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The availability of electronic health record (EHR)-linked biobank data for research presents opportunities to better understand complex ocular diseases. Developing accurate computable phenotypes for ocular diseases for which gold standard diagnosis includes imaging remains inaccessible in most biobank-linked EHRs. The objective of this study was to develop and validate a computable phenotype to identify primary open-angle glaucoma (POAG) through accessing the Department of Veterans Affairs (VA) Computerized Patient Record System (CPRS) and Million Veteran Program (MVP) biobank. Accessing CPRS clinical ophthalmology data from VA Medical Center Eye Clinic (VAMCEC) patients, we developed and iteratively refined POAG case and control algorithms based on clinical, prescription, and structured diagnosis data (ICD-CM codes). Refinement was performed via detailed chart review, initially at a single VAMCEC (n = 200) and validated at two additional VAMCECs (n = 100 each). Positive and negative predictive values (PPV, NPV) were computed as the proportion of CPRS patients correctly classified with POAG or without POAG, respectively, by the algorithms, validated by ophthalmologists and optometrists with access to gold-standard clinical diagnosis data. The final algorithms performed better than previously reported approaches in assuring the accuracy and reproducibility of POAG classification (PPV >83% and NPV >97%) with consistent performance in Black or African American and in White Veterans. Applied to the MVP to identify cases and controls, genetic analysis of a known POAG-associated locus further validated the algorithms. We conclude that ours is a viable approach to use combined EHR-genetic data to study patients with complex diseases that require imaging confirmation.

Introduction Patient-centered care, particularly shared medical decision making, is difficult to measure in critically ill patients where decisions are often made by a designated surrogate, often receiving information from multiple providers with varying degrees of training. The purpose of this study was to compare short-term satisfaction with care and decision making in patients or surrogates between two neurocritical care units [one staffed by a neurocritical care attending and advanced practice providers (APPs) and one staffed by a neurocritical care attending and resident/fellow trainees] using the Family Satisfaction in the ICU (FS-ICU) survey. Methods Over a 6-month period, the FS-ICU was administered on a tablet device to patients or surrogates at least 24 h after admission and stored on REDCap database. Results One hundred and thirty-four patients or surrogates completed the FS-ICU. The response rates were 59.97% and 46.58% in the APP and trainee units, respectively. There were no differences in patient age, sex, ventilator days or ICU length of stay. Overall, there were no differences in satisfaction with care or perceived shared medical making between the units. Respondents who identified their relationship with the patient as “other” (not a spouse, parent, nor a sibling) were less satisfied with care. Additionally, surrogates who identified as parents of the patient were more satisfied with degree of shared medical decision making. Conclusion This study showed that: (1) collecting FS-ICU in a neurocritical care unit is feasible, (2) overall there is no difference in short-term satisfaction with care or shared decision making between a NICU staffed with trainees compared to one staffed with APPs, and (3) parents of patients have a higher short-term satisfaction with degree of shared medical decision making.

Background Context Red flags are questions typically ascertained by providers to screen for serious underlying spinal pathologies. The utility of patient-reported red flags in guiding clinical decision-making for spine care, however, has not been studied. Purpose The aim of this study was to quantify the sensitivity and specificity of patient-reported red flags in predicting the presence of serious spinal pathologies. Study Design This was a retrospective nested case-control study. Patient Sample This study consisted of 120 patients with International Classification of Diseases, Ninth Revision, Clinical Modification codes for spinal pathologies and 380 randomly selected patients, from a population of 4,313 patients seen at a large tertiary care spine clinic between October 9, 2013 and June 30, 2014. Outcome Measures The presence of patient-reported red flags and red flags obtained from medical records was verified for chart review. The spinal pathology (ie, malignancy, fractures, infections, or cauda equina syndrome) was noted for each patient. Methods The sensitivity and specificity of patient-reported red flags for detecting serious spinal pathologies were calculated from data obtained from the 500 patients. Youden's J was used to rank performance. Agreement between patient-reported red flags and those obtained from medical record review was assessed via Cohen's kappa statistic. Results “History of cancer” was the best performing patient-reported red flag to identify malignancy (sensitivity=0.75 [95% confidence intervals, CI 0.53–0.90], specificity=0.79 [95% CI 0.75–0.82]). The best performing patient-reported red flag for fractures was the presence of at least one of the following: “Osteoporosis,” “Steroid use,” and “Trauma” (sensitivity=0.59 [95% CI 0.44–0.72], specificity=0.65 [95% CI 0.60–0.69]). The prevalence of infection and cauda equina diagnoses was insufficient to gauge sensitivity and specificity. Red flags from medical records had better performance than patient-reported red flags. There was poor agreement between patient red flags and those obtained from medical record review. Conclusions Patient-reported red flags had low sensitivity and specificity for identification of serious pathologies. They should not be used in insolation to make treatment decisions, although they may be useful to prompt further probing to determine if additional investigation is warranted.

