Category: Nevin Manimala

Int J Cosmet Sci. 2025 Sep;47 Suppl 1:2-24. doi: 10.1111/ics.70019.

ABSTRACT

OBJECTIVE: This paper presents the experimental design, the statistical model, performance criteria and results of a method performance study conducted in order to characterize the performance of alternative methods for SPF and UVA-PF testing. The performance of alternative methods is characterized against the performance of the ISO 24444 and ISO 24443 methods.

METHODS: A factorial experimental design was implemented. For a given method, such a design allows good statistical reliability of precision estimates with as few as four participating laboratories. To cover the wide range of sunscreen products on the market, 32 sunscreens were tested. These 32 products were classified into eight product groups. The product groups differ in terms of SPF level, application viscosity and type of UV filters and matrix. In co-operation with a WG7 ISO ad hoc group performance criteria for the alternative methods were developed for reproducibility precision, between-laboratory variation, bias and the variation of bias across products and across product groups.

RESULTS: Performance characteristics for the reference method along with reproducibility and repeatability limits are provided. The results for the participating alternative methods will be presented in separate articles, following this paper.

CONCLUSIONS: The precision of ISO 24444 and ISO 24443 was characterized for each of the eight product groups. The main sources of variation were identified for each of the two reference methods. Reproducibility and repeatability limits were derived and are provided.

PMID:40888065 | DOI:10.1111/ics.70019

Int J Cosmet Sci. 2025 Sep;47 Suppl 1:1. doi: 10.1111/ics.70026.

NO ABSTRACT

PMID:40888064 | DOI:10.1111/ics.70026

Int J Cosmet Sci. 2025 Sep;47 Suppl 1:96-114. doi: 10.1111/ics.70007.

ABSTRACT

OBJECTIVE: The consortium ALT-SPF performed an international round robin test to characterize non-invasive methods as alternatives to the erythema-based testing of sun protection factor (SPF) according to ISO 24444:2019.

METHODS: Hybrid diffuse reflectance spectroscopy (HDRS) based on a multi-lambda LED light source uses in vivo reflectance spectra on skin to determine sunscreens in vivo absorbance spectra, which are fused with respective in vitro absorbance spectra measured as thin films transmission as described in ISO 24443:2019. As a part of the ALT-SPF consortium initiative, a blinded study on 64 samples was performed in four European laboratories. After further improvements of the method, a blinded re-evaluation based on 16 samples was performed. Five statistical acceptance criteria for new methods were assessed by an independent statistical institute to compare the obtained results to the reference methods for SPF and UVA-PF.

RESULTS: The initial ALT-SPF study 1 showed that the bias criterion was acceptable, while the reproducibility and interlaboratory variability needed further improvement. The re-evaluation study 2 showed that the reproducibility and interlaboratory variability could be considerably improved. Using only n = 10 volunteers and a bias correction based on the initial ALT-SPF study 1 data, the SPF results of the re-evaluation study 2 were close to the acceptance criteria of the ALT-SPF study with criterion 1 (reproducibility) and only 11% over the limit defined by the performance of the gold standard. The UVA-PF results were within the acceptance limits for the acceptance criteria, except criterion 3 being in the ‘almost met’ range. The re-evaluation study indicates that the method has a comparable precision to the gold standard methods ISO 24444 and ISO 24443.

CONCLUSION: This study showed that the LED-HDRS method is capable of providing reasonable non-invasive SPF and UVA-PF results and that the performance shows close alignment to the reference method. Thus, it can be proposed as an alternative method to the current standards ISO 24444 and ISO 24443.

PMID:40888063 | DOI:10.1111/ics.70007

Int J Cosmet Sci. 2025 Sep;47 Suppl 1:115-132. doi: 10.1111/ics.70015.

ABSTRACT

OBJECTIVE: In the framework of the Alt-SPF consortium, a large ring study was conducted to evaluate different alternative methods for SPF determination. This paper reports and discusses the results of a new in vitro approach, the Fused Method. The study aimed to determine whether the Fused Method would provide similar SPF results to those obtained using ISO 24444 and whether UVA-PF would be comparable to ISO 24443.

