Opioid therapy trajectories of patients with chronic non-cancer pain over 1 year of follow-up after initiation of short-acting opioid formulations.

OBJECTIVE: This study compared opioid utilization trajectories of persons initiating tramadol, short-acting hydrocodone, or short-acting oxycodone, and it characterized opioid dose trajectories and type of opioid in persistent opioid therapy subsamples. METHODS: A retrospective cohort study of adults with chronic non-cancer pain who were initiating opioid therapy was conducted with the IQVIA PharMetrics® Plus for Academics data (2008-2018). Continuous enrollment was required for 6 months before ("baseline") and 12 months after ("follow-up") the first opioid prescription ("index date"). Opioid therapy measures were assessed every 7 days over follow-up. Group-based trajectory modeling (GBTM) was used to identify trajectories for any opioid and total morphine milligram equivalent measures, and longitudinal latent class analysis was used for opioid therapy type. RESULTS: A total of 40 276 tramadol, 141 023 hydrocodone, and 45 221 oxycodone initiators were included. GBTM on any opioid therapy identified 3 latent trajectories: early discontinuers (tramadol 39.0%, hydrocodone 54.1%, oxycodone 61.4%), late discontinuers (tramadol 37.9%, hydrocodone 39.4%, oxycodone 33.3%), and persistent therapy (tramadol 6.7%, hydrocodone 6.5%, oxycodone 5.3%). An additional fourth trajectory, intermittent therapy (tramadol 16.4%), was identified for tramadol initiators. Of those on persistent therapy, 2687 individuals were on persistent therapy with tramadol, 9169 with hydrocodone, and 2377 with oxycodone. GBTM on opioid dose resulted in 6 similar trajectory groups in each persistent therapy group. Longitudinal latent class analysis on opioid therapy type identified 6 latent classes for tramadol and oxycodone and 7 classes for hydrocodone. CONCLUSION: Opioid therapy patterns meaningfully differed by the initial opioid prescribed, notably the presence of intermittent therapy among tramadol initiators and higher morphine milligram equivalents and prescribing of long-acting opioids among oxycodone initiators.

Adherence to Extended Venous Thromboembolism Prophylaxis and Outcomes After Complex Gastrointestinal Oncologic Surgery.

BACKGROUND: Clinical guidelines recommend extended venous thromboembolism (VTE) prophylaxis for cancer patients after major gastrointestinal (GI) operations. However, adherence to the guidelines has been low, and the clinical outcomes not well defined. METHODS: This study retrospectively analyzed a random 10 % sample of the 2009-2022 IQVIA LifeLink PharMetrics Plus database, an administrative claims database representative of the commercially insured population of the United States. The study selected cancer patients undergoing major pancreas, liver, gastric, or esophageal surgery. The primary outcomes were 90-day post-discharge VTE and bleeding. RESULTS: The study identified 2296 unique eligible operations. During the index hospitalization, 52 patients (2.2 %) experienced VTE, 74 patients (3.2 %) had postoperative bleeding, and 140 patients (6.1 %) had a hospital stay of at least 28 days. The remaining 2069 operations comprised 833 pancreatectomies, 664 hepatectomies, 295 gastrectomies, and 277 esophagectomies. The median age of the patients was 49 years, and 44 % were female. Extended VTE prophylaxis prescriptions were filled for 176 patients (10.4 % for pancreas, 8.1 % for liver, 5.8 % for gastric cancer, and 6.5 % for esophageal cancer), and the most used agent was enoxaparin (96 % of the patients). After discharge, VTE occurred for 5.2 % and bleeding for 5.2 % of the patients. The findings showed no association of extended VTE prophylaxis with post-discharge VTE (odds ratio [OR], 1.54; 95 % confidence interval [CI], 0.81-2.96) or bleeding (OR, 0.72, 95 % CI, 0.32-1.61). CONCLUSIONS: The majority of the cancer patients undergoing complex GI surgery did not receive extended VTE prophylaxis according to the current guidelines, and their VTE rate was not higher than for the patients who received it.

Evaluating the temporal association between the recency of prescribed controlled substance acquisition and fatal and non-fatal opioid overdose.

