Fund Industry Research Articles

Phase IV Drug Trials With a Canadian Site: A Comparison of Industry-Funded and Non-Industry-Funded Trials.

Recent regulatory reforms have favored expedited drug marketing and increased reliance on Phase IV clinical trials for safety and efficacy assurance. This study, utilizing ClinicalTrials.gov, assesses the characteristics of Phase IV trials, with at least one site in Canada, examining those funded by industry sponsors and those lacking industry funding. Additionally, it compares the publication status of industry-funded and non-industry-funded trials through a manual review of the medical literature. Between 2000 and 2022, 864 Phase IV trials were completed, with 480 (55.6%) receiving industry funding and 384 (44.4%) funded solely by non-industry sources. Industry-funded clinical trials were larger (mean 204 enrollees versus 70), more likely to be international (57.7% versus 9.6%) and reported results more promptly (1.21 years after completion versus 1.85 years), yet both types shared similar designs, outcomes, and completion times. Publication rates were 81.8% for industry-funded and 65.8% for non-industry-funded trials. The ClinicalTrials. gov registry displayed 48 inaccuracies in publication associations, raising concerns about its accuracy. Our findings underscore the existing institutional limitations in ensuring comprehensive reporting and publication of Phase IV trial results funded by both industry and non-industry sources.

The Role of Uig Linkages in Improving Competitive Advantage: A Case of the Clothing, Textiles, Leather, and Footwear Industry of South Africa

The South African clothing, textiles, leather, and footwear (CTLF) sector has been under competitive attack, mainly from Asian countries. The many studies undertaken so far have not focused on the role of research and development linkages among university, industry, and government (UIG), and hence, this study was undertaken. This study uses mixed methods, interviews of managers and directors from UIG actors, and a survey of CTLF firms to understand the role of UIG linkages in improving competitive advantage. The data was thematically and descriptively analysed. The findings highlight that most CTLF firms were not involved in UIG research and development linkages. As a result, CTLF firms have not utilised researchers available in the universities nor research-related industry and government funding that supports innovation and technological improvements. For the CTLF to improve its competitive advantage, its development strategies must include being engaged in UIG research and development linkages. 
 
 Received: 28 September 2023 / Accepted: 3 February 2024 / Published: 5 March 2024

Integrating Personality Traits and Behavioral Theories in Mutual Fund Investments: Unveiling Investor Dynamics

This article explores the interplay between personality traits, particularly the Big Five model, and the Theory of Planned Behavior (TPB) in shaping individual investment decisions in mutual funds. Utilizing the TPB's framework, the study examines attitudes, subjective norms, and perceived control, linking them to investor intentions. Focusing on India's growing mutual fund industry, the article highlights key industry metrics, indicating robust growth in assets under management and retail participation. Comparisons with developed countries underscore India's untapped potential in mutual fund investments. The research delves into the determinants of investment decisions, considering rationality, socioeconomic factors, and the impact of personality traits. Theoretical frameworks and literature synthesis support the proposed behavior intention model. The findings emphasize the vital role of personality, particularly openness to experience, in influencing investment behavior. In conclusion, the study contributes insights for asset management companies in tailoring schemes to align with investor commonalities. Keywords: Investor, personality traits, Theory of Planned Behavior, Mutual Funds investment

Clinical Outcomes of Rapid Respiratory Virus Testing in Emergency Departments

Rapid tests for respiratory viruses, including multiplex panels, are increasingly available in emergency departments (EDs). Their association with patient outcomes remains unclear. To determine if ED rapid respiratory virus testing in patients with suspected acute respiratory infection (ARI) was associated with decreased antibiotic use, ancillary tests, ED length of stay, and ED return visits and hospitalization and increased influenza antiviral treatment. Ovid MEDLINE, Embase (Ovid), Scopus, and Web of Science from 1985 to November 14, 2022. Randomized clinical trials of patients of any age with ARI in an ED. The primary intervention was rapid viral testing. Preferred Reporting Items for Systematic Reviews and Meta-Analyses reporting guidelines were followed. Two independent reviewers (T.S. and K.W.) extracted data and assessed risk of bias using the Cochrane Risk of Bias, version 2.0. Estimates were pooled using random-effects models. Quality of evidence was assessed using the Grading of Recommendations, Assessment, Development, and Evaluations framework. Antibiotic use and secondary outcomes were pooled separately as risk ratios (RRs) and risk difference estimates with 95% CIs. Of 7157 studies identified, 11 (0.2%; n = 6068 patients) were included in pooled analyses. Routine rapid viral testing was not associated with antibiotic use (RR, 0.99; 95% CI, 0.93-1.05; high certainty) but was associated with higher use of influenza antivirals (RR, 1.33; 95% CI, 1.02-1.75; moderate certainty) and lower use of chest radiography (RR, 0.88; 95% CI, 0.79-0.98; moderate certainty) and blood tests (RR, 0.81; 95% CI, 0.69-0.97; moderate certainty). There was no association with urine testing (RR, 0.95; 95% CI, 0.77-1.17; low certainty), ED length of stay (0 hours; 95% CI, -0.17 to 0.16; moderate certainty), return visits (RR, 0.93; 95%, CI 0.79-1.08; moderate certainty) or hospitalization (RR, 1.01; 95% CI, 0.95-1.08; high certainty). Adults represented 963 participants (16%). There was no association of viral testing with antibiotic use in any prespecified subgroup by age, test method, publication date, number of viral targets, risk of bias, or industry funding. The results of this systematic review and meta-analysis suggest that there are limited benefits of routine viral testing in EDs for patients with ARI. Further studies in adults, especially those with high-risk conditions, are warranted.

