Initial Visit Research Articles

Effect of 2 Years of Monthly Calcifediol Administration in Postmenopausal Women with Vitamin D Insufficiency.

We assessed the long-term (24 months) efficacy and safety of monthly calcifediol (0.266 mg) in the correction and maintenance of total 25(OH)D levels in postmenopausal women with basal values <30 ng/mL. We initially enrolled 45 consecutive patients during the period September 2019-September 2020. After an initial visit, patients were instructed to return at 3, 6, 9, 12 and 24 months for measuring serum total 25(OH)D, ionised calcium, creatinine and isoenzyme of alkaline phosphatase (bALP). Here, we report only the per-protocol analysis, because the COVID-19 pandemic precluded adherence to the scheduled visits for some patients. The patients' mean age was 62.4 ± 9.0 years. Mean basal 25(OH)D levels were 20.5 ± 5.3 ng/mL. There was a continuous increase of mean 25(OH)D values (p for trend < 0.001). However, mean values at month 24 (36.7 ± 15.9) were not significantly different in respect to values at month 12 (41.2 ± 11.18). At 24 months, only 1 out 19 patients had a value <20 ng/mL. There was a significant decrease with time of mean values of bALP (p < 0.0216), with no significant changes between 12 and 24 months. No significant changes were observed as far as ionised calcium or creatinine were concerned. The long-term administration of calcifediol maintains stable and sustained 25(OH)D concentrations, with no safety concerns.

Associations between longitudinal changes in sleep stages and risk of cognitive decline in older men.

To investigate the relationships between longitudinal changes in sleep stages and the risk of cognitive decline in older men. This study included 978 community-dwelling older men who participated in the first (2003-2005) and second (2009-2012) sleep ancillary study visits of the Osteoporotic Fractures in Men Study. We examined the longitudinal changes in sleep stages at the initial and follow-up visits, and the association with concurrent clinically relevant cognitive decline during the 6.5-year follow-up. Men with low to moderate (quartile 2, Q2) and moderate increase (Q3) in N1 sleep percentage had a reduced risk of cognitive decline on the modified mini-mental state examination compared to those with a substantial increase (Q4) in N1 sleep percentage. Additionally, men who experienced a low to moderate (Q2) increase in N1 sleep percentage had a lower risk of cognitive decline on the Trails B compared with men in the reference group (Q4). Furthermore, men with the most pronounced reduction (Q1) in N2 sleep percentage had a significantly higher risk of cognitive decline on the Trails B compared to those in the reference group (Q4). No significant association was found between changes in N3 and rapid eye movement sleep and the risk of cognitive decline. Our results suggested that a relatively lower increase in N1 sleep showed a reduced risk of cognitive decline. However, a pronounced decrease in N2 sleep was associated with concurrent cognitive decline. These findings may help identify older men at risk of clinically relevant cognitive decline.

Stepped Palliative Care for Patients With Advanced Lung Cancer

Despite the evidence for early palliative care improving outcomes, it has not been widely implemented in part due to palliative care workforce limitations. To evaluate a stepped-care model to deliver less resource-intensive and more patient-centered palliative care for patients with advanced cancer. Randomized, nonblinded, noninferiority trial of stepped vs early palliative care conducted between February 12, 2018, and December 15, 2022, at 3 academic medical centers in Boston, Massachusetts, Philadelphia, Pennsylvania, and Durham, North Carolina, among 507 patients who had been diagnosed with advanced lung cancer within the past 12 weeks. Step 1 of the intervention was an initial palliative care visit within 4 weeks of enrollment and subsequent visits only at the time of a change in cancer treatment or after a hospitalization. During step 1, patients completed a measure of quality of life (QOL; Functional Assessment of Cancer Therapy-Lung [FACT-L]; range, 0-136, with higher scores indicating better QOL) every 6 weeks, and those with a 10-point or greater decrease from baseline were stepped up to meet with the palliative care clinician every 4 weeks (intervention step 2). Patients assigned to early palliative care had palliative care visits every 4 weeks after enrollment. Noninferiority (margin = -4.5) of the effect of stepped vs early palliative care on patient-reported QOL on the FACT-L at week 24. The sample (n = 507) mostly included patients with advanced non-small cell lung cancer (78.3%; mean age, 66.5 years; 51.4% female; 84.6% White). The mean number of palliative care visits by week 24 was 2.4 for stepped palliative care and 4.7 for early palliative care (adjusted mean difference, -2.3; P < .001). FACT-L scores at week 24 for the stepped palliative care group were noninferior to scores among those receiving early palliative care (adjusted FACT-L mean score, 100.6 vs 97.8, respectively; difference, 2.9; lower 1-sided 95% confidence limit, -0.1; P < .001 for noninferiority). Although the rate of end-of-life care communication was also noninferior between groups, noninferiority was not demonstrated for days in hospice (adjusted mean, 19.5 with stepped palliative care vs 34.6 with early palliative care; P = .91). A stepped-care model, with palliative care visits occurring only at key points in patients' cancer trajectories and using a decrement in QOL to trigger more intensive palliative care exposure, resulted in fewer palliative care visits without diminishing the benefits for patients' QOL. While stepped palliative care was associated with fewer days in hospice, it is a more scalable way to deliver early palliative care to enhance patient-reported outcomes. ClinicalTrials.gov Identifier: NCT03337399.

