Real-world diagnostic potential of bacterial biomarkers of canine periodontitis.

Introduction: The objective of this study was to investigate the diagnostic potential of bacterial biomarkers by comparing the performance of molecular detection assays with clinical assessments of dog's oral health performed by veterinarians. Methods: Supragingival and subgingival plaque samples were collected from 127 client-owned dogs, pre-booked for procedures under general anesthesia, visiting veterinary practices in the United States. DNA was extracted and bacterial biomarkers quantified using quantitative polymerase chain reaction. Gingivitis and periodontitis were recorded by a trained clinician using the Weighted Gingivitis Periodontitis Score which involved assessing the buccal surfaces of 18 teeth while under general anesthesia. Intraoral dental radiographs of the left and right mandibular first molar teeth were also obtained. These data were then used to establish the diagnostic performance of the molecular assay to detect periodontitis. Results: An initial conscious, visual oral examination performed by the veterinarian identified 67.7% of dogs as having periodontitis, but examination under general anesthesia indicated a higher proportion (86.6%). Analysis of supragingival plaque samples collected by veterinarians from conscious and unconscious dogs demonstrated the assay had an accuracy of 77.7 to 80.9%, a sensitivity of 77.6 to 81.0%, and a specificity of 80.0%. Discussion: Use of this molecular screening tool in conscious dogs has the potential to improve early periodontal disease detection and support veterinary decision making, ultimately improving the oral health of dogs and consequently their quality of life.

Decídetexto: Mobile cessation support for Latino adults who smoke. A randomized clinical trial.

BACKGROUND: Latino adults experience multiple barriers to healthcare access and treatment that result in tobacco-related disparities. Mobile interventions have the potential to deliver smoking cessation treatment among Latino adults, the highest users of mobile technologies. RESEARCH QUESTION: Is Decídetexto, a culturally accommodated mobile health intervention, more effective for smoking cessation compared to standard care among Latino adults who smoke? STUDY DESIGN AND METHODS: A two-arm parallel group randomized clinical trial (RCT) was conducted in Kansas, New Jersey, and New York between October 2018 and September 2021. Eligible Latino adults who smoke (n=457) were randomly assigned to Decídetexto or a standard care group. The primary outcome was biochemically verified 7-day smoking abstinence at week 24. Secondary outcomes included self-reported 7-day smoking abstinence at weeks 12 and 24, and uptake and adherence of nicotine replacement therapy (NRT). RESULTS: Participants mean age was 48.7 (SD 11.1) years, 45.2% were female, and 50.3% smoked ≥10 cigarettes per day. Two hundred twenty-nine participants were assigned to Decídetexto and 228 to standard care. Treating those lost to follow-up as participants who continued smoking, 14.4% of participants in the Decídetexto group were biochemically verified abstinent at week 24 compared to 9.2% in the standard care group (OR 1.66 [95% CI, 0.93-2.97], p=0.09). Treating those lost to follow-up as participants who continued smoking, 34.1% of the participants in the Decídetexto group self-reported smoking abstinence at week 24 compared to 20.6% of participants in the standard care group (OR 1.99 [95%, 1.31-3.03]; p<0.001). Analyzing only participants who completed the assessment at week 24, 90.6% (174/192) of participants in the Decídetexto group self-reported using NRT for at least one day compared to 70.2% (139/198) of participants in standard care (OR 4.10 [95% CI, 2.31-7.28]; p<0.01). INTERPRETATION: Among Latino adults who smoke, the Decídetexto intervention was not associated with a statistically significant increase in biochemically verified abstinence at week 24. However, the Decídetexto intervention was associated with a statistically significant increase in self-reported 7-day smoking abstinence at weeks 12 and 24, and uptake of NRT. This RCT provides encouragement for the use of Decídetexto for smoking cessation among Latino adults. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT03586596.

Premalignant Progression in the Lung: Knowledge Gaps and Novel Opportunities for Interception of Non-Small Cell Lung Cancer. An Official American Thoracic Society Research Statement.