METHODS: The Fused Method is based on assessing UV transmittance through a film of sunscreen applied to PMMA plates, before and after 1MED irradiation through the film. An individual calibration curve is measured by each operator using standard sunscreens to correct for individual/equipment error throughout the process. This calibration is formulation-dependent: there is one calibration for emulsion, one for single-phase formulations, and one for mineral UV filters.

RESULTS: Optimization of the calibration step to an asymptotic regression model improved inter-laboratory reproducibility and showed lower method bias compared to ISO 24444. Most PGs met the full statistical validation criterion for SPF results. The results of PG1 (low viscosity emulsion SPF30), PG2 (medium viscosity emulsion SPF6) and PG4 (medium viscosity emulsion SPF30) indicate a product and product group-specific method bias. This observation was confirmed for PG1 in the follow-up study. The same conclusion could be drawn for the evaluation of UVA-PF versus ISO 24443, as this parameter is directly linked to the SPF results.

CONCLUSION: The use of the Fused Method to determine the SPF of sunscreen formulations meets the statistical criteria for most PGs. However, intra-laboratory reproducibility needs to be improved for low SPF values and low viscosity emulsions. Nevertheless, this fast, simple, and cost-effective method remains a good alternative for SPF & UVA-PF screening in the development of sunscreen formulations. It is a pragmatic approach to manage the various known biases (applicator/device) of in vitro transmittance SPF measurement. No significant change to ISO 24443 is required, and the method allows in vitro SPF & UVA-PF to be determined in the same setup.

PMID:40888056 | DOI:10.1111/ics.70015

Int J Cosmet Sci. 2025 Sep;47 Suppl 1:78-95. doi: 10.1111/ics.13086.

ABSTRACT

This paper presents the results of the Alt-SPF consortium ring test, obtained by the in-silico methodology, and discusses these results in the context of existing standards. To evaluate the effectiveness of the in-silico methodology in correlating with these standards, a comparison was made between the in-silico sun protection factor (SPF) and the UVA protection factor (UVA-PF) and the values derived by standard in vivo SPF (ISO24444) and in vitro UVA-PF (ISO24443). The model utilises the same algorithm as in vitro measurements of SPF and UVA-PF, with the measured UV transmission substituted by calculated transmission simulated through an applied sunscreen film. The in-silico approach necessitates quantitative UV absorbance data of all UV-filters, their photodegradation and photointeraction properties, oil/water phase synergies and a model describing the irregular distribution of the film thickness on the skin. The performance factors are calculated using an initial analytical evaluation of the 32 test formulations of the ring test, to ascertain the presence and concentration of individual UV absorbers. The filter concentrations obtained are then processed via computational analysis to calculate the SPF and UV-PF values. It has been demonstrated that, in accordance with defined statistical parameters to characterize the ability of a method to correlate with the in vivo SPF standard, the in-silico methodology is a highly reproducible and accurate tool for SPF prediction. The alignment with the lowest measured in vivo SPF values serves to ensure the safety of the end consumer and is not a weakness of the method. Additionally, it has been demonstrated that the methodology facilitates precise prediction of UVA protection in comparison to the in vitro standard ISO 24443. These calculations can be employed to engineer novel sunscreens, thereby diminishing the necessity for ethically questionable and extensive laboratory measurements. In case still in-vivo measurements are needed, the methodology can deliver the frequently required SPF/UVA-PF values and may also support functions such as those of responsible persons, including safety assessors, in their evaluations.

PMID:40888055 | DOI:10.1111/ics.13086

Int J Hyperthermia. 2025 Dec;42(1):2553205. doi: 10.1080/02656736.2025.2553205. Epub 2025 Sep 1.

ABSTRACT

PURPOSE: This study aims to evaluate the feasibility, efficacy, and safety of microwave ablation (MWA) for cervical lymph node metastasis (CLNM) originating from papillary thyroid carcinoma (PTC) versus non-papillary thyroid carcinoma (non-PTC).

METHODS: In this retrospective study, 262 patients with CLNM treated by MWA between July 2016 and May 2024 were included. Comparative study based on propensity score matching (PSM) between the PTC and non-PTC groups was carried out.

