Not all phenotypes are created equal: covariates of success in e-phenotype specification.

BACKGROUND: Electronic (e)-phenotype specification by noninformaticist investigators remains a challenge. Although validation of each patient returned by e-phenotype could ensure accuracy of cohort representation, this approach is not practical. Understanding the factors leading to successful e-phenotype specification may reveal generalizable strategies leading to better results. MATERIALS AND METHODS: Noninformaticist experts (n = 21) were recruited to produce expert-mediated e-phenotypes using i2b2 assisted by a honest data-broker and a project coordinator. Patient- and visit-sets were reidentified and a random sample of 20 charts matching each e-phenotype was returned to experts for chart-validation. Attributes of the queries and expert characteristics were captured and related to chart-validation rates using generalized linear regression models. RESULTS: E-phenotype validation rates varied according to experts' domains and query characteristics (mean = 61%, range 20-100%). Clinical domains that performed better included infectious, rheumatic, neonatal, and cancers, whereas other domains performed worse (psychiatric, GI, skin, and pulmonary). Match-rate was negatively impacted when specification of temporal constraints was required. In general, the increase in e-phenotype specificity contributed positively to match-rate. DISCUSSIONS AND CONCLUSIONS: Clinical experts and informaticists experience a variety of challenges when building e-phenotypes, including the inability to differentiate clinical events from patient characteristics or appropriately configure temporal constraints; a lack of access to available and quality data; and difficulty in specifying routes of medication administration. Biomedical query mediation by informaticists and honest data-brokers in designing e-phenotypes cannot be overstated. Although tools such as i2b2 may be widely available to noninformaticists, successful utilization depends not on users' confidence, but rather on creating highly specific e-phenotypes.

Assessment of the Cost Burden of Episodic Recurrent Vestibular Vertigo in the US.

Importance: Understanding of the economic burden of recurrent vestibular causes of vertigo and areas contributing to the cost is needed. Objective: To analyze and identify the factors contributing to the direct medical costs associated with Ménière disease (MD), vestibular migraine (VM), and benign paroxysmal positional vertigo (BPPV). Design, Setting, and Participants: This economic evaluation used MarketScan Commercial Database claims data from 2018 to identify the non-Medicare patient population with the diagnoses of MD, VM, or BPPV. Data were analyzed January 1 to December 31, 2018. Main Outcomes and Measures: The total direct medical costs associated with MD, VM, and BPPV. Results: A total of 53 210 patients (mean [SD] age, 47.8 [11.8] years; 67.6% female) were included in this study, with 34 738 normal comparisons. There were 5783 (10.9%) patients with MD, 3526 (6.6%) patients with VM, and 43 901 (82.5%) patients with BPPV in the data set. Mean age and sex were different across the different vestibular disorders. Across the different groups, patients with no comorbidities or with a Charlson Comorbidity Index score of zero ranged from 98.4% to 98.8%. Around 5% of patients were hospitalized with inpatient stay lasting between 4.6 and 5.2 days. After adjusting for age, sex, and comorbidities, there were large differences in mean adjusted annual payments/direct costs across the different groups (MD, $9579; VM, $11 371; and BPPV, $8247). This equated to a total incremental estimated cost of $60 billion compared with the normal population. The number of outpatient brain magnetic resonance imaging or computed tomography scans per patient ranged anywhere from 1 to 20, while the number of inpatient brain magnetic resonance imaging or computed tomography scans per patient ranged anywhere from 1 to 6. A heat map of the total cost expenditure indicated that the costs were concentrated around the Midwest, Lake Michigan, and the East Coast. Conclusions and Relevance: In this economic evaluation, the 3 most common causes of recurrent vertigo-MD, VM, and BPPV-had considerable medical costs associated with them. Extraneous imaging orders and vestibular testing are factors to consider for cost reduction. However, further research and widespread education is needed to optimize the diagnosis, treatment, and care of patients presenting with vestibular disorders or dizziness.

Dabigatran and Wet AMD, Results From Retinal Pigment Epithelial Cell Monolayers, the Mouse Model of Choroidal Neovascularization, and Patients From the Medicare Data Base.

