Adherence Metrics Research Articles

Healthy at Home for COPD: An Integrated Digital Monitoring, Treatment, and Pulmonary Rehabilitation Intervention.

Chronic Obstructive Pulmonary Disease (COPD) is a leading cause of morbidity and mortality in the United States. Frequent exacerbations result in higher use of emergency services and hospitalizations, leading to poor patient outcomes and high costs. Demonstrate the feasibility of a multimodal, digitally enhanced remote monitoring, treatment, and tele-pulmonary rehabilitation intervention among patients with COPD. In this pilot clinical trial, community-dwelling adults with moderate-severe COPD were enrolled in a multimodal digital monitoring and treatment program including a Fitbit wearable device, study app that tracked COPD-related symptoms, on-demand mobile integrated health (MIH) services for acute home-based treatment, and tele-pulmonary-rehabilitation. Participants were enrolled in the program for six months. COPD severity and health-related quality of life assessments were performed at baseline, 3 months, and 6 months. Primary feasibility outcomes include recruitment and retention rate, and participant protocol fidelity, which were reported descriptively. Exploratory clinical outcomes included patient-reported quality of life, activation, and intervention satisfaction. Over 18 months, 1,333 patients were approached and 100 (7.5%) were enrolled (mean age 66, 52% female). Ninety-six participants (96%) remained in the study for the full enrollment period. Fifty-five (55%) participated in tele-pulmonary-rehabilitation. Participants wore the Fitbit for a median of 114 days (IQR 183.6) and 16.85 hours/day (4.05), resulting in a median of 1133 minutes (243) per day. Completion rates for scheduled instruments ranged from 78-93%. Nearly all participants (85%) performed COPD ecological momentary assessment at least once with a median of 4.85 recordings. On average, a 2.48-point improvement (p=0.03) in COPD Assessment Test Score was observed from baseline to study completion. The adherence and symptom improvement metrics were not associated with baseline patient activation measures. A multimodal intervention combining preventative care, symptom and biometric monitoring, and home treatment was feasible in adults living with COPD. Participants demonstrated high protocol fidelity and engagement and reported improved quality of life.

Identifying the Relationship Between CGM Time in Range and Basal Insulin Adherence in People With Type 2 Diabetes.

The study aimed to determine the relationship between basal insulin adherence and glycemic control evaluated by time in range (TIR) in people with insulin-treated type 2 diabetes (T2D), using data from both continuous glucose monitors (CGM) and connected insulin pens. Furthermore, the study aimed to determine the best basal insulin adherence metric. CGM data and basal insulin data were collected from 106 insulin-treated people (aged ≥18 years) with T2D. Three different adherence metrics were employed (dose deviation, dose deviation ≤20%, and a traditional metric) and a three-step methodology was used to measure insulin adherence level. The coefficient of determination (R2), based on a univariate linear regression analysis, was used to determine the relationship between each adherence metric and TIR. A statistically significant relationship was observed between TIR and adherence quantified as the dose deviation ≤20% metric (R2 = 0.67, P = .006). Neither the relationship between the dose deviation metric and TIR (R2 = 0.43, P = .08) nor the relationship between the traditional metric and TIR (R2 = 0.35, P =.23) was found to be statistically significant. Our study indicates a relationship between basal insulin adherence and TIR in people with insulin-treated T2D. This seems to underscore the role of basal insulin adherence for optimal glycemic outcomes and utilizing TIR as a clinical marker. Furthermore, the results suggest that the magnitude of deviation from the recommended basal insulin dose impacts glycemic control, indicating dose deviation ≤20% as a more accurate metric for quantifying adherence.

Predictive modeling of medication adherence in post myocardial infarction patients: a bayesian approach using beta-regression.

Predicting medication adherence in post myocardial infarction (MI) patients has the potential to improve patient outcomes. Most adherence prediction models dichotomize adherence metrics and status. This study aims to develop medication adherence prediction models that avoid dichotomizing adherence metrics and to test whether a simplified model including only 90-days adherence data would perform similarly to a full multivariable model. Post MI adult patients were followed for 1-year post the event. Data from pharmacy records were used to calculate proportion of days covered (PDC). We used Bayesian beta-regression to model PDC as a proportion, avoiding dichotomization. For each medication group, statins, P2Y12 inhibitors and aspirin, two prediction models were developed, a full and a simplified model. 3692 patients were included for model development. The median (Inter quartile range) PDC at 1-year for statins, P2Y12 inhibitors and aspirin was 0.8 (0.33, 1.00), 0.79 (0.23, 0.99) and 0.79 (0.23, 0.99), respectively. All models showed good fit to the data by visual predictive checks. Bayesian R2 for statins, P2Y12 inhibitors and aspirin models were 61.4%,71.2% and 55.2%, respectively. The simplified models showed similar performance compared with full complex models as evaluated by cross validation. We developed Bayesian multilevel models for statins, P2Y12 inhibitors and aspirin in post MI patients that handled 1-year PDC as a proportion using the beta-distribution. In addition, simplified models, with 90-days adherence as single predictor, had similar performance compared with full complex models.