Objective To explore the role of several genetic polymorphisms (APOE e4, BDNF Met, and COMT Val) in executive functioning performance in patients with pharmacoresistant temporal lobe epilepsy (TLE). Methods Ninety-three adults (51 female, mean age = 39 years) with TLE completed executive functioning measures as part of a comprehensive preoperative neuropsychological evaluation, including Trail Making Test (Part B), Wisconsin Card Sorting Test (Conceptual Level Responses and Perseverative Errors), Color Word Interference from the Delis Kaplan Executive Function System, and measures of phonemic and semantic verbal fluency. Genotyping of the APOE, BDNF, and COMT genes was conducted using DNA extracted from peripheral blood or brain tissue (from epilepsy surgery). Results After adjustment for general cognitive ability, COMT Val carriers showed poorer performance on semantic verbal fluency and color word interference than non-carriers, and BDNF Met carriers showed poorer performance on phonemic verbal fluency than those without a Met allele. Significance Results suggest that COMT and BDNF polymorphisms are associated with performance on several EF measures in patients with TLE, including tasks assessing verbal fluency and response inhibition and account for up to 16% of the variance in test performance. The APOE polymorphism was not significantly associated with any of the executive function measures analyzed.

Glaucoma leads to millions of cases of visual impairment and blindness around the world. Its susceptibility is shaped by both environmental and genetic risk factors. Although over 120 risk loci have been identified for glaucoma, a large portion of its heritability is still unexplained. Here we describe the foundation of the Genetics of GLaucoma Evaluation in the AMish (GGLEAM) study to investigate the genetic architecture of glaucoma in the Ohio Amish, which exhibits lower genetic and environmental heterogeneity compared to the general population. To date, we have enrolled 81 Amish individuals in our study from Holmes County, Ohio. As a part of our enrollment process, 62 GGLEAM study participants (42 glaucoma-affected and 20 unaffected individuals) received comprehensive eye examinations and glaucoma evaluations. Using the data from the Anabaptist Genealogy Database, we found that 80 of the GGLEAM study participants were related to one another through a large, multigenerational pedigree containing 1586 people. We plan to integrate the health and kinship data obtained for the GGLEAM study to interrogate glaucoma genetics and pathophysiology in this unique population.

Background Continuous tracking of ambulatory activity in real-world settings using step activity monitors has many potential uses. However, feasibility, accuracy, and correlation with performance measures in stroke patients have not been well-established. Objective The primary study objective was to determine adherence with wearing a consumer-grade step activity monitor, the Fitbit Charge HR, in home-going ischemic stroke patients during the first 90 days after hospital discharge. Secondary objectives were to (1) determine accuracy of step counts of the Fitbit Charge HR compared with a manual tally; (2) calculate correlations between the Fitbit step counts and the mobility performance scores at discharge and 30 days after stroke; (3) determine variability and change in weekly step counts over 90 days; and (4) evaluate patient experience with using the Fitbit Charge HR poststroke. Methods A total of 15 participants with recent mild ischemic stroke wore a Fitbit Charge HR for 90 days after discharge and completed 3 mobility performance tests from the National Institutes of Health Toolbox at discharge and Day 30: (1) Standing Balance Test, (2) 2-Minute Walk Endurance Test, and (3) 4-Meter Walk Gait Speed Test. Accuracy of step activity monitors was assessed by calculating differences in steps recorded on the step activity monitor and a manual tally during 2-minute walk tests. Results Participants had a mean age of 54 years and a median modified Rankin scale score of 1. Mean daily adherence with step activity monitor use was 83.6%. Mean daily step count in the first week after discharge was 4376. Daily step counts increased slightly during the first 30 days after discharge (average increase of 52.5 steps/day; 95% CI 32.2-71.8) and remained stable during the 30-90 day period after discharge. Mean step count difference between step activity monitor and manual tally was –4.8 steps (–1.8%). Intraclass correlation coefficients for step counts and 2-minute walk, standing balance, and 4-meter gait speed at discharge were 0.41 (95% CI –0.14 to 0.75), –0.12 (95% CI –0.67 to 0.64), and 0.17 (95% CI –0.46 to 0.66), respectively. Values were similarly poor at 30 days. Conclusions The use of consumer-grade Fitbit Charge HR in patients with recent mild stroke is feasible with reasonable adherence and accuracy. There was poor correlation between step counts and gait speed, balance, and endurance. Further research is needed to evaluate the association between step counts and other outcomes relevant to patients, including patient-reported outcomes and measures of physical function.