Background: Age-related macular degeneration (AMD), the leading cause of irreversible blindness in elderly Caucasian populations, includes destruction of the blood-retina barrier (BRB) generated by the retinal pigment epithelium-Bruch's membrane complex (RPE/BrM), and complement activation. Thrombin is likely to get access to those structures upon BRB integrity loss. Here we investigate the potential role of thrombin in AMD by analyzing effects of the thrombin inhibitor dabigatran. Material and Methods: MarketScan data for patients aged ≥65 years on Medicare was used to identify association between AMD and dabigatran use. ARPE-19 cells grown as mature monolayers were analyzed for thrombin effects on barrier function (transepithelial resistance; TER) and downstream signaling (complement activation, expression of connective tissue growth factor (CTGF), and secretion of vascular endothelial growth factor (VEGF)). Laser-induced choroidal neovascularization (CNV) in mouse is used to test the identified downstream signaling. Results: Risk of new wet AMD diagnosis was reduced in dabigatran users. In RPE monolayers, thrombin reduced TER, generated unique complement C3 and C5 cleavage products, led to C3d/MAC deposition on cell surfaces, and increased CTGF expression via PAR1-receptor activation and VEGF secretion. CNV lesion repair was accelerated by dabigatran, and molecular readouts suggest that downstream effects of thrombin include CTGF and VEGF, but not the complement system. Conclusions: This study provides evidence of association between dabigatran use and reduced exudative AMD diagnosis. Based on the cell- and animal-based studies, we suggest that thrombin modulates wound healing and CTGF and VEGF expression, making dabigatran a potential novel treatment option in AMD.

Automatically identifying opioid use disorder in non-cancer patients on chronic opioid therapy.

Background: Using the International Classification of Diseases (ICD) codes alone to record opioid use disorder (OUD) may not completely document OUD in the electronic health record (EHR). We developed and evaluated natural language processing (NLP) approaches to identify OUD from the clinal note. We explored the concordance between ICD-coded and NLP-identified OUD.Methods: We studied EHRs from 13,654 (female: 8223; male: 5431) adult non-cancer patients who received chronic opioid therapy (COT) and had at least one clinical note between 2013 and 2018. Of eligible patients, we randomly selected 10,218 (75%) patients as the training set and the remaining 3436 patients (25%) as the test dataset for NLP approaches.Results: We generated 539 terms representing OUD mentions in clinical notes (e.g., "opioid use disorder," "opioid abuse," "opioid dependence," "opioid overdose") and 73 terms representing OUD medication treatments. By domain expert manual review for the test dataset, our NLP approach yielded high performance: 98.5% for precision, 100% for recall, and 99.2% for F-measure. The concordance of these NLP and ICD identified OUD was modest (Kappa = 0.63).Conclusions: Our NLP approach can accurately identify OUD patients from clinical notes. The combined use of ICD diagnostic code and NLP approach can improve OUD identification.

Budget impact and pharmacy costs with targeted use of oliceridine for postsurgical pain in patients at high risk of opioid-related adverse events.

BACKGROUND: Oliceridine, a new class of µ-opioid receptor agonist, may be associated with fewer opioid-related adverse events (ORAEs) due to its unique mechanism of action. Thus, it may provide a cost-effective alternative to conventional opioids such as morphine. PATIENTS AND METHODS: Using a decision tree with a 24-hour time horizon, we calculated costs for medication and management of the three most common AEs (oxygen saturation <90%, vomiting, somnolence) following postoperative oliceridine or morphine in high-risk patients. Costs were enumerated as differences in cost of analgesics and resource utilization in the first 24 hours post-surgery. An economic model compared expected AEs and costs in a blended cohort where elderly/obese patients at higher risk for ORAEs received oliceridine while those presumed to be at lower risk received morphine with a cohort that received morphine alone. RESULTS: In high-risk patients, use of oliceridine resulted in overall savings of $363,944 (in 1,000 patients). Implementing a targeted approach of oliceridine utilization in patients with high risk for ORAEs can save a typical hospital system $122,296 in total cost of care. CONCLUSION: Use of oliceridine in postoperative care among patients at high risk provides a favorable health economic benefit compared to the use of morphine.

