Compliance Metrics Research Articles

Impact of AI on cybersecurity and security compliance

Artificial Intelligence (AI) is transforming the field of cybersecurity and reshaping security compliance practices. As cyber threats become increasingly complex, AI offers powerful tools for identifying, mitigating, and preventing attacks in real-time. AI-driven systems excel at processing vast amounts of data, detecting anomalies, and identifying patterns that traditional security systems might miss. Machine learning and deep learning algorithms enhance the ability to predict potential threats, reducing response time and improving the accuracy of threat detection. These capabilities make AI a valuable asset in addressing sophisticated threats such as zero-day vulnerabilities, advanced persistent threats (APTs), and ransomware attacks. In the realm of security compliance, AI plays a pivotal role by automating routine tasks such as monitoring, auditing, and reporting. This reduces the burden on organizations to manually enforce regulatory standards, leading to more efficient compliance with frameworks like GDPR, HIPAA, and PCI-DSS. AI can continuously assess systems to ensure that they meet compliance requirements, enhancing the ability to detect and respond to violations. Furthermore, AI contributes to governance by helping organizations develop robust security policies, track compliance metrics, and streamline incident response. However, the integration of AI in cybersecurity also presents challenges, including adversarial AI, data privacy concerns, and transparency in AI decision-making processes. Additionally, AI-driven attacks are an emerging threat that necessitates further research and regulation. Despite these challenges, the future of AI in cybersecurity and compliance looks promising, with advancements in predictive analytics, quantum computing, and autonomous security systems poised to further revolutionize the field. As AI technologies evolve, they will continue to play a critical role in fortifying cybersecurity defenses and ensuring regulatory compliance across industries.

MLSE Output Visualization and Transmitter Compliance Metric

MLSE Output Visualization and Transmitter Compliance Metric

Reduced dynamic changes in pulmonary artery compliance during isometric handgrip exercise in patients with heart failure

Exercise intolerance is a debilitating symptom in heart failure (HF), adversely affecting both quality of life and long-term prognosis. Emerging evidence suggests that pulmonary artery (PA) compliance may be a contributing factor. This study aims to non-invasively assess PA compliance and its dynamic properties during isometric handgrip (HG) exercise in HF patients and healthy controls, using cardiovascular magnetic resonance (CMR). We prospectively enrolled 36 subjects, comprising 17 HF patients (NYHA class II and III) and 19 healthy controls. Participants performed an HG test, and we assessed changes in PA compliance and hemodynamic flow parameters using advanced CMR techniques. We also explored the relationship between CMR-derived PA compliance metrics and established clinical indicators, ensuring the validity of our findings through intra- and interobserver agreements. HF patients had significantly lower resting PA compliance compared to controls (28.9% vs. 50.1%, p < 0.01). During HG exercise, HF patients exhibited a dampened adaptability in PA compliance. Hemodynamic responses, including heart rate and blood pressure, were not significantly different between the groups. Further analyses revealed a significant correlation between changes in PA compliance and functional capacity, and an inverse relationship with NYHA class. Our study demonstrates a marked difference in PA vascular responses during HG exercise between HF patients and healthy controls. The compromised adaptability in PA compliance in HF patients is correlated with diminished functional capacity. These findings have significant clinical implications and may guide future interventional strategies in HF management.

MEDINA Catalogue of Cloud Security controls and metrics: Towards Continuous Cloud Security compliance.

In order to address current challenges on security certification of European ICT products, processes and services, the European Comission, through ENISA (European Union Agency for Cybersecurity), has developed the European Cybersecurity Certification Scheme for Cloud Services (EUCS). This paper presents the overview of the H2020 MEDINA project approach and tools to support the adoption of EUCS and offers a detailed description of one of the core components of the framework, the MEDINA Catalogue of Controls and Metrics. The main objective of the MEDINA Catalogue is to provide automated functionalities for CSPs' compliance managers and auditors to ease the certification process towards EUCS, through the provision of all information and guidance related to the scheme, namely categories, controls, security requirements, assurance levels, etc. The tool has been enhanced with all the research and implementation works performed in MEDINA, such as definition of compliance metrics, suggestion of related implementation guidelines, alignment of similar controls in other schemes, and a set of self-assessment questionnaires, which are presented and discussed in this paper.

