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Nevin Manimala Statistics

Effect of Total Breast Reconstruction With Autologous Fat Transfer Using an Expansion Device vs Implants on Quality of Life Among Patients With Breast Cancer: A Randomized Clinical Trial

JAMA Surg. 2023 Mar 1. doi: 10.1001/jamasurg.2022.7625. Online ahead of print.

ABSTRACT

IMPORTANCE: There is a need for a new, less invasive breast reconstruction option for patients who undergo mastectomy in their breast cancer treatment.

OBJECTIVE: To investigate quality of life (QoL) among patients undergoing a new breast reconstruction technique, autologous fat transfer (AFT), compared with that among patients undergoing implant-based reconstruction (IBR).

DESIGN, SETTING, AND PARTICIPANTS: The BREAST trial was a randomized clinical trial conducted between November 2, 2015, and October 31, 2021, performed in 7 hospitals across the Netherlands. Follow-up was 12 months. Referrals could be obtained from general practitioners and all departments from participating or nonparticipating hospitals. The patients with breast cancer who had undergone mastectomy and were seeking breast reconstruction were screened for eligibility (radiotherapy history and physique) by participating plastic surgeons. Patients receiving postmastectomy radiotherapy were excluded.

INTERVENTIONS: Breast reconstruction with AFT plus expansion or 2-phased IBR. Randomization was done in a 1:1 ratio.

MAIN OUTCOMES AND MEASURES: The statistical analysis was performed per protocol. The predefined primary outcome was QoL at 12 months after final surgery. This was measured by the BREAST-Q questionnaire, a validated breast reconstruction surgery questionnaire. Questions on the BREAST-Q questionnaire are scored from 0 to 100, with a higher score indicating greater satisfaction or better QoL (depending on the scale). Secondary outcomes were breast volume and the safety and efficacy of the techniques.

RESULTS: A total of 193 female patients (mean [SD] age, 49.2 [10.6] years) 18 years or older who desired breast reconstruction were included, of whom 91 patients in the AFT group (mean [SD] age, 49.3 [10.3] years) and 80 in the IBR group (mean age, 49.1 [11.0] years) received the allocated intervention. In total, 64 women in the AFT group and 68 women in the IBR group completed follow-up. In the IBR group, 18 patients dropped out mainly due to their aversion to implant use while in the AFT group 6 patients ended their treatment prematurely because of the burden (that is, the treatment being too heavy or tiring). The BREAST-Q scores were higher in the AFT group in all 5 domains and significantly higher in 3: satisfaction with breasts (difference, 9.9; P = .002), physical well-being: chest (difference; 7.6; P = .007), and satisfaction with outcome (difference, 7.6; P = .04). Linear mixed-effects regression analysis showed that QoL change over time was dependent on the treatment group in favor of AFT. The mean (SD) breast volume achieved differed between the groups (AFT: 300.3 [111.4] mL; IBR: 384.1 [86.6] mL). No differences in oncological serious adverse events were found.

CONCLUSIONS AND RELEVANCE: This randomized clinical trial found higher QoL and an increase in QoL scores over time in the AFT group compared with the IBR group. No evidence was found that AFT was unsafe. This is encouraging news since it provides a third, less invasive reconstruction option for patients with breast cancer.

TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02339779.

PMID:36857058 | DOI:10.1001/jamasurg.2022.7625

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Assessment of a Text Message-Based Smoking Cessation Intervention for Adult Smokers in China: A Randomized Clinical Trial

JAMA Netw Open. 2023 Mar 1;6(3):e230301. doi: 10.1001/jamanetworkopen.2023.0301.

ABSTRACT

IMPORTANCE: Successful smoking cessation strategies are an important part of reducing tobacco use. However, providing universal smoking cessation support can be a challenge for most countries because it requires sufficient resources. One way to expand access is to use mobile technologies to provide cessation support.

OBJECTIVE: To assess the efficacy of a behavior change theory-based smoking cessation intervention using personalized text messages.

DESIGN, SETTING, AND PARTICIPANTS: This study was a 2-arm double-blind randomized clinical trial conducted in 5 cities in China. Daily or weekly smokers 18 years or older were eligible for inclusion if they owned a mobile phone and used the WeChat social media app. A total of 722 participants were randomized to the intervention or control group between April 1 and July 27, 2021.