(080) Psychological Outcomes and Sexual Satisfaction Rates in Males with Phimosis Following the Novoglan Foreskin Extender Treatment

Abstract Introduction Phimosis can be associated with sexual dysfunction since it often causes discomfort or pain on erection or during sexual intercourse. While circumcision is routinely advocated in patients with phimosis, many males would prefer conservative treatment and are keen to preserve their foreskins. Novoglan foreskin tissue expander is a non-surgical device that uses a balloon to produce gradual stretching of the phimotic foreskin. Objective To assess the impact of phimosis and Novoglan treatment on sexual health and psychological domains. Methods Following Institutional Ethics Board approval (HREC/2020/QMS/66682), 20 males with phimosis were recruited across two Australian sites. Inclusion criteria include male aged ≥ 18 years, who has phimosis and normal erectile function, while those with balanoposthitis and/or recurrent UTIs were excluded. All participants received informed consent and completed questionnaires before and after the Novoglan treatment. The questionnaires included questions on pain or discomfort during sexual activity and levels of anxiety or depression. Circumcision was offered to all patients at the start and end of the study period. Results Nineteen (95%) patients with phimosis recruited in the Novoglan trial reported pain or discomfort during sexual activity, with one (5%) participant reporting pain or discomfort as severe, while moderate or mild levels were reported by ten (50%) and eight (40%) participants, respectively. The level of pain or discomfort during sexual activity improved significantly after the Novoglan treatment with no patients reporting severe level of pain or discomfort, with most males reporting mild or no pain or discomfort (80%). While all participants documented mild to moderate levels of anxiety or depression prior to treatment, 17 participants (85%) reported no anxiety or depression and only three (15%) men reported a mild degree of psychological distress. None of the participants elected for circumcision. Conclusions The Novoglan foreskin tissue expander device significantly improves the psychological outcomes and sexual function in males with phimosis. All patients reported minimal or no pain or discomfort during sexual activity, had minimal or no anxiety or depression related to foreskin issues, and declined circumcision at the end of the study period. Disclosure Yes, this is sponsored by industry/sponsor: Novoglan device company. Clarification: Industry funding only - investigator initiated and executed study.

(122) Disability and Men’s Experience of Sexual Dysfunction Associated with Prostate Cancer

Abstract Introduction The physical and psychological health benefits of sexual activity are well documented. However, sexual needs in people with disabilities are often unrecognised and they are less likely to access professional support when problems arise. Almost all prostate cancer (PCa) treatments are associated with sexual side effects that can have negative effects on sexual well-being. Objective To explore the impact disability has on PCa patients' experiences of sexual dysfunction and accessing support. Methods An anonymous online survey was distributed to men with PCa in collaboration with the charity Prostate Cancer UK. Questions focused on participants’ experience of sexual dysfunction and the level of support they received. The focus of the current sub-analysis was on participants who self-reported any kind of disability. Chi-square testing was used for categorical variable analysis. Results 654 out of 893 adult participants (73.2%) reported having a diagnosis of prostate cancer. Of those 95 (14.5%) self-reported having a disability, 553 (84.6%) reported not having a disability, and 6 (0.9%) said they would ‘prefer not to say’. Physical and psychological sexual problems were common among men with self-reported disabilities, with more than 50% reporting sexual dysfunction in 9 out of 13 domains. They were more likely to report sexual dysfunction than men with no disability in 11 out of those 13 domains, reaching the level of significance in five of those (p<.05). [Fig 1] Sexual activity was rated as ‘fairly/very important’ by 77.9% (n=74) of men with a disability. Further, 60.0% (n=57) reported ‘sexual problems’ to be in their top three current concerns, the highest ranked concern from a list of 15 categories. There was no significant difference in these two results when compared with those for men who did not self-report a disability (p=.90 & p=.68). Despite this, men with a disability were significantly less likely to have discussed the sexual side effects of PCa treatment with a healthcare professional (HCP) (44.2% vs 65.3%, p<.05). Of the men who did discuss sexual side effects, only a minority in both groups were offered a referral on to a specialist clinic, with no significant difference between the groups (27.6% vs 29.9%, p=.71). Men with a disability reported lower levels of satisfaction in each of five statements assessing satisfaction with support for sexual side effects, reaching the level of significance in four (p<0.05) [Fig 2]. Conclusions This study is the first to report on disability and men’s experience of sexual dysfunction associated with PCa. Our findings suggest wide-ranging physical and psychological sexual side effects are common and distressing among men with disabilities. Sexual activity is equally as important to men with disabilities but they are less likely to access support through HCPs. This results in high levels of dissatisfaction with care. The results suggest men with disabilities face additional barriers to accessing sexual support and highlight the importance of giving all men equitable access to supportive care. Disclosure Yes, this is sponsored by industry/sponsor: Astellas Pharma Clarification: Industry funding only - investigator initiated and executed study.