BACKGROUND: Previous studies have explored psychosocial effects as possible triggers of opioid overdose (OOD). However, little is known about the temporal association between OOD and prescribed controlled substance (CS) acquisition. OBJECTIVE: The objective of this study was to evaluate the temporal relationship between OOD and acquiring prescribed CSs prior to OOD. METHODS: This study is an exploratory descriptive analysis using Arkansas Prescription Drug Monitoring Program (AR-PDMP) data linked to death certificate and statewide inpatient discharge records. All persons with ≥1 AR-PDMP prescription fill(s) between 1 January 2014 and 31 December 2017 were included (n = 1,946,686). For persons that experienced OOD and had ≥1 PDMP record(s), the difference in days between OOD and the most recent AR-PDMP prescription filled prior to an OOD was recorded. To account for censoring, a sensitivity analysis was conducted restricting the study group to "New AR-PDMP Entrants" that had at least a 180-day gap between consecutive AR-PDMP fill dates. RESULTS: 28,998,307 AR-PDMP records were analyzed for 1,946,686 individuals. 7195 persons experienced 9223 OODs and 414 (4.49%) of those were fatal. Of these, 6236 experienced ≥1 OOD and acquired prescribed CSs prior to or on the day of the first OOD. Of those that experienced ≥1 OOD(s), 2201 (30.59%) had an AR-PDMP record in the 0- to 5-day period prior to their overdose and 497 (6.91%) had an AR-PDMP record the day prior to their overdose. Among New AR-PDMP Entrants that experienced ≥1 OOD(s), 408 (27.38%) had an AR-PDMP record in the 0- to 5-day period prior to their overdose. CONCLUSION: Though the vast majority of persons accessing CSs in Arkansas did not experience an OOD, a sizable proportion of persons that experience an OOD(s) obtained prescribed CSs immediately prior.

Association between opioid therapy trajectories and potential opioid-related adverse health events.

PURPOSE: We identified associations between membership in seven group-based trajectories based on supply of filled opioid prescriptions and potential opioid-related adverse health events over a 720-day window. METHODS: We identified two veteran cohorts with chronic non-cancer pain who initiated treatment with long-term opioid therapy between 2008 and 2015, excluding those with prior substance use disorder (n = 373 941) or non-SUD, opioid-related adverse outcome (n = 405 631) diagnoses. Outcomes of interest included opioid use disorder, non-opioid drug use disorder, and alcohol use disorder for the first cohort; or accidents resulting in wounds or injuries, self-inflicted injuries, opioid-related accidents and overdoses, alcohol and non-opioid drug-related accidents and overdoses, and violence-related injuries for the second cohort. Using a cross-sectional design, Veterans were followed until the specific outcome of interest was diagnosed, they died, the study ended, or they were lost to follow up. Accelerated failure time models were estimated for each outcome. RESULTS: Membership in persistent moderate days covered and persistent modest days covered trajectories was associated with decreased risk of opioid use disorder (Moderate: θ = 0.59, 95%CI:0.54, 0.64; Modest: θ = 0.54, 95%CI:0.50, 0.59) and opioid overdose (Moderate: θ = 0.67,95%CI: 0.57, 0.79; Modest: θ = 0.72, 95%CI:0.61, 0.85) versus higher-utilizing persistent users. Rapid discontinuation was associated with decreased risk of opioid use disorder (θ = 0.86, 95% CI:0.77, 0.95) and opioid overdose (θ = 0.54, 95%CI:0.41, 0.71), but increased risk of alcohol use disorder (θ = 1.07, 95%CI:1.00, 1.15) and other substance use disorders. Delayed discontinuation or delayed reduction was associated with increased risk for most opioid related adverse health events. CONCLUSION: Persistent use trajectories with low levels of opioid utilization were associated with lower risks of potential opioid-related adverse health events.

Statewide trends and factors associated with genetic testing for hereditary cancer risk in Arkansas 2013-2018.

