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Feasibility and safety of calcium alginate hydrogel sealant for the treatment of cryptoglandular fistula-in-ano: phase I/IIa clinical trial

Colorectal Dis. 2021 Mar 2. doi: 10.1111/codi.15608. Online ahead of print.

ABSTRACT

BACKGROUND: Complex perianal fistulas pose a challenge to the surgeon since the fistulous tract must be eliminated without impairing continence. Although without strong scientific evidence, some bibliography has demonstrated the efficacy of some sealants in the treatment of anal fistulas. We aimed to assess the feasibility and safety of calcium alginate hydrogel injections into the fistulous tract as treatment for trans-sphincteric cryptoglandular fistulas.

METHODS: A prospective, single-center, case series of this novel technique was conducted in a level 3 Spanish hospital, including patients diagnosed with trans-sphincteric perianal fistulas and treated with a calcium alginate hydrogel sealant. A strict follow-up was performed by an independent surgeon at 1, 3, 6, and 12 months. The main outcome measures were feasibility, safety (number of adverse events) and efficacy of the treatment.

RESULTS: Twenty patients were treated. The treatment was performed in all patients. Seven adverse events related to the injection product or the surgical procedure were identified. After a 12-month follow-up, 12 patients were completely cured and 8 were not cured, with a greater response in the first 6 months. These findings were confirmed by endoanal ultrasound, with a Cohen’s kappa concordance rate of 0.89. No statistically significant differences were observed in pain measured using the Visual Analogue Scale, faecal incontinence measured using the Wexner scoring system, and quality of life analysed by the SF-36 Health Survey.

CONCLUSION: The treatment was feasible, safe, and with discrete satisfactory healing results. It also demonstrated an acceptable safety profile, without worsening of faecal incontinence, quality of life, and pain following treatment.

PMID:33655675 | DOI:10.1111/codi.15608

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Impact of cardiometabolic factors on retinal vasculature: A 3×3, 6×6 and 8×8-mm optical coherence tomography angiography study

Clin Exp Ophthalmol. 2021 Mar 2. doi: 10.1111/ceo.13913. Online ahead of print.

ABSTRACT

BACKGROUND: Optical coherence tomography angiography (OCTA) is available in varying size and resolution. We sought to characterize associations of cardiometabolic factors with retinal microvascular changes using 3×3-mm, 6×6-mm and 8×8-mm OCTA scans to determine differences in detection with varying scan size.

METHODS: Cross-sectional study of 247 cardiovascular patients from a single-centre tertiary-care hospital. Demographic, comorbidity, and medication data were obtained. Patients underwent 3×3-mm, 6×6-mm and 8×8-mm macula OCTA scanning using Carl Zeiss CIRRUS HD-OCT Model 5000. Angioplex and AngioTool software was used to quantify vascular parameters in the superficial capillary plexus.

RESULTS: Increasing age, hypertension, dyslipidemia, diabetes, chronic kidney disease, coronary artery disease, and peripheral vascular disease were associated with reductions in vessel density, vessel perfusion, average vessel length and/or junction density in 3×3-mm OCTA (p<0.05 for all). Conversely, smoking was associated with increased vessel density, vessel length, and junction density in 3×3-mm OCTA (p<0.05 for all). Associations of vessel abnormalities with cardiometabolic factors were progressively weakened and statistically attenuated in 6×6-mm and 8×8-mm OCTA scans. In multivariate analyses, dyslipidemia remained an independent predictor of reduced vessel density, average vessel length, and junction density (p<0.05).

CONCLUSIONS: Cardiometabolic factors are associated with multiple retinal microvascular changes in 3×3-mm OCTA scans. These associations were weakened and progressively attenuated in OCTA scans of larger 6×6-mm and 8×8-mm size. These findings advance our understanding of microcirculatory dysfunction and may have future implications for the screening and management of patients with cardiometabolic risk factors. Additional studies are required to further investigate these important associations.

PMID:33655679 | DOI:10.1111/ceo.13913

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Temporal trends and outcomes among patients admitted for immune-related adverse events: A single-center retrospective cohort study from 2011-2018

Oncologist. 2021 Mar 3. doi: 10.1002/onco.13740. Online ahead of print.

ABSTRACT

BACKGROUND: The aim of this study was to characterize severe irAEs seen among hospitalized patients and to examine risk factors for irAE admissions and clinically relevant outcomes, including length of stay, ICI discontinuation, readmission, and death.

