Showing papers by "Regenstrief Institute published in 2014"

The somatic symptom scale-8 (SSS-8): a brief measure of somatic symptom burden.

Abstract: Importance Somatic symptoms are the core features of many medical diseases, and they are used to evaluate the severity and course of illness. The 8-item Somatic Symptom Scale (SSS-8) was recently developed as a brief, patient-reported outcome measure of somatic symptom burden, but its reliability, validity, and usefulness have not yet been tested. Objective To investigate the reliability, validity, and severity categories as well as the reference scores of the SSS-8. Design, Setting, and Participants A national, representative general-population survey was performed between June 15, 2012, and July 15, 2012, in Germany, including 2510 individuals older than 13 years. Main Outcomes and Measures The SSS-8 mean (SD), item-total correlations, Cronbach α, factor structure, associations with measures of construct validity (Patient Health Questionnaire–2 depression scale, Generalized Anxiety Disorder–2 scale, visual analog scale for general health status, 12-month health care use), severity categories, and percentile rank reference scores. Results The SSS-8 had excellent item characteristics and good reliability (Cronbach α = 0.81). The factor structure reflects gastrointestinal, pain, fatigue, and cardiopulmonary aspects of the general somatic symptom burden. Somatic symptom burden as measured by the SSS-8 was significantly associated with depression ( r = 0.57 [95% CI, 0.54 to 0.60]), anxiety ( r = 0.55 [95% CI, 0.52 to 0.58]), general health status ( r = −0.24 [95% CI, −0.28 to −0.20]), and health care use (incidence rate ratio, 1.12 [95% CI, 1.10 to 1.14]). The SSS-8 severity categories were calculated in accordance with percentile ranks: no to minimal (0-3 points), low (4-7 points), medium (8-11 points), high (12-15 points), and very high (16-32 points) somatic symptom burden. For every SSS-8 severity category increase, there was a 53% (95% CI, 44% to 63%) increase in health care visits. Conclusions and Relevance The SSS-8 is a reliable and valid self-report measure of somatic symptom burden. Cutoff scores identify individuals with low, medium, high, and very high somatic symptom burden.

A comparison of four frailty models

Abstract: Frailty is a condition that places older persons at risk of poor outcomes when exposed to stressful events.1 Frailty is present in approximately 5% of the population aged 60 and older.2 Numerous studies have suggested that frailty is a predictor of functional deterioration and mortality.3–5 Models of frailty have been developed using three different domains: functional, deficit accumulation, and biological.6–11 The Frailty Index (FI) was developed based on the concept that deficit accumulation—a combination of symptoms, diseases, conditions, and disability—can predict frailty.9 A biological model of frailty based on five components—weight loss, exhaustion, low energy expenditure, slowness, and weakness—is known as the Cardiovascular Health Study (CHS) scale.12 The Study of Osteoporotic Fractures (SOF) scale included one functional and two biological factors in its frailty index—inability to rise from a chair five times without using the arms, weight loss, and reduced energy level.13 The CHS and FI measures are not practical for use in a busy clinic. The CHS scale requires measured performance (walking speed, grip strength) and is scored based on relative values in a population. The FI includes numerous items, typically 40 or more, and may include measured performance (e.g., cognition, physical performance). The SOF scale is brief and easy to administer in a clinic but requires measured performance (chair stands). The FRAIL scale was recently developed as a simple measure that combines components of functional, deficit accumulation, and biological frailty models.14,15 The FRAIL scale was constructed to include only interview questions and require minimal administration time so that physicians and other health professionals can easily use it in clinical practice. Initial studies have shown that the FRAIL scale predicts adverse health outcomes,16–18 but research directly comparing different models of frailty is limited,19,20 and these studies have not included the FRAIL scale. African Americans have a higher level of functional impairment and disability than do Caucasians21 and have been shown to have a higher prevalence of frailty than Caucasians using the CHS model.22 Thus there is a need for a brief frailty tool that can be used to identify African Americans at risk of disability and mortality so that early interventions can be developed. African American Health (AAH) is a population-based study of late middle-aged African Americans from two socioeconomically diverse areas of St. Louis. The AAH population has been demonstrated to have excess disability21 and represents a population that could benefit greatly from early frailty identification by clinicians. The objective of this study was to investigate how well the interview-based, clinic-friendly FRAIL scale predicts future disability and mortality compared with the clinic-friendly SOF scale, the phenotype-based CHS scale, and the comprehensive FI in the AAH cohort. It was hypothesized that the FRAIL, CHS, and SOF measures and the FI would have predictive validity for disability and mortality and that the predictive validity of the FRAIL scale for disability and mortality would be similar to that of the SOF and CHS scales and the FI using receiver operating characteristic (ROC) contrasts.