Enhancing Tuberculosis Treatment Adherence: Evaluating the Efficacy of the Support for Treatment Adherence and Medication Protocols (STAMP) Device for Automatic Dispensing and Real-Time Medication Monitoring.

Tuberculosis (TB) remains a significant global health challenge, necessitating strict adherence to medication for successful treatment and prevention of drug resistance. Adherence to a regular medication regimen is crucial in TB management, yet achieving high adherence rates among patients proves challenging due to various factors including forgetfulness, complexity of treatment schedules, and socioeconomic barriers. This study explores the potential of an automatic medicine dispenser (AMD) anchored system to improve medication adherence among TB patients and evaluates its impact through monitoring and feedback mechanisms. The AMD integrates advanced technology to dispense medications at scheduled times, thereby reducing reliance on patient memory and manual adherence tracking. This device is complemented by a monitoring system where healthcare mentors oversee adherence data in real-time via a web-linked dashboard. Such real-time monitoring enables mentors to promptly intervene in cases of non-adherence, offering personalized support and guidance tailored to individual patient needs. The study employs a mixed-methods approach, combining quantitative analysis of adherence rates derived from the AMD anchored system with qualitative data from patient surveys. These surveys gather insights into patient experiences and perceptions regarding the use of the AMD anchored system, including feedback on the accuracy of medication intake recorded by the device. Data obtained from the surveys are analyzed alongside adherence metrics from the dashboard to elucidate factors influencing adherence behavior and the device's effectiveness in fostering sustained treatment adherence. Preliminary findings indicate promising outcomes associated with the AMD anchored system intervention. High rates of adherence are observed among patients utilizing the device, attributed to the device's automated dispensing mechanism and the supportive role of healthcare mentors. Challenges such as technical malfunctions and patient acceptance are also identified, prompting continuous refinement of the AMD and mentorship strategies. In conclusion, the integration of an AMD coupled with real-time monitoring through a web-linked dashboard represents a significant advancement in TB treatment adherence management. Future research should focus on the scalability and sustainability of this technology-augmented, holistic approach across diverse healthcare settings to maximize its impact on global TB management strategies.

Impact of a point-of-care urine tenofovir assay on adherence to HIV pre-exposure prophylaxis among women in Kenya: a randomised pilot trial.

Adherence challenges with oral tenofovir-based pre-exposure prophylaxis (PrEP) are common. We developed a point-of-care assay to objectively assess tenofovir in urine and conducted a pilot trial examining the impact of counselling informed by use of this urine assay on long-term PrEP adherence. This randomised trial enrolled women not in serodiscordant partnerships 3 months after PrEP initiation at the Kenya Medical Research Institute to compare standard-of-care adherence counselling versus counselling informed by the urine assay (urine-test counselling group) every 3 months for 12 months. In the standard of care group, urine samples were stored and tested at study end without participant feedback. Here we report the adherence primary outcome of hair concentrations of tenofovir at 12 months as a long-term metric (undetectable levels defined long-term non-adherence), as well as urine concentrations of tenofovir at each visit as a short-term adherence metric and acceptability of the assay assessed by quantitative surveys. Data were analysed by randomisation group. This completed trial was registered with ClinicalTrials.gov (NCT03935464). From March 17, 2021 to Jan 18, 2022 we enrolled 49 women in the urine-test counselling group and 51 in the standard of care group; retention was 86 (86%) of 100. Nine (21%) of 42 in the urine-test counselling group had hair samples at 12 months with tenofovir concentrations below the limit of quantification compared with 15 (37%) of 41 in the standard of care group. The relative odds of long-term non-adherence in the standard of care group compared with urine-test counselling were 3·53 (95% CI 1·03-12·03; p=0·044). Pre-intervention, urine tenofovir was detectable in 65% in the urine-test counselling group and 71% in the standard of care group (p=0·68). At 12 months, 31 (72%) of 43 in the intervention group had detectable urine tenofovir compared with 19 (45%) of 42 in the standard of care group (p=0·0015). 40 (93%) of 43 participants liked the test very much and only one disliked the test. One participant in the standard of care group was withdrawn at the 6-month visit due to HIV seroconversion. A low-cost urine tenofovir assay to inform PrEP counselling resulted in improvement in both short-term and long-term metrics of adherence. This urine tenofovir assay could help to improve long-term PrEP adherence. National Institute of Allergy and Infectious Diseases and National Institutes of Health.

