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Ryan Fischer,1 Pat Furlong,1 Annie Kennedy,2 Kelly Maynard,3,4 Marissa Penrod,4,5 Debra Miller,6 Chamindra G Laverty,7 Linda P Lowes,8,9 Nancy L Kuntz,10,11 Perry B Shieh,12 Jane Kondejewski,13 Peter J Neumann,14 Jason Shafrin,15 Richard J Willke16 1Parent Project Muscular Dystrophy, Washington, DC, USA; 2EveryLife Foundation for Rare Diseases, Washington, DC, USA; 3Little Hercules Foundation, Dublin, OH, USA; 4Duchenne Family Assistance Program, Detroit, MI, USA; 5Team Joseph, West Bloomfield, MI, USA; 6Cureduchenne, Newport Beach, CA, USA; 7Department of Neuroscience, University of California San Diego, San Diego, CA, USA; 8Center for Gene Therapy, Abigail Wexner Research Institute, Nationwide Children’s Hospital, Columbus, OH, USA; 9Department of Pediatrics, the Ohio State University, Columbus, OH, USA; 10Division of Neurology, Department of Pediatrics, Northwestern University Feinberg School of Medicine, Chicago, IL, USA; 11Division of Neurology, Ann and Robert H. Lurie Children’s Hospital of Chicago, Chicago, IL, USA; 12Department of Neurology and Pediatrics, University of California Los Angeles, Los Angeles, CA, USA; 13SNELL Medical Communication, Inc., Montreal, QC, Canada; 14Center for the Evaluation of Value and Risk in Health, Institute for Clinical Research and Health Policy Studies, Tufts Medical Center, Boston, MA, USA; 15FTI Consulting, Los Angeles, CA, USA; 16Scintegral Health Economics, Chattanooga, TN, USACorrespondence: Richard J Willke, Scintegral Health Economics, Chattanooga, TN, USA, Tel +1-908-672-4156, Email willkerj@aol.comPurpose: Traditional value assessment frameworks are challenged in comprehensively assessing the societal value new therapies bring to individuals with rare, progressive, genetic, fatal, neuromuscular diseases such as Duchenne muscular dystrophy (DMD). The objective of this study was to identify how value assessment frameworks may need to be adapted to measure the value to society of DMD therapies.Patients and Methods: Three stakeholder groups (6 patient advocates, 4 clinicians, 3 health economists; N = 13) participated in semi-structured interviews around the International Society for Pharmacoeconomics and Outcomes Research’s Value Flower, which includes elements to consider within value assessments of healthcare technologies.Results: All stakeholders agreed that traditional value assessment frameworks based on the quality-adjusted life year (QALY) are narrow and will undervalue new DMD therapies. All stakeholders expressed some level of concern that using the QALY as a key metric of value discriminates against patients with severe progressive diseases and disabilities. Some stakeholders saw value in using the QALY for cross-disease comparisons in resource-constrained environments if the methodology was appropriate. All stakeholders recommended considering additional elements of value in decision-making around new DMD therapies. These elements reflect: economic and humanistic costs incurred by patients, caregivers, and families with Duchenne, such as indirect out-of-pocket costs, lost productivity, and family spillovers; meaningful attributes for individuals with disabilities and high unmet need, such as severity of disease, value of hope, and real option value; and factors that contribute to improvements in population health, such as insurance value, equity, and scientific spillovers.Conclusion: These findings highlight the need to expand traditional value assessment frameworks and take a holistic approach that incorporates the perspectives of individuals with Duchenne, caregivers, clinicians, and health economists when assessing the societal value of new DMD therapies. Broadening value assessment will prevent restricted or delayed access to therapies for individuals with Duchenne.Keywords: value assessment framework, qualitative research, rare diseases, ISPOR value flower