Reaching Regulatory Compliance Metrics: A New Nurse Leader's Experience

It can be challenging to meet regulatory compliance measures when there are competing priorities with short staffing and workplace burnout. Finding a way to reach regulatory compliance standards without heavily relying on dispensary actions to enforce compliance can help reengage nursing teams, create a sense of purpose, and establish a leader and staff collaborative approach to nursing excellence. By creating a shared vision for the unit, nurse leaders can collaborate with staff to reach needed standards that support patient care outcomes. Additional methods, such as routine audits, tracking, leader commitment, staff communication, individualized teaching, feedback, and team building, are all efforts that supported two units in reaching compliance standards for the first time in 4 years through a team project. Unit A had a 4-year pain reassessment completion average of 77.6%. Unit A's average after the project was 88.1%, a 10.9% increase. Unit C had a 4-year running average of 78.0%. After the project, unit C's average increased to 90.1%, a 12.4% increase. Unit A's skipped function usage 6 months before the unit project was 21.05%, and postproject intervention use was down to 6.55%. Unit C's skipped function usage 6 months before the project was 22.84%, and postproject intervention use was 6.99%. Overall severity compliance had a remarkable upward trend. Lastly, a 10.2% increase in patient responses to the NRC Health question on staff eased discomfort compared to the results from the previous 6 months.

A Review of the Evaluation of Building Energy Code Compliance in the United States

Building energy codes are essential tools for achieving energy efficiency in buildings. However, the full energy savings potential of these codes can only be realized if buildings are constructed in compliance with them. Therefore, evaluating building energy code compliance is crucial in bridging the gap between the energy efficiency requirements set by energy codes and the actualized energy savings achieved. An energy code compliance evaluation serves as a mechanism to assess construction practices, evaluate the effectiveness of code enforcement, identify gaps in compliance, and guide strategies for improvement through training and education. Conducting code compliance evaluation activities involves field studies that require careful design and significant resources. Historically, more emphasis has been placed on developing and adopting building energy codes, while efforts to evaluate compliance have been relatively limited and lacking consistent approaches. The passage of the 2009 American Recovery and Reinvestment Act (ARRA), which mandated that states create plans for achieving 90% compliance within eight years, stimulated the need for an energy code compliance evaluation. As a result, federal, state, and local governments, and utilities have invested in the development of methodologies and tools for code compliance evaluation studies. This paper reviews the code compliance evaluation studies conducted in the United States over the past three decades. It describes and compares the methodologies and metrics used to assess building energy code compliance, summarizes the general elements and steps involved in the evaluation process, and discusses common issues in these studies. Over time, code compliance evaluation methodologies have evolved from isolated development within individual states, regions, and utilities, to widely accepted protocols applicable across different states and local jurisdictions. There has been a transition in compliance metrics, shifting from historical compliance rates to energy-consumption-oriented approaches.

Intense exercise for survival among men with metastatic prostate cancer: 12 months feasibility results from the INTERVAL-GAP4 trial.