Telecare Collaborative Management of Chronic Pain in Primary Care: A Randomized Clinical Trial

Abstract: Importance Chronic musculoskeletal pain is among the most prevalent, costly, and disabling medical disorders However, few clinical trials have examined interventions to improve chronic pain in primary care Objective To determine the effectiveness of a telecare intervention for chronic pain Design, Setting, and Participants The Stepped Care to Optimize Pain Care Effectiveness (SCOPE) study was a randomized trial comparing a telephone-delivered collaborative care management intervention vs usual care in 250 patients with chronic (≥3 months) musculoskeletal pain of at least moderate intensity (Brief Pain Inventory [BPI] score ≥5) Patients were enrolled from 5 primary care clinics in a single Veterans Affairs medical center from June 2010 through May 2012, with 12-month follow-up completed by June 2013 Interventions Patients were randomized either to an intervention group (n = 124) or to a usual care group whose members received all pain care as usual from their primary care physicians (n = 126) The intervention group received 12 months of telecare management that coupled automated symptom monitoring with an algorithm-guided stepped care approach to optimizing analgesics Main Outcomes and Measures Primary outcome was the BPI total score, which ranges from 0 (“no pain”) to 10 (“pain as bad as you can imagine”) and for which a 1-point change is considered clinically important Secondary pain outcomes included BPI interference and severity, global pain improvement, treatment satisfaction, and use of opioids and other analgesics Results Overall, mean (SD) baseline BPI scores in the intervention and control groups were 531 (181) and 512 (180), respectively Compared with usual care, the intervention group had a 102-point lower (95% CI, −158 to −047) BPI score at 12 months (357 vs 459) Patients in the intervention group were nearly twice as likely to report at least a 30% improvement in their pain score by 12 months (517% vs 271%; relative risk, 19 [95% CI, 14 to 27]), with a number needed to treat of 41 (95% CI, 30 to 64) for a 30% improvement Secondary pain outcomes also improved Few patients in either group required opioid initiation or dose escalation Conclusions and Relevance Telecare collaborative management increased the proportion of primary care patients with improved chronic musculoskeletal pain This was accomplished by optimizing nonopioid analgesic medications using a stepped care algorithm and monitoring Trial Registration clinicaltrialsgov Identifier:NCT00926588

Trends in office-based mental health care provided by psychiatrists and primary care physicians.

Abstract: Objective To assess recent national trends in mental health care provided by office-based psychiatrists and primary care physicians. Method Trends in mental health-related visits to psychiatrists and primary care physicians are evaluated with the 1995-2010 National Ambulatory Medical Care Surveys. Rates and percentages of visits with mental health complaints, mental disorder diagnoses, psychotropic medications, and psychotherapy or mental health counseling were calculated for 1995-1998, 1999-2002, 2003-2006, and 2007-2010 by dividing the number of visits of a given type by intercensal population estimates. Results Between 1995-1998 and 2007-2010, a significant increase occurred in the rate per 100 population of primary care visits with mental health complaints (5.96 to 8.49) (OR = 0.45; 95% CI, 0.33-0.62, mental disorders (8.75 to 13.23) (OR = 1.40; 95% CI, 1.26-1.56), and psychotropic medications (11.08 to 26.74) (OR=3.43; 95% CI, 2.16-2.71). Significant corresponding increases occurred in psychiatrist visits with psychotropic medications (5.28 to 7.85) (OR = 2.25; 95% CI, 1.49-3.41), but not mental disorders (7.60 to 8.95) (OR = 0.87; 95% CI, 0.34-2.23), and the rate with mental health complaints significantly declined (5.87 to 5.20) (OR = 0.45; 95% CI, 0.33-0.62). During this period, the percentages of visits to primary care physicians that included prescriptions for antidepressants (interaction P = .0001), antipsychotics (interaction P = .03), and anxiolytics/hypnotics (interaction P = .0009) increased significantly faster than the corresponding percentages of visits to psychiatrists. A similar pattern occurred for visits that resulted in a bipolar disorder diagnosis (interaction P = .01). Conclusions In recent years, office-based primary care physicians have significantly increased their involvement in providing mental health care. These trends underscore the importance of collaboration between primary care physicians and psychiatrists to help ensure provision of high quality outpatient mental health care.