INTERVENTIONS: Intervention group participants received a personalized text message-based smoking cessation intervention that was based on the transtheoretical model and protection motivation theory and developed by this study’s investigators. Control group participants received a nonpersonalized text message-based smoking cessation intervention developed by the US National Cancer Institute. Both groups received 1 to 2 text messages per day for 3 months through the app.

MAIN OUTCOMES AND MEASURES: The primary outcome was the biochemically verified 6-month sustained abstinence rate, defined as the self-report of no smoking of any cigarettes after the designated quit date, which was validated biochemically by an expired air carbon monoxide level of less than 6 ppm at each follow-up point.

RESULTS: A total of 722 participants (mean [SD] age, 41.5 [12.7] years; 716 men [99.2%]; all of Chinese ethnicity) were randomly assigned to the intervention group (360 participants) or the control group (362 participants). Biochemically verified continuous abstinence at 6 months was 6.9% in the intervention group and 3.0% in the control group (odds ratio [OR], 2.66; 95% CI, 1.21-5.83). Among smokers with low nicotine dependence, the intervention group had significantly better abstinence rates for most of the indicators after adjusting for covariates (eg, biochemically verified 24-hour point prevalence of abstinence at 1 month: adjusted OR, 2.15; 95% CI, 1.05-4.38). Among smokers with moderate and high nicotine dependence, only the biochemically verified 24-hour point prevalence of abstinence at 6 months was statistically significant (adjusted OR, 4.17; 95% CI, 1.34-3.00). The pattern was similar for quitting intention, and the personalized text message-based intervention was more effective for smokers who had strong quitting intention than for those who had weak quitting intention.

CONCLUSIONS AND RELEVANCE: In this study, the behavior change theory-based smoking cessation intervention using personalized text messages was more effective than an intervention using nonpersonalized text messages. The intervention was most effective among smokers with low nicotine dependence and strong quitting intention. This study’s findings also provide further evidence regarding the potential benefits of mobile health interventions for other behaviors.

TRIAL REGISTRATION: Chinese Clinical Trial Registry Identifier: ChiCTR2100041942.

PMID:36857056 | DOI:10.1001/jamanetworkopen.2023.0301

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Association of Intensive vs Standard Blood Pressure Control With Regional Changes in Cerebral Small Vessel Disease Biomarkers: Post Hoc Secondary Analysis of the SPRINT MIND Randomized Clinical Trial

JAMA Netw Open. 2023 Mar 1;6(3):e231055. doi: 10.1001/jamanetworkopen.2023.1055.

ABSTRACT

IMPORTANCE: Little is known about the associations of strict blood pressure (BP) control with microstructural changes in small vessel disease markers.

OBJECTIVE: To investigate the regional associations of intensive vs standard BP control with small vessel disease biomarkers, such as white matter lesions (WMLs), fractional anisotropy (FA), mean diffusivity (MD), and cerebral blood flow (CBF).

DESIGN, SETTING, AND PARTICIPANTS: The Systolic Blood Pressure Intervention Trial (SPRINT) is a multicenter randomized clinical trial that compared intensive systolic BP (SBP) control (SBP target <120 mm Hg) vs standard control (SBP target <140 mm Hg) among participants aged 50 years or older with hypertension and without diabetes or a history of stroke. The study began randomization on November 8, 2010, and stopped July 1, 2016, with a follow-up duration of approximately 4 years. A total of 670 and 458 participants completed brain magnetic resonance imaging at baseline and follow-up, respectively, and comprise the cohort for this post hoc analysis. Statistical analyses for this post hoc analysis were performed between August 2020 and October 2022.

INTERVENTIONS: At baseline, 355 participants received intensive SBP treatment and 315 participants received standard SBP treatment.

MAIN OUTCOMES AND MEASURES: The main outcomes were regional changes in WMLs, FA, MD (in white matter regions of interest), and CBF (in gray matter regions of interest).

