Complete Compliance Research Articles

Symptoms, Functioning, and Health-Related Quality of Life in Patients with Relapsed/Refractory Multiple Myeloma Treated with Talquetamab: Updated Patient-Reported Outcomes from the Phase 1/2 MonumenTAL-1 Study

Introduction: Patients (pts) with advanced and heavily pretreated relapsed/refractory multiple myeloma (RRMM) have worse health-related quality of life (HRQoL) than those at earlier stages of the disease and have limited treatment options available to enable improvement in HRQoL, particularly those who are triple-class exposed. Talquetamab (tal), a novel GPRC5D×CD3 bispecific antibody, has shown deep and durable responses in the MonumenTAL-1 study (NCT03399799/NCT04634552) in pts with RRMM. Here, we report patient-reported outcomes (PROs) from the MonumenTAL-1 study, focusing on data through cycle 21 from the tal 0.4 mg/kg weekly (QW) dosing cohort (initial results presented at ASH 2022) and new data through cycle 15 from the tal 0.8 mg/kg every other week (Q2W) dosing cohort. Methods: MonumenTAL-1 is a first-in-human, phase 1/2, single-arm study of tal monotherapy. Pts with triple-class exposed RRMM received the recommended phase 2 doses of tal (0.4 mg/kg QW or 0.8 mg/kg Q2W). PRO assessments included the following instruments: the European Organisation for Research and Treatment of Cancer quality of life questionnaire core 30 (EORTC QLQ-C30), a cancer-specific PRO instrument, with scores ranging from 0 to 100 (higher scores indicate better global health status [GHS] and functioning, whereas higher scores for symptoms represent worse severity, and a 10-point change from baseline indicates meaningful change); the EuroQol 5-Dimension 5-Level (EQ-5D-5L) visual analogue scale (VAS), which rates pt health from 0 (worst) to 100 (best); and the Patient Global Impression of Severity (PGIS) instrument, a single item that assesses severity of disease. PRO instruments were administered at screening, day 1 of cycle 1, then day 1 of every other cycle. Results for each instrument are presented for specific cycles that have a larger sample size (n≥30); later cycles presented for the QW cohort are due to longer follow-up duration (median,18.7 months) compared with the Q2W cohort (median, 12.3 months), for which earlier cycles are presented. Results: As of January 17, 2023, phase 2 data were available for 122 and 109 pts who received ≥1 administration of tal QW or Q2W, respectively; compliance for completion of the EORTC QLQ-C30 was >97% at baseline and >80% at most post-treatment visits (in each cohort). Least squares (LS) mean change from baseline demonstrated clinically significant improvements in GHS (16.4 points QW, 8.8 points Q2W) and physical functioning (9.6 points QW, 3.1 points Q2W) at cycle 15 in QW and cycle 11 in Q2W cohorts, respectively, along with reductions in fatigue (-10.1 points QW, -5.9 points Q2W) and pain (-16.8 points QW, -1.9 points Q2W) symptoms at cycle 15 in QW and cycle 11 in Q2W cohorts, respectively (Figure). An increasing ability to engage in social roles and activities (role functioning) was also reported by pts in the QW cohort, with an 8.5-point improvement from baseline at cycle 15. Pts in the QW cohort reported meaningful improvement from baseline at later cycles; these improvements were particularly evident in GHS (57%) and social function (47%) at cycle 15. In the Q2W cohort, meaningful improvements from baseline in fatigue (45%) and emotional function (42%) were larger at cycle 7. Pts' global impression of their MM disease severity (PGIS) also improved from baseline, consistent with the meaningful improvement data: for example, in the QW cohort, ratings were 10.8% (very severe) and 40.8% (severe) at baseline compared with 0% and 6.7%, respectively, at cycle 15; in the Q2W cohort, ratings were 11.1% (very severe) and 34.3% (severe) at baseline compared with 2.8% and 19.4%, respectively, at cycle 11. Pts reported improvements from baseline in their health status (EQ-5D-5L VAS score), with LS mean change of 8.1 (95% CI, 2.6, 13.7) and 2.7 (95% CI -2.3, 7.7) at cycle 9 in the QW and Q2W cohorts, respectively. Median time to improvement from baseline in most EORTC QLQ-C30 subscales and EQ-5D-5L VAS scores was ~2 months in both cohorts; estimates of median time to first worsening ranged from 2 to ~9 months. Conclusions: Meaningful improvements from baseline in MM symptoms, physical function, and overall HRQoL were observed in tal QW and Q2W cohorts, with durable and short-term improvements, respectively. These favorable results in PROs add to the efficacy and safety profile of tal, highlighting tal as a compelling treatment option for pts with triple-class exposed RRMM.