Association of Area Deprivation Index with Adherence to Proposed Regimen in Patients with Sarcoidosis in Detroit, Michigan.

Social predictors affect severity of sarcoidosis, with Black patients, older individuals, those with lower income, and those without insurance having greater severity. This study aimed to explore potential disparities affecting access to care in sarcoidosis patients with a primary focus on metrics such as area deprivation index (ADI) and its association with adherence to the proposed regimen. A retrospective chart review study of all patients seen in pulmonary clinics at a large urban tertiary care center over 2 years with sarcoidosis patients identified with International Classification of Diseases diagnosis code D86. Data collected included age, race, sex, ADI, insurance, online patient portal usage, chest x-rays, pulmonary function tests, missed visits, hospitalizations, positive biopsy, communication and visits around bronchoscopy. Categorical variables were described using frequency and percentage. Numerical variables were described using median, mean and standard deviation. Statistical analysis included chi-square test, two-sample T-test and Wilcoxon rank sum test. Multivariate logistic regression analysis was performed to model independent association with 12 month no-show occurrence as a metric of adherence to the proposed regimen. Among sarcoidosis patients (N = 788), univariate models showed the presence of active online patient portal use among younger patients (58.6 years with portal vs. 65.1 years without portal, p < 0.001), those with lower ADI (73 with portal vs. 92 without portal, p < 0.001) and with commercial insurance (48.5% with portal vs. 20.7% without portal, p < 0.001); more x-rays (45.6% with x-rays vs. 36.6% without x-rays, p = 0.018) and hospitalizations (50.3% with hospitalizations vs. 36.2% without hospitalizations, p < 0.001) in Medicare patients. Sarcoidosis patients with positive biopsies on file from 2013-2023 were more likely to be male (44.19% with positive biopsy vs. 33.91% without positive biopsy, p = 0.006), White (36.29% with positive biopsy vs. 22.9% without positive biopsy, p < 0.001) or other races (3.23% with positive biopsy vs. 2.25% without positive biopsy, p < 0.001), younger (55.8 years with positive biopsy vs. 61.7 years without positive biopsy, p < 0.001) and belonged to lower national ADI ranks (73 with positive biopsy vs. 80 without biopsy, p = 0.041). A multivariate analysis was done with those variables found to be significant in the univariate analyses, which revealed that higher ADI national was associated with failure to adhere to the proposed regimen. We identified intricate patterns of sociodemographic variables affecting access to care in sarcoidosis patients, especially higher ADI national associated with failure to adhere to the proposed regimen, raising concerns for potential healthcare barriers. Understanding these barriers is vital for equitable high-quality care, assisting in timely and efficient management of the patient's disease.

993-P: Exploring CGM Adherence and Glycemic Metrics in People with Diabetes—Real-World Data from Dexcom Users

993-P: Exploring CGM Adherence and Glycemic Metrics in People with Diabetes—Real-World Data from Dexcom Users

Drug Concentrations in Hair and Dried Blood Spots as Preexposure Prophylaxis Adherence Metrics During Pregnancy and Postpartum.

We evaluated hair tenofovir (TFV) concentrations as an adherence metric for HIV preexposure prophylaxis during pregnancy and postpartum and compared hair levels with TFV-diphosphate levels in dried blood spots (DBSs). Overall 152 hair samples from 102 women and 36 hair-DBS paired samples from 29 women were collected from a subset of women in a cluster-randomized trial. Having a partner with HIV was associated with higher hair TFV levels (P < .001). Hair TFV concentrations were strongly correlated with DBS TFV-diphosphate levels (r = 0.76, P < .001), indicating hair as a promising cumulative adherence metric for perinatal preexposure prophylaxis assessment.

Improved Outcomes in Eosinophilic Esophagitis with Higher Medication Possession Ratio.