(005) Can Novel SDS-089 Nasal Vardenafil Spray Solution Achieve Satisfactory Drug Plasma Level Similar to Oral Vardenafil Formulation? A Bioanalysis Study Comparing Vardenafil Nasal vs Oral Formulations Using Liquid Chromatography Tandem Mass Spectrometry

Abstract Introduction The nasal drug delivery system offers many advantages when compared with oral administration, such as a faster onset of action, easily accessible, less drug degradation, and a high rate of absorption. The SDS-089 nasal Vardenafil (VDF) solution is a unique drug formulation designed to be delivered as a spray formulation. Objective To assess the bioavailability of SDS-089 nasal Vardenafil solution in human plasma levels using Liquid Chromatography Tandem Mass Spectrometry analysis. Methods The SDS-089 Vardenafil HCl formulation was prepared with the active pharmaceutical ingredient to the United States Pharmacopeia (USP) standard (batch 1704002361). The SDS-089 nasal spray solution was filtered (0.22 μm filter) and fitted with a nasal spray device to deliver 100 μL per spray which is equivalent to 2 mg Vardenafil HCl alcoholic solution per spray. This study received approval from the Institutional Review Board and Biosafety Committee (FB18/IRB/099). Blood samples from participants were collected at time 0 (pre-dose) and across different time intervals up to 10 hours and analyzed using Liquid Chromatography Tandem Mass Spectrometry (LC/MS) to quantify the level of Vardenafil and the internal standard. This protocol allows for the preparation and analysis of human samples, quality controls (QC), standard curve preparation, and instrumental analysis. During the validation experiments, each calibration standard and QC sample was prepared by spiking a specified amount of Vardenafil in human plasma with oral Vardenafil drug served as the internal standard for comparison. The concentration of analytes in each standard was quantified using LC/MS and detected using multiple-reaction monitoring for each of the respective analytes. The lower limit of quantitation (LLOQ) was defined as the lowest concentration that could be quantified with accuracy and precision within 20%, as calculated from chromatograms for the independent samples. Intra- and inter-run accuracy and precision were calculated for the three QC samples, and independent triplicate measurements with best-fit lines were selected using a linear regression model with a 1/x2 weighting factor in the calibration curves. Results The SDS-089 nasal Vardenafil solution showed excellent accuracy (mean 100, Standard Deviation, SD 4.1, % Relative Standard Deviation, RSD of 4%) and good precision (mean 50.1, SD 2.1, %RSD of 4%) on high (50ng/ml) QC assay tests. Similarly, the stability of QC on high (50ng/ml) plasma assay tests showed excellent accuracy (mean 100.8, SD 3.7, %RSD of 4%) and good precision (mean 50.4, SD 1.8, %RSD of 4%) on high (50ng/ml). Comparison between pharmacokinetic parameters of Vardenafil SDS-089 nasal spray (4mg) and oral tablet (10mg) showed T1/2 (2.52±0.99 vs 2.46±0.73 hour), Tmax (0.17±0.54 vs 0.97±0.35 hour), Cmax (time concentrations) (9.21±4.11 vs 11.24±7.83 ng/mL) and AUC0-inf (area under the curve from zero to infinity) (21.03±12.54 vs 37.25±41.51 ng/mL*h) (see Table 1: Pharmacokinetic parameters of Vardenafil HCI as SDS-089 nasal spray vs. oral tablet using non-compartmental analysis WinNonlin software). Conclusions SDS-089 nasal formulation appeared to deliver a high plasma concentration level of Vardenafil drug based on pharmacokinetic LC/MS data analysis with robust accuracy and precision. Disclosure Yes, this is sponsored by industry/sponsor: LTR Pharma Clarification: Industry funding only - investigator initiated and executed study

(065) A Randomized, Single-Dose, Bioavailability and Safety Study on Novel SDS-089 Nasal Vardenafil 4mg Spray Solution in Comparison to Oral Vardenafil Tablet 10 mg in Healthy Volunteers