Scope and Outcomes of Surrogate Decision Making Among Hospitalized Older Adults

Abstract: Importance Hospitalized older adults often lack decisional capacity, but outside of the intensive care unit and end-of-life care settings, little is known about the frequency of decision making by family members or other surrogates or its implications for hospital care. Objective To describe the scope of surrogate decision making, the hospital course, and outcomes for older adults. Design, Setting, and Participants Prospective, observational study conducted in medicine and medical intensive care unit services of 2 hospitals in 1 Midwestern city in 1083 hospitalized older adults identified by their physicians as requiring major medical decisions. Main Outcomes and Measures Clinical characteristics, hospital outcomes, nature of major medical decisions, and surrogate involvement. Results According to physician reports, at 48 hours of hospitalization, 47.4% (95% CI, 44.4%-50.4%) of older adults required at least some surrogate involvement, including 23.0% (20.6%-25.6%) with all decisions made by a surrogate. Among patients who required a surrogate for at least 1 decision within 48 hours, 57.2% required decisions about life-sustaining care (mostly addressing code status), 48.6% about procedures and operations, and 46.9% about discharge planning. Patients who needed a surrogate experienced a more complex hospital course with greater use of ventilators (2.5% of patients who made decisions and 13.2% of patients who required any surrogate decisions; P P P P P Conclusions and Relevance Surrogate decision making occurs for nearly half of hospitalized older adults and includes both complete decision making by the surrogate and joint decision making by the patient and surrogate. Surrogates commonly face a broad range of decisions in the intensive care unit and the hospital ward setting. Hospital functions should be redesigned to account for the large and growing role of surrogates, supporting them as they make health care decisions.

Effect of Collaborative Care for Depression on Risk of Cardiovascular Events: Data from the IMPACT Randomized Controlled Trial

Abstract: ObjectiveAlthough depression is a risk and prognostic factor for cardiovascular disease (CVD), depression trials involving cardiac patients have not observed the anticipated cardiovascular benefits. To test our hypothesis that depression treatment delivered before clinical CVD onset reduces risk of

Effect of collaborative care for depression on risk of cardiovascular events: data from the IMPACT randomized controlled trial

Abstract: ObjectiveAlthough depression is a risk and prognostic factor for cardiovascular disease (CVD), depression trials involving cardiac patients have not observed the anticipated cardiovascular benefits. To test our hypothesis that depression treatment delivered before clinical CVD onset reduces risk of