Oliceridine, a new class of opioid analgesics, administered directly into a vein, is a unique medication in that it provides pain relief equivalent to morphine and may have less costly side effects. It is given in a hospital/clinic or surgery center for the treatment of postoperative pain and can reduce costs compared to other opioid analgesics, possibly due to less side effects. An economic model was developed that compares morphine to oliceridine in patients more likely to experience sides effects due to traditional pain medications, comparing common side effects and pain relief following surgery. Although oliceridine costs more than morphine, in our economic model, the use of oliceridine resulted in cost savings ($363,944 US 2020 Dollars in 1,000 patients), and a positive return of investment of over 7 times, when compared to morphine.

Patterns of dispensed opioids after tonsillectomy in children and adolescents in South Carolina, United States, 2010-2017.

OBJECTIVES: Tonsillectomy (with or without adenoidectomy) is a common pediatric surgical procedure requiring post-operative analgesia. Because of the respiratory depression effects of opioids, clinicians strive to limit the use of these drugs for analgesia post-tonsillectomy. The objective of this study was to identify demographic and medication use patterns predictive of persistent opioid dispensing (as a proxy for opioid use) to pediatric patients post-tonsillectomy. PATIENTS AND METHODS: Retrospective cohort of South Carolina (USA) Medicaid-insured children and adolescents 0-18 years old without malignancy who had tonsillectomy in 2014-2017. We evaluated opioid dispensing pre-surgery and in the 30 days exposure period after hospital discharge. The main outcome, persistent opioid dispensing, was defined as any subject dispensed ≥1 opioid prescription 90-270 days after discharge. Group-based trajectory analyses described post-procedure opioid dispensing trajectories. RESULTS: There were 11,578 subjects representing 12,063 tonsillectomy procedures. Few (3.5%) procedures were followed by persistent opioid dispensing. Any opioid dispensing during the exposure period was associated with an increased odds of persistent opioid dispensing status during the follow up period (OR 1.51 for 1-6 days of exposure and OR 1.65 for 7-30 days of opioid exposure), as was pre-procedure opioid dispensing, having >1 tonsillectomy procedure, and having complex chronic medical conditions. Group-based trajectory analyses identified 4 distinct patterns of post-discharge opioid dispensing. CONCLUSIONS: Any opioid dispensing during the 30 days after tonsillectomy increased the odds of persistent opioid dispensing by > 50%. Multivariable and group-based trajectory analyses identified patient and procedure variables that correlate with persistent opioid dispensing, primarily driven by groups receiving pre-tonsillectomy opioids and a second group who experienced multiple episodes of tonsillectomy.

Comparative Effectiveness of Community-Based vs Clinic-Based Healthy Choices Motivational Intervention to Improve Health Behaviors Among Youth Living With HIV: A Randomized Clinical Trial.