81 Background: Exercise is now considered an important therapy to ameliorate treatment side effects, improve quality of life and physical function however, causation of survival benefit and the underlying mechanisms is not yet established. In 2015, the Intense Exercise for Survival among Men with Metastatic Castrate-Resistant Prostate Cancer (INTERVAL-GAP4) – a worldwide multicentre phase III trial – was launched to determine if high-intensity combined resistance and aerobic exercise plus psychosocial support improves overall survival in men with metastatic prostate cancer. Here, while exercise delivery and follow-up assessments are still taking place in 6 different countries, we aim to examine the feasibility, exercise compliance and safety of a 12-month exercise medicine program in patients with mCRPC. Methods: Experimental design was a longitudinal analysis of attrition rates, exercise attendance and compliance metrics and programme safety over the initial 12 months of patients participating in the INTERVAL-GAP4 trial at the Edith Cowan University site in Perth, Australia. Results: 201 patients were screened for participation and 46 patients (22.9%) were randomly assigned to the two study arms. Median time since prostate cancer diagnosis was 72.0 (interquartile range (IQR): 19.5-118.5) months. Most patients were previously treated with radiotherapy (53.3%). Metastases present mostly in the lymph nodes (53.3%), followed by bones (51.1%), lungs (2.2%) and bladder (2.2%). Participants attended a total of 2,907 out of 3,744 exercise sessions scheduled, with a median exercise attendance of 78.8% (IQR: 71.6%-82.7%) per participant. Majority of sessions were performed at an RPE of 7-8 indicating “vigorous intensity” or at an RPE of 5-6 indicating “moderate intensity” (67.2%). Tolerance was moderate-to-high in most sessions (83.0%). 191 adverse events (AEs) were observed throughout the study period. A total of 136 adverse events were reported by 19 participants from the exercise group, and these were mainly disease related (n= 69, 50.7%). Most AEs were grade 1 and 2 (n= 126, 92.7%). In the control group, 55 AEs were observed, and these were mainly disease related (n= 22, 40.0%) and grade 1 and 2 (n= 51, 92.7%). The most common intervention-related adverse events experienced in the exercise group were pain (n= 6, 50.0%; i.e., back pain, bone pain, lymph node pain, and general pain). Conclusions: Patients with mCPRC can participate in high-intensity aerobic and resistance training with moderate to high attendance and tolerance. The exercise intervention appears safe with limited intervention-related adverse events experienced and mostly minor and expected. However, with only 22.9% of screened patients deemed suitable and willing, this aspect of feasibility requires attention. Clinical trial information: NCT02730338 .

Source separated graywater: Chemistry, unit operations, and criteria towards re-use

Water scarcity due to increasing population, climate change, and natural resource depletion has led to exploring alternate sources of useable water through the treatment and reuse of wastewater. Additionally, increasing complexity of logistics and costs to transport water are driving the development and demonstration of decentralized wastewater treatment units. Graywater, or wastewater that does not include water from toilets, is a particularly promising source of water for reuse due to lower contaminant loading when compared to other wastewater streams. In this study, ultrafiltration (UF) and reverse osmosis (RO) membrane technologies with ultraviolet (UV) disinfection was evaluated for the treatment of low strength graywater from shower facilities over a six-month period. With >100,000-gallons of source separated graywater treated, this is one of the largest and most comprehensive graywater treatment events to date. Water reuse guidelines were established to reflect the most stringent reuse requirements in the United States. The combined treatment train of UF and RO met compliance metrics for all analytes of interest. This UF/RO system not only addresses issues with water quality, but water quantity as well. A water recovery rate of 85 % multiplies the effective volume of usable water by a factor of 6.5, creating a significant reduction in volume required. Both the quality of the treated water and the effective volume gains from the multiplier effect make decentralized treatment of source separated graywater by UF/RO a viable technology to address physical and economical water scarcity. This system can be used in austere environments to capture a currently untapped source of water for reuse.

Assessing the sustainability of compliance with surgical site infection prophylaxis after discontinuation of mandatory active reporting: study protocol

BackgroundSurgical site infections are common. Risk can be reduced substantially with appropriate preoperative antimicrobial administration. In 2005, the VA implemented the Surgical Care Improvement Project (SCIP) in the setting of high rates of non-compliance with antimicrobial prophylaxis guidelines. SCIP included public reporting of evidenced-based antimicrobial guideline compliance metrics in high-risk surgeries. SCIP was highly successful and led to high rates of adoption of preoperative antimicrobials and early discontinuation of postoperative antimicrobials (>95%). The program was retired in 2015, as the manual measurement and reporting process was costly with limited expected additional benefit. To our knowledge, no studies have assessed whether the gains achieved by SCIP were sustained since active support for the program was discontinued. Furthermore, there has been no investigation of the spread of antimicrobial prophylaxis guideline adoption beyond the limited set of procedures that were included in the program.MethodsUsing a mixed methods sequential exploratory approach, this study will (1) quantitatively measure compliance with SCIP metrics over time and across all procedures in the five major surgical specialties targeted by SCIP and (2) collect qualitative data from stakeholders to identify strategies that were effective for sustaining compliance. Diffusion of Innovation Theory will guide assessment of whether improvements achieved spread to procedures not included under the umbrella of the program. Electronic algorithms to measure SCIP antimicrobial use will be adapted from previously developed methodology. These highly novel data mining algorithms leverage the rich VA electronic health record and capture structured and text data and represent a substantial technological advancement over resource-intensive manual chart review or incomplete electronic surveillance based on pharmacy data. An interrupted time series analysis will be used to assess whether SCIP compliance was sustained following program discontinuation. Generalized linear models will be used to assess whether compliance with appropriate prophylaxis increased in all SCIP targeted and non-targeted procedures by specialty over the duration the program’s active reporting. The Dynamic Sustainability Framework will guide the qualitative methods to assess intervention, provider, facility, specialty, and contextual factors associated with sustainability over time. Barriers and facilitators to sustainability will be mapped to implementation strategies and the study will yield an implementation playbook to guide future sustainment efforts.RelevanceSustainability of practice change has been described as one of the most important, but least studied areas of clinical medicine. Learning how practices spread is also a critically important area of investigation. This study will use novel informatics strategies to evaluate factors associated with sustainability following removal of active policy surveillance and advance our understanding about these important, yet understudied, areas.