A Practical and Evidence-Based Approach to Common Symptoms: A Narrative Review

Abstract: Physical symptoms account for more than half of all outpatient visits, yet the predominant disease-focused model of care is inadequate for many of these symptom-prompted encounters. Moreover, the amount of clinician training dedicated to understanding, evaluating, and managing common symptoms is disproportionally small relative to their prevalence, impairment, and health care costs. This narrative review regarding physical symptoms addresses 4 common epidemiologic questions: cause, diagnosis, prognosis, and therapy. Important findings include the following: First, at least one third of common symptoms do not have a clear-cut, disease-based explanation (5 studies in primary care, 1 in specialty clinics, and 2 in the general population). Second, the history and physical examination alone contribute 73% to 94% of the diagnostic information, with costly testing and procedures contributing much less (5 studies of multiple types of symptoms and 4 of specific symptoms). Third, physical and psychological symptoms commonly co-occur, making a dualistic approach impractical. Fourth, because most patients have multiple symptoms rather than a single symptom, focusing on 1 symptom and ignoring the others is unwise. Fifth, symptoms improve in weeks to several months in most patients but become chronic or recur in 20% to 25%. Sixth, serious causes that are not apparent after initial evaluation seldom emerge during long-term follow-up. Seventh, certain pharmacologic and behavioral treatments are effective across multiple types of symptoms. Eighth, measuring treatment response with valid scales can be helpful. Finally, communication has therapeutic value, including providing an explanation and probable prognosis without "normalizing" the symptom.

A randomized trial exploring the effect of a telephone call follow-up on care plan compliance among older adults discharged home from the emergency department.

Abstract: Objectives Older patients discharged from the emergency department (ED) have difficulty comprehending discharge plans and are at high risk of adverse outcomes. The authors investigated whether a postdischarge telephone call–mediated intervention by a nurse would improve discharge care plan adherence, specifically by expediting post–ED visit physician follow-up appointments and/or compliance with medication changes. The second objectives were to determine if this telephone call intervention would reduce return ED visits and/or hospitalizations within 35 days of the index ED visit and to determine potential cost savings of this intervention. Methods This was a 10-week randomized, controlled trial among patients aged 65 and older discharged to home from an academic ED. At 1 to 3 days after each patient's index ED visit, a trained nurse called intervention group patients to review discharge instructions and assist with discharge plan compliance; placebo call group patients received a patient satisfaction survey call, while the control group patients were not called. Data collection calls occurred at 5 to 8 days and 30 to 35 days after the index ED visits for all three groups. Chi-square or Fisher's exact tests were performed for categorical data and the Kruskal-Wallis test examined group differences in time to follow-up. Results A total of 120 patients completed the study. Patients were 60% female and 72% white, with a mean age of 75 years (standard deviation [SD] ± 7.58 years). Intervention patients were more likely to follow up with medical providers within 5 days of their ED visits than either the placebo or the control group patients (54, 20, and 37%, respectively; p = 0.04). All groups performed well in medication acquisition and comprehension of medication indications and dosage. There were no differences in return visits to the ED or hospital within 35 days of the index ED visit for intervention patients, compared to placebo or control group patients (22, 33, and 27%, respectively; p = 0.41). An economic analysis showed an estimated 70% chance that this intervention would reduce total costs. Conclusions Telephone call follow-up of older patients discharged from the ED resulted in expedited follow-up for patients with their primary care physicians. Further study is warranted to determine if these results translate into improved patient outcomes, decreased return ED visits or hospital admissions, and cost savings resulting from this intervention.

Redesigning Systems Of Care For Older Adults With Alzheimer’s Disease

Abstract: Best-practice models of dementia care have evolved from strategies focused on family caregivers to guidelines predicated on supporting the patient-caregiver dyad along the care continuum. These models have grown in complexity to encompass medical and team-based care that is designed to coordinate dementia care across settings and providers for a defined population of patients. Although there is evidence that the models can improve outcomes, they have not been widely adopted. Barriers to the models’ increased adoption include workforce limitations, the cost of necessary practice redesign, and limited evidence of their potential cost-effectiveness. We summarize the origins, evidence base, and common components of best-practice models of dementia care, and we discuss barriers to their implementation. We conclude by describing two current efforts to implement such models on a broad scale, supported by the Center for Medicare and Medicaid Innovation. Taken together, these models seek to demonstrate improved de...