Objectives To examine the accuracy of general health cross-walk tables in a clinical sample of patients with spine disorders. Published tables (Schalet BD, Rothrock NE, Hays RD, et al. Linking physical and mental health summary scores from the Veterans RAND 12-Item Health Survey (VR-12) to the PROMIS(®) Global Health Scale. J Gen Intern Med 2015;30:1524–30) link scores from the Veterans RAND 12-Item Health Survey (VR-12) to the 10-Item Patient-Reported Outcome Measurement Information System (PROMIS), a global health scale metric for both mental (GMH) and physical (GPH) summary scores. Methods We assessed the accuracy of administered PROMIS and VR-12 scores with scores predicted by cross-walks in 4606 adult patients seen in a spine clinic from October 2015 to 2016. Accuracy of linking scores was evaluated using Pearson correlation, intraclass correlation coefficients, and mean and SD of score differences. Bland-Altman plots were used to graphically assess the levels of agreement. The consistency in scores’ discrimination across levels of pain severity, depression, and other patient characteristics was assessed. Bootstrap methods estimated linking precision across varying sample sizes. Results Actual and cross-walked PROMIS scores showed moderate correlation (ICC(3,1): GMH 0.73; GPH 0.81), with Bland-Altman plots suggesting smaller differences between scores in patients with lower and higher general health. Significant discrimination between patient subgroups was demonstrated reliably by both actual and estimated scores. Bootstrapped resamples indicated adequate precision for 200 patients (95% confidence interval for mean difference: GMH −1.38 to 0.60; GPH 0.39 to 1.93). Conclusions VR-12 and PROMIS global health scores can be accurately linked within a sample of patients with spine disorders; nevertheless, bias is high and precision is low for linking on the patient level. Linked scores at the group level for more than 200 patients can be used in comparative effectiveness research and for comparing results across studies.

Return of results is not common in research settings as standards are not yet in place for what to return, how to return, and to whom. As a pioneer of large-scale of return of research results, the Precision Medicine Initiative Cohort now known of All of Us plans to return pharmacogenomic results and variants of clinical significance to its participants starting late 2019. To better understand the local landscape of possibilities regarding return of research results, we assessed the frequency of pathogenic variants and APOL1 renal risk variants in a small diverse cohort of chronic kidney disease patients (CKD) ascertained from a public hospital in Cleveland, Ohio genotyped on the Illumina Infinium MegaEX. Of the 23,720 ClinVar-designated variants directly assayed by the MegaEX, 8,355 (35%) had at least one alternate allele in the 130 participants genotyped. Of these, 18 ClinVar variants deemed pathogenic by multiple submitters with no conflicts in interpretation were distributed across 27 participants. The majority of these pathogenic ClinVar variants (14/18) were associated with autosomal recessive disorders. Of note were four African American carriers of TTR rs76992529 associated with amyloidogenic transthyretin amyloidosis, otherwise known as familial transthyretin amyloidosis (FTA). FTA, an autosomal dominant disorder with variable penetrance, is more common among African-descent populations compared with European-descent populations. Also common in this CKD population were APOL1 renal risk alleles G1 (rs73885319) and G2 (rs71785313) with 60% of the study population carrying at least one renal risk allele. Both pathogenic ClinVar variants and APOL1 renal risk alleles were distributed among participants who wanted actionable genetic results returned, wanted genetic results returned regardless of actionability, and wanted no results returned. Results from this local genetic study highlight challenges in which variants to report, how to interpret them, and the participant's potential for follow-up, only some of the challenges in return of research results likely facing larger studies such as All of Us.

OBJECTIVES Propose an empirical amyotrophic lateral sclerosis (ALS) staging approach called Fine'til 9 (FT9) based on how many of the patient's ALS functional rating scale (ALSFRS-R) subscores are 9 or less (of normal 12). Gain insights into progression of ALS by applying Markov models to ALS stages by multiple systems (King's, Milan-Torino system (MITOS) and FT9). METHODS Patients from the Pooled Resource Open-Access ALS Clinical Trials (PRO-ACT) dataset were staged using ALSFRS-R responses. Risks of progression through stages and death were estimated, as were effects of prognostic variables on these risks. RESULTS A total of 29,947 time points in 3199 patients from the PRO-ACT dataset were assigned stages. Although the three systems were moderately correlated, MITOS stages were heavily skewed toward advanced disease, whereas King's and FT9 stages were more balanced. Non-sequential progression was observed with King's system. Markov models adequately described transitions from stage to stage in the first year of observation, but underestimated risks beyond that point. Regardless of staging method, initial rate of ALSFRS-R decline had a powerful effect on rate of progression through sequential stages, whereas age predominantly influenced stage-specific mortality. CONCLUSION King's and FT9 are more sensitive to observed progression of disease in clinical trials than MITOS. FT9 can partition the course similar to King's, and may have advantages of sequential progression and easy applicability to retrospective data. Markov transition intensity estimates may be of value for counseling, health economic studies, and research design. In particular, this framework permits estimation of multidimensional effects of variables (including treatment) on outcome.