Comprehension of international safety signs: A prospective technical workers context

An effective method for educating workers about occupational hazards is the use of safety signs in the workplace. However, workers' understanding may vary due to factors such as cultural background, familiarity, and training. This study aimed to assess the comprehension of international safety signs among participants representing the prospective technical workforce in Indonesian industries. Two groups of participants (n = 71), comprising vocational high school students and college-level engineering students, were involved to assess their comprehension of symbol elements, comprehension of complete signs, compliance intention, and familiarity towards a selected set of international safety signs. The study revealed that the complete signs significantly increased the comprehension and compliance intention of the prospective technical workers regarding the selected signs (p < .001). However, most safety signs under the fire equipment and safe condition categories investigated in the study had low comprehension and compliance intention scores (<67%). Conversely, signs under the mandatory and warning categories generally exhibited better comprehension and compliance intention scores. Additionally, participants in the study were generally not familiar with the investigated signs (<50%). The familiarity with the signs was strongly correlated with the comprehension and compliance intention of the participants (p < .001). Relevance to industryUnderstanding the findings, which revealed that the comprehension, compliance intention, and familiarity of the prospective technical worker participants with some international safety signs generally did not meet the standards, interventions such as training and redesigning the safety signs are highly recommended to minimize future adverse safety outcomes when they enter the workforce.

Punca-punca Kelewatan Pengeluaran Perakuan Siap dan Pematuhan (CCC) Projek Perumahan di Malaysia

The Certificate of Completion and Compliance (CCC) was implemented in April 2007. The Certificate of Completion and Compliance is a certificate that confirms that a building is eligible and safe to occupy, issued by the main person who submits it. Most of the housing projects fail to hand over the building to the buyer within a set time period such as in the sale and purchase agreement caused by the failure to issue a completion certificate and compliance. This study aims to identify the causes of delays in issuing certificates of completion and compliance for housing projects in Malaysia. Qualitative methods through literature review have been used to identify the processes of issuing certificates of completion and compliance (CCC) of housing projects in Malaysia and to identify the causes of delays in issuing certificates of completion and compliance (CCC). Next, a questionnaire was conducted on 141 respondents to identify the causes of delays in issuing Certificates of Completion and Compliance (CCC) for housing projects in Malaysia. The results of the literacy study found that 18 causes of delay in the issuance of completion and compliance certificates. The findings found that the main contributors to the delay in issuing completion certificates and compliance for housing projects in Malaysia are caused by developers, consultants, contractors, local authorities, external technical agencies and others.

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Simplifying US state-level obligations to help achieve compliance certainty

This paper provides key insights into how expert augmented intelligence helps simplify and refine state compliance obligation management with dynamic technology. Learn strategies to help financial institutions overcome four unique pain points of achieving complete compliance confidence. Readers will learn how top banks are able to reduce reliance on third-party legal firms, connect various components of regulatory change management together and gain a strategic perspective on how that impact is realised.