METHODS: Patients who received ICI therapy (ipilimumab, pembrolizumab, nivolumab, atezolizumab, durvalumab, avelumab, or any ICI combination) at Massachusetts General Hospital (MGH) and were hospitalized at MGH following ICI initiation between January 1, 2011 and October 24, 2018 were identified using pharmacy and hospital admission databases. Medical records of all irAE admissions were reviewed and specialist review with defined criteria was performed. Demographic data, relevant clinical history (malignancy type and most recent ICI regimen), and key admission characteristics including dates of admission and discharge, immunosuppressive management, ICI discontinuation, readmission, and death were collected.

RESULTS: In total, 450 admissions were classified as irAE admissions and represent the study’s cohort. Alongside the increasing use of ICIs at our institution the number of patients admitted to MGH for irAEs has gradually increased every year from 9 in 2011 to 92 in 2018. The hospitalization rate per ICI recipient has declined over that same time period (25.0% in 2011 to 8.5% in 2018). The most common toxicities leading to hospitalization in our cohort were gastrointestinal (GI; 30.7%; N=138), pulmonary (15.8%; N=71), hepatic (14.2%; N=64), endocrine (12.2%; N=55), neurologic (8.4%; N=38), cardiac (6.7%; N=30), and dermatologic (4.4%; N=20). Multivariable logistic regression revealed statistically significant increases in irAE admission risk for CTLA-4 monotherapy recipients (odds ratio [OR], 2.02; P<0.001) and CTLA-4 plus PD-1 combination therapy recipients (OR, 1.88; P<0.001), relative to PD-1/PD-L1 monotherapy recipients.

CONCLUSION: This study illustrates that cancer centers must be prepared to manage a wide variety of irAE types and that CTLA-4 and combination ICI regimens are more likely to cause irAE admissions that occur earlier after drug initiation.

PMID:33655682 | DOI:10.1002/onco.13740

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The Interplay of Vitamin D and Body Mass Index in Acne Patients Versus Controls

J Cosmet Dermatol. 2021 Mar 2. doi: 10.1111/jocd.14034. Online ahead of print.

ABSTRACT

BACKGROUND: Acne vulgaris is a disease of pilosebaceous units and manifests with polymorphic lesions. Vitamin D acts at various stages in its pathogenesis. Recently, vitamin D and metabolic syndrome have shown to be associated with acne vulgaris and its severity.

AIMS: To see the effects of serum 25(OH)D3 levels and body mass index on acne vulgaris and their correlation with the severity of acne.

METHODS: Fifty patients of acne vulgaris and thirty age and sex-matched healthy volunteers were recruited. Global Acne Grading System was used to grade the acne severity. Body mass index of all patients and control group was calculated and serum levels of 25(OH)D3 were measured using chemiluminescence immunoassay.

RESULTS: Vitamin D deficiency was detected in 28% of patients with acne but only in 6.7% of the healthy controls (p value 0.022). However, there was no significant difference in mean serum 25(OH)D levels in acne patients and controls. Vitamin D deficiency was seen in 60% of the very severe and 33% of the severe acne cases. Eighty percent of patients with very severe acne and 73.33% of severe acne patients had high body mass index. The relationship between severity of acne and body mass index was statistically significant.

CONCLUSION: Vitamin D deficiency was more prevalent in acne and with the increase in severity of acne, an inverse relation between serum levels of vitamin D and body mass index was seen but, statistically significant relation was found only in the very severe cases of acne vulgaris.

PMID:33655695 | DOI:10.1111/jocd.14034

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Clinicopathological features and prognosis of patients with pregnancy-associated breast cancer: A matched case control study

Asia Pac J Clin Oncol. 2021 Mar 2. doi: 10.1111/ajco.13528. Online ahead of print.

ABSTRACT

AIM: We aimed to clarify tumor features and prognosis of pregnancy-associated breast cancer (PABC) among Chinese women.

METHODS: PABC was defined as breast cancer diagnosed during pregnancy or within a year after delivery. Patients with PABC were selected from breast cancer cases of women ≤45 years treated at our institution between December 2012 and December 2017, and one non-PABC control was matched for stage, age, and year of diagnosis for each case.

RESULTS: Forty-one women with PABC were identified (22 diagnosed during pregnancy and 19 within 1 year of delivery). There were significantly more progesterone receptor (PR)- and triple-negative tumors in the PABC (56.1% and 24.4%, respectively) than in the non-PABC group (31.7% and 4.9%, respectively) (P = .045 and .026, respectively). Human epidermal growth factor receptor 2 positivity was the same in both groups (31.7%). Median disease-free survival (DFS) was 29.0 months (95% confidence interval [CI], 6.5-51.5 months) in the PABC and 40.9 months (95% CI, 22.8-58.8 months) in the non-PABC group (P = .167). Median overall survival (OS) was 82.8 months in the PABC (95% CI, 39.3-126.5 months) versus 80.1 months (95% CI, 56.7-103.6 months) in the non-PABC group (P = .131).

