Assessment of Rehabilitation Journal Requirements for the Use of Reporting Guidelines and Clinical Trial Registration.

OBJECTIVE: To assess reporting guideline and clinical trial registration requirements in rehabilitation journals. DESIGN: We examined rehabilitation journals with 5-year impact factors exceeding 1.00 from the 2021 Scopus CiteScore tool, alongside the 28 journals included in the 2014 rehabilitation and disability quality improvement initiative. Journals outside the traditional rehabilitation scope were excluded. SETTING: A publicly-funded academic health center in the United States. PARTICIPANTS AND INTERVENTIONS: N/A. MAIN OUTCOME MEASURE(S): The proportion of journals requiring/recommending reporting guideline use and clinical trial registration. RESULTS: Over 90% (57/63) of journals required/recommended clinical trial reporting guidelines, while 68% (39/57) specified guideline requirements for systematic review/meta-analysis protocols. The 2014 collaborative initiative journals demonstrated higher rates of requiring/recommending reporting guidelines for clinical trials (24/26; 92.3%), systematic reviews/meta-analyses (23/26; 88.5%), observational studies in epidemiology (22/25; 88%), and diagnostic accuracy studies (20/24; 83.3%). Conversely, the 2021 Scopus CiteScore journals displayed higher rates for the remaining study designs. Overall, 52/63 (82.5%) journals required/recommended trial registration. Trial registration policies were comparable, with a slight advantage favoring the 2021 Scopus CiteScore journals. CONCLUSION: Rehabilitation journals variably promoted reporting guideline use and clinical trial registration. Common study designs like clinical trials, observational studies in epidemiology, and diagnostic accuracy studies demonstrated robust requirement/recommendation rates, while less common designs like economic evaluations and animal research had suboptimal rates. Journals can enhance reporting guideline use and trial registration by directing authors to the EQUATOR Network, requiring adherence to registration and reporting standards, and clarifying language in author instructions.

Clinical Outcomes Among Immunotherapy-Treated Patients With Primary Cardiac Soft Tissue Sarcomas: A Multicenter Retrospective Study.

Background: Primary cardiac soft tissue sarcomas (CSTS) affect young adults, with dismal outcomes. Objectives: The aim of this study was to investigate the clinical outcomes of patients with CSTS receiving immune checkpoint inhibitors (ICIs). Methods: A retrospective, multi-institutional cohort study was conducted among patients with CSTS between 2015 and 2022. The patients were treated with ICI-based regimens. The Kaplan-Meier method was used to estimate overall survival (OS) and progression-free survival (PFS). Objective response rates were determined according to Response Evaluation Criteria in Solid Tumors version 1.1. Treatment-related adverse events were graded per the Common Terminology Criteria for Adverse Events version 5.0. Results: Among 24 patients with CSTS, 17 (70.8%) were White, and 13 (54.2%) were male. Eight patients (33.3%) had angiosarcoma. At the time of ICI treatment, 18 patients (75.0%) had metastatic CSTS, and 4 (16.7%) had locally advanced disease. ICIs were administered as the first-line therapy in 6 patients (25.0%) and as the second-line therapy or beyond in 18 patients (75.0%). For the 18 patients with available response data, objective response rate was 11.1% (n = 2 of 18). The median PFS and median OS in advanced and metastatic CSTS (n = 22) were 5.7 months (95% CI: 2.8-13.3 months) and 14.9 months (95% CI: 5.7-23.7 months), respectively. The median PFS and OS were significantly shorter in patients with cardiac angiosarcomas than in those with nonangiosarcoma CSTS: median PFS was 1.7 vs 11 months, respectively (P < 0.0001), and median OS was 3.0 vs 24.0 months, respectively (P = 0.008). Any grade treatment-related adverse events occurred exclusively in the 15 patients with nonangiosarcoma CSTS (n = 7 [46.7%]), of which 6 (40.0%) were grade ≥3. Conclusions: Although ICIs demonstrate modest activity in CSTS, durable benefit was observed in a subset of patients with nonangiosarcoma, albeit with higher toxicity.

