Tag: nevin manimala

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

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

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

J Glob Health. 2023 Sep 15;13:04101. doi: 10.7189/jogh.13.04101.

ABSTRACT

BACKGROUND: We noted that there remains some confusion in the health-science literature on reporting sample odds ratios as estimated rate ratios in case-control studies.

METHODS: We recap historical literature that definitively answered the question of when sample odds ratios (ORs) from a case-control study are consistent estimators for population rate ratios. We use numerical examples to illustrate the magnitude of the disparity between sample ORs in a case-control study and population rate ratios when sufficient conditions for them to be equal are not satisfied.

RESULTS: We stress that in a case-control study, sampling controls from those still at risk at the time of outcome event of the index case is not sufficient for a sample OR to be a consistent estimator for an intelligible rate ratio. In such studies, constancy of the exposure prevalence together with constancy of the hazard ratio (HR) (i.e., the instantaneous rate ratio) over time is sufficient for this result if sampling time is not controlled; if time is controlled, constancy of the HR will suffice. We present numerical examples to illustrate how failure to satisfy these conditions adds a small systematic error to sample ORs as estimates of population rate ratios.

CONCLUSIONS: We recommend that researchers understand and critically evaluate all conditions used to interpret their estimates as consistent for a population parameter in case-control studies.

PMID:37712381 | DOI:10.7189/jogh.13.04101

Sarcoidosis Vasc Diffuse Lung Dis. 2023 Sep 13;40(3):e2023036. doi: 10.36141/svdld.v40i3.13847.

ABSTRACT

BACKGROUND: Bleomycin causes increased production of reactive oxygen species, leads to pulmonary toxicity, fibroblast activation, and fibrosis.

OBJECTIVES: This study aimed to evaluate the protective effect of pirfenidone on bleomycin-induced lung toxicity in rats.

METHODS: Twenty-eight adult rats were randomly divided into 3 groups; Bleomycin (B group, n=10), Bleomycin and Pirfenidone (B-PND group, n=13), and the control group (n=5). The bleomycin regimen was administered for 9 weeks. Pirfenidone was administered at 100 mg/kg daily. Total antioxidant level (TAS), total oxidant level (TOS), tumor necrosis factor (TNF-α), transforming growth factor (TGF-β1), matrix metalloproteinase-2 (MMP-2), plasminogen activator inhibitor (PAI) levels were studied. Histopathologically, sections were stained with Hematoxylin-eosin and Masson-trichrome for grading-scoring according to the Ashcroft score.

RESULTS: Stage 3 fibrosis was observed in 50% of the B group rats, stage 3 and higher fibrosis was never detected in the B-PND group and the difference was statistically significant (p=0.003). When evaluating tissue inflammation, the inflammation was higher in the B-PND group than in the other groups (p<0.001). Pleuritis was detected in all rats in group B, while was not observed in B-PND and control group (p<0.001). The TAS level was found to be significantly higher in group B than in group B-PND (p=0.034), while no difference was found between TOS, TNF-α, MMP-2, PAI, TGF-β1.

CONCLUSIONS: Pirfenidone had a statistically significant protective effect in bleomycin-induced lung fibrosis and pleuritis in rats. Despite the presence of inflammation in the tissue, no significant changes were observed in inflammation markers in the peripheral blood. Novel serum biomarkers are needed to indicate the presence of inflammation and fibrosis in the lung.

PMID:37712376 | DOI:10.36141/svdld.v40i3.13847

Sarcoidosis Vasc Diffuse Lung Dis. 2023 Sep 13;40(3):e2023038. doi: 10.36141/svdld.v40i3.14743.

ABSTRACT

BACKGROUND AND AIM: Tuberculosis and sarcoidosis are the two most important granulomatous diseases that physicians have difficulty in differential diagnosis. In our study, we aimed to observe the place of systemic immune-inflammation index (SII) level in the differentiation of patients diagnosed with endoboronchial ultrasonography (EBUS).

METHODS: Our study included 494 patients who applied to our hospital’s chest diseases outpatient clinic between 2015 and 2020 and underwent endobronchial ultrasonography (EBUS) for mediastinal lymphadenopathy (LAP). Patients’ follow-up for at least 2 years after diagnosis and pre-procedural hematologic parameters were retrospectively recorded.

