Patient Convenience Research Articles

FIGO-GCH joint consensus statement on the current status and recommendations for the use of blind intrauterine procedures in the evaluation and management of women withsuspected intrauterine pathologies.

Historically, blind intrauterine procedures such as dilation and curettage (D&C) and blind endometrial biopsies have been the primary approach for diagnosing and managing intrauterine pathologies. However, these techniques lack direct visualization, leading to diagnostic limitations, incomplete treatment, and increased complication rates. Despite substantial advances in hysteroscopic technology, including high-definition imaging and minimally invasive instruments, blind procedures remain widely used. This paper examines the limitations of blind intrauterine procedures, underscoring the advantages of hysteroscopy, which provides real-time visualization and allows for more accurate, targeted interventions. With the adoption of the "See and Treat" philosophy, hysteroscopy enables nearly 90% of procedures to be performed in an office setting, enhancing both patient convenience and outcomes. FIGO and GCH advocate for the gradual replacement of blind procedures with hysteroscopic approaches whenever feasible, noting that hysteroscopy improves diagnostic accuracy, reduces risks, and minimizes the need for repeat interventions. Recommendations include expanding access to hysteroscopy through targeted training, especially in low- and middle-income countries, where financial and logistical barriers limit access to advanced gynecological care. Furthermore, this paper emphasizes the importance of patient-centered care, encouraging transparent counseling to support informed decision-making.

The usefulness of an application-supported nutritional intervention on non-high-density lipoprotein cholesterol in people with a risk of lifestyle-related diseases.

Lifestyle-related diseases, such as diabetes, are mostly caused by poor lifestyle habits; therefore, modifying these habits is important. In Japan, a system of specific health checkups (SHC) and specific health guidance (SHG) was introduced in 2008. The challenges faced include low retention rates and difficulty in maintaining results. Digital technologies can support self-management and increase patient convenience, although evidence of the usefulness of this technology for SHG is limited. This study evaluated the usefulness of nutritional guidance using a smartphone application (app) added to conventional SHG. We recruited eligible participants for SHG in Japan from November 2018 to March 2020. We assigned them to "Intervention Group: Application-Supported Nutrition Therapy" or "Control Group: Human Nutrition Therapy" based on their desire to use the app. The primary outcome was a change in non-high-density lipoprotein cholesterol (non-HDL-C) levels post-intervention. The secondary outcomes were a change in lipid profile, metabolic indices, and frequency of logins to the app. We assessed 109 participants in two cohorts: 3-month (short-term) and 6-month (long-term). The short-term cohort had 23 intervention and 29 control participants, while the long-term cohort had 35 and 22, respectively. There was a significant improvement in non-HDL-C levels in the short-term intervention group compared to the control group. There was no significant difference in non-HDL-C levels in the long-term groups or at 1 year. There were significant improvements in body weight (BW) in the short-term cohort until 1 year compared within the groups. The retention rate remained high in the short-term cohort (92%) but decreased to 57.8% at 6 months in the long-term cohort. Using an app system to facilitate dietary recordings and guidance for patients at risk of lifestyle-related diseases led to improved lipid levels and BW. These benefits persisted to some extent after 1 year. This app may partially supplement conventional SHG.

Assessment of Administrative Services in State Mental Health Hospitals Among Muslim Patients in the Kingdom of Saudi Arabia: A Descriptive Study

Kingdom of Saudi Arabia (KSA) leads mental health research in the Arabic world, addressing challenges for Muslim patients seeking treatment at hospitals. This study aims to evaluate the quality of administrative services at public mental health hospitals, as perceived by Muslim recipients in the KSA. This descriptive quantitative study used a self-reported questionnaire to collect data from 200 public mental health service recipients in the KSA from 4 January 2022 to 4 March 2022. More than 95% of participants were optimistic about the entry process procedures. Approximately 88% of the participants accepted the policies for booking an appointment with a doctor. The study’s findings highlight the need to streamline and improve the communication of administrative procedures to provide recipients with optimal clarity and convenience. By addressing the moderately reported issues with policy transparency related to visit cancellations, referrals, and treatment completion, patient satisfaction and compliance could be improved, leading to a more efficient and patient-centred healthcare experience. These findings underscore the importance of streamlining administrative procedures to enhance clarity and convenience for Muslim patients, ultimately contributing to a more patient-centred healthcare experience in mental health hospitals in the KSA.

Daily versus Twice Daily Nifedipine for Blood Pressure Control in Pregnancy and Postpartum.