CME/CNE Information Activity Available Online: To access the article, post-test, and evaluation online, go to http://www.cmscscholar.org. Target Audience: The target audience for this activity is physicians, physician assistants, nursing professionals, and other health-care providers involved in the management of patients with multiple sclerosis (MS). Learning Objectives: Accreditation Statement: In support of improving patient care, this activity has been planned and implemented by the Consortium of Multiple Sclerosis Centers (CMSC) and Delaware Media Group. CMSC is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team. Physician Credit The CMSC designates this journal-based activity for a maximum of 0.75 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity. Nurse Credit The CMSC designates this enduring material for 0.75 contact hours (none in the area of pharmacology). Disclosures: Editor in Chief of the International Journal of MS Care (IJMSC), has served as Physician Planner for this activity. He has received royalties from Springer Publishing and consulting fees from Ipsen and has performed contracted research for Biogen, Adamas Pharmaceuticals, Acorda Therapeutics, and Atlas5D.Francois Bethoux, MD, has served as reviewer for this activity. She has disclosed no relevant financial relationships.Laurie Scudder, DNP, NP, has disclosed no relevant financial relationships.Samantha Domingo, PsyD, has disclosed no relevant financial relationships.Tyler Kinzy, MS, has disclosed salary support to his institution from Novartis Pharmaceuticals for research outside of this study.Nicolas Thompson, MS, has disclosed no relevant financial relationships.Shauna Gales, PA-C, has disclosed no relevant financial relationships.Lael Stone, MD, has received a consulting fee from and served on a speakers' bureau for Novartis.Amy Sullivan, PsyD, ABPP, One peer reviewer for the IJMSC has received royalties from UpToDate Inc and served on speakers' bureaus for Allergan Inc and Astellas Inc. The other peer reviewer has disclosed no relevant financial relationships. The staff at the IJMSC, CMSC, and Delaware Media Group who are in a position to influence content have disclosed no relevant financial relationships. Note: Disclosures listed for authors are those applicable at the time of their work on this project and within the previous 12 months. Method of Participation: Release Date: August 1, 2018 Valid for Credit Through: August 1, 2019 In order to receive CME/CNE credit, participants must: Statements of Credit are awarded upon successful completion of the post-test with a passing score of >70% and the evaluation. There is no fee to participate in this activity. Disclosure of Unlabeled Use: This educational activity may contain discussion of published and/or investigational uses of agents that are not approved by the FDA. CMSC and Delaware Media Group do not recommend the use of any agent outside of the labeled indications. The opinions expressed in the educational activity are those of the faculty and do not necessarily represent the views of CMSC or Delaware Media Group. Disclaimer: Participants have an implied responsibility to use the newly acquired information to enhance patient outcomes and their own professional development. The information presented in this activity is not meant to serve as a guideline for patient management. Any medications, diagnostic procedures, or treatments discussed in this publication should not be used by clinicians or other health-care professionals without first evaluating their patients' conditions, considering possible contraindications or risks, reviewing any applicable manufacturer's product information, and comparing any therapeutic approach with the recommendations of other authorities.

Purpose Electrographic seizures detected by continuous electroencephalography (CEEG) in critically ill patients with altered mental status is becoming increasingly recognized. Data guiding the appropriate selection of patients to be monitored on CEEG are lacking. The aims of this article were to study the incidence of seizures in the critical care setting and to evaluate for clinical predictors to improve the efficiency of CEEG monitoring. Methods Retrospective review of the CEEG and clinical data on 1,123 consecutive patients who had continuous video EEG over a 24-month period. Results Seizures were recorded in 215 patients on CEEG monitoring (19.1%). In total, 89.3% of these seizures occurred without clinical signs. Patients who were in a coma were more likely to have EEG seizures (odds ratio, 3.64; 95% confidence interval, 2.23-5.95) compared with those awake. The incidence of seizures was overrepresented in patients with extra-axial tumors (41.9%), multiple sclerosis (35.7%), and intra-axial tumors (33.0%). Lateralized periodic discharges were predictive (odds ratio, 8.27; 95% confidence interval, 5.52-12.46) of seizure occurrence compared with those with no epileptiform patterns. Only generalized periodic discharges with triphasic morphology had no increased odds of seizure (odds ratio, 1.02; 95% confidence interval, 0.24-3.03). When present, electroencephalography seizures were detected within 24 hours in 92% of monitored patients. Conclusions Continuous electroencephalography monitoring in the critical care setting demonstrates a linear increase in seizure incidence with declining mental status. Recognizing clinical conditions and electroencephalography markings may help in the appropriate selection of critically ill patients for CEEG monitoring.