Ki-67 Proliferation Index Is Associated With Tumor Grade and Survival in Pleural Epithelioid Mesotheliomas.

Pleural epithelioid mesothelioma (PEM) is divided into low and high grades based on nuclear atypia, mitoses, and necrosis in the tumor. Assessing mitoses and nuclear atypia tend to be labor-intensive with limited reproducibility. Ki-67 proliferation index was shown to be a prognostic factor in PEM, but its performance has not been directly correlated with tumor grade or mitotic score. This study evaluated the potential of Ki-67 index as a surrogate of tumor grade. We also compared the predictability of mitoses and Ki-67 index for overall survival (OS). Ninety-six PEM samples from 85 patients were identified from the surgical pathology file during 2000-2021 at our institution, and all glass slides were reviewed by 2 pulmonary pathologists to confirm the diagnosis and assign the tumor grade. Digital image analysis (DIA) was done for Ki-67 index. The agreement on tumor grading between 2 reviewers was moderate (kappa value = 0.47). The correlation between mitotic count (average count by 2 reviewers) and Ki-67 index was 0.65. The areas under the curve for predicting tumor grade by mitotic score and Ki-67 index were 0.84 and 0.74 (reviewer 1) and 0.85 and 0.81 (reviewer 2), respectively. High Ki-67 index and mitoses were significantly associated with poor OS ( P =0.03 and 0.0005, using 30% and 10/2 mm 2 as cutoffs, respectively). In conclusion, Ki-67 index by DIA was associated with tumor grade as well as mitotic count, and its predictability for OS was comparable to that of mitotic score, thus being a potential surrogate for tumor grade.

Examining crossover and postprotocol therapies in first-line immunotherapy trials in non-small cell lung cancer (NSCLC).

BACKGROUND: Immune checkpoint inhibitor (ICI) therapy has led to significant improvement in outcomes for patients with nononcogene-driven advanced non-small cell lung cancer (NSCLC). The rate of crossover and receipt of postprotocol ICI in frontline trials for advanced NSCLC has not been systematically evaluated. METHODS: ClinicalTrials.gov was used to identify phase 3 studies evaluating the use of immunotherapy or combination chemoimmunotherapy against chemotherapy alone in the frontline management of advanced NSCLC. Data on outcomes, rate of crossover and/or subsequent post-protocol receipt of immunotherapy, and the start dates of these clinical trials were then extracted. RESULTS: Twenty-three frontline trials in nononcogene-driven advanced NSCLC were identified. Six trials with ICI monotherapy/dual ICI therapy and 17 trials evaluating chemotherapy/ICI in first-line advanced NSCLC were included in the analysis. The crossover rate ranged 0% to 54% in ICI monotherapy/dual ICI trials and 0% to 52% in chemotherapy/ICI trials. Nineteen of 23 trials provided information on subsequent postprotocol therapies. Among the trials not allowing crossover, postprotocol ICI was administered to 17% to 45.8% of patients. Information regarding the eventual receipt of ICI therapy was available for 22 of 23 trials. Of 6631 patients, 2507 (37.8%) randomized to the control arm eventually received ICI therapy. CONCLUSION: The rate of crossover and postprotocol ICI use was low in frontline trials for first-line NSCLC incorporating ICI. Given the proven survival overall survival of ICI in a broad population, there is a need to ensure availability of this life-prolonging therapy in future trials, either by crossover treatment or postprotocol administration.

Endorsement of reporting guidelines and clinical trial registration across Scopus-indexed rheumatology journals: a cross-sectional analysis.