BACKGROUND: Early identification of hereditary cancer risk would save lives, but genetic testing (GT) has been inadequate. We assessed i) trends for hereditary breast and ovarian cancer (HBOC), Lynch syndrome, and other GT and ii) factors associated with receipt of GT. METHODS: We used data from the Arkansas All-Payer Claims Database from January 2013 through June 2018 (commercial, Medicaid), December 2017 (state employee), or December 2016 (Medicare) and identified enrollees with ≥1 month of enrollment. Using Current Procedural Terminology (CPT-4) codes, rates for GT were calculated per 100,000 person-quarters and time series regressions estimated. Second, GT and covariate information for enrollees with 24 months of continuous enrollment were used to estimate separate logistic regression models for each GT category. RESULTS: Among 2,520,575 unique enrollees, HBOC testing rates were 2.2 (Medicaid), 22.0 (commercial), 40.4 (state employee), and 13.1(Medicare) per 100,000 person-quarters and increased linearly across all plans. Older age (OR=1.24; 95%CI 1.20 - 1.28), female sex (OR=18.91; 95%CI 13.01 - 28.86), higher comorbidity burden (OR=1.08; 95%CI 1.05 - 1.12), mental disorders (OR=1.53; 95%CI 1.15 - 2.00), and state employee coverage (OR=1.65; 95%CI 1.37 - 1.97) were positively associated with HBOC testing. Less than 1 of 10,000 enrollees received Lynch syndrome testing, while < 5 of 10,000 received HBOC testing. CONCLUSION: GT rates for hereditary cancer syndromes have increased in Arkansas but remain low. Receipt of GT was explained with high discrimination by sex and plan type. IMPACT: Expansion of GT for hereditary cancer risk in Arkansas is needed to identify high-risk individuals who could benefit from risk-reduction strategies.

Using data science to improve outcomes for persons with opioid use disorder.

Medication treatment for opioid use disorder (MOUD) is an effective evidence-based therapy for decreasing opioid-related adverse outcomes. Effective strategies for retaining persons on MOUD, an essential step to improving outcomes, are needed as roughly half of all persons initiating MOUD discontinue within a year. Data science may be valuable and promising for improving MOUD retention by using "big data" (e.g., electronic health record data, claims data mobile/sensor data, social media data) and specific machine learning techniques (e.g., predictive modeling, natural language processing, reinforcement learning) to individualize patient care. Maximizing the utility of data science to improve MOUD retention requires a three-pronged approach: (1) increasing funding for data science research for OUD, (2) integrating data from multiple sources including treatment for OUD and general medical care as well as data not specific to medical care (e.g., mobile, sensor, and social media data), and (3) applying multiple data science approaches with integrated big data to provide insights and optimize advances in the OUD and overall addiction fields.

Cost-Effectiveness of Intranasal Naloxone Distribution to High-Risk Prescription Opioid Users.

OBJECTIVES: To determine the cost-effectiveness of pharmacy-based intranasal naloxone distribution to high-risk prescription opioid (RxO) users. METHODS: We developed a Markov model with an attached tree for pharmacy-based naloxone distribution to high-risk RxO users using 2 approaches: one-time and biannual follow-up distribution. The Markov structure had 6 health states: high-risk RxO use, low-risk RxO use, no RxO use, illicit opioid use, no illicit opioid use, and death. The tree modeled the probability of an overdose happening, the overdose being witnessed, naloxone being available, and the overdose resulting in death. High-risk RxO users were defined as individuals with prescription opioid doses greater than or equal to 90 morphine milligram equivalents (MME) per day. We used a monthly cycle length, lifetime horizon, and US healthcare perspective. Costs (2018) and quality-adjusted life-years (QALYs) were discounted 3% annually. Microsimulation was performed with 100 000 individual trials. Deterministic and probabilistic sensitivity analyses were conducted. RESULTS: One-time distribution of naloxone prevented 14 additional overdose deaths per 100 000 persons, with an incremental cost-effectiveness ratio (ICER) of $56 699 per QALY. Biannual follow-up distribution led to 107 additional lives being saved with an ICER of $84 799 per QALY compared with one-time distribution. Probabilistic sensitivity analyses showed that a biannual follow-up approach would be cost-effective 50% of the time at a willingness-to-pay (WTP) threshold of $100 000 per QALY. Naloxone effectiveness and proportion of overdoses witnessed were the 2 most influential parameters for biannual distribution. CONCLUSION: Both one-time and biannual follow-up naloxone distribution in community pharmacies would modestly reduce opioid overdose deaths and be cost-effective at a WTP of $100 000 per QALY.