Abstract Introduction Oral phosphodiesterase type 5 inhibitor (PDE5i) is recognized as an effective first-line medical therapy for males with erectile dysfunction. However, oral PDE5i drug adherence and satisfaction rates were not high due to the need for oral ingestion, lack of sexual spontaneity, and delay in time to clinical effect. Hence, a nasal delivery of PDE5i drug may circumvent these limitations. Objective To assess the bioavailability and safety profile of SDS-089 nasal Vardenafil spray compared to oral Vardenafil 10mg tablet. Methods Following approval from Institutional Review Board and Biosafety Committee (FB18/IRB/099), 13 subjects out of the 32 healthy volunteers met the study criteria and were randomized to receive SDS-089 nasal Vardenafil spray (4 mg) or oral Vardenafil tablet (10 mg). The vardenafil HCl formulation SDS-089 was prepared with the active pharmaceutical ingredient meeting the United States Pharmacopeia (USP) standard (batch 1704002361). Blood tests were conducted on the subjects to evaluate Vardenafil drug bioavailability and treatment-related adverse events (TRAEs) data was collected. Results All 13 subjects completed the study. Based on the drug pharmacokinetics data, SDS-089 nasal spray was shown to have a faster onset and achieve optimal dose with a lower amount of drug compared to oral formulation. Of the 42 recorded TRAEs, 33 TRAEs were associated with the nasal spray, and 9 TRAEs were related to oral drugs. Transient headache is the most common TRAE in the nasal group and was very tolerable. The reported headaches showed no relationship with Cmax (peak concentration) and AUC0-inf (the total drug exposure across time) based on the Vardenafil drug levels. Conclusions SDS-089 nasal spray formulation Vardenafil HCl at 4 mg successfully achieved a similar Cmax with that of oral Vardenafil 10 mg tablet, and while it appeared to have more TRAEs, these were transient and well-tolerated by the subjects. Disclosure Yes, this is sponsored by industry/sponsor: LTR Pharma. Clarification: Industry funding only - investigator initiated and executed study.

(160) Prospective Evaluation of Proximal Decompression for the Management of Refractory Ischemic Priapism

Abstract Introduction A prolonged undesired erection of the penis that is often unrelated to sexual arousal is referred to as priapism. Over 95% of people who experience priapism are ischemic, which causes blood to become stuck in the corpora, increase hypoxia, hypercarbia, and acidosis that resemble compartment syndrome, and hinders penile venous outflow. IP is a urological emergency due to the risk of cavernosal fibrosis and consequent permanent ED. Injections of α-agonist and corporal irrigation/aspiration are the main forms of treatment for short-duration priapism, with distal shunting as a last resort. Patients with refractory and/or prolonged ischemic priapism (PIP) find their strategy more challenging. There is a low probability that irrigation/aspiration procedures, α-agonist injections, and distal shunting will work for people who have priapism that lasts longer than 24 hours. Objective This study was conducted on 21 male patients with refractory and\or prolonged IP to evaluate the outcomes of proximal decompression in the management of those patients. The primary end point was to assess priapism resolution in the patients. While the secondary end point was to assess erection recovery in those patients and their ability to perform sexual intercourse. Methods Patients’ information had been collected from the hospital data and connection with them had been through phone calls and hospital follow-up visits. Results Among the current study patients, the most detected etiology was tramadol intake (23.8%), followed by THC addiction and idiopathic ischemic priapism, while the least common were papaverine injection and hematological disorder (4.8%). 23.8% of the patients had twice aspirations, while 33.3% had a once. 14.3% of the patients had T shunt. 33.3% had bilateral PSD, and the other 66.7% had unilateral PSD. In the present study the decompression was successful in all the patients, where all the patients showed resolution of priapism, however 57.1% were able to perform sexual intercourse. The mean duration to achieve complete detumescence after surgery in this study was 24.2 ± 8.4 days. 33.3% had no complications, 52.4% had edema, while 14.3% had wound infection. The mean baseline IIEF score of the present study patients was 22.6 ± 2.2 (most of the patients (75%) hadn’t erectile dysfunction, 9.5% had mild erectile dysfunction and 4.8% had mild to ED), which was decreased after 3 months of the surgery (7.7 ± 2.8). Three months post-operatively severe ED was detected in 52.4% of the patients, 33.3% had moderate ED and 14.3% had mild to moderate ED. Six months after surgery the erectile dysfunction improved, where the mean IIEF score was 12.2 ± 5.0. Mild ED was detected in 23.8 %, Mild to moderate ED in 33.3 %, Moderate ED in 19 % and Severe ED in 23.8 %. The difference between the IIEF scores at base line, 3 months postoperatively and 6 months postoperatively was statistically significant. Conclusions Penoscrotal decompression (PSD) is a simple, safe, highly effective, and easily reproducible procedure for resolution of RIP with glans preservation in addition to more satisfactory erectile function outcomes to a certain extent Disclosure Yes, this is sponsored by industry/sponsor: alexandria main university hospital Clarification: Industry funding only - investigator initiated and executed study Any of the authors act as a consultant, employee or shareholder of an industry for: alexandria main university hospital.

"Top 20" residency-trained academic orthopaedic surgeons have higher academic productivity and funding in their careers.

