Barriers to non-small cell lung cancer trial eligibility

Introduction: Cancer clinical trial (CCT) enrollment is low potentially threatening the generalizability of trial results and expedited regulatory approvals. We assessed whether type of initial patient appointment for non-small cell lung cancer (NSCLC) is associated with CCT eligibility. Methods: Using a patient-to-accrual framework, we conducted a quasi-retrospective cohort pilot study at Sidney Kimmel Comprehensive Cancer Center (SKCCC), Baltimore, Maryland. 153 NSCLC patients new to SKCCC were categorized based on type of initial appointment: patients diagnosed or treated and patients seen for a consultation. CCT eligibility was determined by comparing eligibility criteria for each open trial to the electronic medical record (EMR) of each patient at every office visit occurring within 6-months of initial visit. Results: We found no association between type of initial appointment and CCT eligibility (OR, 1.15; 95% CI, 0.49–2.73). Analyses did suggest current smokers were less likely to be eligible for trials compared to never smokers (OR, 0.15; 95% CI, 0.03–0.64), and stage 4 patients with second line therapy or greater were more likely to be eligible than stage 1 or 2 patients (OR, 5.18; 95% CI, 1.08–24.75). Additional analyses suggested most current smokers and stage 1 or 2 patients had trials available but were still ineligible. Conclusions: SKCCC has a diverse portfolio of trials available for NSCLC patients and should consider research strategies to re-examine eligibility criteria for future trials to ensure increased enrollment of current smokers and stage 1 or 2 patients. We could not confirm whether type of initial visit was related to eligibility

The Effectiveness of Cigarette Pack Health Warning Labels with Religious Messages in an Urban Setting in Indonesia: A Cross-Sectional Study

This study sought to assess the effectiveness of religious cigarette health warning labels (HWLs) in Indonesia, a country with a high public health burden from tobacco use. The study tested different religious and nonreligious messages related to suicide, secondhand smoke (SHS) and gangrene. Participants were smokers and non-smokers from Surabaya, Indonesia (n = 817). Participants rated each HWL for its effectiveness on a scale of 1 to 10 (1 = “not at all”, 10 = “extremely”) with respect to 10 items. Nonreligious HWLs were marginally superior for SHS and suicide while religious HWLs were marginally superior for gangrene. Given the close rating scores between religious and nonreligious HWLs, they were functionally equal in effectiveness. With proper assessment of potential unintended consequences, the implementation of religious HWLs could be considered for a proportion of HWLs

Heterogeneity in sociodemographic characteristics of people who use different ENDS devices

Background: The electronic nicotine delivery systems (ENDS) market is heterogeneous with a wide variety of devices and liquids available to consumers. People with distinct sociodemographic characteristics may have different ENDS device and liquid preferences. Methods: 1290 U.S. adults (21 + ) using ENDS 5 + days/week completed the Wave 5 (February-April 2023) VAPER study survey and submitted photos of their most used ENDS device and liquid. Latent class analysis (LCA) was performed based on sociodemographic characteristics and cigarette smoking status to identify groups among respondents. We examined the association between identified groups and the device (disposable device/disposable pod/refillable pod/tank, power/airflow/coil modifiability)/liquid (nicotine salt/freebase) groupings found by exploratory factor analysis. Results: Among our sample, there were three groups of adults frequently using ENDS: (1) group of women who are older, heterosexual, and have smoked cigarettes (62 % of the sample); (2) group of men who are higher-income and heterosexual (23 % of the sample); and (3) group of women who are younger and LGBTQ+ (16 % of the sample). The third group was more likely to use non-adjustable disposable devices with a nicotine salt liquid and less likely to use adjustable tanks with a freebase liquid than the other two groups (p < 0.001). Conclusions: We found three distinct groups of adults frequently using ENDS. The group of younger LGBTQ + women was different from the other two groups in use of device and liquid characteristics. Our findings can enhance understanding of people using ENDS and inform the expected impacts of ENDS regulatory efforts to protect public health

The Effectiveness of Cigarette Pack Health Warning Labels with Religious Messages in an Urban Setting in Indonesia: A Cross-Sectional Study

This study sought to assess the effectiveness of religious cigarette health warning labels (HWLs) in Indonesia, a country with a high public health burden from tobacco use. The study tested different religious and nonreligious messages related to suicide, secondhand smoke (SHS) and gangrene. Participants were smokers and non-smokers from Surabaya, Indonesia (n = 817). Participants rated each HWL for its effectiveness on a scale of 1 to 10 (1 = “not at all”, 10 = “extremely”) with respect to 10 items. Nonreligious HWLs were marginally superior for SHS and suicide while religious HWLs were marginally superior for gangrene. Given the close rating scores between religious and nonreligious HWLs, they were functionally equal in effectiveness. With proper assessment of potential unintended consequences, the implementation of religious HWLs could be considered for a proportion of HWLs