Timothy Deer,1,* Robert Heros,2,* Edward Tavel,3 Sayed Wahezi,4 Robert Funk,5 Patrick Buchanan,6 Anne Christopher,7 Jacqueline Weisbein,8 Christopher Gilligan,9 Denis Patterson,10 Ajay Antony,11 Mohab Ibrahim,12 Nathan Miller,13 Keith Scarfo,14 Gayle Johnson,15 Thadchaigeni Panchalingam,15 Udoka Okaro,15 James Yue16 1Pain Management, The Spine and Nerve Center of the Virginias, Charleston, WV, USA; 2Pain Management, Spinal Diagnostics, Tualatin, OR, USA; 3Pain Management, Clinical Trials of South Carolina, Charleston, SC, USA; 4Pain Management, Montefiore Medical Center, Bronx, NY, USA; 5Pain Management, Indiana Spine Group, Indianapolis, IN, USA; 6Pain Management, Spanish Hills Interventional Pain Specialists, Camarillo, CA, USA; 7Pain Management, Saint Louis Pain Consultants, Chesterfield, MO, USA; 8Pain Management, Napa Valley Orthopedic Medical Group, Napa, CA, USA; 9Pain Management, Robert Wood Johnson University Hospital, New Brunswick, NJ, USA; 10Pain Management, Nevada Advanced Pain Specialists, Reno, NV, USA; 11Pain Management, the Orthopedic Institute, Gainesville, FL, USA; 12Pain Management, Coastal Pain & Spinal Diagnostics Medical Group, Carlsbad, CA, USA; 13Pain Management, Banner University Medical Center, Tucson, AZ, USA; 14Pain Management, Rhode Island Hospital, Providence, RI, USA; 15Neuromodulation, Abbott Labs, Austin, TX, USA; 16Orthopaedic spine Surgery, Connecticut Orthopedics, Hamden, CT, USA*These authors contributed equally to this workCorrespondence: Timothy Deer, Pain Management, The Spine and Nerve Center of the Virginias, 400 Court Street, Suite 100, Charleston, WV, 25301, USA, Tel +1 304 347 – 6120, Fax +1 304 347 – 6126, Email doctdeer@aol.comAim: Low Back Pain (LBP) is a prevalent condition. Spinal cord stimulation (SCS) has emerged as a more effective, long-term treatment compared to conventional medical management (CMM). The DISTINCT study enrolled and randomized chronic LBP patients with no indication of traditional spine surgery. This analysis focuses comparing study outcomes on patients initially randomized to receive CMM treatment and subsequently crossed over to SCS after 6 months.Purpose: To compare the therapeutic effectiveness and cost-efficiency of passive recharge burst SCS to CMM.Patients and Methods: A total of 269 patients were enrolled with 162 randomly assigned to SCS and 107 to CMM. The DISTINCT study design allowed a crossover to the alternative treatment arm after 6 months. Patients underwent a trial and received a permanent implant if they reported ≥ 50% pain reduction. Outcome analysis included pain (NRS), disability (ODI), catastrophizing (PCS), quality of life (PROMIS-29) and health care utilization.Results: Seventy out of eighty-one patients opted to cross over to trial SCS at 6M with 94% (66/70) undergoing a trial. Among those, 88% (58/66) reported a ≥ 50% or more pain relief and 55 received a permanent implant. At 12M visit, 71.4% reported a ≥ 50% pain improvement sustained at the 18M visit, with 24.5% (12/49) indicating a ≥ 80% improvement. Disability reductions (79% meeting the minimally important difference of a 13-point decrease), decreased catastrophizing, and significant improvements in all PROMIS-29 domains were noted. Furthermore, 42% of the patients reported decreased or discontinued opioid usage. Clinical benefits at the 12M visit were sustained through the 18M visit accompanied by a significant reduction in healthcare utilization and a $1214 cost savings.Conclusion: SCS demonstrates superior, long-term performance and safety outcomes compared to CMM therapy in LBP patients who received both CMM and SCS therapy. Additionally, SCS patients experienced reduced healthcare resource utilization and lower costs compared to those receiving CMM.Keywords: DISTINCT, low back pain, BurstDR, spinal cord stimulation, healthcare utilization, persistent spinal pain syndrome, neuromodulation

