Tag: statistics

Arch Dermatol Res. 2025 Jan 18;317(1):292. doi: 10.1007/s00403-024-03791-7.

ABSTRACT

Skin cancers continue to present unresolved challenges, particularly regarding the association with sex hormones, which remains a topic of controversy. A systematic review is currently warranted to address these issues. To analyze if sex hormones result in a higher incidence of skin cancers (cutaneous melanoma, basal cell carcinoma, squamous cell carcinoma). Data sources and study selection-The database of PubMed, Embase and Web of Science (WOS) was searched until July 3, 2024. The search yielded 1016 articles. 42 eligible studies were identified for meta-analysis. Data extraction and synthesis-Eligible trials reported skin cancer data and outcomes, confirming diagnoses and collecting hormone use information. Other extracted data included study methods, demographics, and reproductive factor. Relative risk (RR) and odds ratios (OR) and hazard ratios (HR) with 95% confidence intervals (CI), were synthesized after adjusting. The primary outcome was the incidence of cutaneous melanoma and non-cutaneous melanoma. 95% CI and OR are estimate effects. Participants using oral contraceptives (OCs) showed a higher incidence of cutaneous melanoma (CM) [OR 1.08, 95%CI 1.03-1.13, p < 0.01]. There is positively related statistic difference in Squamous cell carcinoma (SCC) [OR 1.37, 95%CI 1.15-1.63, p < 0.01]. Hormone replacement therapy (HRT) was associated with a higher incidence of CM [OR 1.18, 95%CI 1.13-1.24, p < 0.01]. And for non-melanoma skin cancer (NMSC), HRT also increased the incidence [OR 1.13, 95%CI 1.03-1.24, p = 0.01]. Menopausal hormone therapy (MHT) also showed an increased incidence of CM [OR 1.09, 95%CI 1.00-1.18, p < 0.05]. For age at first birth, > 30 years demonstrated a positive correlation with increased the incidence of CM [OR 1.21, 95%CI 1.00-1.46, p = 0.05]. OCs and HRT were associated with increased risks of skin cancers. MHT elevated the risk of CM. In women whose menopause age was older than 50 years, endogenous sex hormones decreased gradually, which caused higher risks of skin cancers. First birth aged older than 30 years indicated increasing effects of skin cancers.Trial registration number : CRD42024517445.

PMID:39825969 | DOI:10.1007/s00403-024-03791-7

Arch Dermatol Res. 2025 Jan 18;317(1):285. doi: 10.1007/s00403-025-03798-8.

ABSTRACT

Vulvar lichen planus (VLP) is a rare mucocutaneous disorder with significant impacts on quality of life and a potential risk of malignancy. Comprehensive data on its clinical features and treatment outcomes remain limited. To analyze the demographic and clinical characteristics of patients diagnosed with VLP and to evaluate the efficacy of current therapeutic approaches. A retrospective review was conducted on 70 female patients diagnosed with VLP at a single institution between January 2014 and August 2024. Clinical characteristics, treatment modalities, and outcomes were analyzed. Statistical comparisons were performed using Student’s t-test, Mann-Whitney U test, and χ² test as appropriate. The mean age at diagnosis was 59.3 ± 12.4 years, with a median disease duration of 2 years (range: 6 months-10 years). Pruritus (80.0%) and dyspareunia (62.9%) were the most prevalent symptoms. Corticosteroid therapy was the mainstay treatment, administered to 97.1% of patients, with superpotent topical corticosteroids being the most common (47.1%). Remission was achieved in 25.7% of cases, with younger patients exhibiting significantly higher remission rates (p = 0.005). Thyroid disease was the most common comorbid autoimmune condition, present in 32.9% of patients. VLP predominantly affects middle-aged women, with corticosteroids remaining the first-line therapy. Younger age appears to be associated with better treatment outcomes. These findings underscore the importance of early intervention and individualized therapeutic strategies. Further studies are warranted to explore the underlying mechanisms driving age-related differences in disease outcomes.

PMID:39825959 | DOI:10.1007/s00403-025-03798-8

Arch Dermatol Res. 2025 Jan 18;317(1):280. doi: 10.1007/s00403-024-03784-6.