RESULTS: At baseline, 355 participants (mean [SD] age, 67.7 [8.0] years; 200 men [56.3%]) received intensive BP treatment and 315 participants (mean [SD] age, 67.0 [8.4] years; 199 men [63.2%]) received standard BP treatment. Intensive treatment was associated with smaller mean increases in WML volume compared with standard treatment (644.5 mm3 vs 1258.1 mm3). The smaller mean increases were observed specifically in the deep white matter regions of the left anterior corona radiata (intensive treatment, 30.3 mm3 [95% CI, 16.0-44.5 mm3]; standard treatment, 80.5 mm3 [95% CI, 53.8-107.2 mm3]), left tapetum (intensive treatment, 11.8 mm3 [95% CI, 4.4-19.2 mm3]; standard treatment, 27.2 mm3 [95% CI, 19.4-35.0 mm3]), left superior fronto-occipital fasciculus (intensive treatment, 3.2 mm3 [95% CI, 0.7-5.8 mm3]; standard treatment, 9.4 mm3 [95% CI, 5.5-13.4 mm3]), left posterior corona radiata (intensive treatment, 26.0 mm3 [95% CI, 12.9-39.1 mm3]; standard treatment, 52.3 mm3 [95% CI, 34.8-69.8 mm3]), left splenium of the corpus callosum (intensive treatment, 45.4 mm3 [95% CI, 25.1-65.7 mm3]; standard treatment, 83.0 mm3 [95% CI, 58.7-107.2 mm3]), left posterior thalamic radiation (intensive treatment, 53.0 mm3 [95% CI, 29.8-76.2 mm3]; standard treatment, 106.9 mm3 [95% CI, 73.4-140.3 mm3]), and right posterior thalamic radiation (intensive treatment, 49.5 mm3 [95% CI, 24.3-74.7 mm3]; standard treatment, 102.6 mm3 [95% CI, 71.0-134.2 mm3]).

CONCLUSIONS AND RELEVANCE: This study suggests that intensive BP treatment, compared with standard treatment, was associated with a slower increase of WMLs, improved diffusion tensor imaging, and FA and CBF changes in several brain regions that represent vulnerable areas that may benefit from more strict BP control.

TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01206062.

PMID:36857053 | DOI:10.1001/jamanetworkopen.2023.1055

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Effect of an Exclusive Human Milk Diet on the Gut Microbiome in Preterm Infants: A Randomized Clinical Trial

JAMA Netw Open. 2023 Mar 1;6(3):e231165. doi: 10.1001/jamanetworkopen.2023.1165.

ABSTRACT

IMPORTANCE: The effect of using an exclusive human milk diet compared with one that uses bovine products in preterm infants is uncertain, but some studies demonstrate lower rates of key neonatal morbidities. A potential mediating pathway is the gut microbiome.

OBJECTIVE: To determine the effect of an exclusive human milk diet on gut bacterial richness, diversity, and proportions of specific taxa in preterm infants from enrollment to 34 weeks’ postmenstrual age.

DESIGN, SETTING, AND PARTICIPANTS: In this randomized clinical trial conducted at 4 neonatal intensive care units in the United Kingdom from 2017 to 2020, microbiome analyses were blind to group. Infants less than 30 weeks’ gestation who had only received own mother’s milk were recruited before 72 hours of age. Statistical analysis was performed from July 2019 to September 2021.

INTERVENTIONS: Exclusive human milk diet using pasteurized human milk for any shortfall in mother’s own milk supply and human milk-derived fortifiers (intervention) compared with bovine formula and bovine-derived fortifier (control) until 34 weeks’ postmenstrual age. Fortifier commenced less than 48 hours of tolerating 150 mL/kg per day.

MAIN OUTCOMES AND MEASURES: Gut microbiome profile including alpha and beta diversity, and presence of specific bacterial taxa.