Importance: Youth living with HIV make up one-quarter of new infections and have high rates of risk behaviors but are significantly understudied. Effectiveness trials in real-world settings are needed to inform program delivery. Objective: To compare the effectiveness of the Healthy Choices intervention delivered in a home or community setting vs a medical clinic. Design, Setting, and Participants: This randomized clinical trial was conducted from November 1, 2014, to January 31, 2018, with 52 weeks of follow-up. Participants, recruited from 5 adolescent HIV clinics in the United States, were youths and young adults living with HIV aged 16 to 24 years who were fluent in English, were currently prescribed HIV medication, had a detectable viral load, and had used alcohol in the past 12 weeks. Individuals with an active psychosis that resulted in an inability to complete questionnaires were excluded. Data were analyzed from May to December, 2019. Interventions: Participants were randomized to receive the Healthy Choices intervention in either a home or clinic setting. Four 30-minute individual sessions based on motivational interviewing to improve (1) medication adherence and (2) drinking behavior were delivered during 10 weeks by trained community health workers. In session 1, participants chose which behavior to discuss first. Using motivational interviewing strategies, the community health worker elicited motivational language, guided the development of an individualized change plan while supporting autonomy, delivered feedback, and addressed knowledge gaps. Session 2 focused on the second target behavior. In subsequent sessions, community health workers reviewed the individualized change plan, monitored progress, guided problem solving, and helped maintain changes made. Main Outcomes and Measures: Primary outcomes were viral load and alcohol use change trajectories during 52 weeks of follow-up. Alcohol use severity and frequency were measured using the Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) (scores range from 0 to 33, with higher scores indicating greater severity of alcohol-related problems) and number of drinks consumed each day over a 30-day period, with timeline followback. Results: A total of 183 young people living with HIV (145 male [79.2%]; mean [SD] age, 21.4 [1.9] y) were randomized to the home setting (n = 90) or clinical setting (n = 93). Using growth-curve analysis, both groups showed declines in viral load after the intervention: among participants with available viral load information, in the home group, 12 participants (21%) had an undetectable viral load at 16 weeks, 12 (22%) at 28 weeks, and 10 (20%) at 52 weeks; in the clinic group, 16 participants (24%) had an undetectable viral load at 16 weeks, 20 (39%) at 28 weeks, and 18 (35%) at 52 weeks. However, the clinic group maintained gains, whereas those counseled at home had a significantly different and increasing trajectory during follow-up (unstandardized ß = -0.07; 95% CI,-0.14 to -0.01; P = .02). A similar pattern was observed in ASSIST scores during follow-up, with reduced ASSIST scores in the clinic group (unstandardized ß = -0.44; 95% CI,-0.81 to -0.07; P = .02). Conclusions and Relevance: In this trial, the Healthy Choices intervention resulted in improvements in viral load and alcohol use over 12 months. Unexpectedly, the clinic setting outperformed home-based delivery for viral suppression. Although cross-sectional differences in ASSIST scores were nonsignificant, clinic delivery did improve the trajectory of ASSIST scores during follow-up. Thus, clinics may be the more effective site for interventions aimed at viral load reduction for young people living with HIV. Trial Registration: ClinicalTrials.gov Identifier: NCT01969461.

Leveraging health system telehealth and informatics infrastructure to create a continuum of services for COVID-19 screening, testing, and treatment.

OBJECTIVES: We describe our approach in using health information technology to provide a continuum of services during the coronavirus disease 2019 (COVID-19) pandemic. COVID-19 challenges and needs required health systems to rapidly redesign the delivery of care. MATERIALS AND METHODS: Our health system deployed 4 COVID-19 telehealth programs and 4 biomedical informatics innovations to screen and care for COVID-19 patients. Using programmatic and electronic health record data, we describe the implementation and initial utilization. RESULTS: Through collaboration across multidisciplinary teams and strategic planning, 4 telehealth program initiatives have been deployed in response to COVID-19: virtual urgent care screening, remote patient monitoring for COVID-19-positive patients, continuous virtual monitoring to reduce workforce risk and utilization of personal protective equipment, and the transition of outpatient care to telehealth. Biomedical informatics was integral to our institutional response in supporting clinical care through new and reconfigured technologies. Through linking the telehealth systems and the electronic health record, we have the ability to monitor and track patients through a continuum of COVID-19 services. DISCUSSION: COVID-19 has facilitated the rapid expansion and utilization of telehealth and health informatics services. We anticipate that patients and providers will view enhanced telehealth services as an essential aspect of the healthcare system. Continuation of telehealth payment models at the federal and private levels will be a key factor in whether this new uptake is sustained. CONCLUSIONS: There are substantial benefits in utilizing telehealth during the COVID-19, including the ability to rapidly scale the number of patients being screened and providing continuity of care.

Patient barriers to cancer clinical trial participation and navigator activities to assist.

