Showing papers by "Regenstrief Institute published in 2013"

Alzheimer's Association recommendations for operationalizing the detection of cognitive impairment during the Medicare Annual Wellness Visit in a primary care setting

Abstract: The Patient Protection and Affordable Care Act added a new Medicare benefit, the Annual Wellness Visit (AWV), effective January 1, 2011. The AWV requires an assessment to detect cognitive impairment. The Centers for Medicare and Medicaid Services (CMS) elected not to recommend a specific assessment tool because there is no single, universally accepted screen that satisfies all needs in the detection of cognitive impairment. To provide primary care physicians with guidance on cognitive assessment during the AWV, and when referral or further testing is needed, the Alzheimer's Association convened a group of experts to develop recommendations. The resulting Alzheimer's Association Medicare Annual Wellness Visit Algorithm for Assessment of Cognition includes review of patient Health Risk Assessment (HRA) information, patient observation, unstructured queries during the AWV, and use of structured cognitive assessment tools for both patients and informants. Widespread implementation of this algorithm could be the first step in reducing the prevalence of missed or delayed dementia diagnosis, thus allowing for better healthcare management and more favorable outcomes for affected patients and their families and caregivers.

Variants in the ATP-Binding Cassette Transporter (ABCA7), Apolipoprotein E ε4, and the Risk of Late-Onset Alzheimer Disease in African Americans

Abstract: Importance Genetic variants associated with susceptibility to late-onset Alzheimer disease are known for individuals of European ancestry, but whether the same or different variants account for the genetic risk of Alzheimer disease in African American individuals is unknown. Identification of disease-associated variants helps identify targets for genetic testing, prevention, and treatment. Objective To identify genetic loci associated with late-onset Alzheimer disease in African Americans. Design, Setting, and Participants The Alzheimer Disease Genetics Consortium (ADGC) assembled multiple data sets representing a total of 5896 African Americans (1968 case participants, 3928 control participants) 60 years or older that were collected between 1989 and 2011 at multiple sites. The association of Alzheimer disease with genotyped and imputed single-nucleotide polymorphisms (SNPs) was assessed in case-control and in family-based data sets. Results from individual data sets were combined to perform an inverse variance–weighted meta-analysis, first with genome-wide analyses and subsequently with gene-based tests for previously reported loci. Main Outcomes and Measures Presence of Alzheimer disease according to standardized criteria. Results Genome-wide significance in fully adjusted models (sex, age, APOE genotype, population stratification) was observed for a SNP in ABCA7 (rs115550680, allele = G; frequency, 0.09 cases and 0.06 controls; odds ratio [OR], 1.79 [95% CI, 1.47-2.12]; P = 2.2 × 10 −9 ), which is in linkage disequilibrium with SNPs previously associated with Alzheimer disease in Europeans (0.8 −47 ). Several loci previously associated with Alzheimer disease but not reaching significance in genome-wide analyses were replicated in gene-based analyses accounting for linkage disequilibrium between markers and correcting for number of tests performed per gene (CR1, BIN1, EPHA1, CD33; 0.0005 Conclusions and Relevance In this meta-analysis of data from African American participants, Alzheimer disease was significantly associated with variants in ABCA7 and with other genes that have been associated with Alzheimer disease in individuals of European ancestry. Replication and functional validation of this finding is needed before this information is used in clinical settings.

Improving dementia care: The role of screening and detection of cognitive impairment

Abstract: The value of screening for cognitive impairment, including dementia and Alzheimer's disease, has been debated for decades. Recent research on causes of and treatments for cognitive impairment has converged to challenge previous thinking about screening for cognitive impairment. Consequently, changes have occurred in health care policies and priorities, including the establishment of the annual wellness visit, which requires detection of any cognitive impairment for Medicare enrollees. In response to these changes, the Alzheimer's Foundation of America and the Alzheimer's Drug Discovery Foundation convened a workgroup to review evidence for screening implementation and to evaluate the implications of routine dementia detection for health care redesign. The primary domains reviewed were consideration of the benefits, harms, and impact of cognitive screening on health care quality. In conference, the workgroup developed 10 recommendations for realizing the national policy goals of early detection as the first step in improving clinical care and ensuring proactive, patient-centered management of dementia.