RESULTS: Of 126 preterm infants enrolled in the study, 63 were randomized to control (median [IQR] gestation: 27.0 weeks [26.0-28.1 weeks]; median [IQR] birthweight: 910 g [704-1054 g]; 32 [51%] male) and 63 were randomized to intervention (median [IQR] gestation: 27.1 weeks [25.7-28.1 weeks]; median [IQR] birthweight: 930 g [733-1095 g]; 38 [60%] male); 472 stool samples from 116 infants were analyzed. There were no differences in bacterial richness or Shannon diversity over time, or at 34 weeks between trial groups. The exclusive human milk diet group had reduced relative abundance of Lactobacillus after adjustment for confounders (coefficient estimate, 0.056; P = .03), but not after false discovery rate adjustment. There were no differences in time to full feeds, necrotizing enterocolitis, or other key neonatal morbidities.

CONCLUSIONS AND RELEVANCE: In this randomized clinical trial in preterm infants using human milk-derived formula and/or fortifier to enable an exclusive human milk diet, there were no effects on overall measures of gut bacterial diversity but there were effects on specific bacterial taxa previously associated with human milk receipt. These findings suggest that the clinical impact of human milk-derived products is not modulated via microbiomic mechanisms.

TRIAL REGISTRATION: ISRCTN trial registry identifier: ISRCTN16799022.

PMID:36857051 | DOI:10.1001/jamanetworkopen.2023.1165

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Overall and Racial and Ethnic Subgroup Prevalences of Alopecia Areata, Alopecia Totalis, and Alopecia Universalis

JAMA Dermatol. 2023 Mar 1. doi: 10.1001/jamadermatol.2023.0016. Online ahead of print.

ABSTRACT

IMPORTANCE: Prevalences of alopecia areata (AA), alopecia totalis (AT), and alopecia universalis (AU) are poorly established.

OBJECTIVE: To estimate overall and subgroup prevalences of AA and its subtypes.

DESIGN, SETTING, AND PARTICIPANTS: This cross-sectional study using electronic records comprising the Explorys database (Watson Health, IBM Corporation) included children, adolescents, and adults seeking healthcare across the 4 census regions in the US between January 1, 2019, and December 31, 2019. The statistical analysis was conducted between July 21, 2022, and December 22, 2022.

MAIN OUTCOMES AND MEASURES: Prevalent cases of AA, AT, and AU.

RESULTS: Of the 1 093 176 patients who met inclusion criteria, 1812 had at least 1 code for AA, 1216 female (67%) and 596 male (33%) patients. Overall age-and-sex standardized prevalences among adults and among children and adolescents were observed to be 0.18% and 0.10%, respectively. The age-standardized prevalence ratio in women to men was 1.32. Standardized prevalence was highest in those aged 30 to 39 (297 per 100 000; 95% CI, 263-335) and 40 to 49 (270 per 100 000; 95% CI, 240-303) years. The highest standardized prevalence was observed among Asian patients (414 per 100 000; 95% CI, 306-548), followed by patients reporting another race or multiple races (314 per 100 000; 95% CI, 266-368), Black (226 per 100 000; 95% CI, 199-255), and Hispanic/Latino (212 per 100 000; 95% CI, 129-328) patients. White patients had the lowest standardized prevalence (168 per 100 000; 95% CI, 157-179) among racial and ethnic subgroups. Relative to White patients, standardized prevalence ratios for Asian, Black, and Hispanic/Latino patients were 2.47 (95% CI, 2.17-2.81), 1.35 (95% CI, 1.26-1.44), and 1.26 (95% CI, 1.03-1.55), respectively. Cases of AT and AU comprised approximately 9% of patients diagnosed with AA.

CONCLUSIONS AND RELEVANCE: The findings of this cross-sectional study suggest that there is a significant burden of AA, AT, and AU in the US in which people of color, particularly Asian Americans, appear to be disproportionately affected.

PMID:36857044 | DOI:10.1001/jamadermatol.2023.0016

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Texture statistics involved in specular highlight exclusion for object lightness perception

J Vis. 2023 Mar 1;23(3):1. doi: 10.1167/jov.23.3.1.

