Real-World Effectiveness of High-Dose Tafamidis on Neurologic Disease Progression in Mixed-Phenotype Variant Transthyretin Amyloid Cardiomyopathy.

INTRODUCTION: Transthyretin amyloidosis (ATTR) is a progressive, heterogeneous rare disease manifesting as ATTR polyneuropathy (ATTR-PN), ATTR cardiomyopathy (ATTR-CM), or a mixed phenotype. Tafamidis meglumine (20 mg po qd) is approved in some markets to delay neurologic progression in ATTR-PN, while high-dose tafamidis (80/61 mg po qd) is approved worldwide to reduce cardiovascular mortality and cardiovascular-related hospitalization in ATTR-CM. The objective of this study was to assess the real-world benefit of high-dose tafamidis for delaying neurologic progression in patients with mixed-phenotype variant ATTR-CM (ATTRv-CM). METHODS: This exploratory, retrospective, observational cohort study evaluated anonymized electronic medical records and included adult patients with mixed-phenotype ATTRv-CM treated with high-dose tafamidis for at least 6 months. Neurologic assessments included the Medical Research Council (MRC) Scale for Muscle Strength, Neuropathy Impairment Score (NIS) muscle weakness subscale, and Polyneuropathy Disability (PND) instrument. Modified body mass index (mBMI) was also assessed. RESULTS: Patients (N = 10) started tafamidis treatment an average of 3.8 months after diagnosis, with an average treatment duration of 20.8 months. Seven of 10 patients demonstrated normal muscle strength on the MRC scale throughout the study, and 9 of 10 patients had no decline in muscle strength during the post-treatment period. The NIS muscle weakness subscale score was ≤ 60 for all patients in the study at all time points, suggesting normal function to mild impairment. Six of 10 patients had no change in walking capacity as measured by the PND instrument at pre- and post-assessments, while one-third of patients had a decrease in PND stage (signaling improvement) from pre- to post-assessment. mBMI remained relatively stable throughout the study. CONCLUSION: This is the first real-world study to demonstrate the potential value of high-dose tafamidis for delaying neurologic disease progression in patients with mixed-phenotype ATTRv-CM. The findings underscore the importance of multidisciplinary assessment for patients with ATTR amyloidosis. TRIAL REGISTRATION: ClinicalTrials.gov: NCT05139680.

Prescription Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) and Incidence of Depression Among Older Cancer Survivors With Osteoarthritis: A Machine Learning Analysis.

ObjectiveS: This study examined prescription NSAIDs as one of the leading predictors of incident depression and assessed the direction of the association among older cancer survivors with osteoarthritis. Methods: This study used a retrospective cohort (N = 14, 992) of older adults with incident cancer (breast, prostate, colorectal cancers, or non-Hodgkin's lymphoma) and osteoarthritis. We used the longitudinal data from the linked Surveillance, Epidemiology, and End Results -Medicare data for the study period from 2006 through 2016, with a 12-month baseline and 12-month follow-up period. Cumulative NSAIDs days was assessed during the baseline period and incident depression was assessed during the follow-up period. An eXtreme Gradient Boosting (XGBoost) model was built with 10-fold repeated stratified cross-validation and hyperparameter tuning using the training dataset. The final model selected from the training data demonstrated high performance (Accuracy: 0.82, Recall: 0.75, Precision: 0.75) when applied to the test data. SHapley Additive exPlanations (SHAP) was used to interpret the output from the XGBoost model. Results: Over 50% of the study cohort had at least one prescption of NSAIDs. Nearly 13% of the cohort were diagnosed with incident depression, with the rates ranging between 7.4% for prostate cancer and 17.0% for colorectal cancer. The highest incident depression rate of 25% was observed at 90 and 120 cumulative NSAIDs days thresholds. Cumulative NSAIDs days was the sixth leading predictor of incident depression among older adults with OA and cancer. Age, education, care fragmentation, polypharmacy, and zip code level poverty were the top 5 predictors of incident depression. Conclusion: Overall, 1 in 8 older adults with cancer and OA were diagnosed with incident depression. Cumulative NSAIDs days was the sixth leading predictor with an overall positive association with incident depression. However, the association was complex and varied by the cumulative NSAIDs days.

Cost impact of different treatment regimens of brolucizumab in neovascular age-related macular degeneration: A budget impact analysis.

