Categories
Nevin Manimala Statistics

Evaluating a shrinkage estimator for the treatment effect in clinical trials

Stat Med. 2023 Dec 19. doi: 10.1002/sim.9992. Online ahead of print.

ABSTRACT

The main objective of most clinical trials is to estimate the effect of some treatment compared to a control condition. We define the signal-to-noise ratio (SNR) as the ratio of the true treatment effect to the SE of its estimate. In a previous publication in this journal, we estimated the distribution of the SNR among the clinical trials in the Cochrane Database of Systematic Reviews (CDSR). We found that the SNR is often low, which implies that the power against the true effect is also low in many trials. Here we use the fact that the CDSR is a collection of meta-analyses to quantitatively assess the consequences. Among trials that have reached statistical significance we find considerable overoptimism of the usual unbiased estimator and under-coverage of the associated confidence interval. Previously, we have proposed a novel shrinkage estimator to address this “winner’s curse.” We compare the performance of our shrinkage estimator to the usual unbiased estimator in terms of the root mean squared error, the coverage and the bias of the magnitude. We find superior performance of the shrinkage estimator both conditionally and unconditionally on statistical significance.

PMID:38111969 | DOI:10.1002/sim.9992

Categories
Nevin Manimala Statistics

Associations of serum uric acid levels and anthropometric parameters with non-alcoholic fatty liver disease in healthy individuals: innovative insights from a cross-sectional study

Curr Med Res Opin. 2023 Dec 19:1-10. doi: 10.1080/03007995.2023.2296967. Online ahead of print.

ABSTRACT

OBJECTIVE: Non-alcoholic fatty liver disease (NAFLD is a spectrum of liver disease with a rising prevalence, ranging from simple steatosis to steatohepatitis and cirrhosis, where a significant minority face potential complications. Determining the predictive markers plays a crucial role. This study examined the relationship between serum uric acid (SUA) levels and NAFLD in healthy individuals and identified potential other predictors.

MATERIAL AND METHODS: A cohort of 2162 healthy participants attending routine check-up visits between February 2021 and May 2023 were included. Participants underwent abdominal ultrasound, uric acid measurements, and anthropometric assessments by TANITA. NAFLD was graded using a “hepatic steatosis score.” Statistical analysis included nonparametric tests, chi-squared tests, Fisher’s exact test, ROC curve analysis, and logistic regression.

RESULTS: The median age was 45 years (range:18-65). 1017 were male, and 1145 were female. Among the participants, 53.9%, 26.3%, 17.9%, and 1.9% exhibited Grade 0, 1, 2, and 3 hepatic steatosis, respectively. ROC analysis showed 80.0% sensitivity and 78.8% specificity for detecting grade 2 or higher hepatic steatosis with a cutoff value of 5.21 mg/dl of SUA (AUC = 0.82, p < 0.001, 95%CI 0.79-0.84). There were significant associations between elevated uric acid levels and NAFLD. Participants with higher body fat percentages, BMI values, and waist-to-hip ratios also demonstrated an increased prevalence of steatosis. Gender significantly influenced liver steatosis, with males exhibiting higher grades compared to females. Logistic regression analysis highlighted positive associations between NAFLD and body fat percentage, waist-to-hip ratio, and uric acid levels. Each unit increase in uric acid levels corresponded to a 2.5-fold increase in the odds of NAFLD (p < 0.001, 95% CI = 2.20-2.84).

CONCLUSION: Our findings suggest a significant relationship between serum uric acid levels and NAFLD in healthy individuals. Elevated uric acid levels, in conjunction with other anthropometric parameters, may serve as potential predictive markers for NAFLD.

PMID:38111962 | DOI:10.1080/03007995.2023.2296967

Categories
Nevin Manimala Statistics

Retinal laser photocoagulation and intravitreal injection of anti-VEGF for hemorrhagic retinal arterial microaneurysm

Int J Ophthalmol. 2023 Dec 18;16(12):2041-2048. doi: 10.18240/ijo.2023.12.17. eCollection 2023.

ABSTRACT

AIM: To evaluate the efficacy of retinal laser photocoagulation and intravitreal injection of anti-vascular endothelial growth factor (anti-VEGF) for hemorrhagic retinal arterial macroaneurysm (RAM).

