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Nevin Manimala Statistics

Salivary CD44 and Total Protein Levels to Detect Risk for Oral and Oropharyngeal Cancer Recurrence: A Nonrandomized Clinical Trial

JAMA Otolaryngol Head Neck Surg. 2024 Aug 15. doi: 10.1001/jamaoto.2024.2490. Online ahead of print.

ABSTRACT

IMPORTANCE: Oral and oropharyngeal cancer have low survival rates, and incidence continues to increase.

OBJECTIVE: To determine whether soluble CD44 and total protein (TP) are useful for monitoring head and neck cancer recurrence, either used in a point-of-care (POC) test or as individual laboratory-based biomarkers.

DESIGN, SETTING, AND PARTICIPANTS: This multi-institutional nonrandomized clinical trial testing a novel diagnostic/screening assay took place across the University of California, San Diego; Johns Hopkins University; the Greater Baltimore Medical Center; New York University; and the San Diego Veterans Affairs Hospital. Patients with newly biopsy-proven, untreated oral cavity and oropharyngeal cancer were enrolled. Patients were enrolled April 2017 to April 2019, and data were analyzed December 2022 to June 2023.

EXPOSURE: POC salivary oral rinse test.

MAIN OUTCOMES AND MEASURES: Oral rinses were collected at pretreatment baseline and 3, 6, 12, and 18 months after completion of therapy; participants were then followed up for 3 years to define disease status. Associations of baseline characteristics with a positive test were evaluated by Fisher exact test. The association of a positive value on the CD44 or TP test with progression-free survival was evaluated in an adjusted multivariable proportional hazards model.

RESULTS: Of 172 patients enrolled, the mean (SD) age was 62.5 (10.2) years, and 122 (70.9%) identified as male. Additionally, 92 patients (53.3%) had never smoked, 99 (57.6%) formerly or currently drank alcohol, and 113 (65.7%) presented with oropharyngeal cancers, which were positive for human papillomavirus in 95 (84.1%). Tumor site was associated with test results at baseline; patients with oral cavity cancer had a higher baseline positive POC test rate (47 of 51 [92.2%]) compared to patients with oropharyngeal cancer (85 of 110 [77.3%]). Using Cox regression models with CD44 or TP level as a time-varying covariate, a higher CD44 level showed a statistically significant association with a higher hazard of recurrence (hazard ratio, 1.06; 95% CI, 1.00-1.12), though the TP level was not statistically significant. In multivariate adjusted analysis, higher CD44 and TP levels were associated with increased hazard ratios of recurrence of 1.13 (95% CI, 1.04-1.22) and 3.51 (95% CI, 1.24-9.98), respectively.

CONCLUSION AND RELEVANCE: In this multi-institutional nonrandomized clinical trial of an assay, posttreatment longitudinal monitoring for elevated salivary CD44 and TP levels using an enzyme-linked immunosorbent assay-based laboratory test identified patients at increased risk of future cancer recurrence. The CD44 and TP rapid POC test holds some promise, but further development is needed for this indication.

TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03148665.

PMID:39145961 | DOI:10.1001/jamaoto.2024.2490

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Breast Cancer Index in Premenopausal Women With Early-Stage Hormone Receptor-Positive Breast Cancer

JAMA Oncol. 2024 Aug 15. doi: 10.1001/jamaoncol.2024.3044. Online ahead of print.

ABSTRACT

IMPORTANCE: Adjuvant ovarian function suppression (OFS) with oral endocrine therapy improves outcomes for premenopausal patients with hormone receptor-positive (HR+) breast cancer but adds adverse effects. A genomic biomarker for selecting patients most likely to benefit from OFS-based treatment is lacking.

OBJECTIVE: To assess the predictive and prognostic performance of the Breast Cancer Index (BCI) for OFS benefit in premenopausal women with HR+ breast cancer.

