intensity and interference will be the primary clinical outcomes. The study emphasizes pragmatic over explanatory methodological features.</p><p><strong>Summary: </strong>This pragmatic trial will examine implementation facilitation versus training-as-usual in implementing SBIRT-PM to promote veteran engagement in nonpharmacological pain services. Using innovative methods to train and support VA case managers in SBIRT-PM, study outcomes could have broad implications for case management systems of care across the VA.</p>","PeriodicalId":19744,"journal":{"name":"Pain Medicine","volume":"25 Supplement_1","pages":"S99-S106"},"PeriodicalIF":2.9,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142605936","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":"Neuropsychiatric drugs and a neurophysiological marker as predictors of health-related quality of life in patients with phantom limb pain.","authors":"Valton Costa, Kevin Pacheco-Barrios, Anna Carolyna Gianlorenço, Felipe Fregni","doi":"10.1093/pm/pnae053","DOIUrl":"10.1093/pm/pnae053","url":null,"abstract":"<p><strong>Objective: </strong>To explore the relationship between sociodemographic, clinical, and neurophysiological variables and health-related quality of life (HR-QOL) of patients with phantom limb pain (PLP).</p><p><strong>Methods: </strong>This is a cross-sectional analysis of a previous clinical trial. Univariate and multivariate linear and logistic regression analyses were used to model the predictors of HR-QOL. We utilized a sequential modeling approach with increasing adjustment levels, controlling for age and sex, and other relevant clinical variables (time since amputation, level of amputation, and pain). HR-QOL was assessed by the SF-36 Health Survey and its 8 subdomains.</p><p><strong>Results: </strong>We analyzed baseline data from 92 patients with lower-limb amputations. They were mostly male (63%), 45.2 ± 15.6 years, with a mean time since amputation of 82.7 ± 122.4 months, and an overall SF-36 score of 55.9 ± 21.5. We found an association between intracortical facilitation (ICF) in the affected hemisphere, gabapentin usage, and HR-QOL. ICF is a predictor of better HRQOL, whereas gabapentin usage was associated with a poorer HR-QOL, with the main model explaining 13.4% of the variance in the outcome. For the SF-36 subdomains, ICF was also a positive predictor for social functioning, bodily pain, and vitality, while medication usage was associated with lower scores in mental health, general health perception, bodily pain, and vitality.</p><p><strong>Conclusion: </strong>We found firsthand 2 new independent predictors of HR-QOL in individuals with PLP, namely, the neurophysiological metric ICF and gabapentin usage. These results highlight the role of the motor cortex excitability in the HR-QOL and stress the need for treatments that favor the neuroplastic adaptation after amputation, for which ICF may be used as a possible marker.</p>","PeriodicalId":19744,"journal":{"name":"Pain Medicine","volume":" ","pages":"679-686"},"PeriodicalIF":2.9,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11532630/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141535052","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":"Perspectives on pain management from the veterans health administration and the defense health agency.","authors":"Benjamin Kligler, Deydre Teyhen, Paul Cordts","doi":"10.1093/pm/pnae047","DOIUrl":"https://doi.org/10.1093/pm/pnae047","url":null,"abstract":"","PeriodicalId":19744,"journal":{"name":"Pain Medicine","volume":"25 Supplement_1","pages":"S4-S6"},"PeriodicalIF":2.9,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142605925","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":"The implementation of a pain navigator program in the department of Veterans Affairs' (VA) health care systems: a cluster randomized pragmatic clinical trial.","authors":"Courtni France, Chad E Cook, Cynthia J Coffman, Christa Tumminello, Ashley Choate, Steven Z George, Trevor A Lentz, Susan N Hastings","doi":"10.1093/pm/pnae074","DOIUrl":"10.1093/pm/pnae074","url":null,"abstract":"<p><strong>Objective: </strong>This manuscript describes the uptake of the AIM-Back Pain Navigator Pathway (PNP) designed to encourage use of non-pharmacologic care options within the Veterans Health Administration (VHA).