METHODS: This was a retrospective clinical study. Patients with hemorrhagic RAM were divided into 4 groups defined by different treatments: a retinal laser photocoagulation therapy monotherapy group, an anti-VEGF intravitreal injection monotherapy group, a laser and anti-VEGF combination therapy group, and an observation group. Visual acuity (VA), central macular thickness (CMT), and retinal hemorrhage area (RHA) were collected.

RESULTS: Forty-seven eyes of 47 patients were enrolled. VA improved and had a significant difference between baseline and final in each treatment group (logMAR; laser group: 1.90±0.53 vs 1.05±0.63, P<0.001; anti-VEGF group: 1.75±0.63 vs 1.12±0.54, P=0.009; combination group: 1.76±0.38 vs 1.01±0.52, P<0.001); however, VA decreased and had no significant difference in observation group (1.63±0.51 vs 1.76±0.61, P=0.660). CMT decreased and had a significant difference between baseline and final in each group (laser group: 815.16±310.83 vs 252.05±83.90 µm, P<0.001; anti-VEGF group: 725.00±290.79 vs 203.56±69.89 µm, P=0.001; combination group: 595.50±186.51 vs 253.13±55.06 µm, P=0.001; observation group: 758.88±195.65 vs 267.00±120.90 µm, P=0.001). RHA were 28.99±28.15, 25.94±11.58, 19.64±8.97, and 27.45±13.76 mm2 in laser group, anti-VEGF group, combination group and observation group, respectively. RHA was statistically correlated with final VA (P=0.032) in the observation group.

CONCLUSION: Both laser and anti-VEGF treatments are effective for hemorrhagic RAM. Combination therapy reduces the number of injections of anti-VEGF. RHA is a visual prognosis predictor in the natural history of hemorrhagic RAM.

PMID:38111952 | PMC:PMC10700086 | DOI:10.18240/ijo.2023.12.17

Categories
Nevin Manimala Statistics

Risk factors and prognosis of pediatric rhegmatogenous retinal detachment in Egypt: a university hospital based study

Int J Ophthalmol. 2023 Dec 18;16(12):2034-2040. doi: 10.18240/ijo.2023.12.16. eCollection 2023.

ABSTRACT

AIM: To study and compare the predisposing factors and clinical features of pediatric, adult, and elderly rhegmatogenous retinal detachment (RRD).

METHODS: This is an observational analytic cross-sectional study in which patients with RRD admitted for surgery during 6mo period were divided into 3 age groups: pediatric (<18y), adult (18-60y), and elderly (>60y). Patients’ demographic data, clinical features, RRD predisposing factors/features including myopia (axial length ≥26.5 mm), aphakia/pseudophakia, blunt trauma, peripheral retinal degenerations, history of RRD in the fellow eye, and surgical interventions/findings were recorded and analyzed.

RESULTS: Totally 142 patients (142 eyes) were studied: 26 (18.31%) pediatrics, 86 (60.56%) adults, and 30 (21.13%) elderly. Elderly patients had a significantly higher intraocular pressures and cataracts compared to the other 2 groups (P=0.04). The RRD extent was larger in pediatric group (mostly 4 quadrants) compared to adults and elderly (mostly 2 quadrants), but it was not statistically insignificant (P=0.242). There were not statistically significantly differences in proliferative vitreoretinopathy (PVR) rate, posterior vitreous detachment (PVD) rate, number, site, shape, and size of breaks in three groups. All three groups had macular detachment in all eyes. Myopia and peripheral retinal degenerations were found to be more significant in adults (P=0.049, P=0.035, respectively), while blunt trauma was higher but insignificant in pediatric eyes (P=0.052). Pars plana vitrectomy (PPV) with silicone oil as a tamponade was the most used surgery in all groups.

CONCLUSION: There are no significant difference in PVR rate in pediatric eyes but a significant higher rate of total RRD. Blunt trauma is more frequent in pediatrics eyes while myopia and/or peripheral retinal degenerations are more frequent in older ages. The rate of PPV as a choice for surgery is similar among all age groups.

PMID:38111951 | PMC:PMC10700087 | DOI:10.18240/ijo.2023.12.16

Categories
Nevin Manimala Statistics

Quality of life and depression among patients with high myopia in Nigeria: a cross sectional study

Int J Ophthalmol. 2023 Dec 18;16(12):2071-2081. doi: 10.18240/ijo.2023.12.21. eCollection 2023.

