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Nevin Manimala Statistics

Patterns of Treatment and Real-World Outcomes of Patients With Non-small Cell Lung Cancer With EGFR Exon 20 Insertion Mutations Receiving Mobocertinib: The EXTRACT Study

Cancer Med. 2025 Feb;14(3):e70369. doi: 10.1002/cam4.70369.

ABSTRACT

BACKGROUND: Real-world data regarding patients with non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion (ex20ins) mutations receiving mobocertinib are limited. This study describes these patients’ characteristics and outcomes.

METHODS: A chart review was conducted across three countries (Canada, France, and Hong Kong), abstracting data from eligible patients (NCT05207423). The inclusion criteria were: ≥ 18 years old; diagnosis of stage IIIB-IV NSCLC with EGFR ex20ins between January 1, 2017 and November 30, 2021; received mobocertinib. Data on demographics, clinical parameters, treatment patterns, mobocertinib exposure, real-world outcomes, and adverse events (AEs) were collected. Results are also reported by Asian/Non-Asian races.

RESULTS: Overall, 105 patients were enrolled (median [IQR] age at initial diagnosis: 64.0 years [56, 71]; women: 62.9%). The most common first-line of therapy (LoT) was chemotherapy; the most common second LoT was EGFR tyrosine kinase inhibitors. Most patients received mobocertinib during LoT two and three (74.3%); the maximum dose was 160 mg/day for 67.6% of the cohort (mean [SD] daily dose: 130.6 mg [36.68]). The median real-world progression-free survival (PFS) on mobocertinib was 4.76 months (95% CI: 3.98, 6.21). The overall response rate and disease control rate were 20.0% and 48.6%, respectively (median duration of response: 8.34 months [95% CI: 3.61, 9.49]). The median overall survival (OS) was 26.28 months (95% CI: 20.21, 36.44). Asian patients had numerically superior PFS and OS compared with non-Asian patients. Regarding safety analysis, 73 patients (69.5%) experienced any AE. The most common AE was diarrhea (any grade) (52 patients; 49.5%).

CONCLUSIONS: These data illustrate the real-world effectiveness of mobocertinib.

PMID:39861957 | DOI:10.1002/cam4.70369

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Efficacy of Orthognathic Surgery in OSAS Patients: A Systematic Review and Meta-Analysis

J Oral Rehabil. 2025 Jan 24. doi: 10.1111/joor.13936. Online ahead of print.

ABSTRACT

BACKGROUND: Obstructive sleep apnea syndrome (OSAS) is a prevalent condition characterised by repeated episodes of partial or complete obstruction of the upper airway during sleep, leading to disrupted sleep and associated morbidities. Orthognathic surgery (OGS) has been proposed as a treatment option for OSAS, aimed at anatomically repositioning the maxillofacial structures to alleviate airway obstruction. This systematic review and meta-analysis aimed to evaluate the efficacy of OGS in reducing apnea-hypopnea index (AHI) and Epworth Sleepiness Scale (ESS) scores among OSAS patients.

METHODS: We conducted a comprehensive literature search across multiple databases for studies assessing the outcomes of OGS in OSAS patients, focusing on changes in AHI and ESS scores. The inclusion criteria encompassed observational studies, cohort studies, and randomised control trials. Data extraction and quality assessment were performed independently by two reviewers. Random-effects meta-analysis was utilised to pool mean differences (MD) of AHI and ESS scores preoperatively and postoperatively, with 95% confidence intervals (CI) calculated.

RESULTS: A total of 8 studies met the inclusion criteria, where OGS was shown to be slightly more effective in correcting OSAS than the other modalities assessed, primarily CPAP. The pooled MD for AHI demonstrated a significant reduction in scores post-OGS (MD = 29.84, 95% CI: 14.17-45.50, p < 0.0001) with substantial heterogeneity (I2 = 95%). For ESS, the pooled MD indicated a non-significant reduction (MD = 1.91, 95% CI: -1.29 to 5.12, p = 0.24) with high heterogeneity (I2 = 81%).