Eosinophilic esophagitis (EoE) disease activity can be caused by treatment non-adherence. Medication possession ratio (MPR) is an established metric of medication adherence. A higher MPR correlates with better outcomes in several chronic diseases, but MPR has not been investigated with respect to EoE. A retrospective cohort study was performed using an established EoE registry for the years 2005 to 2020. Treatment periods were identified, MPRs were calculated, and medical records were assessed for histologic remission (<15 eos/hpf), dysphagia, food impaction, stricture occurrence, and esophageal dilation that corresponded to each treatment period. In total, 275 treatment periods were included for analysis. The MPR in the histologic remission treatment period group was 0.91 (IQR 0.63-1) vs. 0.63 (IQR 0.31-0.95) for the non-remission treatment period group (p < 0.001). The optimal MPR cut-point for histologic remission was 0.7 (Sen 0.66, Spec 0.62, AUC 0.63). With MPRs ≥ 0.7, there were significantly increased odds of histologic remission (odds ratio 3.05, 95% confidence interval 1.79-5.30) and significantly decreased odds of dysphagia (OR 0.27, 95% CI 0.15-0.45), food impaction (OR 0.26, 95% CI 0.11-0.55), stricture occurrence (OR 0.52 95% CI 0.29-0.92), and esophageal dilation (OR 0.29, 95% CI 0.15-0.54). Assessing MPR before repeating an esophagogastroduodenoscopy may decrease unnecessary procedures in the clinical management of eosinophilic esophagitis.

Patient-Centric Approaches to Gastroretentive Floating Tablets: Tailoring for Diverse Clinical Needs

Gastroretentive tablets have emerged as a promising platform for controlled drug delivery, offering the potential for prolonged gastric residence time and enhanced therapeutic outcomes. This comprehensive review explores the paradigm shift towards patient-centric approaches in the development of gastroretentive tablets. The journey begins with an examination of the historical evolution of gastroretentive technologies, tracing advancements in formulation techniques, materials, and technologies that have paved the way for patient-centric designs. The review delves into patient-centric formulation strategies tailored for diverse populations, including pediatrics and geriatrics. It highlights the importance of considering patient-specific needs, preferences, and physiological characteristics in optimizing dosage forms. Regulatory considerations and compliance-enhancing features are scrutinized, providing insights into the delicate balance between personalized medicine and regulatory expectations. Real-world applications are illuminated through case studies, offering success stories across pediatric, geriatric, and personalized medicine contexts. Clinical outcomes, including adherence metrics and patient satisfaction, provide tangible evidence of the impact of patient-centric gastroretentive tablets. Challenges in formulation development and regulatory implementation are critically examined, with a focus on technical hurdles and strategies for navigating evolving regulatory landscapes. The conclusion distills key findings and outlines implications for future research and clinical practice, emphasizing continued innovation, strategic regulatory engagement, and interdisciplinary collaboration. This review serves as a comprehensive resource for researchers, clinicians, and regulatory professionals engaged in advancing patient-centric gastroretentive tablets. It offers a roadmap for the integration of innovative technologies into clinical practice, fostering a patient-centered approach in the evolution of controlled drug delivery systems.

IoT based Remote Patient Monitoring System

Remote Patient Monitoring (RPM) systems have emerged as transformative tools in healthcare, leveraging technological advancements to enhance patient care beyond traditional clinical settings. This abstract explores the design and implementation of a Remote Patient Monitoring System aimed at bridging the gap between patients and healthcare providers. The system employs a network of wearable devices and sensors to continuously collect and transmit relevant patient data to a secure cloud-based platform. Through real- time monitoring, healthcare professionals can remotely assess vital signs, medication adherence, and other crucial health metrics, enabling early intervention and personalized care. The integration of data analytics and machine learning algorithms further enhances the system's ability to detect patterns, predict potential health issues, and optimize treatment plans. This abstract delves into the key features, benefits, and challenges associated with the Remote Patient Monitoring System, emphasizing its potential to revolutionize healthcare delivery by fostering proactive, patient-centered care and improving overall health outcomes.

Development of a Cognitive Training Support Programme for prevention of dementia and cognitive decline in at-risk older adults.