DESIGN, SETTING, AND PARTICIPANTS: This prospective-retrospective translational study used all available tumor tissue samples from female patients from the Suppression of Ovarian Function Trial (SOFT). These individuals were randomized to receive 5 years of adjuvant tamoxifen alone, tamoxifen plus OFS, or exemestane plus OFS. BCI testing was performed blinded to clinical data and outcome. The a priori hypothesis was that BCI HOXB13/IL17BR ratio (BCI[H/I])-high tumors would benefit more from OFS and high BCI portended poorer prognosis in this population. Settings spanned multiple centers internationally. Participants included premenopausal female patients with HR+ early breast cancer with specimens in the International Breast Cancer Study Group tumor repository available for RNA extraction. Data were collected from December 2003 to April 2021 and were analyzed from May 2022 to October 2022.

MAIN OUTCOMES AND MEASURES: Primary end points were breast cancer-free interval (BCFI) for the predictive analysis and distant recurrence-free interval (DRFI) for the prognostic analyses.

RESULTS: Tumor specimens were available for 1718 of the 3047 female patients in the SOFT intention-to-treat population. The 1687 patients (98.2%) who had specimens that yielded sufficient RNA for BCI testing represented the parent trial population. The median (IQR) follow-up time was 12 (10.5-13.4) years, and 512 patients (30.3%) were younger than 40 years. Tumors were BCI(H/I)-low for 972 patients (57.6%) and BCI(H/I)-high for 715 patients (42.4%). Patients with tumors classified as BCI(H/I)-low exhibited a 12-year absolute benefit in BCFI of 11.6% from exemestane plus OFS (hazard ratio [HR], 0.48 [95% CI, 0.33-0.71]) and an absolute benefit of 7.3% from tamoxifen plus OFS (HR, 0.69 [95% CI, 0.48-0.97]) relative to tamoxifen alone. In contrast, patients with BCI(H/I)-high tumors did not benefit from either exemestane plus OFS (absolute benefit, -0.4%; HR, 1.03 [95% CI, 0.70-1.53]; P for interaction = .006) or tamoxifen plus OFS (absolute benefit, -1.2%; HR, 1.05 [95% CI, 0.72-1.54]; P for interaction = .11) compared with tamoxifen alone. BCI continuous index was significantly prognostic in the N0 subgroup for DRFI (n = 1110; P = .004), with 12-year DRFI of 95.9%, 90.8%, and 86.3% in BCI low-risk, intermediate-risk, and high-risk N0 cancers, respectively.

CONCLUSIONS AND RELEVANCE: In this prospective-retrospective translational study of patients enrolled in SOFT, BCI was confirmed as prognostic in premenopausal women with HR+ breast cancer. The benefit from OFS-containing adjuvant endocrine therapy was greater for patients with BCI(H/I)-low tumors than BCI(H/I)-high tumors. BCI(H/I)-low status may identify premenopausal patients who are likely to benefit from this more intensive endocrine therapy.

PMID:39145953 | DOI:10.1001/jamaoncol.2024.3044

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Dissemination of the 2022 ASMBS and IFSO Guidelines for Bariatric Surgery: What Has Reached Primary Care Providers?

Obes Surg. 2024 Aug 15. doi: 10.1007/s11695-024-07449-1. Online ahead of print.

ABSTRACT

BACKGROUND: Only 1% of Americans eligible for metabolic and bariatric surgery (MBS) receive MBS. Prior studies have analyzed primary care provider (PCP) referral patterns and perceptions of MBS as a potential barrier to increasing MBS. However, less data exists regarding PCP knowledge of MBS indications and outcomes. Following the 2022 update to the indications for MBS by the ASMBS and IFSO, the number of eligible patients is only expected to increase. We evaluated PCP knowledge regarding the existence of the 2022 ASMBS and IFSO updated guidelines, MBS indications, and MBS outcomes.

METHODS: An 11-question survey was emailed to primary care residents, advanced practice providers, and faculty at a single institution.

RESULTS: Of 151 surveys distributed, 39.7% responded (n = 60). 95% were unaware of the 2022 updated guidelines. On multiple choice questions, 16.3% correctly identified the average weight loss from MBS, and 46.8% correctly answered the diabetes remission rate following MBS. Trainee answers were not statistically significant from practicing PCPs. Fifteen respondents had referred a patient for MBS, but this subgroup did not perform significantly better on the assessment. A total of 72.3% of respondents reported inadequate MBS education during their training, and 85.1% were interested in additional education.

