Outcome Measures Research Articles

Effects of calcitonin on lumbar spinal stenosis.

Systematic review and meta-analysis. There is some controversy about the effects of calcitonin (CT) on lumbar spinal stenosis (LSS). This systematic review and meta-analysis is to assess the strength of the evidence supporting the use of CT in the treatment of patients with LSS. We performed an electronic search depicting randomized controlled trials (RCTs) through 4 databases from the date of database creation to January 2023. 3 different researchers conducted independent literature screening, data extractions, and quality assessments. The outcome measures included visual analogue scale (VAS), walking distance, and oswestry disability index (ODI). Meta-analysis and trial sequence analysis (TSA) were carried out using RevMan 5.4, Stata 16.0, and TSA 0.9. GRADE 3.6 was used to evaluate the evidence quality. We accepted 9 studies with 496 participants. The meta-analysis revealed that CT offered no significant improvement in VAS, walking distance, or ODI in patients with LSS. There is no evidence that CT has a benefit in patients with LSS, either alone or in combination with other treatments, or depending on the route of administration, according to the systematic review and meta-analysis of relevant RCTs.

(091) Use of a Vibrating Device in the Management of Female Situational Anorgasmia: Prospective Case Series Study in Women from Southeastern Spain

Abstract Introduction Around 40 percent of women in Spain are unable to achieve orgasm during coital relations, although most can do so through other means. Many of these women do not seek treatment, even though this situation may affect their sexual and relational life. Female Orgasm Disorder (FOD) treatment has seen little innovation since the 1980s. The growing acceptance, technological development, and focus on diversity have contributed to the flourishing of the sex toy industry. This sector has enabled the development of therapeutic devices that have already demonstrated usefulness in addressing other female and male sexual dysfunctions, often making treatments more Accessible. However, more scientific studies are needed on this topic. Objective Present the results of the utility and safety of using a vibrating device in the management of situational female orgasm disorder (FOD) in a group of women from Spain. Methods A case report study of an observational, descriptive, prospective nature, involving 19 women undergoing treatment, that meet criteria for lifelong, situational FOD from the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) was conducted in Murcia, Spain, from January 2022 to July 2023. Patients were 18 years or older, generally healthy as evidenced by medical history, were sexually active, in a current relationship of 3 months or longer, and participation was voluntary. Patients did not meet criteria for PTSD, psychosis or dissociative disorders, depression or bipolar disorders, were not pregnant or in menopause and did not use drugs known to interfere with sexual functioning. Main outcome measures were assessed using the Female Sexual Function Index (FSFI) domain for orgasm at baseline and after 6 and 12 weeks, as well as the success rate of achieving orgasm during coital relations. Treatment consisted of an educational session where a vibrating device called Crescendo II® and its accompanying resource of different positions, Play Book was provided, along with instructions for using the device during coital relations. Results Patients had a mean age of 31.19 years (range 27–53). An improvement was observed in the average scores at six and twelve weeks in FSFI orgasmic domain, (mean pre = 1.62 (SD) = 0.42, mean post six weeks = 3.47 (SD) = 1.26, mean post twelve weeks = 3.43 (SD) = 1.25). The success rate (orgasm achievement during intercourse) at the end of the study was 90.47%. Conclusions This case series suggests that the use of a vibration device could be an effective and safe therapeutic option for female situational anorgasmia in addition to reducing the length and cost of treatment. Future research with experimental designs should confirm the clear potential of the use of these devices in treating FOD and clarify issues related to the most appropriate amplitude and frequency of vibration, as well as the possible long-term effects of using these types of vibration devices in patients. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Mysteryvibe.

Inflammatory Arthritis in Systemic Sclerosis: Its Epidemiology, Associations, and Morbidity.

To describe the epidemiology, associations, and impact of inflammatory arthritis (IA) in systemic sclerosis (SSc). Patients with SSc prospectively enrolled in the Australian Scleroderma Cohort Study were included. IA was defined clinically as the presence of synovitis on examination. Logistic regression was used to determine the associations of IA with SSc manifestations and serological parameters. Patient-reported outcome measures were used to capture physical function and health-related quality of life (HRQoL). IA was a common SSc manifestation affecting one-third (33.3%) of patients over a median follow-up of 4.3 (1.7-8.4) years. Associations of IA included diffuse SSc (odds ratio [OR] 1.33, 95% confidence interval [95% CI] 1.01-1.74, P = 0.042), concurrent musculoskeletal manifestations (joint contractures and tendon friction rubs, OR 1.70, 95% CI 1.34-2.15, P < 0.001); myositis (OR 2.11, 95% CI 1.39-3.20, P < 0.001), and sicca symptoms (OR 1.57, 95% CI 1.14-2.16, P = 0.006), whereas IA was negatively associated with pulmonary arterial hypertension (OR 0.52, 95% CI 0.35-0.78, P = 0.002). Neither the presence of rheumatoid factor nor U1 small nuclear RNP were associated with IA (OR 1.13, 95% CI 0.88-1.44, P = 0.331, OR 1.46, 95% CI 0.89-2.39, P = 0.129 respectively). Positive anticyclic citrullinated protein antibodies, although at low frequency, were more common in those with IA compared with those without IA (7.5% vs 1.5%, P < 0.001). IA was associated with significantly lower HRQoL score (P < 0.001) and more physical disability than in those without IA (P < 0.001). IA is a common disease manifestation that is more frquently seen in diffuse disease. IA is associated with poor HRQoL and physical disability. Further research is needed into the effective management of IA in SSc.