Impact of Medical Marijuana Legalization on Opioid Use, Chronic Opioid Use, and High-risk Opioid Use.

OBJECTIVE: To determine the association of medical marijuana legalization with prescription opioid utilization. METHODS: A 10% sample of a nationally representative database of commercially insured population was used to gather information on opioid use, chronic opioid use, and high-risk opioid use for the years 2006-2014. Adults with pharmacy and medical benefits for the entire calendar year were included in the population for that year. Multilevel logistic regression analysis, controlling for patient, person-year, and state-level factors, were used to determine the impact of medical marijuana legalization on the three opioid use measures. Sub-group analysis among cancer-free adults and cancer-free adults with at least one chronic non-cancer pain condition in the particular year were conducted. Alternate regression models were used to test the robustness of our results including a fixed effects model, an alternate definition for start date for medical marijuana legalization, a person-level analysis, and a falsification test. RESULTS: The final sample included a total of 4,840,562 persons translating into 15,705,562 person years. Medical marijuana legalization was found to be associated with a lower odds of any opioid use: OR = 0.95 (0.94-0.96), chronic opioid use: OR = 0.93 (0.91-0.95), and high-risk opioid use: OR = 0.96 (0.94-0.98). The findings were similar in both the sub-group analyses and all the sensitivity analyses. The falsification tests showed no association between medical marijuana legalization and prescriptions for antihyperlipidemics (OR = 1.00; CI 0.99-1.01) or antihypertensives (OR = 1.00; CI 0.99-1.01). CONCLUSIONS: In states where marijuana is available through medical channels, a modestly lower rate of opioid and high-risk opioid prescribing was observed. Policy makers could consider medical marijuana legalization as a tool that may modestly reduce chronic and high-risk opioid use. However, further research assessing risk versus benefits of medical marijuana legalization and head to head comparisons of marijuana versus opioids for pain management is required.

Prevalence of Chronic Kidney Disease, Thrombotic Cardiovascular Events, and Use of Oral P2Y12 Inhibitors among Veterans.

BACKGROUND: Contemporary prevalence of chronic kidney disease (CKD) and thrombotic cardiovascular (CV) events remains unclear in Veterans enrolled in the Veterans Affairs Health Care System (VA) care. Although oral P2Y12 inhibitors (P2Y12i) are increasingly being prescribed to this patient population, the overall prescription trend for P2Y12i remains unclear. METHODS: Using national VA corporate warehouse data, we used International Classification of Diseases-9 codes to identify Veterans with CKD, dialysis-dependent CKD, and CV events. VA pharmacy data were used to count P2Y12i prescriptions for the federal fiscal years (FY) 2011 through 2015. RESULTS: The period prevalence of Veterans with CKD was 378,233 (6.1%). The point prevalence of CKD increased by 49% from 132,979 (2.30%) in FY11 to 213,444 (3.42%) in FY15. The period prevalence of Veterans with dialysis-dependent CKD was 150,298 (2.4%). In all, 128,703 (56.7%) CV events occurred in Veterans with CKD. Veterans with CKD were given 50.1% of prescriptions for clopidogrel, 49.3% for prasugrel, and 60.4% for ticagrelor. In this patient population, year-to-year increases in P2Y12i prescriptions were observed with a dramatic increase in ticagrelor prescriptions. CONCLUSION: CKD is common among Veterans and its true prevalence is likely being underestimated. The prevalence of dialysis-dependent CKD is higher among Veterans than the non-Veteran US population. CV events are widely co-prevalent and these patients are commonly prescribed P2Y12i. The recent increase in ticagrelor prescriptions in this patient population and large cost differences between the 3 P2Y12i underline the need for future studies to identify the preferred P2Y12i for these patients.