ABSTRACT

AIM: To evaluate the quality of life (QOL) and level of depression among participants with high myopia in Nigeria and the demographic factors associated with these outcomes.

METHODS: This cross-sectional study was conducted on 100 adult participants with high myopia (defined as refractive error ≤-5.00 D or worse, and uncorrected visual acuity worse than 6/18 in the better seeing eye) attending ophthalmology centres in Nigeria from 2 October 2021 to 30 August 2022. The means and standard deviations were calculated for each of the four domains of World Health Organization Quality of life scale (WHOQOL-BREF) using the transformed scores. The Beck Depression Inventory (BDI) scale was used to assess the level of depression.

RESULTS: The highest and the lowest mean scores of WHOQOL-BREF domains were found for the psychological and physical health domains (mean percentage scores were 67.0 [95% confidence intervals (CI) 64.1-68.9] and 55.3 (95%CI 51.8-58.8, P<0.001), respectively. One-way analysis of variance (ANOVA) revealed significant differences in physical health with educational status (higher among those with tertiary education: mean difference 0.9, 95%CI -0.2-2.1; P=0.049), differences in psychological health with working status (higher among those who were working 1.2, 95%CI 0.3-2.1; P=0.012). Also, the result showed a statistically significant association between environmental health and marital status (higher among non-married: 1.7, 95%CI -0.9-2.3; P=0.012) while overall health was associated with place of residence (higher in urban areas: 2.3, 95%CI 1.2-3.5; P=0.024). For depression, one in every nine participants reported major depressive symptom, mostly younger people (aged 16-29 vs 30-49y: 17.0% vs 0, P=0.019), and slightly more women than men (14.3% vs 0, P=0.064). There were significant negative correlations between the depression scores and psychological health (r=-0.48, P<0.001), physical health (r=-0.29, P=0.002), social and relationship (r=-0.49, P<0.001), environmental (r=-0.48, P<0.001) and overall health (r=-0.49, P<0.001).

CONCLUSION: People with high myopia have a relatively moderate QOL, but poor physical health, particularly the younger age group, and women who are more likely to experience clinically relevant depression. Eye care professionals should consider possible referrals for counselling for people with high myopia.

PMID:38111950 | PMC:PMC10700079 | DOI:10.18240/ijo.2023.12.21

Categories
Nevin Manimala Statistics

Evaluation of macular choroidal and microvascular network changes by activity scores and serum antibodies in thyroid eye patients and healthy subjects

Int J Ophthalmol. 2023 Dec 18;16(12):2089-2094. doi: 10.18240/ijo.2023.12.23. eCollection 2023.

ABSTRACT

AIM: To investigate the choroidal thickness and the microvascular network changes around the macula in thyroid eye disease (TED) patients at different stages and the relationship of those changes with risk factors, serum antibodies and the severity of TED.

METHODS: A total of 85 participants were enrolled. All participants underwent ophthalmology and endocrinology examinations. Subfoveal choroidal thickness (SFCT), superficial (s) and deep (d) foveal avascular zone (FAZ) area, mean (m) and central (c) superficial vascular density (SVD), deep vascular density (DVD) measurements of the enrolled cases were performed with Topcon swept source optical coherence tomography (OCT)/OCT angiography (OCTA) DRI OCT Triton. Multiple linear regression analysis was used to explore the associations between SFCT, FAZ area, SVD, DVD and the relevant factors of TED.

RESULTS: Those with active TED patients had higher c-DVD and m-DVD levels (P<0.05), however there is no statistically significant difference in SFCT between active and stable TED patients. Among the serum antibodies, it was observed that s-FAZ and d-FAZ increased, c-SVD and m-SVD decreased in patients with high thyroid stimulating hormone-receptor autoantibodies (TRAB) level, whereas SFCT thickened in patients with high levels of both TRAB and human thyroglobulin (hTG). There was no significant difference in SFCT, FAZ, SVD and DVD measurement at gender, between hyperthyroid and euthyroid patients and among those with or without thyroid papillary carcinoma.