Gender and Racialization Status of Medical Eponym Namesakes: Cross-sectional Study.

Many medical eponyms were established when women and racialized individuals were excluded from medicine. The objective of this study was to determine the gender and racialization status of individuals whose names are incorporated in medical eponyms. This study is a cross-sectional analysis of gender and racialization of medical eponym namesakes. The main outcome measures were the study of gender and racialization of medical eponym namesakes found in Whonamedit, Mosby's Medical Dictionary, and the International Classification of Diseases(version 10). The gender and whether the individual was a racialized person were determined using pictures and other available information. We identified 3484 unique eponyms. White men represented the majority of medical eponym namesakes (2190 of 2327, 94.1%) followed by white women (85 of 2327, 3.7%), racialized men (49 of 2327, 2.1%), and racialized women (3 of 2327, 0.1%). In the ICD-10 sub-analysis, white men represented the majority of medical eponym namesakes (476 of 514, 92.6%) followed by white women (22 of 514, 4.3%), racialized men (14 of 514, 2.7%), and racialized women (2 of 514, 0.4%). Most medical eponyms represent men and white individuals, highlighting the underrepresentation of women and racialized individuals. This indicates a need to re-examine the ongoing use of medical eponyms which may entrench sexism and racism in medicine and contribute to an environment that makes some feel unwelcome or undervalued.

Impact of combined propranolol and oxytocin on the process and outcomes of labor: a meta-analysis of randomized controlled trials.

To systematically review the impact of propranolol combined with oxytocin on the process and outcomes of labor. A comprehensive literature search was performed across multiple databases, including China National Knowledge Infrastructure (CNKI), VIP, Wanfang, China Biomedical Literature Database, PubMed, Embase, and the Cochrane Library. All publicly published randomized controlled trials (RCTs) of propranolol combined with oxytocin compared to the use of oxytocin alone in labor were collected. After screening the literature and extracting data, the Cochrane Handbook for Systematic Reviews of Interventions 5.1.0 recommended bias risk assessment tool was used to assess the quality of the included studies. A meta-analysis was conducted using RevMan 5.3 software, and the Grading of Recommendations Assessment, Development and Evaluation (GRADE) system was used to rate the quality of evidence for outcome measures. Meta-analysis results showed that the group receiving propranolol combined with oxytocin was more capable of reducing the cesarean section rate (eight studies, 815 women, RR = 0.67, 95% CI (0.53, 0.86), P = 0.001) and shortening the duration of the latent phase (two studies, 206 women, MD = - 1.20, 95% CI (- 1.97, - 0.43), P = 0.002) and the duration of the active phase on day 1 (two studies, 296 women, MD = - 0.69, 95% CI (- 0.83, - 0.54), P < 0.00001), compared to the oxytocin monotherapy group. No significant difference was found between the two groups in terms of the 5-min Apgar score (five studies, 609 women, MD = - 0.05, 95% CI (- 0.14, 0.04), P = 0.32) and the rate of admissions to the Neonatal Intensive Care Unit (NICU) (three studies, 359 women, RR = 0.82, 95% CI (0.38, 1.79), P = 0.62). The combined use of propranolol and oxytocin can significantly reduce the cesarean section rate, shorten the duration of the latent phase and the duration of the active phase on day 1, and is safe. However, due to the limitations, the conclusions of this article still need to be verified by large-sample, multicenter, rigorously designed high-quality clinical RCTs. Registration number is INPLASY202390107.