"Top 20" status on Doximity, an online networking service for medical professionals, is an indicator of the reputation of a residency program. The study assesses how training at a Top 20 (T20) orthopaedic residency program impacts career productivity and funding. Fellowship and Residency Electronic Interactive Database was used in 2022 to identify active orthopaedic residency programs. Demographic and training data was collected for each orthopaedic surgeon using institutional websites and Doximity. The Residency Navigator feature on Doximity was used to rank residency programs by "reputation." Programs were categorized as either T20 or non-T20. The relative citation ratio (RCR) was calculated using the NIH iCite tool and Hirsch index (h-index) was calculated using Scopus. Industry funding was collected from the Centers for Medicare & Medicaid Services Open Payments Program (CMS) for all available years (2014-2020). A total of 2812 academic orthopaedic surgeons were included in the study. Among academic orthopaedic surgeons in the United States, T20 trained orthopedists had more publications and citations (p < 0.001), along with higher h-indices (p < 0.001), RCR (p < 0.001), and industry funding (p = 0.043). Additionally, T20 trained orthopedists were 1.375 times more likely to obtain professor status (95% confidence interval: 1.150-1.645, p < 0.001). Even after propensity-matched analysis, T20 trained orthopedists maintained these differences. Training at a T20 residency program is associated with promotion, productivity, and funding. These findings are especially of concern to medical students who must consider the importance of a residency program's reputation when deciding where to apply for residency.

Remaining Palestinian

Palestinian filmmakers are largely dependent on foreign funding for production and on foreign festivals for publicity. Making a Palestinian film can seem as “impossible” as remaining Palestinian amid fragmenting effects of occupation/war and peace accords. Against such pressures, Palestinian filmmaker Annemarie Jacir tells stories with protagonists, who, for foreign funders, can seem like “unruly subjects” for remaining Palestinian. As a consequence, her films themselves can seem like “unruly subjects” to industry film critics. Her films like twenty impossibles (ka’inana ashrun mustaheel, 2003), Salt of This Sea (Milh Hadha al-Bahr, 2008), When I Saw You (Lamma Shoftak, 2012), and Wajib (2017) tell stories about Palestinians debating each other (rather than Israelis via US negotiators) during key moments in Palestinian history, including the Nakba (1948), the Naksa (1967), the Oslo Accords (1993), and Al-Aqsa or second Intifada (2000–05). Jacir’s protagonists refuse the limiting choices on offer. They demand to be recognized as Palestinian, as does Jacir as a Palestinian filmmaker against the efforts of Western industry critics, festivals, and funders to label her as an “Arab woman filmmaker,” often carrying colonial assumptions of “oppressed” or “exceptional” women throughout Southwest Asia (“the Middle East”). Her films do more than offer a glimpse of everyday life to “humanize” Palestinians; they are “unruly subjects” that unsettle assumptions to reframe the debates.

Comparative Analysis of Private and Public Mutual Funds: A Performance Evaluation

Abstract: The mutual fund industry is a popular investment avenue that offers investors the opportunity to invest in a diversified portfolio of securities. The industry has witnessed significant growth in recent years, with investors seeking to maximize their returns and reduce risk. This paper presents a comprehensive comparative analysis of private and public mutual funds in terms of their performance. The study aims to evaluate the risk-adjusted returns, expense ratios, fund size, asset allocation, and other relevant factors of both private and public mutual funds to determine which type of fund offers better performance. To conduct the analysis, a sample of four private and four public mutual funds was randomly selected, and their performance was evaluated using various performance metrics such as Sharpe ratio, Treynor ratio, and Jensen's alpha. The data was analyzed using statistical tools such as U test, t-test, and regression analysis. The study found that private sector mutual funds performed comparatively better than public sector mutual funds in terms of risk-adjusted returns, expense ratios, and asset allocation. Private sector mutual funds had higher Sharpe ratios and Treynor ratios compared to public sector mutual funds, indicating that they generated higher returns per unit of risk taken. Private sector mutual funds also had lower expense ratios, indicating that they charged lower fees to investors. In terms of asset allocation, private sector mutual funds had a higher allocation towards equity securities compared to public sector mutual funds, which had a higher allocation towards debt securities. The study also identified significant differences in the investment strategies, portfolio management, and investor base of private and public mutual funds. Private sector mutual funds had a more aggressive investment strategy, with a higher allocation towards equity securities, whereas public sector mutual funds had a more conservative investment strategy, with a higher allocation towards debt securities. Private sector mutual funds were also found to be more actively managed compared to public sector mutual funds. Private sector mutual funds had a higher percentage of assets under management from retail investors, while public sector mutual funds had a higher percentage of assets under management from institutional investors. The study provides valuable insights to investors, fund managers, and policymakers regarding the performance of private and public mutual funds. The findings suggest that investors may benefit from investing in private sector mutual funds due to their higher risk-adjusted returns, lower expense ratios, and higher allocation towards equity securities. Fund managers may also benefit from the study by gaining insights into the investment strategies and portfolio management practices of private and public mutual funds. Policymakers may use the study to design policies that promote the growth and development of the mutual fund industry. Overall, this study contributes to the existing literature on mutual funds by providing a comprehensive comparative analysis of private and public mutual funds in terms of their performance. The study adds to our understanding of the factors that affect the performance of mutual funds and provides insights into the investment strategies and portfolio management practices of private and public mutual funds.