CONCLUSION: Orthognathic surgery appears to be an effective intervention for reducing AHI in patients with OSAS, suggesting a potential to improve the objective measures of sleep apnea. However, the effect on subjective sleepiness scores, as evaluated by ESS, was not statistically significant. The high heterogeneity among studies warrants individualised patient assessment when considering OGS for OSAS. Further research is needed to identify factors contributing to the variability of outcomes and to assess the long-term benefits and risks associated with the procedure.

PMID:39861956 | DOI:10.1111/joor.13936

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A Comparison of Wound Related Complications Between Intramedullary and Lateral Plate Osteosynthesis After Fibula Osteotomy in the Lateral Approach Total Ankle Replacement

Foot Ankle Int. 2025 Jan 24:10711007241309901. doi: 10.1177/10711007241309901. Online ahead of print.

ABSTRACT

BACKGROUND: Total ankle replacement (TAR) has evolved in the last decade from a procedure rife with complication and failure to a promising alternative to arthrodesis. The ability to maintain ankle joint range of motion is showing great promise in patient-reported outcomes, postsurgical pain, as well as long-term sequalae of joint fusion. Although TAR can be performed via either an anterior or lateral approach both with their own sets of benefits and potential complications, the consensus seems to be that one is no better than the other when performed by high-volume surgeons.

METHODS: Data were gathered over a 6-year period looking at an age- and gender-matched cohort of lateral approach TARs with either plate osteosynthesis or fibula nail fixation in the management of the fibula osteotomy and compared reoperation and infection rates with the working hypothesis that nail fixation would afford better outcomes. Secondary outcomes including rates of fibula union, tourniquet time as an adjunct to procedure length, and patient-reported outcome measures (PROMs) in the form of FAOS Quality scores were included.

RESULTS: A total of 234 TARs were analyzed. Forty-five of these used intramedullary nail fixation (IM), and a control group of 45 plate osteosynthesis (PO) fixation cases was correlated. The Foot and Ankle International guidelines on reporting for complications arising from total ankle arthroplasty that resulted in reoperation were applied to the data set, and it was noted that 13 of 19 reoperations were noted in the PO group, which was statistically significant. Also of note, 12 of 16 patients treated with antibiotics, which included all those cases within the reoperation group, were noted to come from the PO group. This was also of statistical significance. Interestingly, the rate of fibula nonunion in the PO group was lower (8.88%) than that of the IM group (23.25%).

CONCLUSION: Our results confirmed that the rates of reoperation and infection were statistically significantly improved with the use of nail fixation over plate fixation. This was tempered by a concerningly high nonunion rate. This article shows promising results for the use of a simple technique in improving long-term outcomes in ankle arthroplasty.

PMID:39861943 | DOI:10.1177/10711007241309901

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Nevin Manimala Statistics

The Impact of Sleep Position Preferences on the Sleep Quality, Comfort and Catheter Care Quality in Patients After Endoscopic Nasobiliary Drainage: A Cross-Sectional Study

J Clin Nurs. 2025 Jan 24. doi: 10.1111/jocn.17649. Online ahead of print.

ABSTRACT

AIMS AND OBJECTIVES: This study aimed to investigate the impact of sleep position preferences (SPP) on sleep quality, comfort and catheter care quality in patients after endoscopic nasobiliary drainage (ENBD).

DESIGN: This was an observational prospective study.

METHODS: This study included 167 participants with common bile duct stones (CBDS) who underwent ENBD from the gallstone ward of a hospital as a convenience sample. Data were collected between June 2022 and August 2023. The study utilised the Pittsburgh Sleep Quality Index, Athens Insomnia Scale, comfort level, medical device-related pressure injuries (MDRPI), catheter displacement, bile drainage volume and a self-designed questionnaire on demographic and clinical data for data collection. Data analysis included chi-square tests and one-way analysis of variance, with differences between two groups assessed using the LSD-t test. The STROBE checklist was followed.