(054) Novel Use of Clitoral Pulse Sensor During Arousal

Abstract Introduction Penile erection is well understood in men and has been extensively studied. The Erectile Hardness Score is a commonly used tool to quantify the strength of an erection. No such measurement tool exists for women. This study builds on the work done by Mechelmans et al exploring Clitoral Pulse Amplitude (CPA) as a marker for physical arousal in women. CPA has been shown to be related to clitoral blood volume, erection, and engorgement of the clitoris. This erection in the clitoris is homologous to penile erection. Objective To test a new clitoral pulse sensor for correlation with subjective arousal for proof of concept. To test the comfort and usability of such a device configured with an internal (vaginal) portion and a clitoral portion. Methods In the study, 20 healthy female participants wore the device while watching a control (non-arousing) video and during progressively more sexually arousing activities. They were allowed to choose their own materials to watch, read, or listen to for arousal, and a masturbation phase was included for additional information. Participants also reported their subjective arousal after each phase. After the test, participants were also surveyed about the comfort and usability of the device. Results The main outcome measures are CPA, subjective sexual arousal, and usability feedback ratings. The pulse sensor successfully detected CPA and results show that most participants had increasing levels of subjective arousal correlating with increasing CPA. Statistical correlation between CPA and arousal was positive but low, which could be attributed to differences of sensor calibration and/or device placement by participants. Overall, this positive relationship indicates that a commercially available pulse sensor could be integrated into a future device to measure physical arousal in women, a metric which was previously not widely available. Furthermore, participants reported high satisfaction with the comfort and usability of the device. These insights give us confidence that this device shape will be comfortable and usable in further iterations. Eventually, we hope to commercialize a similar device which would give women greater insights into their sexual health and provide valuable information to their doctors. Conclusions This study showed a positive relationship between CPA and subjective sexual arousal, opening possibilities for future measurement devices. Participants felt the device was very comfortable and easy to use, suggesting this form factor with vaginal (internal) and clitoral (external) portions is a viable configuration for further development. We anticipate improving both the pulse sensing system and device usability as the device is further commercialized. Disclosure Yes, this is sponsored by industry/sponsor: FirmTech. Clarification: Industry initiated, executed and funded study. Any of the authors act as a consultant, employee or shareholder of an industry for: FirmTech.

(053) Efficacy of Mindfulness Based Cognitive Therapy in Management of Provoked Vulvodynia: A Feasibility Pilot Study

Abstract Introduction Provoked Vulvodynia (PVD) is an evolving and chronic pain disorder frequently reported by women of reproductive age. Provoked Vulvodynia is a debilitating disorder and causes significant impairment in daily functioning. Objective The present study was designed with an aim to compare the efficacy of mindfulness based cognitive therapy (MBCT) with pharmacotherapy in the management of PVD in Pakistani women. Methods The present study was approved by the Ethics Review Board (ERB) of Institute of Psychological Research, Pakistan vide No. IPR/ERB/PVD/2023/006. A randomized trial design was used in this study. The women suffering from vulvodynia were included in the study. On the other hand, the women suffering from any gynecological disease, psychiatric disease, or any other medical disease or using any substance were excluded from the study. A total of 43 women suffering from PVD were referred for the treatment. 14 women were excluded as they did not meet the inclusion criteria. All women signed the compulsory informed consent form before enrolling for the study. 29 women were randomized in two treatment groups namely Group A which received 1 hour weekly session of mindfulness based cognitive therapy and Group B which received pharmacotherapy for a period of 3 months. Pharmacotherapy included Amitriptyline 25–50mg daily, Gabapentin 100–300 mg daily, and Lidocaine ointment 5% applied locally to the vestibule. There were 14 women in Group A and 15 women in Group B. A total of 6 women were dropped from the Group A and Group B because they did not want to complete the treatment protocol. 11 women in Group A and 12 women in Group B completed the treatment protocol and their data were added to the statistical analyses. The Vulvar Pain Functional Questionnaire (V-Q) was used as the main outcome measure for pretest and posttest assessments. The data was analyzed by using the Statistical Package for the Social Sciences (SPSS) version 27. Results The mean age of the women was (M=34, SD=3.13) for Group A and (M=34.41, SD=3.26) for Group B. The data was analyzed by using the Wilcoxon Signed Rank Test as the data was non parametric. There was statistical significant Z= -2.94, p&amp;lt;.05 for Group A and Z= -3.07, p&amp;lt;.05 for Group B. The results established that both mindfulness based cognitive therapy and pharmacotherapy were effective in relieving symptoms of PVD. Conclusions The present study concluded that mindfulness based cognitive therapy was as effective in relieving symptoms of PVD as pharmacotherapy. The lack of control group was a major limitation of the study. However, the future studies may be conducted with other treatment arms such as pelvic floor therapy and by adding more women in treatment and control groups. The present study may be considered as a feasibility/pilot study for the efficacy of MBCT for treatment of PVD in Pakistani women. Disclosure No.