The objective of this study was to compare 60mg daily (QD) extended released (XR) nifedipine to 30mg twice daily (BID) for blood pressure (BP) control antepartum and postpartum. This is a retrospective chart review conducted at the Mount Sinai Health System. Patients admitted from 1/1/2015-4/30/2021, diagnosed with a hypertensive disorder of pregnancy, who received nifedipine XR 30mg BID or 60mg QD for intrapartum or postpartum BP control were included. Primary outcome was need for up titration (i.e., need for increase in nifedipine dose or addition of another anti-hypertensive) after reaching one of the study doses (30mg BID or 60mg QD). Patients were excluded if they had preexisting renal disease or were already on oral anti-hypertensives. In a 1:1 ratio between single and twice daily dosing groups, the sample size needed to detect a 20% difference in up-titration rate to achieve 0.80 power is 97 patients per group, for a total of 194 patients. This is based on a Pearson Chi-square test with a significance level of 0.05. 237 patients were included, 139 (59%) received 30 mg BID and 98 (41 %) 60 mg QD. There was no statistically significant difference in the need for increase in nifedipine dose or addition of another oral anti-hypertensive agent between those receiving 30mg BID versus 60mg QD (33.8% vs 35.7%; aOR (95% CI): 0.90 (0.50-1.60); p=0.71). There was no difference in need for emergency hypertensive treatment after reaching study dose (p=0.19) or readmission for BP control between groups (p>0.99). These findings suggest that BID dosing does not confer better blood pressure control in the antepartum or postpartum periods. Thus, daily dosing is reasonable and may be preferable for patient convenience and compliance.

Pharmacokinetics of Tarlatamab, a Delta-Like Ligand-3 (DLL3) Targeted Half-Life Extended Bispecific T-Cell Engager (BiTE®) Immunotherapy in Adult Patients with Previously Treated Small-Cell Lung Cancer: Results from DeLLphi-300, a Phase I Multiple-Dose-Escalation Study.

Tarlatamab binds to delta-like ligand 3 on cancer cells and cluster of differentiation-3 on T cells, leading to T-cell-mediated tumor lysis, and has demonstrated a promising safety and efficacy profile in patients with previously treated small-cell lung cancer (SCLC). Here, we present pharmacokinetic results from DeLLphi-300 (NCT03319940), an ongoing international, open-label, first-in-human study in previously treated adult patients with SCLC. Multiple escalating doses of tarlatamab were administered every 2 weeks (Q2W; 0.003, 0.01, 0.03, 0.1, 0.3, 1, 3, 10, 30, and 100 mg) in a 28-day cycle. To reduce the risk of cytokine-release syndrome, starting at the 3 mg dose level, a step dose regimen was employed consisting of a 1 mg infusion on cycle 1 day 1 (C1D1), followed by the target dose on C1D8, C1D15, and Q2W thereafter. All doses were infused over 1 h. Other tarlatamab dosing regimens were also explored, either for patient convenience (every 3 weeks) or to mitigate cytokine-release syndrome (extended intravenous infusion over a period of 3 days). Intensive pharmacokinetic samples were collected during cycles 1 and 2, and additional samples for pharmacokinetic and immunogenicity measurement were collected at regular intervals in later cycles. Pharmacokinetic data were analyzed using noncompartmental analysis, and antidrug antibody (ADA) incidence, including any effect on tarlatamab pharmacokinetic parameters, was summarized. Pharmacokinetic data were available from 203 patients. The median age was 62 years (range 32-80), and 55.7% (n = 113) of patients were male, 78.3% (n = 159) were white, and 8.3% (n = 17) were of Japanese descent. Following intravenous infusion, serum tarlatamab concentrations declined with time in a biphasic manner. Serum exposures increased in an approximately dose-proportional manner across the evaluated target dose range with a mean (standard deviation) estimated terminal phase elimination half-life of 5.8 (1.6) days, and steady state achieved by approximately C2D15. Of the 183 evaluable patients, 12 (6.6%) developed treatment-emergent ADAs; the distribution of dose-normalized serum concentrations were similar between patients who were ADA positive and ADA negative. In addition, the distribution of exposures was comparable in Japanese and non-Japanese patients. In patients with previously treated SCLC, tarlatamab demonstrated dose-proportional pharmacokinetic and extended half-life characteristics that support a Q2W dosing interval. Neither Japanese race nor ADA had a clinically relevant impact on exposures.

Comparison of the effects of deferasirox film-coated tablets (Jadenu®) and deferasirox dispersible tablets (Exjade®) in patients with beta thalassemia major: a preliminary report of the effects on the satisfaction, convenience, cardiac/liver MRI T2*, serum ferritin level, and biochemical profiles.

