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Nevin Manimala Statistics

Cumulative pregnancy rates of two strategies: Day 3 fresh embryo transfer followed by Day 3 or Day 5/6 vitrification and embryo transfer: a randomized controlled trial

Hum Reprod. 2023 Oct 26:dead222. doi: 10.1093/humrep/dead222. Online ahead of print.

ABSTRACT

STUDY QUESTION: Are cumulative pregnancy rates better if supernumerary embryos are vitrified on Day 5/6 instead of Day 3?

SUMMARY ANSWER: The results do not show a significant difference in cumulative pregnancy rates between the Day 3 and Day 5/6 vitrification groups.

WHAT IS KNOWN ALREADY: Pregnancy and live birth rates following IVF or ICSI treatment are higher after extended embryo culture and blastocyst transfer (Day 5/6) compared to cleavage-stage (Day 3) transfer. Cumulative pregnancy rates from one oocyte retrieval (OR) cycle show no significant difference after fresh and frozen embryo transfers, but only one study has used vitrification for the cryopreservation of supernumerary embryos while four studies have used a slow freezing protocol.

STUDY DESIGN, SIZE, DURATION: Our prospective randomized controlled trial was performed in an academic centre between January 2018 and August 2020. Patients were randomized into vitrification Day 3 (n = 80) or Day 5/6 (n = 81) groups. The primary outcome was the cumulative ongoing pregnancy rate (cOPR), considering only the first pregnancy for each couple. The power calculation revealed that 75 patients were required in each group, when assuming a 50% cOPR with four embryo transfers in the vitrification Day 3 group vs two transfers in the vitrification Day 5/6 group.

PARTICIPANTS/MATERIALS, SETTING, METHODS: Patients <38 years undergoing their first or second OR cycles were randomized at the start of the first cycle. Up to two cycles were included in the analysis. A fresh embryo transfer was performed on Day 3. Supernumerary embryos (with ≥6 cells, <25% fragmentation, and equal blastomeres) or blastocysts (with expansion grade ≥2 with inner cell mass and trophectoderm score A/B) were vitrified on Day 3 or Day 5/6, respectively, and then transferred at a later date. A time-to-event analysis was performed with the patient’s first ongoing pregnancy as the event of interest and the number of embryo transfers as the time component. The statistical comparison was performed by a Cox proportional hazards model. Cumulative costs of vitrification on Day 3 vs Day 5/6 were explored and compared using Mann-Whitney U tests.

MAIN RESULTS AND THE ROLE OF CHANCE: By December 2021, 233 transfers (96 fresh and 137 frozen) in 77 patients were performed in the vitrification Day 3 group and 201 transfers (88 fresh and 113 frozen) in 77 patients were performed in the vitrification Day 5/6 group. The time-to-event analysis did not show a difference between the two arms with regard to the patient’s first ongoing pregnancy as the primary study outcome (hazard ratio [HR] 1.25, 95% CI 0.82; 1.92, P = 0.30). The cumulative ongoing pregnancy rate after eight transfers (from one or two ORs) was 57% in the vitrification Day 3 group vs 58% in the vitrification Day 5/6 group. The median number of embryo transfers until a pregnancy was achieved was five vs four, respectively, in the vitrification Day 3 group vs the Day 5/6 group. Similar results were found for the secondary study outcome, i.e. clinical pregnancy with foetal heart rate (HR 1.19, 95% CI 0.78; 1.80, P = 0.41). The cumulative clinical pregnancy rate (cCPR) after eight embryo transfers was 62% in the vitrification Day 3 group vs 59% in the vitrification Day 5/6 group. The median number of transfers until a pregnancy was achieved was four in both groups. The healthcare consumption pattern differed between the two groups and we observed higher costs for the vitrification Day 3 group compared to the vitrification Day 5/6 group, although these differences were not statistically significant.

LIMITATIONS, REASONS FOR CAUTION: Although our power calculation revealed that only 75 patients were needed in each study group (β = 0.87, α < 0.05), the numbers were low. Also, different numbers of single and double embryo transfers were performed between the two groups, which may have affected the results. The cost analysis was performed on a subset of the patients and is therefore exploratory.