BACKGROUND: Brolucizumab is a new anti-vascular endothelial growth factor (anti-VEGF) approved for treating neovascular age-related macular degeneration (nAMD). Multiple treatment regimens are available for treating nAMD. These regimens include manufacturer-recommended regimens, pro re nata (PRN) regimens, and treat-and-extend (T&E) regimens, which are based on clinical practice guidelines and data observed in the real-world clinical setting, classified as real-world evidence (RWE). Most budget impact models predict the financial consequences of adding a new drug to the formulary based on the manufacturer-recommended regimen. With different anti-VEGF treatment regimens being used in nAMD by ophthalmologists, it is OBJECTIVE: To estimate the budget impact of different treatment regimens of brolucizumab in nAMD from a US payer perspective. METHODS: A Microsoft Excel-based budget impact model was developed for different treatment regimens of brolucizumab over a 1-year time frame from a US payer perspective. A separate analysis was performed to estimate the budget impact from a US patient population perspective. Model inputs included drug costs, administration costs, physician visit costs, and disease monitoring costs. Outcomes in the budget impact model included the cost per member per month, annual health plan cost, and the US patient population-based annual cost. Based on the prevalence of nAMD in public and commercial health plans, a scenario analysis was conducted on the US population to account for the differences in the drug cost to the public and commercial payers. Further, 1-way sensitivity analyses were conducted to test model assumptions and uncertainty in model inputs. RESULTS: The addition of brolucizumab to the formulary increased the net budgetary impact under PRN and T&E regimens. The maximum increase in expenditure for a hypothetical health plan with 1 million enrollees was associated with the PRN regimen ($824,696), followed by the T&E regimen ($163,101). In contrast, using the manufacturer-recommended and RWE regimens led to an annual saving of $93,068 and $94,170 for the health plan, respectively. In the US patient population model, the introduction of brolucizumab resulted in savings in the manufacturer-recommended ($30.99 million) and RWE regimens ($31.35 million) but led to an increase in annual expenditures for the PRN ($274.58 million) and T&E ($54.30 million) regimens. CONCLUSIONS: Payers need to evaluate the cost impact of different treatment regimens of existing and new anti-VEGFs when making formulary decisions in nAMD management. DISCLOSURES: Mr Siddiqui, Ms Dhumal, Dr Patel, and Dr LeMasters have nothing to disclose. Dr Kamal has received research funding from Cerevel Therapeutics, served as a consultant to Pfizer/Cytel Inc, and received honoraria from Pharmacy Times Continuing Education. Dr Almony has served as a consultant to Cardinal Health and received honoraria from Pharmacy Times Continuing Education and Prime Education.

Distinguishing clinical factors associated with unintentional overdose, suicidal ideation, and attempted suicide among opioid use disorder in-patients.

Opioid and other drug-related overdoses and suicides are leading causes of injury death and represent a significant public health threat in the United States (U.S.). This study examined clinical factors of three patient groups from two inpatient addiction treatment facilities in Appalachian West Virginia (n = 66). Patients were classified as having: 1) unintentional overdose(s) (OD), 2) suicidal ideation or suicide attempt(s) (SI/SA), and 3) suicidal ideation or suicide attempt, and unintentional overdose (SI/SA/OD). Multinomial logistic regression models were used to determine whether adverse childhood experiences, self-injurious behaviors, substance use history, overdose history, and past year stressful life events were differentially associated with history of SI/SA/OD. Participants in the OD group were more likely to have used heroin in the 24-h preceding their most recent overdose compared to either the SI/SA or SI/SA/OD groups. The multivariable model found participants with history of SI/SA had higher adverse childhood experience scores and more participants with history of SI/SA endorsed childhood physical abuse and teen dating violence. Overall, there are characteristics that distinguish unintentional overdose from suicidal ideation and attempt. Patients with SI/SA/OD appear to have greater clinical severity. More thorough evaluation of drugs involved in overdose and history of self-injury may help distinguish future risk and inform treatment planning.

Survival and recovery modeling of acute kidney injury in critically ill adults.