VestAid: A Tablet-Based Technology for Objective Exercise Monitoring in Vestibular Rehabilitation.

(1) Background: Current vestibular rehabilitation therapy is an exercise-based approach aimed at promoting gaze stability, habituating symptoms, and improving balance and walking in patients with mild traumatic brain injury (mTBI). A major component of these exercises is the adaptation of the vestibulo-ocular reflex (VOR) and habituation training. Due to acute injury, the gain of the VOR is usually reduced, resulting in eye movement velocity that is less than head movement velocity. There is a higher chance for the success of the therapy program if the patient (a) understands the exercise procedure, (b) performs the exercises according to the prescribed regimen, (c) reports pre- and post-exercise symptoms and perceived difficulty, and (d) gets feedback on performance. (2) Methods: The development and laboratory evaluation of VestAid, an innovative, low-cost, tablet-based system that helps patients perform vestibulo-ocular reflex (VORx1) exercises correctly at home without therapist guidance, is presented. VestAid uses the tablet camera to automatically assess patient performance and compliance with exercise parameters. The system provides physical therapists (PTs) with near real-time, objective (head speed and gaze fixation compliance), and subjective (perceived difficulty and pre- and post- exercise symptoms) metrics through a web-based provider portal. The accuracy of the head-angle and eye-gaze compliance metrics was evaluated. The accuracy of estimated head angles calculated via VestAid’s low-complexity algorithms was compared to the state-of-the-art deep-learning method on a public dataset. The accuracy of VestAid’s metric evaluation during the VORx1 exercises was assessed in comparison to the output of an inertial measurement unit (IMU)-based system. (3) Results: There are low mean interpeak time errors (consistently below 0.1 s) across all speeds of the VORx1 exercise, as well as consistently matching numbers of identified peaks. The spatial comparison (after adjusting for the lag measured with the cross-correlation) between the VestAid and IMU-based systems also shows good matching, as shown by the low mean absolute head angle error, in which for all speeds, the mean is less than 10 degrees. (4) Conclusions: The accuracy of the system is sufficient to provide therapists with a good assessment of patient performance. While the VestAid system’s head pose evaluation model may not be perfectly accurate as a result of the occluded facial features when the head moves further towards an extreme in pitch and yaw, the head speed measurements and associated compliance measures are sufficiently accurate for monitoring patients’ VORx1 exercise compliance and general performance.