(153) Laparoscopic Radical Prostatectomy with the Simultaneous Implant of a Penile Prosthesis: Penile Length Preservation After 10 years Follow Up

Abstract Introduction The preservation of the full dimensions of the penis is an important consideration for improving patients' compliance for the treatment after prostatectomy. We performed twenty laparoscopic extraperitoneal RP and simultaneous penile prosthesis implantation (PPI) in order to preserve the full length of the penis and to improve patients' satisfaction in 2013. Objective Objective of the study is to evaluate the ten years follow up of this unique series in the world. Oncological and functional results were analyzed. Methods From June 2013 to June 2014, 20 patients underwent simultaneous PPI (with an AMS InhibiZone prosthesis) and RP laparoscopic. Patients were evaluated by means of urological visits, questionnaires, and objective measurements before surgery, at discharge from the hospital, on postoperative days 21 to 28, each 3 months for the first year, and each 1 year thereafter. The main outcome measures were biochemical recurrence-free rate, penile length, and quality of life. Results 15 patients mean age 71 range 66–75 were reached at the 10-year follow-up-1 died of acute infarction 10 years after surgery, 1 died of disease 7 years after surgery; 3 lost to followup. Partners had mean age 60 with range 37–71 years. Mean preoperative PSA 9.3 (6.3–13.7) at 10 years 0.08 (range 0.01–1.2); Pre-surgical IIEF 11 (range 9–14) to 10 years 23 (range 22–25). 10-year partner satisfaction rating had increased from 8 post-surgical to 7. Penis size unchanged after 10 years: surgery day 9 cm (range: 8.5–9.5) at 10 years 8.8 range (8–9.5). Conclusions In our cases, the simultaneous extraperitoneal laparoscopic surgery of radical prostatectomy and penile prosthesis implantation is an interesting option to offer to selected and highly motivated patients. Preservation of the size of the penis, the possibility of resuming normal sexual activity 21 days after surgery, partner satisfaction and oncological safety with a 10-year follow-up make it a surgical technique to be proposed in clinical practice if performed by a team with experience in prosthetic surgery. Disclosure No.

Can Alveolar Bone Grafting Using Posterior Iliac Crest be a Day Surgery Procedure?

The purpose of this study was to determine if patients undergoing alveolar bone grafting (ABG) can be discharged home on the day of surgery safely and with high satisfaction. This is a prospective cohort study of patients who underwent ABG over a 6-month period (August 2022 to February 2023). Medical records were reviewed, and postoperative surveys were provided to assess patient/family experience. Tertiary care free-standing pediatric hospital. Participants who had ABG using iliac marrow from the posterior iliac crest. Subjects were assigned to overnight admission (ON) or day surgery (DS) based on hospital bed capacity. Main outcome measures were postoperative medical events and satisfaction with discharge timing. 41 participants were included: ON, n = 20 (48.8%); DS, n = 21 (51.2%), and there were no differences between groups in any predictor variable. There were no postoperative medical events. Overall, families reported comfort managing pain, nausea, bleeding, hydration, and nutrition after discharge. Most (83.3% of the DS group and 69.2% of the ON group, P = .644) reported satisfaction with the discharge timing they received, despite this being driven by hospital rather than patient factors. Reasons for some families preferring longer admission included fluid management (n = 2), anxiety about postoperative swelling (n = 2), and a long drive home (n = 1). For the ON group, 16.7% would have preferred same-day discharge. Same day discharge is safe and well-received in appropriately selected patients who undergo ABG using posterior iliac crest. Perioperative patient/family education is essential.

Predicting individuals’ behaviors during a pandemic: why we might have acted as we did during the COVID-19 pandemic

BackgroundThis study examined individual differences in how people behave in response to a pandemic – more specifically, the current coronavirus pandemic.Participants and procedureA sample of 420 participants was recruited through the online data collection platform MTurk. Participants were directed via an online link to a Qualtrics survey. This survey was composed of several demographic questions and self-report personality and belief scales, followed by a set of outcome measures designed to measure specific behaviors relating to avoidant behavior, protective behavior, and impulsive buying which the participants might, or might not, have engaged in during the COVID-19 pandemic.ResultsThe results showed that locus of control was the best personality-related predictor of peoples’ pandemic-relevant behavior, such that externally oriented people were more likely to report both protective behavior and impulsive buying behavior. In addition, perceived threat was significantly associated with all three types of pandemic-relevant behaviors (avoidant, protective, and impulsive buying).ConclusionsIndividuals’ personality traits and beliefs clearly play a major role in determining their behavior during health crises. In the case of the current COVID-19 crisis, some people adopt behaviors that ensure their safety and the safety of others, whereas other people display careless behaviors that contribute to spreading the infection. Because individual differences in this situation matter, it is important to determine which variables accurately predict which behaviors.

Examining the Role of Cerebral Embolic Protection Devices in Preventing Postoperative Stroke in Patients with a History of Stroke or Transient Ischemic: Insights from the National Inpatient Sample.