</p><p><strong>Design: </strong>This manuscript describes the implementation of a telehealth intervention from one arm of a multisite, embedded, cluster-randomized pragmatic trial comparing the effectiveness of two novel clinical care pathways that provide access to non-pharmacologic care for Veterans with low back pain (LBP).</p><p><strong>Setting: </strong>Ten VHA clinics.</p><p><strong>Subjects: </strong>19 pain navigators, >200 primary care physicians, and over 1000 Veterans were involved in the PNP implementation.</p><p><strong>Methods: </strong>Data were generated within the VHA electronic health record (EHR) for the ongoing AIM-Back trial to describe PNP implementation for system-level findings in terms of number of visits, and type of care received.</p><p><strong>Results: </strong>Over a 3-year period, 9 of 10 clinics implemented the PNP within the context of the AIM-Back trial. The most frequent care recommended in the PNP included physical therapy, chiropractic, acupuncture, and yoga/tai chi. During follow-up at six-weeks, ∼50% of Veterans elected to receive a different care choice than what was initially prescribed. Notable variation across clinics was documented for PNP based on time to initiation of care and follow-up rates.</p><p><strong>Conclusions: </strong>Implementation of the telehealth delivered PNP provides a nuanced understanding of the introduction of novel care programs within diverse clinical settings. These findings are most applicable to care programs that are delivered remotely and involve facilitation of existing care options.</p>","PeriodicalId":19744,"journal":{"name":"Pain Medicine","volume":"25 Supplement_1","pages":"S83-S90"},"PeriodicalIF":2.9,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11548858/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142605944","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":"Effectiveness of fremanezumab treatment in patients with migraine headache.","authors":"Shoji Kikui, Danno Daisuke, Junichi Miyahara, Hanako Sugiyama, Kuniko Ota, Kenji Murakata, Yoshihiro Kashiwaya, Takao Takeshima","doi":"10.1093/pm/pnae050","DOIUrl":"10.1093/pm/pnae050","url":null,"abstract":"<p><strong>Objective: </strong>To evaluate the efficacy and safety of fremanezumab for migraine prevention.</p><p><strong>Design: </strong>Retrospective, single-center, real-world study.</p><p><strong>Setting: </strong>Regional tertiary headache center in Japan.</p><p><strong>Subjects: </strong>Adult individuals with migraine (n = 165, male = 17, female = 148; average age = 45.5 ± 16.0 years) who received fremanezumab between September 2021 and August 2022.</p><p><strong>Methods: </strong>Fremanezumab was administered subcutaneously at a monthly dose of 225 mg or quarterly dose of 675 mg based on patient preferences. Patients received fremanezumab treatment for up to 1 year unless it was discontinued. Monthly data were collected on migraine days, headache days, and days requiring acute medication.</p><p><strong>Results: </strong>Of the 165 patients, 125 (75.7%) received fremanezumab as their first anti-calcitonin gene-related peptide-related antibody drug. Significant reductions in monthly migraine days, headache days, and days requiring acute medication were observed in those with episodic and chronic migraines. The baseline monthly headache days was 8.1 ± 4.0 in the episodic migraine group, which reduced to 6.1 ± 4.8, 5.8 ± 4.4, 4.7 ± 3.6, and 4.6 ± 3.3 days at 1, 3, 6, and 12 months, respectively; in the chronic migraine group, the baseline monthly headache days was 20.9 ± 6.1, which reduced to 17.0 ± 8.9, 15.0 ± 9.2, 13.0 ± 7.7, and 12.0 ± 9.1 days at 1, 3, 6, and 12 months, respectively. Treatment benefits were enhanced after 6 months of administering fremanezumab in the chronic migraine group.</p><p><strong>Conclusions: </strong>In this real-world study of patients with migraine, fremanezumab appears to be effective and safe. Further studies are required to identify additional predictors of treatment success and failure with fremanezumab.