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Nevin Manimala Statistics

ChitoHeal gel use on the nasal site for prevention of N95 masks caused pressure injuries: A randomised clinical trial

Int Wound J. 2023 Apr 14. doi: 10.1111/iwj.14193. Online ahead of print.

ABSTRACT

Prolonged use of personal protective equipment can cause pressure injuries on the skin. The current study was conducted with the aim of investigating the effect of ChitoHeal gel on the nasal site on the prevention of N 95 masks that caused pressure injuries in nurses working in intensive care units. This is a randomised controlled clinical trial that was conducted in 2022. The study sample consisted of 92 nurses working in the intensive care units. A randomised block method was used to allocate the nurses to two equal groups of intervention and control. However, in the intervention group, ChitoHeal gel was applied on nurses’ nose bridge. To perform this, the researcher referred to the department during the morning and evening shifts and applied the gel on nurses’ nose bridge at the beginning of each shift. Then, the N95 mask was installed on the face by the nurse. Before and at the end of each work shift, the skin in both groups was assessed for any signs of pressure injuries. No significant differences were observed between the two intervention and control groups in terms of demographic variables. The frequency distribution of mask-caused pressure injuries on nurses’ nose bridge in the two groups was analysed using the Chi-square test (Fisher’s exact test). The results showed that after the intervention, it was 0 in the intervention group. However, 4 nurses (8.6%) in the control group developed pressure injuries, and this difference between the two groups was statistically significant (P > .05). The result of the current study showed that the use of ChitoHeal gel is effective in preventing N95 mask-related pressure injuries. Considering the cheapness and rational global availability of this gel, it seems that its use is an effective strategy in order to prevent N95 mask-related pressure injuries. Given the lack of studies in this regard, similar studies are strongly recommended to be conducted.

PMID:37057654 | DOI:10.1111/iwj.14193

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Regular high-frequency whole blood donation and risk of cardiovascular disease in middle-aged and older blood donors in Australia

Transfusion. 2023 Apr 14. doi: 10.1111/trf.17358. Online ahead of print.

ABSTRACT

BACKGROUND: Previous mixed findings on the associations between whole blood (WB) donation and risk of cardiovascular diseases (CVD) may in part reflect inadequate adjustment for the “healthy donor effect” (HDE).

METHODS: We used the Sax Institute’s 45 and Up Study linked with blood donation history and other health-related databases to examine the association between regular, high-frequency WB donation and the risk of CVD. To mitigate the impact of HDE, we used a “5-years qualification period,” in which donors must donate at least 1 WB donation in the 1st and 5th year of “qualification period.” We then compared the risk of CVD in the years following the “qualification period” between the regular high-frequency WB donors (≥2 WB donation in each qualification year) and others using Cox proportional-hazards models. Analyses were adjusted for potential confounders, such as sociodemographic, lifestyle, and health-related variables, and results are reported separately for male and female donors.

RESULTS: A total of 2736 male and 2917 female donors were included in the analyses. The median years of follow-up per donor was 5.84 years (Q1-Q3, 5.47-6.23). The rate of CVD hospitalization was 11.20 and 4.50 per 1000 person-years for males and females, respectively. In fully adjusted models, the risk (hazard ratio) of CVD in regular high-frequency donors compared to other donors was 0.93 (95% Confidence Interval (CI), 0.68-1.29) for males and 0.79 (95% CI, 0.49-1.28) for females.

CONCLUSIONS: We did not observe a statistically significant reduction of CVD risk in regular, high-frequency WB donors when adjusted for potential confounders.

PMID:37057641 | DOI:10.1111/trf.17358

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Do bone elasticity and postmortem interval affect forensic fractographic analyses?

J Forensic Sci. 2023 Apr 14. doi: 10.1111/1556-4029.15237. Online ahead of print.

