Tag: statistics

JAMA Otolaryngol Head Neck Surg. 2024 Mar 28. doi: 10.1001/jamaoto.2023.4739. Online ahead of print.

ABSTRACT

IMPORTANCE: Sex differences in head and neck cancer (HNC) incidence suggest a potential contribution of sex hormones.

OBJECTIVE: To assess the role of exogenous estrogen exposure in the development of HNC in female patients.

DESIGN, SETTINGS, AND PARTICIPANTS: This large multicenter cohort study using clinical records from the TriNetX real-world database included 20 years of data (through May 31, 2023) from 87 health care organizations. The TriNetX database was searched for medical records for female patients with and without exogenous estrogen exposure according to their chronological age. Cohort 1 included 731 366 female patients aged 18 to 45 years old with regular oral contraceptive (OC) intake and cohort 2 included 3 886 568 patients in the same age group who did not use OC. Cohort 3 comprised 135 875 female patients at least 50 years old receiving hormone replacement therapy (HRT), whereas cohort 4 included 5 875 270 patients at least 50 years old without HRT. Propensity score matching was performed for the confounders age, alcohol dependence, and nicotine dependence. Data analyses were performed in May 2023.

MAIN OUTCOME AND MEASURES: Diagnosis of HNC (International Statistical Classification of Diseases and Related Health Problems, Tenth Revision: C00-C14), and after propensity score matching (1:1 nearest-neighbor greedy matching), a risk analysis to investigate risk differences and risk ratios (RRs) with a 95% CI.

RESULTS: Among the 718 101 female patients in each of cohorts 1 and 2 (mean [SD] age at diagnosis, 25.9 [6.7] years), those with OC intake had a higher risk of an HNC diagnosis (RR, 1.47; 95% CI, 1.21-1.78) than those without OC use. Among the 131 835 female patients in each of cohorts 3 and 4 (mean [SD] age, 67.9 [12.0] years), those with postmenopausal HRT intake had a lower risk of an HNC diagnosis (RR, 0.77; 95% CI, 0.64-0.92) than those without HRT use.

CONCLUSIONS AND RELEVANCE: The findings of this cohort study illustrate a positive association between OC and a negative association between HRT and the development of HNC in female patients. Given the limitations of the TriNetX database, future research should include detailed information on the intake of OC and HRT and reproductive health information (eg, age at menarche/menopause, number of pregnancies) to more accurately define the strength and direction of the possible association between exogeneous estrogen exposure and the development of HNC in female patients.

PMID:38546631 | DOI:10.1001/jamaoto.2023.4739

Personal Disord. 2024 Mar 28. doi: 10.1037/per0000657. Online ahead of print.

ABSTRACT

The goal of this study was to compare the predictive validity of the alternative model for personality disorders (AMPD) versus the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) Section II categorical model regarding clinician judgments about mental health outcomes. To do so, we instructed a national sample of 136 mental health professionals to provide clinical judgments on a random subset of four (out of a possible 12) case vignettes. For each case, they made a variety of diagnostic judgments corresponding to each model, as well as clinical outcome judgments (e.g., prognosis). Our analyses included hierarchical and individual regressions to compare the predictive value of each diagnostic system toward these clinical outcome judgments. We found that the AMPD predictors consistently added unique variance beyond the Section II predictors, whereas the Section II predictors were rarely incremental above the AMPD. Further, the AMPD judgments predicted outcome judgments very consistently (98.3% of regressions) compared to the Section II predictors (70% of regressions), and the single Criterion A judgment (level of personality functioning) was the strongest overall predictor. Finally, the categorical borderline personality disorder diagnoses from the two systems performed similarly in predicting clinical outcomes and agreed in 79% of cases. We interpreted our results to suggest that the AMPD is at least as effective, and by some measures more effective, than the DSM-5 categorical model at predicting clinician’s judgment of outcomes in clinical cases. We conclude by discussing the value of this evidence in relation to the broader AMPD literature, as well as possible paths forward for the diagnosis of personality disorders. (PsycInfo Database Record (c) 2024 APA, all rights reserved).

PMID:38546613 | DOI:10.1037/per0000657

JAMA Oncol. 2024 Mar 28. doi: 10.1001/jamaoncol.2023.7304. Online ahead of print.

ABSTRACT

IMPORTANCE: Biologic features may affect pathologic complete response (pCR) and event-free survival (EFS) after neoadjuvant chemotherapy plus ERBB2/HER2 blockade in ERBB2/HER2-positive early breast cancer (EBC).