Factors Associated with Opioid Initiation in OEF/OIF/OND Veterans with Traumatic Brain Injury.

Objective: These analyses examined opioid initiation and chronic use among Iraq (OIF) and Afghanistan (OEF/OND) veterans with a new diagnosis of traumatic brain injury (TBI) in the Veterans Health Administration (VHA). Methods: Data were obtained from national VHA data repositories. Analyses included OEF/OIF/OND veterans with a new TBI diagnosis in 2010-2012 who used the VHA at least twice, had not received a VHA opioid prescription in the 365 days before diagnosis, and had at least 365 days of data available after TBI diagnosis. Results: Analyses included 35,621 veterans. Twenty-one percent initiated opioids; among new initiators, 23% used chronically. The mean dose was 24.0 mg morphine equivalent dose (MED) daily (SD = 24.26); mean days supplied was 60.52 (SD = 74.69). Initiation was significantly associated with age 36-45 years (odds ratio [OR] = 1.09, 95% CI = 1.01-1.17, P = 0.04), female gender (OR = 1.22, P < 0.001), having back pain (OR = 1.38, P < 0.0001), arthritis/joint pain (OR = 1.24, P < 0.0001), or neuropathic pain (OR = 1.415, P < 0.02). In veterans age 36-45 years, those living in small rural areas had higher odds of chronic opioid use (OR = 1.31, P < 0.0001, and OR = 1.33, P = 0.006, respectively) and back pain (OR = 1.36, P = 0.003). Headache/migraine pain was associated with decreased odds of chronic opioid use (OR = 0.639, P = 0.003). Conclusions: Prevalence of opioid use is relatively low among OEF/OIF/OND veterans with newly diagnosed TBI who are using VHA. Among those who initiated opioids, about 25% use them chronically. Prescribing was mostly limited to moderate doses, with most veterans using opioids for approximately two months of the 12-month study period.

Characteristics of Initial Prescription Episodes and Likelihood of Long-Term Opioid Use - United States, 2006-2015.

Because long-term opioid use often begins with treatment of acute pain (1), in March 2016, the CDC Guideline for Prescribing Opioids for Chronic Pain included recommendations for the duration of opioid therapy for acute pain and the type of opioid to select when therapy is initiated (2). However, data quantifying the transition from acute to chronic opioid use are lacking. Patient records from the IMS Lifelink+ database were analyzed to characterize the first episode of opioid use among commercially insured, opioid-naïve, cancer-free adults and quantify the increase in probability of long-term use of opioids with each additional day supplied, day of therapy, or incremental increase in cumulative dose. The largest increments in probability of continued use were observed after the fifth and thirty-first days on therapy; the second prescription; 700 morphine milligram equivalents cumulative dose; and first prescriptions with 10- and 30-day supplies. By providing quantitative evidence on risk for long-term use based on initial prescribing characteristics, these findings might inform opioid prescribing practices.

Comparative Effectiveness of Intra-Articular Hyaluronic Acid and Corticosteroid Injections on the Time to Surgical Knee Procedures.

BACKGROUND: Use of intra-articular hyaluronic acid (HA) injections to manage knee osteoarthritis (OA) remains controversial because of weak and conflicting evidence. The objective was to evaluate the effectiveness of intra-articular HA injections for knee OA management. METHODS: A nested cohort of persons with knee OA seeing a specialist was created using a 10% random sample of LifeLink Plus claims (2010-2015) to compare the risk of composite (any) knee surgical interventions, total (TKA)/unicompartmental knee arthroplasty (UKA) and TKA only among HA users and 2 comparison groups: corticosteroid (CS) users and HA/CS nonusers. A high-dimensional propensity score (hdPS) was used to match HA users with CS users and with HA/CS nonusers on background covariates. The risk of surgical interventions among HA users relative to the comparison groups was assessed using Cox proportional hazard models. RESULTS: Among 13,849 patients, 797 were HA users, 5327 were CS users, and 7725 were HA/CS nonusers. After hdPS matching, the risk of composite surgical interventions did not differ between HA users and HA/CS nonusers (hazard ratio [HR], 0.88; 95% confidence interval [CI], 0.67-1.16) and CS users (HR, 0.89; 95% CI, 0.65-1.12). Seven of the 8 sensitivity analyses demonstrated no significant benefit among HA users compared to CS users and HA/CS nonusers. A sensitivity analysis that restricted the study cohort to those who ultimately have knee surgery showed a lower risk of surgery of HA (HR, 0.87; 95% CI, 0.79-0.95). CONCLUSION: There were no significant differences in the risk of surgical interventions among HA users compared to HA/CS nonusers and CS users after accounting for residual confounding using an hdPS.