Gonadotropin-Releasing Hormone (GnRH) Agonist Protocol Improves Pregnancy Outcomes During In Vitro Fertilization (IVF) and Intracytoplasmic Sperm Injection (ICSI) Treatment in Young Infertile Women: A Retrospective Study.

Objective The objective of this study was to determine if gonadotropin-releasing hormoneagonist (GnRH-a) orgonadotropin-releasing hormoneantagonist (GnRH-ant) protocols during in vitrofertilization (IVF) or intracytoplasmic sperm injection (ICSI)treatment in younginfertile women improvetheir pregnancy outcomes. Methodology We retrospectively reviewed the records of 876young infertile women aged 20-35 years who underwentfresh embryo transfer in IVF/ICSI cycles.The data were collected from their initial visits to the reproductive medicine center ofthe Second Affiliated Hospital of Zhengzhou University between January 2019 and December 2022. We divided them into two groups according to the controlled ovarian hyperstimulation (COH) protocols: GnRH-a (n = 580) and GnRH-ant (n = 296).The primary outcome assessed in this study was the live birth rate. The secondary observation indicators included the total dose and duration of gonadotropin (Gn),total embryo transfer,day three (D3) embryo transfer, total two pro-nuclei (2PN) cleavage count, number of fertilizations, and implantation rate. Results The live birth rate had no clinical significance (P> 0.05). The total dose and duration of Gn stimulation in the GnRH-ant group were lower than in the GnRH-a group (P < 0.05). The total embryo transfer, D3 embryo transfer, total cleavage count, total 2PN cleavage count, number of fertilizations, transfer, and mature oocytes in metaphase II (MII) of D3 embryos in the GnRH-a group were higher than those in the GnRH-ant group (P < 0.05). The clinical pregnancy rate and implantation rate of the GnRH-a group were higher than those of the control group. Conclusions The total embryo transfer, D3 embryo transfer, total cleavage count, total 2PN cleavage count, number of fertilizations, transfer and MII of D3 embryos, clinical pregnancy, and implantation rateswere significantly higher in the GnRH-a protocol group.The total dosage of Gn and duration of Gn stimulation were lower in the GnRH-ant group than in the GnRH-a group. These findings provide the basis for the selection of the COH protocol in normal Chinese ovarian response patients undergoing IVF/ICSI.

A Case of Nonarteritic Anterior Ischemic Optic Neuropathy that Recurred in the same Eye within a Month

A 78-year-old woman presented with an upper visual field defect in the left eye. On ophthalmic examination, her best-corrected visual acuity (BCVA) was 1.2 in both eyes. Fundoscopy revealed inferior optic disc swelling. Goldmann visual field test showed an upper visual field defect. The patient was diagnosed with nonarteritic anterior ischemic optic neuropathy (NAION) of the left eye and was followed up without treatment. One month after the initial visit, her BCVA decreased to 0.15 in the left eye. Fundoscopy revealed superior optic disc swelling. Goldmann visual field test showed an inferior visual field defect and central relative scotoma. Based on her clinical findings, she was diagnosed with recurrent NAION. Three months after the initial visit, her BCVA was 0.2 in the left eye, and the optic nerve developed atrophy. This case highlights the importance for clinicians to be aware of NAION recurred in the same eye within a short period of time.

The burden of significant pain in the cirrhosis population: Risk factors, analgesic use, and impact on health care utilization and clinical outcomes.

We aimed to characterize pain and analgesic use in a large contemporary cohort of patients with cirrhosis and to associate pain with unplanned health care utilization and clinical outcomes in this population. We included all patients with cirrhosis seen in UCSF hepatology clinics from 2013 to 2020. Pain severity and location were determined using documented pain scores at the initial visit; "significant pain" was defined as moderate or severe using established cutoffs. Demographic, clinical, and medication data were abstracted from electronic medical records. Associations between significant pain and our primary outcome of 1-year unplanned health care utilization (ie, emergency department visit or hospitalization) and our secondary outcomes of mortality and liver transplantation were explored in multivariable models. Among 5333 patients with cirrhosis, 32% had a nonzero pain score at their initial visit and 25% had significant (ie moderate/severe) pain. Sixty percent of patients with significant pain used ≥1 analgesic; 34% used opioids. Patients with cirrhosis with significant pain had similar Model for End-Stage Liver Disease-Sodium scores (14 vs. 13), but higher rates of decompensation (65% vs. 55%). The most common pain location was the abdomen (44%). Patients with abdominal pain, compared to pain in other locations, were more likely to have decompensation (72% vs. 56%). Significant pain was independently associated with unplanned health care utilization (adjusted odds ratio: 1.3, 95% CI: 1.1-1.5) and mortality (adjusted hazard ratio: 1.4, 95% CI: 1.2-1.6). Pain among patients with cirrhosis is often not well-controlled despite analgesic use, and significant pain is associated with unplanned health care utilization and mortality in this population. Effectively identifying and treating pain are essential in reducing costs and improving quality of life and outcomes among patients with cirrhosis.