ABSTRACT

Forensic fractographic features of bone reliably establish crack propagation in perimortem injuries. We investigated if similar fracture surface features characterize postmortem fractures. Experimentally induced peri- and postmortem fractures were used to assess if fractographic features vary as bone elasticity decreases during the postmortem interval (PMI). Thirty-seven unembalmed, defleshed human femoral shafts from males and females aged 33-81 years were fractured at varying PMIs with a drop test frame using a three-point bending setup and recorded with a high-speed camera. Vital statistics, cause of death, PMI length, temperature, humidity, collagen percentage, water loss, fracture energy, and fractography scores were recorded for each sample. Results showed that fractographic features associated with perimortem fractures were expressed in PMIs up to 40,600 accumulated degree hours (ADH), or 60 warm weather days. Hackle was the most consistently expressed feature, occurring in all fractures regardless of ADH. The most variable characteristics were wake features (78.4%) and arrest ridges (70.3%). Collagen percentage did not correlate strongly with ADH (r = -0.04, p = 0.81); however, there was a strong significant correlation between ADH and water loss (r = 0.74, p < 0.001). Multinomial logistic regression showed no association between fractographic feature expression and ADH or collagen percentage. In conclusion, forensic fractographic features reliably determine initiation and directionality of crack propagation in experimentally induced PMIs up to 40,600 ADH, demonstrating the utility of this method into the recent postmortem interval. This expression of reliable fractographic features throughout the early PMI intimates these characteristics may not be useful standalone features for discerning peri- versus postmortem fractures.

PMID:37057637 | DOI:10.1111/1556-4029.15237

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Long Term Mortality and Reintervention Following Repair of Ruptured Abdominal Aortic Aneurysms using VQI Matched Medicare Claims

Ann Surg. 2023 Apr 14. doi: 10.1097/SLA.0000000000005876. Online ahead of print.

ABSTRACT

OBJECTIVE: To compare endovascular aortic aneurysm repair (EVAR) versus open aortic repair (OAR) on mortality and reintervention after ruptured infrarenal abdominal aortic aneurysm (rAAA) repair in the Vascular Quality Initiative (VQI).

BACKGROUND: The optimal treatment modality for rAAA remains debated with little data on long-term comparisons.

METHODS: VQI rAAA repairs (2004-2018) were matched with Medicare claims (VQI-VISION). Primary outcomes were in-hospital and long-term mortality. Secondary outcome was reintervention. Inverse probability weighting (IPW) was used to adjust for treatment selection and Cox Proportional Hazards models, and negative binomial regressions were used for analysis. Landmark analysis was performed among patients surviving hospital discharge.

RESULTS: Among 1,885 VQI/Medicare rAAA patients, 790 underwent OAR and 1,095 underwent EVAR. Median age 76 years; 73% were male. IPW produced comparable groups. In-hospital mortality was lower after EVAR versus OAR (21% vs. 37%, OR 0.52, 95%CI 0.4-0.7). One-year mortality rates were lower for EVAR versus OAR (HR 0.74, 95%CI 0.6-0.9), but not statistically different after one year (HR 0.95, 95%CI 0.8-1.2). This implies additional benefit to EVAR in the short term. Reintervention rates were higher after EVAR than OAR at 2 and 5-years (RR 1.79 95%CI 1.2-2.7 and RR 2.03 95%CI 1.4-3.0), but not within the first year. Reintervention was associated with higher mortality risk for both OAR (HR 1.66 95%CI 1.1-2.5) and EVAR (HR 2.14 95%CI 1.6-2.9). Long-term mortality was similar between repair types (HR 0.99, 95%CI 0.8-1.2).

CONCLUSIONS: Within VQI/Medicare patients undergoing rAAA repair, the perioperative mortality rate favors EVAR but equalizes after one year. Reinterventions were more common following EVAR and were associated with higher mortality regardless of treatment.

PMID:37057613 | DOI:10.1097/SLA.0000000000005876

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Bayesian finite mixture of regression analysis for cancer based on histopathological imaging-environment interactions

Biostatistics. 2023 Apr 14;24(2):425-442. doi: 10.1093/biostatistics/kxab038.