Clinical research is vital to the discovery of new cancer treatments that can enhance health and prolong life for cancer patients, but breakthroughs in cancer treatment are limited by challenges recruiting patients into cancer clinical trials (CT). Only 3-5% of cancer patients in the United States participate in a cancer CT and there are disparities in CT participation by age, race and gender. Strategies such as patient navigation, which is designed to provide patients with education and practical support, may help to overcome challenges of CT recruitment. The current study evaluated an intervention in which lay navigators were utilized to provide patient education and practical support for helping patients overcome barriers to CT participation and related clinical care. A patient barrier checklist was utilized to record patient barriers to CT participation and care, actions taken by navigators to assist patients with these barriers, and whether or not these barriers could be overcome. Forty patients received patient navigation services. The most common barriers faced by navigated patients were fear (n=9), issues communicating with medical personnel (n=9), insurance issues (n=8), transportation difficulties (n=6) and perceptions about providers and treatment (n=4). The most common activities undertaken by navigators were making referrals and contacts on behalf of patients (e.g., support services, family, clinicians; n=25). Navigators also made arrangement for transportation, financial, medication and equipment services for patients (n=11) and proactively navigated patients (n=8). Barriers that were not overcome for two or more patients included insurance issues, lack of temporary housing resources for patients in treatment and assistance with household bills. The wide array of patient barriers to CT participation and navigator assistance documented in this study supports the CT navigator role in facilitating quality care.

Disparities in Bariatric Surgery Utilization in Underserved Diabetes Populations.

INTRODUCTION: Bariatric surgery is cost-effective for treating obesity and diabetes. There are higher rates of obesity and diabetes in medically-underserved populations, yet it is unclear if disparities in bariatric surgery utilization exist in this population. METHODS: Bariatric surgery rates were calculated for underserved populations with obesity and diabetes using secondary data sets of four states in the diabetes belt (Florida, Georgia, Kentucky, South Carolina), a region in the southeast United States with higher rates of diabetes and obesity. Surgery rates were compared across states and demographic groups. RESULTS: Males, Blacks, and patients in rural areas had lower rates of bariatric surgery compared to females, Whites, and patients in urban areas. Payer rates were mixed across states. Surprisingly, minorities in Florida had higher surgery rates. DISCUSSION: Disparities exist in bariatric surgery rates in underserved populations with obesity and diabetes. It is vital to improve surgery access to this population to promote health equity.

Changes in Efficiency and Quality of Nursing Electronic Health Record Documentation After Implementation of an Admission Patient History Essential Data Set.

The objective of this quality improvement study was to evaluate whether electronic health record system timers and event logs can measure the efficiency and quality of a clinical process in an electronic health record. Using an experimental pre- and post-nonrandomized prospective cohort design, the researchers introduced a newly defined admission patient history essential data set and examined the electronic health record event files and timers to analyze the nursing experience from an efficiency and quality perspective. The researchers evaluated efficiency by measuring the time and clicks required to complete an admission history. The average active time spent documenting the admission patient history decreased by 72% from the preintervention measure (mean = 9.30 minutes) to the postintervention measure (mean = 2.55 minutes). The number of clicks decreased by 76% from the preintervention number of clicks (mean = 151.5) to the postintervention number of clicks (mean = 35.93). The quality of documentation was measured as the proportion of completed essential items and the frequency of completing an assessment in one sequence. The capture of essential data elements improved by almost 6%, and admission patient history data completed in one sequence increased by 24%. These study results demonstrate that system timers and event logs can measure the preintervention and postintervention changes in efficiency and quality of a defined clinical workflow into an electronic health record.

Preoperative Shoulder Injections Are Associated With Increased Risk of Revision Rotator Cuff Repair.

PURPOSE: The goal of this study was to determine whether the timing of preoperative shoulder injections is associated with an increased risk of revision rotator cuff repair following primary rotator cuff repair (RCR). METHODS: A retrospective analysis of claims data of privately insured subjects from the MarketScan database for the years 2010 to 2014 was conducted. Multivariable logistic regression models were used to compare the odds of reoperation between groups. Laterality for the injection, index procedure, and subsequent surgery were verified for all subjects. RESULTS: A total of 4,959 subjects with an arthroscopic RCR were identified, 392 of whom required revision RCR within the following 3 years. Patients who had an injection within 6 months preceding the index surgery were at a much higher risk of undergoing reoperation for revision RCR: 0 to 3 months prior, adjusted odds ratio (AOR) 1.375 (95% confidence interval [CI], 1.027-1.840); 3 to 6 months prior, AOR 1.822 (95% CI, 1.290-2.573); and 6 to 12 months prior, AOR 1.237 (95% CI, 0.787-1.943). CONCLUSIONS: Patients who had received an injection within 6 months prior to RCR were much more likely to undergo a revision cuff repair within the following 3 years. The risk of reoperation significantly declines if there is more than 6 months between injection and RCR. Consideration should be given to minimizing preoperative injections in patients requiring RCR or delaying primary RCR for 6 months following injection. LEVEL OF EVIDENCE: Level III, therapeutic study.