Quality of life in patients with malignant wounds treated at a wound care clinic.

e24075 Background: Malignant wounds can present in up to 14.5% of patients with advanced cancer, significantly reducing quality of life (QoL). Patients with chronic leg ulcers experienced improved QoL, as determined by a reduction in Skindex-16 score after treatment at a dedicated wound care clinic. We sought to assess the effect of wound care clinics on QoL in patients with malignant wounds. Objectives: To describe the baseline QoL, physical symptoms, and treatment modalities that affect QoL in patients with malignant wounds. To assess changes in QoL over time of patients attending a wound care clinic. Methods: This retrospective study included 36 patients seen from 1/1/2016 - 4/1/2023 at a wound care clinic at an oncologic hospital with at least one completed Skindex-16 questionnaire, which is a validated measure of the effects of skin diseases on QoL. Data were extracted from the electronic medical record. Descriptive statistics, graphical methods, and random effects models for change were used to describe the patient population and the QoL measures over time. Results: Of the 36 patients who completed at least one Skindex-16 questionnaire, 69% were female, and 50% developed malignant wounds from metastatic breast cancer, 22.2% from cutaneous squamous cell carcinoma, and 27.8% from various malignancies such as sarcoma. Most patients had advanced cancer; 9.7% were stage II, 41.9% stage III, and 48.4% stage IV. At the initial visit, patients had drainage associated with their wound 86.1% of the time, odor 47.2%, bleeding 63.9%, pain 69.4%, and itch 50% of the time. Patients were treated with dressings 100% of the time, and 88.2% of patients received topical treatment for odor, 73.9% received topical treatment for bleeding, 55.6% topical itch treatment, 44% topical pain treatment, 36% gabapentin, and 24% received an opioid. The median baseline Skindex-16 score was 59.5, falling into the “extremely severe” category, with a median score of 17.5, 21, and 23 for the symptom, emotion, and function domains, respectively. Nineteen patients completed an additional Skindex-16 questionnaire at follow up visits (visit two 52.8%, visit three 33.3%, visit four 19.4%, visit five or greater 13.9%). Compared to the median Skindex-16 score at baseline, there was a 34.5% improvement at visit two, 45.4% at visit three, 73.1% at visit four, and 83.2% improvement in QoL at visit five or more. Conclusions: Malignant wounds severely reduce patients’ quality of life; however, patients experienced significantly improved quality of life after being treated at dedicated wound clinics.

Geriatric assessment-directed supportive care intervention (GAIN-S)-implementation via telehealth in a lower-resourced community.

1510 Background: Based on randomized controlled trials,ASCO guidelines recommend use of geriatric assessment (GA)-directed interventions for older adults with cancer. The translation of these models to lower resourced settings has been limited. We assessed the feasibility of implementing GA-directed supportive care (GAIN-S) via telehealth in a lower resourced community setting. Methods: A quality improvement study was conducted in a high poverty, limited access, and low resourced community oncology practice (City of Hope - Antelope Valley [COH-AV]). Eligible participants were 65+ years with a new diagnosis of a malignant neoplasm under evaluation for cancer therapy. Before starting therapy, patients completed: baseline GA, SupportScreen, and the Fulmer SPICES assessment. A geriatric nurse practitioner (GNP) reviewed GA results and implemented multidisciplinary supportive care interventions (GAIN-S) via telehealth between April 2020 and January 2023. Key evaluation measures included: number of patients who completed GAIN-S; number of referrals to multidisciplinary supportive care services and completion rate; advance directives (ADs); and patient satisfaction with telehealth visits. Participants’ demographics, including distance traveled for care, type of cancer, stage, treatment, and telehealth satisfaction items, were summarized using descriptive statistics. To analyze and visualize the implementation process, run charts were utilized. Results: 251 patients (mean age 74, 62% Non-Hispanic White, 22% live 60+ miles from COH-AV, 56% stage II or less, 30% received chemotherapy) completed baseline assessments. 242 had initial visits with GNP, 197 via televideo and 45 via telephone. GNP reviewed vulnerabilities with 209 patients and generated 460 referrals for supportive care services, with 85% of services implemented. Highest numbers of referrals were to pharmacy (177), social work (142), occupational therapy (76), and physical therapy (48). GNP discussed GA-guided care plans with all patients and 43 patients completed AD after discussion with GNP. Over 92% of patients were satisfied with telehealth-based GAIN-S in terms of both ease of visit and access to care with their provider and with telehealth. Conclusions: Telehealth-based GAIN-S has proven to be feasible in providing accessible healthcare to older patients with cancer in a lower resourced community setting. This approach, well-received by most patients, highlights the potential of telehealth in delivering GAIN-S effectively in such settings.

