Research Activities, May 2010: Research Briefs

Research Briefs
Alexander, G. C. (2010, April). "Clinical prescribing (and off-label use) in a second-best world." (AHRQ grant HS15699). Medical Care 48(4), pp. 285-287.

Given the existence of medication overuse, underuse, misuse, adverse effects, and nonadherence, there is no shortage of ways that the use of prescription drugs could be improved. Into this mix, there is important evidence of off-label use, which may represent an important source of clinical innovation, but can also reflect unsupported uses that expose patients to ineffective therapies. The author discusses a study published in the same issue of the journal that examines the case of gabapentin, whose alleged off-label promotion led to a substantial legal settlement. This study focuses on gabapentin use among nonelderly adults with bipolar affective disorder who were enrolled in the Florida Medicaid program. The case of gabapentin highlights the importance of ensuring that off-label uses are rooted soundly in scientific evidence. The author also discusses the role of the FDA in improving the safe use of prescription drugs. He concludes by cautioning that comparative effectiveness research may be necessary, but is far from sufficient to optimize clinical prescribing.

Carr, B. G., Conway, P. H., Meisel, Z. F., and others (2009). "Defining the emergency care sensitive condition: A health policy research agenda in emergency medicine." Annals of Emergency Medicine 20(10), pp. 1-3. Reprints (AHRQ Publication No. 10-R041) are available from the AHRQ Publications Clearinghouse.

The authors define emergency-care-sensitive conditions as those for which rapid diagnosis and early intervention in acute illness or acutely decompensated chronic illness improve patient outcomes. They propose as a first step the identification and cataloging of the universe of emergency-care-sensitive conditions. Next, for those conditions in which systems of care are identified as essential to improving outcomes, multidisciplinary physician partners and administrators must join in bridging traditional barriers to care both within and between institutions. Finally, demonstration projects and outcomes researchers will need to measure the effectiveness of emergency-care- sensitive, condition-specific interventions.

Clancy, C. M. (2010). "Common Formats allow uniform collection and reporting of patient safety data by patient safety organizations." American Journal of Medical Quality 25(1), pp. 73-75. Reprints (AHRQ Publication No. 10-R036) are available from the AHRQ Publications Clearinghouse.

The Agency for Healthcare Research and Quality (AHRQ) recently published evidence-based common definitions and reporting formats (Common Formats) for patient safety work products that will allow Patient Safety Organizations (PSOs), health providers, and other entities to collect and report patient safety events in a uniform manner. The term "Common Formats" describes clinical definitions and reporting formats (for electronic transmission) used by PSOs to uniformly collect and report patient safety data. At present, the focus is on acute care hospitals, but future versions will include other health care settings. Common Formats apply to all patient safety concerns, including incidents that reach the patient (regardless of whether harm occurred), close calls, and unsafe conditions. In order to develop and maintain the Common Formats, AHRQ has convened a Federal patient safety work group including many agencies within the Department of Health and Human Services, notes the author, the director of AHRQ. The release of the Common Formats helps lay the groundwork for providers to report patient safety work products to PSOs that will collect, analyze, and collaborate with organizations to reduce the risk of medical error.

Clancy, C. M. (2010). "The promise and future of comparative effectiveness research." Journal of Nursing Care Quality 25(10), pp. 1-4. Reprints (AHRQ Publication No. 10-R040) are available from the AHRQ Publications Clearinghouse.

Comparative effectiveness research (CER) compares existing interventions to determine which poses the greatest benefits and harms for which patients. The Agency for Healthcare Research and Quality (AHRQ) has been funding CER since 2003, according to the director of AHRQ. The American Recovery and Reinvestment Act of 2009 has allotted an additional $1.6 billion for CER, which will be divided among several components of the Department of Health and Human Services. The future direction of CER will be guided by two reports: Initial National Priorities for Comparative Effectiveness Research, issued by the Institute of Medicine, and a report by the Federal Coordinating Council for CER. AHRQ's Effective Health Care (EHC) Program, initiated by Congress in 2003, offers a useful initial model for CER. Since 2005, the EHC Program has issued more than 45 products, including comparisons of treatments for osteoarthritis of the knee and treatments of clinically localized prostate cancer.

Czeisler, C. A. (2009). "Medical and genetic differences in the adverse impact of sleep loss on performance: Ethical considerations for the medical profession." (AHRQ grants HS12032, HS13333, HS15906, HS14130). Transactions of the American Clinical and Climatological Association 120, pp. 249-285.

