Tag: pubmed

Rev Med Inst Mex Seguro Soc. 2024 Nov 4;62(6):1-7. doi: 10.5281/zenodo.13306762.

ABSTRACT

BACKGROUND: Melanoma is the third most common type of skin cancer in Mexico and represents 75% of skin cancer deaths. Dermoscopy is a diagnostic tool that increases early detection of melanoma compared to naked eye examination.

OBJECTIVE: The aim of this study was to describe the clinical, dermoscopic and histological characteristics of patients with a confirmed diagnosis of cutaneous melanoma treated at the “La Raza” National Medical Center.

MATERIAL AND METHODS: A retrospective, descriptive and cross-sectional study was carried out from March 1998 to December 2013, with 187 histologically confirmed cases, considering: sex, age, skin phototype, history, topography of the lesion, dermoscopic pattern, metastasis at the time of diagnosis and histological subtype, Breslow index and Clark index, using the chi-square test as a non-parametric statistical method to analyze the data obtained.

RESULTS: Most patients had skin phototype III and the most affected location was the lower limb. Clinically, acral lentiginous melanomas and nodular melanomas were the most observed. The most common dermoscopic finding was the multicomponent pattern. Clinically and histologically, the most frequent subtype associated with metastasis was nodular melanoma. Acral lentiginous melanoma was more common among patients without metastasis.

CONCLUSIONS: Unfortunately, melanoma is still diagnosed in advanced stages in Mexico; for its early recognition, training in the use of dermoscopy and greater awareness about melanoma in the Mexican population must be encouraged.

PMID:39570666 | DOI:10.5281/zenodo.13306762

JAMA Otolaryngol Head Neck Surg. 2024 Nov 21. doi: 10.1001/jamaoto.2024.3719. Online ahead of print.

ABSTRACT

IMPORTANCE: Understanding the clinical course and malignant transformation rate of oral potentially malignant disorders (OPMDs)-including oral leukoplakia, oral erythroplakia, oral submucous fibrosis, and oral lichen planus-is crucial for early detection and improved survival rates in patients with oral cancer.

OBJECTIVE: To evaluate the progression of oral cancer from OPMDs using a large US electronic medical database.

DESIGN, SETTING, AND PARTICIPANTS: This retrospective cohort study used data from the University of California, San Francisco’s PatientExploreR database between January 1973 and March 2024. Patients with oral leukoplakia, oral erythroplakia, oral submucous fibrosis, and oral lichen planus were identified using International Statistical Classification of Diseases and Related Health Problems, Tenth Revision, codes and keywords. Demographics, tobacco and alcohol use, HIV status, and other known risk factors for oral cancer were recorded to identify factors associated with malignant transformation. Logistic regression and descriptive analyses were used.

EXPOSURE: Diagnosis of oral leukoplakia, oral erythroplakia, oral submucous fibrosis, or oral lichen planus.

MAIN OUTCOMES AND MEASURES: Incidence of oral cancer, malignant transformation rate, median time to progression, and associations between demographics and risk factors and the development of oral cancer.

RESULTS: Among 4 225 251 individuals in the database, 4371 were diagnosed with oral cancer (median [IQR] age, 63 [53-71] years; 2610 [59.9%] male; 0.1% of the cohort), and 110 (2.5%) had a preceding OPMD. Oral leukoplakia was found in 1124 patients, with 94 (8.4%) undergoing malignant transformation (median [IQR] time to progression, 25 [7-129] months). HIV-positive patients with oral leukoplakia were more likely to develop oral cancer (odds ratio, 3.80; 95% CI, 1.35-10.70). Of 22 patients with oral erythroplakia, 11 (50.0%) developed oral cancer (median [IQR] time to progression, 3.7 [0.2-334] months). Those who smoked tobacco with oral erythroplakia showed a higher malignant transformation rate (odds ratio, 3.75; 95% CI, 0.54-26.05). Of the 78 patients with oral submucous fibrosis, 4 (5.1%) underwent malignant transformation (median [IQR] time to progression, 36 [36-48] months). Only 1 patient with oral lichen planus developed oral cancer after 5 years.

CONCLUSIONS AND RELEVANCE: This cohort study showed that OPMDs have notable but varying propensities to progress to oral cancer. Early detection and monitoring of OPMDs are crucial for improving patient outcomes. However, the risk, etiopathogenesis, and clinical presentation vary for each OPMD and should, therefore, be considered distinct diseases.

PMID:39570632 | DOI:10.1001/jamaoto.2024.3719

Bioinformatics. 2024 Nov 21:btae701. doi: 10.1093/bioinformatics/btae701. Online ahead of print.