CONCLUSIONS: We present the first assessment of PCP MBS knowledge since the release of the 2022 updated ASMBS and IFSO guidelines. This study indicates a gap in PCPs’ knowledge regarding the updated guidelines and represents an opportunity for collaboration with our primary care colleagues to provide further MBS education.

PMID:39145917 | DOI:10.1007/s11695-024-07449-1

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Analyzing effects on anterior open bite in twins by PLS-SEM and sobel test

Clin Oral Investig. 2024 Aug 15;28(9):488. doi: 10.1007/s00784-024-05874-1.

ABSTRACT

OBJECTIVE: This study aimed to assess the different pathways between predictor factors such as zygosity, atypical swallowing, mouth breathing, breastfeeding and bottle feeding related to anterior open bite (AOB) in twins.

METHODS: The study was conducted in monozygotic (MZ) and dizygotic (DZ) twin children aged 3-15 years. AOB, atypical swallowing, mouth breathing, feeding type, duration of bottle use, and mouth opening status during sleep were recorded during oral examination. Partial least squares structural equation model (PLS-SEM) and sobel tests were performed to assess the total and indirect effects among the variables on AOB.

RESULTS: A total of 404 children (29.2% MZ;70.8% DZ) participated in this study. The effect of zygosity on mouth breathing in the PLS-SEM model was statistically significant. Conversely, it was determined that mouth breathing effected that atypical swallowing (p = 0.001). Atypical swallowing triggered AOB (p = 0.001). The atypical swallowing has a mediation effect between AOB and mouth breathing (p = 0.020). Mouth breathing causes atypical swallowing and therefore indirectly increases the likelihood of AOB. While breastfeeding decreases AOB incidence (p = 0.023), bottle feeding increases AOB incidence (p = 0.046). The sobel tests show that the fully mediator variable feature of mouth breathing is statistically significant in the negative relation between zygosity and atypical swallowing.

CONCLUSION: The PLS-SEM model showed that mouth breathing triggers atypical swallowing and atypical swallowing triggers AOB. As a result of this chain of relationships, an indirect effect of zygosity on AOB was observed. According to sobel tests, zygosity has an indirect effect on atypical swallowing through mouth breathing, while mouth breathing has a positive indirect effect on AOB through atypical swallowing.

CLINICAL RELEVANCE: This study identified the relationships between different factors and the presence of AOB. The findings of this study demonstrate in detail the relationships between AOB and zygosity, atypical swallowing, mouth breathing, breastfeeding and bottle feeding. Brestfeeding has a reducing effect on the frequency of AOB. Among the nutritional forms, breastfeeding ensures the proper development of the stomatognathic system by working the oro-facial muscles.

PMID:39145904 | DOI:10.1007/s00784-024-05874-1

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Major depressive disorder: point prevalence, suicidal ideation, and risk factors among Sudanese children and adolescents during Sudan army conflict: a cross-sectional study

Discov Ment Health. 2024 Aug 15;4(1):28. doi: 10.1007/s44192-024-00084-3.

ABSTRACT

BACKGROUND: Tiredness, poor concentration, disturbed sleep and poor appetite can all be caused by depression, which is a common mental disorder and a leading cause of disability worldwide. This study aimed to assess the prevalence of major depressive disorder, suicidal ideation, and risk factors in Sudanese children and adolescents during the Sudanese army conflict.

METHODS: A descriptive cross-sectional community-based study was carried out among Sudanese children between 11 and 17 years old who living in Sudan at the start of the conflict by using a self-administered questionnaire under the guidance of parents, if necessary. The questionnaire was adapted from the Patients Health Questionnaire-9 (PHQ-9) checklist for the assessment of major depression disorder symptoms according to the Diagnostic and Statistical Manual Edition 5th Edition (DSM-5). The questionnaire was translated into Arabic by two expert translators, and its validity and reliability were confirmed. Data analysis was performed using Statistical Package for the Social Sciences version 25 software, and descriptive analysis and any appropriate statistical tests were performed.