Deferasirox (DFX) is a once-daily oral iron chelator with proven dose-dependent efficacy in patients with thalassemia major (TM). The reason for switching from DFX dispersible tablets (Exjade®) to DFX film-coated tablets (Jadenu®) was intolerance. Many patients also reported that deferasirox® did not taste good. In this study, we compared the effect of Jadenu® and Exjade® on satisfaction, convenience, cardiac/liver MRI T2*, serum ferritin levels, and biochemical profiles in patients with thalassemia major. Sixty-two patients with thalassemia over 2years of age, who had iron overload indicated by chelation therapy, were randomly divided into two groups. The first group (n = 32) is treated with Exjade®, and the second group (n = 30) is treated with Jadenu®. Laboratory investigations included alkaline phosphatase (ALK), alanine transferase (ALT), aspartate transferase (AST), and serum ferritin levels. Cardiac/liver MRI T2* levels and patient satisfaction and convenience, were assessed before and 1year after starting therapy. The study found that 53.3% of Jadenu® patients were satisfied with the taste of the medication compared to only 12.5% of Exjade® patients, which was statistically significant (p = 0.001). Additionally, 40% of Jadenu® patients were satisfied with the ease of taking the medication compared to 28.1% of Exjade® patients, and again, the difference was statistically significant (p = 0.047). A comparison of the cardiac MRI T2* levels between the two studied groups showed no significant difference (p = 0.851). Jadenu® offers patients an improved formulation that can be taken on an empty stomach, has a better taste, and presents fewer gastrointestinal tolerability concerns. Overall, patient satisfaction is higher with Jadenu®, which may improve adherence and reduce the frequency and severity of complications associated with iron overload. This, in turn, may help mitigate cardiovascular and hepatic complications from iron overload in the long term. https://irct.behdasht.gov.ir/search/result?query=IRCT20210830052346N1.

Formulation and Evaluation of Gastroretentive Floating Microspheres of Amiloride Hydrochloride

Background: Amiloride, a potassium-sparing diuretic, is widely prescribed for the management of hypertension, congestive heart failure, and various renal disorders. However, its low oral bioavailability due to extensive first-pass metabolism and short half-life necessitates frequent dosing, leading to patient inconvenience and compromised therapeutic outcomes. To address these limitations, the development of novel drug delivery systems capable of enhanced gastrointestinal retention of amiloride has garnered significant attention. Among these, gastroretentive microspheres represent a promising approach, offering prolonged drug release and improved absorption. Objectives: The present work by formulation and evaluation of gastroretentive floating microsphere (FM) plays a highly significant role as a particulate drug delivery method. Particle sizes for microspheres range from 0.1 to 200 μm, and they can be administered orally, parenterally, nasally, ophthalmologically, transdermal, colonically, etc. Site-specific targeting and enhanced release kinetics are just two of the issues that have been solved through recent advances in microspheres, including those that are mucoadhesive, hollow, floating, micro-balloons, and magnetic. Microspheres will play a key role in novel drug delivery in the future by fusing different new methods, particularly sick cell sorting, genetic materials, safe, targeted, and effective drug delivery. Discussion: Hydroxypropyl methylcellulose (HPMC), polyvinylpyrrolidone, and ethylcellulose were used in varying concentrations to give the FMs of amiloride HCl release-controlling properties by increasing their bioavailability. Lactose was used as a diluent and sodium bicarbonate served as an effervescent agent. Using a solvent evaporation method approach, the gastroretentive FM of amiloride HCl was created. The generated microsphere indicated good floating strength and remained buoyant in the sustained released medium for 24 h. For systemic delivery of amiloride, a potassium-sparing diuretic and antihypertensive medication, through the oral route, a gastroretentive FMs drug delivery system was developed. The different ratios of ethylcellulose and HPMC K-100, sodium lauryl sulfate, sodium bicarbonate, and ethanol are used in formulation. The weight, thickness, percentage of moisture absorbed and lost, surface pH, folding resistance, content homogeneity, in vitro residence time, in vitro release, and ex vivo penetration of the microspheres were all assessed. Conclusion: The formulation and evaluation of gastroretentive FMs represent a significant advancement in particulate drug delivery systems. These microspheres, with particle sizes ranging from 0.1 to 200 μm, offer versatility in administration.