Objectives: Acute kidney injury is common among the critically ill. However, the incidence, medication use, and outcomes of acute kidney injury have been variably described. We conducted a single-center, retrospective cohort study to examine the risk factors and correlates associated with acute kidney injury in critically ill adults with a particular focus on medication class usage. Methods: We reviewed the electronic medical records of all adult patients admitted to an intensive care unit between 1 February and 30 August 2020. Acute kidney injury was defined by the 2012 Kidney Disease: Improving Global Outcomes guidelines. Data included were demographics, comorbidities, symptoms, laboratory parameters, interventions, and outcomes. The primary outcome was acute kidney injury incidence. A Least Absolute Shrinkage and Selection Operator regression model was used to determine risk factors associated with acute kidney injury. Secondary outcomes including acute kidney injury recovery and intensive care unit mortality were analyzed using a Cox regression model. Results: Among 226 admitted patients, 108 (47.8%) experienced acute kidney injury. 37 (34.3%), 39 (36.1%), and 32 patients (29.6%) were classified as acute kidney injury stages I-III, respectively. Among the recovery and mortality cohorts, analgesics/sedatives, anti-infectives, and intravenous fluids were significant (p-value < 0.05). The medication classes IV-fluid electrolytes nutrition (96.7%), gastrointestinal (90.2%), and anti-infectives (81.5%) were associated with an increased odds of developing acute kidney injury, odd ratios: 1.27, 1.71, and 1.70, respectively. Cox regression analyses revealed a significantly increased time-varying mortality risk for acute kidney injury-stage III, hazard ratio: 4.72 (95% confidence interval: 1-22.33). In the recovery cohort, time to acute kidney injury recovery was significantly faster in stage I, hazard ratio: 9.14 (95% confidence interval: 2.14-39.06) cohort when compared to the stage III cohort. Conclusion: Evaluation of vital signs, laboratory, and medication use data may be useful to determine acute kidney injury risk stratification. The influence of particular medication classes further impacts the risk of developing acute kidney injury, necessitating the importance of examining pharmacotherapeutic regimens for early recognition of renal impairment and prevention.

Initial maintenance therapy adherence among older adults with asthma-COPD overlap.

OBJECTIVES: To examine the impact of initial maintenance therapy (IMT) type (inhaled corticosteroid [ICS] vs fixed-dose combination of ICS and long-acting ß agonist [ICS/LABA]) on trajectories of adherence among older adults (≥ 65 years) with coexisting asthma and chronic obstructive pulmonary disease (COPD), known as asthma-COPD overlap (ACO). STUDY DESIGN: We used a longitudinal, retrospective cohort design. METHODS: This study used a cohort of older adults with ACO using longitudinal data from a 10% sample of Optum's Deidentified Clinformatics Data Mart. We adopted group-based trajectory modeling to identify medication adherence trajectories over 12 months. Multinomial logistic regressions were used to evaluate the unadjusted and adjusted associations of IMT medication and adherence trajectory categories. All analyses accounted for treatment option selection bias with inverse probability treatment weighting. RESULTS: Of 1555 individuals, 73% of the sample used ICS/LABA for IMT. Four medication adherence trajectories were observed regardless of regimen: (1) persistent high adherence (12.0%), (2) progression to high adherence (20.8%), (3) progression to low adherence (10.5%), and (4) persistent low adherence (56.7%). Those who were initiated on ICS/LABA were less likely to have persistent low adherence (unadjusted odds ratio [OR], 0.44; 95% CI, 0.29-0.67) compared with those initiated on ICS monotherapy when "persistent high adherence" was used as the reference group. The relationship remained significant in adjusted regressions (adjusted OR, 0.38; 95% CI, 0.24-0.59). CONCLUSIONS: Real-world evidence suggests that using ICS/LABA for IMT may decrease the likelihood of persistent low adherence over time among older adults with ACO compared with ICS monotherapy.

Economic Burden of Treatment-Resistant Depression among Adults with Chronic Non-Cancer Pain Conditions and Major Depressive Disorder in the US.

OBJECTIVE: Major depressive disorder (MDD) and chronic non-cancer pain conditions (CNPC) often co-occur and exacerbate one another. Treatment-resistant depression (TRD) in adults with CNPC can amplify the economic burden. This study examined the impact of TRD on direct total and MDD-related healthcare resource utilization (HRU) and costs among commercially insured patients with CNPC and MDD in the US. METHODS: The retrospective longitudinal cohort study employed a claims-based algorithm to identify adults with TRD from a US claims database (January 2007 to June 2017). Costs (2018 US$) and HRU were compared between patients with and without TRD over a 12-month period after TRD/non-TRD index date. Counterfactual recycled predictions from generalized linear models were used to examine associations between TRD and annual HRU and costs. Post-regression linear decomposition identified differences in patient-level factors between TRD and non-TRD groups that contributed to the excess economic burden of TRD. RESULTS: Of the 21,180 adults with CNPC and MDD, 10.1% were identified as having TRD. TRD patients had significantly higher HRU, translating into higher average total costs (US$21,015TRD vs US$14,712No TRD) and MDD-related costs (US$1201TRD vs US$471No TRD) compared with non-TRD patients (all p < 0.001). Prescription drug costs accounted for 37.6% and inpatient services for 30.7% of the excess total healthcare costs among TRD patients. TRD patients had a significantly higher number of inpatient (incidence rate ratio [IRR] 1.30, 95% CI 1.14-1.47) and emergency room visits (IRR 1.21, 95% CI 1.10-1.34) than non-TRD patients. Overall, 46% of the excess total costs were explained by differences in patient-level characteristics such as polypharmacy, number of CNPC, anxiety, sleep, and substance use disorders between the TRD and non-TRD groups. CONCLUSION: TRD poses a substantial direct economic burden for adults with CNPC and MDD. Excess healthcare costs may potentially be reduced by providing timely interventions for several modifiable risk factors.