CONCLUSION: Histological features were similar in both groups, except that PR- and triple-negative tumors were more frequent in the PABC group. Survival analyses show similar OS for patients with PABC and non-PABC. DFS tended to be shorter in the PABC group; however, this difference was not statistically significant.

PMID:33655647 | DOI:10.1111/ajco.13528

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Otopathogen interactions in the nasopharynx of children, and the predictive value of nasopharyngeal aspirate culture for the aetiology of upper respiratory infections

J Paediatr Child Health. 2021 Mar 3. doi: 10.1111/jpc.15370. Online ahead of print.

ABSTRACT

AIM: To evaluate nasopharyngeal aspirate cultures for screening otopathogen carriage in the adenoid in children 2-7 years of age.

METHODS: Thirty-seven children, 2-7 years of age, scheduled for adenoidectomy were enrolled into this prospective study at Rockhampton, Australia. Adenoid biopsy and nasopharyngeal aspirate bacteriology were assessed by conventional culture. Demographic and environmental data were collected by questionnaire. Statistical analyses for descriptive, comparison and logistic regression tests between microbial, demographic, environmental and clinical groups were applied.

RESULTS: Streptococcus pneumoniae, Staphylococcus aureus, non-typeable Haemophilus influenzae and Moraxella catarrhalis were detected in 38, 38, 35 and 24% of cases, respectively. Streptococcus pneumoniae was an independent determinant for non-typeable H. influenzae and S. aureus colonisation, and S. aureus was an independent determinant for S. pneumoniae colonisation. The nasopharyngeal aspirate otopathogen cultures were strong predictors for otopathogens in the adenoid, with moderate-high test accuracy for all otopathogens (receiver operator characteristics area under the curve ranging from 71 to 97% for the otopathogens tested). Children with positive non-typeable H. influenzae, M. catarrhalis, S. pneumoniae and S. aureus nasopharyngeal aspirate cultures were more likely to have the equivalent species in adenoid cultures (positive likelihood ratios = undefined, 15.0, 9.09 and 5.85, respectively).

CONCLUSIONS: This study provides evidence that nasopharyngeal aspirate cultures are an indicator of otopathogens in the adenoid. Nasopharyngeal aspirate cultures may provide clinicians with information that informs clinical management. Strategies for improved management to reduce otopathogen carriage could reduce the prevalence of chronic upper respiratory infections that contribute to adenoidectomy.

PMID:33655670 | DOI:10.1111/jpc.15370

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Race Reporting and Representation in Onychomycosis Clinical Trials: A Systematic Review

Mycoses. 2021 Mar 2. doi: 10.1111/myc.13262. Online ahead of print.

ABSTRACT

BACKGROUND: Onychomycosis is the most common nail disease seen in clinical practice. Inclusion of diverse groups in onychomycosis clinical trials subjects is necessary to generalize efficacy data.

OBJECTIVES: We aimed to systematically review race and ethnicity reporting and representation, as well as, treatment outcomes in onychomycosis clinical trials.

METHODS: A PubMed search for onychomycosis clinical trials was performed in August 2020. Primary clinical trial data were included and post-hoc analyses were excluded. Categorical variables were compared using chi-squared and Fisher’s exact tests. Statistical significance was set at P<0.05. Photos in articles were categorized by Fitzpatrick skin type.

RESULTS: Only 32/182 (17.5%) trials reported on race and/or ethnicity and only one trial compared treatment efficacy in different subgroups. Darker skin colors were infrequently depicted in articles. Topical treatment, location with ≥ 1 US-based site, industry funding type, and publication date after 2000 were significantly associated with reporting of racial/ethnic data (P<0.05 for all comparisons).

LIMITATIONS: Demographics on excluded subjects and methods of recruitment were not available. Assigning Fitzpatrick skin type is inherently subjective.

CONCLUSIONS: This study highlights a need for consistent reporting of races and ethnicities of onychomycosis clinical trial participants with subgroup analyses of treatment efficacies.

PMID:33655595 | DOI:10.1111/myc.13262

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Identification and characterization of sex-biased and differentially expressed miRNAs in gonadal developments of the Chinese mitten crab, Eriocheir sinensis

Mol Reprod Dev. 2021 Mar 3. doi: 10.1002/mrd.23459. Online ahead of print.