ABSTRACT

Cancer is a heterogeneous disease. Finite mixture of regression (FMR)-as an important heterogeneity analysis technique when an outcome variable is present-has been extensively employed in cancer research, revealing important differences in the associations between a cancer outcome/phenotype and covariates. Cancer FMR analysis has been based on clinical, demographic, and omics variables. A relatively recent and alternative source of data comes from histopathological images. Histopathological images have been long used for cancer diagnosis and staging. Recently, it has been shown that high-dimensional histopathological image features, which are extracted using automated digital image processing pipelines, are effective for modeling cancer outcomes/phenotypes. Histopathological imaging-environment interaction analysis has been further developed to expand the scope of cancer modeling and histopathological imaging-based analysis. Motivated by the significance of cancer FMR analysis and a still strong demand for more effective methods, in this article, we take the natural next step and conduct cancer FMR analysis based on models that incorporate low-dimensional clinical/demographic/environmental variables, high-dimensional imaging features, as well as their interactions. Complementary to many of the existing studies, we develop a Bayesian approach for accommodating high dimensionality, screening out noises, identifying signals, and respecting the “main effects, interactions” variable selection hierarchy. An effective computational algorithm is developed, and simulation shows advantageous performance of the proposed approach. The analysis of The Cancer Genome Atlas data on lung squamous cell cancer leads to interesting findings different from the alternative approaches.

PMID:37057611 | DOI:10.1093/biostatistics/kxab038

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Historical controls in clinical trials: a note on linking Pocock’s model with the robust mixture priors

Biostatistics. 2023 Apr 14;24(2):443-448. doi: 10.1093/biostatistics/kxab040.

ABSTRACT

Several Bayesian methods have been proposed to borrow information dynamically from historical controls in clinical trials. In this note, we identify key features of the relationship between the first method proposed, the bias-variance method, which is strongly related to the commensurate prior approach, and a more recent and widely used approach called robust mixture priors (RMP). We focus on the two key terms that need to be chosen to define the RMP, namely $w$, the prior probability that the new trial differs systematically from the historical trial, and $s_v^2$, the variance of the vague component of the RMP. The relationship with Pocock’s prior reveals that different combinations of these two terms can express similar prior beliefs about the amount of information provided by the historical data. This demonstrates the value of fixing $s_v^2$, e.g., so the vague component is “worth one subject.” Prior belief about the relevance of the historical data is then driven by a single value, the prespecified weight $w$.

PMID:37057610 | DOI:10.1093/biostatistics/kxab040

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Effect of Chamomile Vaginal Gel on the Sexual Function in Postmenopausal Women: A Double-Blind Randomized Controlled Trial

J Sex Med. 2022 Jun 1;19(6):983-994. doi: 10.1016/j.jsxm.2022.03.536.

ABSTRACT

BACKGROUND: Female sexual dysfunction (FSD) is a common complaint among postmenopausal women, which is largely because of the genitourinary syndrome in these women (GSM).

AIM: Considering the phytoestrogenic effects of chamomile, the present study was primarily aimed to investigate the effect of chamomile vaginal gel on the sexual function of postmenopausal women. The side effects of these drugs were evaluated as a secondary outcome of the study.

METHODS: This randomized double-blind clinical trial and placebo-controlled study was conducted on postmenopausal women with sexual dysfunction (FSFI ≤26.55). To this aim, 96 postmenopausal women were randomly assigned into three groups (n = 32 each) including women receiving (i) chamomile vaginal gel 5%, (ii) conjugated estrogen vaginal cream, and (iii) placebo vaginal gel, for 12 weeks (ie, every night in the first 2 weeks, and 2 nights per week in the next 10 weeks, each night 1 g was used). The sexual function was measured using female sexual function index (FSFI) before and after the intervention. Data analysis was performed by chi-square, one-way ANOVA, descriptive statistics, analysis of covariance (ANCOVA), and paired t test using SPSS software version 22. P < .05 was considered statistically significant.

OUTCOMES: The main study outcome measure was evaluate the effects of vaginal administration of chamomile gel in comparison with conjugated estrogen cream and placebo gel on postmenopausal FSD using the FSFI.

RESULTS: The findings showed that chamomile vaginal gel in compared to placebo vaginal gel caused a significant improvement in all six sexual function domains and the total FSFI score (effect size = +2.9 [95% CI, +2.1 to +3.6], P < .001). Also, there was no significant difference between the chamomile vaginal gel and conjugated estrogen vaginal cream groups in terms of the total score and all sub-domains of sexual function with the exception of orgasm (effect size = +0.13 [95% CI, -0.36 to +0.63], P = .02) and sexual satisfaction (effect size = 0 [95% CI, -0.49 to +0.49], P = .04). Two women in the chamomile group and one in the placebo group experienced a burning sensation (P = .345).