Vaccine Message Framing and Parents’ Intent to Immunize Their Infants for MMR

Abstract: BACKGROUND AND OBJECTIVE: Emphasizing societal benefits of vaccines has been linked to increased vaccination intentions in adults. It is unclear if this pattern holds for parents deciding whether to vaccinate their children. The objective was to determine whether emphasizing the benefits of measles-mumps-rubella (MMR) vaccination directly to the vaccine recipient or to society differentially impacts parents9 vaccine intentions for their infants. METHODS: In a national online survey, parents ( N = 802) of infants RESULTS: Compared with the VIS-only group (mean intention = 86.3), parents reported increased vaccine intentions for their infants when receiving additional information emphasizing the MMR vaccine’s benefits either directly to the child (mean intention = 91.6, P = .01) or to both the child and society (mean intention = 90.8, P = .03). Emphasizing the MMR vaccine’s benefits only to society did not increase intentions (mean intention = 86.4, P = .97). CONCLUSIONS: We did not see increases in parents’ MMR vaccine intentions for their infants when societal benefits were emphasized without mention of benefits directly to the child. This finding suggests that providers should emphasize benefits directly to the child. Mentioning societal benefits seems to neither add value to, nor interfere with, information highlighting benefits directly to the child.

APOE ε4 and the risk for Alzheimer disease and cognitive decline in African Americans and Yoruba.

Abstract: Background: There is little information on the association of the APOEe4 allele and AD risk in African populations. In previous analyses from the Indianapolis-Ibadan dementia project, we have reported that APOE e4 increased the risk for Alzheimer's disease (AD) in African Americans but not in Yoruba. This study represents a replication of this earlier work using enriched cohorts and extending the analysis to include cognitive decline. Methods: In this longitudinal study of two community dwelling cohorts of elderly Yoruba and African Americans, APOE genotyping was conducted from blood samples taken on or before 2001 (1,871 African Americans & 2,200 Yoruba). Mean follow up time was 8.5 years for African Americans and 8.8 years for Yoruba. The effects of heterozygosity or homozygosity of e4 and of the possession of e4 on time to incident AD and on cognitive decline were determined using Cox's proportional hazards regression and mixed effects models. Results: After adjusting for covariates, one or two copies of the APOE e4 allele were significant risk factors for incident AD (p < 0.0001) and cognitive decline in the African-American population (p < 0001). In the Yoruba, only homozygosity for APOE e4 was a significant risk factor for AD (p = 0.0002) but not for cognitive decline (p = 0.2346), however, possession of an e4 allele was significant for both incident AD (p = 0.0489) and cognitive decline (p = 0.0425). Conclusions: In this large longitudinal comparative study, APOE e4 had a significant, but weaker, effect on incident AD and on cognitive decline in Yoruba than in African Americans. The reasons for these differences remain unclear.

Healthy Aging Brain Center Improved Care Coordination And Produced Net Savings

Abstract: Over the past two decades the collaborative care model within primary care has proved to be effective in improving care quality, efficiency, and outcomes for older adults suffering from dementia and depression. In collaboration with community partners, scientists from Indiana University have implemented this model at the Healthy Aging Brain Center (HABC), a memory care clinic that is part of Eskenazi Health, an integrated safety-net health care system in Indianapolis, Indiana. The HABC generates an annual net cost savings of up to $2,856 per patient, which adds up to millions of dollars for Eskenazi Health’s patients. This article demonstrates the financial sustainability of the care processes implemented in the HABC, as well as the possibility that payers and providers could share savings from the use of the HABC model. If it were implemented nationwide, annual cost savings could be in the billions of dollars.

Mild Cognitive Impairment, Incidence, Progression, and Reversion: Findings from a Community-Based Cohort of Elderly African Americans

Abstract: Objective: To examine the long-term outcomes of community-based elderly African Americans by following their transitions from normal cognition to mild cognitive impairment (MCI) to dementia. Methods: Participants were from the communitybased Indianapolis Dementia Project. A total of 4,104 African Americans were enrolled in 1992 or 2001 and followed until 2009 with regularly scheduled evaluation of cognitive assessment. A two-stage sampling was used at each evaluation to select individuals for extensive clinical assessment following the results of Stage 1 cognitive testing. Age- and gender-specific incidence, progression, and reversion rates for MCI were derived using the person-year method in a dynamic cohort and predicted probabilities from weighted multinomial logistic models of transitional probabilities among normal cognition, MCI, and dementia. Results: Annual overall incidence rate for MCI was 5.6% (95% confidence interval [CI]: 4.6%e6.6%). Annual progression rate from MCI to dementia was 5.9% (95% CI: 5.3%e6.5%), and annual reversion rate from MCI to normal was 18.6% (95% CI: 16.7%e20.4%). Both MCI incidence rates and MCI to dementia progression rates increased with age, whereas reversion rates from MCI to normal decreased with age. Conclusion: MCI progression to dementia was much more frequent in the older age groups than in younger participants where reversion to normal cognition is more common. Future research is needed to determine factors related to the heterogeneous outcomes in MCI individuals. (Am J Geriatr Psychiatry 2014; 22:670e681)