This study examined the impact of integrated intensivist consultation in the immediate postoperative period on outcomes for cardiac surgery patients. A retrospective cohort study was conducted in 1711 adult cardiac surgery patients from a single quaternary care center in Minnesota. Outcomes were compared across 2 consecutive 2-year time periods reflecting an elective intensivist model (n = 801) and an integrated intensivist model (n = 910). Patients under the 2 models were comparable with respect to demographics, comorbidities, procedure types, and Society for Thoracic Surgery predicted risk of mortality score; however, patients in the earlier cohort were slightly older and more likely to have chronic kidney disease ( P = .003). Integrated intensivist involvement was associated with reduced postoperative ventilator time, length of stay (LOS), stroke, encephalopathy, and reoperations for bleeding (all P < .01) but was not associated with mortality. Intensivist integration into the postoperative care of cardiac surgery patients may reduce ventilator time, LOS, and complications but may not improve survival.

Author(s): Boland, MPH, Lori L.; Hokanson, MD, Jonathan S.; Fernstrom, MPH, Karl M.; Kinzy, MS, Tyler G.; Lick, MD, Charles J.; Satterlee, MD, Paul A.; LaCroix, EMT-P, Brian K. | Abstract: Introduction: We aimed to pilot test the delivery of sepsis education to emergency medical services (EMS) providers and the feasibility of equipping them with temporal artery thermometers (TATs) and handheld lactate meters to aid in the prehospital recognition of sepsis. Methods: This study used a convenience sample of prehospital patients meeting established criteria for sepsis. Paramedics received education on systemic inflammatory response syndrome (SIRS) criteria, were trained in the use of TATs and hand-held lactate meters, and enrolled patients who had a recent history of infection, met ≥ 2 SIRS criteria, and were being transported to a participating hospital. Blood lactate was measured by paramedics in the prehospital setting and again in the emergency department (ED) via usual care. Paramedics entered data using an online database accessible at the point of care. Results: Prehospital lactate values obtained by paramedics ranged from 0.8 to 9.8 mmol/L, and an elevated lactate (i.e. ≥ 4.0) was documented in 13 of 112 enrolled patients (12%). The unadjusted correlation of prehospital and ED lactate values was 0.57 (pl 0.001). The median interval between paramedic assessment of blood lactate and the electronic posting of the ED-measured lactate value in the hospital record was 111 minutes. Overall, 91 patients (81%) were hospitalized after ED evaluation, 27 (24%) were ultimately diagnosed with sepsis, and 3 (3%) died during hospitalization. Subjects with elevated prehospital lactate were somewhat more likely to have been admitted to the intensive care unit (23% vs 15%) and to have been diagnosed with sepsis (38% vs 22%) than those with normal lactate levels, but these differences were not statistically significant. Conclusion: In this pilot, EMS use of a combination of objective SIRS criteria, subjective assessment of infection, and blood lactate measurements did not achieve a level of diagnostic accuracy for sepsis that would warrant hospital prenotification and committed resources at a receiving hospital based on EMS assessment alone. Nevertheless, this work provides an early model for increasing EMS awareness and the implementation of novel devices that may enhance the prehospital assessment for sepsis. Additional translational research studies with larger numbers of patients and more robust methods are needed. [West J Emerg Med. 2016;17(5)648-655.]

Author(s): Boland, Lori L.; Kinzy, Tyler G.; Myers, Russell N.; Fernstrom, Karl M.; Kamrud, Jonathan W.; Mink, Pamela J.; Stevens, Andrew C. | Abstract: Introduction: Very little quantitative data on occupational burnout and exposure to critical incidents are available from contemporary United States emergency medical services (EMS) cohorts. Given that burnout has been associated positively with turnover intentions and absenteeism in EMS workers, studies that uncover correlates of burnout may be integral to combating growing concerns around retention in the profession. Methods: We administered a 167-item electronic survey that included the Maslach Burnout Inventory (MBI) and a modified version of the Critical Incident History Questionnaire (n=29 incident types) to paramedics, emergency medical technicians (EMTs), and dispatchers of a single ambulance service. We defined the presence of burnout as a high score on either the emotional exhaustion or depersonalization subscales of the MBI. Results: Survey respondents who provided regular 911 response at the time of the survey and completed the MBI portion of the survey were included in our analysis (190 paramedics/EMTs, 19 dispatchers; 54% response). The overall prevalence of burnout was 18%, with prevalence reaching 32% among dispatchers. The seven pediatric critical incident types presented in the survey accounted for seven of the top eight rated most difficult to cope with, and severity ratings for pediatric critical incidents did not differ by parental status (all pg0.30). A significant number of respondents reported that they had been threatened with a gun/weapon (43%) or assaulted by a patient (68%) at least once while on duty. Being over the age of 50, a parent, or in a committed relationship was associated with reduced odds of burnout in unadjusted models; however, these associations did not remain statistically significant in multivariate analysis. Increasing tertile of career exposure to critical incidents was not associated with burnout.Conclusion: Medical dispatchers may be an EMS subgroup particularly susceptible to burnout. These data also demonstrate quantitatively that in this EMS agency, responders find pediatric critical incidents especially distressing and that violence against responders is commonplace. In this study, a simple measure of career exposure to potentially critical incidents was not associated with burnout; however, individual reactions to incidents are heterogeneous, and assessment tools that more accurately enumerate encounters that result in distress are needed.