The purpose of this study was to investigate the instructions for authors of rheumatology journals and analyze their endorsement of reporting guidelines and clinical trial registration. Sixty rheumatology journals were selected by a research librarian and an investigator through the 2021 Scopus CiteScore tool. The instructions for authors' subsection of each journal was assessed to determine endorsement of study design-specific reporting guidelines or clinical trial registration. Descriptive statistics were calculated using R (version 4.2.1) and RStudio. Of the 58 journals analyzed, 34 (34/58; 59%) mentioned the EQUATOR Network: an online compendium of best practice reporting guidelines. The most commonly mentioned reporting guidelines were CONSORT with 44 journals (44/58; 75%), and PRISMA with 35 journals (35/58; 60%). The least mentioned guidelines were QUOROM with 56 journals not mentioning the guideline (56/58; 97%), and SRQR with 53 journals not mentioning the guideline (53/57, 93%). Clinical trial registration was required by 38 journals (38/58; 66%) and recommended by 8 journals (8/58; 14%). Our study found that endorsement of reporting guidelines and clinical trial registration within rheumatology journals was suboptimal with great room for improvement. Endorsement of reporting guidelines have shown to not only mitigate bias, but also improve research methodologies. Therefore, we recommend rheumatology journals broadly expand their endorsement of reporting guidelines and clinical trial registration to improve the quality of evidence they publish.

Analysis of Medicare Expenditure for Discarded Infused Cancer Therapeutics From 2017-2020.

OBJECTIVE: To explore patterns in Medicare reimbursement for wasted oncologic and hematologic infusion drugs from 2017 to 2020 and estimate the savings that implementation of the Infrastructure Investment and Jobs Act (IIJA) would have had. METHODS: Using the publicly available Medicare Part B Discarded Drug Units database, we analyzed reimbursement data for discarded antineoplastic and hematology therapies from 2017 to 2020. RESULTS: Medicare Part B utilization data was extracted for 77 therapies. From 2017 to 2020, the median annual dollar value of discarded therapies was $590 million. Every year, bortezomib, azacitidine, cabazitaxel, and decitabine were among the most wasted products, an average 24% waste. The IIJA policy would have impacted a median of 20 oncology agents and resulted in median annual refund of $172 million. Had the top five most discarded therapies been redistributed, they could have treated 18,289 patients. The five most wasted drugs were all dosed by weight and distributed in single-use vials. CONCLUSION: The IIJA could potentially significantly reduce waste or encourage redistribution to treat thousands of additional patients. We propose that a fusion of fixed and weight-based dosing may help reduce wasteful medication administration by offering doses that better accommodate most patients. We anticipate that manufacturers will adapt to the IIJA perhaps by adjusting fixed doses or simply increasing drug prices. If price changes from dose delivery adjustment occur, rebates offered to pharmacy benefit managers and insurers will likely follow suit and may alter formulary positioning.

Real-World Outcomes With Lurbinectedin in Second-Line Setting and Beyond for Extensive Stage Small Cell Lung Cancer.

BACKGROUND: Lurbinectedin has emerged as a potential treatment option for relapsed small cell lung cancer (SCLC). While clinical trials have demonstrated its efficacy and safety, real-world data are limited. This study aimed to evaluate the safety and efficacy of lurbinectedin in a real-world setting, focusing on its use as a second-line agent and beyond in SCLC patients. METHODS: A retrospective analysis was conducted on 90 patients who received lurbinectedin between June 2020 and June 2022 within the Mayo Clinic Health System. Of these, 50 patients received lurbinectedin as a second-line agent, and 14 patients received it as a third-line or later agent. The primary outcomes assessed were overall survival (OS), progression-free survival (PFS), and treatment-related adverse events. RESULTS: Lurbinectedin was generally well tolerated in this real-world cohort, with a median OS of 5.1 months in the second-line cohort and 5.6 months in the third-line or later cohort. Median PFS was 2.1 months in the second-line cohort and 3.4 months in the third-line or later cohort. Adverse events were manageable, with the most common being neutropenia, anemia, fatigue, and febrile neutropenia. No treatment-related deaths or grade 5 toxicities were reported. CONCLUSION: This real-world study provides valuable insights into the safety and efficacy of lurbinectedin in relapsed SCLC. Lurbinectedin demonstrated modest efficacy and a comparable safety profile to that observed in clinical trials. However, outcomes for relapsed SCLC remain suboptimal, particularly for patients with a shorter chemotherapy-free interval and central nervous system metastases.