ABSTRACT

MOTIVATION: Phylogenetic reconstruction is a fundamental problem in computational biology. The Neighbor Joining (NJ) algorithm offers an efficient distance-based solution to this problem, which often serves as the foundation for more advanced statistical methods. Despite prior efforts to enhance the speed of NJ, the computation of the n 2 entries of the distance matrix, where n is the number of phylogenetic tree leaves, continues to pose a limitation in scaling NJ to larger datasets.

RESULTS: In this work, we propose a new algorithm which does not require computing a dense distance matrix. Instead, it dynamically determines a sparse set of at most O(n log n) distance matrix entries to be computed in its basic version, and up to O(n log 2n) entries in an enhanced version. We show by experiments that this approach reduces the execution time of NJ for large datasets, with a trade-off in accuracy.

AVAILABILITY AND IMPLEMENTATION: Sparse Neighbor Joining is implemented in Python and freely available at https://github.com/kurtsemih/SNJ.

SUPPLEMENTARY INFORMATION: Supplementary data are available at Bioinformatics online.

PMID:39570613 | DOI:10.1093/bioinformatics/btae701

JAMA Netw Open. 2024 Nov 4;7(11):e2445771. doi: 10.1001/jamanetworkopen.2024.45771.

ABSTRACT

IMPORTANCE: Being born either small for gestational age (SGA) or large for gestational age (LGA) and experiencing rapid or slow growth after birth are associated with later-life obesity. Understanding the associations of dietary quality during pregnancy with infant growth may inform obesity prevention strategies.

OBJECTIVE: To evaluate the associations of prenatal dietary quality according to the Healthy Eating Index (HEI) and the Empirical Dietary Inflammatory Pattern (EDIP) with infant size at birth and infant growth from birth to age 24 months.

DESIGN, SETTING, AND PARTICIPANTS: This cohort study used data from birthing parent-child dyads in 8 cohorts participating in the Environmental influences on Child Health Outcomes program between 2007 and 2021. Data were analyzed from March 2021 to August 2024.

EXPOSURES: The HEI and the EDIP dietary patterns.

MAIN OUTCOMES AND MEASURES: Outcomes of interest were infant birth weight, categorized as SGA, reference range, or LGA, and infant growth from birth to ages 6, 12, and 24 months, categorized as slow growth (weight-for-length z score [WLZ] score difference <-0.67), within reference range (WLZ score difference -0.67 to 0.67), or rapid (WLZ score difference, >0.67).

RESULTS: The study included 2854 birthing parent-child dyads (median [IQR] maternal age, 30 [25-34] years; 1464 [51.3%] male infants). The cohort was racially and ethnically diverse, including 225 Asian or Pacific Islander infants (7.9%), 640 Black infants (22.4%), 1022 Hispanic infants (35.8%), 664 White infants (23.3%), and 224 infants (7.8%) with other race or multiple races. A high HEI score (>80), indicative of a healthier diet, was associated with lower odds of LGA (adjusted odds ratio [aOR], 0.88 [95% CI, 0.79-0.98]), rapid growth from birth to age 6 months (aOR, 0.80 [95% CI, 0.37-0.94]) and age 24 months (aOR 0.82 [95% CI, 0.70- 0.96]), and slow growth from birth to age 6 months (aOR, 0.65 [95% CI, 0.50-0.84]), 12 months (aOR, 0.74 [95% CI, 0.65-0.83]), and 24 months (OR, 0.65 [95% CI, 0.56-0.76]) compared with an HEI score 80 or lower. There was no association between high HEI and SGA (aOR, 1.14 [95% CI, 0.95-1.35]). A low EDIP score (ie, ≤63.6), indicative of a less inflammatory diet, was associated with higher odds of LGA (aOR, 1.24 [95% CI, 1.13-1.36]) and rapid infant growth from birth to age 12 months (aOR, 1.50 [95% CI, 1.18-1.91]) and lower odds of rapid growth to age 6 months (aOR, 0.77 [95% CI, 0.71-0.83]), but there was no association with SGA (aOR, 0.80 [95% CI, 0.51-1.25]) compared with an EDIP score of 63.6 or greater.

CONCLUSIONS AND RELEVANCE: In this cohort study, a prenatal diet that aligned with the US Dietary Guidelines was associated with reduced patterns of rapid and slow infant growth, known risk factors associated with obesity. Future research should examine whether interventions to improve prenatal diet are also beneficial in improving growth trajectory in children.

PMID:39570591 | DOI:10.1001/jamanetworkopen.2024.45771

JAMA Netw Open. 2024 Nov 4;7(11):e2446243. doi: 10.1001/jamanetworkopen.2024.46243.