Economic Burden of Asthma-Chronic Obstructive Pulmonary Disease Overlap among Older Adults in the United States.

The objective of this study is to estimate the excess economic burden of Asthma-COPD Overlap (ACO) among older adults in the United States. We used a cross-sectional study design with data from a nationally representative survey of Medicare beneficiaries (Medicare Current Beneficiary Survey) linked to Medicare fee-for-service claims. Older adults with ACO had higher average total healthcare expenditures ($45,532 vs. $12,743) and higher out-of-pocket spending burden (19% vs. 8.5%) compared to those with no-asthma no-COPD (NANC). Individuals with ACO also had almost two, and 1.5 times higher expenditures compared to individuals with asthma only and COPD only, respectively. Multivariable regression models indicated that the adjusted associations of ACO to economic burden remained positive and statistically significant. In comparison with NANC, nearly three-quarters of the excess total healthcare expenditures and 83% of the out-of-pocket spending burden of older adults with ACO were explained by differences in predisposing, enabling, need, personal healthcare practices, and external factors among the two groups. The higher number of unique medications and the increased incidence of fragmented care were the leading contributors to the excess economic burden among older adults with ACO comparing to NANC individuals. Interventions that reduce the number of medications and fragmented care have the potential to reduce the excess economic burden among older adults with ACO.

Using a machine learning approach to investigate factors associated with treatment-resistant depression among adults with chronic non-cancer pain conditions and major depressive disorder.

OBJECTIVE: Presence of chronic non-cancer pain conditions (CNPC) among adults with major depressive disorder (MDD) may reduce benefits of antidepressant therapy, thereby increasing the possibility of treatment resistance. This study sought to investigate factors associated with treatment-resistant depression (TRD) among adults with MDD and CNPC using machine learning approaches. METHODS: This retrospective cohort study was conducted using a US claims database which included adults with newly diagnosed MDD and CNPC (January 2007-June 2017). TRD was identified using a clinical staging algorithm for claims data. Random forest (RF), a machine learning method, and logistic regression was used to identify factors associated with TRD. Initial model development included 42 known and/or probable factors that may be associated with TRD. The final refined model included 20 factors. RESULTS: Included in the sample were 23,645 patients (73% female mean age: 55 years; 78% with ≥2 CNPC, and 91% with joint pain/arthritis). Overall, 11.4% adults (N = 2684) met selected criteria for TRD. The five leading factors associated with TRD were the following: mental health specialist visits, polypharmacy (≥5 medications), psychotherapy use, anxiety, and age. Cross-validated logistic regression model indicated that those with TRD were younger, more likely to have anxiety, mental health specialist visits, polypharmacy, and psychotherapy use with adjusted odds ratios (AORs) ranging from 1.93 to 1.27 (all ps < .001). CONCLUSION: Machine learning identified several factors that warrant further investigation and may serve as potential targets for clinical intervention to improve treatment outcomes in patients with TRD and CNPC.

Identifying knowledge gaps in heart failure research among women using unsupervised machine-learning methods.

Aim: To identify knowledge gaps in heart failure (HF) research among women, especially postmenopausal women. Materials & methods: We retrieved HF articles from PubMed. Natural language processing and text mining techniques were used to screen relevant articles and identify study objective(s) from abstracts. After text preprocessing, we performed topic modeling with non-negative matrix factorization to cluster articles based on the primary topic. Clusters were independently validated and labeled by three investigators familiar with HF research. Results: Our model yielded 15 topic clusters from articles on HF among women. Atrial fibrillation was found to be the most understudied topic. From articles specific to postmenopausal women, five clusters were identified. The smallest cluster was about stress-induced cardiomyopathy. Conclusion: Topic modeling can help identify understudied areas in medical research.