The author summarizes much evidence on the adverse impact of sleep loss on performance by medical residents. In particular, he points to evidence that genetic polymorphisms, sleep disorders, and other interindividual differences may convey a vulnerability to the performance-impairing effects of 24 hours of wakefulness. He raises questions about how the work hours of physicians should be limited to optimally protect patient safety. He also discusses various ethical principles that are relevant to the hazards posed by work shifts of 30 consecutive hours. For example, the principle of beneficence requires implementation of safer work schedules that reduce risk. The principle of autonomy requires that physicians respect the right of the patient to be informed of any impairment and to withhold consent to treatment.

De Cordova, P. B., Lucero, R. J., Hyun, S., and others (2010, January/March). "Using the Nursing Interventions Classification as a potential measure of nurse workload." (AHRQ grant HS17423). Journal of Nursing Care Quality 25(1), pp. 39-45.

The Nursing Interventions Classification (NIC) is a comprehensive standardized nursing terminology that has been used to systematically classify nursing care in clinical settings. An advantage of the NIC over other nursing terminology classification systems is its link to SNOMED (Systematized Nomenclature of Medicine), which is a more comprehensive controlled vocabulary for biomedical sciences. This link integrates the NIC with other health care classifications from different disciplines. The researchers conducted an exploratory descriptive study to ascertain the utility of the NIC terminology to classify nursing care interventions of a nursing workload measure. Focus groups were used to gather information from RNs who worked on a 42-bed orthopedic surgical unit of a level III urban teaching hospital. The study found that the NIC terminology captured the full scope of work performed by the nurses.

Finch, S. A., Barkin, S. L., Wasserman, R. C., and others (2009, December). "Effects of local institutional review board review on participation in national practice-based research network studies." (AHRQ grant HS10746). Archives of Pediatric Adolescent Medicine 163(120), pp. 1130-1134.

Primary care practice-based research networks (PBRNs) conduct multisite studies addressing community-based practice and are aimed at improving the effectiveness of primary care. PBRN research typically requires that multiple Institutional Review Board (IRB) applications be submitted for local review. Pediatric Research in Office Settings (PROS) is a PBRN organized by the American Academy of Pediatrics. It conducted two national studies, one on child abuse and the other on violence prevention. The researchers queried practices about local IRB rules at PROS enrollment and study recruitment. Practices requiring additional local IRB approval were less likely to participate than those that did not. The researchers suggest that the need for local IRB approval appears to be an impediment to participation in PBRN-based research, may also discourage the inclusion of minority and urban patients, and seems to result in little if any significant change in the research protocols.

George, S., Garth, B., Wohl, A. R., and others (2009). "Sources and types of social support that influence engagement in HIV care among Latinos and African Americans." (AHRQ grant HS14022). Journal of Health Care for the Poor and Underserved 20, pp. 1012-1032.

HIV disease changed from an acute to a chronic disease as a result of the introduction of highly active antiretroviral therapy in the mid-1990s. This increased the importance of HIV disease management requiring regular appointments with medical providers and consistent medication use, which, in turn, imposed substantial lifestyle adjustments on HIV-positive people and their support networks. Social support systems may be formal (professional support organizations) or informal (family, friends). The researchers interviewed 24 HIV-positive adults, including six each of Latinas, black women, black men who have sex with men, and Latino men who have sex with men. Formal networks were more critical for engagement in HIV-specific medical care. Informal networks were crucial for other general subsistence care, such as emotional, household-related, and financial support.

Hansen, R. A., Dusetzina, S. B., Song, L., and others (2009, November/December). "Depression affects adherence measurement but not the effectiveness of an adherence intervention in heart failure patients." (AHRQ grant HS10049). Journal of the American Pharmacists Association 49(6), pp. 760-768.

Patients with congestive heart failure are prescribed one or more medications under current clinical practice guidelines. Among patients with heart failure, depression, which increases nonadherence to medications, is an important predictor of hospital admissions and death. The researchers sought to determine whether depression might influence the effectiveness of a pharmacy-based intervention to improve heart failure management. The intervention involved the pharmacist in counseling and monitoring patients at each dispensing and special written instructions on the prescription bottles. The researchers found that intervention effectiveness did not differ for patients with and without depression. Also, medication adherence as measured electronically was somewhat lower than self-report for both groups of patients.

Kroner, E. L., Hoffmann, R. G., and Brousseau, D. C. (2010, January). "Emergency department reliance: A discriminatory measure of frequent emergency department users." (AHRQ grant HS15482). Pediatrics 125(1), pp. 133-138.