CLINICAL IMPLICATIONS: This treatment can be considered as a treatment option for postmenopausal women with sexual dysfunction who have contraindications to the use of hormone therapy.

STRENGTHS & LIMITATIONS: This study is the first study to investigate the effectiveness of chamomile vaginal gel on sexual function in postmenopausal women. However, in this study, treatment duration was 12 weeks and no follow up was performed beyond this time.

CONCLUSION: Based on the results of this study, the use of vaginal chamomile gel improved sexual function in postmenopausal women.

PMID:37057581 | DOI:10.1016/j.jsxm.2022.03.536

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Longitudinal Impact of Social Restrictions on Sexual Health in the Italian Population

J Sex Med. 2022 Jun 1;19(6):923-932. doi: 10.1016/j.jsxm.2022.03.607.

ABSTRACT

BACKGROUND: Several trials have reported on the impact of social restrictions due to SARS-CoV-2 (COVID-19) pandemic on sexual function and psycho-physical well-being. However, data showing modifications of these outcomes over time and at the end of lock-down are scant.

AIM: We investigated the longitudinal changes in sexual function during social restrictions for COVID-19 pandemic in Italy.

METHODS: A web-based survey was administered to Italian citizens of legal age via social networks. The Beck Depression Inventory Primary Care, the General Health Survey, Female Sexual Function Index, International Index of Erectile Function, UCLA Loneliness Scale-version 3 questionnaires were used to test mental, physical and sexual well-being. The questionnaires were administered at the beginning of the lockdown (T0), 15 days from the first assessment (T1) and 1 month after the end of the restrictions in 2020 (T2).

OUTCOMES: Descriptive statistics and multiple regression analysis were applied to investigate changes in sexual function over and at the end of social restrictions.

RESULTS: Data were available for 2543 people (47.2% of men; 43.4% women; 9.4% undefined). Mean age was 48.3 ± 15.1 years for males and 43.9 ± 13.4 for females. Overall, 2.6% reported depressive symptoms according to Beck Depression Inventory Primary Care, 7.4% reported a high level of UCLA loneliness and 19.4% low levels of general mental health. Mild to severe erectile dysfunction was reported by 59.1% of men at T0, while 68.4% of women reported sexual dysfunction. Sexual function levels remain generally unchanged at further follow-up over the social restriction time period (T1), although those who were sexually active at baseline showed a decrease in sexual function scores. At T2, there was an overall improvement in sexual function scores with a rate of severe erectile dysfunction decreasing from 37.1% to 24.1% from T0 to T2 among males and a significant decrease of female sexual dysfunction from 68.4% to 51.2%.

CLINICAL IMPLICATIONS: Young individuals and those with good mental and physical health were more likely to improve sexual function at the end of social restrictions.

STRENGTHS & LIMITATIONS: Valid and reliable questionnaires and longitudinal approach design represent strengths; a large but convenient sample and lack of pre-pandemic baseline data represent limits.

CONCLUSION: Social restrictions due to COVID-19 pandemic led to an increase in sexual dysfunctions in both genders. However, these conditions appeared temporary since an overall improvement was observed at the end of lockdown and especially in younger individuals with higher psycho-physical well-being.

PMID:37057575 | DOI:10.1016/j.jsxm.2022.03.607

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Comprehensiveness of Online Information in Gender-Affirming Surgery: Current Trends and Future Directions in Academic Plastic Surgery

J Sex Med. 2022 May 1;19(5):846-851. doi: 10.1016/j.jsxm.2022.02.014.

ABSTRACT

BACKGROUND: Despite high rates of online misinformation, transgender and gender diverse (TGD) patients frequently utilize online resources to identify suitable providers of gender-affirming surgical care.

AIM: The objective of this study was to analyze the webpages of United States academic plastic surgery programs for the types of gender-affirming surgery (GAS) procedures offered and to determine how this correlates with the presence of an institutional transgender health program and geographic region in order to identify potential gaps for improvement.