Evidence for the beneficial effects of cognitive training on cognitive function and daily living activities is inconclusive. Variable study quality and design does not allow for robust comparisons/meta-analyses of different cognitive training programmes. Fairly low adherence to extended cognitive training interventions in clinical trials has been reported. The aim of further developing a Cognitive Training Support Programme (CTSP) is to supplement the Computerised Cognitive Training (CCT) intervention component of the multimodal Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability (FINGER), which is adapted to different cultural, regional and economic settings within the Word-Wide FINGERS (WW-FINGERS) Network. The main objectives are to improve adherence to cognitive training through a behaviour change framework and provide information about cognitive stimulation, social engagement and lifestyle risk factors for dementia. Six CTSP sessions were re-designed covering topics including (1) CCT instructions and tasks, (2) Cognitive domains: episodic memory, executive function and processing speed, (3) Successful ageing and compensatory strategies, (4) Cognitive stimulation and engagement, (5) Wellbeing factors affecting cognition (e.g., sleep and mood), (6) Sensory factors. Session content will be related to everyday life, with participant reflection and behaviour change techniques incorporated, e.g., strategies, goal-setting, active planning to enhance motivation, and adherence to the CCT and in relevant lifestyle changes. Through interactive presentations promoting brain health, the programme provides for personal reflection that may enhance capability, opportunity and motivation for behaviour change. This will support adherence to the CCT within multidomain intervention trials. Efficacy of the programme will be evaluated through participant feedback and adherence metrics.

Drop-out, adherence, and compliance in randomized controlled trials of exercise training in multiple sclerosis: Short report

We documented reporting and rates of drop-out, adherence, and compliance from 40 randomized controlled trials (RCTs) included in our meta-analysis on safety of exercise training (ET) in MS. We adopted definitions and metrics of adherence and compliance provided by the MoXFo adherence group. Drop-out was reported in 100% of the RCTs and approximated 10% for intervention and control conditions. Adherence and compliance were reported in approximately 50% and 10% of the RCTs, respectively, and approximated 80% and 70%, respectively. Standardized metrics for reporting adherence and compliance are important in future RCTs for understanding the impact on outcomes and translation of research evidence into practice.

Adherence Monitoring Package (AMoPac) in patients suspected of non-response to antihypertensive treatment: perceived usefulness by general practitioners

BackgroundNon-adherence to antihypertensive agents is common, mainly because of the low perceived burden of high blood pressure. General practitioners (GPs) are unable to predict whether patients are adhering to a...

Adherence determination using urine-tenofovir point-of-care testing and pharmacy refill records: A cross-sectional study.

Pharmacy refill records (PRR), are an accessible strategy for estimating adherence in low- and middle-income countries (LMICs). However, the low-cost urine-tenofovir point-of-care test opens up the possibility of an objective metric of adherence that is scalable to LMICs. This study compared adherence to tenofovir-based regimens using urine-tenofovir point-of-care (POC) test with pharmacy refill records in a Nigerian population of HIV-positive persons. This was a cross-sectional study among 94 HIV-positive adults, which was conducted from June to August 2021, in a large outpatient clinic in Lagos, Nigeria. Adherence to pharmacy appointments was automatically calculated using a computerized pharmacy appointment system (FileMaker Pro™). Urine drops on the urine-tenofovir POC test strip developed 2 lines for a negative test (tenofovir absent) and one line for a positive test. Fisher's exact test was used to examine the association between pharmacy refill record and urine-tenofovir point-of-care test. Logistic regression was performed to predict viral suppression (<1000 copies/mL, based on WHO recommendations) using both methods of adherence determination. A Receiver Operating Characteristic (ROC) curve of the association between specificity and sensitivity was generated to evaluate the predictive value of adherence determined using pharmacy-refill record and urine-tenofovir point-of-care test in forecasting viral suppression. The statistical significance level was set at 0.05. Fisher's exact test showed no statistically significant difference in adherence using urine-tenofovir point-of-care test or pharmacy refill record. The logistic regression model showed that an increase in pharmacy-refill record of ≥ 95% was associated with viral suppression (P = .019). From the ROC curve, the sensitivity was same at 95.5% for both methods, but the specificity of the urine-tenofovir point-of-care test was greater (96.6% vs 95.5%) than pharmacy refill record (P = .837). Urine-tenofovir point-of-care test provided equivalent adherence data to pharmacy refill data.

Patient Engagement and Provider Effectiveness of a Novel Sleep Telehealth Platform and Remote Monitoring Assessment in the US Military: Pilot Study Providing Evidence-Based Sleep Treatment Recommendations.