Effect of Footwear Versus Barefoot on Double-Leg Jump-Landing and Jump Height Measures: A Randomized Cross-Over Study.

Background: Assessing individuals in their own athletic footwear in clinics is common, but can affect movement, performance, and clinical measures. Purpose: The aim was to compare overall Landing Error Scoring System (LESS) scores, injury risk categorization, specific LESS errors, and jump heights between habitual athletic footwear and barefoot conditions. Study design: Randomized cross-over laboratory study. Methods: Eighty healthy individuals (55% male) completed the LESS following standard procedures (i.e., land from a 30-cm box to a distance of 50% of body height and then jump upwards maximally). Participants performed the LESS three times in two randomized conditions: footwear and barefoot. LESS data were extracted from 2D videos to compare group-level mean LESS scores, group-level and individual-level injury risk categorization (5-error threshold), specific landing errors, and jump heights between conditions. Results: LESS scores were significantly greater (0.3 errors, p=0.022) and jump heights were significantly lower (0.6 cm, p=0.029) in footwear than barefoot, but differences were trivial (d = 0.18 and -0.07, respectively) and not clinically meaningful. Although the number of high injury-risk participants was not statistically different at a group level (p=1.000); 27 individuals (33.8%) exhibited a clinically meaningful difference between conditions of one error or more in LESS score, categorization was inconsistent for 16.3% of individuals, and four of the 17 landing errors significantly differed between conditions. Conclusion: At a group level, habitual athletic footwear does not meaningfully influence LESS scores, risk categorization, or jump height. At an individual level, footwear can meaningfully affect LESS scores, risk categorization, and alter landing strategies. Use of consistent protocol and footwear is advised for assessing movement patterns and injury risk from the LESS given the unknown predictive value of this test barefoot. Level of Evidence: Level 3.©The Author(s).

Brainstem astrocytes control homeostatic regulation of caloric intake.

Prolonged high-fat diet (HFD) exposure is associated with hyperphagia, excess caloric intake and weight gain. After initial exposure to a HFD, a brief (24-48 h) period of hyperphagia is followed by the regulation of caloric intake and restoration of energy balance within an acute (3-5 day) period. Previous studies have demonstrated this occurs via a vagally mediated signalling cascade that increases glutamatergic transmission via activation of NMDA receptors located on gastric-projecting neurons of the dorsal motor nucleus of the vagus (DMV). The present study used electrophysiological recordings from thin brainstem slice preparations, in vivo recordings of gastric motility and tone, measurement of gastric emptying rates, and food intake studies to investigate the hypothesis that activation of brainstem astrocytes in response to acute HFD exposure is responsible for the increased glutamatergic drive to DMV neurons and the restoration of caloric balance. Pharmacological and chemogenetic inhibition of brainstem astrocytes reduced glutamatergic signalling and DMV excitability, dysregulated gastric tone and motility, attenuated the homeostatic delay in gastric emptying, and prevented the decrease in food intake that is observed during the period of energy regulation following initial exposure to HFD. Understanding the mechanisms involved in caloric regulation may provide critical insights into energy balance as well as into the hyperphagia that develops as these mechanisms are overcome. KEY POINTS: Initial exposure to a high fat diet is associated with a brief period of hyperphagia before caloric intake and energy balance is restored. This period of homeostatic regulation is associated with a vagally mediated signalling cascade that increases glutamatergic transmission to dorsal motor nucleus of the vagus (DMV) neurons via activation of synaptic NMDA receptors. The present study demonstrates that pharmacological and chemogenetic inhibition of brainstem astrocytes reduced glutamatergic signalling and DMV neuronal excitability, dysregulated gastric motility and tone and emptying, and prevented the regulation of food intake following high-fat diet exposure. Astrocyte regulation of glutamatergic transmission to DMV neurons appears to involve release of the gliotransmitters glutamate and ATP. Understanding the mechanisms involved in caloric regulation may provide critical insights into energy balance as well as into the hyperphagia that develops as these mechanisms are overcome.