ABSTRACT

BACKGROUND: Celiac disease (CeD) has shown an association with autoimmune disorders including vitiligo and alopecia areata (AA). Ritlecitinib, a JAK3 and TEC kinase family inhibitor, has been approved for treatment of patients with AA and is in late-stage development for vitiligo. Ritlecitinib inhibits cytotoxic T cells, NK cells, and B cells which play a role in the pathogenesis of CeD.

OBJECTIVE: We aimed to explore the potential effect of ritlecitinib on CeD serology levels before and after ritlecitinib treatment in research participants of clinical trials.

METHODS: The effect of ritlecitinib on CeD serology (tTG-IgA, DGP-IgA/IgG) levels was retrospectively evaluated in participants from three phase 2 and one phase 3 ritlecitinib clinical trials including participants with active AA, rheumatoid arthritis (RA) and vitiligo, whose serum samples at baseline and post-treatment were available. All statistical comparisons of the changes between initial and follow-up samples used the Wilcoxon matched pairs exact test.

RESULTS: Of 1146 research participants, 21 individuals had a positive tTG-IgA in their baseline samples (positivity rate, 0.018, 95% CI = 0.011-0.028). Among these 21 individuals, follow-up samples were available in 15 participants from the ritlecitinib group and in 3 from the placebo group. In follow-up samples, the values of tTG-IgA in the 15 participants treated with ritlecitinib significantly decreased from baseline (p < 0.01), while in the placebo group the tTGA-IgA levels remained close to the baseline values.

CONCLUSION: A decrease in CeD serology levels with ritlecitinib treatment suggests that ritlecitinib may provide beneficial effect in CeD.

PMID:39825945 | DOI:10.1007/s00403-024-03784-6

Arch Dermatol Res. 2025 Jan 18;317(1):291. doi: 10.1007/s00403-024-03786-4.

ABSTRACT

This study aims to explore the measurement agreement between direct and indirect health utility measures in four chronic dermatological conditions (atopic dermatitis, hidradenitis suppurativa, pemphigus, psoriasis). Outpatients survey data collected between 2015 and 2021 were analysed. Health-related quality of life (HRQoL) outcome measures included time trade-off (TTO), EQ-5D-5L and Dermatology Life Quality Index (DLQI). Descriptive statistics were computed for the pooled sample and four diseases. Mean, standard deviation (SD), median, interquartile range (IQR), ceiling and floor effects were calculated for TTO, EQ-5D-5L and DLQI utilities. Bland‒Altman plots and intraclass correlation coefficients (ICC) were applied to investigate the agreement between health utility measures. Sociodemographic characteristics (age, sex, educational level, employment status) and health-related information (disease duration, outpatient care visits in the past 3 months and disease severity) impact on utilities was investigated by Tobit regressions. The sample includes N = 765 patient responses with a mean age of 41.5 (SD = 16.2), majority being males (52.7%). Total sample mean utilities were the highest according to TTO (0.83), followed by EQ-5D-5L and vDLQI (0.81 and 0.81) and lowest in mDLQI (0.77). Measurement agreement was found only between TTO and EQ-5D-5L. Skin-disease severity impacted all health state utilities, though only TTO differentiated utility values according to disease type. The discrepancies between the TTO and DLQI warn to compare DLQI-based utilities in different dermatological conditions with extreme caution.

PMID:39825944 | DOI:10.1007/s00403-024-03786-4

Arch Dermatol Res. 2025 Jan 18;317(1):286. doi: 10.1007/s00403-025-03818-7.

ABSTRACT

Atherosclerosis, in which chronic inflammation is also effective in it’s pathogenesis, is an important cause of morbidity and mortality in psoriasis patients. Early diagnosis and management of atherosclerosis is important. Measurement of carotid intima media thickness is a method used to determine subclinical atherosclerosis. Our aim in this study is to evaluate subclinical atherosclerosis in psoriasis patients and to examine the effects of targeted therapies on atherosclerosis. This study included 105 psoriasis patients who applied to psoriasis outpatient clinic between May 2022 and December 2022. The patients’ age, gender, psoriasis area severity index (PASI) and the initiated treatment agent (topical treatment, sekukinumab, iksekizumab, guselkumab, risankizumab) were noted. Carotid intima-media thickness measurements were taken at baseline and after 6 months of treatment. In patients who were treated with secukinumab, ixekizumab, risankizumab, and guselkumab, there was a statistically significant decrease in catorid-intima media thickness at 6th month when compared with the baseline measurements (p = 0,002 p < 0,001 p < 0,001 p = 0,036 p < 0,001). On the other hand, an increase in the thickness was observed in the topical treatment group. According to our study results, targeted systemic treatments contribute to the improvement of subclinical atherosclerosis in psoriasis patients, while this effect was not seen in topical treatments. These results are consistent with literature data reporting that psoriasis is a systemic inflammatory disease.