Rationale: Despite significant advances in precision treatments and immunotherapy, lung cancer is the most common cause of cancer death worldwide. To reduce incidence and improve survival rates, a deeper understanding of lung premalignancy and the multistep process of tumorigenesis is essential, allowing timely and effective intervention before cancer development. Objectives: To summarize existing information, identify knowledge gaps, formulate research questions, prioritize potential research topics, and propose strategies for future investigations into the premalignant progression in the lung. Methods: An international multidisciplinary team of basic, translational, and clinical scientists reviewed available data to develop and refine research questions pertaining to the transformation of premalignant lung lesions to advanced lung cancer. Results: This research statement identifies significant gaps in knowledge and proposes potential research questions aimed at expanding our understanding of the mechanisms underlying the progression of premalignant lung lesions to lung cancer in an effort to explore potential innovative modalities to intercept lung cancer at its nascent stages. Conclusions: The identified gaps in knowledge about the biological mechanisms of premalignant progression in the lung, together with ongoing challenges in screening, detection, and early intervention, highlight the critical need to prioritize research in this domain. Such focused investigations are essential to devise effective preventive strategies that may ultimately decrease lung cancer incidence and improve patient outcomes.

Estimating the Effects of Cancer Screening in Clinical Practice Settings: The Role of Selective Uptake and Suboptimal Adherence along the Cancer Screening Continuum.

Randomized controlled trials (RCT) are the gold standard in determining efficacy of cancer screening tests. Yet, systematic differences between RCT and the general populations eligible for screening raise concerns about the generalizability and relevance of RCT findings to guide the development and dissemination of cancer screening programs. Observational studies from clinical practice settings have documented selective uptake in screening-i.e., variation across subgroups regarding who is screened and not screened-as well as suboptimal adherence to screening recommendations, including follow-up of positive findings with subsequent imaging studies and diagnostic invasive procedures. When the effectiveness of a screening intervention varies across subgroups, and there is selective uptake and suboptimal adherence to screening in clinical practice relative to that in the RCT, the effects of screening reported in RCTs are not expected to generalize to clinical practice settings. Understanding the impacts of selective uptake and suboptimal adherence on estimates of the effectiveness of cancer screening in clinical practice will generate evidence that can be used to inform future screening recommendations and enhance shared decision-making tools.

Nivolumab plus ipilimumab combination therapy in patients with advanced hepatocellular carcinoma previously treated with sorafenib: 5-year results from CheckMate 040.

BACKGROUND: Nivolumab plus ipilimumab demonstrated promising clinical activity and durable responses in sorafenib-treated patients with advanced hepatocellular carcinoma (HCC) in the CheckMate 040 study at 30.7-month median follow-up. Here, we present 5-year results from this cohort. PATIENTS AND METHODS: Patients were randomized 1 : 1 : 1 to arm A [nivolumab 1 mg/kg plus ipilimumab 3 mg/kg Q3W (four doses)] or arm B [nivolumab 3 mg/kg plus ipilimumab 1 mg/kg Q3W (four doses)], each followed by nivolumab 240 mg Q2W, or arm C (nivolumab 3 mg/kg Q2W plus ipilimumab 1 mg/kg Q6W). The primary objectives were safety, tolerability, investigator-assessed objective response rate (ORR), and duration of response (DOR) per RECIST version 1.1. RESULTS: A total of 148 patients were randomized across treatment arms. At 60-month minimum follow-up (62.6-month median follow-up), the ORR was 34% (n = 17), 27% (n = 13), and 29% (n = 14) in arms A, B, and C, respectively. The median DOR was 51.2 months [95% confidence interval (CI) 12.6 months-not estimable (NE)], 15.2 months (95% CI 7.1 months-NE), and 21.7 months (95% CI 4.2 months-NE), respectively. The median overall survival (OS) was 22.2 months (34/50; 95% CI 9.4-54.8 months) in arm A, 12.5 months (38/49; 95% CI 7.6-16.4 months) in arm B, and 12.7 months (40/49; 95% CI 7.4-30.5 months) in arm C; 60-month OS rates were 29%, 19%, and 21%, respectively. In an exploratory analysis of OS by response (6-month landmark), the median OS was meaningfully longer for responders versus nonresponders for all arms. No new safety signals were identified with longer follow-up. There were no new discontinuations due to immune-mediated adverse events since the primary analysis. CONCLUSIONS: Consistent with the primary analysis, the arm A regimen of nivolumab plus ipilimumab continued to demonstrate clinically meaningful responses and long-term survival benefit, with no new safety signals in patients with advanced HCC following sorafenib treatment, further supporting its use as a second-line treatment in these patients.