Evaluating The Reporting of Patient-Reported Outcomes in Surgical Management of Stress Urinary Incontinence in Women: An Analysis of Randomized Controlled Trials.

BACKGROUND: Stress urinary incontinence (SUI) significantly reduces women's quality of life (QoL). Use of patient-reported outcomes (PROs) is increasing in randomized controlled trials (RCTs), thus standardization is important to ensure reporting completeness. We aim to evaluate completeness of reporting of RCTs for surgical management of SUI in women based on an adaptation of the Consolidated Standards of Reporting Trials statement with PRO extension (CONSORT-PRO). STUDY DESIGN: A literature search was conducted and all RCTs meeting inclusion criteria were evaluated using the CONSORT-PRO adapted checklist and the Cochrane Collaboration risk of bias assessment tool (RoB). We calculated a completion percentage score for each trial's adherence to the CONSORT-PRO adapted checklist and used bivariate regression analysis to examine associations between trial characteristics and completion percentage scores. RESULTS: Forty-three RCTs underwent data extraction and analysis. Mean completion percentage of the CONSORT-PRO was 50.53% (SD = 15.63). A total of 38 (of 43; 88.37%) RCTs received an RoB 2.0 rating of "some concern." RCTs with follow-up longer than 3 months had statistically significantly higher CONSORT-PRO completion: 3-6 months (p = .049), 6-12 months (p = .009), more than 12 months (p = .021). Compared with studies without a conflict of interest statement, studies reporting a conflict of interest (p < .001) or reporting no conflict of interest (p = .048) had higher reporting completeness. CONCLUSIONS: Our results suggest many RCTs addressing surgical management of SUI in women have poor adherence to CONSORT-PRO reporting guidelines. Improving reporting completeness through adherence to the CONSORT-PRO checklist can better inform clinical decision making and improve QoL.

Effect of an overhead goal on landing error scoring system and jump height measures.

OBJECTIVES: Compare overall Landing Error Scoring System (LESS) scores, risk categorisation, specific LESS errors, and double-leg jump-landing jump heights between overhead goal and no goal conditions. DESIGN: Randomised cross-over. SETTING: Laboratory. PARTICIPANTS: 76 (51% male). MAIN OUTCOME MEASURES: Participants landed from a 30-cm box to 50% of their body height and immediately jumped vertically for maximum height. Participants completed three trials under two random-ordered conditions: with and without overhead goal. Group-level mean LESS scores, risk categorisation (5-error threshold), specific landing errors, and jump heights were compared between conditions. RESULTS: Mean LESS scores were greater (0.3 errors, p < 0.001) with the overhead goal, but this small difference was not clinically meaningful. Similarly, although the number of high-risk participants was greater with the overhead goal (p = 0.039), the 9.2% difference was trivial. Participants jumped 2.7 cm higher with the overhead goal (p < 0.001) without affecting the occurrence of any specific LESS errors. DISCUSSION: Performing the LESS with an overhead goal enhances sport specificity and elicits greater vertical jump performances with minimal change in landing errors and injury-risk categorisation. Adding an overhead goal to LESS might enhance its suitability for injury risk screening, although the predictive value of LESS with an overhead goal needs confirmation.

Award rate inequities in biomedical research.