Effects of Macroeconomic Variables on the Performance of Mutual Funds: Evidence from Bangladesh Financial Market

Using multiple regression analysis in this research paper, this is examined that these macroeconomic variables (Money Supply-M2, Inflation Rates and Exchange Rates) have significant relationships with the performance of mutual funds (represented by monthly return based on NAV) in Bangladesh. According to this project paper, money supply M2 has negative relationship with the performance of mutual funds in the financial market of Bangladesh. Because, higher level of money supply in the market weaken the monetary value of taka which makes the market more vulnerable. And this vulnerable market leads a negative impact on the whole financial market as well as mutual fund industry. Interest rates have positive relationship with the performance of mutual funds in the financial market of Bangladesh because higher level of interest rate increases the tendency of savings in the ultimate consumers and they try to consume less and save more. This savings is going to be invested in the capital market as well as in mutual fund industry which leads the market to a better position for the fund managers. Inflation rates have negative relationship with the performance of mutual funds in the financial market of Bangladesh as the higher level of inflation make the price of commodities higher and the monetary price of the taka lower. This tendency of making the less value of money, most of the investors want to withdraw their investment from the market which leads a downturn in the financial market as well as in the mutual fund industry. At the end, exchange rates have positive relationship with the performance of mutual funds as the higher level of exchange rate makes the Bangladeshi taka more powerful in the international market.

Financial conflicts of interest among presenters, panellists and moderators at haematology and oncology FDA workshops.

To assess the characteristics and financial conflicts of interest of presenters, panellists and moderators at haematology and oncology workshops held jointly with or hosted by the US FDA. We included information on all publicly available haematology or oncology FDA workshop agendas held between 1 January 2018 and 31 December 2022. General and research payments reported on Open Payments, industry funding to patient advocacy organizations reported on their webpages or 990 tax forms and employment in both pharmaceutical and regulatory settings. Among physicians eligible for payments, 78% received at least one payment from the industry between 2017 and 2021. The mean general payment amount was $82,170 for all years ($16,434 per year) and the median was $14,906 for all years ($2981 per year). Sixty-nine per cent of patient advocacy speakers were representing organizations that received financial support from the pharmaceutical industry. Among those representing regulatory agencies or pharmaceutical companies, 16% had worked in both settings during their careers. Our findings in this cross-sectional study show a majority of US-based physician presenters at haematology and oncology workshops held jointly with members of the US FDA have some financial conflict of interest with the pharmaceutical industry. These findings support the need for clear disclosures and suggest that a more balanced selection of presenters with fewer conflicts may help to limit bias in discussions between multiple stakeholders.

Financial Conflicts of Interest and Industry Funding are Associated With Conclusions Favorable to New Technologies: A Review of Published Economic Analyses in Hip and Knee Arthroplasty

BackgroundNew technologies in hip and knee arthroplasty are commonly evaluated using cost-effectiveness analyses and similar economic assessments. There is a wide variation in the methodology of these studies, introducing the potential for bias. The purpose of this study was to evaluate associations between potential financial conflicts of interest (COI) and the outcomes of economic analyses. We hypothesized that authors’ COI and industry funding would be associated with conclusions favorable to a new technology. MethodsEconomic analyses making cost-effectiveness or economic implementation claims on patient-specific instrumentation, robotics, and implants used in hip and knee arthroplasty published from 2010 to 2022 were identified. Papers were evaluated to determine if conclusions were favorable to the new technology being studied. Fisher’s exact test was utilized to determine the relationship between the presence of COI and an article’s conclusions. ResultsOf 43 eligible articles, 76.7% were cost-effectiveness analyses, 23.2% were cost analyses, and 67.4% of articles had conclusions favorable to a technology. Of the 29 articles with favorable conclusions, 26 had an author with a financial COI (89.7%), and 14 had industry funding (48.3%). Of the 33 articles with a financial COI, 26 (78.8%) had favorable conclusions, and of the 16 articles with industry funding, 14 (87.5%) had favorable conclusions. Fisher’s exact test revealed a statistically significant association between an article having favorable conclusions and the presence of an author’s COI or industry funding (odds ratio, 13.5; 95% CI [confidence interval], 2.3 to 79.9; P = .003). ConclusionsFinancial COIs were present in 79.1% of lower extremity arthroplasty economic analyses on technologies and were associated with an article having conclusions favorable to the new technology. Surgeons and decision-makers should be aware of the variability and assumptions in these studies and the potential bias of the conclusions.

AN ANALYSIS OF PERFORMANCE PERSISTENCE IN INDIAN MUTUAL FUND USING HURST EXPONENT

We empirically investigated the presence of long memory in financial return series data of selected equity oriented mutual funds in India. The Hurst exponent, a non parametric test was used as the measurement of performance persistence to show presence of long memory. We used Net Asset Value (NAV) of 33 equity oriented growth based Indian mutual funds from different categories which showed a diversified picture of the mutual fund industry in India for the period 2003-2019. We empirically found that the degree of performance persistence is positive in case of selected funds and a few funds showed randomness or Brownian motion. The result suggested that the performance persistence exists in Indian mutual funds, applying the Rescaled Range method of Hurst exponent analysis.