Cerebral embolic protection devices (CEPD) during transcatheter aortic valve replacement (TAVR) have been shown to lower the risk of stroke during the procedure. However, their long-term and clinical effects on neuro-cognition are unknown. Therefore, we hypothesized the benefit of CEPD in TAVR patients with a prior history of stroke or transient ischemic attack (TIA). National Inpatient Sample (2019) and International Classification of Diseases, 10th Revision codes were used to identify patients undergoing TAVR with prior stroke or TIA. Propensity-matched analysis was performed to adjust for baseline characteristics and comorbidities. Primary outcome measures were postoperative stroke and all-cause mortality. Length of stay and hospital cost were secondary outcomes. Of 8450 unmatched TAVR patients with prior stroke or TIA in 2019, 1095 (13%) utilized CEPD. After propensity matching previous myocardial infarction (MI), coronary artery bypass grafting, and drug abuse were higher in the TAVR-only cohort. Postoperative stroke rate (1.4% vs 2.2%; P = 0.081) and odds [adjusted odds ratio (aOR), 0.48; 95% confidence interval (CI), 0.11-2.17; P = 0.341] were lower in the CEPD group. There was no difference in all-cause in-hospital mortality between the 2 groups (0.9% vs 1.0%). Length of stay (3 vs 2 days, P <0.001) and hospital expenditure ($172,711 vs $162,284; P = 0.002) were higher for the TAVR-only cohort. CEPD in TAVR patients with prior stroke or TIA did not show statistically significant postoperative stroke benefits. However, further larger-scale prospective studies are needed to evaluate the long-term neurocognitive benefits of CEPD in these patients. As the use of TAVR continues to expand, optimizing peri-procedural strategies such as the use of CEPD remains a critical area of research to improve patient outcomes.

Economic evaluations of assisted reproductive technologies in high-income countries: a systematic review.

Which assited reproductive technology (ART) interventions in high-income countries are cost-effective and which are not? Among all ART interventions assessed in economic evaluations, most high-cost interventions, including preimplantation genetic testing for aneuploidy (PGT-A) for a general population and ICSI for unexplained infertility, are unlikely to be cost-effective owing to minimal or no increase in effectiveness. Approaches to reduce costs in order to increase access have been identified as a research priority for future infertility research. There has been an increasing number of ART interventions implemented in routine clinical practice globally, before robust assessments of evidence on economic evaluations. The extent of clinical effectiveness of some studied comparisons has been evaluated in high-quality research, allowing more informative decision making around cost-effectiveness. We performed a systematic review and searched seven databases (MEDLINE, PUBMED, EMBASE, COCHRANE, ECONLIT, SCOPUS, and CINAHL) for studies examining ART interventions for infertility together with an economic evaluation component (cost-effectiveness, cost-benefit, cost-utility, or cost-minimization assessment), in high-income countries, published since January 2011. The last search was 22 June 2022. Two independent reviewers assessed publications and included those fulfilling the eligibility criteria. Studies were examined to assess the cost-effectiveness of the studied intervention, as well as the reporting quality of the study. The chosen outcome measure and payer perspective were also noted. Completeness of reporting was assessed against the Consolidated Health Economic Evaluation Reporting Standard. Results are presented and summarized based on the intervention studied. The review included 40 studies which were conducted in 11 high-income countries. Most studies (n = 34) included a cost-effectiveness analysis. ART interventions included medication or strategies for controlled ovarian stimulation (n = 15), IVF (n = 9), PGT-A (n = 7), single embryo transfer (n = 5), ICSI (n = 3), and freeze-all embryo transfer (n = 1). Live birth was the mostly commonly reported primary outcome (n = 27), and quality-adjusted life years was reported in three studies. The health funder perspective was used in 85% (n = 34) of studies. None of the included studies measured patient preference for treatment. It remains uncertain whether PGT-A improves pregnancy rates compared to IVF cycles managed without PGT-A, and therefore cost-effectiveness could not be demonstrated for this intervention. Similarly, ICSI in non-male factor infertility appears not to be clinically effective compared to standard fertilization in an IVF cycle and is therefore not cost-effective. Interventions such as use of biosimilars or HMG for ovarian stimulation are cheaper but compromise clinical effectiveness. Lack of both preference-based and standardized outcomes limits the comparability of results across studies. The selection of efficacy evidence offered for some interventions for economic evaluations is not always based on high-quality randomized trials and systematic reviews. In addition, there is insufficient knowledge of the willingness to pay thresholds of individuals and state funders for treatment of infertility. There is variable quality of reporting scores, which might increase uncertainty around the cost-effectiveness results. Investment in strategies to help infertile people who utilize ART is justifiable at both personal and population levels. This systematic review may assist ART funders decide how to best invest to maximize the likelihood of delivery of a healthy child. There was no funding for this study. E.C. and R.W. receive salary support from the National Health and Medical Research Council (NHMRC) through their fellowship scheme (EC GNT1159536, RW 2021/GNT2009767). M.D.-T. reports consulting fees from King Fahad Medical School. All other authors have no competing interests to declare. Prospero CRD42021261537.

