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A Real-World Comparison of Apixaban and Rivaroxaban in Obese and Morbidly Obese Patients With Nonvalvular Atrial Fibrillation

J Pharm Pract. 2023 Sep 15:8971900231202643. doi: 10.1177/08971900231202643. Online ahead of print.

ABSTRACT

Background: Contemporary guidelines for managing nonvalvular atrial fibrillation (NVAF) include apixaban and rivaroxaban as first-line anticoagulation treatment options. Minimal guidance is available regarding selecting anticoagulants for patients with class I-III obesity. Objective: This study aims to evaluate the comparative effectiveness and safety of apixaban and rivaroxaban in both obese and morbidly obese patients with NVAF. Methods: A retrospective cohort study was conducted at an outpatient cardiovascular clinic after Institutional Review Board approval. Patients were eligible if they were ≥18 years of age, had a BMI ≥30 kg/m2, and took apixaban or rivaroxaban for NVAF for ≥3 months. The primary endpoint was the composite rate of stroke, transient ischemic attack (TIA), myocardial infarction (MI), or presence of atrial thrombosis. Bleeding events were evaluated as the primary safety endpoint. Results: Combined, the cohorts consisted of 303 obese or morbidly obese patients. The primary composite endpoint occurred in 3.8% of patients taking apixaban and 1.7% of patients taking rivaroxaban (P = .28). Both clinically relevant, non-major and major bleeding occurred more often in the apixaban arm, but this difference was not statistically significant; however, bleeding risk may have been skewed due to differences in baseline characteristics. Conclusion and Relevance: For obese and morbidly obese patients prescribed either apixaban or rivaroxaban for NVAF, rates of stroke, TIA, MI, and atrial thrombosis did not differ. The preferred DOAC for patients with class I-III obesity remains elusive, but current data points to a patient-centered approach for anticoagulant selection.

PMID:37713139 | DOI:10.1177/08971900231202643

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Surgical Anatomy of Transversus Abdominis Muscle for Transversus Abdominis Release: A CT-Based Study in Three Patient Groups

World J Surg. 2023 Sep 15. doi: 10.1007/s00268-023-07163-6. Online ahead of print.

ABSTRACT

BACKGROUND: The anatomy of the transversus abdominis muscle and its aponeurosis is important in transversus abdominis release surgery. We studied the CT anatomy of the transversus abdominis muscle medial to the linea semilunaris at different levels in the abdomen and measured the thickness of this muscle.

METHODS: In this retrospective study, we analysed 150 abdominal computed tomography at L1, L3, and L5 vertebral levels corresponding to subxiphoid, umbilical, and suprapubic regions, respectively. The patients were divided into three groups based on age and sex: women aged 15-20 years (nulliparous), women aged 30-60 years (multiparous), and men aged 15-60 years, with each group having 50 patients. We compared the thickness of the TA muscle at the L1 level between men and women and between nulliparous and multiparous women.

RESULTS: Transversus abdominis muscle was consistently present medial to the linea semilunaris at L1 vertebral level in the subxiphoid region (150/150). At the L3 vertebral level in the mid-abdomen, only eight patients had the transversus abdominis muscle there (8/150, 5%). At the L5 vertebral level in the suprapubic region, no patient had the transversus abdominis muscle medial to the linea semilunaris. The mean thickness of the transversus abdominis muscle at the L1 level was 3.4 mm, and at the L3 level, it was 1.6 mm. There was no statistically significant difference in the transversus abdominis muscle thickness between the men and women; however, a significant difference was found between the nulliparous and multiparous women, with thinner TA muscle in later.

CONCLUSION: There is good transversus abdominis muscle bulk medial to the linea semilunaris for doing transversus abdominis muscle division in the upper abdomen. However, as we move towards the mid-abdomen, we have TA aponeurosis or rarely TA muscle of little bulk.

PMID:37713128 | DOI:10.1007/s00268-023-07163-6

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High body mass index is not a contraindication for an arthroscopic ligament repair with biological augmentation in case of chronic ankle instability

Knee Surg Sports Traumatol Arthrosc. 2023 Sep 15. doi: 10.1007/s00167-023-07557-y. Online ahead of print.

ABSTRACT

PURPOSE: Obesity remains frequently mentioned as a contraindication for lateral ankle ligament repair. The aim of the study was to compare the clinical results of an arthroscopic lateral ligament repair with biological augmentation between patients with a body mass index (BMI) of more than 30 and less than 30.

METHODS: Sixty-nine patients with an isolated lateral ankle instability were treated with an arthroscopic anterior talofibular ligament (ATFL) repair with biological augmentation using the inferior extensor retinaculum (IER). Patients were divided into two groups according to their BMI: ≥ 30 (Group A; n = 26) and < 30 (Group B; n = 43). Patients were pre-and post-operatively evaluated, with a minimum of 2 years follow-up, and using the Karlsson Score. Characteristics of the patients, complications, ankle instability symptoms recurrence, and satisfaction score were recorded.