Puzzling undetectable haptoglobin in a transfused pregnant patient.

BACKGROUND-AIM: Pregnancy induces physiological changes that can affect serologic and immunologic markers, potentially resulting in lower or undetectable haptoglobin values compared to non-pregnant counterparts. Such variations may lead to inaccurate diagnosis of hemolysis. METHODS: We report a case of a patient in second trimester of pregnancy receiving induction chemotherapy due to B-cell acute lymphocytic leukemia with undetectable haptoglobin levels in a routine laboratory sample collected less than 12 h posttransfusion of red cell unit. Despite undetectable haptoglobin, lactate dehydrogenase (LD) was within reference intervals (RI). The patient was evaluated for acute hemolytic transfusion reaction (AHTR) and followed up. Haptoglobin levels showed an upward trend during follow-up visits, reaching 15 mg/dL, and within RI in the third trimester. RESULTS: The patient did not meet the Center for Disease Control (CDC) criteria for AHTR. Alternative explanations for the observed laboratory findings were explored. Undetectable haptoglobin levels were attributed to various factors, including recent RBC transfusion, pregnancy-related physiological changes, and potential hyperhydration treatment plan due to chemotherapy. CONCLUSION: This case underscores the importance of cautious interpretation of laboratory results in pregnant patients, necessitating trimester-specific reference intervals for haptoglobin. A multidisciplinary approach to patient care is crucial for accurate diagnosis and management.

Increasing Uptake of Lung Cancer Screening Among Emergency Department Patients: A Pilot Study.

BACKGROUND: Lung cancer is the leading cause of cancer death in the United States. Lung cancer screening (LCS) decreases lung cancer mortality. Emergency department (ED) patients are at disproportionately high risk for lung cancer. The ED, therefore, is an optimal environment for interventions to promote LCS. OBJECTIVES: Demonstrate the operational feasibility of identifying ED patients in need of LCS, referring them to LCS services, deploying a text message intervention to promote LCS, and conducting follow-up to determine LCS uptake. METHODS: We conducted a randomized clinical trial to determine the feasibility and provide estimates of the preliminary efficacies of 1) basic referral for LCS and 2) basic referral plus a text messaging intervention, grounded in behavioral change theory, to promote uptake of LCS among ED patients. Participants aged 50 to 80, identified as eligible for LCS, were randomized to study arms and followed up at 150 days to assess interval LCS uptake (primary outcome), barriers to screening, and perceptions of the study interventions. RESULTS: A total of 303 patients were surveyed, with 198 identified as eligible for LCS and subsequently randomized. Results indicated that 24% of participants with follow-up data received LCS (11% of the total randomized sample). Rates of screening at follow-up were similar across study arms. The intervention significantly improved normative perceptions of LCS (p = 0.015; Cohen's d = 0.45). CONCLUSION: This pilot study demonstrates the feasibility of ED-based interventions to increase uptake of LCS among ED patients. A scalable ED-based intervention that increases LCS uptake could reduce lung cancer mortality.

Comparing characteristics of individuals screened for lung cancer with 2021 versus 2013 USPSTF recommendations.

We conducted a cross-sectional multi-center study to compare the demographics, clinical characteristics, and lung cancer screening (LCS) results among those eligible for LCS per 2013 vs 2021 US Preventive Services Task Force (USPSTF) recommendations. Statistical tests are two-sided, with p < .05 considered statistically significant. Among 17,702 screened individuals (85.2% 2013 Eligible, 14.8% 2021 Newly Eligible), a higher proportion of those screened per 2021 vs 2013 criteria were female (56.1% vs 48.1%, p < .0001) and non-Hispanic Black (19.3% vs 13.4%, p < .0001). The risk of developing and dying from lung cancer per 1000 was statistically significantly higher among those eligible per 2013 vs 2021 criteria. A higher proportion of LCS exams had an increased suspicion of lung cancer in the 2013 vs 2021 criteria groups. Our data suggest that, as intended, updated 2021 USPSTF recommendations are leading to a higher proportion of LCS exams among non-Hispanic Black individuals and women.