Peripapillary Hyperreflective Ovoid Mass-Like Structures in a Patient with Nonarteritic Anterior Ischemic Optic Neuropathy

A 78-year-old woman presented with an upper visual field defect in the left eye. Her best-corrected visual acuity (BCVA) was 1.2 in both eyes. Fundoscopy revealed inferior optic disc swelling. Peripapillary optical coherence tomography (OCT) demonstrated the presence of peripapillary hyperreflective ovoid mass–like structures (PHOMS) that was located in the inferior portion of the left eye. The patient was diagnosed with nonarteritic anterior ischemic optic neuropathy (NAION) of the left eye. One month after the initial visit, her BCVA decreased to 0.15 in the left eye. Fundoscopy revealed superior optic disc swelling. OCT demonstrated the presence of PHOMS that was located in the superior portion of the left eye. She was diagnosed with recurrent NAION. Three months later, her BCVA was maintained at 0.2, however, the optic disc looked diffusely pale. This case highlights the importance for clinicians to be aware of PHOMS with NAION.

Impact of Migraine and Vestibular Migraine on Audiometric Profiles and Quality of Life in Patients With Tinnitus.

To investigate the clinical manifestations and complete auditory function in primary tinnitus patients with and without migraine or vestibular migraine. Retrospective case-control study. A tertiary referral center. This study enrolled 298 patients from the Kaohsiung Veterans General Hospital. All patients were diagnosed with primary tinnitus by a neurotologist between April 2020 and August 2021. Patients were excluded if they had histories of chronic otitis media, idiopathic sudden sensorineural hearing loss, Ménière's disease, skull base neoplasm, or temporal bone trauma. Twenty-five-item Tinnitus Handicap Inventory (THI), speech audiometry including speech recognition threshold, most comfortable level, uncomfortable loudness levels, dynamic range, and pure-tone audiometry. Objective hearing loss is defined as a mean threshold greater than 25 dB. Extremely elevated THI is defined as a score greater than 1 standard deviation above the mean THI. Among the 298 patients with tinnitus, 149 were women and 149 were men, with a mean age of 57.06 (range, 19.22-94.58) years.A total of 125 patients completed the THI questionnaire during their initial visit. The median THI score was 32 (95% confidence interval: 13.98-56.00), and the mean score was 34.99 with a standard deviation of 21.01. The sole contributing factor significantly associated with higher total THI score was the diagnosis of migraine or vestibular migraine (p < 0.001, odds ratio = 19.41).Tinnitus patients with migraine or vestibular migraine exhibited significantly lower mean pure-tone auditory thresholds (right 22.2 versus 29.5, p = 0.002; left 22.5 versus 30.4, p < 0.001), speech recognition threshold (right 20.0 versus 25.2, p = 0.016; left 20.2 versus 25.5, p = 0.019), and most comfortable levels values (right 46.1 versus 51.4, p = 0.007; left 46.9 versus 51.4, p = 0.021) compared with the tinnitus patients without migraine. In this population-based study, patients with primary tinnitus experienced significantly higher THI scores and exhibited concurrent symptoms, including dizziness/vertigo, cervicalgia, and migraine or vestibular migraine. Among these parameters, the diagnosis of migraine or vestibular migraine was the sole contributor to significant higher THI score.

Telehealth consultations and recruitment trends in clinical trials: A retrospective analysis at investigational cancer therapeutics, a dedicated phase I department at The University of Texas MD Anderson Cancer Center.