Comparison of Low-, Moderate-, and High-Molecular-Weight Hyaluronic Acid Injections in Delaying Time to Knee Surgery.

BACKGROUND: We compared the effectiveness of low-molecular-weight (MW) hyaluronic acid (HA) injections (LMWHA), moderate-MW HA injections (MMWHA), and high-MW HA injections (HMWHA) for prevention or delay of knee surgery in patients with knee osteoarthritis. METHODS: An observational cohort study using LifeLink Plus claims (2006-2015) was used. The primary outcome measure of the study included all surgical interventions of the knee. The secondary outcome measures were the following: (1) unicompartmental knee arthroplasty or total knee arthroplasty and (2) total knee arthroplasty only. A high-dimensional propensity score (hdPS) using 1:1 matching was used to adjust for confounding. The likelihood of each outcome was assessed using Cox proportional hazard models. RESULTS: A cohort of 30,417 incident HA users with knee osteoarthritis met our inclusion-exclusion criteria. There was no difference in the likelihood of composite surgical events between LMWHA users (hazard ratio, 0.939; 95% confidence interval, 0.870-1.013) and MMWHA users (hazard ratio, 1.032; 95% confidence interval, 0.952-1.119) when compared with HMWHA users in a matched hdPS analysis. However, a significantly lower likelihood for all outcome measures was demonstrated in LMWHA and MMWHA users compared with HMWHA users when hdPS was not used. CONCLUSION: There was no significant difference in the likelihood of surgical interventions between LMWHA, MMWHA, and HMWHA users after accounting for empirically derived confounders.

Cost-Effectiveness of Oral Anticoagulants for Ischemic Stroke Prophylaxis Among Nonvalvular Atrial Fibrillation Patients.

BACKGROUND AND PURPOSE: The objective of the study is to compare the cost-effectiveness of oral anticoagulants among atrial fibrillation patients at an increased stroke risk. METHODS: A Markov model was constructed to project the lifetime costs and quality-adjusted survival (QALYs) of oral anticoagulants using a private payer's perspective. The distribution of stroke risk (CHADS2 score: congestive heart failure, hypertension, advanced age, diabetes mellitus, stroke) and age of the modeled population was derived from a cohort of commercially insured patients with new-onset atrial fibrillation. Probabilities of treatment specific events were derived from published clinical trials. Event and downstream costs were determined from the cost of illness studies. Drug costs were obtained from 2015 National Average Drug Acquisition Cost data. RESULTS: In the base case analysis, warfarin was the least costly ($46 241; 95% CI, 44 499-47 874) and apixaban had the highest QALYs (9.38; 95% CI, 9.24-9.48 QALYs). Apixaban was found to be a cost-effective strategy over warfarin (incremental cost-effectiveness ratio=$25 816) and dominated other anticoagulants. Probabilistic sensitivity analysis showed that apixaban had at least a 61% chance of being the most cost-effective strategy at willingness to pay value of $100 000 per QALY. Among patients with CHADS2 ≥3, dabigatran was the dominant strategy. The model was sensitive to efficacy estimates of apixaban, dabigatran, and edoxaban and the cost of these drugs. CONCLUSIONS: All the newer oral anticoagulants compared were more effective than adjusted dosed warfarin. Our model showed that apixaban was the most effective anticoagulant in a general atrial fibrillation population and has an incremental cost-effectiveness ratio <$50 000/QALY. For those with higher stroke risk (CHADS2≥3), dabigatran was the most cost-effective treatment option.