RESULTS: In group A, the median Karlsson Score increased from 43.5 (Range 22-72) to 85 (Range 37-100) at follow-up. Complications were observed in seven patients (27%). Nineteen patients (73%) reported that they were “very satisfied”. One patient (4%) described persistent ankle instability symptoms. In group B, the median Karlsson Score increased from 65 (Range 42-80) to 95 (Range 50-100) at follow-up. Complications were observed in four patients (9%). Thirty-three patients (77%) reported that they were “very satisfied”. Two patients (5%) described persistent ankle instability symptoms. Pre-operative and at last follow-up Karlsson Score, results were significantly different between the two groups. There was no significant statistical difference in favour of satisfaction score, complications and recurrence of ankle instability between the two groups.

CONCLUSION: ATFL repair with biological augmentation using IER gives excellent results for patients with BMI ≥ 30. Compared to patients with BMI < 30, they present a slightly lower preoperative and postoperative Karlsson score, however, with a similar satisfaction rate, but are at higher risk of transient superficial peroneal nerve dysesthesia.

LEVEL OF EVIDENCE: Level III.

PMID:37713126 | DOI:10.1007/s00167-023-07557-y

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Constipation is associated with depression of any severity, but not with suicidal ideation: insights from a large cross-sectional study

Int J Colorectal Dis. 2023 Sep 15;38(1):231. doi: 10.1007/s00384-023-04520-8.

ABSTRACT

OBJECTIVE: The association between constipation and depression or suicidal ideation (SI) has not been adequately studied. This study aims to examine whether constipation is associated with depression or SI in US adults.

METHOD: 4,562 adults aged 20 and older were selected from the National Health and Nutrition Examination Survey 2009-2010 for the sample. The Bowel Health Questionnaire provided constipation information. Clinical depression and depression severity were assessed by the validated Patient Health Questionnaide-9 (PHQ-9), and item 9 of the PHQ-9 assessed SI. Adjusted odds ratios (ORs) were calculated using multivariate logistic regression models. Stability of the results was ensured by a subgroup analysis.

RESULT: After adjusting for covariates such as demographics, risk behaviors, associated comorbidities, dietary intake, and related medications, the PHQ-9 score and clinical depression were both significantly associated with constipation, with ORs and 95%CIs of 1.13 (1.10-1.16) and 3.76 (2.65-5.34). Depression of all severities was also significantly associated with constipation. The ORs and 95%CIs of constipation with mild depression, moderate depression, and moderately severe to severe depression were 2.21 (1.54-3.16), 3.69 (2.34-5.81) and 6.84 (4.19-11.15), respectively. Subgroup analyses showed no statistically significant interactions (P > 0.05), and the association was stronger in men than in women (OR: 7.81, 95%CI: 3.67-16.61 vs OR: 3.46, 95%CI: 2.31-5.19). The association between constipation and SI was not significant (OR: 1.36, 95%CI: 0.78-2.37).

CONCLUSION: In conclusion, constipation was significantly associated with depression of any severity, but not with SI, suggesting that enough attention should be paid to the emotional and psychological status of patients with constipation, especially male patients.

PMID:37713119 | DOI:10.1007/s00384-023-04520-8

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The relationship between abnormal urinalysis findings and appendicitis location

Int J Colorectal Dis. 2023 Sep 15;38(1):232. doi: 10.1007/s00384-023-04527-1.

ABSTRACT

AIMS: Acute appendicitis is a common cause of acute abdomen in general surgery and early diagnosis is crucial for prognosis. Abnormal urinalysis results have been associated with appendicitis in some studies, with reports of microscopic hematuria or pyuria in laboratory tests. The aim of this article is to evaluate the relationship between laboratory findings of hematuria, pyuria, and the location of acute appendicitis.

METHODS: This retrospective study included 577 patients who underwent appendectomy for suspected acute appendicitis between January 1, 2018, and December 31, 2022, at the general surgery clinic of Samsun Training and Research Hospital.

RESULTS: Among the 577 patients, 247 were female and 330 were male, with a median age of 34 years. A statistically significant difference was observed between appendicitis location and erythrocyte values (p = 0.009), specifically in paraileal and retrocecal locations. There was a statistically significant difference between appendicitis location and leukocyte values (p < 0.001), with significant differences found in paraileal, promontoric, and retrocecal locations. A statistically significant difference was observed between appendicitis location and leukocyte esterase values (p = 0.002), specifically in paraileal and retrocecal locations.