Out-of-pocket medical expenses in severe CHD.

IntroductionFamilies of children born with CHD face added stress owing to uncertainty about the magnitude of the financial burden for medical costs they will face. This study seeks to assess the family responsibility for healthcare bills during the first 12 months of life for commercially insured children undergoing surgery for severe CHD. METHODS: The MarketScan ® database from Truven was used to identify commercially insured infants in 39 states from 2010 to 2012 with an ICD-9 diagnosis code for transposition of the great arteries, tetralogy of Fallot, or truncus arteriosus, as well as the corresponding procedure code for complete repair. Data extraction identified payment responsibilities of the patients' families in the form of co-payments, deductibles, and co-insurance during the 1st year of life. RESULTS: There were 481 infants identified who met the criteria. Average family responsibility for healthcare bills during the 1st year of life was $2928, with no difference between the three groups. The range of out-of-pocket costs was $50-$18,167. Initial hospitalisation and outpatient care accounted for the majority of these responsibilities. CONCLUSIONS: Families of commercially insured children with severe CHD requiring corrective surgery face an average of ~$3000 in out-of-pocket costs for healthcare bills during the first 12 months of their child's life, although the amount varied considerably. This information provides a framework to alleviate some of the uncertainty surrounding healthcare financial responsibilities, and further examination of the origination of these expenditures may be useful in informing future healthcare policy discussion.

Effect of frailty on resource use and cost for Medicare patients.

Aim: The effects of frailty and multiple chronic conditions (MCCs) on cost of care are rarely disentangled in archival data studies. We identify the marginal contribution of frailty to medical care cost estimates using Medicare data. Materials & methods: Use of the Faurot frailty score to identify differences in acute medical events and cost of care for patients, controlling for MCCs and medication use. Results: Estimated marginal cost of frailty was US$10,690 after controlling for demographics, comorbid conditions, polypharmacy and use of potentially inappropriate medications. Conclusion: Frailty contributes greatly to cost of care, but while often correlated, is not synonymous with MCCs. Thus, it is important to control separately for frailty in studies that compare medical care use and cost.

Impact of Gastrostomy Feeding Tube Placement on the 1-Year Trajectory of Care in Patients After Stroke.

BACKGROUND: Percutaneous endoscopic gastrostomy (PEG) feeding tubes are commonly placed in acute stroke patients with a need for enteral nutrition. However, PEG tubes are associated with medical complications and a decrease in quality of life. We compared the 1-year care trajectory of stroke patients with and without PEG tube placement to enhance knowledge about the long-term impact of PEG tube placement. METHODS: We conducted a retrospective analysis of commercially insured stroke patients included in the Truven Health MarketScan Research Databases of 2011. We analyzed their index hospital stay and conducted 1-month, 3-months, 6-months, and 1-year follow-ups. We compared admissions to inpatient rehabilitation facilities, acute hospitals, skilled nursing facilities, outpatient hospital visits, and home visits for stroke patients with and without PEG tube placement using unadjusted and adjusted modelling. RESULTS: Of the 8911 included stroke patients, 148 patients (1.7%) had a PEG tube placed during their index hospital stay. After controlling for age, gender, stroke severity, comorbidities, and stroke type, PEG tube placement was an independent predictor for admissions to inpatient rehabilitation facilities and skilled nursing facilities. Furthermore, PEG tube placement was an independent predictor for all-cause, unplanned hospital readmissions in a multivariable logistic model (area under the receiver operating characteristic curve was .84). CONCLUSION: Stroke patients who receive a PEG tube can expect a significantly different care trajectory after being discharged from the acute hospital. Our findings can aide in predicting recovery and planning resources and identifying gaps and points for improvement in stroke care for patients with PEG tube placement.