ABSTRACT

IMPORTANCE: Although intensive follow-up of patients after curative surgery for colorectal cancer is common in clinical practice, evidence for a long-term survival benefit of more frequent testing is limited.

OBJECTIVE: To examine overall and colorectal cancer-specific mortality rates in patients with stage II or III colorectal cancer who underwent curative surgery and underwent high-frequency or low-frequency follow-up testing.

DESIGN, SETTING, AND PARTICIPANTS: This randomized clinical trial with posttrial prespecified follow-up was performed in 23 centers in Sweden and Denmark. The original study enrolled 2509 patients with stage II or III colorectal cancer from Sweden, Denmark, and Uruguay (1 center) who received treatment from January 1, 2006, through December 31, 2010, and were followed up for up to 5 years. The participants from Sweden and Denmark were then followed up for 10 years through population-based health registries. The 53 patients from Uruguay were not included in the posttrial follow-up. Statistical analysis was performed from March to June 2024.

INTERVENTIONS: Patients were randomly allocated to follow-up testing with computed tomography (CT) scans and serum carcinoembryonic antigen (CEA) screening at 6, 12, 18, 24, and 36 months after surgery (high-frequency group; 1227 patients), or at 12 and 36 months after surgery (low-frequency group, 1229 patients).

MAIN OUTCOMES AND MEASURES: The outcomes were 10-year overall mortality and colorectal cancer-specific mortality rates. Both intention-to-treat and per-protocol analyses were performed.

RESULTS: Of the 2555 patients who were randomly allocated, 2509 were included in the intention-to-treat analysis, of whom 2456 (97.9%) were included in this posttrial analysis (median age, 65 years [IQR, 59-70 years]; 1355 male patients [55.2%]). The 10-year overall mortality rate for the high-frequency group was 27.1% (333 of 1227; 95% CI, 24.7%-29.7%) compared with 28.4% (349 of 1229; 95% CI, 26.0%-31.0%) in the low-frequency group (risk difference, 1.3% [95% CI, -2.3% to 4.8%]). The 10-year colorectal cancer-specific mortality rate in the high-frequency group was 15.6% (191 of 1227; 95% CI, 13.6%-17.7%) compared with 16.0% (196 of 1229; 95% CI, 14.0%-18.1%) in the low-frequency group (risk difference, 0.4% [95% CI, -2.5% to 3.3%]). The same pattern resulted from the per-protocol analysis.

CONCLUSIONS AND RELEVANCE: Among patients with stage II or III colorectal cancer, more frequent follow-up testing with CT scans and CEA testing did not result in a significant reduction in 10-year overall mortality or colorectal cancer-specific mortality. The results of this trial should be considered as the evidence base for updating clinical guidelines.

TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT00225641.

PMID:39570590 | DOI:10.1001/jamanetworkopen.2024.46243

JAMA Netw Open. 2024 Nov 4;7(11):e2446591. doi: 10.1001/jamanetworkopen.2024.46591.

ABSTRACT

IMPORTANCE: Health-related quality of life is a critical health outcome and a clinically important patient-reported outcome in clinical trials. Hearing loss is associated with poorer health-related quality-of-life in older adults.

OBJECTIVE: To investigate the 3-year outcomes of hearing intervention vs health education control on health-related quality of life.

DESIGN, SETTING, AND PARTICIPANTS: This secondary analysis of a randomized clinical trial included participants treated for hearing loss at multiple US centers between 2018 and 2019 with 3-year follow-up completed in 2022. Eligible participants were aged 70 to 84 years, had untreated hearing loss, and were without substantial cognitive impairment. Participants were randomized (1:1) to hearing intervention or health education control and followed every 6 months.

INTERVENTION: Hearing intervention (provision of hearing aids and related technologies, counseling, education) or health education control (individual sessions covering topics relevant to chronic disease, disability prevention).

MAIN OUTCOMES AND MEASURES: Three-year change in the RAND-36 physical and mental health component scores over 3 years. The 8 individual domains of health-related quality-of-life were additionally assessed. Outcomes measured at baseline and at 6-month, 1-year, 2-year, and 3-year follow-ups. Intervention effect sizes estimated using a 2-level linear mixed effects model under the intention-to-treat principle.