WIDER IMPLICATIONS OF THE FINDINGS: Our study shows no difference in the cumulative pregnancy rate nor costs after fresh and frozen embryo transfers of at most two sequential OR cycles between the Day 3 and Day 5/6 vitrification groups; however, obstetric and perinatal outcomes should be taken into account to determine the best strategy.

STUDY FUNDING/COMPETING INTEREST(S): This study was funded as an investigator-sponsored study of S.D. by Merck nv/sa Belgium, an affiliate of Merck KGaA, Darmstadt, Germany, and by Gedeon Richter Benelux (PA18-0162). The authors declare no conflict of interest related to this study.

TRIAL REGISTRATION NUMBER: NCT04196036.

TRIAL REGISTRATION DATE: 15 January 2018.

DATE OF FIRST PATIENT’S ENROLMENT: 15 January 2018.

PMID:37886820 | DOI:10.1093/humrep/dead222

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Nevin Manimala Statistics

Signal detection statistics of adverse drug events in hierarchical structure for matched case-control data

Biostatistics. 2023 Oct 26:kxad029. doi: 10.1093/biostatistics/kxad029. Online ahead of print.

ABSTRACT

The tree-based scan statistic is a data mining method used to identify signals of adverse drug reactions in a database of spontaneous reporting systems. It is particularly beneficial when dealing with hierarchical data structures. One may use a retrospective case-control study design from spontaneous reporting systems (SRS) to investigate whether a specific adverse event of interest is associated with certain drugs. However, the existing Bernoulli model of the tree-based scan statistic may not be suitable as it fails to adequately account for dependencies within matched pairs. In this article, we propose signal detection statistics for matched case-control data based on McNemar’s test, Wald test for conditional logistic regression, and the likelihood ratio test for a multinomial distribution. Through simulation studies, we demonstrate that our proposed methods outperform the existing approach in terms of the type I error rate, power, sensitivity, and false detection rate. To illustrate our proposed approach, we applied the three methods and the existing method to detect drug signals for dizziness-related adverse events related to antihypertensive drugs using the database of the Korea Adverse Event Reporting System.

PMID:37886808 | DOI:10.1093/biostatistics/kxad029

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Nevin Manimala Statistics

Trends and long-term variation explaining nutritional determinants of child linear growth: analysis of Bangladesh Demographic and Health Surveys 1996-2018

Public Health Nutr. 2023 Oct 27:1-30. doi: 10.1017/S1368980023002288. Online ahead of print.

ABSTRACT

OBJECTIVE: Examining the height-for-age z-score (HAZ) of 0-35 months children along with stunting prevalence to identify trends, changes, and available nutrition-sensitive and specific determinants that could help explain the long-term variation in child linear growth using successive Bangladesh Demographic and Health Surveys (BDHS) data from 1996 to 2018.

DESIGN: The BDHS pooled data is used for determining the key outcome variables HAZ, stunting, and severe stunting. Trends, kernel-weighted local polynomial smoothing illustrations, pooled multivariable Linear Probability Model (LPM), Ordinary Least Squares method (OLS), and regression decomposition were used.

PARTICIPANTS: Mothers having 0-35 months children, the most critical age range for growth faltering.

RESULTS: The mean HAZ increased by 0.91(±1.53) with 0.041 annual average change, while the percentages of stunting (-26.63 ±0.54) and severe stunting (-21.12 ±0.48) showed a reduction with 1.21 and 0.96 average annual changes, respectively. The average HAZ improvement (0.42 ±1.56) in urban areas was less than the rural areas (1.16 ±1.44). Similar patterns followed for stunting and severe stunting. The prenatal doctor visits (3064.65%), birth in a medical facility (1054.32%), breastfeeding initiation (153.18%), and asset index (144.73%) demonstrated a huge change. The findings of OLS, PLS, and regression decomposition identified asset index, birth order, paternal and maternal education, bottle-fed, prenatal doctor visit, birth in a medical facility, vaccination, maternal BMI, and ever-breastfed as influencing factors to predict the long-term changes of stunting and severe stunting.

CONCLUSION: The nutrition-sensitive and specific factors identified through regression decomposition describing long-term variation in child linear growth should be focused further to attain the sustainable development goals (SDGs).

