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Research Briefs

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Brunner, E.J., Hemingway, H., Walker, B.R., and others (2002, November). "Adrenocortical, autonomic, and inflammatory causes of the metabolic syndrome." (AHRQ grant HS06516). Circulation 106, pp. 2659-2665.

This study provides the first evidence that chronic stress may be a cause of metabolic syndrome, which may be a precursor of coronary disease. The authors conducted a double-blind case-control study of working men aged 45 to 63 years drawn from a study of British government workers. They compared 30 patients with metabolic syndrome (elevated glucose, cholesterol, and blood pressure, and BMI above 26) with 153 healthy controls. The researchers measured several stress indicators and obtained cardiac autonomic activity (CAA) from power spectral analysis of heart rate variability (HRV) recordings. They found that 24-hour cortisol metabolite and normetanephrine outputs were higher among cases than controls. HRV and total power were lower among cases, while serum interleukin-6, plasma C-reactive protein (an indicator of inflammation), and viscosity were higher among cases. Psychosocial factors accounted for 37 percent of the link between metabolic syndrome and normetanephrine output, and 7 percent and 19 percent for CAA. The researchers conclude that neuroendocrine stress axes are activated in metabolic syndrome, but these changes may be reversible.

Califf, R.M., Peterson, E.D., Gibbons, R.J., and others (2002). "Integrating quality into the cycle of therapeutic development." (AHRQ grant HS10548). Journal of the American College of Cardiology 40, pp. 1895-1901.

Debate about the role of evidence-based medicine has raised questions about the value of applying randomized trial results in practice. These authors provide a perspective on this issue by describing a model that integrates quantitative measures of quality and performance into the development cycle of existing and future therapeutics in cardiovascular medicine. The ultimate goal is the best possible patient outcomes. For most cardiovascular problems, survival, freedom from major cardiovascular events such as stroke and heart attack, and improved symptoms are the cornerstones of outcomes measurement. The model uses clinical research networks and practice databases as a convenient mechanism to tie together the quality cycle. After a concept has been developed and undergone basic testing, a network could conduct clinical trials and measure incorporation of the findings (in the form of recommendations) into practice. Multiple practice registries could provide feedback about performance for individual practices while also validating the relation between greater adherence to guidelines and improved patient outcomes in the whole registry.

Ferrie, J.E., Shipley, M.J., Smith, G.D., and others (2002). "Change in health inequalities among British civil servants: The Whitehall II study." (AHRQ grant HS06516). Journal of Epidemiology and Community Health 56, pp. 922-926.

This study of London-based white collar civil servants, 6,895 men and 3,413 women, found little evidence of an increase in socioeconomic differences in disease and cardiovascular risk factors. The researchers screened the employees from 1985 to 1998 for self-rated health, longstanding illness, minor psychiatric problems, cholesterol, blood pressure, body mass index, alcohol intake, and smoking. They also assessed these twice at a mean of 5.3 and 11.1 years. They compared employment grades (an indicator of socioeconomic status) of the workers at each phase. There was little evidence of an increase in inequality for most measures over the 11 years to 1998. However, the gap between those in the lowest employment category and those in the highest category widened considerably for minor psychiatric problems for both sexes and for cholesterol level in men. The increased likelihood of physical illness over time among the lower grade workers may explain the greater psychiatric problems over time.

Fishman, P.A., Goodman, M.J., Hornbrook, M.C., and others (2003). "Risk adjustment using automated ambulatory pharmacy data: The RxRisk model." (AHRQ grant HS11314). Medical Care 41(1), pp. 84-99.

Medical risk assessments are used to adjust capitated health plan payments, as a case-mix adjuster for clinical and health services research, and as a tool for profiling health plans and providers. The Hierarchical Coexisting Conditions (HCCs) and Ambulatory Clinical Groups (ACG) are risk assessment measures based on disease codes available on automated information systems or from claims. These researchers developed an RxRisk model, a risk assessment instrument that classifies prescription drug fills into chronic disease classes in order to predict future health care costs. They compared its ability to predict cost with a demographic-only model and with the ACG and the HCC diagnosis-based risk assessment instruments. Costs were predicted for all individuals enrolled in five HMOs from different U.S. regions. HCCs produced more accurate forecasts of total costs than either RxRisk or ACGs, but RxRisk performed similarly to ACGs. The researchers conclude that the pharmacy-based RxRisk is an alternative risk assessment instrument that, depending on the nature of the application, may be a more appropriate option for medical risk analysis.

Forrest, C.B., Shipman, S.A., Dougherty, D., and Miller, M.R. (2003, January). "Outcomes research in pediatric settings: Recent trends and future directions." Pediatrics 111(1), pp. 171-178.