RESULTS: In the comparison of SII between groups, it was observed that SII was statistically significantly higher in patients followed up for tuberculous lymphadenitis compared to patients with sarcoidosis and reactive LAP (p=0.01, <0.001). In sarcoidosis patients, SII levels were statistically significantly higher than in patients with reactive LAP (p=0.002). Platelet, sedimentation and SII levels were statistically significantly higher in stage 2 patients compared to stage 1 patients, while lymphocyte levels were lower (p=0.009, 0.001, 0.001, 0.001, 0.001 respectively). In the ROC curve analysis of the SII level of patients with sarcoidosis and tuberculosis LAP, the AUC was 0.668 and when the cut-off value for the SII level was 890.667, the sensitivity was 70% and the specificity was 66% in the differentiation of tuberculosis and sarcoidosis lymphadenitis.

CONCLUSION: SII may be an easily applicable parameter in the differentiation of tuberculosis and sarcoidosis LAP with granuloma and in the differentiation of granulomatous diseases from reactive LAP.

PMID:37712366 | DOI:10.36141/svdld.v40i3.14743

NMR Biomed. 2023 Sep 15:e5038. doi: 10.1002/nbm.5038. Online ahead of print.

ABSTRACT

The arterial input function (AIF) plays a crucial role in estimating quantitative perfusion properties from dynamic susceptibility contrast (DSC) MRI. An important issue, however, is that measuring the AIF in absolute contrast-agent concentrations is challenging, due to uncertainty in relation to the measured $R_2^{\ast }$ -weighted signal, signal depletion at high concentration, and partial-volume effects. A potential solution could be to derive the AIF from separately acquired dynamic contrast enhanced (DCE) MRI data. We aim to compare the AIF determined from DCE MRI with the AIF from DSC MRI, and estimated perfusion coefficients derived from DSC data using a DCE-driven AIF with perfusion coefficients determined using a DSC-based AIF. AIFs were manually selected in branches of the middle cerebral artery (MCA) in both DCE and DSC data in each patient. In addition, a semi-automatic AIF-selection algorithm was applied to the DSC data. The amplitude and full width at half-maximum of the AIFs were compared statistically using the Wilcoxon rank-sum test, applying a 0.05 significance level. Cerebral blood flow (CBF) was derived with different AIF approaches and compared further. The results showed that the AIFs extracted from DSC scans yielded highly variable peaks across arteries within the same patient. The semi-automatic DSC-AIF had significantly narrower width compared with the manual AIFs, and a significantly larger peak than the manual DSC-AIF. Additionally, the DCE-based AIF provided a more stable measurement of relative CBF and absolute CBF values estimated with DCE-AIFs that were compatible with previously reported values. In conclusion, DCE-based AIFs were reproduced significantly better across vessels, showed more realistic profiles, and delivered more stable and reasonable CBF measurements. The DCE-AIF can, therefore, be considered as an alternative AIF source for quantitative perfusion estimations in DSC MRI.

PMID:37712359 | DOI:10.1002/nbm.5038

Anat Histol Embryol. 2023 Sep 15. doi: 10.1111/ahe.12968. Online ahead of print.

ABSTRACT

Testis is considered the main organ of the male reproductive system. Dogs are used as a suitable experimental model of testicular diseases in humans. From the veterinary aspect, several disorders have been reported to affect the testis in dogs. Thus, the objective of the present study was to investigate the morphometrical features of the dog testis using design-based stereology. The testes of six male dogs were used. Isotropic, uniform random sections were obtained and processed for light microscopy. Testicular total volume and the fractional volume of the seminiferous tubules, interstitial tissue and germinal epithelium were measured using the Cavalieri’s estimator and the point counting system. Germinal epithelial surface area was estimated using test lines, and total length of seminiferous tubules was analysed using the counting frames. The total volume of testis was calculated 13.64 ± 1.94 cm³ . The relative volume fractions of the seminiferous tubules, interstitial tissue and germinal layer expressed as a percentage of total testicular volume were found to be 75.87 ± 6.11%, 23.68 ± 5.15% and 64.15 ± 4.82%, respectively. The surface area of the germinal layer was 915.25 ± 150.48 cm² . The thickness of germinal layer was estimated to be 96.18 ± 10.72 μm. The total length of seminiferous tubules measured 290.8 ± 35.86 m. No statistical difference in investigated parameters was found between the left and right testes (p > 0.05). Our data might contribute to the male reproductive knowledge, help develop experimental studies in this field and possibly lead to advancement in the diagnosis and treatment of testicular diseases in the dog.