Measuring adherence to antiretroviral therapy in children and adolescents in western Kenya

Abstract: Introduction : High levels of adherence to antiretroviral therapy (ART) are central to HIV management. The objective of this study was to compare multiple measures of adherence and investigate factors associated with adherence among HIV-infected children in western Kenya. Methods : We evaluated ART adherence prospectively for six months among HIV-infected children aged ≤14 years attending a large outpatient HIV clinic in Kenya. Adherence was reported using caregiver report, plasma drug concentrations and Medication Event Monitoring Systems (MEMS ® ). Kappa statistics were used to compare adherence estimates with MEMS ® . Logistic regression analyses were performed to assess the association between child, caregiver and household characteristics with dichotomized adherence (MEMS ® adherence ≥90% vs. <90%) and MEMS ® treatment interruptions of ≥48 hours. Odds ratios (ORs) and 95% confidence intervals (95% CIs) were calculated. Results : Among 191 children, mean age at baseline was 8.2 years and 55% were female. Median adherence by MEMS ® was 96.3% and improved over the course of follow-up ( p <0.01), although 49.5% of children had at least one MEMS ® treatment interruption of ≥48 hours. Adherence estimates were highest by caregiver report, and there was poor agreement between MEMS ® and other adherence measures (Kappa statistics 0.04–0.37). In multivariable logistic regression, only caregiver-reported missed doses in the past 30 days (OR 1.25, 95% CI 1.14–1.39), late doses in the past seven days (OR 1.14, 95% CI 1.05–1.22) and caregiver-reported problems with getting the child to take ART (OR 1.10, 95% CI 1.01–1.20) were significantly associated with dichotomized MEMS ® adherence. The caregivers reporting that ART made the child sick (OR 1.12, 95% CI 1.01–1.25) and reporting difficulties in the community that made giving ART more difficult (e.g. stigma) (OR 1.14, 95% CI 1.02–1.27) were significantly associated with MEMS ® treatment interruptions in multivariable logistic regression. Conclusions : Non-adherence in the form of missed and late doses, treatment interruptions of more than 48 hours and sub-therapeutic drug levels were common in this cohort. Adherence varied significantly by adherence measure, suggesting that additional validation of adherence measures is needed. Few factors were consistently associated with non-adherence or treatment interruptions. Keywords: adherence; paediatric HIV; best practice; resource-limited setting. To access the supplementary material to this article please see Supplementary Files in the column to the right (under Article Tools). (Published: 25 November 2014) Citation: Vreeman RC et al. Journal of the International AIDS Society 2014, 17 :19227 http://www.jiasociety.org/index.php/jias/article/view/19227 | http://dx.doi.org/10.7448/IAS.17.1.19227

Health Outcomes and Cost of Care Among Older Adults with Schizophrenia: A 10-Year Study Using Medical Records Across the Continuum of Care

Abstract: Objectives The population of older patients with schizophrenia is increasing. This study describes health outcomes, utilization, and costs over 10 years in a sample of older patients with schizophrenia compared with older patients without schizophrenia. Methods An observational cohort study of 31,588 older adults (mean age: 70.44 years) receiving care from an urban public health system, including a community mental health center, during 1999–2008. Of these, 1,635 (5.2%) were diagnosed with schizophrenia and 757 (2.4%) had this diagnosis confirmed in the community mental health center. Patients' electronic medical records were merged with Medicare claims, Medicaid claims, the Minimum Dataset, and the Outcome and Assessment Information Set. Information on medication use was not available. Measurements Rates of comorbid conditions, healthcare utilization, costs, and mortality. Results Patients with schizophrenia had significantly higher rates of congestive heart failure (45.05% versus 38.84%), chronic obstructive pulmonary disease (52.71% versus 41.41%), and hypothyroidism (36.72% versus 26.73%) than the patients without schizophrenia (p Conclusions The management of older adult patients with schizophrenia is creating a serious burden for our healthcare system, requiring the development of integrated models of healthcare.