CONCLUSION: The results show that both disease activation and serum antibodies differentially affect both superficial and deep retinal vascular density. It has also been shown that high serum antibody levels affect choroidal thickness independent of clinical activity.

PMID:38111941 | PMC:PMC10700066 | DOI:10.18240/ijo.2023.12.23

Categories
Nevin Manimala Statistics

Different approaches for treating myopic choroidal neovascularization: a network Meta-analysis

Int J Ophthalmol. 2023 Dec 18;16(12):2105-2116. doi: 10.18240/ijo.2023.12.25. eCollection 2023.

ABSTRACT

AIM: To evaluate the efficacy of intravitreal injection of anti-vascular endothelial growth factor (anti-VEGF), photodynamic therapy (PDT), and laser treatment (LT) for anatomical and functional improvement in myopic choroidal neovascularization (mCNV) patients.

METHODS: Two researchers independently searched PubMed, Cochrane Library, Web of Science, and other databases to screen studies comparing best-corrected vision acuity (BCVA) and foveal center thickness (FCT) changes after mCNV treatment. Post-treatment chorioretinal atrophy (CRA) is a secondary outcome indicator. The retrieval time limit is from the database construction to January 30, 2023.

RESULTS: A total of 1072 eyes in 16 articles were included. In the RCTs, intravitreal bevacizumab (IVB) and intravitreal ranibizumab (IVR) were superior to PDT (MD=0.18, 95%CI: 0.02, 0.40, MD=0.18, 95%CI: 0.01, 0.42) in improving BCVA of mCNV patients (P<0.05). The relative effectiveness in improving BCVA, from high to low, appeared to be IVR, intravitreal aflibercept (IVA), IVB, LT, PDT, and sham first followed by IVA (Sham/IVA). While improving the FCT from high to low was IVA, IVR, IVB, PDT. In retrospective studies, the results of BCVA after long-term treatment showed that all the therapeutic effects from high to low was IVA, intravitreal conbercept (IVC), IVR, IVB, IVB/IVR, PDT with IVB/IVR, PDT. The effect of improving FCT was IVA, IVR, IVC, PDT, and IVB from high to low. And in the effects of improving CRA, the IVB appeared to be higher than IVR, while the PDT was the smallest, but none of the differences in the results were statistically significant.

CONCLUSION: Anti-VEGF has the best effect on long-term vision improvement in mCNV patients, using IVB or IVR alone to treat mCNV may be better than IVB or IVR combined with PDT. There is no significant difference in the improvement of visual acuity, macular edema, and CRA in mCNV patients treated with any different anti-VEGF drugs.

PMID:38111927 | PMC:PMC10700081 | DOI:10.18240/ijo.2023.12.25

Categories
Nevin Manimala Statistics

Dynamic tear meniscus parameters in complete blinking: insights into dry eye assessment

Int J Ophthalmol. 2023 Dec 18;16(12):1911-1918. doi: 10.18240/ijo.2023.12.01. eCollection 2023.

ABSTRACT

AIM: To investigate the relationship between dynamic tear meniscus parameters and dry eye using an automated tear meniscus segmentation method.

METHODS: The analysis of tear meniscus videos captured within 5s after a complete blink includes data from 38 participates. By processing video data, several key parameters including the average height of the tear meniscus at different lengths, the curvature of the tear meniscus’s upper boundary, and the total area of the tear meniscus in each frame were calculated. The effective values of these dynamic parameters were then linearly fitted to explore the relationship between their changing trends and dry eye disease.

RESULTS: In 94.74% of the samples, the average height of central tear meniscus increased over time. Moreover, 97.37% of the samples exhibited an increase in the overall tear meniscus height (TMH) and area from the nasal to temporal side. Notably, the central TMH increased at a faster rate compared to the nasal side with the temporal side showing the slowest ascent. Statistical analysis indicates that the upper boundary curvature of the whole tear meniscus as well as the tear meniscus of the nasal side (2, 3, and 4 mm) aid in identifying the presence of dry eye and assessing its severity.

CONCLUSION: This study contributes to the understanding of tear meniscus dynamics as potential markers for dry eye, utilizing an automated and non-invasive approach that has implications for clinical assessment.