PURPOSE: The analysis of existing institutional research proposal databases can provide novel insights into science funding parity. The purpose of this study was to analyze the relationship between race/ethnicity and extramural research proposal and award rates across a medical school faculty and to determine whether there was evidence that researchers changed their submission strategies because of differential inequities across submission categories. METHOD: The authors performed an analysis of 14,263 biomedical research proposals with proposed start dates between 2010-2022 from the University of Michigan Medical School, measuring the proposal submission and award rates for each racial/ethnic group across 4 possible submission categories (R01 & Equivalent programs, other federal, industry, and non-profit). RESULTS: Researchers from each self-identified racial/ethnic group (Asian, Black/African American, Hispanic/Latino) pursued a different proposal submission strategy than the majority group (White). The authors found that Black/African American researchers experienced negative award rate differentials across all submission categories, which resulted in the lowest R01 & Equivalent and Other Federal submission rates of any racial/ethnic group and the highest submission rate to non-profit sources. The authors did not find support for the hypothesis that researchers changed submission strategies in response to award rate inequalities across submission categories. CONCLUSIONS: Biomedical researchers from different racial/ethnic groups follow markedly different proposal submission strategies within the University of Michigan Medical School. There is also a clear relationship between race/ethnicity and rates of proposal award. Black/African American and Asian researchers appear disadvantaged across all submission categories relative to White researchers. This study can be easily replicated by other academic research institutions, revealing opportunities for positive intervention.

The evaluation of reporting of patient-reported outcomes in MDD: A meta-epidemiological study of clinical trials.

Major depressive disorder (MDD) is a multifaceted disease that profoundly affects quality of life. Patient reported outcomes (PROs) are used in randomized controlled trials (RCTs) to better understand patient perspectives on interventions. Therefore, we sought to assess the completeness of reporting PROs in RCTs addressing MDD. We identified RCTs evaluating MDD containing a PRO measure published between 2016 and 2020 from MEDLINE, Embase, and the Cochrane Central Register of Controlled Trials. Inclusion of studies was performed in duplicate. The completion of reporting of RCTs was assessed using the Consolidated Standards of Reporting Trials (CONSORT-PRO) adaptation. Bivariate regression analyses were used to evaluate reporting completeness and trial characteristics. A total of 49 RCTs were included in our analysis, with a mean CONSORT-PRO completion score of 56.7% (SD = 17.3).Our findings show a significant association with completeness of reporting and the following: secondary PRO trials were less completely reported as compared to primary PRO trials (t = -3.19, p = .003); studies with a follow-up period between six months and year were more completely reported as compared to three months or less (6 months to a year, t = 2.34, p = .024); and increased trial sample size was associated with more completeness of reporting (t = 3.17, p = .003). As compared to brain stimulation, the intervention types classified as combination, other, and psychotherapy had greater completeness of reporting (combination, t = 2.35, p = .024; other, t = 3.13, p = .003; psychotherapy, t = 3.41, p = .001). There were no other significant findings. Our study found the completeness of PRO reporting to be inconsistent in RCTs regarding MDD. Moreover, we advocate for the need to establish a core outcome set relevant to the management of adults diagnosed with MDD and facilitate training on the application of PRO data.

Evaluating a Tobacco Treatment Program's Transition to Telehealth Using a Social Determinants of Health Lens.

INTRODUCTION: While strong associations exist between social determinants of health (SDOH), socioeconomic status, and smoking, these factors are not routinely assessed in tobacco treatment programs (TTP). This study addresses this gap by evaluating a composite metric of SDOH and a measure of access to care to determine program reach before and after the implementation of telehealth tobacco treatment delivery. AIMS AND METHODS: We examined inpatient data from a large TTP during two comparable time periods from April 1, 2019 to September 30, 2019 (pre-telehealth) and from April 1, 2020 to September 30, 2020 (telehealth). The populations were compared using point-of-care data, including 5-digit zip codes mapped to the CDC's Social Vulnerability Index (SVI) and driving distance (in 60-min increments) to the study hospital. Chi-square tests for homogeneity were performed for SVI and driving distance comparisons. RESULTS: While distance distributions were significantly different between the pre-telehealth and telehealth populations (χ 2 = 13.5 (df = 3, N = 3234), p = .004, no significant differences existed in the proportion of SVI categories between the two populations (χ 2 = 5.8 (df = 3, N = 3234), p = .12). In the telehealth population, patients with the highest SVI vulnerability had the greatest proportions living >1 h from the hospital. CONCLUSIONS: This study offers a novel evaluation of tobacco treatment in relation to an SDOH metric (SVI) and care access (distance to the hospital) for inpatient populations. Patient reach, including to those with high vulnerabilities, remained consistent in a transition to telehealth. These methods can inform future reach and engagement of patients who use tobacco products, including patients with high vulnerability or who reside at greater distances from treatment programs. IMPLICATIONS: This study provides the first analysis of inpatient tobacco use treatment (TUT) transition to telehealth delivery of care during the COVID-19 pandemic using the CDC's SVI metric and patient distance to the hospital. The transition resulted in consistent reach to patients at the highest vulnerability. These findings can inform efforts to evaluate SDOH measures and improve reach, engagement, and research on telehealth delivery of inpatient TUT.