This study describes the dissolution release profiles of nicotine and flavor markers from three loose moist smoke-less tobacco (MST) products, same brand, each made with a distinct flavor. The US Pharmacopeia flow-through cell dissolution apparatus 4 (USP-4) was employed, following a previously published method that was validated to study the nicotine release from MST products. Herein, we expanded the scope of the analytical method by incorporating three flavor markers including methyl salicylate, ethyl salicylate, and glycyrrhizic acid to provide an understanding of the dissolution release profiles of not only nicotine but also of flavor markers. The dissolution release profiles of nicotine were found to be equivalent across all three tobacco products. In contrast, the release profiles of the studied flavor markers exhibited distinct differences, primarily influenced by their chemical properties, particularly polarity. Notably, glycyrrhizic acid demonstrated the most rapid release rate, while ethyl salicylate exhibited the slowest release rate. This study serves as a valuable resource for researchers, manufacturers, and regulatory bodies involved in the evaluation of MST products attributes and performance.

This essay explores how artifice and queer form in Bertrand Mandico’s film The Wild Boys (2017. Dir. Bertrand Mandico. Ecce Films) interrogate more-than-human entanglements to orient viewers toward a trans ecology. In Mandico’s botanical imaginary, he crafts a world of excessive artifice where both the characters and the land in which they inhabit are entirely mutable. By creating a polymorphously perverse world where there is no such thing as a hermetically sealed body, Mandico uses plants to explore the possibilities of transness and how it may provide a focus for epistemological positions, knowledge, and orientations toward a post-anthropocentric future.

Jaimee K Miller, Simon L Evans School of Psychology, Faculty of Health and Medical Sciences, University of Surrey, Guildford, GU2 7XH, UKCorrespondence: Jaimee K Miller, Email jaimeekmiller@outlook.comObjective: Poor sleep among young adults is prevalent, yet the mediating variables are largely understudied, and there is limited relevant work utilizing objective sleep measures. The present study investigated the mediating effects of perceived stress and rumination in the relationship between trait mindfulness and subjective and objective sleep quality in young adults.Methods: A total of 170 healthy adults (aged 18– 37, M = 20.8, SD = 2.9) self-reported on trait mindfulness, perceived stress, and rumination. The primary (N = 140) and secondary (N = 30) samples both completed the Pittsburgh Sleep Quality Index (PSQI) to assess subjective sleep quality. The secondary sample (N = 30) additionally provided sleep diaries, as well as wrist-worn actigraphy data for assessing objective sleep quality. A mediation analysis was conducted to assess the effect of trait mindfulness on sleep quality with perceived stress and rumination as mediators.Results: Trait mindfulness was positively associated with better subjective sleep quality; this was fully mediated by perceived stress, b = − 0.08, 95% CI [− .12, − 0.06]. Rumination was negatively associated with subjective sleep quality but did not mediate the relationship between trait mindfulness and sleep quality, b = − 0.01, 95% CI [− .03, 0.02]. Only trait mindfulness was correlated with diary-based sleep ratings, and none of the measures were associated with actigraphy-based sleep quality.Conclusion: This study indicates that perceived stress is an important mediator in the relationship between trait mindfulness and subjective sleep quality among young adults, rather than rumination. These findings have implications for mindfulness-based therapeutic approaches to address the high prevalence of sleep disorders among young adults, adding mechanistic detail to the literature.Keywords: mindfulness, perceived stress, rumination, sleep

This study explores the pivotal concept of “objective possibility” within Lukács’s History and Class Consciousness, a concept that has received less attention compared to more prominent ideas such as reification or totality. Lukács frequently refers to “objective possibility” and related terms in essays like “What Is Orthodox Marxism?” and “Class Consciousness,” emphasizing its importance in understanding class consciousness theoretically. The term’s roots for Lukács derive from Max Weber’s methodological writings, which drew from John Stuart Mill and Johannes von Kries and applied to historical and social causation. However, Lukács diverges from Weber’s use, focusing not on counterfactual historical events but on latent historical tensions in the present that can be actualized through collective action. The study argues that Lukács integrates Weberian objective possibility with Marxist and Hegelian language, utilizing it within a modal social ontology. This approach allows Lukács to theorize key questions of class consciousness, historical action, and revolution. By drawing on Hegel’s dialectics of possibility, actuality, and necessity, as well as Marxian contradictions in material conditions, Lukács reconfigures objective possibility from a heuristic tool for the writing of history to an ontologically significant element in the field of historical action.