PMID:38111923 | PMC:PMC10700063 | DOI:10.18240/ijo.2023.12.01

Categories
Nevin Manimala Statistics

Club cell protein (CC16) in serum as an effect marker for small airway epithelial damage caused by diesel exhaust and blasting fumes in potash mining

Int Arch Occup Environ Health. 2023 Dec 18. doi: 10.1007/s00420-023-02035-x. Online ahead of print.

ABSTRACT

OBJECTIVE: The effect marker club cell protein (CC16) is secreted by the epithelium of the small respiratory tract into its lumen and passes into the blood. Increased amounts of CC16 in serum are observed during acute epithelial lung injury due to air pollutants. CC16 in serum was determined as part of this cross-sectional study in underground potash miners on acute and chronic health effects from exposures to diesel exhaust and blasting fumes.

METHODS: Nitrogen oxides, carbon monoxide, and diesel particulate matter were measured in 672 workers at a German potash mining site on a person-by-person basis over an early shift or midday shift, together with CC16 serum concentrations before and after the respective shift. CC16 concentrations and CC16 shift-differences were evaluated with respect to personal exposure measurements and other quantitative variables by Spearman rank correlation coefficients. CC16 shift-differences were modeled using multiple linear regression. Above-ground workers as reference group were compared to the exposed underground workers.

RESULTS: Serum concentrations of CC16 were influenced by personal characteristics such as age, smoking status, and renal function. Moreover, they showed a circadian rhythm. While no statistically significant effects of work-related exposure on CC16 concentrations were seen in never smokers, such effects were evident in current smokers.

CONCLUSION: The small airways of current smokers appeared to be vulnerable to the combination of measured work-related exposures and individual exposure to smoking. Therefore, as health protection of smokers exposed to diesel exhaust and blasting fumes, smoking cessation is strongly recommended.

PMID:38110551 | DOI:10.1007/s00420-023-02035-x

Categories
Nevin Manimala Statistics

Mushroom poisoning outbreaks in Guizhou Province, China: a prediction study using SARIMA and Prophet models

Sci Rep. 2023 Dec 18;13(1):22517. doi: 10.1038/s41598-023-49095-0.

ABSTRACT

Mushroom poisoning is a public health concern worldwide that not only harms the physical and mental health of those who are poisoned but also increases the medical and financial burden on families and society. The present study aimed to describe and analyze the current situations and factors influencing mushroom poisoning outbreaks in Guizhou province, Southwest China, between January 2012 and June 2022, and to predict the future trends of its occurrence. Our study provides a basis for the rational formulation of prevention and control and medical resource allocation policies for mushroom poisoning. The epidemiological characteristics and factors influencing mushroom poisoning incidence were analyzed using descriptive epidemiological methods and the chi-squared test, respectively. Then, future occurrence trends were predicted using the SARIMA and Prophet models. In total, 1577 mushroom poisoning incidents were recorded in Guizhou Province, with 7347 exposures, 5497 cases, 3654 hospitalizations, and 93 fatalities. The mortality rate was 4.45% in 1 ~ 6 years higher than other age groups. There were notable geographic and seasonal characteristics, with the number of occurrences much higher in rural areas (1198) than in cities (379), and poisoning cases were more common during the rainy season (June to September). The mortality rate of household poisoning cases was 1.86%, with the most deaths occurring in households. Statistically significant differences were observed in the incidence across various cities, periods, and poisoning locations (P < 0.05). Both models had advantages and disadvantages for prediction. Nevertheless, the SARIMA model had better overall prediction results than the Prophet model (R > 0.9, the residual plot of the prediction results was randomly distributed, and RMSESARIMA < RMSEProphet). However, the prediction result plot of the Prophet model was more explanatory than the SARIMA model and could visualize overall and seasonal trends. Both models predicted that the prevalence of mushroom poisoning would continue to increase in the future; however, the number of fatalities is generally declining. Seasonal patterns indicated that a high number of deaths from gooseberry mushroom poisoning occurred in October. The epidemiological trends of mushroom poisoning remain severe, and health education on related knowledge must be strengthened in rural areas, with June to October as the key prevention and control phase. Further, medical treatment of mushroom poisoning cases with clinical symptoms should pay attention to inquiries to check whether the mushroom is similar in appearance to the Amanita, particularly in October.

PMID:38110518 | DOI:10.1038/s41598-023-49095-0