RESULTS: The postoperative sleep quality of ENBD patients was rated at (8.65 ± 2.91) points. Significant variations in sleep quality were evident among ENBD patients with different SPPs (p < 0.01). Patients favouring left-side and supine positions demonstrated differences in sleep quality compared to those favouring the right-side position (t = 1.45, p < 0.05; t = 1.72, p < 0.01). However, when comparing patients favouring the supine position to those favouring the left-side position, the difference in sleep quality was not statistically significant (t = 0.26, p > 0.05). The postoperative comfort score of ENBD patients was recorded at (5.67 ± 1.54) points. Significant variances in comfort levels were observed among ENBD patients with different SPPs (p < 0.01). Patients favouring left-side and supine positions exhibited differences in comfort levels compared to those favouring the right-side position (t = 1.02, p < 0.05; t = 0.78, p < 0.01). Nevertheless, when comparing patients favouring the supine position to those favouring the left-side position, the difference in comfort level was not statistically significant (t = -0.24, p > 0.05). Among ENBD patients with different SPPs, there were no statistically significant differences in the occurrence of MDRPI, catheter displacement and 24-h bile drainage volume (p > 0.05).

CONCLUSIONS: The sleep quality and comfort of patients following ENBD are suboptimal, warranting increased attention from healthcare providers. Nasobiliary tube conversion and fixation via the right nostril can negatively impact the sleep quality and comfort of patients with a preference for right-side sleeping. Preoperative training focusing on adjusting sleep positions is recommended, particularly for these patients. Alternatively, personalised modifications in the positioning and fixation of the nasal catheter could be made based on patients’ sleeping position preferences. A multidisciplinary team, including nurses and surgeons, should collaboratively develop tailored nasobiliary drainage plans.

RELEVANCE TO CLINICAL PRACTICE: This study highlights the importance of addressing sleep quality and comfort in patients undergoing nasobiliary drainage. It is recommended that patients with a preference for the right lateral sleeping position receive preoperative training to adjust their sleep posture. Alternatively, the nasobiliary tube’s exit and fixation points should be customised based on individual sleep preferences. A multidisciplinary team, including nurses and surgeons, should collaborate to develop personalised nasobiliary drainage plans.

PMID:39861927 | DOI:10.1111/jocn.17649

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Presentation and Surgical Outcomes of Primary Hyperparathyroidism After Radioactive Iodine Therapy

J Surg Res. 2025 Jan 23;306:424-430. doi: 10.1016/j.jss.2024.12.043. Online ahead of print.

ABSTRACT

BACKGROUND: Radioactive iodine (RAI) is a common treatment for various thyroid diseases. Previous studies have suggested susceptibility of parathyroid glands to the mutagenic effect of RAI and the development of primary hyperparathyroidism (PHPT). We tested the possible link between prior RAI treatment, disease presentation, and treatment outcomes.

METHODS: A retrospective analysis of 704 individuals who underwent parathyroidectomy for PHPT at a tertiary care center between the years 2015 and 2023 was performed. Preoperative and postoperative parameters, including demographic characteristics, biochemical markers, imaging data, and surgical and pathology findings were collected and analyzed to compare differences in patients who had previous RAI treatment and those who did not (non-RAI). Univariate statistical analyses were performed.

RESULTS: Twenty-nine patients had a history of RAI treatment. Indications for RAI treatment included hyperthyroidism (n = 18), papillary thyroid cancer (n = 6), subacute thyroiditis (n = 1), follicular cancer (n = 1), and toxic goiter (n = 1). Average latency time between RAI exposure and development of PHPT was 18.4 ys. On comparison of the two groups, there was no difference in age, sex, race/ethnicity, day of surgery body mass index, preoperative parathyroid hormone, calcium, glomerular filtration rate, creatinine, vitamin D, or phosphate levels. There was also no difference in preoperative diagnosis of osteoporosis or nephrolithiasis. Postoperatively, there was no difference in parathyroid hormone, calcium, or creatinine levels, or in rate of cure. There was significantly higher chance of unilateral exploration in the operating room (75.9% RAI, 54.1% non-RAI, P = 0.02) and increased rate of single-gland disease in the RAI group, although the latter finding was not statistically significant (79.3% RAI, 65.2% non-RAI, P = 0.12). There was no difference in adenoma size as noted on the pathology report (greatest dimension 1.7 cm RAI, 1.7 cm non-RAI, P = 0.28). Subgroup analysis of the RAI group based on reason for RAI treatment (cancer versus hyperthyroidism) showed no statistically significant differences in the examined demographic or clinical data.

CONCLUSIONS: There does not seem to be a relationship between prior RAI treatment and the clinical presentation of PHPT. Additionally, differences in RAI dose do not appear to be associated with a change in clinical presentation. Our study revalidates that age and latency are inversely related, which is a previously shown finding. Clinicians may be reassured that patients with prior RAI history may not have differences in clinical characteristics, disease presentation, or treatment outcomes.