Impact of patient adherence on the efficacy of penetrating keratoplasty

Objective: to determine the relationship between adherence to treatment in patients undergoing penetrating keratoplasty (PKP) and corneal graft survival over a 12-month follow-up period. Material and methods. A retrospective analysis of 56 patients who underwent "high risk" PKP was performed. Patients were divided into 2 groups according to their compliance. The full compliance group included those with more than 90% of visits within the first year after the intervention; the poor compliance group included those with more than 10% of missed visits. Results. The high adherence group was characterised by a higher proportion of women (p=0.033), a mean 7 years younger age of the patients (p=0.021) and a predominance of higher education (p=0.014). One year after PKP, patients with complete compliance (74%) were more likely to have a favourable outcome than those with incomplete compliance (48%) (p=0.046). The calculation of the odds ratio (OR 3.52; Cl: 1.1362-10.88; p=0.045) indicated a statistically significant role of treatment adherence as a factor in keratoplasty efficacy. The high compliance group had a visual acuity gain of 2 lines at 12 months (p=0.003). Conclusion. Compliance after corneal transplantation has a significant impact on graft survival and clinical outcome. The development and implementation of a set of measures to increase adherence could significantly improve the safety and efficacy of this high-tech treatment for patients with disabling corneal pathology.

Antibiotic Utilization and Prophylaxis in Paediatric Cardiac Surgery: A Retrospective Observational Study at a Rural Tertiary Care Hospital in India.

Introduction Antimicrobial prophylaxis, involving short antibiotic courses preceding surgical procedures, is recommended to minimize postoperative infections. Paediatric cardiac surgeries are classified as clean procedures, though infection challenges persist due to illness severity and extended ICU stays. Antimicrobial prophylaxis varies, ranging from single doses to extended administration until catheters are removed. Typically lasting 24 to 48 hours, it has proven infection-reduction benefits. Despite these practices, uncertainties surround the optimal nature, timing, and duration of administration. This concern is amplified by escalating antimicrobial resistance driven by antibiotic overuse. Vulnerable paediatric populations bear heightened consequences of irrational antimicrobial use, contributing to global resistance trends. Yet, a defined optimal prophylaxis schedule for paediatric cardiac surgery is lacking. Importing adult guidelines may be inadequate due to paediatric research complexities and population diversity. Developing effective prophylaxis protocols is crucial for children undergoing cardiac surgery, given global antibiotic overuse and evolving drug resistance. Establishing an optimal prophylactic strategy remains a challenge, necessitating further research for evidence-based protocols to mitigate infections in this vulnerable patient cohort. Methods This study investigates antibiotic use in paediatric cardiac surgery. A retrospective analysis of 100 patients from a rural Indian hospital (2017-2018) assesses antibiotic patterns, including type, dose, duration, and adherence to prophylaxis protocols. Results In the studied cohort of paediatric cardiac surgery patients, complete compliance (100%) with antibiotic prophylaxis was observed. However, deviations were identified: 30% received antibiotics prematurely, and 30% did not align with institutional protocol criteria. Concerning antibiotic selection, 87% followed hospital policy with the recommended cefoperazone and sulbactam combination plus amikacin, while 9% received piperacillin/tazobactam + amikacin due to sepsis. Irregular use (22%) based on clinical records occurred. Furthermore, 4% received piperacillin/tazobactam + teicoplanin, with one instance of inappropriate higher antibiotic use. Regarding prophylaxis duration, only 27% adhered to the appropriate timeline, with 40% exceeding 48 hours, indicating extended use. Upon discharge, a notable proportion (45 patients) received antibiotic prescriptions. Among them, 73% were prescribed rationally, while 27% exhibited irrational antibiotic use. Conclusion The findings of this study shed a significant light on the issue of antibiotic misuse within the context of paediatric cardiac surgery. It underscores the pressing need for more stringent measures to regulate and address this concerning trend. The study underscores the pivotal importance of adhering rigorously to established protocols and guidelines for antibiotic prophylaxis. This adherence not only holds the potential to elevate the overall quality of patient care but also plays a critical role in combating the escalating challenge of antibiotic resistance. Through a concerted effort to optimize antibiotic usage, we can simultaneously enhance patient outcomes and contribute to the ongoing fight against the emergence of antibiotic-resistant strains, thus preserving the efficacy of these vital medications for future generations.