OBJECTIVE: To define the quantitative association between pCR and EFS by intrinsic subtype and by other gene expression signatures in a pooled analysis of 3 phase 3 trials: CALGB 40601, NeoALTTO, and NSABP B-41.

DESIGN, SETTING, AND PARTICIPANTS: In this retrospective pooled analysis, 1289 patients with EBC received chemotherapy plus either trastuzumab, lapatinib, or the combination, with a combined median follow-up of 5.5 years. Gene expression profiling by RNA sequencing was obtained from 758 samples, and intrinsic subtypes and 618 gene expression signatures were calculated. Data analyses were performed from June 1, 2020, to January 1, 2023.

MAIN OUTCOMES AND MEASURES: The association of clinical variables and gene expression biomarkers with pCR and EFS were studied by logistic regression and Cox analyses.

RESULTS: In the pooled analysis, of 758 women, median age was 49 years, 12% were Asian, 6% Black, and 75% were White. Overall, pCR results were associated with EFS in the ERBB2-enriched (hazard ratio [HR], 0.45; 95% CI, 0.29-0.70; P < .001) and basal-like (HR, 0.19; 95% CI, 0.04-0.86; P = .03) subtypes but not in luminal A or B tumors. Dual trastuzumab plus lapatinib blockade over trastuzumab alone had a trend toward EFS benefit in the intention-to-treat population; however, in the ERBB2-enriched subtype there was a significant and independent EFS benefit of trastuzumab plus lapatinib vs trastuzumab alone (HR, 0.47; 95% CI, 0.27-0.83; P = .009). Overall, 275 of 618 gene expression signatures (44.5%) were significantly associated with pCR and 9 of 618 (1.5%) with EFS. The ERBB2/HER2 amplicon and multiple immune signatures were significantly associated with pCR. Luminal-related signatures were associated with lower pCR rates but better EFS, especially among patients with residual disease and independent of hormone receptor status. There was significant adjusted HR for pCR ranging from 0.45 to 0.81 (higher pCR) and 1.21-1.94 (lower pCR rate); significant adjusted HR for EFS ranged from 0.71 to 0.94.

CONCLUSIONS AND RELEVANCE: In patients with ERBB2/HER2-positive EBC, the association between pCR and EFS differed by tumor intrinsic subtype, and the benefit of dual ERBB2/HER2 blockade was limited to ERBB2-enriched tumors. Immune-activated signatures were concordantly associated with higher pCR rates and better EFS, whereas luminal signatures were associated with lower pCR rates.

PMID:38546612 | DOI:10.1001/jamaoncol.2023.7304

JAMA Ophthalmol. 2024 Mar 28. doi: 10.1001/jamaophthalmol.2024.0363. Online ahead of print.

ABSTRACT

IMPORTANCE: Effects of genetic variants on primary angle-closure disease remained uncertain.

OBJECTIVE: To systematically review the associations of common single-nucleotide variants (SNVs) and rare coding variants with primary angle-closure disease, its subtypes (including primary angle-closure glaucoma, primary angle-closure suspect, and primary angle-closure) and progression.

DATA SOURCES: Eligible studies from PubMed, Embase, and Web of Science were retrieved up to April 3, 2023. SNV information was extracted from eligible reports and 2 genome-wide association studies summary statistics, UK BioBank and FinnGen.

STUDY SELECTION: Studies providing analyzable genotype or allele data in a case-control design for primary angle-closure disease association and longitudinal case-only design for primary angle-closure disease progression.

DATA EXTRACTION AND SYNTHESIS: PRISMA guidelines were used for literature screening and the Newcastle Ottawa Scale for data quality assessment. Pooled effect size with 95% CIs of SNV associations were calculated using fixed- or random-effect models according to I2 statistics.

MAIN OUTCOMES AND MEASURES: SNVs reported in 2 or more studies were meta-analyzed to generate pooled odds ratios and P values. Common and rare coding variants from single reports were summarized.

RESULTS: Sixty-nine citations were eligible for meta-analysis on overall primary angle-closure disease, involving 206 SNVs in 64 genes or loci. Seventeen SNVs in 15 genes or loci showed associations with primary angle-closure disease, and 15 SNVs in 13 genes or loci showed associations with primary angle-closure glaucoma. Two SNVs, ABCA1 rs2422493 and ZNRF3 rs3178915, were associated only with primary angle-closure disease. Two SNVs, PCMTD1-ST18 rs1015213 and COL11A1 rs3753841, were associated with primary angle-closure suspect, and 1 SNV, MMP9 rs3918249, was associated with primary angle-closure. This systematic review and meta-analysis newly confirmed 7 genes or loci associated with primary angle-closure glaucoma: ATOH7, CALCRL, FBN1, IL6, LOXL1, MMP19, and VAV3. Common and rare coding variants in 16 genes or loci that have been associated with primary angle-closure disease were cataloged. Stratification analysis revealed different primary angle-closure disease-associated genes in different ethnic populations. Only 1 study regarding the genetic association of primary angle-closure glaucoma progression was identified.