Background: The risk–benefit ratio of continuing immunomodulating disease-modifying therapy (DMT) in older multiple sclerosis (MS) patients is unknown. Objective: To evaluate clinical and patient-reported outcomes after stopping DMT in older MS patients. Methods: Retrospective, observational study identifying patients from our MS clinics who were aged over 60 and on DMT > 2 years. Cause-specific Cox proportional hazards regression modeled time to discontinuation and time to reinitiation of therapy. Pre- and post-discontinuation comparisons of Performance Scales (PS), Timed 25-Foot Walk, and Patient Health Questionnaire-9 (PHQ9) were analyzed using linear mixed models. Results: A total of 600 patients were included, with 178 (29.7%) discontinuing. Discontinuers were 2.2 years older, had 3.2 years longer disease duration, and 1.6 years lesser treatment exposure. Providers initiated discontinuation more than patients (68.0%). Only one clinical relapse occurred in discontinuers. A proportion (10.7%) reinitiated DMT. Provider-initiated discontinuers restarted less often (hazard ratio (HR): 0.34; 95% confidence interval (CI): 0.12–0.9). In discontinuers, relapsing-remitting patients had lower PS on average than primary progressive. Provider-initiated discontinuation was associated with lower PS than patient- initiated discontinuation. PHQ9 scores appeared higher in those stopping intravenous (IV) therapies than interferons. Lower PS and PHQ9 indicate better outcomes. Conclusion: Most patients over age 60, who discontinued DMT, remained off DMT. This study provides real-world data that may guide clinicians considering discontinuing DMT.

OBJECTIVES/SPECIFIC AIMS: Glaucoma is a leading cause of irreversible blindness worldwide; in the United States alone, over 2.7 million individuals are affected. Various risk factors for glaucoma are known and include age, race/ethnicity, genetics, and ocular measures. Despite numerous studies, molecular and environmental factors that contribute to glaucoma remain elusive. Our objective was to conduct a genome-wide association for glaucoma among black and white HRS respondents, and to determine the feasibility for future analyses examining shared genetic markers between glaucoma and other comorbidities, behaviors, and environmental risk factors. METHODS/STUDY POPULATION: The University of Michigan Health and Retirement Study (HRS) is a longitudinal survey of a representative sample of Americans over the age of 50. Supported by the National Institute on Aging and the Social Security Administration, the HRS is designed to provide reliable data on the decisions, choices, and behaviors of people as they age and respond to changes in public policy, the economy, and health. The study obtains information every two years about income and wealth, health and use of health services, work and retirement, and family connections. Through its unique and in-depth interviews, the HRS provides an invaluable and growing body of multidisciplinary data that researchers can use to address important questions about the challenges and opportunities of aging. Because of its innovation and importance, the HRS has become the model and hub for a growing network of harmonized longitudinal aging studies around the world. Saliva was collected on half of the HRS sample each wave starting in 2006 and respondents were genotyped on the Illumina Human Omni2.5-Quad (Omni2.5) BeadChip at the NIH Center for Inherited Disease Research. We accessed survey results to evaluate prevalence of glaucoma in this dataset and performed a genome-wide association study (GWAS) adjusting for age, sex, and significant Principal Components and stratifying by self-reported race (White / Black). RESULTS/ANTICIPATED RESULTS: Of 8179 respondents passing quality filters, 6409 (78.40%) were white and 985 (12.05%) were black. Self-reported glaucoma prevalence was 7.85% and 16.34% in white and black respondents, respectively. White respondents had a mean age of 76.97 (SD 7.53) and were 57.25% female. Black respondents had a similar mean age of 74.96 (SD 7.27) and were 62.54% female. More than 87% of both groups were assessed in 2012. Preliminary GWAS analyses did not replicate known glaucoma loci and no variants attained genome-wide significance. A suggestive variant (p

Patient participation in cancer clinical trials is low. Little is known about attitudinal barriers to participation, particularly among patients who may be offered a trial during an imminent initial oncology consult. The aims of the present study were to confirm the presence of proposed subscales of a recently developed cancer clinical trial attitudinal barriers measure, describe the most common cancer clinical trials attitudinal barriers, and evaluate socio-demographic, medical and financial factors associated with attitudinal barriers. A total of 1256 patients completed a survey assessing demographic factors, perceived financial burden, prior trial participation and attitudinal barriers to clinical trials participation. Results of a factor analysis did not confirm the presence of the proposed four attitudinal barriers subscale/factors. Rather, a single factor represented the best fit to the data. The most highly-rated barriers were fear of side-effects, worry about health insurance and efficacy concerns. Results suggested that less educated patients, patients with non-metastatic disease, patients with no previous oncology clinical trial participation, and patients reporting greater perceived financial burden from cancer care were associated with higher barriers. These patients may need extra attention in terms of decisional support. Overall, patients with fewer personal resources (education, financial issues) report more attitudinal barriers and should be targeted for additional decisional support.