Late Life Leisure Activities and Risk of Cognitive Decline

Abstract: Background. Studies concerning the effect of different types of leisure activities on various cognitive domains are limited. This study tests the hypothesis that mental, physical, and social activi ...

Long-term anticholinergic use and the aging brain.

Abstract: Background Older Americans are facing an epidemic of chronic diseases and are thus exposed to anticholinergics (ACs) that might negatively affect their risk of developing mild cognitive impairment (MCI) or dementia. Objective To investigate the association between impairment in cognitive function and previous AC exposure. Design A retrospective cohort study. Setting Primary care clinics in Indianapolis, Indiana. Participants A total of 3690 older adults who have undergone cognitive assessment and had a 1-year medication-dispensing record. Outcome Cognitive function was measured in two sequential steps: a two-step screening process followed by a formal diagnostic process for participants with positive screening results. Exposure Three patterns of AC exposure were defined by the duration of AC exposure, the number of AC medications dispensed at the same time, and the severity of AC effects as determined by the Anticholinergic Cognitive Burden list. Results Compared with older adults with no AC exposure and after adjusting for age, race, gender, and underlying comorbidity, the odds ratio for having a diagnosis of MCI was 2.73 (95% confidence interval, 1.27–5.87) among older adults who were exposed to at least three possible ACs for at least 90 days; the odds ratio for having dementia was 0.43 (95% confidence interval, 0.10–1.81). Conclusion Exposure to medications with severe AC cognitive burden may be a risk factor for developing MCI.

The Mentoring Competency Assessment: validation of a new instrument to evaluate skills of research mentors.

Abstract: Purpose To determine the psychometric properties of the Mentoring Competency Assessment (MCA), a 26-item skills inventory that enables research mentors and mentees to evaluate six competencies of mentors: maintaining effective communication, aligning expectations, assessing understanding, addressing diversity, fostering independence, and promoting professional development. Method In 2010, investigators administered the MCA to 283 mentor–mentee pairs from 16 universities participating in a trial of a mentoring curriculum for clinical and translational research mentors. The authors analyzed baseline MCA data to describe the instrument’s psychometric properties. Results Coefficient alpha scores for the MCA showed reliability (internal consistency). The hypothesized model with its six latent constructs (competencies) resulted in an acceptable fit to the data. For the instrument completed by mentors, chi-square = 663.20; df = 284; P < .001; root mean square error of approximation (RMSEA) = 0.069 (90% CI, 0.062–0.076); comparative fit index (CFI) = 0.85; and Tucker-Lewis index (TLI) = 0.83. For the instrument completed by mentees, chi-square = 840.62; df = 284; P < .001; RMSEA = 0.080 (90% CI, 0.063–0.077); CFI = 0.87; and TLI = 0.85. The correlations among the six competencies were high: 0.49–0.87 for mentors, 0.58–0.92 for mentees. All parameter estimates for the individual items were significant; standardized factor loadings ranged from 0.32 to 0.81 for mentors and 0.56 to 0.86 for mentees. Conclusions The findings demonstrate that the MCA has reliability and validity. In addition, this study provides preliminary norms derived from a national sample of mentors and mentees.

Defining a Reference Set to Support Methodological Research in Drug Safety

Abstract: Methodological research to evaluate the performance of methods requires a benchmark to serve as a referent comparison. In drug safety, the performance of analyses of spontaneous adverse event reporting databases and observational healthcare data, such as administrative claims and electronic health records, has been limited by the lack of such standards. To establish a reference set of test cases that contain both positive and negative controls, which can serve the basis for methodological research in evaluating methods performance in identifying drug safety issues. Systematic literature review and natural language processing of structured product labeling was performed to identify evidence to support the classification of drugs as either positive controls or negative controls for four outcomes: acute liver injury, acute kidney injury, acute myocardial infarction, and upper gastrointestinal bleeding. Three-hundred and ninety-nine test cases comprised of 165 positive controls and 234 negative controls were identified across the four outcomes. The majority of positive controls for acute kidney injury and upper gastrointestinal bleeding were supported by randomized clinical trial evidence, while the majority of positive controls for acute liver injury and acute myocardial infarction were only supported based on published case reports. Literature estimates for the positive controls shows substantial variability that limits the ability to establish a reference set with known effect sizes. A reference set of test cases can be established to facilitate methodological research in drug safety. Creating a sufficient sample of drug-outcome pairs with binary classification of having no effect (negative controls) or having an increased effect (positive controls) is possible and can enable estimation of predictive accuracy through discrimination. Since the magnitude of the positive effects cannot be reliably obtained and the quality of evidence may vary across outcomes, assumptions are required to use the test cases in real data for purposes of measuring bias, mean squared error, or coverage probability.