The development and implementation of the Northern Health lung cancer digital care pathway: a case study in service change.

This case study details the approach utilised to establish an easy to use, accessible and sustainable method for routine collection of Patient Reported Outcome Measures for patients newly diagnosed with lung cancer. We sought to enhance communication with patients and their families, particularly around shared decision making, their quality of life and symptoms, as well as the impacts of their care or treatment. We detail the co-design methodology utilised with consumers and healthcare providers to develop and implement a multi-lingual, fully automated digital care pathway which has been proven to be highly impactful and powerful for both healthcare providers working within the service and consumers enrolled within the digital pathway. This innovative initiative has changed the practice of the lung cancer service across a health service. Furthermore, its success has evolved the organisational strategy, to embed 'Outcomes for Impact' across the health service.

(237) Patient Reported Outcomes in Men Received Focal Therapy for Prostate Cancer

Abstract Introduction Although focal therapy as a definite treatment modality for prostate cancer patients has been increasing in the United States, there has been paucity of patient reported outcome measures (PROM) specific to urinary, erectile, and sexual function Objective We aim to evaluate the long-term PROM in men undergone focal therapy for prostate cancer since 2019. Methods Web search was performed on the PubMed database. The search was limited to articles published in the English language and reporting focal therapy outcomes between 2019 and 2023, including randomized controlled trials, prospective and retrospective studies. The following data were extracted from each study: year, type of focal therapy, design, participants, demographic, IIEF, ED proportion, IPSS, EPIC, pad incontinence use, fistula rate, urinary retention rate, hematuria, Gleason scores, time to oncologic follow-up, recurrence, and presence of cancer after treatment. Results Twenty-three studies, consisting of cryotherapy, HIFU, TULSA, focal and microwave ablation where met the inclusion criteria and reviewed. Oncologic outcomes were reported in 17 of 23 studies. Median follow-up ranged from 3 to 42 months. Main oncologic outcomes analyzed were in-field/out-of-field recurrence and presence of prostate cancer after treatment. The two largest HIFU studies (n=90, n=101) had 9% and 24% respectively for clinically significant recurrence. The two focal microwave ablation studies (n=55, n=5) had 9% and 20% recurrence rates respectively. Functional outcomes were assessed by IPSS and IIEF. IPSS scores were consistent, with most studies reporting only minimal changes in IPSS after treatment. IIEF scores were generally consistent before and 6 months after procedure for all studies, with some reporting only marginal declines in erectile function. Complication rates among studies were low. Nine studies reported UTI rates ranging from 0% (n=6, n=41) to 30% (n=10) in a TULSA prospective study. Urinary retention rates were reported in 14 studies, with a range from 0% (n=41) to 30% (n=10). Conclusions This review suggests that focal therapies remain safe and effective treatment modality for patients with low-intermediate risk prostate cancer. PROM pertaining to urinary and erectile functions in men undergone focal therapy modality seems to be adequate without worse oncological or complication outcomes. Larger data with oncological and functional outcomes is warranted to further validate its safety and efficacy over longer follow up period. Disclosure No.

(236) Does MDMA Have Treatment Potential in Sexual Dysfunction? A Systematic Review of Outcomes Across the Female and Male Sexual Response Cycles

Abstract Introduction Sexual health is a fundamental dimension of overall human well-being, deeply intertwined with physical health, interpersonal relationships, and the overall quality of life. However, sexual dysfunction is prevalent among both men and women. Despite it's common occurrence, it often remains underdiagnosed and undertreated. In an attempt to improve the treatment landscape and offer new hope for those suffering from sexual dysfunction, researchers have turned to explore unconventional therapies, examining substances beyond the traditional medicinal spectrum. Compounds typically associated with recreational use, like cannabis and LSD, have been subjects of recent studies, exploring their potential therapeutic value. Notably, 3,4-Methylenedioxymethamphetamine (MDMA), colloquially known as 'Ecstasy,' has been attracting significant scientific interest. This synthetic amphetamine is known for its psychostimulant and entactogenic properties, and anecdotally noted for its potential effects on the sexual response cycle. Objective To examine the existing literature on the effects of MDMA on male and female sexual responsiveness and the potential role of MDMA in treating sexual dysfunction of various etiologies. Methods We conducted a systematic review on the effects of MDMA on each domain of the female and male sexual response cycles. PubMed, MEDLINE, and EMBASE were queried, and results were screened using Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Search terms utilized were “MDMA” or “Ecstasy” in combination with “desire,” “arousal”, “lubrication”, “orgasm”, “pleasure”, “libido”, “erection” and “ejaculation”. Inclusion criteria for this review were MDMA use by study subjects, sexual outcomes in at least one domain of the female and/or male sexual response cycles were described and measured. Randomized control trials (RCT), cohort studies (both prospective and retrospective), surveys, and literature reviews published between January 2000 and June 2022 were included. Results We identified 181 studies, of which six met criteria for assessment of the female sexual response cycle and eight met criteria for assessment of the male sexual response cycle. Four of six studies reported increased sexual desire with MDMA use among women. Arousal and lubrication were improved with MDMA use in three of four studies, but they were not affected in one randomized control study. In men, seven studies evaluated the effects of MDMA on desire and/or arousal, five studies measured impact on erection, three on orgasm, and two on ejaculation. Sixty percent of interview-based studies reported increased sexual desire in men, while 40% reported mixed or no effect. Two studies reported impairment of erection, two reported mixed effects, and one reported “fear of erection impairment.” In both men and women, all studies evaluating orgasm reported delay in achieving orgasm, but increased intensity and pleasure if achieved. Primary outcome measures were variable and largely qualitative. Conclusions Our findings suggest that MDMA generally increases sexual desire and intensifies orgasm when achieved. While producing conflicting evidence on sexual arousal in both sexes, MDMA may impair erectile and ejaculatory function in men. Disclosure No.