Designing More Effective Cigar Warnings: An Experiment Among Adult Cigar Smokers.

INTRODUCTION: Little systematic evidence exists about the effectiveness of cigar warnings. This study examined the perceived message effectiveness (PME) of warning statements about different health consequences caused by cigars. PME is a validated self-report scale of how effectively a health message discourages smoking. AIMS AND METHODS: We conducted an online study from April to May 2020 with adults in the United States who used cigars in the past 30 days (n = 777). Participants were randomly assigned to view and rate PME (three items, range 1-5) for seven out of 37 text warning statements about different health consequences from cigar use. Linear mixed effects models evaluated the most effective warning characteristics (eg, type of health consequence), controlling for repeated measures and participant demographics. RESULTS: Analyses showed that health consequences about the cardiovascular system (B = 0.38), mouth (B = 0.40), other digestive (B = 0.45), respiratory system (B = 0.36), and early death (B = 0.36) were associated with higher PME scores than reproductive health consequences (all p values <.001). Similar results were found for these health consequences compared with addiction (all p values p < .001). We also observed that awareness of the health consequence was associated with higher PME scores (B = 0.19, p < .001) and length of the warning message (number of characters) was associated with lower PME scores (B = -0.007, p = .03). No differences were observed between cancer and noncancer health consequences (p = .27) or health consequences that used plain language versus medical jargon (p = .94). CONCLUSIONS: Our study provides new evidence about the perceived effectiveness of different cigar health warning statements and identifies features that may strengthen statements. IMPLICATIONS: Our study with cigar smokers from across the United States provides much-needed evidence concerning the perceived effectiveness of different cigar health warning statements and features that may strengthen such statements. Mandated cigar warnings in the United States could be strengthened by including health consequences that were perceived as more effective in our study (eg, early death), using health consequences that participants were aware of, and using short warning statements.

Surgical Reduction of Spondylolisthesis During Lumbar Fusion: Are Complications Associated With Slip Correction?

STUDY DESIGN: This was a retrospective cohort study. OBJECTIVE: The objective of this study was to quantify the rates of complication following surgical treatment for symptomatic degenerative and isthmic spondylolisthesis and to examine the association between slip reduction and complication rates. SUMMARY OF BACKGROUND DATA: It is unclear if the degree of spondylolisthesis reduction during lumbar spine fusion in adults influences the rate of surgical complications. METHODS: This is a retrospective cohort study of 1-level and 2-level adult fusion patients with degenerative or isthmic spondylolisthesis. The degree of reduction and complications were calculated, and complication rates between those with and without reduction were compared. RESULTS: The surgical reduction was improved by 1 Meyerding grade in 56.5% of the 140 patients included in this analysis. Of those patients, 60% had a grade 1 spondylolisthesis. In addition, 62.5% of grade 2 slips had an improvement by 1 grade. Surgical reduction during lumbar fusion did not result in a higher rate of complications compared with in situ fusion. CONCLUSIONS: During 1-level or 2-level lumbar fusion for degenerative or isthmic spondylolisthesis, a 1-grade reduction of the slip was achieved in 56% of patients in this retrospective case series. Reduction of the spondylolisthesis was not associated with a higher rate of complication when compared with in situ fusion. LEVEL OF EVIDENCE: Level IV.

An Analysis of Inpatient Tobacco Use Treatment Transition to Telehealth.