Abstract 4143224: Feasibility of Left Atrial Appendage Occlusion with Dual-Seal Technology without Pre-Procedural CT: Early Single-Center Experience

Background: Left Atrial Appendage (LAA) Occlusion with Amulet has shown promising results in achieving complete closure with minimal periprocedural leak. Amulet’s dual-sealed technology and numerous sizing options provide versatility for different LAA morphologies. Pre-procedural CT is routinely recommended for pre-procedural planning. However, this brings risks including use of contrast, risk of renal failure, radiation exposure, and patient inconvenience. Here, we share initial results of our Amulet implantation protocol without pre-procedural CT: 83 cases were reviewed; number of devices used, procedural time, periprocedural bleeding complications, success in coming off oral anticoagulation, and incidences of stroke and embolism were followed. Methods: We followed 83 AF patients who underwent LAA closure with Amulet, implanted with intraprocedural TEE, intracardiac left atrial echocardiography, and intraprocedural angiography. Pre-procedural CT was not used. Patients were followed to assess safety and efficacy of this protocol. Safety endpoints included rates of procedural and bleeding complications. Efficacy endpoints included rates of stroke and embolism, and number of devices used. Results: All 83 procedures were successfully completed with no perioperative procedural complications and no documented leaks on follow-up TEE. Patients had early ambulation with closure. On average, 1.14 devices were used per case: 88% of cases required 1 device, and nine cases required 2 devices; one case required 4 devices to fit as patient was noted to have an interrupted IVC, requiring implantation via right IJV. There were no cases of stroke or embolism following implantation, and all patients were safely able to come off oral anticoagulation. Conclusions: Results demonstrate that Amulet with its dual-sealed technology can be effectively and safely implanted without pre-procedural CT. No perioperative complications were observed. 88% of cases closed with single device usage. No post-procedure leaks were noted on follow-up TEE. Safety endpoints revealed minimal adverse events, with 2 cases of late pericardial effusion managed without long-term consequences. This protocol demonstrated high efficacy, as all patients were successfully able to come off oral anticoagulation with no reported strokes or embolic events. Intraprocedural TEE, intracardiac left atrial echocardiography, and intraprocedural angiography are typically appropriate for periprocedural sizing of the device.

Effect of co-loaded vitamin D3 on intravenous injectable raloxifene delivery system

Owing to its promising advantages, including improved drug bioavailability and therapeutic efficiency at low doses and frequency, increased patient convenience and compliance, and prolonged storage life, nanomedicine has received heightened attention over conventional pharmaceuticals. Human serum albumin (HSA)-based nanoparticles have been used as drug carriers in injectable formulations, with great success and versatility. In this study, raloxifene and vitamin D3 were co-encapsulated in HSA-based nanoparticles (Ral/VitaD/HSA/PSS NPs) as an intravenously injected pharmaceutical formulation in order to enhance their availability in the body. The lyophilization–hydration method was utilized to develop the Ral/VitaD/HSA/PSS NPs. In addition, the characteristics and stability of the NP and the effect of the co-loading of vitamin D3 on raloxifene release in vitro and in vivo were discussed. The raloxifene and vitamin D3 molecules were successfully encapsulated and well dispersed in an amorphous state within Ral/VitaD/HSA/PSS NPs. The prepared Ral/VitaD/HSA/PSS NPs were lyophilized for long-term storage and were both biocompatible and hemocompatible, enhancing alkaline phosphtase activity in osteoblasts. Delivered via intravenous injection, Ral/VitaD/HSA/PSS NPs addressed the low bioavailability of raloxifene and vitamin D3 caused by oral administration, and improved their compatibility and residence time in the body. Overall, the established raloxifene–vitamin D3-co-loaded NPs may be a potential nanomedicine contender for treating postmenopausal osteoporosis.

RTID-05. STUDY PROTOCOL: A MULTICENTER, INTERNATIONAL RANDOMIZED CONFIRMATORY TRIAL: LOW-ENERGY X-RAY INTRAOPERATIVE RADIATION THERAPY (LEX-IORT) VS. ADJUVANT FRACTIONATED STEREOTACTIC RADIOTHERAPY (FSRT) IN THE MANAGEMENT OF BRAIN METASTASES (LEXIMATE)

Abstract BACKGROUND Fractionated stereotactic radiotherapy to the resection cavity boosts local control of resected brain metastases significantly. However, start of systemic tumor-directed treatment may be protracted and in-hospital times prolonged. Lately, lex-ioRT of BM has been described as a safe and effective one stop-shop treatment modality with a 1-year local control rate of up to 98% while potentially improving patient convenience. Study Design: The LEXIMATE-trial is a multicenter, international, randomized open-label confirmatory trial comparing lex-IORT with FSRT of resected BM. In the experimental arm, INTRABEAM (Carl Zeiss Meditec AG) is used to deliver IORT by application of 50-kV photons at a standard dose of 30 Gy prescribed to the applicator surface. Standard linear accelerator or Gamma Knife based FSRT (3-7 fractions) to the surgical bed is used in the control arm. The primary endpoint is the cumulative incidence of local recurrences (as per RANO-BM) considering death without prior local recurrence as competing event. Inclusion criteria include histologically confirmed BM with indication for resection according to EANO-ESMO/ASCO-SNO-ASTRO guidelines, ≤5 other brain lesions compatible with BM and amenable to radiosurgery and history of solid cancer or CT scan suggestive for localized or metastasized solid cancer (except germ cell tumors, lymphoma, small-cell lung cancer). The resection cavity must be <5cm in size, IORT doses to brainstem or optical tract may not exceed 8 Gy. Study design: Randomized, open-label, non-inferiority. Sample size: 70 patients per group to show a non-inferiority of the experimental therapy compared to the control therapy with a power of approximately 80%. DISCUSSION The best radio-oncologic procedure for resected BM remains under debate. The LEXIMATE-trial offers an opportunity to provide more solid prospective data on effectiveness, safety and patient comfort both for established and new RT techniques.