(202) Comparative Study of the Efficacy of Avanafil and Atorvastatin Daily Dose in Management of Vasculogenic Erectile Dysfunction

Abstract Introduction Erectile dysfunction (ED) is defined as the “consistent inability to attain or maintain a penile erection, or both, sufficient for adequate sexual relations”. ED is not only a medical problem but affects the marital relations and patient's self-esteem and causes the quality of life to decrease. which in turn causes the patient to go into depression or develop anxiety. In the past, erectile dysfunction was considered, in most cases, to be a purely psychogenic disorder, but current evidence suggests that more than 80% of cases have an organic aetiology. Causes of organic erectile dysfunction can now be broadly divided into nonendocrine and endocrine. Of the nonendocrine aetiologies, vasculogenic (affecting blood supply) is the most common and can involve arterial inflow disorders and abnormalities of venous outflow (corporeal veno-occlusion). Avanafil is a second-generation phosphodiesterase type 5 inhibitor approved for erectile dysfunction by the FDA on 2012 and by EMA in 2013. With a high selectivity for phosphodiesterase type 5 isoform AND faster onset of action compared with other PDE5 inhibitors, it offers more tolerability and less adverse events. Atorvastatin is 3-hydroxy-methylglutaryl (HMG)-CoA reductase inhibitor act on the rate-limiting step in cholesterol biosynthesis (the conversion of HMG-CoA to mevalonate) and are effective in treating dyslipidemia. statins reverse endothelial dysfunction by decreasing the action of oxidized low-density lipoprotein (LDL) on endothelial cells, resulting in an increase of NO activity. Objective is to evaluate and compare the efficacy of avanafil and atorvastatin daily dose in management of patients with vasculogenic erectile dysfunction. Methods A 60 adult heterosexual males complaining of vasculogenic erectile dysfunction proven by penile duplex were collected from outpatient andrology clinics of Al-Azhar University Hospitals. The patients were divided into two treatment groups: (Group A): 30 patients received daily dose of 100 mg avanafil. (Group B): 30 patients received daily dose of 40 mg atorvastatin, The main outcome measures and the difference in penile duplex ultrasound results and IIEF-EF scores between the two groups are evaluated and compared at the end of the study, Age of patients between 20 and 50 years, established diagnoses of Vasculogenic erectile dysfunction, Normal lipid profile, Normal Total and Free testosterone levels and No contraindications to the study medications were included criteria. However patients who failed to fulfill any of the inclusion criteria, psychogenic or neurogenic erectile dysfunction, dyslipidemia Patients with Renal or Hepatic insufficiency and Patients with advanced cardiovascular diseases such as heart failure and coronary artery disease on antianginal drugs especially nitrates were excluded. Results Our study revealed statistically significant improvement in Penile Doppler ultrasonography parameters (PSV, EDV&amp; RI) and IIEF-EF scores in avanafil group compared to atorvastatin group. Conclusions avanafil 100 mg daily dose leads to significant improvement in men with vasculogenic erectile, while atorvastatin 40 mg caused no significant differences, neither positively nor adversely. In summary, avanafil at dose of 100 mg can be a therapeutic appropriate choice in cases of vasculogenic ED. Disclosure No.