CONCLUSIONS AND RELEVANCE: This study revealed the genetic complexity of primary angle-closure disease, involving common SNVs and rare coding variants in more than 30 genes or loci, with ethnic and phenotypic diversities. Further replication, genotype-phenotype correlation, and pathway analyses are warranted.

PMID:38546604 | DOI:10.1001/jamaophthalmol.2024.0363

Am J Orthopsychiatry. 2024 Mar 28. doi: 10.1037/ort0000732. Online ahead of print.

ABSTRACT

Black and Latinx people are disproportionately impacted by HIV, COVID-19, and other syndemic health crises with similar underlying social determinants of health. Lessons learned from the HIV pandemic and COVID-19 response have been invoked to improve health equity at the systemic level in the face of other emergent health crises. However, few have examined the potential translation of strategies between syndemics at the individual level. The current mixed-methods study examined strategies used to manage HIV during the COVID-19 pandemic and the extent to which they were helpful in managing COVID-19 vulnerability among Black and Latinx people living with HIV. Participants (n = 30) were interviewed by telephone and completed demographic, mental health, alcohol and substance use, health literacy, and clinical measures in October and November 2020 in Los Angeles County. Rapid qualitative analysis, descriptive statistics, and mixed-methods merging were used to analyze the data. Qualitative results demonstrated that participants found HIV self-management strategies translated to aspects of the COVID-19 pandemic including hygiene and social distancing and coping with a health-related stressor. Although telemedicine provided continuity of HIV care for most participants, technology access and literacy posed a potential barrier, particularly to those facing other sociodemographic marginalization (i.e., low education, disability). Findings suggest providers can encourage leveraging individual HIV self-management strategies in response to other public health crises. However, these interventions must be culturally responsive and address intersecting social determinants of health. Future research should examine mechanisms that predict individual translation of HIV management strategies to other health concerns. (PsycInfo Database Record (c) 2024 APA, all rights reserved).

PMID:38546560 | DOI:10.1037/ort0000732

JAMA Oncol. 2024 Mar 28. doi: 10.1001/jamaoncol.2023.7333. Online ahead of print.

ABSTRACT

IMPORTANCE: Despite the clear potential benefits of neoadjuvant therapy, the optimal neoadjuvant regimen for patients with high-risk resectable melanoma (HRRM) is not known.

OBJECTIVE: To compare the safety and efficacy of dual checkpoint inhibitors with anti-programmed cell death protein-1 (anti-PD1) therapy in a neoadjuvant setting among patients with HRRM.

DESIGN, SETTING, AND PARTICIPANTS: In this pooled analysis of clinical trials, studies were selected provided they investigated immune checkpoint inhibitor treatment, were published between January 2018 and March 2023, and were phase 1, 2, or 3 clinical trials. Participant data included in the analysis were derived from trials evaluating the efficacy and safety of anti-PD1 monotherapy and the combination of anti-cytotoxic T lymphocyte-associated protein-4 with anti-PD1 in the neoadjuvant setting, specifically among patients with HRRM.

INTERVENTIONS: Patients were treated with either anti-PD1 monotherapy; dual checkpoint inhibition (DCPI) with a conventional dose of 3-mg/kg ipilimumab and 1-mg/kg nivolumab; or DCPI with an alternative-dose regimen of 1-mg/kg ipilimumab and 3-mg/kg nivolumab.

MAIN OUTCOMES AND MEASURES: The main outcomes were radiologic complete response (rCR), radiologic overall objective response (rOOR), and radiologic progressive disease. Also, pathologic complete response (pCR), the proportion of patients undergoing surgical resection, and occurrence of grade 3 or 4 immune-related adverse events (irAEs) were considered.