LDHzyme-assisted high-performance on-site tracking of levodopa pharmacokinetics for Parkinson's disease management

Parkinson's disease (PD) is a progressive neurodegenerative disorder marked by the loss of dopaminergic neurons and the consequent decline in motor and cognitive functions. The primary therapeutic agent levodopa necessitates precise dosing due to its narrow therapeutic window and complex pharmacokinetics. This study presents the development of a novel CuCoFe-LDHzyme-based sweat sensor for real-time monitoring of levodopa concentration in PD patients. Employing differential pulse voltammetry (DPV) technique, the sensor demonstrates high sensitivity and selectivity, achieving a detection limit of 28.1 nM. The sensor's design allows for non-invasive, continuous monitoring, significantly enhancing patient convenience compared to traditional blood sampling methods. Through pH correction, precise quantification of levodopa in sweat is accomplished, and a strong correlation (Pearson coefficient = 0.833) with blood levodopa levels is established. The pharmacokinetic profile of levodopa is reconstructed in real-time, offering a promising tool for optimizing PD treatment regimens. This study highlights the potential of CuCoFe-LDHzyme sensors to advance personalized treatment strategies, aiming to improve the quality of life for PD patients by providing clinicians with real-time data for medication adjustments.

New Diagnostic Technology for the Isolation and Analysis of Live Myeloma Cell from the Blood of Multiple Myeloma Patients

Introduction Multiple Myeloma (MM) is characterized by the proliferation of abnormal plasma cells within the bone marrow. Abnormal plasma cells are examined by bone marrow (BM) biopsy but it causes great pain to patients, so it is hard to get BM sample frequently for the monitoring of drug efficacy and minimal residual disease. Therefore, the development of new diagnostic method is absolutely necessary for patient's diagnostic convenience. We are developing new diagnostic system for multiple myeloma to isolate and analyze myeloma cells in peripheral blood (PB) using automated CytoGen Smart Biopsy™ platform. In this study, it was performed the feasibility of a technology to isolate myeloma cells from the PB of MM patients and a cross-analysis with clinical data to explore the possibility of utilization of MM diagnosis. Method Spiking test using MM cell line (RPMI8226, 200 cells) mixed into human blood samples (5mL, healthy donor) was conducted to check the recovery rate of CytoGen Smart BiopsyTM platform. For the clinical evaluation, patient selection was performed on patients who visited the Department of Hematology and Oncology at Samsung Medical Center (Seoul, Korea) based on the MM diagnosis criteria. We evaluated 9 newly diagnosed patients with MM (ISS I, II, and III (3 per group)) and 2 patients with MGUS. The median age of the MM cohort was 71 years (range 51-84) and 54% were females. Live MM cells in PB (7.5 mL) were isolated by CytoGen Smart BiopsyTM Cell Isolator, subsequently the quantification of number of isolated MM cells in PB was accessed with automated CytoGen Smart BiopsyTM Cell Image Analyzer after immunofluorescence (IF) staining with MM specific markers, CD138 and/or CD38. Result In the spiking test with MM cell line, CytoGen Smart BiopsyTM platform showed a high level of recovery rate (over 80%). Clinical evaluation of CytoGen Smart BiopsyTM platform was conducted with 9 MM and 2 MGUS patients. Among the 9 MM patients, more than 100 MM cells in 7.5 mL of PB were observed in all of MM patients except 1 patient with ISS I. In two MGUS, only 3 and 52 cells were observed, respectively. The median value based on ISS staging system was as follows. In stage I: 166 cells, in stage II: 1,739 cells, and in stage III: 2,093 cells were identified. Even a small number of patient samples, an increase tendency in the number of cells by ISS stage was observed. When classified based on R-ISS, the median value for each stage was in stage I: 52 cells, in stage II: 1,737 cells, and in stage III: 5,928 cells, showing a clear tendency to increase by stage. This clinical evaluation clearly demonstrated the possibility of isolation and quantification of MM cells in the PB of MM patients. Conclusions Multiple myeloma is a blood cancer showing a very high recurrence rate even after treatment, so a new diagnostic system replacing BM biopsy is absolutely necessary for patient's convenience. Although various methods have been attempted to identify MM cells in the PB, but it was difficult to use it for diagnosis because they could not isolate live MM cells retaining intact MM markers for accurate analysis. In this study, we verified through clinical evaluation that live MM cells in PB can be isolated and analyzed with CytoGen Smart BiopsyTM platform, a size-based separation technology can isolate live MM cells with a large size compared with other PBMCs. Furthermore, we found an increase tendency of MM cells' number in PB by the stage of MM patients. Expanded clinical study will be performed with more MM samples for clinical validation. We expected that further study will be able to identify the correlation between the number of myeloma cells in the PB and prognostic index such as progression-free survival.