PMID:39825924 | DOI:10.1007/s00403-025-03818-7

Arch Dermatol Res. 2025 Jan 18;317(1):281. doi: 10.1007/s00403-025-03819-6.

ABSTRACT

Knowledge on the effect of different nicotine consumption modalities on dermatologic surgical outcomes is limited, with conflicting conclusions. Cigarette smoking is known to adversely affect outcomes, but the impact of other nicotine consumption modalities like cigars, smokeless tobacco, and nicotine replacement therapy (NRT) is less understood. Our objective was to evaluate the impact of various nicotine consumption modalities on complication rates after Mohs micrographic surgery (MMS). We conducted a prospective cohort study of 404 MMS patients. Variables analyzed included patient age, sex, post-operative complications, and nicotine history via a questionnaire. We found that patients with any history of nicotine use had an 8.5% absolute risk of experiencing complications while the risk for patients without a history of nicotine use was 3.1%, representing a relative risk of 2.75. Cox proportional hazard testing found patient sex and past smoked tobacco use as statistically significant factors for complications. Patients who have smoked tobacco appear to be at a significantly increased risk of experiencing a complication following MMS compared to never-nicotine users. Larger studies are needed to clarify the surgical risks posed by smokeless nicotine products.

PMID:39825914 | DOI:10.1007/s00403-025-03819-6

Arch Gynecol Obstet. 2025 Jan 18. doi: 10.1007/s00404-024-07930-3. Online ahead of print.

ABSTRACT

PURPOSE: This updated systematic review and meta-analysis aims to evaluate the impact of a birthing ball (BB) exercises on low-risk parturients during labor, offering a more comprehensive understanding through a larger sample size, robust analysis, and focus on relevant endpoints that were underexplored in previous studies due to limited data.

METHODS: We searched PubMed, Embase, Scopus, and Cochrane Central for randomized controlled trials (RCTs) comparing BB (also named Swiss ball) exercises with no intervention or standard care in parturients undergoing low-risk labor. Risk ratios (RR) and mean differences (MD) were calculated using a random-effects model. I² heterogeneity was assessed. All statistical analyses were performed using Review Manager 5.4.

RESULTS: We included 10 RCTs with 1,008 parturients, 51.2% of whom were assigned to BB exercises. In the pooled analysis, the BB group showed significantly lower cesarean section rates (MD 0.55, p = 0.007, I² = 32%), reduced pain scores at 4 and 8 cm dilation by approximately 20% (p < 0.001), and a reduction of over two hours in the duration of the first stage of labor (MD -130.12 min, p < 0.001). There were no significant differences between groups in the duration of the second stage of labor (p = 0.090) and in the incidence of instrumental delivery, amniotomy, labor induction, oxytocin use, or epidural analgesia.

CONCLUSIONS: BB exercises significantly reduced cesarean section rates, alleviated labor pain, and shortened the first stage of labor, supporting their use as a safe and effective non-pharmacological intervention in low-risk labor management.

PMID:39825901 | DOI:10.1007/s00404-024-07930-3

Anal Bioanal Chem. 2025 Jan 18. doi: 10.1007/s00216-024-05724-9. Online ahead of print.

ABSTRACT

Closely related species of Salmonidae, including Pacific and Atlantic salmon, can be distinguished from one another based on nucleotide sequences from the cytochrome c oxidase sub-unit 1 mitochondrial gene (COI), using ensembles of fragments aligned to genetic barcodes that serve as digital proxies for the relevant species. This is accomplished by exploiting both the nucleotide sequences and their quality scores recorded in a FASTQ file obtained via Next Generation (NextGen) Sequencing of mitochondrial DNA extracted from Coho salmon caught with hook and line in the Gulf of Alaska. The alignment is done using MUSCLE (Muscle 5.2) (Edgar in Nat Commun 13:6968, 2022), applied to multiple versions of each fragment perturbed according to the nucleobase identification error probabilities underlying the quality scores. The Damerau-Levenshtein distance was used to determine the genetic barcode of the candidate species that is closest to each aligned, perturbed fragment. The “votes” that the sampled fragments cast for the different candidate species are then pooled and converted into identification probabilities, using weights determined by the entropy of the fragment-specific identification probability distributions. This novel approach to quantify the uncertainty associated with measurements made using NextGen Sequencing can be applied to discriminate closely related species, hence to value-assignment for reference materials supporting determinations of the authenticity of seafood, for example, NIST Reference Materials 8256 and 8257 (Coho salmon) (Ellisor et al., 2021).