PMID:37886806 | DOI:10.1017/S1368980023002288

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Nevin Manimala Statistics

Coupling coordination and spatio-temporal pattern evolution between ecological protection and high-quality development in the Yellow River Basin

Heliyon. 2023 Oct 17;9(10):e21089. doi: 10.1016/j.heliyon.2023.e21089. eCollection 2023 Oct.

ABSTRACT

The Yellow River Basin is one of the most important economic development belt and ecological management regions in China, it is of vital importance to study the coupling coordination between ecological protection and high-quality development. However, the systematic research from the perspective of ecological-production-living is still lacking. Therefore, a comprehensive evaluation index system including 29 indicators is constructed from ecological, production and living dimension. To evaluate the high-quality development level and coupling coordination degree of 61 cities in the Yellow River Basin, a comprehensive measurement model and coupling coordination model are established using the entropy weight TOPSIS method. With the help of ArcGIS, the spatial characteristics of high-quality development level and coupling coordination are visually illustrated. The results showed that: (1) From 2011 to 2020, the high-quality development of 61cities in the Yellow River Basin showed an increasing trend, and the level of upper and lower reaches was higher than that of the middle reaches. (2) According to the high-quality development level of 61 cities, it was divided into three types: sustainable growth type with 44 cities, the fierce fluctuation type with 11 cities and the other 6 cities was stable type. (3) The coupling coordination degree of ecology, production and living system also showed an increasing trend, while the degree was not high. (4)About the year-on-year growth rate of coupling coordination degree for 61 cities in 2020 compared with 2011, there are 19 cities more than 30 %, and 23 cities between 20% and 30 %, 11cities was 10%-20 %, the other 8 cities was less than 10 %. (5) There is a significant spatial difference in the level of high-quality development in the Yellow River Basin, while coupling coordination degree does not significant in spatial layout. Therefore, the development of different regions should adjust measures to local conditions, give full play to their advantages, and make up for their shortcomings to promote the overall development of the city.

PMID:37886786 | PMC:PMC10597863 | DOI:10.1016/j.heliyon.2023.e21089

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Nevin Manimala Statistics

Comparison of the efficacy and safety of removing bandage contact lenses on the fourth and seventh postoperative day after transepithelial photorefractive keratectomy

Heliyon. 2023 Oct 17;9(10):e21129. doi: 10.1016/j.heliyon.2023.e21129. eCollection 2023 Oct.

ABSTRACT

PURPOSE: To compare the differences in the removal of bandage contact lenses (BCLs) at 4 and 7 days after transepithelial photorefractive keratectomy (TransPRK) in term of visual rehabilitation, eye discomfort, and postoperative complications.

METHODS: This retrospective cohort study included patients with myopia undergoing TransPRK; in Group 1, the BCLs were removed on the 4th postoperative day, while in Group 2, the BCLs were removed on the 7th postoperative day. All patients underwent a 6-month follow-up, including slit-lamp examination and visual acuity assessment. Subjective evaluations of pain and eye discomfort were recorded after the BCLs removal.

RESULTS: In total, 376 eyes of 191 patients in Group 1 and 346 eyes of 177 patients in Group 2 were enrolled. The two groups were matched for sex, age, preoperative corrected distance visual acuity, and tear film break-up time. Patients in Group 1 exhibited slightly lower levels of myopia, resulting in a shallower ablation depth and shorter ablation time than those in Group 2. No statistically significant differences in visual acuity recovery, haze severity, and incidence of infectious keratitis were observed within 6 months after surgery between the two groups. However, patients in Group 2 experienced significantly fewer discomfort symptoms (discharge, foreign body sensation, and blurred vision) after BCLs removal than patients in Group 1 and had fewer postoperative complications (recurrent corneal epithelial erosion).

CONCLUSION: Delayed removal of the BCLs one week after TransPRK effectively alleviated early discomfort symptoms and reduced the risk of recurrent corneal epithelial erosion without increasing the likelihood of infectious keratitis.