Description of on-farm treatment compliance and risk factors for culling in sows

BackgroundIn commercial pig farming, sick or injured sows are often treated by producers or hired staff. To date, limited quantitative data exists on treatment compliance and the possible effect on sow longevity post-treatment. The objective of the study was to quantify on-farm compliance of treatment selection, frequency, and dosage, as well as to investigate the association between body condition scores (BCS) and other sow-level factors on post-treatment cull risk.ResultsOn-farm treatment records, including culling reason or reason of death up to 6 months post-treatment, production records and sow characteristics were obtained for 134 sows over an 8-week period. Treatment compliance was based on the accuracy of recorded treatments compared to the herd veterinarian’s established treatment guidelines. Univariable and multivariable logistic regression models including treatment reason, treatment compliance, BCS, parity, production stage and production metrics, were constructed to investigate associations between those variables and sow culling or death. This study found low compliance for on-farm sow treatment protocols, with only 22.4% (30/134) of the sows receiving correct and complete treatment during the duration of the study. No effect of individual treatment components (drug, dosage, or frequency) on sow culling was observed. A trend for an interaction between treatment compliance and BCS was found, and parity and number of piglets born alive were identified as predictors for sow maintenance in the herd.ConclusionsOn-farm sow treatment compliance was low, resulting in that approximately 80% of the enrolled sows were not treated according to existing guidelines. Non-compliance of treatment guidelines did not seem to affect the risk of culling in treated sows but may have prolonged any associated pain, recovery time and negatively impacted the sow welfare during that time period.

Linking Fortification Compliance Metrics With Decision Making Needs: From Brand Level Data to Market Share Weighted Information

Abstract Objectives A fortification program can only be effective if (1) each brand producer complies with fortification standards (i.e., adequately fortified), and (2) the adequately fortified products are consumed by a large proportion of the population. We quantified fortification quality (extent to which levels of fortification align with food standards) of oil, salt and wheat flour products; and ascertained the degree of food brand penetration and market share in Tanzanian markets. Methods Food inspectors collected multiple samples of food products at the production and/or market and laboratory analysts quantified the micronutrient content. We compared the average content for each individual brand product to the national fortification standards considering lab measurement uncertainty and classified into one of 4 fortification status categories (not fortified, fortified below, according to, or above the fortification standard). To establish penetration and market share, we visited 1500 retail outlets across regions in Tanzania to ascertain brand product availability and sales volumes. We applied weights using the market share estimates to extrapolate the fortification quality of the food market volume in the country. Results Of the different brand products of salt (26), wheat flour (25), and oil (68) found in the market, samples were collected and micronutrient content analyzed in the main oil (30%), salt (62%), and wheat flour brand products (85%). While 12% of salt, 35% of wheat flour, and 22% of oil brand products were fortified above the fortification standard minimum, when weighted by their market share, these represent 90% of the salt, 86% of wheat flour, and only 2% of the oil market volume respectively. Conclusions Fortification compliance of brand products provides important data for industry and regulatory authorities to identify where corrective action is necessary. Health and development staff are concerned about the extent to which additional nutrients are delivered to the population to anticipate public health impact, for which adjustment using reliable market share data is key. Weighted brand data can help resource constrained regulatory staff prioritize monitoring and enforcement activities to industries/producers with greatest influence. Funding Sources Bill and Melinda Gates Foundation (BMGF).

Gridded bias correction of modeled PM2.5 for exposure assessment, and estimation of background concentrations over a coastal valley region of northwestern British Columbia, Canada

ABSTRACT Chemical transport models (CTM) can have large biases and errors when simulating pollutant concentrations. To improve the characterization of fine particulate matter (PM2.5) over complex terrain for exposure assessments, three mathematical formulae that utilized the relationship between modeled and observed quantile concentrations at a monitor location were developed. These were then applied to 1 year of CMAQ model output of PM2.5 over the Terrace–Kitimat Valley of northwestern British Columbia, Canada. The final products enhanced the representation of ambient levels at existing monitoring stations when evaluated with conventional statistical measures. Better agreement of corrected outputs with observed compliance metrics was also found. On average, the absolute errors of amended outputs were 11% and 10% for the annual mean PM2.5 and 98th percentiles of daily concentrations, respectively, compared to 45% and 61%, respectively, in the original outputs. These improvements provided greater confidence to use the amended outputs to estimate concentrations at locations without monitors. The predominance of pristine conditions in the modeling domain was exploited to derive annual background PM2.5 concentrations over the valley, which was estimated to be 2.0–2.3 μg m−3. To our knowledge, this is the first study to calculate background PM2.5 concentrations over northern BC coastlands using bias-corrected outputs from an air quality model. Implications: Bias correction of CMAQ model output was necessary for assessing regulatory compliance for ambient PM2.5. The implications are notable. First, for low to moderate spatial heterogeneity in monitoring data, the use of regression equations that relates quantile mean concentrations of model outputs to those of observational data enhances the estimation of PM2.5 at unmonitored locations. Second, by providing spatial pollutant distribution ahead of planned industrial development in Terrace–Kitimat Valley (TKV), corrected model output offers a baseline for tracking progress in airshed management. Third, correction improved pollutant exposure classification, for which the risk was predominantly low. Finally, 2.0–2.3 μg m−3 should be considered as PM2.5 concentrations that are irreducible when setting voluntary targets for ambient levels in the area.

