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Nevin Manimala Statistics

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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Nevin Manimala Statistics

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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Nevin Manimala Statistics

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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Nevin Manimala Statistics

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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Nevin Manimala Statistics

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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Nevin Manimala Statistics

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

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Is There a Relationship Between Overactive Bladder and Sexual Dysfunction in Women with Multiple Sclerosis?

J Sex Med. 2022 May 1;19(5):729-737. doi: 10.1016/j.jsxm.2022.02.019.

ABSTRACT

BACKGROUND: Lower urinary tract Symptoms (LUTS) and Sexual dysfunction (SD) are common in women with MS and affect quality of life.

AIM: The aim of this study was to determine the relationship between sexual dysfunction (SD) and overactive bladder in women with Multiple Sclerosis (MS).

METHODS: From January 2019 to January 2021, we evaluated 89 female MS patients admitted for LUTS in a Neuro-Urology Department. SD was investigated using the Female Sexual Function Index (FSFI). All subjects completed the Urinary Symptom Profile scale (USP) and Hospital Anxiety and Depression Scale (HAD A/HAD D). Neurological impairment was assessed using the Expanded Disability Status Scale (EDSS). All patients underwent neurological examination and urodynamic studies. Univariate analysis and Multivariate logistic regression analysis were performed to identify predictors of SD in women with MS (FSFI <26.55).

OUTCOMES: Primary outcome was to determine the association between sexual dysfunction in women with MS and LUTS (overactive bladder, stress incontinence or voiding dysfunction).

RESULTS: Sexual dysfunction (FSFI<26,55) affected 74% of women with MS, even with low physical disabilities (EDSS<5). Univariate analysis showed that overactive bladder was more frequent in SD group, but no statistical difference was found (P < .12). No relationship was found between sexual dysfunction and stress incontinence (P = ,47), voiding dysfunction (P= 0.79) or urinary retention (P= .96). Multivariate logistic regression analysis identified overactive bladder to be an independent predictor of sexual dysfunction [aOR 0.03 (CI 0,0.98)]. Sexual dysfunction was not associated with detrusor overactivity on urodynamic studies or with impairment mobility but was strongly associated with the presence of depression (P < .01).

CLINICAL IMPLICATIONS: Sexual disorders in women with MS should be assessed as much as urinary disorder.

STRENGTHS AND LIMITATIONS: this study included the largest cohort of women with MS. But the sample was obtained in an outpatient setting with low neurological impairment.

CONCLUSION: In our study, SD was frequent affecting young women with no anticholinergic treatment and low physical impairment. Overactive bladder seemed to be independent predictor of sexual dysfunction. Conversely, SD was not associated with detrusor overactivity, neurological impairment, or duration of disease but was strongly associated with depression.

PMID:37057559 | DOI:10.1016/j.jsxm.2022.02.019

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Professional Help-Seeking in Men Experiencing Sexual Problems – The Role of Sexual Identity and Minority Stress

J Sex Med. 2022 Jul 1;19(7):1090-1097. doi: 10.1016/j.jsxm.2022.04.012.

ABSTRACT

BACKGROUND: Only a minority of men experiencing sexual problems will seek professional help and the proportion of gay or bisexual men can be even lower.

AIM: To investigate if sexual identity and minority stress are related to professional help-seeking in Polish gay and bisexual men.

METHODS: Sexual identity was measured with the standard question: “Do you consider yourself to be heterosexual, gay, or bisexual?” Men who provided a complete set of answers to the study tools and replied “yes” to the question: “Have you ever had a problem with sexual functioning that lasted at least several months?” were included (Ntotal =644, Nstraight = 203, Ngay = 324, Nbi = 117). A simple question on help-seeking was: “Did you seek professional assistance then?” Other data were gathered with the use of a self-constructed questionnaire. Minority stress processes, that is, internalized homophobia, expectations of rejection, and identity concealment, were measured with the subscales of the Sexual Minority Stress Scale.Bivariate analyses and multivariate logistic regressions were performed to test the statistical significance of sexual identity and minority stress processes as predictors of professional help-seeking.

OUTCOMES: Contacting a specialist when experiencing a sexual problem.

RESULTS: A total of 84.5% of all men did not seek professional help. Gay identity (OR = 0.58, P = .045), as opposed to bisexual identity, was significantly related to reduced odds of consulting a specialist. Age (OR = 1.03, P = .005), number of doctor’s visits per year (OR = 1.51, P < .001), and a psychiatric diagnosis (OR = 1.65, P = .043) were positively related to help-seeking behaviors. Identity concealment significantly decreased the likelihood of consulting a specialist (OR = 0.94, P = .017).

CLINICAL TRANSLATION: Specialists need to be aware that gay identity and identity concealment may prevent a proportion of men from seeking their help and thus should be publicly explicit about their inclusive and nonpathologizing approach to sexual diversity.

STRENGTHS AND LIMITATIONS: The major strengths of the study include the use of a relatively large sample size and data from the little recognized Polish context characterized by a predominantly hostile anti-LGBT social climate, and exploration of a neglected topic of substantial significance at the public and individual levels. The major limitations are the use of nonprobability sampling, cross-sectional self-report design, and a single question to capture the presence of sexual problems with no measurement of associated distress.