1635 Background: Recruitment to phase I/II clinical trials have been reported to vary between 30% and 55% across centers, primarily relying on in-person visits. However, with the onset of the COVID-19 pandemic, there has been a noticeable surge in telehealth consultations. Consequently, there is currently a dearth of data available regarding this approach within the context of early phase-clinical trials. Methods: Data on patient’s first visits to the Investigational Cancer Therapeutics (ICT), a dedicated Phase I department at The University of Texas MD Anderson Cancer Center (MDACC), were retrieved from the institution's electronic platform. The ICT department offers phase I-II clinical trials for patients with advanced cancer. We included first visits between January 2020 and December 2023. Initial telehealth visits were conducted via video or telephone, with patients from either Texas or other states in the United States. Visits were classified into two groups: internal referrals, originating from other departments within MDACC, and new patient visits, including patients who had not been seen at MDACC prior to the ICT visit. Recruitment was defined as the percentage of patients who consented to participate in a clinical trial. Statistical analysis was performed using Statistical Package for Social Sciences (SPSS). Results: A total of 6,965 patients had a first visit in the Investigational Cancer Therapeutics Department between January 2020 and December 2023. Of these, 4,321 patients (62%) had their initial in-person visit, while 2,644 patients (38%) opted for telehealth consultations. Internal referrals accounted for 6,304 patients (90.5%), while new patient visits comprised 661 patients (9.5%). Among the entire cohort, recruitment rate for phase I-II clinical trials was 53.2% (n= 3,702). Patients with initial telehealth consultations had a recruitment rate of 55.1%, compared to 52.0% among those with in-person consultations (χ2=6.538, p&lt;0.011). Recruitment was higher among internal referrals at 53.7% compared to 47.5% for external referrals (χ2= 9.355, p=0.002). Notably, recruitment was statistically higher in internal consults that underwent telehealth versus in-person visits (55.4% versus 52.6%, p=0.027), while there were no statistical differences in new patient visits (47.4% vs. 47.8%, p=0.939). Conclusions: Telemedicine consultations emerge as a valuable alternative for evaluating and discussing treatment options for patients with advanced solid tumors, thereby enhancing accessibility to early-phase clinical trials. The flexibility of conducting initial visits remotely may mitigate geographical and logistical challenges and allow for a more inclusive and diverse participant pool, fostering broader representation in clinical trial research.

Un "boxing" the reality: Knowledge, attitude, and perception of orthodontists, dental practitioners, and orthodontic patients toward mouthguards' wear during contact sports-A cross-sectional study.

Mouthguards (MGs) have the potential to prevent contact sport-related dental injuries. However, varying perceptions of their effectiveness persist, influencing recommendations by dental professionals. To assess the attitudes, knowledge, and perceptions of orthodontists, other dental practitioners (general dentists and other dental specialists), and orthodontic patients involved in contact sports regarding the use of MGs. A cross-sectional survey was designed to collect information from dental clinicians (orthodontists and other dental practitioners) and their orthodontic patients about using MGs during sports participation. A convenience sampling technique was used to recruit the participants for an online survey. A total of 107 (32 males/75 females) dental clinicians and 147 (75 males/72 females) orthodontic patients (mean age 17.5 ± 5.84 years) participated in the study. Pre-validated questionnaires, specifically designed for dental clinicians and orthodontic patients, were used. Data were analyzed using SPSS software (version 28.0; SPSS). Nearly 50% of dental clinicians have recently recommended MGs to their patients in their clinical practice out of which 59% preferred the stock type; 33% of dental clinicians enquired their patients about involvement in contact sports during initial visits. The majority of orthodontic patients acquired knowledge about MGs through the Internet. More than half of orthodontic patients expressed unwillingness to pay for MGs, and 89% of orthodontic patients found using MGs during contact sports uncomfortable. The findings provide valuable insights into the practices and attitudes of dental clinicians and orthodontic patients regarding MGs, their recommendations, and the comfort levels associated with using them during contact sports.

Implementation of universal germline testing in underserved patients with young onset gastrointestinal cancer.

10602 Background: Universal germline testing (UGT) in solid cancer patients increases the detection of pathogenic germline variants (PGVs) over guideline-based testing. There is a rising incidence of young onset (YO) gastrointestinal (GI) cancers (50 years and under). PGV rates in this population can be as high as 20%, highlighting the benefit of UGT. Underserved populations experience significant disparities in germline testing. The primary aim of this study is to evaluate rates of germline testing among patients with young onset (YO) GI cancers in a large safety net population and identify barriers and facilitators of testing in order to improve the process. Methods: In this retrospective study, we identified 202 patients ages 18-50 diagnosed with GI cancers between January 2019 and December 2022 at the Lyndon B. Johnson Hospital. Demographic and clinical data were collected and the rate, outcome and process of standard of care germline testing evaluated. Paired T-tests were used to identify factors associated with timeliness and completion of germline. Results: The majority of patients had colorectal (68%) followed by gastro-esophageal cancers (16%). Median age at diagnosis was 42 years. One third were diagnosed with stage IV disease. Half of all patients were recipients of financial assistance based on household income less than 150% of the Federal Poverty Level. Spanish was the primary language spoken by 58% of patients. Among all patients, 148 (73%) were referred to a genetics counselor with germline testing offered in 111 (55%) and completed in 99 (49%). PGVs were identified in 17% of patients tested while variants of uncertain significance were found in 19%. Patients with colon cancer (p&lt;0.001), microsatellite instability on immunohistochemistry (p&lt;0.001), and those with a first-degree relative with cancer (p&lt;0.001) were more likely to complete genetic testing. The average time from initial oncology visit to genetics referral was 20 weeks while that from referral to genetics appointment was 22.5 weeks. The average time from genetics appointment to completion of testing was 14.5 weeks. Patients with private insurance had a significantly shorter time to genetics referral (p&lt;0.05) while English-speakers had a longer time from referral to initial genetics appointment (p 0.019) and to completion of testing (p 0.044). Uninsured patients had significantly lengthier times to test completion (p 0.013). Conclusions: PGVs were detected in 17% of patients with YO GI cancers. Along the genetics services care delivery continuum, patient selection for genetic counselor referral, uptake of genetic testing and timeliness of testing were identified as key barriers to germline testing. Given the high detection rate and barriers to testing identified in this underserved population, we have designed a multilevel intervention aimed at optimizing the implementation of UGT in patients with YO GI cancers.