Effect of a group logotherapeutic program for older adults on mental health indicators

AbstractThe study aimed to evaluate a logotherapeutic program for its potential to improve mental well‐being in the elderly. Group logotherapy programs comprising eight sessions were provided to 44 older adults. Participants completed baseline, postintervention, and follow‐up questionnaires assessing mental well‐being, self‐esteem, life satisfaction, meaning in life, and psychological distress. The logotherapeutic program did not affect outcome measures when analyzed for the total sample. Separate analyses by participants scoring below or above the respective thresholds at baseline revealed increased well‐being and self‐esteem and decreased symptoms of depression, anxiety, obsessive–compulsive disorders, and somatoform symptoms, but only in individuals who were already experiencing poor well‐being, poor self‐esteem, or some level of psychological distress before the intervention. Results suggest that the logotherapy‐based group program can be particularly effective for older adults who are already experiencing psychological distress or have lower self‐esteem.

Efficiency of PROMIS MCAT Assessments for Orthopaedic Care

ABSTRACT Administration of patient-reported outcome measures (PROs), using multidimensional computer adaptive tests (MCATs) has the potential to reduce patient burden, but the efficiency of MCAT depends on the degree to which an individual’s responses fit the psychometric properties of the assessment. Assessing patients’ symptom burden through the administration of MCATs is gaining popularity in clinical settings, especially in orthopeadics where patients reporting low physical functioning and high pain interference may not always report high levels of depression. Are MCATs more efficient and precise than unidimensional CATs in a patient profile where the person-item fit varies between symptoms? Results depend on the item selection algorithm used in the assessments. Constraining item selection algorithm can substantially reduce test lengths where person-item fit is poor. This study demonstrates how MCAT can reduce patient burden in settings where collecting PROs is becoming part of routine care. Abbreviations: PRO: Patient-reported outcome; PROMIS®: Patient-Reported Outcomes Measurement Information System; CAT: Computer Adaptive Test; IRT: item response theory; EHR: electronic health record; UCAT: unidimensional computer adaptive tests; MCAT: multidimensional computer adaptive tests; HRQOL: health-related quality of life; MEPV: minimum expected posterior variance; SE: standard error; RMSE: root mean squared error; EAP: Expected a priori; MPEV-P: minimum expected posterior variance with domain preference; KL: Kullback-Leibler.

Treatment Outcomes of Retinoblastoma in Children Less than 6 Months of Age

Treatment Outcomes of Retinoblastoma in Children Less than 6 Months of Age

Abstract B023: Modeling of new drugs clinical trials outcome with patients’ digital twins cohorts

Abstract There is a problem of clinical trial failure, as each new drug should surpass the effectiveness of existing treatment regimens, which becomes increasingly challenging over time. Another significant issue is treating patients who have developed resistance to the current therapies. Essentially, the use of drug combinations or off-label drug use, where the indication does not match the diagnosis, is akin to an experiment, as there is insufficient data on which drug or combination to use. This work proposes an approach utilizing computer modeling of patients using gene expression and clinical data. Deep learning and generative adversarial networks are employed as modeling tools. The training data for the algorithms were sourced from publicly available databases such as TCGA, Drugbank, CCLE, and GDSC. The modeling is based on the hypothesis of similarity between patients, similarity between drugs, as well as the similarity between individual organs and patient tissues with cell lines, with similarity being computed mathematically. As a result, a patient model is created, where the input consists of drugs and their combinations, and the output provides survival probability values. These model data can be generated in any required quantity with generative adversarial networks (GAN) technology to create observation and control groups. Consequently, it becomes possible to simulate clinical trials, forecasting their outcomes, and, most importantly, optimizing the trial parameters to maximize the likelihood of success. We obtained patient data and drug information from the TCGA (The Cancer Genome Atlas) database. Biologicals were excluded, and only small molecules, including targeted therapies and chemotherapeutic agents, were retained. The dataset consisted of information on 3225 patients and the effects of 161 drugs. According to our hypothesis, the patient's profile includes three groups of factors, and each of these groups contributes approximately equally to the duration of overall survival (OS) and disease-free survival (DFS) intervals. The first group comprises clinical data such as age, diagnosis, and disease stage. The second group consists of genetic data, specifically gene expression profiles, which capture the functional characteristics of genes. The third group represents the drug or combination of drugs used for patient treatment. Therefore, it is necessary to ensure that all three groups of factors have comparable dimensions of influence. For drug data, we obtained information from the DrugBank database. We represented the drug molecules using SMILES (Simplified Molecular Input Line Entry System) notation, which were then converted into 100-dimensional vectors using embedding techniques derived from natural language processing technologies. To represent combinations of drugs, we employed vector addition of the individual drug vectors. As the outcome measure for prediction, we considered numerical values representing the durations of OS and DFS intervals for each respective task. Citation Format: Dmitrii K. Chebanov, Vsevolod A. Misyurin. Modeling of new drugs clinical trials outcome with patients’ digital twins cohorts [abstract]. In: Proceedings of the AACR Special Conference on Ovarian Cancer; 2023 Oct 5-7; Boston, Massachusetts. Philadelphia (PA): AACR; Cancer Res 2024;84(5 Suppl_2):Abstract nr B023.