Understanding the perceived benefits, barriers, and cues to action for lung cancer screening among Latinos: A qualitative study.

Introduction: Rates of lung cancer screening among Latinos remain low. The purpose of the study was to understand the perceived benefits, barriers, and cues to action for lung cancer screening among Latinos. Methods: Participants (N=20) were recruited using community-based recruitment strategies. Eligibility criteria included: 1) self-identified as Hispanic/Latino, 2) spoke English and/or Spanish, and 3) met the USA Preventive Services Task Force eligibility criteria for lung cancer screening. Interviews were conducted in Spanish and English, audio recorded, and transcribed verbatim. Using the health belief model, a qualitative theoretical analysis was used to analyze the interviews. Results: Participants' mean age was 58.3 years old (SD=5.8), half of the participants were female, 55% had completed high school or lower educational level, and 55% reported speaking more Spanish than English. All participants were currently smoking. Fourteen participants (70%) were unaware of lung cancer screening, and eighteen (90%) did not know they were eligible for lung cancer screening. Regarding lung cancer screening, participants reported multiple perceived benefits (e.g., smoking cessation, early detection of lung cancer, increased survivorship) and barriers (e.g., fear of outcomes, cost, lung cancer screening not being recommended by their clinician). Lastly, multiple cues to actions for lung cancer screening were identified (e.g., family as a cue to action for getting screened). Conclusions: Most Latinos who were eligible for lung cancer screening were unaware of it and, when informed, they reported multiple perceived benefits, barriers, and cues to action. These factors provide concrete operational strategies to address lung cancer screening among Latinos.

Prevalence of Lung Cancer Screening in the US, 2022.

This cross-sectional study compares lung cancer screening prevalence in 2022 among individuals eligible by 2021 vs 2013 criteria by sociodemographics and state.

Assessment of Advanced Diagnostic Bronchoscopy Outcomes for Peripheral Lung Lesions: A Delphi Consensus Definition of Diagnostic Yield and Recommendations for Patient-centered Study Designs. An Official American Thoracic Society/American College of Chest Physicians Research Statement.

Background: Advanced diagnostic bronchoscopy targeting the lung periphery has developed at an accelerated pace over the last two decades, whereas evidence to support introduction of innovative technologies has been variable and deficient. A major gap relates to variable reporting of diagnostic yield, in addition to limited comparative studies. Objectives: To develop a research framework to standardize the evaluation of advanced diagnostic bronchoscopy techniques for peripheral lung lesions. Specifically, we aimed for consensus on a robust definition of diagnostic yield, and we propose potential study designs at various stages of technology development. Methods: Panel members were selected for their diverse expertise. Workgroup meetings were conducted in virtual or hybrid format. The cochairs subsequently developed summary statements, with voting proceeding according to a modified Delphi process. The statement was cosponsored by the American Thoracic Society and the American College of Chest Physicians. Results: Consensus was reached on 15 statements on the definition of diagnostic outcomes and study designs. A strict definition of diagnostic yield should be used, and studies should be reported according to the STARD (Standards for Reporting Diagnostic Accuracy Studies) guidelines. Clinical or radiographic follow-up may be incorporated into the reference standard definition but should not be used to calculate diagnostic yield from the procedural encounter. Methodologically robust comparative studies, with incorporation of patient-reported outcomes, are needed to adequately assess and validate minimally invasive diagnostic technologies targeting the lung periphery. Conclusions: This American Thoracic Society/American College of Chest Physicians statement aims to provide a research framework that allows greater standardization of device validation efforts through clearly defined diagnostic outcomes and robust study designs. High-quality studies, both industry and publicly funded, can support subsequent health economic analyses and guide implementation decisions in various healthcare settings.

The quality of teaching behaviors in learning environments of DHH students.