In the past decade, emergency department (ED) visits for children have increased to more than 25 million per year. Many of these visits (between 37 and 60 percent) are for nonurgent care. Emergency department reliance (EDR) is a measure defined as the percentage of all ambulatory health visits that occur in the ED. The researchers sought to show the discriminatory ability of EDR within frequent ED user populations. They analyzed data on 8,823 children collected from the Agency for Healthcare Research and Quality's Medical Expenditure Panel Survey from 2000 to 2002. They found that 10.5 percent of the children within the study population had high EDR. Children (0-2 years) were 26.3 percent of the frequent ED users but only 14.6 percent of those with high EDR. The study demonstrates the ability of the EDR to discriminate within frequent-ED-user populations and provides the first description of EDR across a nationally representative sample of children.

Leape, L., Berwick, D., and Clancy, C. (2009). "Transforming healthcare: A safety imperative." Quality and Safety in Health Care 18, pp. 424-428. Reprints (AHRQ Publication No. 10-R035) are available from the AHRQ Publications Clearinghouse.

Health care remains unsafe despite efforts by public and private organizations that have initiated major programs to develop and implement new safe practices and to train health care workers in patient safety. Too many health care organizations are hierarchical and deficient in mutual respect, teamwork, and transparency, note the authors. The Lucian Leape Institute, established by the U.S. National Patient Safety Foundation to provide vision and strategic direction for patient safety work, has identified five concepts fundamental to meaningful improvement in health care system safety: transparency, integrated care platform, consumer engagement, joy and meaning in work, and medical education reform. The authors outline all five concepts and conclude by calling for leaders to view their organizations not as industrial models, but as composed of people with the skills and energy to perform meaningful work.

Lin, H., Liu, D., and Zhou, X-H. (2009). "A correlated random-effects model for normal longitudinal data with nonignorable missingness." (AHRQ grant HS13105). Statistics in Medicine 29, pp. 236-247.

The missing data problem is common in longitudinal or repeated measurements data. The authors focus on normal longitudinal data or cluster data when the missingness mechanism is nonignorable. The missing pattern could be either monotone or nonmonotone. They develop a correlated random-effects model to fit the normal longitudinal or cluster data with nonignorable missingness. By transforming the integral in the likelihood function into a conditional expectation, an accurate approximation of the likelihood function that has a closed form was obtained. The simulations showed that their approximation was accurate, but with minimal computational burden. The estimates and inferences based on the approximate likelihood function were also reliable.

MacPherson, D. W., Gushulak, B. D., Baine, W. B., and others (2009, November). "Population mobility, globalization, and antimicrobial drug resistance." Emerging Infectious Diseases 15(11), pp. 1727-1732. Reprints (AHRQ Publication No. 10-R039) are available from the AHRQ Publications Clearinghouse.

Human mobility is causing an increase in antimicrobial drug-resistant organisms and drug-resistant infectious diseases. Each year 2 billion persons move across large geographic distances, with half of those crossing international boundaries. Recent descriptions of primary community-associated methicillin-resistant Staphylococcus aureus (MRSA) infections causing death have raised concerns about the control and management of this and other organisms that humans can asymptomatically carry and transmit from zones of high to low prevalence. The volume, rapidity, and complexity of international movements exceed current international disease control practices. To deal with this problem, the authors propose greater international collaboration and standardization in the following areas: prescriber education and training; infection control training, certification, and practice; active and passive surveillance systems; and engagement of process and regulatory tools such as good manufacturing practices and quality systems for medical devices and pharmaceuticals.

Min, L., Yoon, W., Mariano, J., and others (2009, November). "The Vulnerable Elders-13 Survey predicts 5-year functional decline and mortality outcomes in older ambulatory care patients." (AHRQ grant HS17621). Journal of the American Geriatric Association 57(11), pp. 2070-2076.

Several screening tools have been designed to target older populations at risk for functional decline and death. The Vulnerable Elders-13 Survey (VES-13) is a short tool that predicts functional decline over a 1- to 2-year followup interval. The researchers sought to determine its usefulness in predicting functional decline and death over an observation time of 5 years in older ambulatory patients with common geriatric conditions. Higher VES-13 scores were associated with greater predicted probability of death and decline in older patients over a mean observation time of 4.5 years. There was a linear relationship between increasing scores on the VES-13 and the odds of death and functional decline. The VES-13 was found to be an excellent predictor of health outcomes over a 5-year period. This finding greatly expands the clinical utility of the tool.