Do US Active Mutual Funds Make Good of Their ESG Promises? Evidence from Portfolio Holdings

We investigate the occurrence of greenwashing in the US mutual fund industry. Using panel regression methods, we test whether there exist differences in the portfolio investment behaviors of active equity funds that are self-declared to be driven by ESG motives when compared to all other funds. In particular, we focus on two aspects of funds’ portfolio allocation decisions, i.e., the actual implied average ESG ratings of the stocks a mutual fund invests in and the portfolio share invested in sin stocks. We do not find strong evidence that ESG and non-ESG funds make identical investment choices and hence reject the hypothesis of widespread greenwashing. ESG funds, on average, invest more in companies with higher ESG ratings and avoid sin stocks more than non-ESG funds. Nonetheless, we obtain evidence that some degree of greenwashing may still be occurring. However, over time, the differences between ESG and non-ESG funds in these behaviors seem have declined, suggesting a potential reduction in greenwashing practices.

(235) Use of Bremelanotide (Vyleesi) in Men with Sexual Dysfunctions

Abstract Introduction Bremelanotide (Vyleesi) is an FDA approved medication for the safe and efficacious treatment of hypoactive sexual desire disorder in premenopausal women, however phase 3 trials revealed it improved arousal and orgasm as well. As a centrally acting drug it was expected to be effective to treat sexual dysfunctions in men and has been prescribed off label routinely in our practice. Objective The primary aim of this study was to evaluate the use of bremelanotide in men with various sexual dysfunctions, the reasons why the medication was prescribed, improvements in sexual function and overall satisfaction, and side effects experienced. Methods This one-group study design involved men from a single clinic with various sexual dysfunctions prescribed bremelanotide beginning May 1, 2021. After signing consent participants answered the Quality of Life (QOL) Dimension of Sexual Quality of Life Questionnaire, the Patient Global Impression of Improvement (PGI-I) and the General Assessment Questions (GAQ) online. After confirming they had used the medication at least twice, participants completed a structured interview over the telephone with a single interviewer. Descriptive statistics were used to characterize the study cohort. Adverse events were collected. Results To date a total of 21 men signed consent and 19 completed the online questionnaires. 80% of these men were more satisfied with their lovemaking and duration of lovemaking; 93% reported vaginal insertion was easier and 71% said it was easier to orgasm. With regard to feelings about initiating lovemaking, 86% were more at ease and 79% anticipated it would be more pleasurable and more carefree. 69% believed orgasm was more pleasurable and 73% said that lovemaking was more pleasurable while 79% reported that the partner’s overall experience was more pleasurable. Using the PGI-I, 53% of participants felt that sexual function after using bremelanotide was a little better, much better, or very much better. Additional questions online revealed similar results. Twelve men completed the one-on-one interview: 69% of participants were prescribed bremelanotide for erectile dysfunction. 64% had at least other one sexual health issue, including anxiety about sex (54%), low sexual desire (45%), not enjoying sex (36%), orgasm difficulties (18%), and ejaculation difficulties and sensation loss (9% each). A total of 91% experienced improvements in sexual function, all with improved erectile function. 100% of those with complaints of low sexual desire and/or complaints of anxiety around sex reported improvement; 64% had decreased anxiety around sex; 55% had more enjoyment with sex; and orgasm improved for 36% of participants. Men reported longer erection and ability for additional erection for 18-24 hours after bremelanotide injection, better connection between genitals and brain, improved sensitivity, and increased confidence. Side effects included flushing (36%), nausea (36%), headache (27%), bothersome spontaneous erections without sexual stimulation for about 24 hours after injection (27%), and incontinence, cramping and abdominal burning (9% each). All adverse events were transient. Conclusions While bremelanotide is approved for hypoactive sexual desire disorder in premenopausal women, it has been prescribed and used successfully for men with erectile dysfunction and other concomitant sexual health issues. Disclosure Yes, this is sponsored by industry/sponsor: Palatin Technologies. Clarification: Industry funding only - investigator initiated and executed study. Any of the authors act as a consultant, employee or shareholder of an industry for: Palatin Technologies.