RESULTS: Among 573 patients enrolled in 6 clinical trials, neoadjuvant therapy with DCPI was associated with higher odds of achieving pCR compared with anti-PD1 monotherapy (odds ratio [OR], 3.16; P < .001). DCPI was associated with higher odds of grade 3 or 4 irAEs compared with anti-PD1 monotherapy (OR, 3.75; P < .001). When comparing the alternative-dose ipilimumab and nivolumab (IPI-NIVO) regimen with conventional-dose IPI-NIVO, no statistically significant difference in rCR, rOOR, radiologic progressive disease, or pCR was noted. However, the conventional-dose IPI-NIVO regimen was associated with increased grade 3 or 4 irAEs (OR, 4.76; P < .001). Conventional-dose IPI-NIVO was associated with greater odds of achieving improved rOOR (OR, 1.95; P = .046) and pCR (OR, 2.99; P < .001) compared with anti-PD1 monotherapy. The alternative dose of IPI-NIVO also was associated with higher odds of achieving rCR (OR, 2.55; P = .03) and pCR (OR, 3.87; P < .001) compared with anti-PD1 monotherapy. The risk for grade 3 or 4 irAEs is higher with both the conventional-dose (OR, 9.59; P < .001) and alternative-dose IPI-NIVO regimens (OR, 2.02; P = .02) compared with anti-PD1 monotherapy.

CONCLUSION AND RELEVANCE: In this pooled analysis of 6 clinical trials, although DCPI was associated with increased likelihood of achieving pathological and radiologic responses, the associated risk for grade 3 or 4 irAEs was significantly lower with anti-PD1 monotherapy in the neoadjuvant setting for HRRM. Additionally, compared with alternative-dose IPI-NIVO, the conventional dose of IPI-NIVO was associated with increased risk for grade 3 or 4 irAEs, with no significant distinctions in radiologic or pathologic efficacy.

PMID:38546551 | DOI:10.1001/jamaoncol.2023.7333

Can J Diet Pract Res. 2024 Mar 28:1-6. doi: 10.3148/cjdpr-2023-026. Online ahead of print.

ABSTRACT

Purpose: The Canadian federal government has expressed an intention to work with provinces and territories to develop a national school food program (SFP). This study aimed to explore caregivers’ perception of attributes important to include in a future SFP.Methods: An online cross-sectional survey was conducted. Fifteen elementary schools from high, medium, or low median income neighbourhoods in Saskatoon were invited to participate. School principals sent a survey link to students’ caregivers. The 37-item survey included an item with 15 statements asking caregivers to rate the importance of various components of a SFP. Descriptive statistics and exploratory factor analysis were conducted.Results: A total of 510 caregivers completed the survey (response rate of 52%). The factor analysis indicated four key components of a future SFP: (1) learning opportunities on growing and preparing food, (2) offering healthy food following Canada’s Food Guide, (3) affordability of the meals offered, and (4) cultural adaptability of the meal program. Over 90% of caregivers thought providing healthy meals and ample time to eat meals to be very important.Conclusion: Our results indicate caregivers support multicomponent meal programs that, along with providing nutritious food, help children build healthy habits and sustainable food systems. These findings will help dietitians understand caregivers’ perspectives to inform the design of a national SFP.

PMID:38546536 | DOI:10.3148/cjdpr-2023-026

Environ Sci Process Impacts. 2024 Mar 28. doi: 10.1039/d3em00464c. Online ahead of print.

ABSTRACT

Diabetes is a global public health problem, and the impact of air pollutants on type 2 diabetes mellitus (T2DM) has attracted people’s attention. This study aimed to assess the association of short-term exposure to six criteria air pollutants with T2DM outpatient visits in Lanzhou, China. We collected data on daily outpatient visits for T2DM, daily meteorological data and hourly concentrations of air pollutants in Lanzhou from 2013 to 2019. An over-dispersed passion generalized addictive model combined with a distributed lag non-linear model was applied to estimate the associations and stratified analyses were performed by gender, age, and season. The models were fitted with different lag structures, including single lag days from the current to the previous seven days (lag0 to lag7) and moving average concentrations over seven lag days (lag01 to lag07). A positive association between multiple air pollutants, especially PM_2.5, NO₂, O₃8h and CO and hospital outpatient visits for T2DM was observed. The largest association between T2DM outpatient visits and PM_2.5 was observed at lag06 (RR 1.013, 95% CI: 1.001, 1.027), NO₂ at lag03 (RR 1.034, 95% CI: 1.018, 1.050), O₃8h at lag05 (RR 1.012, 95% CI: 1.001, 1.023) for an increase of 10 μg m^-3 and CO at lag03 (RR 1.084, 95% CI: 1.029, 1.142) for an increase of 1 mg m^-3 in the concentrations. In addition, people aged <65 and males are more susceptible, and air pollutants have a greater impact on the cold season. This study showed that although the air pollution in Lanzhou was improved, there was still a statistical correlation between air pollution exposure and T2DM outpatient visits. Therefore, the local government still needs to strengthen the control of air pollution and enhance the protection awareness of the diabetic population through education and publicity.