Low-value care and excess out-of-pocket expenditure among older adults with incident cancer - A machine learning approach.

OBJECTIVE: To evaluate the association of low-value care with excess out-of-pocket expenditure among older adults diagnosed with incident breast, prostate, colorectal cancers, and Non-Hodgkin's Lymphoma. METHODS: We used a retrospective cohort study design with 12-month baseline and follow-up periods. We identified a cohort of older adults (age ≥ 66 years) diagnosed with breast, prostate, colorectal cancers, or Non-Hodgkin's lymphoma between January 2014 and December 2014. We assessed low-value care and patient out-of-pocket expenditure in the follow-up period. We identified relevant low-value services using ICD9/ICD10 and CPT/HCPCS codes from the linked health claims and patient out-of-pocket expenditure from Medicare claim files and expressed expenditure in 2016 USD. RESULTS: About 29 % of older adults received at least one low-value care procedure during the follow-up period. Low-value care differed by gender, and rates were higher in women with colorectal cancer (32.7 %) vs. (28.8 %) and NHL (40 %) vs. (39 %) compared to men. Individuals who received one or more low-value care procedures had significantly higher mean out-of-pocket expenditure ($8,726 ± $7,214) vs. ($6,802 ± $6,102). XGBOOST, a machine learning algorithm revealed that low-value care was among the five leading predictors of OOP expenditure. CONCLUSION: One in four older adults with incident cancer received low-value care in 12-months after a cancer diagnosis. Across all cancer populations, individuals who received low-value care had significantly higher out-of-pocket expenditure. Excess out-of-pocket expenditure was driven by low-value care, fragmentation of care, and an increasing number of pre-existing chronic conditions. POLICY STATEMENT: This study focuses on health policy issues, specifically value-based care and its findings have important clinical and policy implications for Centers for Medicare and Medicaid Services (CMS) which has issued a roadmap for states to accelerate the adoption of value-based care, with the Department of Health and Human Services (HHS) setting a goal of converting 50 % of traditional Medicare payment systems to alternative payment models tied to value-based care by 2022.

Facility and state-level factors associated with telemental health (TMH) adoption among mental health facilities in the United States.

INTRODUCTION: Telemental health (TMH) is a promising approach to increase access to mental healthcare. This study examined the TMH adoption rates and associations with facility- and state-level factors among US mental health (MH) facilities. METHODS: This retrospective, cross-sectional study used linked data for 2016 from the National Mental Health Services Survey (N = 11,833), Area Health Resources File, and national reports for broadband access and telehealth policies. The associations of facility and state-level characteristics with TMH adoption were examined with multi-level logistic regressions. RESULTS: Overall, 25.9% had used TMH. Having veteran affiliation [Adjusted Odds Ratio (AOR) = 18.53, 95% Confidence Interval (95%CI): 10.66-32.21] and greater Information Technology (IT) capacity [AOR(95%CI): 2.89(2.10-3.98)] were the strongest correlates of TMH adoption. Other facility characteristics associated with higher likelihood of TMH adoption were: public ownership, high patient volumes, having comprehensive MH treatments or Quality Improvement practices, having private or non-Medicaid public payers, and treating elderly patients (AORs: 1.16-2.41). TMH adoption was less likely among facilities treating more African Americans or patients with substance abuse disorders. TMH adoption varied substantially across states, with adoption more likely in states issuing special telehealth licences and those with more rural counties. DISCUSSION: One in four MH facilities adopted TMH in 2016. TMH adoption varied by multiple facility- and state-level factors. Our findings suggest that: legal/regulatory burden and lower facility IT capacity may discourage TMH adoption; significant racial disparities exist in TMH adoption; and there is a need to increase TMH use for substance abuse disorders.

Predictors of Co-occurring Cardiovascular and Gastrointestinal Disorders among Elderly with Osteoarthritis.