Sleep problems are common and costly in the US military. Yet, within the military health system, there is a gross shortage of trained specialist providers to address sleep problems. As a result, demand for sleep medicine care far exceeds the available supply. Telehealth including telemedicine, mobile health, and wearables represents promising approaches to increase access to high-quality and cost-effective care. The purpose of this study was to evaluate patient engagement and provider perceived effectiveness of a novel sleep telehealth platform and remote monitoring assessment in the US military. The platform includes a desktop web portal, native mobile app, and integrated wearable sensors (ie, a commercial off-the-shelf sleep tracker [Fitbit]). The goal of the remote monitoring assessment was to provide evidence-based sleep treatment recommendations to patients and providers. Patients with sleep problems were recruited from the Internal Medicine clinic at Walter Reed National Military Medical Center. Patients completed intensive remote monitoring assessments over 10 days (including a baseline intake questionnaire, daily sleep diaries, and 2 daily symptom surveys), and wore a Fitbit sleep tracker. Following the remote monitoring period, patients received assessment results and personalized sleep education in the mobile app. In parallel, providers received a provisional patient assessment report in an editable electronic document format. Patient engagement was assessed via behavioral adherence metrics that were determined a priori. Patients also completed a brief survey regarding ease of completion. Provider effectiveness was assessed via an anonymous survey. In total, 35 patients with sleep problems participated in the study. There were no dropouts. Results indicated a high level of engagement with the sleep telehealth platform, with all participants having completed the baseline remote assessment, reviewed their personalized sleep assessment report, and completed the satisfaction survey. Patients completed 95.1% of sleep diaries and 95.3% of symptom surveys over 10 days. Patients reported high levels of satisfaction with most aspects of the remote monitoring assessment. In total, 24 primary care providers also participated and completed the anonymous survey. The results indicate high levels of perceived effectiveness and identified important potential benefits from adopting a sleep telehealth approach throughout the US military health care system. Military patients with sleep problems and military primary care providers demonstrated high levels of engagement and satisfaction with a novel sleep telehealth platform and remote monitoring assessment. Sleep telehealth approaches represent a potential pathway to increase access to evidence-based sleep medicine care in the US military. Further evaluation is warranted.

Collection and Analysis of Adherence Information for Software as a Medical Device Clinical Trials: Systematic Review.

The rapid growth of digital health apps has necessitated new regulatory approaches to ensure compliance with safety and effectiveness standards. Nonadherence and heterogeneous user engagement with digital health apps can lead to trial estimates that overestimate or underestimate an app's effectiveness. However, there are no current standards for how researchers should measure adherence or address the risk of bias imposed by nonadherence through efficacy analyses. This systematic review aims to address 2 critical questions regarding clinical trials of software as a medical device (SaMD) apps: How well do researchers report adherence and engagement metrics for studies of effectiveness and efficacy? and What efficacy analyses do researchers use to account for nonadherence and how appropriate are their methods? We searched the Food and Drug Administration's registration database for registrations of repeated-use, patient-facing SaMD therapeutics. For each such registration, we searched ClinicalTrials.gov, company websites, and MEDLINE for the corresponding clinical trial and study articles through March 2022. Adherence and engagement data were summarized for each of the 24 identified articles, corresponding to 10 SaMD therapeutics. Each article was analyzed with a framework developed using the Cochrane risk-of-bias questions to estimate the potential effects of imperfect adherence on SaMD effectiveness. This review, funded by the Richard King Mellon Foundation, is registered on the Open Science Framework. We found that although most articles (23/24, 96%) reported collecting information about SaMD therapeutic engagement, of the 20 articles for apps with prescribed use, only 9 (45%) reported adherence information across all aspects of prescribed use: 15 (75%) reported metrics for the initiation of therapeutic use, 16 (80%) reported metrics reporting adherence between the initiation and discontinuation of the therapeutic (implementation), and 4 (20%) reported the discontinuation of the therapeutic (persistence). The articles varied in the reported metrics. For trials that reported adherence or engagement, there were 4 definitions of initiation, 8 definitions of implementation, and 4 definitions of persistence. All articles studying a therapeutic with a prescribed use reported effectiveness estimates that might have been affected by nonadherence; only a few (2/20, 10%) used methods appropriate to evaluate efficacy. This review identifies 5 areas for improving future SaMD trials and studies: use consistent metrics for reporting adherence, use reliable adherence metrics, preregister analyses for observational studies, use less biased efficacy analysis methods, and fully report statistical methods and assumptions.