PMID:38546508 | DOI:10.1039/d3em00464c

J Laparoendosc Adv Surg Tech A. 2024 Mar 28. doi: 10.1089/lap.2024.0076. Online ahead of print.

ABSTRACT

Backgrounds: In the renal intrarenal stone surgery (RIRS) procedure, ureteral access sheath (UAS) is still used in the majority of surgeries to both protect the flexible ureteroscope (FURS) and reduce intrarenal pressure. ClearPETRA is a new UAS that has an integrated aspiration port. We aimed to evaluate the clinical outcomes and effectiveness of Aspiration-Assisted UAS (ClearPETRA) in the RIRS procedure. Methods: One thousand six hundred twenty patients who underwent RIRS between January 2021 and January 2024 were evaluated retrospectively and 512 patients were included in the study. According to stone size, patients with stones less than 2 cm and those with stones between 2 and 3 cm were analyzed separately. Patient’s demographic data, stone size, body mass index, Extracoporeal Shockwave Lithotripsy (ESWL) history, stone side, stone density (Hounsfield Unit), operation time, stone-free rate (SFR), and the number of patients with sepsis were recorded. SFR was evaluated with kidney urinary bladder 3 months after surgery for opaque calculi. Nonopaque calculi patients were evaluated with noncontrast computed tomography 3 months after surgery. In the postoperative evaluation, patients with stones less than 4 mm were evaluated as SFR. P value of <0.01 was considered statistically significant. Results: Patient’s demographic data, stone characteristics, and history of ESWL were similar in the ClearPETRA and UAS groups (P > .05). A total of 328 patients who underwent RIRS for stones less than 2 cm were included (80 ClearPETRA, 248 UAS). Length of hospital stay, operation time, SFR, secondary intervention, or postoperative sepsis (P ≥ .01) were similar in both groups. The incidence of postoperative fever was statistically significantly lower in the ClearPETRA group (P = .006). A total of 184 patients who underwent RIRS for stones between 2 and 3 cm were included (42 ClearPETRA, 142 UAS). In the ClearPETRA group, operation time was statistically significantly shorter (P = .002), SFR was statistically significantly higher (P = .003), and the number of fever and sepsis were statistically significantly less (P = .003 and 0.002, respectively). Conclusion: We found that ClearPETRA reduces the likelihood of postoperative fever after RIRS surgeries. Moreover, we can say that the use of ClearPETRA in RIRS, especially for stones larger than 2 cm, reduces the operation time, increases the SFR, and also reduces sepsis rates.

PMID:38546503 | DOI:10.1089/lap.2024.0076

Cancer Med. 2024 Apr;13(7):e7141. doi: 10.1002/cam4.7141.

ABSTRACT

BACKGROUND: Although socioeconomic factors are important determinants of population mortality, the effect of educational level on the survival of patients with cancer in China is unclear. This study aimed to assess whether educational level is associated with the prognosis of patients with cancer and to explore the mediators of this association.

METHODS: This multicentre cohort study included 18,251 patients diagnosed with cancer between May 2013 and December 2018. The main parameters measured were overall survival (OS) and all-cause mortality. The relationship between educational level and all-cause mortality was assessed using multifactor-corrected Cox survival analysis. Logistic regression was used to analyze the association between educational level and patient-generated subjective global assessment (PG-SGA).

RESULTS: The mean age of the 18,251 participants (men, 9939 [54.4%]) was 57.37 ± 11.66 years. Multifactorial survival analysis showed that patients survived longer with increasing education (university and above vs. elementary school and below; p = p = <0.001, HR = 0.84, 95% CI: 0.77-0.92), and the differences were statistically significant in different subgroups. The potential impact factors included sex, age, TNM stage, and PG-SGA score. Logistic regression showed a significant negative association between educational level and the modifiable factor PG-SGA (secondary vs. primary and below; p = 0.004, HR = 0.90, 95% CI: 0.83-0.97; university and above vs. primary and below; p < 0.001, HR = 0.79, 95% CI: 0.71-0.88).

CONCLUSIONS: Educational level was a significant prognostic factor for patients with cancer, independent of other known prognostic factors. This association was further improved by modifying the nutritional status.

PMID:38545856 | DOI:10.1002/cam4.7141