PENGARUH ISLAMIC CORPORATE GOVERNANCE TERHADAP KECURANGAN PADA PERBANKAN SYARIAH DI INDONESIA

This study aims to examine the influence of Islamic corporate governance on fraud in Islamic banks in Indonesia. The population of this study is all Islamic banking in Indonesia in 2016-2020. The sampling technique in this study uses a purposive sampling method with the criteria of the company publishing a complete compliance report on the website of each Islamic bank. 10 Islamic banks become the research sample. This research is quantitative research with a multiple linear regression analysis method. The results of this study indicate that Islamic corporate governance, proxied by the duties and responsibilities of the board of directors, affects fraud in Islamic banking in Indonesia, while the implementation of the duties and responsibilities of the Sharia Supervisory Board has no effect on fraud in Islamic banking in Indonesia. These results contribute valuable insights to the understanding of how Islamic corporate governance can serve as a potent tool in mitigating fraudulent activities within the Islamic banking industry. Moreover, the findings have implications for regulatory bodies and stakeholders aiming to enhance the effectiveness of Islamic banking regulations and governance frameworks, ultimately fortifying the integrity and trustworthiness of Islamic financial institutions.

Impacts of Digitization of Business Permits and Licenses in District 3 Quezon City

This study aimed to determine the Impacts of Digitization of Business Permits and Licenses in District 3 Quezon City in terms of service satisfaction on time efficiency, reliability, cost-effectiveness, and convenience in business permit and license application of the business owners as the respondents of the study. The researchers used a descriptive method of research instruments to gather vital data from 380 business owners and guided the researchers in determining the result of the study. The researchers found that the respondents were very satisfied with digitizing business permits and licenses.&#x0D; It was recommended by the researchers that in order to enhance e-governance, the Business Permit and Licensing Department must include alert/reminder messages thru Short Message Service (SMS) in informing the status and deficiency of business permit and license application documents submitted by the business owners. Furthermore, there must be a system integration of all departments involved in processing business permits and licenses to ensure complete compliance in order not to hamper the business owners’ applications.

WTP4.5 An Evaluation of the Introduction of a Perioperative Care Bundle to Reduce Surgical Site Infections after Bowel Resection Surgery in a DGH Setting

Abstract Background The surgical site infection (SSI) rate for colonic resections at a District General Hospital (DGH) in South-Central England was 25.3%. The UK national average is 8.6%. The aim of this study was to evaluate if the implementation of a perioperative care bundle based on NICE guidance improved SSI rates. Methods Retrospective data was collected prior to the bundle implementation (Group 1) and prospective data following bundle introduction (Group 2). Inclusion criteria were all emergency and elective bowel resections. The primary outcome assessed was the development of an SSI within the 30-day postoperative period. The secondary outcomes were related to confounding variables, such as diabetes and immunosupression. Data was collected from the electronic patient record system and follow-up telephone consultations using a standardised questionnaire. Results The SSI rate in Group 1 (n=55) was 30.9% (95% CI,19.0%-43.1%) as opposed to 19.2% (95 CI, 8.5%-30.0%) in Group 2 (n=52), p=0.16. Interestingly, for patients of a BMI &amp;gt;30 the SSI rate dropped from 45.5% (95% CI, 16.7%-76.6%) to 20.0% (95% CI, 4.3%- 48.1%). Conclusion The 10-step perioperative care bundle did not significantly reduce the SSI rate. However, bundle uptake was moderate (73%), and only 65.4% of prospective cases achieved complete bundle compliance. Further research is required to investigate the effectiveness of this bundle on high-risk groups, as well as implementation barriers.