PMID:37886779 | PMC:PMC10597848 | DOI:10.1016/j.heliyon.2023.e21129

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Nevin Manimala Statistics

Effect of servitization on performance in manufacturing firms: A mediating effect model of digitalisation moderated by ESG performance

Heliyon. 2023 Oct 16;9(10):e20831. doi: 10.1016/j.heliyon.2023.e20831. eCollection 2023 Oct.

ABSTRACT

Servitization and digitalisation are current trends in high-quality sustainable development in manufacturing firms. To clarify how manufacturing companies can improve their environmental, social, and governance (ESG) performance through servitization and digitalisation, this study develops a moderated mediating effects model for analysis and further investigates corporate heterogeneity. This study uses the CSMAR and WIND databases and official website of the National Bureau of Statistics of China to obtain relevant data from 2013 to 2020. Python software was used to crawl corporate annual report data from the CNINFO Website for collation and analysis, obtaining a total of 1261 companies with 9379 sample values. The findings are as follows: (i) Servitization of manufacturing enterprises can significantly enhance their performance. (ii) The service-oriented transformation of manufacturing enterprises can significantly enhance their performance through digitalisation. In contrast to the capabilities of the practical application of digital technology, digital transformation primarily manifests itself as the capability of digital underpinning technology and the practical application of digital technology. (iii) The ESG performance of companies can positively regulate the promotion of service-oriented manufacturing enterprises towards digital transformation, as well as directly foster the development of digital transformation in the manufacturing industry. When examining the individual components of ESG performance, environmental and social performance have a positive effect on regulating the promotion of service-oriented manufacturing towards digital transformation and directly driving the digital transformation of manufacturing companies. However, the governance performance does not have a significant effect. Additionally, environmental performance can restrain the positive effect of digital transformation on performance in manufacturing companies. (iv) Manufacturing companies in the eastern part of the country are improving their performance mainly by promoting digitisation, whereas those in the central and western regions are improving their profitability mainly through servitization. This study reveals the mechanism of ESG performance and the role of servitization and digitalisation of manufacturing companies on performance and suggests new paths for the development of corporate sustainability strategies.

PMID:37886777 | PMC:PMC10597834 | DOI:10.1016/j.heliyon.2023.e20831

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Nevin Manimala Statistics

Personal data protection compliance assessment: A privacy policy scoring approach and empirical evidence from Thailand’s SMEs

Heliyon. 2023 Oct 17;9(10):e20648. doi: 10.1016/j.heliyon.2023.e20648. eCollection 2023 Oct.

ABSTRACT

Privacy policies, intended to provide information to individuals regarding how their personal data is processed, are often complex and challenging for users to understand. Businesses often demonstrate non-compliance with personal data protection laws, ranging from the absence of privacy policies to the existence of policies that do not adhere to legal requirements. This paper aims to (1) develop a quantitative and systematic tool for evaluating privacy policies’ compliance with the Personal Data Protection Act (PDPA), (2) assess compliance among Small and Medium Enterprises (SMEs) in Thailand, and (3) provide recommendations for enhancing compliance practices. To achieve this, we proposed a multi-criteria privacy policy scoring model integrated with comprehensive statistical data analyses. The privacy policy scoring model consists of ten privacy principles and 31 privacy criteria, providing a structured framework for evaluating privacy policies. During a two-year postponement period for enforcing the PDPA law, we conducted a stratified random-sampling survey of 384 SMEs to evaluate their privacy policies using the proposed scoring model. The accomplished results revealed significantly lower scores than anticipated, with the nationwide average score of SMEs reaching only 6.1909 out of 100 points. More than half of the SMEs collected personal data without announcing privacy policies, and those with privacy policies adhered to an average of only 12.15 out of 31 privacy criteria. These findings highlight the pressing need to improve compliance practices among SMEs in Thailand. The proposed methodology can be customized and applied to align with the requirements of personal data protection laws in other countries. Additionally, our findings indicate that compliance with the PDPA is influenced by the Thailand Standard Industrial Classification (TSIC) sections, suggesting the adoption of tailored approaches by policymakers to address the specific needs of different TSIC sections.

PMID:37886776 | PMC:PMC10597812 | DOI:10.1016/j.heliyon.2023.e20648

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Nevin Manimala Statistics

Laser light absorption of high-temperature metal surfaces

Heliyon. 2023 Oct 16;9(10):e21021. doi: 10.1016/j.heliyon.2023.e21021. eCollection 2023 Oct.