Objective: To identify the leading predictors of co-occurring cardiovascular or gastrointestinal disorders (CV-GID) in a real-world cohort of elderly with osteoarthritis (OA). Method: An observational retrospective cohort study using data from Optum's deidentified Clinformatics® Data Mart was conducted. Elderly with OA were identified in 2015 and were followed for two years to identify co-occurring CV-GID including ischemic heart disease, stroke, heart failure, dyspepsia, gastroesophageal reflux disorder, and peptic ulcer disease. Random Forest (RF) and Partial Dependence Plots (PDP) were used to identify the leading predictors of CV-GID and to examine their associations. Multivariable logistic regression was also used to examine the association of the leading predictors with CV-GID. Results: Our study cohort consisted of 45,385 elderly with OA (mean age 76.0 years). CV-GID were present in 59% of elderly. Using RF, age was found to be the strongest predictor of CV-GID followed by cardiac arrhythmia, duration of opioid use, number of orthopedist or physical therapy visits, number of intra-articular corticosteroid injections, polypharmacy, duration of non-selective nonsteroidal anti-inflammatory drugs or oral corticosteroids, and hypertension. The PDPs demonstrated that higher age, cardiac arrhythmia, longer durations of opioid or oral corticosteroids, higher number of physical therapy visits or intra-articular corticosteroid use, polypharmacy, and hypertension were associated with a higher risk of CV-GID. Conclusion: CV-GIDs are common among elderly with OA and can be predicted based on certain clinical factors. Machine learning methods with PDPs can be used to improve the interpretability and inform decision-making.

A Machine Learning Approach to Identify Predictors of Potentially Inappropriate Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) Use in Older Adults with Osteoarthritis.

Evidence from some studies suggest that osteoarthritis (OA) patients are often prescribed non-steroidal anti-inflammatory drugs (NSAIDs) that are not in accordance with their cardiovascular (CV) or gastrointestinal (GI) risk profiles. However, no such study has been carried out in the United States. Therefore, we sought to examine the prevalence and predictors of potentially inappropriate NSAIDs use in older adults (age > 65) with OA using machine learning with real-world data from Optum De-identified Clinformatics® Data Mart. We identified a retrospective cohort of eligible individuals using data from 2015 (baseline) and 2016 (follow-up). Potentially inappropriate NSAIDs use was identified using the type (COX-2 selective vs. non-selective) and length of NSAIDs use and an individual's CV and GI risk. Predictors of potentially inappropriate NSAIDs use were identified using eXtreme Gradient Boosting. Our study cohort comprised of 44,990 individuals (mean age 75.9 years). We found that 12.8% individuals had potentially inappropriate NSAIDs use, but the rate was disproportionately higher (44.5%) in individuals at low CV/high GI risk. Longer duration of NSAIDs use during baseline (AOR 1.02; 95% CI:1.02-1.02 for both non-selective and selective NSAIDs) was associated with a higher risk of potentially inappropriate NSAIDs use. Additionally, individuals with low CV/high GI (AOR 1.34; 95% CI:1.20-1.50) and high CV/low GI risk (AOR 1.61; 95% CI:1.34-1.93) were also more likely to have potentially inappropriate NSAIDs use. Heightened surveillance of older adults with OA requiring NSAIDs is warranted.

Feasibility and acceptability of safety screening among patients receiving addiction treatment.

INTRODUCTION: Premature mortality associated with opioid-related overdose and suicide is a significant public health problem in the United States. Approximately 20-30% of individuals with opioid use disorder (OUD) have a history of both suicide attempt and unintentional opioid overdose. The objective of this study is to evaluate the feasibility of a standardized screen for suicide and overdose among patients receiving addiction treatment. METHODS: We conducted a cross-sectional study using a convenience sample of patients (n = 113) recruited from two inpatient treatment programs. We used a modified version of the Patient Safety Screener (mPSS) to screen for suicidal ideation, suicide attempt, and overdose. Study staff administered the screen in-person during treatment, and we linked results to administrative clinical data. Subjects (n = 108) and members of their clinical care team (n = 20) completed a screening acceptability survey. We recorded a positive mPSS if a patient reported suicidal ideation in the past two weeks, a suicide attempt, and/or an overdose in the past six months. RESULTS: Fifty-eight percent of subjects had a positive mPSS screen, and 30.3% reported suicidal ideation, suicide attempt, and overdose. Subjects and clinical staff reported that it was acceptable to screen for suicide attempt(s) and overdose(s). About a third of the clinical staff reported concerns about administration time (n = 7) and impact on workflow (n = 6). CONCLUSIONS: Both suicide and overdose are important patient safety factors that should be incorporated into addiction treatment and discharge planning. This study's findings support simultaneously screening for suicide and overdose in OUD inpatient treatment settings. Future research needs to determine whether screening improves provision of services and reduces self-injurious behavior.

Associations of multimorbidity and patient-reported experiences of care with conservative management among elderly patients with localized prostate cancer.