Evaluation of cancer screening services provided for people living with HIV in Botswana, 2022-2023.

People living with human immunodeficiency virus (PLHIV) have an increased risk of cancers. Currently, Botswana has no screening guidelines for common cancers in PLHIV except cervical cancer. Also, the proportion of PLHIV who are screened for cancer is unknown. This study aimed to evaluate cancer screening services for PLHIV receiving care in the human immunodeficiency virus (HIV) clinics. Resources for cancer screening were assessed and medical records of adults initiating antiretroviral therapy (ART) from 2020 to 2021 in 20 high-volume HIV clinics in Gaborone and Francistown were reviewed. Questionnaires assessing knowledge and practices of cancer screening were administered to health workers. The majority of clinics had the required resources for cancer screening (specifically cervical cancer). Of the 62 health workers working at the HIV clinics, 57 (91.9%) completed the questionnaire: 35 (62.5%) nurses and 22 (37.5%) doctors. Only 26.3% of the health workers were trained in cervical cancer screening. Doctors were more likely to report practicing routine screening of other cancers (e.g. breast) (p = 0.003) while more nurses reported assessing patients for cancer history during follow-up visits (p = 0.036). Most health workers did not perform physical examinations to detect cancer at initial or follow-up visits. Of the 1000 records of PLHIV reviewed, 57.3% were females, and only 38% of these were screened for cervical cancer. Besides cervical cancer, almost all (97.8%) were not screened for any cancer at ART initiation and during follow-up. These findings highlight the need to improve cancer screening services of PLHIV in Botswana through the training of health workers, and the development and enhanced use of screening guidelines.

Patient satisfaction with cancer care delivery through telemedicine at a comprehensive cancer center across three years during and after the COVID-19 pandemic.

1632 Background: Telemedicine, once sparingly utilized, surged during the COVID-19 pandemic to enhance care accessibility and safety concerns. Despite initial satisfaction, its usage remains highly variable across institutions. We sought to explore patient satisfaction at a comprehensive cancer center, associations with demographic characteristics, and change over time. Methods: A survey was sent to all first-time telemedicine users at Memorial Sloan Kettering Cancer Center from September 2021 to October 2023. Adult patients who had their initial telemedicine visit, regardless of specialty, received the questionnaire. It comprised 10 general questions about the telemedicine experience and 11 questions regarding clinical trial education and informed consent. To analyze the unstructured free text responses, we employed BERTopic, a topic modeling algorithm that leverages transformer-based embeddings to facilitate the creation of easily interpretable topics within a collection of text documents. Through topic modeling with BERT embeddings, we captured subtle nuances and semantic relationships in language to identify topics more effectively. Results: A total of 15,111 patients completed 15,251 questionnaires; 140 patients completing two surveys. Patient demographics are summarized in Table 1; the median age at encounter was 66 years and 98% of patients preferred English. Satisfaction levels were high, with 92% expressing willingness for future telemedicine visits and 90% recommending it to other patients. Notably, 21% found telemedicine superior to in-person visits, while 53% considered them equal. Further, satisfaction remained consistent across six-month intervals from 2021-2023. In 1606 (11%) surveys, patients noted discussing clinical trials; 17% preferred in-person discussions for the informed consent process while most either preferred telemedicine or had no preference. Topic modeling revealed 18 topics within the unstructured dataset; key topics included comments on video &amp; audio quality, connectivity and technology issues, convenience for patients who live outside of the city and those with physical limitations, and long wait time to see a doctor. Conclusions: Our analysis confirms high patient satisfaction with telemedicine, including discussions on clinical trial enrollment, that has remained consistent in the years following the COVID-19 pandemic. Given variability in use, it is important to identify how to better deliver telemedicine to those patients who prefer it.[Table: see text]

Implementing geriatric assessment for dose optimization of CDK 4/6 inhibitors in older breast cancer patients (IMPORTANT trial): A pragmatic randomized-controlled trial.

