Research Activities October 2011, No. 374
Alexander, G.C. (2011). "Enhancing prescription drug innovation and adoption." (AHRQ grant HS18960). Annals of Internal Medicine 154, pp. 833-837.
Newly released and branded therapies continue to be adopted in clinical practice without evidence of their comparative effectiveness or superior safety. The authors propose five mechanisms to address these problems: increasing the threshold of evidence required for approval; moving to a period of conditional approval; altering incentives to encourage value-added innovation; changing drug labeling to better inform patients and physicians; and modifying the structure of drug reimbursement by health care providers.
Braithwaite, S.A., Pines, J.M., Asplin, B.R., and Epstein, S.K. (2011). "Enhancing systems to improve the management of acute, unscheduled care." (AHRQ grant HS18114). Academic Emergency Medicine 18, pp. e39-e44.
Neither the emergency department nor primary care environments have adequate capacity to handle the entire volume of acute unscheduled care. The authors propose a research agenda to explore the advantages and disadvantages of each of these settings, offering guidance to policymakers in determining the optimum settings for acute, unscheduled care.
Brown, J.R., and Thompson, C.A. (2011). "Contrast-induced acute kidney injury: The at-risk patient and protective measures."(AHRQ grant HS18443). Current Cardiology Report 12, p. 440-445.
Contrast-induced acute kidney injury (CI-AKI) is a major complication following cardiac catheterization, percutaneous coronary intervention, and other procedures using radiocontrast dye. The authors recommend that clinicians pay attention to preventing this problem via mandatory standing orders before and after cardiac catheterization for hydration with normal saline or sodium bicarbonate and use of high-dose (1200 mg) N-acetylcysteine. They also recommend minimizing the volume of contrast dye used for each patient.
Clancy, C.M. (2011). "New research highlights the role of patient safety culture and safer care." Journal of Nursing Care Quality 26(3), pp. 193-196. Reprints (AHRQ Publication No. 11-R070) are available from the AHRQ Publications Clearinghouse.
Assessing an organization's patient safety culture remains a critical first step for health care organizations of all sizes. Organizations such as the Agency for Healthcare Research and Quality and Johns Hopkins University have led the field in developing surveys that help organizations measure their patient safety culture. Other related efforts include the Keystone Project to reduce central line-associated bloodstream infections and the comprehensive unit-based safety program that works with providers to improve safety.
Devine, E.B., Patel, R., Dixon, D.R., and Sullivan, S.D. (2011). "Assessing attitudes toward electronic prescribing adoption in primary care: A survey of prescribers and staff." (AHRQ grants HS15319, HS14739). Informatics in Primary Care 18, pp. 177-187.
The researchers used a brief survey instrument, based on theoretical constructs, that assesses attitudes toward adoption of electronic health records and e-prescribing, which may be useful in informing strategies for successful adoption. The 37-item survey covered four areas (finesse, intent to use, perceived usefulness, and perceived ease of use) and was completed by 59 prescribers and 50 staff. It found that computer use at home for professional purposes and self-assessed computer knowledge were associated with more positive adoption attitudes.
Dusetzina, S.B., and Alexander, G.C. (2011). "Drug vs. class-specific black box warnings: Does one bad drug spoil the bunch?" (AHRQ grant HS189960). Journal of General Internal Medicine 26(6), pp. 570-572.
The authors draw on a study published in the same issue that assesses the application of U.S. Food and Drug Administration black box warnings across drugs within the same chemical class. They describe three settings where black box warning information on one or more drugs within a chemical class was absent from other agents within that class. These three cases are used to highlight the importance of considering the clinical context when applying black box warnings to agents within the same chemical class.
Flanagan, M.E., Welsh, C.A., Kiess, C., and others (2011, June). "A national collaborative for reducing health care-associated infections: Current initiatives, challenges, and opportunities." (Contract No. 290-06-000131). American Journal of Infection Control, pp. 1-5.
The authors characterize the current state of hospital-associated infection (HAI) reduction initiatives in 33 hospitals participating in a national HAI collaborative. They describe the types of HAI reduction initiatives and reasons that some hospitals are not implementing HAI initiatives. Improving hand hygiene was the most frequently mentioned HAI reduction initiative implemented in the previous year.
Fleishman, J.A., Selim, A.J., and Kazis, L.E. (2011). "Deriving SF-12v2 physical and mental health summary scores: A comparison of different scoring algorithms." Quality of Life Research 19, pp. 231-241. Reprints (AHRQ Publication No. 11-R071) are available from the AHRQ Publications Clearinghouse.