Use of Survivorship Care Plans in the United States: Associations With Survivorship Care

Abstract: Background Survivorship care plans (SCPs), including a treatment summary and follow-up plan, intend to promote coordination of posttreatment cancer care; yet, little is known about the provision of these documents by oncologists to primary care physicians (PCPs). This study compared self-reported oncologist provision and PCP receipt of treatment summaries and follow-up plans, characterized oncologists who reported consistent provision of these documents to PCPs, and examined associations between PCP receipt of these documents and survivorship care. Methods A nationally representative sample of medical oncologists (n = 1130) and PCPs (n = 1020) were surveyed regarding follow-up care for breast and colon cancer survivors. All statistical tests were two-sided. Multivariable regression models identified factors associated with oncologist provision of treatment summaries and SCPs to PCPs (always/almost always vs less frequent). Results Nearly half of oncologists reported always/almost always providing treatment summaries, whereas 20.2% reported always/almost always providing SCPs (treatment summary + follow-up plan). Approximately one-third of PCPs indicated always/almost always receiving treatment summaries; 13.4% reported always/almost always receiving SCPs. Oncologists who reported training in late- and long-term effects of cancer and use of electronic medical records were more likely to report SCP provision (P < .05). PCP receipt of SCPs was associated with better PCP-reported care coordination, physician–physician communication, and confidence in survivorship care knowledge compared to receipt of neither treatment summaries nor SCPs (P < .05). Conclusions Providing SCPs to PCPs may enhance survivorship care coordination, physician–physician communication, and PCP confidence. However, considerable progress will be necessary to achieve implementation of sharing SCPs among oncologists and PCPs. J Natl Cancer Inst;2013;105:1579–1587

Use of Survivorship Care Plans in the United States: Associations With Survivorship Care

Abstract: Background Survivorship care plans (SCPs), including a treatment summary and follow-up plan, intend to promote coordination of posttreatment cancer care; yet, little is known about the provision of these documents by oncologists to primary care physicians (PCPs). This study compared self-reported oncologist provision and PCP receipt of treatment summaries and follow-up plans, characterized oncologists who reported consistent provision of these documents to PCPs, and examined associations between PCP receipt of these documents and survivorship care. Methods A nationally representative sample of medical oncologists (n = 1130) and PCPs (n = 1020) were surveyed regarding follow-up care for breast and colon cancer survivors. All statistical tests were two-sided. Multivariable regression models identified factors associated with oncologist provision of treatment summaries and SCPs to PCPs (always/almost always vs less frequent). Results Nearly half of oncologists reported always/almost always providing treatment summaries, whereas 20.2% reported always/almost always providing SCPs (treatment summary + follow-up plan). Approximately one-third of PCPs indicated always/almost always receiving treatment summaries; 13.4% reported always/almost always receiving SCPs. Oncologists who reported training in late- and long-term effects of cancer and use of electronic medical records were more likely to report SCP provision (P < .05). PCP receipt of SCPs was associated with better PCP-reported care coordination, physician–physician communication, and confidence in survivorship care knowledge compared to receipt of neither treatment summaries nor SCPs (P < .05). Conclusions Providing SCPs to PCPs may enhance survivorship care coordination, physician–physician communication, and PCP confidence. However, considerable progress will be necessary to achieve implementation of sharing SCPs among oncologists and PCPs. J Natl Cancer Inst;2013;105:1579–1587

Older adults and forgoing cancer screening: "I think it would be strange"