RESULTS: A total of 977 participants were analyzed (mean [SD] age, 76.8 [4.0] years; 523 female [53.5%]; 112 Black [11.5%], 858 White [87.8%]; 521 had a Bachelor’s degree or higher [53.4%]), with 490 in the hearing intervention and 487 in the control group. Over 3 years, hearing intervention (vs health education control) had no significant association with physical (intervention, -0.49 [95% CI, -3.05 to 2.08]; control, -0.92 [95% CI, -3.39 to 1.55]; difference, 0.43 [95% CI, -0.64 to 1.51]) or mental (intervention, 0.38 [95% CI, -1.58 to 2.34]; control, -0.09 [95% CI, -1.99 to 1.81]; difference, 0.47 [95% CI, -0.41 to 1.35]) health-related quality of life.

CONCLUSIONS AND RELEVANCE: In this secondary analysis of a randomized clinical trial, hearing intervention had no association with physical and mental health-related quality-of-life over 3 years among older adults with hearing loss. Additional intervention strategies may be needed to modify health-related quality among older adults with hearing loss.

TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03243422.

PMID:39570588 | DOI:10.1001/jamanetworkopen.2024.46591

Med Care. 2024 Nov 15. doi: 10.1097/MLR.0000000000002100. Online ahead of print.

ABSTRACT

OBJECTIVES: To provide population utility norms from the Health Utilities Index Mark 3 (HUI3) for the province of Quebec, Canada.

METHODS: This study used data from the Care Trajectories Enriched Data (TorSaDE) cohort, which combines data from the Canadian Community Health Survey (CCHS) and the Quebec Provincial Insurance Board [Régie de l’assurance maladie du Quebec (RAMQ)]. The CCHS is a multiround health-related survey conducted by Statistics Canada since 2007. For each round spanning over 2 years, respondents were randomly selected and completed an online questionnaire. Quebec data for the HUI3 were available in the CCHS for rounds 2007, 2009, and 2013. The RAMQ database is an administrative database that contains information on health care services use and medical diagnostics. HUI3 scores were stratified by sociodemographic variables, as well as by self-reported health problems in the CCHS and by medical diagnostics from the RAMQ. Medical diagnostics were retrieved for the CCHS completion year and the year before and identifiable with the ICD-9 code in the RAMQ database.

RESULTS: A total of 55,656 individuals were considered in this analysis. The mean (95% CI) and the median interquartile range of HUI3 were respectively 0.919 (0.918-0.919) and 0.973 (0.905-1) for the entire population. Individuals with lower scores were females, those aged 75 and over, divorced or widowed, unemployed during the last 12 months, less educated, or with a lower annual household income. Individuals born abroad and with normal weight of body mass index had higher utility scores. HUI3 score decreased with the number of diagnosed diseases from 0.946 (0.946-0946) for individuals without diagnosed disease to 0.682 (0.678-0.686) for individuals diagnosed with up to 18 diseases. Regardless of the number of diagnosed diseases in the RAMQ database, individuals who self-reported suffering from a single health problem presented a significantly lower HUI3 ranging from 0.944 (0.943-0.944) for Asthma to 0.789 (0.782-0.796) for Alzheimer compared with 0.956 (0.956-0.957) for individuals with no reported health problems. The same pattern was observed when considering individuals regardless of the diagnosed and self-reported diseases.

CONCLUSION: Utility score norms for HUI3 were produced in the general population of Quebec. Significant differences among various health problems were identified and norms can be used to compare populations in studies that do not have a control group.

PMID:39570579 | DOI:10.1097/MLR.0000000000002100

Int J Clin Pharm. 2024 Nov 21. doi: 10.1007/s11096-024-01836-5. Online ahead of print.

ABSTRACT

BACKGROUND: Neutropenia can easily progress to febrile neutropenia and is a risk factor for life-threatening infections. Predicting and preventing severe neutropenia can help avoid such infections.

AIM: This study aimed to develop an optimal model using advanced statistical methods to predict neutropenia after 5-fluorouracil/cisplatin chemotherapy for esophageal cancer and to create a nomogram for clinical application.

METHOD: Patients who received 5-fluorouracil/cisplatin chemotherapy at Chiba University Hospital, Japan, between January 2011 and March 2021 were included. Clinical parameters were measured before the first, second, and third chemotherapy cycles and were randomly divided by patient into a training cohort (60%) and test cohort (40%). The predictive performance of Logistic, Stepwise, Lasso, and GLMMLasso models was evaluated by the area under the receiver-operating characteristic curve (AUC). A nomogram based on GLMMLasso was developed, and the accuracy of probabilistic predictions was evaluated by the Brier score.