Motorcycle Chassis Design Utilizing Multi-Material Topology Optimization

&lt;div class="section abstract"&gt;&lt;div class="htmlview paragraph"&gt;Evolving fuel efficiency and emissions standards, along with consumer demand for performance, are strong pressures for light-weighting of performance oriented motorcycles. The field of topology optimization (TO), with the extension of multi-material topology optimization (MMTO) provide manufacturers with advanced structural light-weighting methodology. TO methodology has been adopted in many industries, including automotive where light-weighting assists in meeting efficiency regulations. The development of process specific manufacturing constraints within MMTO is a critical step in increasing adoption within industries dealing with manufacturing cost restrictions. This capability can decrease design complexity, lowering manufacturing costs of optimization solutions.&lt;/div&gt;&lt;div class="htmlview paragraph"&gt;A conventional all-aluminum perimeter style motorcycle chassis is analyzed to develop baseline compliance (total strain energy) metrics. An MMTO design space is created and optimized with steel and aluminum, such that results match the baseline design weight. This formulation demonstrates increased structural efficiency through stiffer structures at equivalent weight. Results are generated with standard MMTO, symmetry, and extrusion constraints to demonstrate utility of these manufacturing constraints. Material ratios are used to enforce lower cost material distribution selections.&lt;/div&gt;&lt;div class="htmlview paragraph"&gt;The usage of MMTO with manufacturing and material ratio constraints has resulted in up to 60.4% reduction in structural compliance of designs, and a multitude of lower cost alternative designs. The usage of symmetry constraints provides effectively identical results to standard MMTO, with a computational time reduction of 29%. Extrusion constraints demonstrate decreased manufacturing difficulty with a computational time reduction of 52% and structural performance penalty of 58.6% from the lowest compliance MMTO result. The enforcement of steel has demonstrated a decrease in structural performance (increase in compliance) and material costs, with varying degrees depending on manufacturing constraints and enforcement limits. The MMTO based designs provide a range of solutions to designers, which can be selected based on the importance of structural efficiency, manufacturing difficulty, and material costs.&lt;/div&gt;&lt;/div&gt;

A 2-Year Experience With Enhanced Recovery After Surgery: Evaluation of Compliance and Outcomes in Pancreatic Surgery.

Enhanced Recovery After Surgery (ERAS) programs reduce recovery time, length of stay (LOS), and complications after major surgical procedures. We evaluated our 2-year experience with a newly implemented comprehensive ERAS program at a high-volume center after pancreatic surgery. Outcomes, cost, and compliance metrics were assessed in 215 patients who underwent elective pancreatic surgery (pre-ERAS; n = 99; post-ERAS: n = 116). Mann-Whitney U and χ2 tests were used to evaluate continuous and categorical variables. There were significant decreases in LOS and cost in the post-ERAS cohorts. There were significant increases in compliance with ERAS implementation. Postoperative complication, readmission, and survival rates did not increase. Implementation of ERAS at a large-volume hospital may improve compliance and reduce costs and LOS without increasing adverse outcomes.