Financial Toxicity and Quality-of-Life Outcomes on a Phase 1 5-fraction Stereotactic Partial Breast Irradiation Protocol for Early-Stage Breast Cancer

PurposeWe report the financial toxicity and quality-of-life outcomes of our prospective phase 1 dose-escalation study of 5-fraction stereotactic partial breast irradiation (S-PBI) for early-stage breast cancer. Materials and MethodsWomen with unifocal in situ or invasive epithelial histologies, clinical stages 0, I, or II with tumor size < 3 cm treated with lumpectomy were enrolled in our phase 1 5-fraction S-PBI dose-escalation trial. Our institutionally generated questionnaire on the “Patient Perspective Cost and Convenience of Care” and the EuroQol 5-Dimension 5-level questionnaire were administered to patients treated at follow-up. ResultsBetween 2010 and 2015, 68 of the 75 patients who enrolled and completed treatment on trial completed at least some component of either the EuroQol 5-Dimension 5-level questionnaire or the “Patient Perspective Cost and Convenience of Care” questionnaire. Nearly all patients reported very high satisfaction with their treatment overall, particularly the shortened length of treatment. Over half of the patients reported some level of financial toxicity (FT) despite a significantly shortened treatment time. Patients who reported any FT were significantly younger than patients with no financial burden of treatment (means 59.2 and 63.7, respectively, P = .03). There was no difference in those who reported any level of FT based on patient race, ethnicity, marital, or employment status. This S-PBI regimen did not significantly affect quality of life over a 4-year follow-up. ConclusionsThese patient-reported outcomes suggest that the use of accelerated partial breast irradiation may offer low FT rates in breast cancer care, particularly for disadvantaged patient groups.

Development and in vitro evaluation of acelofenac mouth dissolving films for reduced analgesic activity

Background: The design of the current research work was to formulate mouth-dissolving films (MDFs) of aceclofenac (ACF) to improve patient compliance and convenience for older and younger patients, ultimately leading to improved therapeutic outcomes. Method: Evaluations were conducted on film formers such as HPMC and MC and film modifiers such as PEG and starch acting as solubilizing agents. Results: The physicomechanical qualities, in vitro disintegration time, and in vitro dissolving characteristics of the produced MDFs were assessed. Good mechanical qualities, including as tensile strength, folding durability, and percentage elongation, were demonstrated by every created MDF. FTIR, SEM, and X-RD analyses were used to assess MDFs. In contrast to other formulations, MDFs containing F8 provided superior dissolving properties. Conclusion: When pitted against other mixtures, the MDFs with sodium alginate (5%), methylcellulose (5%), and hydroxypropyl methylcellulose (HPMC)(5%) showed superior dissolving capabilities. In contrast to other mixtures, the F8 mixture, including HPMC, sodium alginate, and methylcellulose, demonstrated a complete and accelerated dissolution within 50 seconds. The mechanism behind this release is diffusion, as indicated by the release kinetics data.