The Relevance of Implementing the Systematic Screening of Perioperative Myocardial Injury in Noncardiac Surgery Patients.

Perioperative myocardial injury (PMI) is a common cardiac complication. Recent guidelines recommend its systematic screening using high-sensitivity cardiac troponin (hs-cTn). However, there is limited evidence of local screening programs. We conducted a prospective, single-center study aimed at assessing the feasibility and outcomes of implementing systematic PMI screening. Hs-cTn concentrations were measured before and after surgery. PMI was defined as a postoperative hs-cTnT of ≥14 ng/L, exceeding the preoperative value by 50%. All patients were followed-up during the hospitalization, at one month and one year after surgery. The primary outcome was the incidence of death and major cardiovascular and cerebrovascular events (MACCE). The secondary outcomes focused on the individual components of MACCE. We included two-thirds of all eligible high-risk patients and achieved almost complete compliance with follow-ups. The prevalence of PMI was 15.7%, suggesting a higher presence of cardiovascular (CV) antecedents, increased perioperative CV complications, and higher preoperative hs-cTnT values. The all-cause death rate was 1.7% in the first month, increasing up to 11.2% at one year. The incidence of MACCE was 9.5% and 8.6% at the same time points. Given the observed elevated frequencies of PMI and MACCE, implementing systematic PMI screening is recommendable, particularly in patients with increased cardiovascular risk. However, it is important to acknowledge that achieving optimal screening implementation comes with various challenges and complexities.

Generalized element-node complete model and its implementation for the optimal design of a piezo-actuated compliant amplifier

Compliant amplification mechanisms are widely applied to extend the stroke of stacked piezoelectric actuators. Accurate modeling of static and dynamic performances is crucial for the optimal design of complex compliant mechanisms. By generalizing the planar element-node model-based finite element method, this paper proposes a new modeling method capable of describing the spatial complete kinetostatics and dynamics for compliant mechanisms. On the basis of the widely reported complete compliance models for flexure hinges, a versatile stiffness model is established for the hinge with an arbitrary notch shape through the force equilibrium model. The generalized model is then demonstrated by applying for modeling and optimizing a compliant mechanism with dual-stage amplification. The verification through finite element simulations suggests that the maximum modeling error for the kinetostatic and first six resonant frequencies for the mechanisms with and without structural optimizations is less than 20%. Finally, the open-loop and closed-loop performance tests on the prototype with optimized parameters are conducted, demonstrating the effectiveness of the developed modeling and optimization methods.

Design, implementation, and evaluation of the smartphone-based application for dental treatment in oral and dental injuries

Background: Injuries to the mouth and teeth due to various incidents have a high prevalence in society; therefore, it is necessary to diagnose them and provide a suitable treatment plan for them. The purpose of this research is to design, implement and evaluate smartphone-based software for dental treatment in oral and dental injuries in pediatric patients. Methods: This study is an applied-production study conducted in three stages: The first step is the preparation and design of algorithms, the second stage is the introduction of diagnostic and therapeutic algorithms into the software system, and in the third stage, the software system is evaluated for its efficiency and accuracy in diagnosing and providing a treatment plan. The samples were all 77 patients who were referred to the trauma department of Shiraz Dental School from June to July 2019. Results: There was a significant correlation between the resident and the professor’s diagnosis with the software diagnosis, with 92.2% complete compliance, 3.9% relative compliance, and 3.9% non-compliance (kappa value=0.91, P value&lt;0.0001). Conclusion: The accuracy and high speed of diagnosis and the offered treatment plan for all types of oral and dental trauma were acceptable. However, the software cannot replace a specialist and should be used in combination with expert opinion.