Classrooms are complex learning environments, with instruction, climate, and teacher-student interactions playing important roles in students' academic progress. To investigate the learning environments of deaf and hard-of-hearing (DHH) students, we developed a new observational tool called the Quality of the Learning Environment-DHH rating scale (QLE-DHH) and rated 98 teachers of DHH students being educated in a range of classroom environments. The present study sought to (1) determine if the items on the QLE-DHH are good indicators of theoretically meaningful dimensions of classroom quality; (2) determine to what extent these dimensions predicted language and reading outcomes of DHH students; and (3) examine how teachers of DHH students were rated on the indicators of classroom quality. The findings suggested that the QLE-DHH has excellent structural validity. Ratings predicted student reading outcomes. Finally, the QLE-DHH was able to capture teachers' strengths and skills in need of improvement. The QLE-DHH appears to hold promise for use in both research and teacher preparation programs.

Methods for Using Race and Ethnicity in Prediction Models for Lung Cancer Screening Eligibility.

Importance: Using race and ethnicity in clinical prediction models can reduce or inadvertently increase racial and ethnic disparities in medical decisions. Objective: To compare eligibility for lung cancer screening in a contemporary representative US population by refitting the life-years gained from screening-computed tomography (LYFS-CT) model to exclude race and ethnicity vs a counterfactual eligibility approach that recalculates life expectancy for racial and ethnic minority individuals using the same covariates but substitutes White race and uses the higher predicted life expectancy, ensuring that historically underserved groups are not penalized. Design, Setting, and Participants: The 2 submodels composing LYFS-CT NoRace were refit and externally validated without race and ethnicity: the lung cancer death submodel in participants of a large clinical trial (recruited 1993-2001; followed up until December 31, 2009) who ever smoked (n = 39 180) and the all-cause mortality submodel in the National Health Interview Survey (NHIS) 1997-2001 participants aged 40 to 80 years who ever smoked (n = 74 842, followed up until December 31, 2006). Screening eligibility was examined in NHIS 2015-2018 participants aged 50 to 80 years who ever smoked. Data were analyzed from June 2021 to September 2022. Exposure: Including and removing race and ethnicity (African American, Asian American, Hispanic American, White) in each LYFS-CT submodel. Main Outcomes and Measures: By race and ethnicity: calibration of the LYFS-CT NoRace model and the counterfactual approach (ratio of expected to observed [E/O] outcomes), US individuals eligible for screening, predicted days of life gained from screening by LYFS-CT. Results: The NHIS 2015-2018 included 25 601 individuals aged 50 to 80 years who ever smoked (2769 African American, 649 Asian American, 1855 Hispanic American, and 20 328 White individuals). Removing race and ethnicity from the submodels underestimated lung cancer death risk (expected/observed [E/O], 0.72; 95% CI, 0.52-1.00) and all-cause mortality (E/O, 0.90; 95% CI, 0.86-0.94) in African American individuals. It also overestimated mortality in Hispanic American (E/O, 1.08, 95% CI, 1.00-1.16) and Asian American individuals (E/O, 1.14, 95% CI, 1.01-1.30). Consequently, the LYFS-CT NoRace model increased Hispanic American and Asian American eligibility by 108% and 73%, respectively, while reducing African American eligibility by 39%. Using LYFS-CT with the counterfactual all-cause mortality model better maintained calibration across groups and increased African American eligibility by 13% without reducing eligibility for Hispanic American and Asian American individuals. Conclusions and Relevance: In this study, removing race and ethnicity miscalibrated LYFS-CT submodels and substantially reduced African American eligibility for lung cancer screening. Under counterfactual eligibility, no one became ineligible, and African American eligibility increased, demonstrating the potential for maintaining model accuracy while reducing disparities.

Are Black and Latino adolescents being asked if they use electronic cigarettes and advised not to use them? Results from a community-based survey.