The progesterone prime protocol: an affordable option for ICSI in Egypt

BackgroundThe two main input indicators needed to assess the success of assisted reproductive technology (ART) strategies are cost-effectiveness and clinical outcome. Therefore, we focused in our study on the direct cost associated with the Progesterone Prime Ovulation Induction Protocol (P-P-OP protocol) compared to other protocols, and the clinical outcomes of this strategy were measured in their effect on implantation and pregnancy rates.MethodsA pilot single-armed study was conducted on 47 infertile women coming for an ICSI cycle. Progesterone priming was started with 10 mg dydrogesterone along with HMG 150–300 IU from the second day of the menstrual cycle and was maintained until the day of ovulation trigger. The primary outcome was the cost per cycle, while the secondary outcome was the clinical pregnancy rate. The cost per cycle, including the cryopreservation cost, was calculated for economic evaluation.ResultsPer each cycle, the number of retrieved oocytes was 14.87 ± 8.09, the number of mature oocytes was 9.81 ± 4.67, the number of total embryos was 8.74 ± 4.28 (grade A = 67.40%, grade B = 11.92%, grade C = 20.68%), and the number of transferred embryos was 2.43 ± 0.68. The clinical pregnancy rate in our study was 42.5%. Economically, the cost of the P-P-OP protocol for each patient was only 56 USD.ConclusionThe P-P-OP protocol is a simplified approach suitable for freeze-only strategies, offering the benefits of positive results, fewer injections, lower costs, and increased patient convenience.

Delivering shared decision-making before transcatheter aortic valve implantation using digital and remote techniques to enhance patient engagement and convenience

Abstract Introduction Transcatheter aortic valve implantation (TAVI) is an alternative to surgical aortic valve replacement for patients with aortic stenosis. However, the choice between TAVI, surgery, wait and watch or conservative management needs to be based upon multiple factors including comorbidity, life expectancy, anatomy, local experience and, critically, informed patient preference. In this context, engaging patients in a shared decision-making (SDM) process becomes essential, but this practice is generally underused. Purpose To comply with both international guidance and the National Institute for Health and Care Excellence (NICE) UK recommendations, in January 2023 we established a formal SDM pathway for TAVI, utilising digital solutions as much as possible to minimise the logistic impact for both hospital and patients. We aimed to quantitatively measure the compliance of the digital SDM meeting from the patients’ perspective with the NICE recommended essential and enhanced discussion standards. Methods Patients are contacted when the multidisciplinary heart team recommends TAVI, then offered digital or, where appropriate, physical patient decision aids and a link to a TAVI-specific explanatory video. One week later, patients are invited to a virtual comprehensive SDM meeting where a specialist nurse discusses aortic stenosis and treatment options with the patient as per the NICE recommended standards, allowing time for questioning and review. From December 2022 to June 2023, a custom developed questionnaire was administered to 20 patients prior to, and 28 patients after the implementation of the SDM meeting protocol, directly addressing the patients’ perception of adherence to the NICE standards. This was provided to the patients after the TAVI procedure via an online tool. The answers to the 12 core questions were converted into a Likert scale (1 to 5) and the global satisfaction scores for the 2 patient groups, reported as the average Likert score across the 12 questions, were compared with the Wilcoxon Rank-Sum Test. Results The global satisfaction score was significantly higher for the post-SDM group than for the pre-SDM group (mean 4.27 vs 3.55, p&amp;lt;0.001). The percentage of patients who gave positive (Likert 4-5) responses to each individual question was consistently higher in the post-SDM group. The percentage of patients giving negative (Likert 1-2) responses was substantially lower in the post-SDM group. Conclusions The SDM pathway and the virtual tools provided proved effective in delivering SDM in compliance with international guidance and NICE recommended standards from the patient’s perspective. A similar approach leveraging digital technology to minimise cost and enhance patient convenience could be implemented for other treatments and across other institutions.Questionnaire results

Making Sense of Topical Pain Relief Options: Comparing Topical Analgesics in Efficacy and Safety.

In patients with musculoskeletal (MSK) conditions, pain is the leading contributor to disability and significantly limits mobility and dexterity. This narrative review describes the efficacy and safety of topical analgesics in common use today. Secondary literature gained via a literature search using PubMed.gov and the Cochrane library were used. Recent literature (2000-2023) on several major classes of topical analgesics and topical delivery systems were reviewed to provide strength of recommendation taxonomy (SORT) levels. A total of 86 articles were reviewed. Level 2. Topical nonsteroidal anti-inflammatory drugs (NSAIDs) and cabbage leaf wraps (CLW) appear to be best suited for multiple types of acute MSK pain, and topical nitroglycerin is helpful when used specifically for rotator cuff pain in patients seeking relief while performing activities of daily living and willing to treat for long periods of time. For compounded topical formulations, it may be better to offer single agent creams based on patient preferences. Little data support the use of cryotherapy. Traumeel could be a promising natural analgesic that compares with diclofenac. Topical lidocaine appears best suited for postherpetic neuropathic pain. O24 is a reasonable alternative with a low risk profile to treat pain in patients with fibromyalgia syndrome. Choice of topical agents should be guided by current evidence accounting for type of pain, medication side effects, patient comorbidities, as well as patient preference, convenience, and cost. Of the topical analgesics and modalities reviewed, SORT level A evidence was found for topical NSAID use in decreasing MSK pain, topical lidocaine for postherpetic neuralgia, and nitroglycerin patches for treating rotator cuff pain if used for prolonged periods of time. Alternative treatments such as CLW and Traumeel show promising results (SORT level B).