Post-partum iron deficiency anemia: Prevalence and impact of moringa oleifera leaves powder on hemoglobin levels in postpartum period

Iron deficiency anemia is a cause of concern for pregnant and lactating mother globally. As per NFHS 5 Data, 52.2% pregnant women (Both Urban and Rural) are anemic in India. Iron Deficiency Anemia is associated with maternal and neonates’ mortality, restricted cognition development, low birth weight babies, Premature babies and majorly stunting which affects the nutritional status throughout the vicious cycle. Postpartum anemia is associated with an impaired quality of life, reduced cognitive abilities, emotional instability, and depression and constitutes a significant health problem in women of reproductive age. Multipronged strategies are required to curtail maternal anemia. Food based approach to prevent anemia is the most sustainable strategy. To investigate the impact of moringa oleifera leaves powder capsules on haemoglobin levels of postpartum mothers. The study was conducted in one of the govt. hospitals of Vadodara District of Gujarat, India and was a part of larger study carried on M Oleifera effects on prolactin levels. An interventional study was carried out amongst 106 postpartum mothers. Fifty-six mothers constituted the interventional group of which 45 mothers did complete compliance and 50 mothers constituted the control group of which 37 mothers did complete compliance of capsules for 30 days. Hemoglobin levels were analysed on day 0 (Baseline) and on day 7 (Endline) post-partum. Data was analysed using independent t test and appropriate statistical analysis.Findings revealed the prevalence of iron deficiency anemia to be 59%in postpartum mothers post-delivery. Mean baseline hemoglobin values for experimental and control group was 10.9 ± 1.4 g/dl and 10.3 ± 1.5 g/dl respectively on day 0 post-partum. The mean end line hemoglobin values for experimental and control group were 12.3 ± 1.5 g/dl and 11.6 ± 1.6 g/dl respectively on day 7 post-partum. The mean rise in haemoglobin levels of experimental group was 1.4g/dl and that of control group was 0.8g/dl which was significant (p=0.00001).Postpartum anemia is a cause of concern.There was a significant impact of Moringa Oleifera Leaves on hemoglobin levels of enrolled lactating mothers. Thus, it can be suggested that Moringa oleifera can be supplemented to lactating mothers’ post-partum to aid curtailing iron deficiency anemia. Improved haemoglobin levels in post-partum mothers may facilitate Exclusive Breastfeeding practices.

Sustainability and impact of the implementation of a frailty checklist for the acute medical unit: experience from a tertiary public hospital in Singapore

BackgroundAccelerated population ageing is associated with an increasing prevalence of frailty. International guidelines call for systematic assessment and timely interventions for older persons requiring acute care. Checklists have been applied...

Analysis of the capacity of existing anti-virus protection systems and their based methods for detecting new malware in military information systems

The article solves the task of analyzing the ability of existing anti-virus systems and the methods based on them to detect new malicious software in information systems of critical infrastructure, in particular, the sector of the state defense forces. It is noted that the official data of the developers of antivirus systems often do not confirm the declared level of accuracy of detecting new malicious software in practice. In addition, in most cases, the declared accuracy rate of detecting new malware is higher than the similar rate of detection of known malware, which indicates that the antivirus systems in question are tested in specific conditions that are too different from real ones. The properties of new malicious software are described in order to find the most suitable class of computer viruses. Classes of polymorphic (oligomorphic) and metamorphic viruses demonstrate the most complete compliance with the specified properties, which allows us to assert their significant share in the use of new malicious software. The characteristics of malicious software detection methods are given, which due to their properties are able to adapt to a certain extent to their metamorphic (polymorphic) nature. Methods based on the theory of fuzzy logic demonstrate the most complete correspondence. The direction of improvement of the existing anti-virus systems in order to increase the adaptability to the detection of new (polymorphic, metamorphic) classes of malicious software is proposed. The obtained results should be considered as a basis for the implementation of new approaches to the detection of malicious software in order to identify previously unknown instances of it, which will allow to significantly increase the effectiveness of ensuring cyber security of modern information systems and networks.