Improvements in Physician Clinical Workflow Measures After Implementation of a Dashboard Program

PurposeTo determine whether a combination of data-driven, personalized feedback and implementation of a graduated, sequential intervention model improved key measures of physician workflow and quality in radiation treatment planning. Methods and MaterialsAll radiation oncologists across 3 facilities at a single academic institution were prospectively evaluated on 5 predefined metrics of timeliness and accuracy in the treatment-planning process using a web-based institutional data repository and an institutional incident learning system. The study period encompassed 10 quarters from 2014 to 2016, with 2013 serving as a retrospective baseline. Physicians received quarterly individualized reports of their compliance metrics (a practice labeled the Physician Dashboard), and administrative interventions were initiated if >20% noncompliance with any metric was exceeded within a quarter. Consecutive quarters of noncompliance resulted in escalating interventions, including progress meetings with department leadership, and culminated in financial penalties. Rates of noncompliance were compared before and after implementation of this model. ResultsThree thousand six hundred sixty pre-Dashboard and 9497 post-Dashboard simulations were analyzed. After Dashboard implementation, significant reductions were observed in the rates of simulation orders requiring signature by a covering physician (14.1% vs 7.4%, P < .001), and the submission of plan contours ≥1 day (43.1% vs 23.1%, P < .001) or ≥2 days (30.8% vs 18.3%, P = .002) after the due date. There was some decrease in rates of inaccurate or incomplete plan submissions (6.2% vs 3.9%, P = .08). Seven of the 12 physicians received at least 1 intervention, with only 2 receiving all levels of intervention. ConclusionsRegular assessment and targeted feedback using the Physician Dashboard significantly improved radiation oncologist compliance with clinically meaningful treatment planning responsibilities at a high-volume academic center.

Reporting Quality of Randomized Controlled Trials in Restless Legs Syndrome Based on the CONSORT Statement.

BackgroundRandomized controlled trials (RCTs) are the cornerstone of modern medical research, and their reporting may not always be optimal. The Consolidated Standards of Reporting Trials (CONSORT) statement is an evidence-based means to improve the quality of RCTs’ reporting by providing a checklist of recommended items.The aim of this study was to assess the reporting quality of published RCTs on the restless legs syndrome (RLS), based on a checklist arising from the CONSORT statement.MethodsMedical electronic databases were searched for RCTs involving patients with RLS. Inclusion criteria were follows: articles must have been published in English and RLS patients must have been randomized into a minimum of two treatment cohorts of different medicinal orientations. CONSORT-recommended items were marked as “reported” or “not reported,” and an overall CONSORT compliance metric was calculated. Comparisons among different time periods, CONSORT-endorsing and non-endorsing, and different levels of impact factor journals were made.ResultsFifty-four eligible trials, published in 21 different scientific journals, were found. The average CONSORT compliance score was 56.6% (23.68–84.21%). CONSORT-endorsing journals had a mean CONSORT compliance of 58.47%, whereas non-endorsing journals had a mean CONSORT compliance of 50.4%. The median CONSORT compliance for articles published in low- (IF<2), medium- (IF 2-7), and high-ranked (IF>7) journals was 52.63, 56.57, and 59.21%, respectively. Only 14 of the 38 CONSORT items (36.8%) were reported in >75% of the articles.DiscussionThis study shows that the reporting of RLS-related RCTs is suboptimal, regardless of the time period, the quality of the publishing journal, and the endorsing or non-endorsing of the CONSORT statement.

Reporting Quality of Randomized Controlled Trials in Restless Legs Syndrome Based on the CONSORT Statement

<strong>Background:</strong> Randomized controlled trials (RCTs) are the cornerstone of modern medical research, and their reporting may not always be optimal. The Consolidated Standards of Reporting Trials (CONSORT) statement is an evidence-based means to improve the quality of RCTs’ reporting by providing a checklist of recommended items. The aim of this study was to assess the reporting quality of published RCTs on the restless legs syndrome (RLS), based on a checklist arising from the CONSORT statement. <strong>Methods:</strong> Medical electronic databases were searched for RCTs involving patients with RLS. Inclusion criteria were follows: articles must have been published in English and RLS patients must have been randomized into a minimum of two treatment cohorts of different medicinal orientations. CONSORT-recommended items were marked as “reported” or “not reported,” and an overall CONSORT compliance metric was calculated. Comparisons among different time periods, CONSORT-endorsing and non-endorsing, and different levels of impact factor journals were made. <strong>Results:</strong> Fifty-four eligible trials, published in 21 different scientific journals, were found. The average CONSORT compliance score was 56.6% (23.68–84.21%). CONSORT-endorsing journals had a mean CONSORT compliance of 58.47%, whereas non-endorsing journals had a mean CONSORT compliance of 50.4%. The median CONSORT compliance for articles published in low- (IF&lt;2), medium- (IF 2-7), and high-ranked (IF&gt;7) journals was 52.63, 56.57, and 59.21%, respectively. Only 14 of the 38 CONSORT items (36.8%) were reported in &gt;75% of the articles. <strong>Discussion:</strong> This study shows that the reporting of RLS-related RCTs is suboptimal, regardless of the time period, the quality of the publishing journal, and the endorsing or non-endorsing of the CONSORT statement.