PMID:39825896 | DOI:10.1007/s00216-024-05724-9

Eur Radiol. 2025 Jan 18. doi: 10.1007/s00330-024-11326-x. Online ahead of print.

ABSTRACT

OBJECTIVE: To compare the clinical outcomes of patients with unifocal paratracheal papillary thyroid microcarcinoma (PTMC) after thermal ablation (TA) vs. partial thyroidectomy (PT).

MATERIALS AND METHODS: This retrospective multicenter study included 436 patients with unifocal, clinical N0 paratracheal PTMC who underwent TA (210 patients) or PT (236 patients) between June 2014 and December 2020. The propensity score matching method was used to mitigate confounding factors between the two groups. Disease progression, progression-free survival (PFS), complications, and treatment variables were compared. Adjusted Cox regression models were utilized to assess the impact of treatment on disease progression.

RESULTS: After matching, a comparable incidence of disease progression (3.3% vs. 2.2%, p = 0.79) and comparable 5-year PFS rates (97.0% vs. 97.4%, p = 0.75) were observed between the TA and PT groups. Adjusted Cox regression models showed no significant correlation between TA and disease progression. TA was associated with shorter hospitalization (0 vs. 6.0 days), less estimated blood loss (0 vs. 15.0 mL), shorter incision length (0.3 vs. 6.0 cm), and lower costs ($1748.3 vs. $2898.0) compared with PT (all p < 0.001). The complication rate was 1.1% after TA and 3.3% after PT (p = 0.28), with permanent complications were exclusively observed in the PT group.

CONCLUSION: The mid-term incidence of disease progression and PFS rates were similar between TA and PT in patients with unifocal paratracheal PTMC. TA might represent a promising alternative treatment to PT for eligible patients with paratracheal PTMC.

KEY POINTS: Question Is thermal ablation a viable alternative treatment to partial thyroidectomy for treating paratracheal papillary thyroid microcarcinoma? Findings Comparable incidence of disease progression and 5-year progression-free survival rates were observed between thermal ablation and partial thyroidectomy. Clinical relevance Thermal ablation, as a minimally invasive procedure, provides a promising alternative to partial thyroidectomy, with comparable clinical outcomes for patients with paratracheal papillary thyroid microcarcinoma.

PMID:39825891 | DOI:10.1007/s00330-024-11326-x

Clin Pharmacol Ther. 2025 Jan 18. doi: 10.1002/cpt.3558. Online ahead of print.

ABSTRACT

Biomarkers play a pivotal role in the selection and enrollment of trial participants. Particularly, predictive biomarkers help tailor medical care to individual patients; however, also prognostic biomarkers require consideration at the design stage. At the time of initiating a clinical trial, there may be uncertainty about whether a biomarker is predictive or prognostic, and the trial design may need to account for this. Relevant discussions between drug developers and regulators on the role of a biomarker in a specific drug development program are expected to take place during Scientific Advice (SA) procedures. SA procedures at the European Medicines Agency from January 1, 2018, to December 31, 2020, were systematically searched for methodological discussions around the use of predictive or prognostic biomarkers. The final analysis included 45 SA procedures for which key characteristics were summarized quantitatively. Selected methodological issues such as the cutoff selection of continuous biomarkers or study design considerations were elaborated in a qualitative summary. Our results identify commonly encountered points for discussion between drug developers and the European Medicines Agency for biomarker-informed patient selection and enrollment. Identified topics addressed during SA procedures include cutoff selection, study design, multiplicity control, and data-driven subgroup selection. The majority of the identified 45 SA procedures concern development programs in oncology. Addressing these issues upfront will allow for an improved dialogue between drug developers and regulators and support the drug development program and ultimately patient-centered access to medicines.

PMID:39825875 | DOI:10.1002/cpt.3558