The researchers examined alternative procedures for deriving the SF-12v2 summary scores using recent, nationally representative U.S. data. Given the controversy regarding methods for constructing summary scores, they compared scores using exploratory factor analysis, principal components analysis, and confirmatory factor analysis, using both orthogonal and oblique rotation. Correlations among summary scores derived using different methods were high.
Funk, M.J., Westreich, D., Wiesen, C., and others (2011). "Doubly robust estimation of causal effects." (AHRQ grant HS17950). American Journal of Epidemiology 173(7), pp. 761-767.
Doubly robust estimation combines two approaches to estimating the causal effect of an exposure or treatment on an outcome. The authors present a conceptual overview of doubly robust estimation, sample calculations for a simple example, and results from a simulation study examining performance of model-based and bootstrapped confidence intervals. They also discuss the potential advantages and limitations of this estimation method.
Garman, A.N., McAlearney, A.S., Harrison, M.I., and others (2011). "High-performance work systems in health care management, part 1: Development of an evidence-informed model." Health Care Management Review 36(3), pp. 201-213. Reprints (AHRQ Publication No. 11-R065) are available from the AHRQ Publications Clearinghouse.
High-performance work practices (HPWPs) can be defined as a set of practices within an organization that enhance organizational outcomes by improving the quality and effectiveness of employee performance. The authors examined the potential of HPWPs to support these objectives in health care settings. They developed a conceptual model showing how HPWPs are hypothesized to relate to one another as a set of related practices and how this set of practices facilitates achievement of organizational quality and efficiency.
Greene, J.A. and Kesselheim, A.S. (2011). "Why do the same drugs look different? Pills, trade dress, and public health." (AHRQ grant HS18465). New England Journal of Medicine 365(1), pp. 83-89.
Consumers of generic drugs who refill a prescription for the same drug must be prepared to receive pills of a different size, color, and shape, depending on which manufacturer is supplying their pharmacies. The authors review the legal basis of trade dress as it has applied to pharmaceutical products, and consider the public health implications of variations in pill appearance. They discuss how a system of more uniform drug appearance could be designed to reduce medical error and promote patient adherence.
Handel, D.A., Wears, R.L., Nathanson, L.A., and Pines, J.M. (2011). "Using information technology to improve the quality and safety of emergency care." (AHRQ grant HS18114). Academic Emergency Medicine 18, pp. e45-e51.
One of the groups participating in the American College of Emergency Physicians conference on improving emergency care recently issued this paper on the impact of information technology on emergency care. The paper provides an overview of issues related to electronic health records and the quality of emergency department (ED) care. The group also proposes a research agenda addressing the following areas: interoperability, patient flow and work integration, patient handoffs, safety-critical computing, and technology-health care interactions.
Hanlon, J.T., Sloane, R.J., Pieper, C.F., and Schmader, K.E. (2011, March). "Association of adverse drug reactions with drug-drug and drug-disease interactions in frail older outpatients." (AHRQ grant HS18721). Age and Ageing 40(2), pp. 274-275.
The objective of this study was to determine whether incorrect dosage, incorrect directions, drug-drug interactions, and drug-disease interactions, as measured by the medication appropriateness index (MAI), are associated with the Type A adverse drug reactions (ADRs) among frail older veterans moving from the hospital to the community. Neither dosage nor medication direction problems were significantly associated with Type A ADRs, but there was some evidence that drug-drug interactions and drug-disease interactions were separately associated with Type A ADRs.
Hornbrook, M.C., and Holup, J. (2011). "Insurance coverage for erectile dysfunction drugs." (AHRQ grant HS16963). Clinical Pharmacology and Therapeutics 89(1), pp. 19-21.
Erectile dysfunction (ED) prevalence exceeds the rate of treatment seeking for ED. In addition, health plans that cover ED drugs have developed successful approaches to control budgetary impact. The authors argue that to address coverage disparities, ED prescriptions should be covered by all public and private payers when indicated to maintain, restore, or compensate for function loss caused by disease, injury, or medical treatment.
Kappagoda, S., Singh, U., and Blackburn, B.G. (2011). "Antiparasitic therapy." (AHRQ grant T32 HS00028). Mayo Clinic Proceedings 86(6), pp. 561-583.
Parasitic diseases cause substantial morbidity and mortality worldwide. This article reviews the treatment of the major protozoan and helminth infections in humans. It focuses on clinical presentations of protozoan and helminth infections in humans, appropriate treatment for these infections, and adverse effects of antiparasitic therapies. There have been significant improvements in the treatment of these infections in the last two decades.
Kesselheim, A.S., Myers, J.A., and Avorn, J. (2011). "Characteristics of clinical trials to support approval of orphan vs. nonorphan drugs for cancer." (AHRQ grant HS18464). Journal of the American Medical Association 305(22), pp. 2320-2326.