Intravesical electrical stimulation treatment for overactive bladder: An observational study

Purpose: Intravesical electrical stimulation treatment (IVES) has been successfully used to treat neurogenic bladder. We report the results of an observational study regarding the use of IVES for women with overactive bladder syndrome (OAB) and/or urgency urinary incontinence (UUI). Materials and Methods: IVES was performed in women with OAB (defined by frequency ≥8/day, nocturia ≥2/night, or ≥3 episodes of UUI on 3-day voiding diary) who failed prior medical therapy. Subjects underwent 4 weeks of treatment with an 8-Fr Detruset™ IVES catheter. Primary outcome was Patient Global Impression of Improvement (PGI-I) at 3 months. Secondary outcomes included Visual Analog Scale (VAS), Short Form OAB Questionnaire (OAB-q SF), Pelvic Floor Distress Inventory (PFDI), Pelvic Floor Impact Questionnaire (PFIQ), reduction in frequency and UUI on voiding diary, and adverse effects. Analysis was done with paired t-tests and Wilcoxon signed rank tests. Results: Seventeen subjects completed the study. At 4 weeks post-treatment, 15 improved on PGI-I (11 subjects: ‘a little better’, 2: ‘much better’, 2: ‘very much better’). There were significant improvements in symptom bother and health-related quality of life as measured by OAB-q SF and pelvic organ prolapse and urinary distress as measured by PFDI. Frequency decreased from 10.3±4.3 at baseline to 8.9±2.3 (p=0.04) at 3 months. No pain was reported during treatment. There was one urinary tract infection during the study period. No other adverse events were reported. Conclusions: IVES appears to be a safe and effective novel treatment for OAB. Larger comparative studies are needed to investigate its potential for long-term treatment

Agreement Between Self-reports and Photos to Assess e-Cigarette Device and Liquid Characteristics in Wave 1 of the Vaping and Patterns of e-Cigarette Use Research Study: Web-Based Longitudinal Cohort Study

Backgrounde-Cigarette device and liquid characteristics are highly customizable; these characteristics impact nicotine delivery and exposure to toxic constituents. It is critical to understand optimal methods for measuring these characteristics to accurately assess their impacts on user behavior and health. ObjectiveTo inform future survey development, we assessed the agreement between responses from survey participants (self-reports) and photos uploaded by participants and the quantity of usable data derived from each approach. MethodsAdult regular e-cigarette users (≥5 days per week) aged ≥21 years (N=1209) were asked questions about and submitted photos of their most used e-cigarette device (1209/1209, 100%) and liquid (1132/1209, 93.63%). Device variables assessed included brand, model, reusability, refillability, display, and adjustable power. Liquid variables included brand, flavor, nicotine concentration, nicotine formulation, and bottle size. For each variable, percentage agreement was calculated where self-report and photo data were available. Krippendorff α and intraclass correlation coefficient (ICC) were calculated for categorical and continuous variables, respectively. Results were stratified by device (disposable, reusable with disposable pods or cartridges, and reusable with refillable pods, cartridges, or tanks) and liquid (customized and noncustomized) type. The sample size for each calculation ranged from 3.89% (47/1209; model of disposable devices) to 95.12% (1150/1209; device reusability). ResultsPercentage agreement between photos and self-reports was substantial to very high across device and liquid types for all variables except nicotine concentration. These results are consistent with Krippendorff α calculations, except where prevalence bias was suspected. ICC results for nicotine concentration and bottle size were lower than percentage agreement, likely because ICC accounts for the level of disagreement between values. Agreement varied by device and liquid type. For example, percentage agreement for device brand was higher among users of reusable devices (94%) than among users of disposable devices (75%). Low percentage agreement may result from poor participant knowledge of characteristics, user modifications of devices inconsistent with manufacturer-intended use, inaccurate or incomplete information on websites, or photo submissions that are not a participant’s most used device or liquid. The number of excluded values (eg, self-report was “don’t know” or no photo submitted) differed between self-reports and photos; for questions asked to participants, self-reports had more usable data than photos for all variables except device model and nicotine formulation. ConclusionsPhotos and self-reports yield data of similar accuracy for most variables assessed in this study: device brand, device model, reusability, adjustable power, display, refillability, liquid brand, flavor, and bottle size. Self-reports provided more data for all variables except device model and nicotine formulation. Using these approaches simultaneously may optimize data quantity and quality. Future research should examine how to assess nicotine concentration and variables not included in this study (eg, wattage and resistance) and the resource requirements of these approaches