Objective. This study used the Ottawa Decision Support Framework to evaluate a model examining associations between clinical trial knowledge, attitudinal barriers to participating in clinical trials, clinical trial self-efficacy, and clinical trial preparedness among 1256 cancer patients seen for their first outpatient consultation at a cancer center. As an exploratory aim, moderator effects for gender, race/ethnicity, education, and metastatic status on associations in the model were evaluated. Methods. Patients completed measures of cancer clinical trial knowledge, attitudinal barriers, self-efficacy, and preparedness. Structural equation modeling (SEM) was conducted to evaluate whether self-efficacy mediated the association between knowledge and barriers with preparedness. Results. The SEM explained 26% of the variance in cancer clinical trial preparedness. Self-efficacy mediated the associations between attitudinal barriers and preparedness, but self-efficacy did not mediate the knowledge-preparedness relationship. Conclusions. Findings partially support the Ottawa Decision Support Framework and suggest that assessing patients’ level of self-efficacy may be just as important as evaluating their knowledge and attitudes about cancer clinical trials.

Background Postoperative pulmonary complications in orthopedic surgery patients have been associated with worse clinical outcomes. Identifying patients with respiratory risk factors requiring enhanced monitoring and management modifications is an important part of postoperative care. Patients with unanticipated respiratory decompensation requiring transfer to the intensive care unit (ICU) have not been studied in sufficient detail. Methods A retrospective case-control study of elective orthopedic surgery patients (knee, hip, shoulder, or spine, n = 51) who developed unanticipated respiratory failure (RF) necessitating transfer to the ICU over a 3-year period was conducted. Controls (n = 153) were frequency matched to cases by gender, age, and surgical procedure. Patient and perioperative care factors, clinical outcomes, and cost of care were examined. Results Transfer to the ICU occurred within 48 h of surgery in 73 % of the cases, 31 % required non-invasive ventilation, and 18 % required mechanical ventilation. Cases had a higher prevalence of chronic obstructive pulmonary disease (COPD), obstructive sleep apnea (OSA), and regular psychotropic medication use than controls. Cases received more intravenous opioids during the first 24 postoperative hours, were hospitalized 4 days longer, had higher in-hospital mortality, and had excess hospitalization costs of US$26,571. COPD, OSA, preoperative psychotropic medications, and anesthesia time were associated with risk of RF in a multivariate analysis. Conclusions Unanticipated RF after orthopedic surgery is associated with extended hospitalization, increased mortality, and higher cost of care. Hospital protocols that include risk factor assessment, enhanced monitoring, and a cautious approach to opioid use in high-risk patients may reduce the frequency of this complication.

Purpose Lack of knowledge and negative attitudes have been identified as barriers to participation in clinical trials by patients with cancer. We developed Preparatory Education About Clinical Trials (PRE-ACT), a theory-guided, Web-based, interactive computer program, to deliver tailored video educational content to patients in an effort to overcome barriers to considering clinical trials as a treatment option. Patients and Methods A prospective, randomized clinical trial compared PRE-ACT with a control condition that provided general clinical trials information produced by the National Cancer Institute (NCI) in text format. One thousand two hundred fifty-five patients with cancer were randomly allocated before their initial visit with an oncologist to PRE-ACT (n = 623) or control (n = 632). PRE-ACT had three main components: assessment of clinical trials knowledge and attitudinal barriers, values assessment with clarification back to patients, and provision of a video library tailored to address each patient’s barriers. Outcomes included knowledge and attitudes and preparation for decision making about clinical trials. Results Both PRE-ACT and control interventions improved knowledge and attitudes (all P < .001) compared with baseline. Patients randomly allocated to PRE-ACT showed a significantly greater increase in knowledge (P < .001) and a significantly greater decrease in attitudinal barriers (P < .001) than did their control (text-only) counterparts. Participants in both arms significantly increased their preparedness to consider clinical trials (P < .001), and there was a trend favoring the PRE-ACT group (P < .09). PRE-ACT was also associated with greater patient satisfaction than was NCI text alone. Conclusion These data show that patient education before the first oncologist visit improves knowledge, attitudes, and preparation for decision making about clinical trials. Both text and tailored video were effective. The PRE-ACT interactive video program was more effective than NCI text in improving knowledge and reducing attitudinal barriers.