Objective: This study aimed to explore whether African American/Black and Hispanic/Latino adolescents are being asked about electronic cigarette (e-cigarette) use (vaping) and advised not to use them. Methods: In 2021, adolescents (N = 362) with no vaping history, self-identified as African American/Black and/or Hispanic/Latino, and able to read and speak English and/or Spanish were recruited through partner schools and community-based organizations. Participants completed a survey reporting sociodemographic characteristics (e.g., race/ethnicity, gender, and language of preference) and they were asked about e-cigarette use and/or were advised not to use them by a health professional. Results: In total, 12% of African American/Black and 5% of Hispanic/Latino participants reported not seeing a health professional in the year prior to enrollment. Of the participants who reported visiting a health professional, 50.8% reported being asked and advised about vaping. Over one-quarter (28.4%) of participants were neither asked nor advised regarding vaping. Compared to English-speaking participants, Spanish-speaking participants were significantly less likely to be asked about e-cigarette use (45.2 vs. 63.9%, p = 0.009) and advised not to use them (40.3 vs. 66.9%, p < 0.001). Moreover, compared to African American/Black participants, Hispanic/Latino participants were significantly less likely to be advised not to use e-cigarettes (52.9 vs. 68.6%, p = 0.018). Furthermore, compared to male participants, female participants were significantly less likely to be advised not to use e-cigarettes (51.3 vs. 68.2%, p = 0.003). Conclusion: Compared to English-speaking participants, Spanish-speaking participants were significantly less likely to self-report being asked about e-cigarette use and advised not to use them. Moreover, Hispanic/Latino and female adolescents were significantly less likely to self-report being advised not to use e-cigarettes compared to their Black/African American and male counterparts. Future research is needed to improve health professional attention toward asking about and advising against vaping among adolescents.

Disparities Across the Continuum of Lung Cancer Care.

Despite the overall decline in lung cancer incidence and mortality, minority populations continue to bear a higher disease burden. Lung cancer remains the leading cause of cancer-related death in the United States and disproportionately impacts minority populations. Social determinants of health-including low-socioeconomic status, lack of health insurance, and access to health care- disproportionately impact racial, ethnic, and rural populations resulting in direct consequences on lung cancer disparities.

Understanding Factors Associated with Uptake of Lung Cancer Screening among Individuals at High Risk.

Early detection using low-dose computed tomography scanning reduces lung cancer-specific mortality by 20% among high-risk individuals. Despite its efficacy, the uptake of lung cancer screening (LCS) remains low. This study aimed to identify factors associated with the uptake of LCS in high-risk individuals. Data for this study were obtained from the Behavioral Risk Factor Surveillance System (n=11,297). Multivariable logistic regression models were used. Individuals with no health insurance (OR: 0.33, 95% CI: 0.19-0.58), no primary health care provider (OR: 0.40, 95% CI: 0.25-0.64), no chronic obstructive pulmonary disease (OR: 0.37, 95% CI: 0.28- 0.49), and racial/ethnic minorities other than Black and Hispanic (OR: 0.49, 95% CI: 0.31-0.78) were less likely to participate in annual LCS. Low-dose computed tomography uptake varied widely across the 24 U.S. states. The findings from this study have important implications for designing more effective interventions to target specific U.S. states and subgroups for the uptake of annual LCS.

Clinical utility of a personalized and long-term monitoring device for Parkinson's disease in a real clinical practice setting: An expert opinion survey on STAT-ON™.

BACKGROUND: STAT-ON™ is an objective tool that registers ON-OFF fluctuations making possible to know the state of the patient at every moment of the day in normal life. Our aim was to analyze the opinion of different Parkinson's disease experts about the STAT-ON™ tool after using the device in a real clinical practice setting (RCPS). METHODS: STAT-ON™ was provided by the Company Sense4Care to Spanish neurologists for using it in a RCPS. Each neurologist had the device for at least three months and could use it in PD patients at his/her own discretion. In February 2020, a survey with 30 questions was sent to all participants. RESULTS: Two thirds of neurologists (53.8% females; mean age 44.9±9 years old) worked in a Movement Disorders Unit, the average experience in PD was 16±6.9 years, and 40.7% of them had previously used other devices. A total of 119 evaluations were performed in 114 patients (range 2-9 by neurologist; mean 4.5±2.3). STAT-ON™ was considered "quite" to "very useful" by 74% of the neurologists with an overall opinion of 6.9±1.7 (0, worst; 10, best). STAT-ON™ was considered better than diaries by 70.3% of neurologists and a useful tool for the identification of patients with advanced PD by 81.5%. Proper identification of freezing of gait episodes and falls were frequent limitations reported. CONCLUSION: STAT-ON™ could be a useful device for using in PD patients in clinical practice.