Polypharmacy and adverse drug events among propensity score matched privately insured persons with and without spinal cord injury.

STUDY DESIGN: Retrospective quasi-experimental design. OBJECTIVES: To compare the incidence of adverse drug events (ADEs) between persons with and without spinal cord injury (SCI), while controlling for all potential and available risk factors. SETTING: A commercially available claims dataset consisting of ~170 million patient cases in the United States between 2012 and 2013. METHODS: Participants (aged 18-64 years) included 2779 persons with polypharmacy and traumatic or non-traumatic SCI and 2779 propensity score-matched persons with polypharmacy without SCI. The cohorts were matched using demographic variables including number of concomitant prescriptions, comorbidities, hospital admissions, age, gender, and geographic region. Inpatient and outpatient claims records containing 395 distinct IDC-9 codes indicative of ADEs were extracted. Incidence and frequency of ADEs were compared between groups using logistic and Poisson regression, respectively. RESULTS: Persons with SCI were significantly more likely to experience an ADE than matched controls (Odds Ratio = 1.45, p < 0.0001). Among persons with ADEs (n = 1552), individuals with SCI experienced fewer ADEs over time than matched controls (Incidence Rate Ratio = 0.91, p < 0.0001). CONCLUSIONS: While persons with SCI and polypharmacy are at a greater risk for experiencing an ADE, their medical care after an ADE may be better managed than that of a matched control population. There may be a need for practice guidelines that facilitate proactive identification of persons with SCI at the highest risk of ADE. Steps may then be taken to mitigate risk, in contrast to current practice trends that appear to take a reactive approach after an ADE has occurred.

Healthcare Costs and Medication Adherence Among Patients with Fibromyalgia: Combination Medication vs. Duloxetine, Milnacipran, Venlafaxine, and Pregabalin Initiators.

OBJECTIVE: To examine medication adherence and healthcare costs for combination prescription initiators (duloxetine/milnacipran/venlafaxine with pregabalin) vs. monotherapy initiators (duloxetine, milnacipran, venlafaxine, and pregabalin) among patients with fibromyalgia syndrome (FMS). METHODS: Our retrospective cohort study used claims data for the South Carolina Blue Cross Blue Shield State Health Plan (SHP). Patients with FMS ≥ 18 years of age, with prescription initiation from July 1, 2007, through June 30, 2010, and SHP enrollment for 12 months pre- and post-index periods were included (combination: n = 100; pregabalin: n = 665; duloxetine: n = 713; milnacipran: n = 131; venlafaxine: n = 272). Medication adherence measures included high adherence (medication possession ratio ≥ 80%) and total supply days. Healthcare costs comprised direct medical expenditures. Propensity score methods of inverse probability of treatment weights were used to control for selection bias due to differing pre-index characteristics. RESULTS: Odds ratios for high adherence were significantly increased (P < 0.05) among the combination cohort vs. the venlafaxine (2.15), duloxetine (1.39), and pregabalin (2.20) cohorts. Rate ratios for total supply days were significantly higher (P < 0.05) for combination vs. venlafaxine (1.23), duloxetine (1.08), and pregabalin (1.32) cohorts. Expenditures for total health care were significantly higher (P < 0.05) for combination vs. duloxetine ($26,291 vs. $17,190), milnacipran ($33,638 vs. $22,886), and venlafaxine ($26,586 vs. $16,857) cohorts. CONCLUSIONS: Medication adherence was considerably better for combination prescription initiators; however, expenditures for total health care were higher. Still, our findings suggest important clinical benefits with the use of combination prescription therapy, and prospective studies of medication adherence are warranted to examine causal relationships with outcomes not captured by healthcare claims databases.

Patient participation in cancer clinical trials: A pilot test of lay navigation.