Assessment of medication adherence app features, functionality, and health literacy level and the creation of a searchable Web-based adherence app resource for health care professionals and patients.

OBJECTIVES: To assess the features and level of health literacy (HL) of available medication adherence apps and to create a searchable website to assist health care providers (HCP) and patients identify quality adherence apps. PRACTICE DESCRIPTION: Medication nonadherence continues to be a significant problem and leads to poor health outcomes and avoidable health care expense. The average adherence rate for chronic medications, regardless of disease state, is approximately 50% leaving significant room for improvement. PRACTICE INNOVATION: Smartphone adherence apps are a novel resource to address medication nonadherence. With widespread smartphone use and the growing number of adherence apps, both HCP and patients should be able to identify quality adherence apps to maximize potential benefits. INTERVENTIONS: Assess the features, functionality and level of HL of available adherence apps and create a searchable website to help both HCP and patients identify quality adherence apps. EVALUATION: Online marketplaces (iTunes, Google Play, Blackberry) were searched in June of 2014 to identify available adherence apps. Online descriptions were recorded and scored based on 28 author-identified features across 4 domains. The 100 highest-scoring apps were user-tested with a standardized regimen to evaluate their functionality and level of HL. RESULTS: 461 adherence apps were identified. 367 unique apps were evaluated after removing "Lite/Trial" versions. The median initial score based on descriptions was 15 (max of 68; range: 3 to 47). Only 77 apps of the top 100 highest-scoring apps completed user-testing and HL evaluations. The median overall user-testing score was 30 (max of 73; range: 16 to 55). CONCLUSION: App design, functionality, and level of HL varies widely among adherence apps. While no app is perfect, several apps scored highly across all domains. The website www.medappfinder.com is a searchable tool that helps HCP and patients identify quality apps in a crowded marketplace.

Exploring the possible association between montelukast and neuropsychiatric events among children with asthma: a matched nested case-control study.

PURPOSE: There is conflicting evidence regarding the association between montelukast and neuropsychiatric events (NE). We sought to examine this association among children with asthma. METHODS: Using a 10% sample of the LifeLink Health Plan Claims data, subjects less than 18 years of age with a primary diagnosis of asthma between 1 January 1998 and 31 December 2009 were identified. A range of case definitions for NE was formulated based on diagnoses of psychiatric disorders and use of psychotropic medications. Using a matched nested case-control design, three controls were matched to each case on age, gender and geographic region, and assigned a matching index date. Exposure to montelukast was measured as any exposure during the year, recency of exposure, cumulative duration of exposure, and cumulative dose. Conditional logistic regression was used to estimate unadjusted and adjusted odds ratio (OR) controlling for potential confounders. RESULTS: Using the broadest case definition, 1920 cases were identified. Subjects exposed to montelukast during the prior year had an unadjusted OR of 1.09 (95%CI [0.96, 1.22]) and adjusted OR of 1.01 (95%CI [0.88, 1.14]) for experiencing NE measured using the broadest definition. A clear dose-response relationship was not observed. Exposure to a moderate chronic cumulative dose of montelukast (481 mg-1050 mg) had a higher odds of being diagnosed with neuropsychiatric disturbances (OR = 1.27; 95%CI [1.03, 1.57]) while exposure to high cumulative doses (>1050 mg) had a lower odds (OR = 0.64; 95%CI [0.50, 0.82]). CONCLUSIONS: These data did not detect a consistent significant positive association between montelukast and NE in children with asthma.

The influence of propoxyphene withdrawal on opioid use in veterans.