Standardization of Outpatient Care after CAR-T Therapy across a Large Cell Therapy Network- through Technology and Decentralized Virtual Nurses: Preliminary Results

Introduction: Shifting Chimeric Antigen Receptor T-cell (CAR-T) therapy to the outpatient setting may increase patient satisfaction and inpatient capacity, and reduce infection risk. Outpatient protocols require resources for patient management outside of clinic hours to be safe and effective. Our Transplant and Cellular Therapy Network (TCTN) leveraged wearable technology and decentralized nurses in four outpatient CAR-T programs. We sought to characterize patient adherence, time spent on patient monitoring, and clinical outcomes. Methods: Patients were deemed eligible for outpatient therapy if they were adults (18+ years), lived within 30-60 minutes of the treating hospital, had a 24/7 caregiver, and received CAR-T with known risks of developing cytokine release syndrome (CRS). The outpatient CAR-T program included enrollment into an FDA-cleared virtual care platform, daily engagement with virtual nurses for the duration of the program, and in-person clinic visits during the highest risk period (Days 1-14). The remote monitoring kit included a wearable device that continuously transmitted vital signs (pulse, respiratory rate, O 2 saturation and skin temperature), a tablet, axillary temperature patch and blood pressure (BP) cuff. Patients were asked to always wear the device outside of clinic visits, take a BP reading 3x/day, and complete surveys via the tablet. A multidisciplinary taskforce established clinical pathways for remote monitoring across sites and developed parameters for alarms, virtual nurse check-ins, and escalation of care to ER/clinic. Virtual nurses contacted patients based on vital sign trends, responded to patient concerns, and triaged in accordance with clinical pathways, escalating as appropriate. The virtual care platform, video and phone call logs with the virtual nurses, and clinical data were extracted for 40 patients between 2/20/23 and 6/15/2023. Inpatient admission, patient adherence, alarms, calls, and clinical metrics were summarized. Non-parametric measures were reported as median (IQR). Metrics for specific windows of time were reported for a subset of variables: wearable adherence (day vs. night) and alarms/calls during clinic hours (weekdays 8 am - 5 pm) vs. non- clinic hours. Adherence was derived from tasks/wear time completed vs. prescribed. Results: Forty patients (66 ± 12 years, 24 male) with diagnoses of Non-Hodgkin Lymphoma (75%), Plasma Cell Disorder (20%), or Acute Lymphoblastic Leukemia (5%) received CAR-T therapy [axi-cel (40%), liso-cel (25%), cilta-cel (20%), brexu-cel (12.5%), tisa-cel (2.5%)] and completed the outpatient CAR-T program. The median length of monitoring on the platform was 14.7 (10.4 - 27.6) days. Overall wearable adherence was 79 (67.7 - 87.9) %; 67 (48.7 - 83.4) % in the day and 89.1 (79.8 - 92.8) % at night. Median survey completion was 50 (7.7 - 80) % and BP compliance was 95 (69.8-100) %. Out of 717 patient days, 68.4% had 100% BP compliance (3 readings/day). There was a total of 780 alarms; 67% operational and 86% clinical alarms occurred during non-clinic hours (Table 1). The operational alarm rate was 0.5 and the clinical alarm rate was 0.6 per patient-day. 75% of patients triggered at least one operational and clinical alarm during their program. The virtual nurses engaged in 1102 calls through the tablet or phone (3.5 ± 3.4 mins). More than half of the calls were during non-clinic hours (63%) and 70% of calls were with a patient/care giver. Calls about a clinical alarm or clinical concern were 3x and 6.8x higher, respectively, during non-clinic hours. Twenty-seven patients required some level of hospital observation service and/or admission to the hospital; 25 patients developed CRS. Median duration from infusion to admission/observation was 5 (1-11) days. Median days to discharge was 5 (1-26). Of those admitted,10 patients were admitted to the ICU with a median stay of 5.5 (1-21) days. Conclusion: Our TCTN established a successful, integrated outpatient management process to ensure patient safety within the first 30 days post CAR T-Cell therapy. The virtual care platform and decentralized virtual nurses have enabled patients to recover safely with more time at home rather than in hospital. Future research will address patient and provider experiences and continue to expand on the safety and resource utilization of this integrated program.