Transdermal Drug Delivery Systems: Different Generations and Dermatokinetic Assessment of Drug Concentration in Skin.

Transdermal drug delivery systems (TDDS) are a highly appealing and innovative method of administering drugs through the skin, as it enables the drugs to achieve systemic effects. A TDDS offers patient convenience, avoids first-pass hepatic metabolism, enables local targeting, and reduces the toxic effect of drug. This review details several generations of TDDS and the advancements made in their development to address the constraints associated with skin delivery systems. Transdermal delivery methods of the first generation have been consistently growing in their clinical application for administering small, lipophilic, low-dose drugs. Second-generation TDDS, utilizing chemical enhancers and iontophoresis, have led to the development of clinical products. Third-generation delivery systems employ microneedles, thermal ablation, and electroporation to specifically target the stratum corneum, which is the skin's barrier layer. Dermatokinetics is the study of the movement of drugs and formulations applied to the skin over a period of time. It provides important information regarding the rate and extent to which drugs penetrate skin layers. Several dermatokinetic techniques, including tape stripping, microdialysis, and laser scanning microscopy, have been used to study the intricate barrier properties and clearance mechanisms of the skin. This understanding is essential for developing and improving effective TDDS.

Breaking the mold: nontraditional approaches to allergen immunotherapy for environmental allergens.

Allergen immunotherapy is a disease-modifying treatment for allergic diseases. The predominant traditional immunotherapy is through subcutaneous administration of allergens to gradually desensitize allergic individuals. While effective, traditional allergen immunotherapy approaches are often lengthy, time consuming for patients and can result in local or systemic adverse reactions. Nontraditional immunotherapies are emerging as promising alternatives, offering potentially more convenient, safe and efficacious treatment options. This review sought to comprehensively examine the safety, efficacy and performance of various nontraditional immunotherapies for environmental allergens. Nontraditional immunotherapy approaches covered in this review include sublingual, local nasal, intralymphatic rush and ultra-rush immunotherapy, allergoid, microbial and anti-IgE immunotherapies. Nontraditional immunotherapies show significant promise in addressing the limitations of traditional subcutaneous immunotherapy. Methods like intralymphatic and rush immunotherapy offer shorter treatment regimens, enhancing patient adherence and convenience. The co-administration of probiotics or monoclonal antibodies, like omalizumab, with AIT appears to improve treatment efficacy and safety. Despite these advancements, further large-scale, long-term studies are needed to establish standardized protocols, dosing and validate long-term effects of these nontraditional immunotherapies. Standardizing outcome measurements across studies is crucial for accurate comparisons of nontraditional immunotherapies prior to widespread clinical adoption of these innovative techniques.

Efficacy and uterine bleeding patterns in initiating goserelin therapy during different menstrual phases in patients with adenomyosis: a prospective cohortstudy.

We carried out this study to explore the possibility of initiating goserelin therapy during the non-menstrual period in patients diagnosed with adenomyosis. 115 premenopausal adenomyosis patients were enrolled and divided into three groups based on their menstrual cycle phase during the initial outpatient visit: menstrual, follicular, and luteal. Each received a 3.6 mg subcutaneous dose of goserelin monthly for three months. The endpoints encompassed alterations in uterine volume, dysmenorrhea Numerical Rating Scale (NRS) score, CA125 level, hemoglobin (HGB) after a 12-week treatment course, and the occurrence and duration of uterine hemorrhage during the first treatment cycle. Analysis revealed that the timing of goserelin therapy initiation in the menstrual cycle did not significantly impact its effectiveness in reducing uterine size, alleviating pain, lowering CA125 levels, or improving hemoglobin concentrations. However, patients starting treatment during the luteal phase experienced increased uterine bleeding (reference: menstrual period, OR = 4.33, 95% CI 1.23-15.25, p = .023). The results suggested non-inferiority of goserelin therapy initiated during the non-menstrual period, but the uterine bleeding rate was higher in the luteal phase group. Therefore, goserelin treatment for outpatient adenomyosis patients should not be limited to starting during the menstrual period; it can also be initiated outside the menstrual period, providing more convenience for patients as most consultations occur outside the menstrual period. However, the use of goserelin during the luteal phase should be avoided to reduce the risk of exacerbated bleeding, especially in anemic patients with heavy menstrual bleeding. This study highlights the importance of individualizing treatment initiation based on the patient's health profile to optimize therapeutic outcomes and minimize adverse effects. ChiCTR2200059548.