PURPOSE: Our aim is to determine if propoxyphene withdrawal from the US market was associated with opioid continuation, continued chronic opioid use, and secondary propoxyphene-related adverse events (emergency department visits, opioid-related events, and acetaminophen toxicity). METHODS: Medical service use and pharmacy data from 19/11/08 to 19/11/11 were collected from the national Veterans Healthcare Administration healthcare databases. A quasi-experimental pre-post retrospective cohort design utilizing a historical comparison group provided the study framework. Logistic regression controlling for baseline covariates was used to estimate the effect of propoxyphene withdrawal. RESULTS: There were 24,328 subjects (policy affected n = 10,747; comparison n = 13,581) meeting inclusion criteria. In the policy-affected cohort, 10.6% of users ceased using opioids, and 26.6% stopped chronic opioid use compared with 3.8% and 13.5% in the historical comparison cohort, respectively. Those in the policy-affected cohort were 2.7 (95%CI: 2.5-2.8) and 3.2 (95%CI: 2.9-3.6) times more likely than those in the historical comparison cohort to discontinue chronic opioid and any opioid use, respectively. Changes in adverse events and Emergency Department (ED) visits were not different between policy-affected and historical comparison cohorts (p > 0.05). CONCLUSIONS: The withdrawal of propoxyphene-containing products resulted in rapid and virtually complete elimination in propoxyphene prescribing in the veterans population; however, nearly 90% of regular users of propoxyphene switched to an alternate opioid, and three quarters continued to use opioids chronically.

Net Clinical Benefits of Guidelines and Decision Tool Recommendations for Oral Anticoagulant Use among Patients with Atrial Fibrillation.

BACKGROUND: The 2012 American College of Chest Physicians' Evidence-Based Clinical Practice (CHEST), the 2012 European Society of Cardiology, and the 2014 American Heart Association guidelines and published decision tools by LaHaye and Casciano offer oral anticoagulant (OAC) recommendations for patients with atrial fibrillation (AF). The aim of our study was to compare the net clinical benefit (NCB) of OAC prescribing that was concordant with these decision aids. METHODS: A cohort study of the 2001-2013 LifeLink claims data was used. NCB in concordance with each decision aid was defined as adverse events (thromboembolic and major bleed events) prevented per 10,000 person-years. Cox proportional hazard models were used to assess the relative risk of AF adverse events associated in concordance with each decision aid adjusted for potential confounders. FINDINGS: The study included 15,129 patients with AF, contributing 33,512 person-years. The NCB of the CHEST guidelines was the highest (NCB = 30.07; 95% confidence interval [CI] = 28.66, 31.49) and the European Society of Cardiology guidelines the lowest (NCB = 7.38; 95% CI = 5.97, 8.80). Significant unadjusted decreases in the risk of AF adverse events associated with concordant OAC use/nonuse were found for the CHEST guidelines (hazard ratio [HR] = .825; 95% CI = .695, .979), Casciano tool (HR = .838; 95% CI = .706, .995), and LaHaye tool (HR = .841; 95% CI = .709, .999); however, none were significant after multivariate adjustment. CONCLUSION: Concordant OAC use with any of the decision aids except for the aggressive LaHaye tool led to a positive NCB. The decision aids based on the CHA2DS2-VASc algorithm did not consistently improve the NCB compared to CHADS2-based aids. Recommending OAC use when CHA2DS2-VASc score = 1 resulted in a lower NCB when all other factors guiding recommendations were held constant.

A questionnaire to assess the relevance and credibility of observational studies to inform health care decision making: an ISPOR-AMCP-NPC Good Practice Task Force report.

Evidence-based health care decisions are best informed by comparisons of all relevant interventions used to treat conditions in specific patient populations. Observational studies are being performed to help fill evidence gaps. Widespread adoption of evidence from observational studies, however, has been limited because of various factors, including the lack of consensus regarding accepted principles for their evaluation and interpretation. Two task forces were formed to develop questionnaires to assist decision makers in evaluating observational studies, with one Task Force addressing retrospective research and the other Task Force addressing prospective research. The intent was to promote a structured approach to reduce the potential for subjective interpretation of evidence and drive consistency in decision making. Separately developed questionnaires were combined into a single questionnaire consisting of 33 items. These were divided into two domains: relevance and credibility. Relevance addresses the extent to which findings, if accurate, apply to the setting of interest to the decision maker. Credibility addresses the extent to which the study findings accurately answer the study question. The questionnaire provides a guide for assessing the degree of confidence that should be placed from observational studies and promotes awareness of the subtleties involved in evaluating those.