TPS1132 Background: Current evidence from both randomized trials and real-world evidence studies suggests that older patients with advanced hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) breast cancer derive clinical benefit from the addition of cyclin-dependent kinase 4 and 6 (CDK4/6) inhibitors to endocrine therapy. However, a higher risk for adverse events due to CDK4/6 inhibitors among older patients is evident, leading to a trend of initiating CDK4/6 inhibitors at a lower dose in clinical practice, though without evidence. The aim of the present randomized trial is to investigate whether lower initial dose of CDK4/6 inhibitors combined with endocrine therapy is comparable to full dose in older patients with advanced HR+/HER2-breast cancer that are assessed as vulnerable/frail based on comprehensive geriatric assessment (CGA). Methods: We designed a multi-national, open-label, pragmatic randomized controlled trial with non-inferiority approach. Patients ≥70 years old with advanced HR+/HER2- breast cancer with no curative intention, no prior treatment in an advanced setting, and suitable to receive a combination of CDK4/6 inhibitors plus endocrine therapy according to treating physician, are eligible for study inclusion. After informed consent, included patients fill out a self-administered CGA tool and categorized accordingly to fit, vulnerable, or frail, depending on the number of impaired CGA domains. Fit patients receive full dose of CDK4/6 inhibitors and endocrine therapy whereas vulnerable/frail patients are randomized to either -1 level lower CDK4/6 inhibitor dose or full dose and endocrine therapy. The randomization is stratified by type of CDK 4/6 inhibitor, type of endocrine therapy, and level of vulnerability. The treating physician decides on the choice of CDK4/6 inhibitor (abemaciclib, ribociclib, palbociclib) and endocrine therapy (aromatase inhibitors, fulvestrant). The primary endpoint is time to treatment failure whereas secondary endpoints include overall treatment utility, progression-free survival, overall survival, time to chemotherapy initiation, toxicity, quality-of-life, time to quality-of-life deterioration and cost-effectiveness. The evaluation of disease progression, toxicity assessment, and the follow-up strategy resembles clinical practice to enhance the pragmatic design approach of IMPORTANT trial. The trial also enables a hybrid decentralized approach where the initial patient visit is in-person whereas the visits for efficacy and toxicity evaluation can be performed digitally according to local practices. In total, 495 patients are planned to be included to allow 346 vulnerable/frail patients to be randomized. Enrollment: The trial is open for recruitment since February 2024 with a recruitment period of 30 months. Clinical trial information: NCT06044623 .

Telehealth in Urology Beyond COVID-19

Introduction: Implementation of telehealth (TH) accelerated during the COVID-19 pandemic and has become a vital part of health care delivery. As we move toward the post-COVID-19 era, clinical practice has demonstrated a need for updated policies and quality improvement to solidify the role of TH in the urology care setting. The AUA Census data were used to explore trends, benefits, and barriers to urology TH implementation. Methods: The AUA Workforce Workgroup and Telehealth Taskforce analyzed data from the 2019-2022 AUA Census. Pertinent variables included utilization, patient satisfaction, care settings, quality, and diagnoses amenable to TH. Results: Pre-COVID-19 TH utilization increased from 11.9% to 81% during and after the COVID-19 pandemic. TH is predominately used in metropolitan academic centers, with usage increasing from 12.8% to 83% in these areas during the pandemic. Usage also increased in non-metropolitan areas from 3.8% to 61.2%. Overall, 76.7% reported increased ease of scheduling follow-ups, 62% ease of ordering tests, and 69.5% ease of accessing patient data in favor of audio visits vs in-person visits. TH utilization increased from 42.4% to 65% for initial visits and 66.8% to 82% for follow-up visits. Over 80% of practicing urologists younger than 54 years desire the use of telemedicine for follow-up visits. TH increased patient access to care by 51.6%, and 54% of urologists expressed desire to continue using or increase utilization of TH. The top 3 barriers of patient’s ability to receive telemedicine were 67.6% noting lack of knowledge in using patient portal/software needed for telemedicine visits, 49.6% had lack of adequate conferencing tools, and 43.9% lacked high-speed internet service to enable video visits. In total, 53.4% of urologists would absolutely or probably increase usage if payment parity of TH was comparable with that of in-office E/M services. Conclusion: TH implementation accelerated during the COVID-19 era. In the post-COVID-19 era, TH continues to be important across multiple areas including patient and physician satisfaction and increasing access to care, particularly in rural areas. Barriers exist, especially concerning payment parity, and could be eliminated through advocacy for policy updates and standardization of technology.