ABSTRACT

The human visual system estimates the physical properties of objects, such as their lightness. Previous studies on the lightness perception of glossy three-dimensional objects have suggested that specular highlights are detected and excluded in lightness perception. However, only a few studies have attempted to elucidate the mechanisms underlying this exclusion. This study aimed to elucidate the image features that contribute to the highlight exclusion of lightness perception. We used Portilla-Simoncelli texture statistics (PS statistics), an image feature set similar to the representation in the early visual cortex, to explore their relationships with highlight exclusion for lightness perception. In experiment 1, computer graphics images of bumpy plastic plates with various physical parameters were used as stimuli, and the lightness perception on them was measured using a lightness matching task. We then calculated the highlight exclusion index, which represented the degree of highlight exclusion. Finally, we evaluated the correlation between the highlight exclusion index and the four PS statistic subsets. In experiment 2, an image synthesis algorithm was used to create images in which either the PS statistic subset was manipulated. The highlight exclusion indexes of the synthesized images were then measured. The results revealed that the PS statistic subset consisting of lowest-order image features, such as moment statistics of luminance, acts as a necessary condition for highlight exclusion, whereas the other three subsets consisting of higher order features are not crucial. These results suggest that the low-order image features are the most important among the features in PS statistics for highlight exclusion, even though image features higher order than those in PS statistics must be directly involved.

PMID:36857040 | DOI:10.1167/jov.23.3.1

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Risk of asthma in preterm infants with bronchopulmonary dysplasia: a systematic review and meta-analysis

World J Pediatr. 2023 Mar 1. doi: 10.1007/s12519-023-00701-1. Online ahead of print.

ABSTRACT

BACKGROUND: This study aimed to systematically review and meta-analyze the available literature on the association between preterm infant bronchopulmonary dysplasia (BPD) and pre-adulthood asthma.

METHODS: Studies examining the association between BPD and asthma in children and adolescents were systematically reviewed, and a meta-analysis was conducted. We searched Scopus, Embase, Web of Science, PubMed, and Cochrane Library from the database inception to March 26, 2022. The pooled odds ratio (OR) estimate was used in our meta-analysis to calculate the correlation between BPD and the probability of developing asthma before adulthood. Stata 12.0 was used to conduct the statistical analysis.

RESULTS: The correlation between asthma and BPD in preterm newborns was examined in nine studies. We used a random effect model to pool the OR estimate. Our results indicated a marked increase in the risk of subsequent asthma in preterm infants with BPD [OR = 1.73, 95% confidence interval (CI) = 1.43-2.09]. Moreover, there was no obvious heterogeneity across the studies (P = 0.617, I2 = 0%). The pooled OR remained stable and ranged from 1.65 (95% CI = 1.35-2.01) to 1.78 (95% CI = 1.43-2.21). Regarding publication bias, the funnel plot for asthma risk did not reveal any noticeable asymmetry. We further performed Begg’s and Egger’s tests to quantitatively evaluate publication bias. There was no evidence of a publication bias for asthma risk (P > |Z| = 0.602 for Begg’s test, and P > |t| = 0.991 for Egger’s test).

CONCLUSIONS: Our findings indicate that preterm infants with BPD have a much higher risk of developing asthma in the future (OR = 1.73, 95% CI = 1.43-2.09). Preterm infants with BPD may benefit from long-term follow-up.

PMID:36857022 | DOI:10.1007/s12519-023-00701-1

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Agreement and prognostic accuracy of three ED vulnerability screeners: findings from a prospective multi-site cohort study

CJEM. 2023 Mar 1. doi: 10.1007/s43678-023-00458-6. Online ahead of print.

ABSTRACT

OBJECTIVES: To evaluate the agreement between three emergency department (ED) vulnerability screeners, including the InterRAI ED Screener, ER2, and PRISMA-7. Our secondary objective was to evaluate the discriminative accuracy of screeners in predicting discharge home and extended ED lengths-of-stay (> 24 h).

METHODS: We conducted a nested sub-group study using data from a prospective multi-site cohort study evaluating frailty in older ED patients presenting to four Quebec hospitals. Research nurses assessed patients consecutively with the three screeners. We employed Cohen’s Kappa to determine agreement, with high-risk cut-offs of three and four for the PRISMA-7, six for the ER2, and five for the interRAI ED Screener. We used logistic regression to evaluate the discriminative accuracy of instruments, testing them in their dichotomous, full, and adjusted forms (adjusting for age, sex, and hospital academic status).