3 Exploring the Relationship Between Cognition, Adherence, and Engagement in Compensatory Strategy Training in Mild Cognitive Impairment

Objective:Compensatory strategy training has been identified as a useful mechanism to improve everyday cognitive function among older adults with Mild Cognitive Impairment (MCI). Despite this, few studies have looked at cognitive factors that support adherence and engagement in these programs, which are key to maximizing benefit. The present study aimed to evaluate the relationship between cognition, adherence, and engagement during a group-based compensatory strategy training for people with MCI. We hypothesized individuals with better memory and executive function performance would show better adherence and higher engagement scores in cognitive training classes.Participants and Methods:Twenty-five participants enrolled in Emory University's Charles and Harriet Schaffer Cognitive Empowerment Program (CEP) completed an 11-week compensatory strategy training group (CEP-CT). CEP-CT is adapted from Ecologically Oriented Neurorehabilitation to be suitable for people with MCI. Participants enrolled were on average 74.3 years old (SD= 5.4), 52% Male, primarily Caucasian (80%; 16% African American), and college educated (M= 16.5 years; SD= 2.7). All participants received clinical diagnoses of MCI prior to enrollment in the program. Participants completed multiple cognitive measures, including Montreal Cognitive Assessment (MoCA), Hopkins Verbal Learning Test (HVLT), Trail Making Test A &amp; B (TMT), Number Span Forward (NSF) and verbal fluency (S-words and Animals). For all group sessions, class attendance (present vs. not present) was recorded for each participant and their care partner, and engagement ratings for participants were recorded by the facilitator on a 1 to 5 scale (higher scores indicate better engagement). Outcomes include adherence to cognitive training (percentage of sessions attended; M= 82% class attendance, SD= 18%) as well as the average engagement ratings across 11 weeks (M= 3.25, SD= .40).Results:Bivariate Pearson correlations revealed that individuals who attended more classes also demonstrated better engagement in class, r= .44, p= .03. Class attendance was significantly related to performance on measures of memory and executive function (HVLT: r= -.42, p= .04; TMT-B: r= .69, p= .04), such that participants who performed worse on these measures attended more CEP-CT classes. Average engagement ratings were unrelated to cognitive performance.Conclusions:Results did not support initial hypotheses, and instead indicate individuals with poorer performance on measures of memory and executive function had better adherence to CEP-CT classes, as measured by attendance. These results may indicate individuals experiencing cognitive difficulties are more likely to attend cognitive training classes. Subjective engagement ratings were unrelated to cognition; however, individuals who attended more sessions were more engaged in cognitive training classes. Future areas of research include objective measurement of class engagement as well as the incorporation of nuanced adherence metrics to further elucidate the relationship between these factors and cognition in MCI.

Novel treatment based on acceptance and commitment therapy versus cognitive behavioral therapy for insomnia: A randomized comparative effectiveness trial in women veterans.

This randomized comparative effectiveness trial evaluated a novel insomnia treatment using acceptance and commitment therapy (ACT) among women veterans. Participants received either the acceptance and the behavioral changes to treat insomnia (ABC-I) or cognitive behavioral therapy for insomnia (CBT-I). The primary objectives were to determine whether ABC-I was noninferior to CBT-I in improving sleep and to test whether ABC-I resulted in higher treatment completion and adherence versus CBT-I. One hundred forty-nine women veterans with insomnia disorder (Mage = 48.0 years) received ABC-I or CBT-I. The main sleep outcomes were Insomnia Severity Index (ISI), Pittsburgh Sleep Quality Index (PSQI), and sleep efficiency (SE) by actigraphy (objective) and sleep diary (subjective). Measures were collected at baseline, immediate posttreatment, and 3-month posttreatment follow-up. Treatment completion and adherence were assessed during the interventions. Both interventions improved all sleep outcomes from baseline to immediate posttreatment and 3-month posttreatment follow-up. At immediate posttreatment, ABC-I was statically noninferior for sleep diary SE and objective SE, but noninferiority was not statistically confirmed for ISI or PSQI total scores. At 3-month posttreatment follow-up, ABC-I was noninferior for all four of the key outcome variables. There was not a statistically significant difference between the number of participants who discontinued CBT-I (11%) versus ABC-I (18%; p = .248) before completing treatment. ABC-I was superior to CBT-I for some adherence metrics. Overall, ABC-I was similar in effectiveness compared to CBT-I for the treatment of insomnia and may improve adherence to some behavioral elements of treatment. (PsycInfo Database Record (c) 2023 APA, all rights reserved).