Concerns have been raised about the safety and efficacy of some approved orphan drugs for rare diseases. This review of new cancer drug approvals from 2004 to 2010 found that the FDA approved alternative trial designs that allowed most orphan cancer drugs to be approved on the basis of single-group, nonrandomized trials enrolling relatively small groups of patients. These trials were usually unblended and relied on surrogate markers of disease response to measure efficacy.
Krist, A.H. and Woolf, S.H. (2011, January). "A vision for patient-centered health information systems." (AHRQ grants HS17046 and HS18811 and Contract No. 290-07-100113). Journal of the American Medical Association 305(3), pp. 300-301.
Personal health records can be far more refined and more appealing to patients than they are at present, note these authors. They identify five distinct levels of functionality that could be incorporated into an electronic personal health record: collecting patient information, integrating patient information, interpreting clinical information, providing individualized clinical recommendations, and facilitating informed patient action. They suggest that a new generation of systems could be designed to serve patient needs at all five levels of functionality.
Lautenbach, E., Lee, I., and Shiley, K.T. (2011, January). "Treating viral respiratory tract infections with antibiotics in hospitals: No longer a case of mistaken identity." (AHRQ grant HS10399). Leonard Davis Institute Issue Brief 16(3), pp. 1-4.
Despite calls to prescribe antibiotics judiciously, many physicians continue to order antibiotics for inpatients who do not need them. This paper investigates antibiotic use in hospitalized adults with a confirmed viral infection—a group of patients that may not benefit from such therapy. Understanding the factors that lead to inappropriate antibiotic use may help change clinical practice and limit antibiotic resistance.
Lawrence, W. (2011). "Starting the conversation." Pharmacoepidemiology and Drug Safety 20, pp. 807-809. Reprints (AHRQ Publication No. 11-R072) are available from the AHRQ Publications Clearinghouse.
This commentary discusses a paper that summarizes the deliberations of a panel of experts convened to discuss a core curriculum in comparative effectiveness research (CER) for researchers and decisionmakers. The author believes that it represents an important start in helping to define the future training needs of new generations of researchers interested in CER for pharmaceuticals.
Lipitz-Snyderman, A., Needham, D.M., Colantuoni, E., and others (2011, May). "The ability of intensive care units to maintain zero central line-associated bloodstream infections." (AHRQ grant HS14246). Archives of Internal Medicine 171(9), pp. 856-858.
The objective of this study was to explore and quantify the ability of intensive care units (ICUs) to sustain zero central line-associated bloodstream infections (CLABSIs). Among the 80 ICUs in the Michigan Keystone ICU Project, sixty percent sustained zero CLABSIs for 12 months and 26 percent for 24 months or longer.
Litvin, C.B., Nietert, P.J., Wessell, A.M., and others (2011). "Recognition and management of CKD in primary care." (AHRQ grant HS17037). American Journal of Kidney Disease 57(40), pp. 646-647.
In 2002, the National Kidney Foundation issued guidelines for the classification of chronic kidney disease (CKD) based on the estimated glomerular filtration rate (eGFR) and for the management of patients with CKD. In a study of the impact of these guidelines on 120 primary care practices 7 years later, researchers found that more than half of patients with a low eGFR had been prescribed an angiotensin converting enzyme inhibitor, angiotensin receptor blocker, or lipid-lowering medication. Yet only a minority of patients met treatment goals for blood-pressure or lipid control.
Lyons, T.W., Wakefield, D.B., and Cloutier, M.M. (2011). "Mold and Alternaria skin test reactivity and asthma in children in Connecticut." (AHRQ grant HS11147). Annals of Allergy, Asthma, and Immunology 106, pp. 301-307.
The researchers examined the relationship among Alternaria skin test reactivity (STR), ethnicity, and asthma severity in a group of 914 ethnically diverse Connecticut children. Their study found that mold and Alternaria STR were uncommon in this group. Alternaria STR was not associated with increasing asthma severity, but was associated with severe, persistent asthma independent of the total number of positive skin test results.
Martinez, E.A., Thompson, D.A., Errett, N.A., and others (2011). "High stakes and high risk: A focused qualitative review of hazards during cardiac surgery." (AHRQ grants HS13904 and HS18762). Anesthesia & Analgesia 112, pp. 1061-1074.
Following a review of the literature to identify and classify types of hazards in cardiac surgery, the researchers selected 55 articles that met the inclusion criteria. Two themes emerged: Studies were predominantly reactive (responding to an event or a report), and minor events were predictive of major problems. Multiple, often minor, deviations from normal procedures caused a cascade effect, ultimately leading to major events.