PMID:39854805 | DOI:10.1016/j.jss.2024.12.043

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The Relationship Between Body Mass Index and Peripheral Artery Disease: Insights from the National Health and Nutrition Examination Survey and Mendelian Randomization Analysis

J Surg Res. 2025 Jan 23;306:407-416. doi: 10.1016/j.jss.2024.12.038. Online ahead of print.

ABSTRACT

INTRODUCTION: Body mass index (BMI) has been implicated in various cardiovascular conditions, but its association with peripheral artery disease (PAD) in both real-world and genetic studies have been contentious and debated.

METHODS: This study enrolled 6707 individuals from the National Health and Nutrition Examination Survey database to investigate the association between BMI and the risk of PAD. The weighted logistic regression, restricted cubic spline, and subgroup analysis were performed using real-world data. Mendelian randomization study was conducted using genetic data from the Genome-Wide Association Study. The inverse variance weighted method was used as the primary analysis approach, and a sensitivity analysis was conducted to identify pleiotropy and heterogeneity bias.

RESULTS: Individuals with PAD had higher mean BMI values compared to those without PAD (28.82 ± 5.87 and 28.31 ± 5.42, P = 0.007). For the categorical variable of BMI, individuals in obesity class 2 (odds ratio [OR] = 1.532, 95% CI = 1.082-2.169; P = 0.013) and obesity class 3 (OR = 2.479, 95% CI = 1.515-4.056; P < 0.001) had a higher risk of PAD analyzed by weighted logistic regression. Subgroup analysis revealed that the association between BMI and PAD persisted. Given that a higher BMI is associated with PAD, we selected obesity for Mendelian randomization analysis and observed that obesity had a relationship with PAD (inverse variance weight: OR = 1.194, 95% CI = 1.099-1.296; P < 0.001). The reliable findings were validated by sensitive analysis (all P > 0.05).

CONCLUSIONS: BMI is a robust risk factor for PAD. A higher BMI (especially ≥35 kg/m2) is associated with an increased risk of developing PAD. Meanwhile, there is a causal relationship between obesity and PAD. Interventions are necessary for targeted obesity prevention and management strategies for PAD.

PMID:39854803 | DOI:10.1016/j.jss.2024.12.038

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Nevin Manimala Statistics

Risk Factors for Delayed (>30 Days) Readmission Following Rectal Cancer Surgery

J Surg Res. 2025 Jan 23;306:397-406. doi: 10.1016/j.jss.2024.12.037. Online ahead of print.

ABSTRACT

INTRODUCTION: Unplanned, delayed readmissions (>30 ds) following oncologic surgeries can increase mortality and care costs and affect hospital quality indices. However, there is a dearth of literature on rectal cancer surgery. Hence, we aimed to assess the risk factors associated with delayed readmissions following rectal cancer surgery to improve targeted interventions, patient outcomes, and quality indices.

METHODS: For this case-control study, all adult patients in the US Rectal Cancer Consortium database who underwent surgery and subsequent readmission were included. Multivariable logistic regression described the association of factors associated with delayed readmission. Descriptive statistics were used to ascertain the most common causes of readmission.

RESULTS: Of the 1417 patients included in the analysis, 403 (28.4%) patients were readmitted postoperatively. Among these, 101 (25.1%) patients had delayed readmission. The median length of stay for early readmission was significantly longer when compared to delayed readmission (4 versus 2 ds, P < 0.01). American Society of Anesthesiologists-Physical Status score > II [odds ratio = 1.81] was associated with an increased risk of delayed readmissions, while intraoperative pelvic drain placement [odds ratio = 0.57] was associated with a reduced risk. Surgical site infection was the most common cause of delayed (18.4%) and early readmissions (27.4%).

CONCLUSIONS: The risk of readmission following surgery for rectal cancer extends beyond the commonly tracked 30 ds, with up to a quarter of readmissions happening more than 30 ds after surgery. Surgical site infection continues to be the leading cause of both early and delayed readmission, underscoring the need to double down on infection prevention bundles.