DISCUSSION/CONCLUSION: Abnormal urinalysis findings are not uncommon in patients with acute appendicitis. Our study demonstrated a significant correlation between tit erythrocyte, tit leukocyte, and tit leukocyte esterase positivity with appendicitis locations. Therefore, we believe that pathological findings in urine tests of patients undergoing surgery with a preliminary diagnosis of appendicitis can provide valuable information to surgeons regarding the location of the appendix, ultimately aiding in optimizing the timing and cost of the operation.

PMID:37713118 | DOI:10.1007/s00384-023-04527-1

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Do adaptive policy adjustments deliver ecosystem-agriculture-economy co-benefits in land degradation neutrality efforts? Evidence from southeast coast of China

Environ Monit Assess. 2023 Sep 15;195(10):1215. doi: 10.1007/s10661-023-11821-6.

ABSTRACT

Ecosystem restoration projects (ERPs) facilitate land degradation neutrality (LDN). However, the response dynamics and interactions of sectors within ecosystem-agriculture-economy nexus (EAEN) have not been sufficiently explored, which constrains the coordinated efficacy of LDN efforts. To bridge the knowledge gaps, the present study selected a land restoration hotspot in southeastern China as a case to investigate the simultaneous responses of the EAEN sectors to ERPs from a novel social-ecological system (SES)-based LDN perspective. Various biophysical models and Manne-Kendall trend test as well as multi-source spatially explicit data and socioeconomic statistics were applied to quantify the co-evolution of natural and socioeconomic indicators. ERPs converting cropland to woodland and grassland promoted vegetation restoration, reduced soil erosion, and enhanced carbon sequestration. However, cropland loss initially resulted in a decline in grain productivity. Policy adjustments and improvements in ecosystem restoration efforts and agricultural production conditions improved food security and increased agricultural production capacity. Effective policymaking and favorable resident engagement accelerated the transformation from a grain-production-based agriculture to diversified industries and, by extension, economic output, income, and population. The success of socioeconomic development under the SES framework for LDN demonstrated that this strategy could achieve the desired environmental, agricultural, and economic targets. EAEN under the SES conceptual framework provides an inclusive, comprehensive LDN perspective and improves ERP efficacy. The findings of the present work might be applicable to other land restoration areas challenged by the complex interactions among multidimensional factors. Comparably successful implementation of these ERPs could be realized if individual environmental and socioeconomic conditions are thoroughly considered during the formulation of coordinated development policies.

PMID:37713117 | DOI:10.1007/s10661-023-11821-6

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Using simulation to enhance primary care sexual health services for breast cancer survivors: a feasibility study

Support Care Cancer. 2023 Sep 15;31(10):576. doi: 10.1007/s00520-023-08037-2.

ABSTRACT

PURPOSE: To evaluate the impact of a virtual simulation game (VSG) to improve primary care sexual health services for breast cancer survivors.

METHODS: We developed a VSG to help primary care providers (PCPs) address sexual health disturbances among breast cancer survivors. We used a pretest-posttest design with a series of validated tools to assess the feasibility and perceived impact of the VGS, including an open-ended question about participants’ perceptions. Quantitative data was analyzed using descriptive and inferential statistics and qualitative data through an inductive content analysis approach.

RESULTS: Of the 60 participants, the majority were nurse practitioner students (n = 26; 43.3%), female (n = 48; 80%), and worked full-time (n = 35; 58.3%). Participants perceived the VSG as feasible and potentially effective. The intervention elicited an improvement in PCPs’ perception of knowledge between pretest and posttest surveys (z = – 1.998, p = 0.046). Professional background and previous exposure to sexual health training were predictors of knowledge perception. Participants described the intervention as an engaging educational strategy where they felt safe to make mistakes and learn from that.

CONCLUSIONS: VSGs can be a potentially effective educational approach for PCPs. Our findings indicate that despite being an engaging interactive strategy, VSG interventions should be tailored for each professional group.

IMPLICATIONS FOR CANCER SURVIVORS: This intervention has potential to improve the knowledge and practice of PCPs related to breast cancer follow-up care to support comprehensive care for survivors, resulting in a better quality of life and patient outcomes.

PMID:37713111 | DOI:10.1007/s00520-023-08037-2

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Enrollment Forecast for Clinical Trials at the Planning Phase with Study-Level Historical Data

Ther Innov Regul Sci. 2023 Sep 15. doi: 10.1007/s43441-023-00564-8. Online ahead of print.