Mathews, R., Peterson, E.D., Chen, A.Y., and others (2011). "In-hospital major bleeding during ST-elevation and non-ST-elevation myocardial infarction care: Derivation and validation of a model from the ACTION Registry-GWTW." (AHRQ grant HS16964). American Journal of Cardiology 107, pp. 1136-1143.
The researchers developed and validated an in-hospital major bleeding risk model that assesses bleeding risk in the acute myocardial infarction population. Baseline characteristics and in-hospital major bleeding were similar between the derivation cohort (72,313 patients) and the validation (17,960 patients) cohort. The researchers concluded that their model stratifies risk for major bleeding, using variables at patient presentation, and enables risk-adjusted outcomes for quality-improvement initiatives and clinical decision-making.
McAlearney, A.S., Garman, A.N., Song, P.H., and others (2011). "High-performance work systems in health care management, part 2: Qualitative evidence from five case studies." Health Care Management Review 36(3), pp. 214-226. Reprints (AHRQ Publication No. 11-R066) are available from the AHRQ Publications Clearinghouse.
The authors seek to improve their understanding of high-performance work practice (HPWP) use in health care through case studies of five high-performing U.S. health care organizations. All organizations reported emphasis on all four HPWP subsystems: engagement; staff acquisition/development; frontline empowerment; and leadership alignment/development. All five organizations also reported links between HPWPs and employee outcomes (turnover and higher satisfaction/engagement).
McHugh, M.D. (2011). "Hospital nurse staffing and public health emergency preparedness: Implications for policy." (AHRQ grant HS17551). Public Health Nursing 27(5), pp. 442-449.
There are two purposes of this review. The first purpose is to outline the challenges facing hospitals in establishing surge capacity for public health emergencies in the context of a nursing shortage. The second purpose is to highlight the need for a national strategy and identify potential policy approaches to develop a robust nursing workforce supply in support of public health and emergency preparedness.
Pan, D., Huey, S.J., and Hernandez, D. (2011). "Culturally adapted versus standard exposure treatment for phobic Asian Americans: Treatment efficacy, moderators, and predictors." (AHRQ grant HS10870). Cultural Diversity and Ethnic Minority Psychology 17(1), pp. 11-22.
This study compared a standard in-vivo exposure treatment for phobia in Asian Americans with a culturally adapted similar treatment. Asian Americans with low acculturation benefitted more from the culturally adapted treatment with respect to catastrophic thinking and general fear. Both treatments were equally effective for Asian Americans with high acculturation.
Payabvash, S., Souza, L.C.S., Wang, Y., and others (2011). "Regional ischemic vulnerability of the brain to hypoperfusion. The need for location specific computed tomography perfusion thresholds in acute stroke patients." (AHRQ grant HS11392). Stroke 42, pp. 1255-1260.
This study evaluated regional ischemic vulnerability of the brain to decreased blood flow in 90 patients with acute first-ever unilateral stroke. Of the brain areas with infarction (damaged tissue due to lack of oxygen) in this group, the researchers found that the caudate and putamen were highly vulnerable, as were specific cortical areas. These findings support the hypothesis that location-specific thresholds may be more accurate than whole-brain thresholds for estimating the likelihood of infarction with computed tomography perfusion.
Pines, J.M. and Asplin, B.R. (2011). "Conference proceedings—improving the quality and efficiency of emergency care across the continuum: A systems approach." (AHRQ grant HS18114). Academic Emergency Medicine 18, pp. 655-661.
This article describes a 2009 conference held by the American College of Emergency Physicians to discuss critical issues and outline a research agenda. The two main panels discussed systems and workflow redesign to improve health care, and improving care coordination for high-cost patients. Five additional panels developed research agendas on topics ranging from health information technology to end-of-life and palliative care in the emergency department.
Pines, J.M., Asplin, B.R., Kaji, A.H., and others (2011). "Frequent users of emergency department services: Gaps in knowledge and a proposed research agenda." (AHRQ grant HS18114). Academic Emergency Medicine 18, pp. e64-e69.
Frequent use of emergency department (ED) services is often perceived to be a potentially preventable misuse of resources. The authors describe several issues in the epidemiologic study of ED use, identify gaps in knowledge, and propose a four-part research agenda. The agenda ranges from creating an accepted categorization system for frequent users to conducting qualitative studies of frequent ED users.
Polinski, J.M. and Kesselheim, A.S. (2011). "Where cost, medical necessity, and morality meet: Should US government insurance programs pay for erectile dysfunction drugs?" (AHRQ HS18465). Clinical Pharmacology & Therapeutics 89(1), pp. 17-21.
Both cost pressures and moral beliefs have led to calls by some to restrict or ban payment for erectile dysfunction (ED) drugs by Medicaid and Medicare Part D. The authors argue that both cost and medical necessity, but not morality, should be the primary drivers in setting drug coverage determinations.