BACKGROUND: Many elderly localized prostate cancer patients could benefit from conservative management (CM). This retrospective cohort study examined the associations of patient-reported access to care and multimorbidity on CM use patterns among Medicare Fee-for-Service (FFS) beneficiaries with localized prostate cancer. METHODS: We used linked Surveillance, Epidemiology, and End Results cancer Registry, Medicare Claims, and the Medicare Consumer Assessment of Healthcare Providers and Systems (MCAHPS) survey files. We identified FFS Medicare Beneficiaries (age ≥ 66; continuous enrollment in Parts A & B) with incident localized prostate cancer from 2003 to 2013 and a completed MCAHPS survey measuring patient-reported experiences of care within 24 months after diagnosis (n = 496). We used multivariable models to examine MCAHPS measures (getting needed care, timeliness of care, and doctor communication) and multimorbidity on CM use. RESULTS: Localized prostate cancer patients with multimorbidity were less likely to use CM (adjusted odds ratio (AOR)=0.42 (0.27- 0.66), P < .001); those with higher scores on timeliness of care (AOR = 1.21 (1.09, 1.35), P < .001), higher education attainment (3.21 = AOR (1.50,6.89), P = .003), and impaired mental health status (4.32 = AOR (1.86, 10.1) P < .001) were more likely to use CM. CONCLUSION(S): Patient-reported experience with timely care was significantly and positively associated with CM use. Multimorbidity was significantly and inversely associated with CM use. Addressing specific modifiable barriers to timely care along the cancer continuum for elderly localized prostate cancer patients with limited life expectancy could reduce the adverse effects of overtreatment on health outcomes and costs.

The impact of telemental health use on healthcare costs among commercially insured adults with mental health conditions.

OBJECTIVE: To determine the impact of telemental health (TMH) use on total healthcare costs and mental health (MH)-related costs paid by a third party among adults with mental health conditions (MHC). METHOD: This study employed a pre-post design with a non-equivalent control group. The cohort comprised adults with MHCs identified using diagnosis codes from de-identified claims data of the Optum Clinformatics DataMart (2010 January 01 to 2017 June 30). We identified mental health (MH) service users and TMH users (N = 348) based on procedure codes. Non-users (N = 238,595) were defined as those who only used in-person MH services. A Difference-in-Differences (DID) analysis was performed within a multivariable two-part model (TPM) framework to examine the impact of TMH use on adjusted standardized costs (2018 US $) of all healthcare services and MH services. Patient-level and state-level factors were adjusted in TPM. RESULTS: TMH use was associated with significantly higher MH-related costs [Marginal effect = $461.3, 95% confidence interval: $142.4-$780.2] and an excess of $370 increase in MH-related costs at follow-up as compared to baseline. However, TMH use was not associated with an increase in total third-party healthcare costs nor with changes in total costs from baseline to follow-up. CONCLUSIONS: Despite having a higher likelihood of MH services use and MH-related costs, TMH users did not have higher total costs as compared to adults using only in-person MH services. Our findings suggest that TMH can increase access to MH care without increasing total healthcare costs among adults with MHC. Future studies exploring whether TMH use can lead to cost-savings over a longer period are warranted.

Tumor Necrosis Factor Inhibitor Therapy and the Risk for Depression Among Working-Age Adults with Rheumatoid Arthritis.

BACKGROUND: Individuals with rheumatoid arthritis (RA) are at high risk for depression because of the overall burden of systemic inflammation. Although some evidence suggests that treatment with powerful anti-inflammatory drugs, such as tumor necrosis factor (TNF) inhibitors, may be effective in reducing the risk for depression in patients with RA, it is unclear whether such reduction in risk is dependent on the response to TNF inhibitor therapy. OBJECTIVE: To evaluate the association between the response to TNF inhibitor therapy and the risk for depression among working-age adults with RA. METHOD: This retrospective, observational cohort study design was based on data derived from commercial claims data in the QuintilesIMS Real World Data Adjudicated Claims database between October 1, 2009, and September 30, 2015. A total of 4222 working-age adults (18-62 years) with RA who started treatment with TNF inhibitor therapy and were continuously enrolled during the 3 observation periods (ie, 1-year baseline, 1-year treatment, and 1-year follow-up periods) were included in the study. Treatment response to a TNF inhibitor was measured using prescription drug claims based on a published validated algorithm. Multivariable logistic regression was used to examine the association between treatment response to TNF inhibitor therapy and the risk for depression, after controlling for baseline demographic characteristics, clinical characteristics, and RA-related medication use. An inverse probability of treatment weighting technique was used to control for observable differences in TNF inhibitor responders' characteristics versus TNF inhibitor nonresponders. RESULTS: Overall, 359 (8.5%) patients with RA had depression during the follow-up period and 1679 (39.8%) patients responded to TNF inhibitor treatment during the 1-year treatment period. A significantly lower percentage of TNF inhibitor responders (7.1%, N = 119) had depression than TNF inhibitor nonresponders (9.4%, N = 239). After controlling for other risk factors, responders to TNF inhibitors were 20% less likely to have depression during the follow-up period (adjusted odds ratio, 0.80; 95% confidence interval, 0.64-0.98) than nonresponders to TNF inhibitor therapy. CONCLUSION: The risk for depression was significantly reduced among patients with RA who responded to TNF inhibitor therapy compared with those who did not respond to such therapy. To determine whether the lower rate of depression observed with TNF inhibition is a direct effect of treatment with a TNF inhibitor, or whether it could be attributed to improvement in RA disease secondary to treatment, future studies need to also incorporate a control population of patients with RA who receive other antirheumatic regimens, such as disease-modifying antirheumatic drugs.