Abstract: Importance Although there is a growing recognition that older adults and those with extensive comorbid conditions undergo cancer screening too frequently, there is little information about patients' perceptions regarding cessation of cancer screening. Information on older adults' views of screening cessation would be helpful both for clinicians and for those designing interventions to reduce overscreening. Objective To obtain a deeper understanding of older adults' perspectives on screening cessation and their experiences communicating with clinicians about this topic. Design Semistructured interview study. Setting Senior health center affiliated with an urban hospital. Participants We interviewed 33 older adults presenting to a senior health center. Their median age was 76 years (range, 63-91 years). Of the 33 participants, 27 were women; 15 were African American, 16 were white, 1 was Asian, and 1 was American Indian. Main Outcome Measures We transcribed audio recordings of interviews and analyzed them using methods of grounded theory to identify themes and illustrative quotes. Results Undergoing screening tests was perceived by participants as morally obligatory. Although many saw continued screening as a habit or custom not involving any decision, cessation of screening would require a major decision. Many asserted that they had never discussed screening cessation with their physicians or considered stopping on their own; some reported being upset when their physician recommended stopping. Although some would accept a physician's strong recommendation to stop, others thought that such a physician's recommendation would threaten trust or lead them to get another opinion. Participants were skeptical about the role of statistics and the recommendations of government panels in screening decisions but were more favorable toward stopping because of the balance of risks and benefits, complications, or test burdens. Conclusions and Relevance For many older adults, stopping screening is a major decision, but continuing screening is not. A physician's recommendation to stop may threaten patient trust. Effective strategies to reduce nonbeneficial screening may include discussion of the balance of risks and benefits, complications, or burdens.

Contrasting Tensions Between Patients and PCPs in Chronic Pain Management: A Qualitative Study

Abstract: Objective With greater scrutiny on primary care providers' (PCPs) approaches to chronic pain management, more research is needed to clarify how concerns and uncertainties about opioid therapy affect the ways both patients with chronic pain and PCPs experience primary care interactions. The goal of this qualitative study was to develop a better understanding of the respective experiences, perceptions, and challenges that patients with chronic pain and PCPs face communicating with each other about pain management. Design Purposive and snowball sampling techniques were used to identify 14 PCPs. Patients who received ≥6 opioid prescriptions during the prior year were selected at random from the panels of participating physicians. Face-to-face in-depth interviews were conducted individually with patients and PCPs. Setting VISN 11 Roudebush VA Medical Center (RVAMC) in Indianapolis, Indiana. Subjects Fourteen PCPs and 26 patients with chronic pain participated. Methods An inductive thematic analysis was conducted separately with patient and PCP interview data, after which the emergent themes for both groups were compared and contrasted. Results Three notable tensions between patients and PCPs were discovered: 1) the role of discussing pain versus other primary care concerns, 2) acknowledgment of pain and the search for objective evidence, and 3) recognition of patient individuality and consideration of relationship history. Conclusions Competing demands of primary care practice, differing beliefs about pain, and uncertainties about the appropriate place of opioid therapy in chronic pain management likely contributed to the identified tensions. Several clinical communication strategies to help PCPs mitigate and manage pain-related tensions are discussed.

The Epidemiology of Delirium: Challenges and Opportunities for Population Studies

Abstract: Delirium is a serious and common acute neuropsychiatric syndrome that is associated with short- and long-term adverse health outcomes. However, relatively little delirium research has been conducted in unselected populations. Epidemiologic research in such populations has the potential to resolve several questions of clinical significance in delirium. Part 1 of this article explores the importance of population selection, case-ascertainment, attrition, and confounding. Part 2 examines a specific question in delirium epidemiology: What is the relationship between delirium and trajectories of cognitive decline? This section assesses previous work through two systematic reviews and proposes a design for investigating delirium in the context of longitudinal cohort studies. Such a design requires robust links between community and hospital settings. Practical considerations for case-ascertainment in the hospital, as well as the necessary quality control of these programs, are outlined. We argue that attention to these factors is important if delirium research is to benefit fully from a population perspective.