</p>","PeriodicalId":19744,"journal":{"name":"Pain Medicine","volume":" ","pages":"664-670"},"PeriodicalIF":2.9,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141420243","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":"Engaging clinical partners in pragmatic clinical trials: lessons learned from the pain management collaboratory.","authors":"Lori A Bastian, Steven P Cohen, Stacie A Salsbury, Alison F Davis, Lily Katsovich, Robert D Kerns","doi":"10.1093/pm/pnae055","DOIUrl":"10.1093/pm/pnae055","url":null,"abstract":"","PeriodicalId":19744,"journal":{"name":"Pain Medicine","volume":" ","pages":"S80-S82"},"PeriodicalIF":2.9,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11548849/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141492939","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":"Monitoring and reporting adverse events in pragmatic clinical trials testing nonpharmacological pain management interventions.","authors":"Amy Burns, Stacey Young-McCaughan, Alison F Davis, Robert Vining, Joseph Ali, Julie M Fritz, Benjamin J Morasco, Daniel I Rhon, Robert Roogow, Tassos C Kyriakides, Robert D Kerns","doi":"10.1093/pm/pnae081","DOIUrl":"10.1093/pm/pnae081","url":null,"abstract":"","PeriodicalId":19744,"journal":{"name":"Pain Medicine","volume":"25 Supplement_1","pages":"S64-S67"},"PeriodicalIF":2.9,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11548853/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142605896","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":"Challenges in clinical data sharing-experiences of the pain management collaboratory.","authors":"Kalyn C Jannace, Cynthia A Brandt, Norman Silliker, Bolatito Adepoju, Michael Raffanello, Michael E Matheny, William T Roddy, Joseph Erdos","doi":"10.1093/pm/pnae063","DOIUrl":"10.1093/pm/pnae063","url":null,"abstract":"","PeriodicalId":19744,"journal":{"name":"Pain Medicine","volume":"25 Supplement_1","pages":"S31-S33"},"PeriodicalIF":2.9,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11548850/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142605867","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":"Do mindfulness interventions cause harm? Findings from the Learning to Apply Mindfulness to Pain (LAMP) Pragmatic Clinical Trial.","authors":"Diana J Burgess, Collin Calvert, Ann Bangerter, Mariah Branson, Lee J S Cross, Roni Evans, John E Ferguson, Jessica K Friedman, Emily M Hagel Campbell, Alexander C Haley, Sierra Hennessy, Colleen Kraft, Mallory Mahaffey, Marianne S Matthias, Laura A Meis, J Greg Serpa, Stephanie L Taylor, Brent C Taylor","doi":"10.1093/pm/pnae056","DOIUrl":"10.1093/pm/pnae056","url":null,"abstract":"<p><strong>Background: </strong>Although mindfulness-based interventions (MBIs) are widely used in clinical and nonclinical settings, there has been little systematic study of their potential risks. To address this gap, we examined differences in psychological and physical worsening among participants in the usual care and intervention conditions of a 3-group, randomized pragmatic trial (Learning to Apply Mindfulness to Pain [LAMP]) that tested the effectiveness of 2 approaches to delivering MBIs to patients with chronic pain.</p><p><strong>Methods: </strong>The sample consisted of 374 male and 334 female patients with chronic pain enrolled in the LAMP trial who completed a 10-week follow-up survey, 61% of whom had a mental health diagnosis. Psychological and physical worsening was assessed by a checklist asking whether participants experienced specific symptoms since beginning the study. We used multivariable logistic regression models with imputed data to determine whether predicted probabilities of increased symptoms differed between usual care and the 2 MBIs.</p><p><strong>Results: </strong>Participants in usual care were more likely to report experiencing increased psychological and physical worsening than were those in the MBIs, including an increase in disturbing memories; sadness, anxiousness, and fatigue; isolation and loneliness; and feeling more upset than usual when something reminded them of the past.</p><p><strong>Conclusions: </strong>MBIs do not appear to cause harm, in terms of increased symptoms, for this population of patients with chronic pain and high levels of mental health comorbidities.</p><p><strong>Clinical trial registration: </strong>Preregistration with an analysis plan at www.ClinicalTrials.gov: NCT04526158. Patient enrollment began December 4, 2020.</p>","PeriodicalId":19744,"journal":{"name":"Pain Medicine","volume":"25 Supplement_1","pages":"S68-S76"},"PeriodicalIF":2.9,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11548848/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142605876","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}