Resnik, L., Plow, M., and Jette, A. (2009). "Development of CRIS: Measure of community reintegration of injured service members." (AHRQ grant T32 HS00011). Journal of Rehabilitation Research & Development 46(4), pp. 469-480.

Community reintegration is especially challenging for injured veterans because it may be complicated by the co-occurrence of physical injuries with postwar adjustment difficulties, such as posttraumatic stress disorder, depression, substance abuse, and severe mental illness. The researchers developed and tested a new measure of community reintegration of injured service members: the Community Reintegration for Service Members (CRIS) measure. They found that the CRIS instrument was a comprehensive measure with conceptual integrity, excellent reliability, strong content, and construct, convergent, and discriminant validity. The researchers believe that use of the CRIS would provide a method for comprehensive, standardized assessment and monitoring of community reintegration outcomes of vulnerable veterans of the Iraq and Afghanistan wars.

Silverman, M., LaPerriere, K., and Haukoos, J. S. (2009, November). "Rapid HIV testing in an urban emergency department: Using social workers to affect risk behaviors and overcome barriers." (AHRQ grant HS17256). Health & Social Work 34(4), pp. 305-308.

The authors describe how the emergency department (ED) of a large urban inner-city teaching hospital provides rapid HIV testing with particular emphasis on the role of social workers in HIV prevention and crisis counseling. EDs are often the only medical setting available to target often marginalized patients at increased risk of harboring unrecognized HIV infection, identify those who are infected, and link them into ongoing care. After referral of a patient by a physician, the social worker obtains informed consent, performs pretest counseling, and provides referrals to medical and preventive care as needed. For patients who test positive, the social worker provides posttest counseling, which consists of intensive crisis counseling, emotional support, and further education about HIV infection. The social worker then coordinates referrals for medical and preventive care and ensures that the patient receives appropriate followup from outside agencies.

Tsalik, E. L., Woods, C. W. (2009). "Sepsis redefined: The search for surrogate markers." (AHRQ grant T32 HS00079). International Journal of Microbial Agents 34S, pp. S16-S20.

Sepsis is a blood infection due to an infectious agent that may be bacterial, viral, fungal, or parasitic. Much effort has been invested in the identification of a sepsis biomarker to aid the clinical diagnosis and management of sepsis. The authors discuss a small sample of current sepsis biomarkers, but state that the number of available biomarkers, either in clinical use or still being researched, is vast. Genomic medicine appears well situated to facilitate the rapid identification of etiological organisms, but the complex physiology and epidemiology of sepsis have slowed progress. New technologies, such as microarray analysis, have significantly advanced our understanding of sepsis biology. Research in functional genomics can now identify candidate molecules that can more readily be measured, potentially fulfilling the need for a reliable sepsis biomarker.

Weissman, M. M. and Olfson, M. (2009). "Translating intergenerational research on depression into clinical practice." (AHRQ grant HS16097). Journal of the American Medical Association 302(24), pp. 2695-2696.

Anxiety, depressive, and disruptive behavior disorders are more common in the children of depressed than nondepressed parents. Three recent studies suggest clinical opportunities for reducing the intergenerational transmission of depression. Two of these studies found that treating depressed mothers reduced depressive symptoms in their children. The third study used group cognitive behavioral therapy to prevent high-risk adolescents from developing depression. The authors believe that there are serious deficits in the training, skill, and competence of health care professionals in managing adult depression and related child psychiatric disorders. Pediatricians are well positioned to follow up identification of child mental health problems with assessments of maternal depression. The authors recommend establishing referral networks and close collaborative relationships between pediatricians and adult mental health professionals to ease the transition of depressed parents in specialty mental health care.

Werner, R. M. and Konetzka, R. T. (2010, January). "Advancing nursing home quality through quality improvement itself." (AHRQ grant HS16478). Health Affairs 29(1), pp. 81-96.

Regulation, inspection, and accountability through public reporting have produced only modest results in improving the quality of care in U.S. nursing homes. Instead of focusing on discrete outcomes such as the percentage of residents with pain, pressure sores, infections, or unexplained weight loss, it might be better to incorporate broader measures of quality—such as quality of life—into current market-based initiatives. Instead of being tied simply to quality levels, with little guidance on how to improve performance, incentives should also be tied to efforts to improve quality. Nursing homes must engage in a formal process of quality improvement such as total quality management. This involves collecting and reviewing data on quality of care; assembling multidisciplinary teams to review data and identify areas for improvement; and empowering all employees to both identify quality problems and identify and implement solutions to address them.

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Research Activities, May 2010: Research Briefs