RESULTS: We evaluated 1855 older ED patients across the four hospital sites. The mean age of our sample was 84 years. Agreement between the interRAI ED Screener and the ER2 was fair (K = 0.37; 95% CI 0.33-0.40); agreement between the PRISMA-7 and ER2 was also fair (K = 0.39; 95% CI = 0.36-0.43). Agreement between interRAI ED Screener and PRISMA-7 was poor (K = 0.19; 95% CI 0.16-0.22). Using a cut-off of four for PRISMA-7 improved agreement with the ER2 (K = 0.55; 95% CI 0.51-0.59) and the ED Screener (K = 0.32; 95% CI 0.2-0.36). When predicting discharge home, the concordance statistics among models were similar in their dichotomous (c = 0.57-0.61), full (c = 0.61-0.64), and adjusted forms (c = 0.63-0.65), and poor for all models when predicting extended length-of-stay.

CONCLUSION: ED vulnerability scores from the three instruments had a fair agreement and were associated with important patient outcomes. The interRAI ED Screener best identifies older ED patients at greatest risk, while the PRISMA-7 and ER2 are more sensitive instruments.

PMID:36857018 | DOI:10.1007/s43678-023-00458-6

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Preoperative Predictors of Early Recurrence After Liver Resection for Multifocal Hepatocellular Carcinoma

J Gastrointest Surg. 2023 Mar 1. doi: 10.1007/s11605-023-05592-1. Online ahead of print.

ABSTRACT

BACKGROUND: Liver transplantation remains the optimal treatment for multifocal hepatocellular carcinoma (HCC). However, due to resource constrains, other therapeutic modalities such as liver resection (LR), are frequently utilized. LR, however, has to be balanced against potential morbidity and mortality along with the risks of early recurrence leading to futile surgery. In this study, we evaluated preoperative factors, including inflammatory indices, in predicting early (< 1 year) recurrence in patients who underwent LR for multifocal HCC.

METHODS: This was a post hoc analysis of 250 consecutive patients with multifocal HCC who underwent LR.

RESULTS: After exclusion of 10 patients with 30-day/in-hospital mortality, 240 were included of which 134 (55.8%) developed early recurrence. Hepatitis B/C aetiology, 3/ > more hepatic nodules and elevated alpha-fetoprotein (AFP) ≥ 200 ng/ml were significant independent preoperative predictors of early recurrence. The early recurrence rate was 72.1% when 2 out of 3 significant predictive factors were present. The conglomerate of all 3 factors predicted early recurrence of 100% with a statistically significant association between number of predictive factors and early recurrence (p < 0.001).

CONCLUSION: Better patient selection via the use of preoperative predictive factors of early recurrence such as hepatitis B/C aetiology, ≥ 3 nodules and elevated AFP ≥ 200 ng/ml may assist in identifying patients in whom LR is deemed futile and improve resource allocation.

PMID:36857014 | DOI:10.1007/s11605-023-05592-1

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Is the development of digital finance conducive to reducing haze pollution? Empirical evidence from 284 cities in China

Environ Sci Pollut Res Int. 2023 Mar 1. doi: 10.1007/s11356-023-25652-y. Online ahead of print.

ABSTRACT

Using the panel data of 284 cities from 2011 to 2020 in China, this research statistically tests the direct impact and internal mechanism of digital finance on urban haze pollution. The results show the following: (1) the development of digital finance can significantly inhibit the concentration of urban haze, and there is a stronger inhibitory effect in areas where the government pays more emphasis to haze pollution and in cities with high levels; (2) after mechanism inspection, it is found that digital finance can indirectly promote urban haze pollution by influencing green innovation, cooperative innovation, industrial structure upgrading, and producer service agglomeration; (3) the results of the spatial econometric analysis show that digital finance can suppress the haze concentration in the region and simultaneously inhibit the neighboring areas through spillover effects; (4) further inspection shows that the spatial spillover effect of digital finance on haze pollution has an obvious spatial attenuation feature, demonstrating that a dense area of spatial spillover is within 310 km. The spillover effect gradually disappears when the threshold is exceeded.

PMID:36857001 | DOI:10.1007/s11356-023-25652-y