ABSTRACT

Given progressive developments and demands on clinical trials, accurate enrollment timeline forecasting is increasingly crucial for both strategic decision-making and trial execution excellence. Naïve approach assumes flat rates on enrollment using average of historical data, while traditional statistical approach applies simple Poisson-Gamma model using time-invariant rates for site activation and subject recruitment. Both of them are lack of non-trivial factors such as time and location. We propose a novel two-segment statistical approach based on Quasi-Poisson regression for subject accrual rate and Poisson process for subject enrollment and site activation. The input study-level data are publicly accessible and it can be integrated with historical study data from user’s organization to prospectively predict enrollment timeline. The new framework is neat and accurate compared to preceding works. We validate the performance of our proposed enrollment model and compare the results with other frameworks on 7 curated studies.

PMID:37713098 | DOI:10.1007/s43441-023-00564-8

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The global landscape of bladder cancer incidence and mortality in 2020 and projections to 2040

J Glob Health. 2023 Sep 15;13:04109. doi: 10.7189/jogh.13.04109.

ABSTRACT

BACKGROUND: Bladder cancer (BCa) is one of the most common urological malignancies worldwide. This study examines the global epidemiological profile of BCa incidence and mortality in 2020 and the projected burden to 2040.

METHODS: The estimated number of BCa cases and deaths were extracted from the GLOBOCAN 2020 database. Age-standardised incidence rates (ASIRs) and age-standardised mortality rates (ASMRs) were calculated using the world standard. The predicted BCa incidence and mortality in 2040 was calculated based on demographic projections.

RESULTS: Globally, approximately 573 000 new BCa cases and 213 000 deaths occurred in 2020, corresponding to ASIRs and ASMRs of 5.6 and 1.9 per 100 000, respectively. The incidence and mortality rates were approximately 4-fold higher in men (9.5 and 3.3 per 100 000, respectively) than women (2.4 and 0.9, respectively). Across world regions, incidence rates varied at least 12-fold among men and 8-fold among women, with the highest ASIRs for both men and women detected in Southern Europe (26.5 and 5.8 per 100 000, respectively) and Western Europe (21.5 and 5.8, respectively) and the lowest in Middle Africa (2.2) in men and South-Central Asia (0.7) in women. The highest ASMRs for both men and women were found in Northern Africa (9.2 and 1.8 per 100 000, respectively). By 2040, the annual number of new BCa cases and deaths will increase to 991 000 (72.8% increase from 2020) and 397 000 (86.6% increase), respectively.

CONCLUSIONS: Geographical distributions of BCa incidence and mortality uncovered higher risk of BCa incidence in Southern and Western European populations and higher risk of mortality in Northern African populations. Considering the predicted 73% and 87% increase in annual BCa cases and deaths by 2040 globally, respectively, there is an urgent need to develop and accelerate BCa control initiatives for high-risk populations to tackle global BCa burden and narrow its geographical disparities.

PMID:37712386 | DOI:10.7189/jogh.13.04109

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High-risk pregnancy in India: Prevalence and contributing risk factors – a national survey-based analysis

J Glob Health. 2023 Sep 15;13:04116. doi: 10.7189/jogh.13.04116.

ABSTRACT

BACKGROUND: High-risk pregnancies (HRP) place women and their offspring at the highest risk for morbidity and mortality. Maternal and medical risks increase pregnancy risk and complications during pregnancy and childbirth. Here, we reported the current prevalence of high-risk pregnancies among Indian women, which is defined through various factors such as maternal, lifestyle, medical, current health risk and adverse birth outcomes.

METHODS: This is a cross-sectional study based on secondary data from India’s National Family Health Survey-5 (NFHS-5). A total of 23 853 currently pregnant women were considered for analysis after considering the inclusion and exclusion criteria. The prevalence and contributing factors of high-risk pregnancies were estimated using descriptive statistics and logistic regression, respectively.

RESULTS: The prevalence of high-risk pregnancies among Indian women was 49.4%, with 33% of women having a single high-risk, and 16.4% having multiple high-risk pregnancies. Notably, pregnant women from Meghalaya and Manipur states had 67.8% and 66.7% with one or more high-risk factors, respectively. About 31.1% of women had short birth spacing, and 19.5% of women had adverse birth outcomes during the last birth. Logistic regression analysis showed that women with no education (adjusted odds ratio (AOR) = 2.02; 95% confidence interval (CI) = 1.84-2.22) and the poorest wealth quintile (AOR = 1.33; 95% CI = 1.04-1.29) had significantly higher odds of having HRP than those with higher education and the highest wealth quintile, respectively.

CONCLUSIONS: Nearly half of all pregnancies in India have one or more high-risk factors, which is a matter of concern, and the risks were higher among the vulnerable population such as no educated, poorest groups etc. The leading high-risk factors such as short-birth spacing, adverse birth outcomes, and caesarean deliveries should be addressed through the health policy and programmes.

PMID:37712385 | DOI:10.7189/jogh.13.04116