RESULTS: After PSM, 30 cases (median age, 54.5 years [IQR 48-65.3]; 26 women) in the PTC group and 10 cases (median age, 56.5 years [IQR 49.5-66]; 7 women) in the non-PTC group were followed for a median of 22.5 months [IQR 12-36] and 8 months [IQR 6-22.5] (p = 0.072), respectively. Statistical analysis revealed significant differences between the PTC and non-PTC groups in disease progression (13.3% vs. 50%, p = 0.029), distant metastasis (0% vs. 30%, p = 0.012), disease progression-free survival (68% vs. 45%, log-rank p = 0.003), and tumor disappearance progression-free survival (99.9% vs. 20%, log-rank p = 0.019). The only complication observed was transient hoarseness, with no significant difference in complication rates between the two groups (6.7% vs. 0%, p > 0.99). Significant reductions in MD and volume were observed between pre- and post-MWA at 1, 3, 6, 9, and 12 months (all p < 0.05).

CONCLUSION: MWA is a safe and effective treatment option for patients with CLNM from PTC. However, for CLNM from non-PTC, more aggressive monitoring and additional therapies after MWA may be necessary.

PMID:40888054 | DOI:10.1080/02656736.2025.2553205

Int J Cosmet Sci. 2025 Sep;47 Suppl 1:37-52. doi: 10.1111/ics.13088.

ABSTRACT

OBJECTIVE: To perform a comprehensive statistical characterization of the Double Plate method (ISO 23675) as a potential in vitro alternative to the in vivo reference method (ISO 24444:2019) for determining the sun protection factor (SPF).

METHODS: Five qualified laboratories were involved in testing the Double Plate method, as part of a large-scale ring test conducted by the International Consortium ‘ALT-SPF’. About 32 sunscreen products, reflecting diverse global formulations, were tested using both the in vivo reference method and the Double Plate method. This method employs spectrophotometric measurements of sunscreen applied to UV-transparent plates with standardized robotic application to minimize the variability. A mathematical adjustment was introduced to address the initial bias compared to the reference method and further assessed in a follow-up ring test with 12 products, including ISO standards.

RESULTS: The Double Plate method exhibited very high intra- and inter-laboratory reproducibility throughout the study, consistently meeting the precision criteria set by ISO/TC217/WG7. Following the mathematical adjustment, the accuracy significantly improved, demonstrating a close alignment with the reference method.

CONCLUSION: The Double Plate method demonstrates excellent reproducibility and, following optimization, high accuracy for the SPF determination. These findings endorse the Double Plate method as a robust and ethical in vitro alternative to the in vivo reference method for SPF testing. This paved the way for its publication as a new ISO standard (ISO 23675), in December 2024, supporting consumer safety and informed product choices.

PMID:40888052 | DOI:10.1111/ics.13088

Anaesthesia. 2025 Sep 1. doi: 10.1111/anae.16757. Online ahead of print.

ABSTRACT

INTRODUCTION: Postoperative delirium is a common complication following cardiac surgery. Despite its known impact on patient outcomes, effective preventative strategies remain elusive. We aimed to perform a comprehensive Bayesian network meta-analysis of randomised controlled trials assessing the effect of pharmacological interventions on the incidence of postoperative delirium.

METHODS: Databases were searched from inception to September 2024. Our search was updated in January 2025. Eligible studies included randomised controlled trials reporting the incidence of postoperative delirium in patients having cardiac surgery treated with pharmacological interventions. Bayesian models were used to estimate risk ratios (RR) and mean differences with 95%CrI through Markov chain Monte Carlo. Interventions were ranked using the surface under the cumulative ranking curve. Sensitivity analyses and grading of recommendations, assessment, development and evaluation assessment were conducted to evaluate the robustness and certainty of evidence.

RESULTS: Seventy-nine randomised controlled trials comprising 24,827 patients were included, with 29 pharmacological interventions compared. Dexmedetomidine combined with melatonin was the most effective intervention, reducing the incidence of postoperative delirium compared with placebo (risk ratio 0.31, 95%CrI 0.13-0.69; low certainty). Dexmedetomidine with melatonin also significantly decreased intensive care unit stay (2.4 days, 95%CrI -3.50-1.10) and hospital stay (1.32 days, 95%CrI -2.09 to -0.57). Other interventions, including ketamine and risperidone, showed potential efficacy but with low or very low certainty of evidence.