Rethinking the Abnormal Uterine Bleeding Consult: Creating a Patient-Centered, See-and-Treat Model of Care

Historically, the evaluation of abnormal uterine bleeding (AUB) has involved a multi-visit process that uses a multitude of care settings (eg, in-office, imaging, laboratory), with the potential for lengthy delays in care due to the now-commonplace scheduling difficulties many clinics face. Although there is strong evidence for the use of in-office uterine assessment as a best practice, uptake has been limited by the learning curve, technology acquisition costs, and other factors. However, due to the coronavirus disease 2019 (COVID-19) pandemic, clinical practice has faced rapid adaptations that have resulted in the redesigned clinical care model of evaluating this common gynecologic condition in a more patient-centered and streamlined way while maximizing the patient experience, health care efficiency, and physician engagement. This procedure would specifically involve one telehealth or initial visit to assess patient history, perform necessary laboratory testing, review results, and plan outpatient procedures to be conducted in the office or the operating room. Due to the COVID-19 pandemic, clinics have, by necessity, implemented this proposed reimagined pathway in a variety of outpatient settings nationally. We propose that, moving forward, this new procedure be permanently adopted in clinics nationwide as the patient-focused evaluation strategy for AUB.

Surgical Treatment of Neovascular Glaucoma Secondary to Proliferative Diabetic Retinopathy in Japanese Patients without the Use of Glaucoma Drainage Devices.

Purpose: The purpose of this study is to investigate outcomes of visual acuity (VA) and intraocular pressure (IOP) in proliferative diabetic retinopathy (PDR)-associated neovascular glaucoma (NVG) in Japanese patients treated with surgical therapies without the use of glaucoma drainage devices. Methods: A retrospective analysis of medical records was conducted for 31 consecutive PDR-associated NVG patients who underwent surgical treatments in our institution between 2013 and 2022. Patient demographics, clinical characteristics, VA, and IOP were recorded at the first and last visits, and surgical procedures, including pars plana vitrectomy with extensive panretinal and ciliary photocoagulation (PPV-PRCP), diode laser trans-scleral cyclophotocoagulation (DCPC), and trabeculectomy with mitomycin C (TLE-MMC), with or without a prior intravitreal bevacizumab (IVB) injection, were reviewed. Results: Of the thirty-one PDR patients with NVG, two patients received PPV-PRCP or DCPC alone (6.5%), respectively, three patients received TLE-MMC alone (9.7%), two patients received TLE-MMC after IVB (6.5%), six patients received PPV-PRCP and TLE-MMC (19.4%), seven patients received PPV-PRCP and TLE-MMC after IVB (22.6%), five patients received PPV-PRCP and DCPC and TLE-MMC (16.1%), and four patients received PPV-PRCP and DCPC and TLE-MMC after IVB (12.9%). The VA of two patients (6.5%) deteriorated to no light perception. In all patients, the mean logMAR VA was 1.28 ± 1.05 at the first visit and remained at 1.26 ± 1.08 at the last visit, with no significant change; the mean IOP was 33.0 ± 15.2 mmHg at the initial visit and decreased significantly to 14.0 ± 7.4 mmHg at the last visit. The number of eyes with IOP ≥ 21 decreased from twenty-eight (90.3%) to three (9.7%). Although IOP in patients with IOP > 30 mmHg at the initial visit reduced to a level comparable to that of patients with IOP ≤ 30 mmHg, the IOP > 30 mmHg group received IVB more frequently and had significantly higher logMAR VA at the last visit compared to the IOP ≤ 30 mmHg group. Hypotony (<6 mmHg) was observed in four eyes (12.9%). Conclusions: In PDR patients with NVG, various combinations of PPV-PRCP, DCPC, and TLE-MMC after adjunctive IVB without the use of glaucoma drainage devices lowered IOP sufficiently; for these patients, neovascular regression was observed, with no further deterioration of VA. However, surgical procedures should be performed for PDR patients with NVG before visual impairment occurs. On the other hand, approximately less than 15% of patients developed blindness or low IOP.

A retrospective study on the clinical characteristics and treatment outcomes of patients with burning mouth syndrome.

Burning mouth syndrome (BMS) refers to a condition characterized by pain sensations such as burning or tingling, or sensory disturbances in the tongue or oral mucosa without any specific local or systemic cause for more than 3 months. This study retrospectively investigated the clinical characteristics of 248 BMS patients (217 women, 31 men, mean age 64.7±11.2 years). Treatment outcomes were assessed using the Numeric Rating Scale (NRS). Parafunctional habit control education, saliva substitute, and counselling for psychological stability were implemented at the first visit, resulting in a significant reduction in NRS scores at the second visit. Medication such as clonazepam or zinc supplements were administered from the second to fourth visit, leading to a significant reduction in NRS scores compared to the initial visit. The various treatment options can be applied to alleviate the symptoms of BMS. Forty-eight patients (19.35%) exhibited serum zinc concentration of 70μg/dL or lower. A well-designed clinical study with a large number of patients is needed to compare the therapeutic effects between underlying conditions, medications, and nutritional supplementation including zinc.