BACKGROUND: Clinical trials (CT) represent an important treatment option for cancer patients. Unfortunately, patients face challenges to enrolling in CTs, such as logistical barriers, poor CT understanding and complex clinical regimens. Patient navigation is a strategy that may help to improve the delivery of CT education and support services. We examined the feasibility and initial effect of one navigation strategy, use of lay navigators. METHODS: A lay CT navigation intervention was evaluated in a prospective cohort study among 40 lung and esophageal cancer patients. The intervention was delivered by a trained lay navigator who viewed a 17-minute CT educational video with each patient, assessed and answered their questions about CT participation and addressed reported barriers to care and trial participation. RESULTS: During this 12-month pilot project, 85% (95% CI: 72%-93%) of patients eligible for a therapeutic CT consented to participate in the CT navigation intervention. Among navigated patients, CT understanding improved between pre- and post-test (means 3.54 and 4.40, respectively; p-value 0.004), and 95% (95% CI: 82%-98%) of navigated patients consented to participate in a CT. Navigated patients reported being satisfied with patient navigation services and CT participation. CONCLUSIONS: In this formative single-arm pilot project, initial evidence was found for the potential effect of a lay navigation intervention on CT understanding and enrollment. A randomized controlled trial is needed to examine the efficacy of the intervention for improving CT education and enrollment.

Practice Patterns of Percutaneous Endoscopic Gastrostomy Tube Placement in Acute Stroke: Are the Guidelines Achievable?

OBJECTIVES: Our objectives were to evaluate trends in percutaneous endoscopic gastrostomy (PEG) tube placement rate and timing in acute stroke patients. We hypothesized that noncompliance with clinical practice guidelines for timing of tube placement and an increase in placement occurred because of a decrease in length of hospital stay. METHODS: We conducted a retrospective observational study of archival hospital billing data from the Florida state inpatient healthcare cost and utilization project database from 2001 to 2012 for patients with a primary diagnosis of stroke. Outcome measures were timing of PEG tube placements by year (2006-2012), rate of placements by year (2001-2012), and length of hospital stay. Univariate analyses and simple and multivariable logistic regression analyses were conducted. RESULTS: The timing of gastrostomy tube placement remained stable with a median of 7 days post admission from 2006 through 2012. The proportion of tubes that were placed at or after 14 days and thereby met the guideline recommendations varied from 14.09% in 2006 to 13.41% in 2012. The rate of tube placement in stroke patients during the acute hospital stay decreased significantly by 25% from 6.94% in 2001 to 5.22% in 2012 (P < .0001). The length of hospital stay for all stroke patients decreased over the study period (P < .0001). CONCLUSIONS: The vast majority of PEG tube placements happen earlier than clinical practice guidelines recommend. Over the study period, the rate of tubes placed in stroke patients decreased during the acute hospital stay despite an overall reduced length of stay.

Hospital Readmissions of Stroke Patients with Percutaneous Endoscopic Gastrostomy Feeding Tubes.

OBJECTIVES: A critical mission of acute care hospitals is to reduce hospital readmissions to improve patient care and avoid monetary penalties. We speculated that stroke patients with enteral tube feeding are high-risk patients and sought to evaluate their hospital readmissions. METHODS: We analyzed archival hospital billing data from stroke patients discharged from acute care hospitals in Florida in 2012 for 30- and 60-day readmission rates, 30-day readmission rates by discharge destination, most frequent primary readmission diagnoses, and predictors of 30-day readmissions. We conducted univariate and multivariable logistic regression analyses. RESULTS: We analyzed 26,774 discharge records. Within 30 days after discharge, 21.06% (N = 299) of stroke patients with percutaneous endoscopic gastrostomy (PEG) tube placement were rehospitalized. Of those readmissions, 11.71% (N = 35) were preventable. Among stroke patients with a PEG tube placement, 53.80% were discharged to skilled nursing facilities and 27.88% were rehospitalized within 30 days. Septicemia was the most frequent primary readmission diagnosis. Comorbidities, stroke type, length of hospital stay, and discharge destinations were predictive for 30-day readmissions (area under the receiver operating characteristic curve was .81). CONCLUSIONS: Stroke patients with a PEG tube placement during their index hospital stay are twice as likely to be readmitted within 30 days compared to stroke patients without PEG tube placements. The primary readmission diagnosis for some patients was directly linked to PEG tube complications. We have identified risk factors that can be used to focus resources for readmission prevention.