Anxiety but not Social Stressors Predict 12-Month Depression and Pain Severity

Abstract: Objectives To determine whether baseline anxiety and social stressors as well their early change (first 3 months) predict 12-month depression and pain severity. Methods We analyzed data from the Stepped Care for Affective Disorders and Musculoskeletal Pain study, a randomized clinical trial of a combined medication-behavioral intervention for primary care patients with chronic musculoskeletal pain and depression. Using multivariable linear regression modeling, we examined the independent association of baseline anxiety and social stressors with depression and pain severity at 12 months. In addition, we modeled whether changes in anxiety and social stressors predicted 12-month depression and pain severity. Results Overall, the sample (N=250) was 52.8% women with a mean age of 55.5 years, and a racial distribution of 60.4% white, 36.4% black, and 3.2% other. Depression and pain were moderately severe at baseline (mean SCL-20 depression=1.9 and Brief Pain Inventory pain severity=6.15) and similar across intervention and usual care arms. Baseline anxiety symptoms predicted both depression (t score=2.13, P=0.034) and pain severity (t score=2.75, P=0.007) at 12 months. Also, early change in anxiety predicted 12-month depression (t score=-2.47, P=0.014), but not pain. Neither baseline nor early change in social stressors predicted depression or pain severity. Conclusions Anxiety, but not social stressors predict 12-month depression and pain severity. The presence of comorbid anxiety should be considered in the assessment and treatment of patients with musculoskeletal pain and depression, particularly as a factor that may adversely affect treatment response.

Lower provider volume is associated with higher failure rates for endoscopic retrograde cholangiopancreatography.

Abstract: BACKGROUND Among physicians who perform endoscopic retrograde cholangiopancreatography (ERCP), the relationship between procedure volume and outcome is unknown OBJECTIVE Quantify the ERCP volume-outcome relationship by measuring provider-specific failure rates, hospitalization rates, and other quality measures RESEARCH DESIGN Retrospective cohort SUBJECTS A total of 16,968 ERCPs performed by 130 physicians between 2001 and 2011, identified in the Indiana Network for Patient Care MEASURES Physicians were classified by their average annual Indiana Network for Patient Care volume and stratified into low (<25/y) and high (≥25/y) Outcomes included failed procedures, defined as repeat ERCP, percutaneous transhepatic cholangiography or surgical exploration of the bile duct≤7 days after the index procedure, hospitalization rates, and 30-day mortality RESULTS Among 15,514 index ERCPs, there were 1163 (75%) failures; the failure rate was higher among low (95%) compared with high volume (57%) providers (P<0001) A second ERCP within 7 days (a subgroup of failure rate) occurred more frequently when the original ERCP was performed by a low-volume (41%) versus a high-volume physician (23%, P=0013) Patients were more frequently hospitalized within 24 hours when the ERCP was performed by a low-volume (283%) versus high-volume physician (148%, P=0002) Mortality within 30 days was similar (low=19%, high=19%) Among low-volume physicians and after adjusting, the odds of having a failed procedure decreased 33% (95% confidence interval, 16%-50%, P<0001) with each additional ERCP performed per year CONCLUSIONS Lower provider volume is associated with higher failure rate for ERCP, and greater need for postprocedure hospitalization

Use of a Computerized Decision Aid for ADHD Diagnosis: A Randomized Controlled Trial

Abstract: OBJECTIVE: To determine if implementing attention-deficit/hyperactivity disorder (ADHD) diagnosis and treatment guidelines in a clinical decision support system would result in better care, including higher rates of adherence to clinical care guidelines. METHODS: We conducted a cluster randomized controlled trial in which we compared diagnosis and management of ADHD in 6- to 12-year-olds after implementation of a computer decision support system in 4 practices. RESULTS: Eighty-four charts were reviewed. In the control group, the use of structured diagnostic assessments dropped from 50% in the baseline period to 38% in the intervention period. In the intervention group, however, it rose from 60% to 81%. This difference was statistically significant, even after controlling for age, gender, and race (odds ratio of structured diagnostic assessment in intervention group versus control group = 8.0, 95% confidence interval 1.6–40.6). Significant differences were also seen in the number of ADHD core symptoms noted at the time of diagnosis. Our study was not powered to detect changes in care and management, but the percent of patients who had documented medication adjustments, mental health referrals, and visits to mental health specialists were higher in the intervention group than the control. CONCLUSIONS: The introduction of a clinical decision support module resulted in higher quality of care with respect to ADHD diagnosis including a prospect for higher quality of ADHD management in children. Future work will examine how to further develop the ADHD module and add support for other chronic conditions.