Bridging islands of information to establish an integrated knowledge base of drugs and health outcomes of interest

Abstract: The entire drug safety enterprise has a need to search, retrieve, evaluate, and synthesize scientific evidence more efficiently. This discovery and synthesis process would be greatly accelerated through access to a common framework that brings all relevant information sources together within a standardized structure. This presents an opportunity to establish an open-source community effort to develop a global knowledge base, one that brings together and standardizes all available information for all drugs and all health outcomes of interest (HOIs) from all electronic sources pertinent to drug safety. To make this vision a reality, we have established a workgroup within the Observational Health Data Sciences and Informatics (OHDSI, http://ohdsi.org) collaborative. The workgroup’s mission is to develop an open-source standardized knowledge base for the effects of medical products and an efficient procedure for maintaining and expanding it. The knowledge base will make it simpler for practitioners to access, retrieve, and synthesize evidence so that they can reach a rigorous and accurate assessment of causal relationships between a given drug and HOI. Development of the knowledge base will proceed with the measureable goal of supporting an efficient and thorough evidence-based assessment of the effects of 1,000 active ingredients across 100 HOIs. This non-trivial task will result in a high-quality and generally applicable drug safety knowledge base. It will also yield a reference standard of drug–HOI pairs that will enable more advanced methodological research that empirically evaluates the performance of drug safety analysis methods.

You and me and the computer makes three: variations in exam room use of the electronic health record

Abstract: Challenges persist on how to effectively integrate the electronic health record (EHR) into patient visits and clinical workflow, while maintaining patient-centered care. Our goal was to identify variations in, barriers to, and facilitators of the use of the US Department of Veterans Affairs (VA) EHR in ambulatory care workflow in order better to understand how to integrate the EHR into clinical work. We observed and interviewed 20 ambulatory care providers across three geographically distinct VA medical centers. Analysis revealed several variations in, associated barriers to, and facilitators of EHR use corresponding to different units of analysis: computer interface, team coordination/workflow, and organizational. We discuss our findings in the context of different units of analysis and connect variations in EHR use to various barriers and facilitators. Findings from this study may help inform the design of the next generation of EHRs for the VA and other healthcare systems.

Use of a computerized decision aid for developmental surveillance and screening: a randomized clinical trial

Abstract: Importance Developmental delays and disabilities are common in children. Research has indicated that intervention during the early years of a child's life has a positive effect on cognitive development, social skills and behavior, and subsequent school performance. Objective To determine whether a computerized clinical decision support system is an effective approach to improve standardized developmental surveillance and screening (DSS) within primary care practices. Design, Setting, and Participants In this cluster randomized clinical trial performed in 4 pediatric clinics from June 1, 2010, through December 31, 2012, children younger than 66 months seen for primary care were studied. Interventions We compared surveillance and screening practices after adding a DSS module to an existing computer decision support system. Main Outcomes and Measures The rates at which children were screened for developmental delay. Results Medical records were reviewed for 360 children (180 each in the intervention and control groups) to compare rates of developmental screening at the 9-, 18-, or 30-month well-child care visits. The DSS module led to a significant increase in the percentage of patients screened with a standardized screening tool (85.0% vs 24.4%,P Conclusions and Relevance Using a computerized clinical decision support system to automate the screening of children for developmental delay significantly increased the numbers of children screened at 9, 18, and 30 months of age. It also significantly improved surveillance at other visits. Moreover, it increased the number of children who ultimately were diagnosed as having developmental delay and who were referred for timely services at an earlier age. Trial Registration clinicaltrials.gov Identifier:NCT01351077