RESULTS: Among the 963 participants, the mean age was 15.18 ± 2.1 years, 65.5% were female, and 67.7% had major depressive disorder. There was a significant relationship between MDD score, age, sex, current residency status, and traumatic event exposure, with P values less than 0.001 for all variables.

CONCLUSION: Major depressive disorder was highly prevalent among Sudanese children and adolescents included in the present study. Additionally, suicidal ideation, which requires immediate intervention, was reported to be very high. The findings will help the government to provide proper mental health interventions for affected people.

PMID:39145898 | DOI:10.1007/s44192-024-00084-3

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Mixed Reality in the Operating Room: A Systematic Review

J Med Syst. 2024 Aug 15;48(1):76. doi: 10.1007/s10916-024-02095-7.

ABSTRACT

Mixed Reality is a technology that has gained attention due to its unique capabilities for accessing and visualizing information. When integrated with voice control mechanisms, gestures and even iris movement, it becomes a valuable tool for medicine. These features are particularly appealing for the operating room and surgical learning, where access to information and freedom of hand operation are fundamental. This study examines the most significant research on mixed reality in the operating room over the past five years, to identify the trends, use cases, its applications and limitations. A systematic review was conducted following the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) guidelines to answer the research questions established using the PICO (Population, Intervention, Comparator and Outcome) framework. Although implementation of Mixed Reality applications in the operations room presents some challenges, when used appropriately, it can yield remarkable results. It can make learning easier, flatten the learning curve for several procedures, and facilitate various aspects of the surgical processes. The articles’ conclusions highlight the potential benefits of these innovations in surgical practice while acknowledging the challenges that must be addressed. Technical complexity, equipment costs, and steep learning curves present significant obstacles to the widespread adoption of Mixed Reality and computer-assisted evaluation. The need for more flexible approaches and comprehensive studies is underscored by the specificity of procedures and limited samples sizes. The integration of imaging modalities and innovative functionalities holds promise for clinical applications. However, it is important to consider issues related to usability, bias, and statistical analyses. Mixed Reality offers significant benefits, but there are still open challenges such as ergonomic issues, limited field of view, and battery autonomy that must be addressed to ensure widespread acceptance.

PMID:39145896 | DOI:10.1007/s10916-024-02095-7

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Correction: A Diagnostic Facet Status Model (DFSM) for Extracting Instructionally Useful Information from Diagnostic Assessment

Psychometrika. 2024 Aug 15. doi: 10.1007/s11336-024-09999-w. Online ahead of print.

NO ABSTRACT

PMID:39145891 | DOI:10.1007/s11336-024-09999-w

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Laser hair removal complications and the associated risk factors at a tertiary dermatology center: a case-control study

Lasers Med Sci. 2024 Aug 15;39(1):218. doi: 10.1007/s10103-024-04169-x.

ABSTRACT

Laser hair removal (LHR) has been established as a safe and efficient method for eliminating unwanted hair. This study aimed to investigate the frequency of LHR complications and assess the contributing factors. During one year, 16,900 patients undergoing LHR therapy were evaluated for complications. For each case, two external controls were selected (matched based on age, sex, Fitzpatrick skin type (FST) III-IV, and the treated anatomical region). To assess the impact of anatomical region on complication occurrence, each patient was used as their internal control if another area was treated during the same session. GEE analysis was used for statistical analysis.The incidence of LHR complications was calculated to be 0.69%. The most common complications were petechia, purpura, and ecchymosis (31.66%) followed by pigmentation changes (20.0%). LHR complications were most commonly observed in the lower limbs (32.0%), face and neck (23.3%), and genitalia and thighs (22.3%), respectively. Possible risk factors were younger age (OR = 0.74, P-value ≤ 0.001), operating LHR in the head and neck (OR = 5.8, P-value = 0.022), utilization of the alexandrite laser (OR = 2.32, P-value = 0.011), and fluence in the Alexandrite laser (OR = 3.47, P-value = 0.003).Overall, the results of this study indicate that LHR is generally a safe method for removing unwanted hair. However, factors such as younger age, treatment of the facial area, and use of the alexandrite laser especially with higher fluence levels in patients with FST III-IV were identified as potential risk factors.