Inappropriate Multi-Target Stool DNA Use for Colorectal Cancer Screening: Risks, Compliance, and Outcomes.

Background Inappropriate or "off-label" use of multi-target stool DNA (mt-sDNA) tests refers to their use in patients for whom colonoscopy or no testing at all is warranted. Examples include a positive family history of colorectal cancer, a history of inflammatory bowel disease, or medical issues necessitating diagnostic colonoscopy, among others. Current understanding of off-label mt-sDNA use for colorectal cancer screening, its associated risks, and outcomes is lacking. We examined off-label mt-sDNA prescription and compliance with testing in an outpatient setting in southeast Michigan. Aims The primary aims of the study were determining the extent of off-label mt-sDNA testing and compliance, and results of all testing, as well as demographic factors associated with off-label prescriptions. The secondary aims were to examine explanations for incomplete testing and factors contributing to successful completion. Methods Using a retrospective design, we identified mt-sDNA orders from outpatient internal medicine clinics between January 1, 2018, to July 31, 2019, to evaluate the proportion of off-label mt-sDNA, results of testing, and follow-up colonoscopies up to one year after order placement. Patients were categorized as "off-label" if any inappropriate criteria were met. Statistical analysis was performed for primary and secondary outcomes. Results From 679 mt-sDNA orders within the study period, 81 (12.1%) had at least one off-label criterion for testing. In total, 404/679 (59.5%) patients completed testing. Lack of follow-up comprised the majority of incompletions (216/275; 78.6%). Only 52 (70.3%) out of 74 positive results were followed by diagnostic colonoscopy. Retired employment status (OR = 1.87; 95%CI, 1.17-2.98; P = 0.008) and age of 76 years or older (OR = 2.28; 95%CI, 0.99-5.21; P = 0.044) were significantly associated with increased risk of off-label mt-sDNA prescription. Increasing age range was associated with higher test completion (χ2 (5) = 12.085, p = 0.034). Multinomial logistic regression revealed an increasing age range (OR = 1.29; 95% CI, 1.09-1.54; P = 0.004), predictive of a positive mt-sDNA result for both groups. There was no significant difference between off-label or on-label groups in the mean number of resected polyps or pathology scores on follow-up colonoscopy. Conclusions Off-label mt-sDNA use remains a concern in the outpatient setting. Compliance for test completion and follow-up colonoscopy for positive results require further improvement. Our findings shed new light on the factors associated with off-label testing while reiterating its burden. We also describe common reasons for incomplete tests in an attempt to augment future colorectal cancer (CRC) screening initiatives.

Completion rates and trends of the patient-reported outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) across 14 oncology clinical trials.

1579 Background: With growing emphasis on patient-centered regulatory decision making, there is a greater need to incorporate the patient’s voice in oncology clinical trials. Regulatory guidelines outline core patient-reported outcomes (PROs) to include which can inform risk/benefit evaluation. Self-reported symptomatic adverse events (AE) form part of these core PROs, with the new 2023 draft FDA guidance acknowledging the benefits of including them to enhance the assessment of tolerability in early phase dose optimization trials. Given the clinical symptoms and disease burden in oncology, patient burden needs to be thoughtfully considered when incorporating PROs into trials. We assessed trends and feasibility of electronic data collection for symptomatic AEs by analyzing completion compliance and time to complete the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) across 14 oncology trials. Methods: All PRO-CTCAE were collected electronically on Clario Tablets. Operational data for completion status (completed or missed) and duration of time to complete the PRO-CTCAE in seconds was extracted. Completion rates over time were examined overall and for every 3-month interval (quarters Q1 to Q9+). The median was selected for analyses of time to complete to account for skewness. Results: The sample included 14 studies across Phase I-III trials across a range of cancers including multiple myeloma, mesothelioma and cancers of the lung, prostate, head/neck, gastric, breast, and ovary. Study durations were 24 weeks and up. The PRO-CTCAE form was completed 13,122 times and missed in 1,182 instances, giving an overall completion rate of 91.7%. On average, 25 questions (range 5-47) covered an average of 13 symptoms (range: 4-25). Completion rate was not associated with the number of questions asked or time since enrollment. The overall median time to complete the PRO-CTCAE was 82s (study-specific median range: 24s to 276s). Examining time to completion as a function of the number of questions revealed a significant positive association, such that each additional question added 5.2 seconds to the time it took to complete the assessment. Conclusions: Completion compliance was high for PRO-CTCAE and remained high regardless of study length and the number of questions included in the PRO-CTCAE form. This suggests that electronic PRO-CTCAE is a feasible solution for collecting self-reported symptomatic AEs. Although time to complete the form increased with the number of questions, results suggest that including a higher number of PRO-CTCAE questions does not negatively impact compliance rate. Our data showing high completion rates may also reflect the benefits of electronic PROs in reducing patient burden and enhancing data quality, as acknowledged by regulatory agencies.