ABSTRACT

MicroRNA (miRNA) is a posttranscriptional downregulator that plays a vital role in a wide variety of biological processes. In this study, we constructed five ovarian and testicular small RNA libraries using two somatic libraries as reference controls for the identification of sex-biased miRNAs and gonadal differentially expressed miRNAs (DEMs) of the Chinese mitten crab, Eriocheir sinensis. A total of 535 known and 243 novel miRNAs were identified, including 312 sex-biased miRNAs and 402 gonadal DEMs. KEGG pathway analysis showed that DEM target genes were statistically enriched in MAPK, Wnt, and GnRH signaling pathway, and so on. A number of the sex-biased miRNAs target genes associated with sex determination/differentiation, such as IAG, Dsx, Dmrt1, and Fem1, while others target the genes related to gonadal development, such as P450s, Wnt, Ef1, and Tra-2c. Dual-luciferase reporter assay in vitro further confirmed that miR-34 and let-7b can downregulate IAG expression, miR-9-5p, let-7d, let-7b, and miR-8915 can downregulate Dsx. Taken together, these data strongly suggest a potential role for the sex-biased miRNAs in sex determination/differentiation and gonadal development in the crab.

PMID:33655621 | DOI:10.1002/mrd.23459

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Yokoyama procedure for esotropia associated with high myopia: real-world data from a large-scale multicentre analysis

Acta Ophthalmol. 2021 Mar 2. doi: 10.1111/aos.14808. Online ahead of print.

ABSTRACT

PURPOSE: High myopic patients may develop strabismus due to globe dislocation out of the normal extraocular muscle cone. Surgical correction of this strabismus type is possible by joining the superior and lateral rectus muscles without the need for a scleral suture called the Yokoyama procedure. Data from large patient samples and the evaluation of a potential effect of an additional medial rectus recession (MRR) have been lacking so far.

METHODS: We pooled retrospective patient data of 14 departments of ophthalmology in Germany and Switzerland and analysed determinants of postoperative results using multivariable regression models.

RESULTS: We included 133 patients (mean age: 59.7 ± 13.4 years, surgery between 2008 and 2017) with a mean preoperative esotropia (both Yokoyama with and without MRR) of 23.8°±4.6°. The angle of preoperative esotropia increased with age. The postoperative esotropia was 8.7° ± 9.9°, and six patients were overcorrected. While preoperative esotropia was highly associated with postoperative results, we found no association of additional MRR with any of our postoperative outcome measures. The Yokoyama procedure had a higher absolute effect in patients with higher preoperative esotropia.

CONCLUSION: Our study confirms the positive effect of the Yokoyama procedure on strabismus due to high myopia in large-scale real-world data. In some cases, MRR may be needed because of muscle contracture, although additional MRR statistically did not affect the postoperative outcome. In patients with bilateral high myopic strabismus, correction of both eyes seems beneficial. The effect size of the Yokoyama procedure appears to be mainly driven by preoperative esotropia.

PMID:33655633 | DOI:10.1111/aos.14808

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The relationship between onset of workplace violence and onset of sleep disturbances in the Swedish working population

J Sleep Res. 2021 Mar 3:e13307. doi: 10.1111/jsr.13307. Online ahead of print.

ABSTRACT

The study investigated the association between onset of workplace violence and onset of sleep disturbances. We used self-reported data from the Swedish Longitudinal Occupational Survey of Health (SLOSH) collected in 2014, 2016, and 2018. A two-wave design was based on participants who had no exposure to workplace violence or sleep disturbances at baseline (n = 6,928). A three-wave design was based on participants who in addition were unexposed to sleep disturbances in the second wave (n = 6,150). Four items of the Karolinska Sleep Questionnaire were used to measure sleep disturbances and one question was used to measure the occurrence of workplace violence or threats of violence. Multivariate logistic regression analyses were performed. In the two-wave approach, onset of workplace violence was associated with onset of sleep disturbances after adjustment for sex, age, occupational position, education, and civil status (adjusted odds ratio 1.41, 95% confidence interval 1.02-1.96). The association was no longer statistically significant after further adjustment for night/evening work, demands, control, and social support at work. In the three-wave approach, results were only suggestive of an association between onset of workplace violence and subsequent onset of sleep disturbances after adjustment for sex, age, occupational position, education, and civil status. Onset of frequent exposure to workplace violence was associated with subsequent onset of sleep disturbances in the adjusted analyses, but these analyses were based on few individuals (13 exposed versus 5,907 unexposed). The results did not conclusively demonstrate that onset of workplace violence predicts development of sleep disturbances. Further research could elucidate the role of other working conditions.

PMID:33655594 | DOI:10.1111/jsr.13307