RESULTS: The AUC for the first cycle of chemotherapy was 0.781 for GLMMLasso, 0.751 for Lasso, 0.697 for Stepwise, and 0.669 for Logistic. The respective AUCs for GLMMLasso in the second and third cycles were 0.704 and 0.900. The variables selected by GLMMLasso were cisplatin dose, 5-fluorouracil dose, use of leucovorin, sex, cholinesterase, and platelets. A nomogram predicting neutropenia was created based on each regression coefficient. The Brier score for the nomogram was 0.139.

CONCLUSION: We have developed a predictive model with high performance using GLMMLasso. Our nomogram can represent risk visually and may facilitate the assessment of the probability of chemotherapy-induced severe neutropenia in clinical practice.

PMID:39570570 | DOI:10.1007/s11096-024-01836-5

Drug Saf. 2024 Nov 21. doi: 10.1007/s40264-024-01487-5. Online ahead of print.

ABSTRACT

INTRODUCTION: Risk minimisation measures (RMMs) aim to ensure safe use of medicines, but their implementation in clinical practice is complicated by the diversity of stakeholders whose clinical decision making they seek to inform. Clinical practice guidelines (CPGs) are considered integral in clinical decision making.

OBJECTIVES: To determine the extent to which RMMs are included in the relevant CPGs and to describe factors that determine RMM inclusion.

METHODS: A multi-case study design using quantitative document analysis of CPGs combined with qualitative interviews with informants from organisations that issue CPGs. Cases from five therapeutic areas (TAs) with a regulatory requirement for further RMMs were studied individually in six EU member states (Denmark, Greece, Latvia, Netherlands, Portugal and Slovenia). Clinical practice guidelines were analysed using pre-defined coding frameworks. Interviewees were sampled purposively for experience and knowledge about CPG development and RMM inclusion. Verbatim interview transcripts were analysed inductively.

RESULTS: In total, 136 CPGs were analysed, and RMM information about TAs was included in 25% of CPGs. Based on 71 interviews we found that factors that determine RMM inclusion in CPGs include clinicians’ low awareness of RMMs despite awareness of RMMs’ safety concern, low expectation of RMMs’ clinical utility, and unfamiliarity with pharmacovigilance data supporting RMMs and perceived incompatibility of CPGs’ scope and purpose and RMM information.

CONCLUSIONS: The inclusion of RMM information in relevant CPGs is remarkably limited. It may be explained by characteristics of CPGs and of RMMs as well as lack of connection between national regulators and organisations and authors developing CPGs. More collaboration between stakeholders, national regulators and the EMA may advance implementation.

PMID:39570566 | DOI:10.1007/s40264-024-01487-5

Adv Ther. 2024 Nov 21. doi: 10.1007/s12325-024-03050-1. Online ahead of print.

ABSTRACT

INTRODUCTION: There is no information on the incidence of severe hypoglycemia in real-world patients with diabetes receiving ultra-rapid lispro (URLi). This post-marketing, observational, safety study assessed the incidence proportion and incidence rate of the first severe hypoglycemia event requiring a hospital visit in URLi-treated patients. It also compared the risk of severe hypoglycemia between patients treated with URLi or other rapid-acting insulin analogs (RAIAs).

METHODS: Claims data were obtained from a nationwide hospital-based administrative database in Japan (Medical Data Vision). Adults with diabetes who initiated URLi or other RAIA on/after June 01, 2020, were followed up through May 31, 2023. Severe hypoglycemia was identified using a validated algorithm. Incidence proportion and incidence rate of the first severe hypoglycemia event requiring a hospital visit was described in URLi-treated patients (descriptive analysis). These outcomes were also compared against propensity score (PS)-matched other RAIA-treated patients (comparator; comparative analysis). Hazard ratio (HR) and 95% confidence interval (CI) was estimated with a Cox proportional hazards model.

RESULTS: The descriptive analysis’ URLi-treated cohort included 17,838 patients [mean (standard deviation, SD) age 65.9 (15.7) years; 58.3% male]. The majority had type 2 diabetes (75.7%). The incidence proportion of the first severe hypoglycemia event requiring a hospital visit was 0.6% (95% CI 0.5, 0.8) and the incidence rate was 1.7 per 100 person-years (95% CI 0.7, 4.3). The comparative analysis included 10,592 URLi-treated and 52,917 comparator-treated patients. The incidence rate of severe hypoglycemia did not significantly differ between these cohorts (HR 0.8; 95% CI 0.5, 1.1; p = 0.132;.

CONCLUSION: This study did not show a statistically significant increase in the incidence and risk of the first severe hypoglycemia event requiring a hospital visit in real-world URLi-treated patients in Japan, compared with a PS-matched cohort of other RAIA-treated patients.

PMID:39570544 | DOI:10.1007/s12325-024-03050-1