Pediatric Eye Care Treatment Rates and Community Compliance to a Spectacle Provision Program in an Underserved School District in San Diego, CA.

The need for early identification and treatment of young children's refractive error needs has become a public health concern. The UCSD Eyemobile for Children (EyeMobile) provides vision screenings and comprehensive eye exams on the Eyemobile among a population of underserved, predominantly Hispanic preschool and elementary school children. The program also provides spectacles for children who fail eye exams due to refractive error. We performed a retrospective cross-sectional analysis of all children screened from 2011 to 2017 by the Eyemobile across 10 San Diego elementary schools. We examined demographics, distance and near visual acuity, autorefraction, stereopsis, and color vision. To measure compliance to our spectacle program, we checked if children who were prescribed spectacles were wearing them, as instructed, at the following year's screening. Differences between compliance measures with respect to school, age, ethnicity, and gender were determined using chi-square analysis, while all other measures were fit to a binary logistic regression to determine statistically significant factors. A total of 12,176 elementary school children were screened between 2011 and 2017. Of these children, 5269 (43.3%) were referred for a comprehensive eye examination. Across six years, 3163 (60.0%) of the children referred completed their eye examinations. There was a significant increase (p < 0.001) in exam completion in the successive years. Exam completion was significantly higher in ten-year-olds (p = 0.0278) and in 3 of the 10 schools (p < 0.0001, p = 0.0027, and p = 0.0309). A total of 1089 (8.9% of screened) children were prescribed spectacles. Of the 409 children that were recorded with the compliance method, 342 (83.6%) were found to be fully compliant and wearing their spectacles as prescribed. The Eyemobile program demonstrated high levels of compliance for both eye examination completion and prescribed spectacle wear in underserved populations in the San Diego region, compared to similar national programs.

Hygiene Sanitation Snack Selling and Snack Consumption Behavior of Middle School Students

The purpose of this research was to examine how educating middle school students about cleanliness and sanitation, enforcing laws on vendors, and implementing school policies affects the students' views and attitudes regarding buying snacks. Methods such as surveys, evaluations of vendors, and discussions in small groups were all part of the overall strategy. While teaching about proper cleanliness and sanitation is crucial, the research found that it may not be enough to get kids to rethink their snack-buying habits on its own. Assessments of vendors also found that many were not in complete compliance with applicable hygiene and sanitation laws, potentially endangering the health of customers. Middle school children may benefit greatly from school regulations that make healthy snack selections more accessible and restrict access to less healthy ones, according to the research. Researchers also found that vendors operating in close proximity to schools with stringent standards were more likely to follow those laws' guidelines for cleanliness and sanitation. Based on these results, it seems that school regulations may be a useful tool for fostering a culture of healthy snacking and assuring the security of school food. This research may help shape public health and food safety regulations and instructional programs that target middle school children and their snacking habits.