Purpose The decision to enroll in a clinical trial is complex given the uncertain risks and benefits of new approaches. Many patients also have financial concerns. We sought to characterize the association between financial concerns and the quality of decision making about clinical trials. Methods We conducted a secondary data analysis of a randomized trial of a Web-based educational tool (Preparatory Education About Clinical Trials) designed to improve the preparation of patients with cancer for making decisions about clinical trial enrollment. Patients completed a baseline questionnaire that included three questions related to financial concerns (five-point Likert scales): “How much of a burden on you is the cost of your medical care?,” “I'm afraid that my health insurance won't pay for a clinical trial,” and “I’m worried that I wouldn’t be able to afford the costs of treatment on a clinical trial.” Results were summed, with higher scores indicating greater concerns. We used multiple linear regressions to measure the association between concerns and self-reported measures of self-efficacy, preparation for decision making, distress, and decisional conflict in separate models, controlling for sociodemographic characteristics. Results One thousand two hundred eleven patients completed at least one financial concern question. Of these, 27% were 65 years or older, 58% were female, and 24% had a high school education or less. Greater financial concern was associated with lower self-efficacy and preparation for decision making, as well as with greater decisional conflict and distress, even after adjustment for age, race, sex, education, employment, and hospital location (P < .001 for all models). Conclusion Financial concerns are associated with several psychological constructs that may negatively influence decision quality regarding clinical trials. Greater attention to patients’ financial needs and concerns may reduce distress and improve patient decision making.

This article describes the rigorous development process and initial feedback of the PRE-ACT (Preparatory Education About Clinical Trials) web-based- intervention designed to improve preparation for decision making in cancer clinical trials.The multi-step process included stakeholder input, formative research, user testing and feedback. Diverse teams (researchers, advocates and developers) participated including content refinement, identification of actors, and development of video scripts. Patient feedback was provided in the final production period and through a vanguard group (N=100) from the randomized trial.Patients/advocates confirmed barriers to cancer clinical trial participation, including lack of awareness and knowledge, fear of side effects, logistical concerns, and mistrust. Patients indicated they liked the tool's user-friendly nature, the organized and comprehensive presentation of the subject matter, and the clarity of the videos.The development process serves as an example of operationalizing best practice approaches and highlights the value of a multi-disciplinary team to develop a theory-based, sophisticated tool that patients found useful in their decision making process. Practice implications Best practice approaches can be addressed and are important to ensure evidence-based tools that are of value to patients and supports the usefulness of a process map in the development of e-health tools.

e20633 Background: Cancer patient (pt) participation in clinical trials (CT) is low. Little is known about the beliefs and attitudes of health care workers (HCW) and how they impact intention to discuss CT with pts. The overall goal of this project was to develop a conceptual model to guide future interventions to enhance communication about CT between HCW and cancer pts. Methods: Two email surveys of non-physician HCW at an NCI-designated comprehensive cancer center were conducted. The first was sent to a random sample of 150 HCW. The second was sent to 80 who completed the first survey. Based on our prior work (Eads et al. ASCO 2011) and Ajzen’s Theory of Planned Behavior, domains of the first included CT knowledge (19 items, agree/disagree) and attitudes (27 items, 5-point Likert); the second included normative beliefs about institutional attitudes toward CT (6 items, 5-point Likert), self-efficacy about engaging in discussion about CT (14 items, 5-point Likert), and intention to discuss CT with pts (4 items, 7-point Likert). Results: 41 HCW completed both anonymous surveys; 27 could be matched by demographics. Median age of matched respondents was 44.3 yrs (range 24-63), 26 female, 22 caucasian, 9 nurses. Overall, CT knowledge was high (median 17/19 items correct). There were strong associations between attitudes and self-efficacy (Spearman r=-0.425, p=0.03), as well as perceived normative beliefs and self-efficacy (r=0.651, p=0.0002). These associations were strong amongst nurses (r=-0.818, p=0.007 and r=0.656, p=0.05, respectively), with a particularly strong correlation between self-efficacy and intention to discuss clinical trials with pts (r=0.891, p=0.001). Conclusions: In spite of a small sample size, these pilot data strongly support a behavioral framework to understand and address the impact of HCW attitudes and beliefs about CT on discussions of CT with pts. Insofar as HCW (especially nurses) have substantial pt contact, and serve as a resource for pts regarding treatment decisions, educational interventions to address HCW barriers to discussing CT with pts (i.e. attitudes, beliefs, and self-efficacy) could positively impact pt attitudes and improve decision making.

6003 Background: Patient (pt) participation in clinical trials remains low. We previously described psychosocial and practical barriers to enrollment (J NCCN, 2007). During development of an interv...