PMID:39145871 | DOI:10.1007/s10103-024-04169-x

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Assessing ecosystem health: A preliminary investigation of the gosikhurd dam ecosystem structure and functioning, an appraisal based on ecological modelling, India

Environ Monit Assess. 2024 Aug 15;196(9):815. doi: 10.1007/s10661-024-12958-8.

ABSTRACT

This study aims to comprehensively understand the Gosikhurd Dam ecosystem (GDE) ecosystem by employing the Ecopath with Ecosim software (version 6.6.5) to construct a trophic mass balancing model. This model consisted of 16 functional groups of organisms, and their interactions and trophic levels were explored. The study focuses on various performance indicators to assess the ecosystem’s maturity and complexity. To achieve these objectives, monthly fish samples were collected from June 2022 to May 2023. Performance indicators such as the connectance index (CI), system omnivory index (SOI), Finn’s cycling index (FCI), mean path length (FML), ascendency, overhead, and Shannon diversity index were calculated to assess ecosystem maturity and complexity. The Finn’s cycling index (FCI) and the mean path length (FML) were calculated as 1.81 and 2.20, respectively, indicating the ecosystem’s responsiveness to environmental changes and overall system health and stability. Ascendency and overhead values were also analysed, with ascendency being relatively higher (41.58%), reflecting a system that utilises less than half of its total capacity. The overhead value (58.42%) indicated that the ecosystem is relatively stable and capable of adapting to external perturbations. Furthermore, the Shannon diversity index was 1.67, illustrating less diversity and validating the ecosystem’s immaturity. The study identifies critical species and their roles in shaping the ecosystem dynamics, highlighting the importance of zooplankton, zoobenthos, and tilapia as keystone species. These indices propound that GDE is in its developmental stage and lacks complexity compared to mature ecosystems. The findings provide valuable insights into the current state of the ecosystem and can guide future management and conservation efforts.

PMID:39145842 | DOI:10.1007/s10661-024-12958-8

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Influence of using different toothpaste during bleaching with violet LED light (405 nm) on the colour and roughness of dental enamel: an in vitro study

Lasers Med Sci. 2024 Aug 15;39(1):217. doi: 10.1007/s10103-024-04161-5.

ABSTRACT

This in vitro study aimed to investigate potential changes in the color and roughness of dental enamel resulting from the use of different toothpaste formulations during bleaching with violet LED light (405 nm). Sixty specimens of bovine incisors, each measuring 6 × 6 × 3 mm, were segregated into six distinct experimental groups based on their respective treatments (n = 10): C + VL: Brushing with Colgate® Total 12 + bleaching with violet LED; LB + VL: Brushing with Colgate® Luminous White Brilliant + bleaching with violet LED; LI + VL: Brushing with Colgate® Luminous White Instant + violet LED bleaching; C: Brushing with Colgate® Total 12; LB: Brushing with Colgate® Luminous White Brilliant; LI: Brushing with Colgate® Luminous White Instant. The examined variables included alterations in color (∆L*, ∆a*, ∆b*, ∆Eab, and ∆E00), surface roughness (Ra), and scanning electron microscopy observations. No statistically significant distinctions emerged in total color variations (∆E00 and ∆E) among the groups under scrutiny. Notably, the groups that employed Colgate® Luminous White Instant displayed elevated roughness values, irrespective of their association with violet LED, as corroborated by scanning electron microscopy examinations. It can be concluded that whitening toothpastes associated to violet LED do not influence the color change of dental enamel in fifteen days of treatment. Toothpastes with a higher number of abrasive particles showed greater changes in enamel roughness, regardless of the use of violet LED.

PMID:39145805 | DOI:10.1007/s10103-024-04161-5