Predictors of Major Bleeding Among Working-Age Adults with Atrial Fibrillation: Evaluating the Effects of Potential Drug-drug Interactions and Switching from Warfarin to Non-vitamin K Oral Anticoagulants.

PURPOSE: This study aims to evaluate the associations between switching from warfarin to non-vitamin K oral anticoagulants (NOACs), exposure to potential drug-drug interactions (DDIs), and major bleeding events in working-age adults with atrial fibrillation (AF). METHODS: We conducted a retrospective cohort study using the claims database of commercially insured working-age adults with AF from 2010 to 2015. Switchers were defined as patients who switched from warfarin to NOAC; non-switchers were defined as those who remained on warfarin. We developed novel methods to calculate the number and proportion of days with potential DDIs with NOAC/warfarin. Multivariate logistic regressions were utilized to evaluate the associations between switching to NOACs, exposure to potential DDIs, and major bleeding events. RESULTS: Among a total of 4126 patients with AF, we found a significantly lower number of potential DDIs and the average proportion of days with potential DDIs in switchers than non-switchers. The number of potential DDIs (AOR 1.14, 95% CI 1.02-1.27) and the HAS-BLED score (AOR 1.64, 95% CI 1.48-1.82) were significantly and positively associated with the likelihood of a major bleeding event. The proportion of days with potential DDIs was also significantly and positively associated with risk for bleeding (AOR 1.42, 95% CI 1.03, 1.96). We did not find significant associations between switching to NOACs and major bleeding events. CONCLUSIONS: The number and duration of potential DDIs and patients' comorbidity burden are important factors to consider in the management of bleeding risk in working-age AF adults who take oral anticoagulants.

Healthcare Utilization and Expenditures in Working-Age Adults with Atrial Fibrillation: The Effect of Switching from Warfarin to Non-Vitamin K Oral Anticoagulants.

OBJECTIVE: Our objective was to evaluate the association between switching from warfarin to non-vitamin K oral anticoagulants (NOACs) and potential drug-drug interactions (DDIs), healthcare utilization, and expenditures in working-age adults with atrial fibrillation (AF). METHODS: We conducted a retrospective cohort study using data from 2010 to 2015 for patients who switched from warfarin to NOACs (switchers) and those who continued to receive warfarin (non-switchers). We identified medications known or suspected to have clinically significant interactions with NOACs or warfarin. We used multivariate logistic regression, negative binomial, and generalized linear models to evaluate the influence of switching to NOACs and of potential DDIs on inpatient visits, outpatient visits, number of outpatient visits, and non-drug medical expenditures. Inverse probability of treatment weighting was also applied in analyses. RESULTS: A total of 4126 patients with AF were included in the study. Switching to NOACs was significantly and negatively related to the number of outpatient, inpatient, and emergency room (ER) visits and non-drug medical expenditures. When potential DDIs were included in the models, switching remained significantly associated only with reduced inpatient and outpatient visits. Notably, having at least one potential DDI was associated with an increased likelihood of ER visits and the number of outpatient visits; it was also significantly and positively associated with non-drug medical expenditures. CONCLUSIONS: Relative to persistent warfarin use, switching to NOACs was associated with fewer inpatient, ER, and outpatient visits and lower non-drug costs. Potential DDIs were also strongly and positively associated with healthcare utilization and expenditures. Both are critical to consider in the management of AF in working-age adults.