ABSTRACT

Laser beam absorption is the basic effect to enable many high-temperature applications and processes. However, high temperature absorption data of metals is often not available or based on theoretical assumptions. In this work, using a newly developed experimental arrangement to measure laser light absorption on liquid metal surfaces even above boiling temperature enabled the derivation of absorption values in those regimes. Results indicate that interband absorption must be considered even at such high temperatures against common theoretical predictions. It is shown that the simulated nearly constant absorption depth and absorption values between melting and boiling temperatures indicate that the increased atom distance due to thermal expansion, denoting a reduced absorption volume, is counterbalanced by the increased statistical availability of conduction electrons due to Fermi band broadening.

PMID:37886775 | PMC:PMC10597851 | DOI:10.1016/j.heliyon.2023.e21021

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Nevin Manimala Statistics

Comparison of the safety, effectiveness, and usability of swab robot vs. manual nasopharyngeal specimen collection

Heliyon. 2023 Oct 13;9(10):e20757. doi: 10.1016/j.heliyon.2023.e20757. eCollection 2023 Oct.

ABSTRACT

BACKGROUND: Healthcare workers face a risk of infection during aerosol-generating procedures, such as nasal swabbing. Robot-assisted nasopharyngeal sampling aims to minimize this risk and reduce stress for healthcare providers. However, its effectiveness and safety require validation.

METHODS: We conducted a controlled trial with 80 subjects at two teaching hospitals and compared robot-collected vs manually-collected nasopharyngeal swabs. The primary outcomes included specimen quality and success rate of nasopharyngeal swab collection. We also recorded the pain index, duration of the collection, and psychological stress using a post-collection questionnaire.

RESULTS: During the study period, from September 23 to October 27, 2020, 40 subjects were enrolled in both the robotic and manual groups. The cycle threshold (Ct) value for nasopharyngeal specimens was statistically higher in the robotic group compared to the manual group (30.9 vs 28.0, p < 0.01). Both groups had Ct values under 35, indicating good quality specimens. In the robotic group, 3 out of 40 subjects required a second attempt at specimen collection, resulting in a success rate of 92.5 %. Further, although the pain levels were lower in the robotic group, the difference was not statistically significant (2.8 vs 3.6, p = 0.07). The manual group had a shorter sampling time, which was 29 s (201 vs 29, p < 0.05). However, when factoring in the time needed to put on personal protective equipment, the average time for the manual group increased to 251 s (201 vs 251, p < 0.05). Participants’ questionnaire results show comparable psychological stress in both groups. Medical staff expressed that using a robot would reduce their psychological stress.

CONCLUSIONS: We propose a safe and effective robotic technology for collecting nasopharyngeal specimens without face-to-face contact, which may reduce the stress of physicians and nurses. This technology can also be optimized for efficiency, making it useful in situations where droplet-transmitted infectious diseases are a concern.

PMID:37886772 | PMC:PMC10597818 | DOI:10.1016/j.heliyon.2023.e20757

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Nevin Manimala Statistics

The dynamic impact mechanism of China’s financial conditions on real economy and international crude oil market

Heliyon. 2023 Oct 17;9(10):e21085. doi: 10.1016/j.heliyon.2023.e21085. eCollection 2023 Oct.

ABSTRACT

As financial conditions become more complex and variable, capturing economic patterns becomes harder. The Financial Conditions Index (FCI) has gained traction as a tool to assess the performance of financial markets in nations or regions. This paragraph has created the China FCI using various financial indicators from 2002 to 2022. And with the use of statistical models like DMA-TVP-FAVAR, mixed-frequency Granger causality test, TVP-SV-VAR, and MS-VAR to analyze the relationship between China’s financial condition, real economy, and the crude oil market. Different impacts were observed over time and in response to economic shocks, Results show that the fluctuation of international oil price has a negative impact on our financial condition. Therefore, the government should consider the impact of external shock factors such as international crude oil price when formulating financial policies to prevent financial risks.

PMID:37886766 | PMC:PMC10597845 | DOI:10.1016/j.heliyon.2023.e21085