PMID:39854802 | DOI:10.1016/j.jss.2024.12.037

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Altered cerebral gray matter volume and functional connectivity in patients with residual dizziness of benign paroxysmal positional vertigo

Clin Radiol. 2024 Dec 19;82:106780. doi: 10.1016/j.crad.2024.106780. Online ahead of print.

ABSTRACT

AIM: To provide a theoretical basis for the study of the pathogenesis of residual dizziness (RD) from the perspective of imaging.

MATERIALS AND METHODS: The general clinical data of the RD group and healthy control (HC) group were statistically analysed by two independent sample t tests, rank sum tests or chi-square tests. The imaging data of the two groups of people were preprocessed and statistically analysed by using the data processing and analysis for brain imaging (DPABI) software package.

RESULTS: Compared with the HC group, the grey matter volume (GMV) in the left medial superior frontal gyrus, the left superior temporal gyrus, the right cerebellum crus1 area, and the right calcarine were significantly reduced in the RD group; the functional connectivity (FC) between the ventromedial prefrontal cortex (vmPFC) and the post insula in the RD group was enhanced; The FC between the vmPFC and the occipital lobe, between the temporal lobe and the inferior parietal lobe, between the mid insula and the mid insula, between the post cingulate gyrus and the post cingulate gyrus was weakened.

CONCLUSION: 1. The GMV of many brain areas processing vestibular information of RD patients is reduced, the FC between them is weakened, which may be an important cause of RD. 2. The FC between many brain areas dealing with emotional information in RD patients is abnormal, which may be the adaptive response of them caused by emotional factors.

PMID:39854796 | DOI:10.1016/j.crad.2024.106780

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Mapping the regional and remote specialised mental health workforce: Commentary on the AIHW data for 2022-2023

Australas Psychiatry. 2025 Jan 24:10398562251316365. doi: 10.1177/10398562251316365. Online ahead of print.

ABSTRACT

OBJECTIVE: The Australian Institute of Health and Welfare publishes statistical indicator reports on the specialised mental health workforce. These include data for 2022-2023 on psychiatrists, mental health nurses, mental health occupational therapists, psychologists and mental health social workers. We provide a brief commentary on these reports, reflecting upon the implications of such changes for psychiatric practice and patient care.

CONCLUSIONS: Overall, there are fewer mental health workers with increasing distance from urban centres. There are insufficient rural psychiatrists with the NT and Queensland having higher rates per 100,000 in outer regional and remote areas. Psychologists and mental health nurses have the highest rates per 100,000 in rural areas. Though low in absolute rates per 100,000, mental health social workers are better distributed in rural compared to urban areas. Further data on public, private and non-governmental sector employment would be useful.

PMID:39854768 | DOI:10.1177/10398562251316365

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Circulating inflammatory cytokines and colorectal cancer: New insights from Mendelian randomization

Medicine (Baltimore). 2025 Jan 24;104(4):e41331. doi: 10.1097/MD.0000000000041331.

ABSTRACT

Colorectal cancer (CRC) is one of the most common cancers worldwide and inflammation is believed to play an important role in CRC. In this study, we comprehensively analyzed the causal association between 91 circulating inflammatory cytokines and the risk of CRC using Mendelian randomization (MR). Based on genome-wide association study summary statistics, we examined the causal effects of 91 circulating inflammatory cytokines on CRC. A series of MR methods, including bidirectional MR, replication sample MR, and multivariable MR, were employed to provide more robust causal estimates. After the validation with 3 MR methods and a series of sensitivity analyses, 2 circulating inflammatory factors were found to be significantly associated with the risk of CRC at the genetic level. Specifically, genetically predicted circulating levels of glial cell line-derived neurotrophic factor (GDNF) (OR = 1.12; 95% CI: 1.05-1.19; P = 2.72 × 10-4) and tumor necrosis factor-related apoptosis-inducing ligand (TRAIL) (OR = 0.93; 95% CI: 0.91-0.99; P = 1.00 × 10-2) exerted causal effects on CRC risk. In conclusion, this study suggests that increased circulating levels of GDNF and TRAIL are associated with a higher and lower risk of CRC, respectively. GDNF and TRAIL may be 2 potential therapeutic targets that deserve future investigation.

PMID:39854755 | DOI:10.1097/MD.0000000000041331