PMID:37712329 | DOI:10.1111/ahe.12968

Clin J Pain. 2023 Aug 29. doi: 10.1097/AJP.0000000000001155. Online ahead of print.

ABSTRACT

OBJECTIVE: Transforaminal epidural steroid injections (TESIs) are widely administered for sciatica. The aim of this trial was to evaluate the effectiveness of TESIs in patients with acute sciatica (<8 wk).

METHODS: This study was conducted in two Dutch hospitals. Participants (n=141) were randomly assigned to: 1) usual care and TESI of 1ml of 40mg/ml Methylprednisolone plus 1ml of 0.5% Levobupivacaine (intervention 1); 2) usual care and transforaminal epidural injection with 1 ml of 0.5% Levobupivacaine and 1ml NaCl 0.9% (intervention 2); 3) usual care consisting of oral pain medication with or without physiotherapy (control). Co-primary outcomes were back- and leg pain intensity, physical functioning and recovery measured during 6-month follow-up.

RESULTS: There were no significant mean differences in co-primary outcomes between groups during follow-up, except for leg pain when comparing intervention group 1 with control (-0.96 95%CI:-1.83 to -0.09). For secondary outcomes, some significant between group differences were found for treatment satisfaction and surgery, but only when comparing intervention group 2 to control. Post-hoc analyses showed a significant difference in response (50% improvement of leg pain [yes/no]) between intervention 1 and the control group at 3 months and that both intervention groups used less opioids.

DISCUSSION: Except for a statistically significanteffect of TESI on leg pain for patients with acute sciatica compared to usual care, there were no differences in co-primary outcomes. Nonetheless, transforaminal epidural injections seem to be associated with less opioid use, which warrants further exploration.

PMID:37712323 | DOI:10.1097/AJP.0000000000001155

J Minim Invasive Surg. 2023 Sep 15;26(3):134-145. doi: 10.7602/jmis.2023.26.3.134.

ABSTRACT

PURPOSE: The robotic approach offers improved visualization and maneuverability for surgeons. This systematic review aims to compare the outcomes of robotic-assisted and conventional laparoscopic approaches for paraesophageal hernia repair, specifically examining postoperative complications, operative time, hospital stay, and recurrence.

METHODS: A systematic review including thorough research through PubMed, Scopus, and Cochrane, was performed and only comparative studies were included. Studies concerning other types of hiatal hernias or children were excluded. A meta-analysis was conducted to compare overall postoperative complications, hospital stay, and operation time.

RESULTS: Ten comparative studies, with 186,259 participants in total, were included in the meta-analysis, but unfortunately, not all of them reported all the outcomes under question. It appeared that there is no statistically significant difference between the conventional laparoscopic and the robotic-assisted approach, regarding the overall postoperative complication rate (odds ratio [OR], 0.56, 95% confidence interval [CI], 0.28-1.11), the mean operation time (t = 1.41; 95% CI, -0.15-0.52; p = 0.22), and the hospital length of stay (t = -1.54; degree of freedom = 8; 95% CI, -0.53-0.11; p = 0.16). Only two studies reported evidence concerning the recurrence rates.

CONCLUSION: Overall, the robotic-assisted method did not demonstrate superiority over conventional laparoscopic paraesophageal hiatal hernia repair in terms of postoperative complications, operation time, or hospital stay. However, some studies focused on cost and patient characteristics of each group. Further comparative and randomized control studies with longer follow-up periods are needed for more accurate conclusions on short- and long-term outcomes.

PMID:37712313 | DOI:10.7602/jmis.2023.26.3.134