DISCUSSION: We identified dexmedetomidine with melatonin as the most effective pharmacological strategy for preventing postoperative delirium following cardiac surgery. Whilst these findings highlight potential benefits, the low certainty of evidence underscores the need for more high-quality primary evidence.

PMID:40888048 | DOI:10.1111/anae.16757

J Environ Qual. 2025 Sep 1. doi: 10.1002/jeq2.70079. Online ahead of print.

ABSTRACT

Korea and the Netherlands historically developed highly fertilized cropping systems, resulting in the highest nitrogen (N) and phosphorus (P) surpluses among Organization for Economic Cooperation and Development (OECD) countries. However, their nutrient balances changed differently over the past three decades. The Netherlands reduced its N and P balances dramatically, from 328 to 166 kg ha^-1 and 35 to 4 kg ha^-1, respectively, while Korea’s balances remained unchanged with the highest levels in 2019 (230 kg N ha^-1 and 46 kg P ha^-1). To find solutions for Korea’s persistent nutrient surpluses, changes in nutrient balances and related parameters were compared using OECD statistics. Despite Korea’s efforts to reduce chemical fertilizer use, a 33% decline in agricultural land area and increased manure production offset the reduction. Conversely, the Netherlands rapidly decreased nutrient balances by reducing N and P inputs by 35% and 52%, respectively. Nutrient outputs in the Netherlands, primarily driven by forage harvest, were over twice as high as in Korea, helping lower its balances despite minor output declines. By the late 2010s, Dutch P input and output were nearly equilibrated, indicating no P surplus. As a result, the Netherlands has improved its nutrient use efficiency substantially, which inversely correlates with nutrient balance, but Korea has not shown considerable changes. Therefore, to address Korea’s nutrient balances, nutrient inputs should be reduced while increasing outputs. Determining the level of nutrient inputs, coupled with advanced agronomic practices and technologies to improve nutrient use efficiency, is essential for achieving reductions in nutrient balances while enhancing crops and forage production.

PMID:40888011 | DOI:10.1002/jeq2.70079

Pediatr Allergy Immunol. 2025 Sep;36(9):e70195. doi: 10.1111/pai.70195.

ABSTRACT

BACKGROUND: Hymenoptera venom allergy is a significant cause of morbidity and mortality, also in pediatric patients, highlighting the importance of effective management through venom immunotherapy (VIT). This study aimed to evaluate the safety profile of VIT, identify factors associated with adverse reactions (ARs), assess the accuracy of insect identification and its impact on VIT extract selection, and determine treatment efficacy by analyzing ARs following re-sting.

METHODS: The medical charts of patients followed up at the Allergy Unit of Meyer Children’s Hospital IRCCS, Florence, Italy, who completed a VIT cycle between 1997 and 2021 were retrospectively analyzed. VIT extract selection was guided by a diagnostic workup following the European Academy of Allergy and Clinical Immunology guidelines and the Italian Consensus on Hymenoptera venom allergy management. We implemented a cluster protocol and adjusted it as needed for ARs during VIT.

RESULTS: Fifty-eight patients, from a total of 60 VIT (2 patients underwent VIT for both Vespula and Polistes) were included, using the following extracts: 17 Apis mellifera (28.4%), 20 Vespula (33.3%), 20 Polistes (33.3%), and 3 Vespa crabro (5.0%). Upon the 3739 injections administered, 355 ARs (9.5%) occurred: local reactions (LRs), 306 (8.2%); extended local reactions (ELRs), 34 (0.9%); and systemic reactions (SRs), 15 (0.4%). The build-up phase was associated with a higher number of ARs and LRs compared with the maintenance phase during VIT (p < .0001), normalized by the number of injections. No other significant factors related to the risk of developing any ARs were highlighted. The highest SR rate was found in the VIT for Polistes, with no significant differences in AR proportions among the venom extracts. Thirty patients reported 51 re-stings following VIT, with only 2 of 51 (3.9%) resulting in SRs. These reactions occurred in individuals stung by a different Hymenoptera species from the one targeted during the VIT.

CONCLUSION: Cluster protocol VIT is safe and effective in pediatric patients.

PMID:40888008 | DOI:10.1111/pai.70195