Characterizing patient compliance over six months in remote digital trials of Parkinson\u2019s and Huntington disease

BackgroundA growing number of clinical trials use various sensors and smartphone applications to collect data outside of the clinic or hospital, raising the question to what extent patients comply with the unique requirements of remote study protocols. Compliance is particularly important in conditions where patients are motorically and cognitively impaired. Here, we sought to understand patient compliance in digital trials of two such pathologies, Parkinson’s disease (PD) and Huntington disease (HD).MethodsPatient compliance was assessed in two remote, six-month clinical trials of PD (n = 51, Clinician Input Study funded by the Michael J. Fox Foundation for Parkinson’s Research) and HD (n = 17, sponsored by Teva Pharmaceuticals). We monitored four compliance metrics specific to remote studies: smartphone app-based medication reporting, app-based symptoms reporting, the duration of smartwatch data streaming except while charging, and the performance of structured motor tasks at home.ResultsWhile compliance over time differed between the PD and HD studies, both studies maintained high compliance levels for their entire six month duration. None (− 1%) to a 30% reduction in compliance rate was registered for HD patients, and a reduction of 34 to 53% was registered for the PD study. Both studies exhibited marked changes in compliance rates during the initial days of enrollment. Interestingly, daily smartwatch data streaming patterns were similar, peaking around noon, dropping sharply in the late evening hours around 8 pm, and having a mean of 8.6 daily streaming hours for the PD study and 10.5 h for the HD study. Individual patients tended to have either high or low compliance across all compliance metrics as measured by pairwise correlation. Encouragingly, predefined schedules and app-based reminders fulfilled their intended effect on the timing of medication intake reporting and performance of structured motor tasks at home.ConclusionsOur findings suggest that maintaining compliance over long durations is feasible, promote the use of predefined app-based reminders, and highlight the importance of patient selection as highly compliant patients typically have a higher adherence rate across the different aspects of the protocol. Overall, these data can serve as a reference point for the design of upcoming remote digital studies.Trial registrationTrials described in this study include a sub-study of the Open PRIDE-HD Huntington’s disease study (TV7820-CNS-20016), which was registered on July 7th, 2015, sponsored by Teva Pharmaceuticals Ltd., and registered on Clinicaltrials.gov as NCT02494778 and EudraCT as 2015–000904-24.

033 Don't Stop in the Name of Love

Assess patient refill patterns in the treatment of vulvar and vaginal atrophy (VVA). Analysis of compliance metrics of prescriptions for 858,311 women who filled at least one prescription for VVA treatment was longitudinally tracked utilizing LifeLinkTM Longitudal LRx Prescription Data from IMS Health. The study period spanned 34 months (2013-2016), divided into the following: 1) cohort selection period (4-month period to select women who had either a new-to-therapy or continued prescription); 2) look-back period (18-month period preceding the prescription; 3) look-forward (observation) period (12-month period following the prescription used to evaluate adherence). Approximately 33% of women were new to therapy; the majority used Premarin® and Estrace® creams. While vaginal creams are the leaders for new prescriptions, ∼ 60% of women filled only their initial prescription. Women using vaginal ring, tablet, or the oral SERM (Osphena®) were likely to fill more than one prescription (65% vs ∼40% creams). The trend for multiple fills (5+) followed a similar pattern: ∼7% of women using vaginal estrogen creams, ∼22% of women using a vaginal ring or tablet, and 31% using the oral SERM. Overall, the average number of refills for all products is low, ranging from 2.0 (creams) to 3.9 for the SERM. Average time on therapy was: 369 days for creams, 560 and 604 days for tablet and ring, respectively, and 417 days for the SERM.