INTRODUCTION: During the COVID-19 pandemic, many tobacco users increased their tobacco use, and calls to quitlines decreased. Among inpatients, the pandemic also necessitated a rapid transition of intensive tobacco use counseling to telehealth counseling. No data exist comparing the outcomes of telehealth inpatient counseling with in-person (pre-telehealth) counseling. AIMS AND METHODS: We examined inpatient data from a large tobacco treatment program (TTP) during two comparable time periods 04/01/2019-09/30/2019 (pre-telehealth) and 04/01/2020-09/30/2020 (telehealth). The pre-telehealth and telehealth populations were compared using Pearson's chi-square test for homogeneity on each populations' patient, visit, and medication acceptance characteristics. Reach to "current tobacco users" was analyzed using TTP flowsheet and electronic health record (EHR) data in relation to aggregate EHR data in the data warehouse. RESULTS: Mean monthly tobacco treatment inpatient counseling and outreach visits increased 38.9% in the telehealth period (M = 376, SD = 36.7) compared with the pre-telehealth period (M = 271, SD = 50.0) (t(10) = 3.8, p = .004). Reach significantly increased from 32.8% to 65.9% among all "current tobacco users" admitted, including 31.8% to 66.6% in races at higher risk for COVID-19 severe disease. Pearson's chi-square tests for homogeneity showed significant differences in the pre-telehealth and telehealth population distributions for age, visit type, ethnicity, and medication acceptance. CONCLUSIONS: This study offers the first understanding of characteristics of patients, visits, and medication acceptances in pre-telehealth and telehealth tobacco use treatment for inpatient populations. Larger reach and counseling were identified in the telehealth population. This study's findings on inpatient tobacco use treatment can inform future reach and engagement of large numbers of patients who use tobacco products. IMPLICATIONS: This study provides the first analysis of inpatient tobacco use treatment transition to telehealth delivery of care during the COVID-19 pandemic. The transition resulted in increases in reach and cessation counseling. These findings can inform efforts to improve reach, engagement, and research on telehealth delivery of inpatient tobacco use treatment.

Facile method to incorporate high-affinity ACAT/SOAT1 inhibitor F12511 into stealth liposome-based nanoparticle and demonstration of its efficacy in blocking cholesteryl ester biosynthesis without overt toxicity in neuronal cell culture.

BACKGROUND: Acyl-CoA:cholesterol acyltransferase (ACAT) inhibitors have been considered as potential therapeutic agents to treat several diseases, including Alzheimer's disease, atherosclerosis, and cancer. While many ACAT inhibitors are readily available, methods to encapsulate them as nanoparticles have not been reported. NEW METHOD: We report a simple method to encapsulate ACAT inhibitors, using the potent hydrophobic ACAT inhibitor F12511 as an example. By mixing DSPE-PEG2000, egg phosphatidylcholine (PC), and F12511 in ethanol, followed by drying, resuspension and sonication in buffer, we show that F12511 can be encapsulated as stealth liposomes at high concentration. RESULTS: We successfully incorporated F12511 into nanoparticles and found that increasing PC in the nanoparticles markedly increased the amount of F12511 incorporated in stealth liposomes. The nanoparticles containing F12511 (Nanoparticle F) exhibit average size of approximately 200 nm and are stable at 4 ºC for at least 6 months. Nanoparticle F is very effective at inhibiting ACAT in human and mouse neuronal and microglial cell lines. Toxicity tests using mouse primary neuronal cells show that F12511 alone or Nanoparticle F added at concentrations from 2 to 10 µM for 24-, 48-, and 72-hours produces minimal, if any, toxicity. COMPARISON WITH EXISTING METHOD(S): Unlike existing methods, the current method is simple, cost effective, and can be expanded to produce tagged liposomes to increase specificity of delivery. This also offers opportunity to embrace water soluble agent(s) within the aqueous compartment of the nanoparticles for potential combinatorial therapy. CONCLUSIONS: This method shows promise for delivery of hydrophobic ACAT inhibitors at high concentration in vivo.