Child Exposure to Parental Violence and Psychological Distress Associated With Delayed Milestones

Abstract: OBJECTIVE: To examine the association between parental report of intimate partner violence (IPV) and parental psychological distress (PPD) with child attainment of developmental milestones. METHODS: By using data collected from a large cohort of primary care patients, this cross-sectional study examined the relationship between parental report of IPV and/or PPD and the attainment of developmental milestones within the first 72 months of a child’s life. Multivariate logistic regression analyses were used to adjust for parental report of child abuse concern and sociodemographic characteristics. RESULTS: Our study population included 16 595 subjects. Children of parents reporting both IPV and PPD ( n = 88; 0.5%) were more likely to fail at least 1 milestone across the following developmental domains: language (adjusted odds ratio [aOR] 2.1; 95% confidence interval [CI] 1.3–3.3), personal-social (aOR 1.9; 95% CI 1.2–2.9), and gross motor (aOR 3.0; 95% CI 1.8–5.0). Significant associations for those reporting IPV-only ( n = 331; 2.0%) were found for language (aOR 1.4; 95% CI 1.1–1.9), personal-social (aOR 1.7; 95% CI 1.4–2.2), and fine motor-adaptive (aOR 1.7; 95% CI 1.0–2.7). Significant associations for those reporting PPD-only ( n = 1920; 11.6%) were found for: language (aOR 1.5; 95% CI 1.3–1.7), personal-social (aOR 1.6; 95% CI 1.5–1.8), gross motor (aOR 1.6; 95% CI 1.4–1.8), and fine-motor adaptive (aOR 1.6; 95% CI 1.3–2.0). CONCLUSIONS: Screening children for IPV and PPD helps identify those at risk for poor developmental outcomes who may benefit from early intervention.

Predictive value of initial triage vital signs for critically ill older adults.

Abstract: Introduction: Triage of patients is critical to patient safety, yet no clear information exists as to the utility of initial vital signs in identifying critically ill older emergency department (ED) patients. The objective of this study is to evaluate a set of initial vital sign thresholds as predictors of severe illness and injury among older adults presenting to the ED. Methods: We reviewed all visits by patients aged 75 and older seen during 2007 at an academic ED serving a large community of older adults. Patients’ charts were abstracted for demographic and clinical information including vital signs, via automated electronic methods. We used bivariate analysis to investigate the relationship between vital sign abnormalities and severe illness or injury, defined as intensive care unit (ICU) admission or ED death. In addition, we calculated likelihood ratios for normal and abnormal vital signs in predicting severe illness or injury. Results: 4,873 visits by patients aged 75 and above were made to the ED during 2007, and of these 3,848 had a complete set of triage vital signs. For these elderly patients, the sensitivity and specificity of an abnormal vital sign taken at triage for predicting death or admission to an ICU were 73% (66,81) and 50% (48,52) respectively (positive likelihood ratio 1.47 (1.30,1.60); negative likelihood ratio 0.54 (0.30,0.60). Conclusion: Emergency provider assessment and triage scores that rely primarily on initial vital signs are likely to miss a substantial portion of critically ill older adults. [West J Emerg Med. 2013;14(5):453–460.]

Electronic health information quality challenges and interventions to improve public health surveillance data and practice.

Abstract: ObjectiveWe examined completeness, an attribute of data quality, in the context of electronic laboratory reporting (ELR) of notifiable disease information to public health agenciesMethodsWe extracted more than seven million ELR messages from multiple clinical information systems in two states We calculated and compared the completeness of various data fields within the messages that were identified to be important to public health reporting processes We compared unaltered, original messages from source systems with similar messages from another state as well as messages enriched by a health information exchange (HIE) Our analysis focused on calculating completeness (i e, the number of nonmissing values) for fields deemed important for inclusion in notifiable disease case reportsResultsThe completeness of data fields for laboratory transactions varied across clinical information systems and jurisdictions Fields identifying the patient and test results were usually complete (97%–100%) Fields contain