METHODS: Online institutional webpages of 82 accredited academic plastic surgery programs were analyzed for the presence of the following: GAS services, specification of type of GAS by facial, chest, body and genital surgery, and presence of a concomitant institutional transgender health program. This data was analyzed for correlations with geographic region and assessed for any significant associations.

OUTCOMES: Frequencies of GAS services, specification of the type of GAS by facial, chest, body and genital surgery, presence of a concomitant institutional transgender health program, and statistical correlations between these items are the primary outcomes.

RESULTS: Overall, 43 of 82 (52%) academic institutions offered GAS. Whether an institution offered GAS varied significantly with the presence of an institutional transgender health program (P < .001) but not with geographic region (P = .329). Whether institutions that offer GAS specified which anatomic category of GAS procedures were offered varied significantly with the presence of an institutional transgender health program (P < .001) but not with geographic region (P = .235).

CLINICAL IMPLICATIONS: This identifies gaps for improved transparency in the practice of communication around GAS for both physicians and academic medical institutions.

STRENGTHS & LIMITATIONS: This is the first study analyzing the quality, content, and accessibility of online information pertaining to GAS in academic institutions. The primary limitation of this study is the nature and accuracy of online information, as current data may be outdated and not reflect actuality.

CONCLUSION: Based on our analysis of online information, many gaps currently exist in information pertaining to GAS in academic settings, and with a clear and expanding need, increased representation and online availability of information regarding all GAS procedure types, as well as coordination with comprehensive transgender healthcare programs, is ideal.

PMID:37057564 | DOI:10.1016/j.jsxm.2022.02.014

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Hormone Concentrations in Transgender Women Who Self-Prescribe Gender Affirming Hormone Therapy: A Retrospective Study

J Sex Med. 2022 May 1;19(5):864-871. doi: 10.1016/j.jsxm.2022.02.023.

ABSTRACT

BACKGROUND: Self-prescribed gender-affirming hormone therapy (GAHT) is common practice among transgender women, especially in resource-limited countries, yet the effectiveness of each GAHT regimen to achieve female range sex hormone concentrations is not known.

AIM: To describe the use and sex hormone concentrations of various GAHT regimens among transgender women who self prescribe in Thailand.

METHODS: This was a retrospective study in a community-based setting. Five hundred and 27 records of transgender women taking GAHT who were receiving care at a community health center between January 1, 2018, and December 31, 2020 were included for the analysis.

MAIN OUTCOME MEASURES: Blood total testosterone and estradiol concentration after at least a 6-month period of GAHT.

RESULTS: Multiple GAHT regimens were identified including oral estradiol valerate (EV), transdermal 17β-estradiol gel, injectable EV with hydroxyprogesterone caproate, injectable estradiol benzoate with progesterone, oral EV with cyproterone acetate (CPA), and oral contraceptive pills (OCPs). The most common GAHT regimen used by 49.1% of the participants was OCPs that contained 0.035 mg of ethinyl estradiol and 2 mg of CPA. Only 25.2% of this group had female range testosterone concentrations (<50 ng/dL). Oral EV and CPA were used by 23.1% of the participants. Most of them used 12.5 mg of CPA and 47.7% of this group had female range testosterone concentrations. There was no statistical significance between mean testosterone concentrations in CPA 12.5 and 25 mg groups, (P = .086).

CLINICAL IMPLICATIONS: The inadequate sex hormone levels found in these commonly self-prescribed GAHT regimens provide information regarding the efficacy and safety of GAHT regimens for health care providers working with transgender women in a community-based setting.

STRENGTHS AND LIMITATIONS: This study reflected a real-world situation and provided hormonal profiles among transgender women taking self-prescribed GAHT. However, issues in recall, medical literacy, and adherence to the medication may limit the results.

CONCLUSION: Combined hormonal contraceptive pill was a commonly used GAHT regimen in Thai transgender women who self prescribe GAHT. However, this regimen was not effective to decrease testosterone concentrations to the recommended range of less than 50 ng/dL. Overall, self-prescription of GAHT does not appear to be effective in reaching target sex hormone concentrations. Including health care providers in the prescription and monitoring of GAHT may be a more effective approach in the delivery of GAHT.

PMID:37057563 | DOI:10.1016/j.jsxm.2022.02.023