CONCLUSION: Gay men are at risk of avoiding help-seeking when experiencing sexual problems because of identity concealment.

PMID:37057549 | DOI:10.1016/j.jsxm.2022.04.012

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Sexual Activity and Physical Tenderness in Older Adults: Prevalence and Associated Characteristics from a Belgian Study

J Sex Med. 2022 Apr 1;19(4):569-580. doi: 10.1016/j.jsxm.2022.01.516.

ABSTRACT

BACKGROUND: Despite the World Health Organization calling for sexuality to be recognized as an aspect of well-being, no studies have explored sexual activity and physical tenderness in older adults aged ≥ 75 years in Belgium or those aged ≥ 85 years worldwide.

AIM: To assess the prevalence and predictors of sexual activity and physical tenderness in a sample of older adults.

METHODS: Using data from a Belgian cross-sectional study on sexual violence (UN-MENAMAIS), information on sexual activity, physical tenderness, and associated characteristics was collected during structured face-to-face interviews with older adults living in the community, assisted living facilities, or nursing homes. Cluster random probability sampling with a random route-finding approach was used to select the participants.

OUTCOMES: Current sexual activity and physical tenderness in the previous 12 months, sociodemographic characteristics, chronological age, subjective age, number of sexual partners, sexual satisfaction, attitudes toward sexuality in later life, quality of life, and lifetime sexual victimisation.

RESULTS: Among the 511 participants included, 50.3% were in a relationship, mainly living with their partner; 31.3% indicated they were sexually active; and 47.3% of sexually inactive participants reported having experienced forms of physical tenderness in the previous 12 months. Sexual activity was associated with the presence of a partner, satisfaction with sexual life, permissive attitudes regarding sexuality in later life, a younger age, and a lack of disability. Physical tenderness was associated with the presence of a partner, community residency, and permissive attitudes regarding sexuality in later life.

CLINICAL IMPLICATIONS: Raising awareness among the general population, healthcare professionals, and older adults about sexuality in later life could contribute to ending this taboo and should therefore be a priority for society.

STRENGTHS AND LIMITATIONS: Our study fills a gap in the literature regarding sexual activity and physical tenderness in older adults aged ≥ 70 years, including respondents aged up to 99 years. Additionally, we explored different forms of sexual expression beyond intercourse, and face-to-face interviews contributed to the quality of the collected data. The main limitation of this study was the sample size, although the findings were similar to recent statistical indicators in Belgium.

CONCLUSION: One in 3 older adults aged ≥ 70 years living in Belgium are sexually active. These findings provide an opportunity to inform the general public and older adults about later life sexuality and to educate healthcare professionals about aging sexuality to increase discussions and avoid assumptions of asexuality in later life.

PMID:37057537 | DOI:10.1016/j.jsxm.2022.01.516

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Pre- and Post-Injection Needle Pain in Patients Undergoing First Intracavernosal Injection

J Sex Med. 2022 Apr 1;19(4):590-593. doi: 10.1016/j.jsxm.2022.01.520.

ABSTRACT

BACKGROUND: Intracavernosal injections (ICI) are a well-established treatment option for men with erectile dysfunction (ED); however, the anticipation of pain with injection remains a significant barrier to the use of ICI.

AIM: To evaluate the patient-anticipated degree of pain versus the experienced degree of pain pre- and post-ICI in men undergoing their first injection with an erectile agent.

METHODS: We studied 51 patients who underwent their first ICI in our men’s health clinic. Anticipated needle-associated pain was judged with a pre-injection score, and pain experienced during the injection was judged with a post-injection score. All patients graded their pre- and post-ICI pain using a standard 10-point scale (0-10).

OUTCOMES: Pre- and post-ICI pain was defined with the visual analogue scale (0-10) in men undergoing their first penile injection.

RESULTS: Medians and interquartile ranges (IQRs) of the patients’ age [65 years (54.5-68.0)], pre-injection pain [5 (4-7)], and post-injection pain [1 (1-2)] were recorded. Most men in the study had erectile dysfunction (68.6%) and/or Peyronie’s Disease (64.7%). The average pre-injection prediction pain score was 5.45 ± 2.15; the average post-injection perceived pain score was 1.20 ± 0.73. Thus, there was an average discrepancy of over 4 points in predicted pain vs perceived pain. A paired t-test was performed which showed a statistically significant difference between pre- and post-injection scores (P < .05). A Wilcoxson Signed Rank Test showed statistical significance in the difference between pre- and post-injection pain scores (P < .05).

CLINICAL IMPLICATIONS: ICI is a safe, effective treatment for patients with ED and is associated with significantly less pain than is anticipated by patients.

STRENGTHS & LIMITATIONS: This is the first report to describe the discrepancy between pre-ICI anticipated pain and post-ICI experienced pain. Limitations include an overall small sample size.

CONCLUSION: Patients experience significantly less pain with ICI than they anticipate having. This represents an important factor to consider when counseling patients about available ED treatments.

PMID:37057531 | DOI:10.1016/j.jsxm.2022.01.520