(127) Sexual Health Implications Associated with Psychotropic Medication Use Among Adolescents During the COVID-19 Pandemic

Abstract Introduction The use of psychotropic medications has a notable effect on sexual well-being. Prolonged use is closely linked to dyspareunia, reduced sexual desire, hypogonadism, and erectile dysfunction. We hypothesized that there was an increase in the prescription rates of psychotropic medications among adolescent patients during the COVID-19 pandemic due to the unprecedented stress experienced by isolated youth. Objective We examined the prescription rates of psychotropic medications and the simultaneous usage of PDE5 inhibitors in adolescent patients during the COVID-19 pandemic in order to compare usage of these medications prior to the pandemic. Methods To conduct our retrospective matched cohort study, we utilized data obtained from the TriNetX Research Network. The study focused on adolescent patients aged 10-19 presenting for outpatient evaluation, and were placed into two cohorts: 1) those evaluated before the COVID-19 pandemic, and 2) those evaluated during the pandemic. Patients with previous psychiatric diagnoses or prior use of psychotropic medications were excluded from the study. Our primary interest was to examine new prescription patterns within 90 days of the outpatient evaluation. To ensure balanced cohorts, propensity score matching was conducted using logistic regression, resulting in cohorts of equal size. Results A total of 1,612,283 adolescents pre-COVID-19 and 1,008,161 adolescents presenting during the COVID-19 pandemic for outpatient evaluations were identified. After propensity matching, a total of 1,005,408 adolescents were included in each cohort each with an average age of 14.7 ± 2.84 and 52% female and 48% male. Prescribing of antipsychotics and benzodiazepines were more frequent during the pandemic for adolescents (RR: 1.58, 95% CI 1.01-2.2). However, they were less likely to receive antidepressants (Risk Ratio (RR): 0.6, 95% Confidence Interval (CI) 0.57-0.63), anxiolytics (RR: 0.78, 95% CI 0.75-0.81), stimulants (RR: 0.26, 95% CI 0.25-0.27), as well as mood stabilizers (RR: 0.44, 95% CI 0.39-0.49). Erectile dysfunction requiring oral PDE5i in this cohort was more frequent during the pandemic for adolescents (RR: 1.53, 95% CI 1.05-2.01). Conclusions During the global COVID-19 pandemic, there was a notable rise in the prescription rates of antipsychotic and benzodiazepine medications compared to previous years. Interestingly, this increase aligned with a statistically significant rise in the prescription of PDE5 inhibitors (PDE5i) for treating erectile dysfunction. These findings indicate that clinicians need to be aware of the potential increased risk of medication-related sexual dysfunction among adolescents. Disclosure Yes, this is sponsored by industry/sponsor: NIH health grant RO1 DK130991 and Clinician Scientist Development Grant from the American Cancer Society. Clarification: Industry funding only - investigator initiated and executed study.

(132) Comparing the Frequencies of Different Species Present in Revision Penile Prostheses Surgery due to Infectious or Non-Infectious Causes

Abstract Introduction Inflatable penile prosthesis (IPP) is a third-line treatment for treating erectile dysfunction in men. However, complications in the prostheses can cause the patient to undergo secondary penile prostheses (PP) surgery. Infection is a feared complication of IPP surgery and has a higher risk at secondary surgery. Next-generation sequencing (NGS) compares DNA to identify species and report relative abundances. NGS is an established method of microbial detection and identification in Orthopedics, Otolaryngology, wound care, and infectious disease. In prosthetic urology, NGS has been shown to provide better and more acute information than traditional cultures. Characterizing biofilm may allow for a better understanding of potential issues that could reduce IPP durability. Objective This study aims to identify the frequency of microbial species present in penile prostheses that needed revision surgery and compare the quantitative data between infectious etiology and mechanical failure cases. We hypothesize that, during secondary surgery, mechanical failure and clinically infected IPPs will display different frequencies of microbial species. Methods This study comprised 126 patients from 2 different centers that underwent revision PP surgery for either infectious or non-infectious issues. Upon entering the pump space (wiped pump/tubing/capsule) during surgery, 2 swabs specimens were collected and sent to the institutional laboratory for routine culture and the other to MicrogenDx for NGS testing. During the specimen evaluation, the frequency of microbial species in each specimen was recorded and sorted based on the reason for revision PP surgery. ANOVA was used to test effects of ethnicity, age, diabetes status, implant duration, and year of implant removal. Results The demographics of the 126 patients consisted of a median age of 69 (1st quartile= 61, 3rd quartile= 76), of which 84 were White, 41 were African American, and 1 was of unknown ethnicity. 104 patients (83%) needed revision PP surgery due to mechanical failure causes, and 22 patients (17%) needed revision PP surgery due to infectious causes. From the data collected and analyzed, the mechanical and infection specimens differed significantly in a few species. In the infection samples, E. coli, C. tuberculostearicum, and C. acnes were significantly underrepresented, and P. aeruginosa was significantly overrepresented compared to the mechanical samples (Figure 1). Asterisks denote these species in Figure 1. Conclusions NGS has been shown to accurately represent the characteristics of biofilm present in secondary PP surgery, supported by similar results in Ortho and ENT literature. When the PP was clinically infected, four microbial species experienced significant differences in expression frequency compared to mechanical failure IPPs. In addition, the NGS data collected contradicts the traditional theory that the coagulase-negative Staphylococcus species is the most present microbial species in PP biofilm, as we observed more prevalence of E. coli in the biofilm we analyzed. Disclosure Yes, this is sponsored by industry/sponsor: MicroGenDX. Clarification: Industry funding only - investigator initiated and executed study. Any of the authors act as a consultant, employee or shareholder of an industry for: MicroGenDX, Irrisept.