Pediatric outcomes research examines the effects of health care delivered in everyday medical settings on the health of children and adolescents. It is a rapidly growing area of inquiry that is acquiring breadth, but so far, it has achieved little depth in any single content area, according to this review of the issue. The authors, including AHRQ's Senior Advisor for Child Health, conducted a systematic review of articles published from 1994 to 1999. They found that the number of pediatric outcomes research articles doubled during the 6-year period. Hospitals and primary care practices were the most common service sectors, accounting for more than half of the articles. Common clinical categories included neonatal conditions, asthma, psychosocial problems, and injuries. Remarkably few studies examined the health effects of preventive, diagnostic, long-term management, or curative services delivered to children and adolescents. The authors call for more research to evaluate the effects of services delivered to children and adolescents in everyday settings.

Reprints (AHRQ Publication No. 03-R018) are available from the AHRQ Publications Clearinghouse.

Hays, R.D., Hahn, H., and Marshall, G. (2002, December). "Use of the SF-36 and other health-related quality of life measures to assess persons with disabilities." (AHRQ grant HS08578). Archives of Physical Medicine and Rehabilitation 83, pp. S4-S9.

The authors evaluated the appropriateness of existing approaches to assessing health-related quality of life (HRQOL) for people with disabilities. They compared the conceptual model of HRQOL from the Medical Outcomes Study with the World Health Organization's International Classification of Functioning, Disability and Health. They also examined the attitudes toward disease "burden" that arise from these two models, noting that the importance attached to domains of health can change with fluctuations in physical health. For example, a person who has a disability may still feel healthy, thus distinguishing health from disability. However, this would not be captured in the HRQOL models. The authors note that users of standard HRQOL measures need to be aware of their limitations for assessing people with disabilities. They suggest developing targeted measures for people with disabilities, including aspects such as the discrimination they may encounter.

Hsia, D.C. (2003, January). "Medicare quality improvement: Bad apples or bad systems?" Journal of the American Medical Association 289(3), pp. 354-356.

The current U.S. system of medical discipline assumes that error derives from failure of an incompetent or careless individual, i.e., that adverse events identify bad apples for removal. In contrast, the continuous quality improvement (CQI) model assumes that most adverse events represent system failures, and that design of work processes should detect and eliminate the human error. This is the approach of medical quality improvement organizations (QIOs) led by the Quality Improvement Group at the Centers for Medicare & Medicaid Services, which use 24 quality indicators that have strong evidence to support them. This approach led to an increase from 70 to 73 percent in the proportion of Medicare patients receiving appropriate care between 1999 and 2001, although this rate varied widely across States and by indicator. The QIOs (formerly the peer review organizations) aggregate data at the hospital level. To secure hospitals' cooperation, the QIOs do not publish hospital-level results. Rather, these results guide the QIOs in targeting technical assistance to improve quality.

Reprints (AHRQ Publication No. 03-R016) are available from the AHRQ Publications Clearinghouse.

Kaplan, R.M. (2002, December). "Quality of life: An outcomes perspective." (AHRQ grant HS09170). Archives of Physical Medicine and Rehabilitation 83, pp. S44-S50.

The traditional biomedical model emphasizes disease pathology and treatment. According to this model, the function of health care is to detect problems by identifying pathology. Once identified, treatment is initiated. The outcomes model focuses on the impact of detection and treatment. Often, identification of pathology and subsequent treatment result in improved patient outcomes. However, there may be cases in which identifying disease does not result in better patient outcomes, notes this author. For example, there are many circumstances in which disease, if left undetected, has no impact on life expectancy or quality of life. As a result of this ambiguity, providers and patients must face difficult decisions about which treatments should or should not be initiated. The outcomes model has been widely applied in rehabilitation research. However, few studies in rehabilitation represent outcomes in terms of quality-adjusted life years (QALYs). Use of QALYs could help prioritize demands on limited health care resources and allow for the comparison of rehabilitation in relation to other areas of medicine and health care.

Lin, H.M., Lyles, R.H., and Williamson, J.M. (2002). "Bias in placebo-controlled study due to mismeasurement of disease status and the regression effect." (AHRQ grant HS11452). Controlled Clinical Trials 23, pp. 497-501.

Recruitment criteria for patients enrolled in randomized controlled trials often require a diagnosis of the disease being investigated prior to intervention. When the diagnostic test is subject to uncertainty, the mismeasurement of disease status prior to a medication intervention can create problems in comparing the effectiveness of the medication with placebo, assert these authors. They conclude that additional information on the validity of the diagnostic test is needed in order to provide an accurate portrayal of a treatment's effectiveness.

Longenecker, J.C., Klag, M.J., Marcovina, S.M., and others (2002, November). "Small apolipoprotein(a) size predicts mortality in end-stage renal disease: The CHOICE study." (AHRQ grant HS08365). Circulation 106, pp. 2812-2818.

The contribution of atherosclerotic cardiovascular disease (ASCVD) to the very high mortality in end-stage renal disease (ESRD) has generated interest in non-traditional ASCVD risk factors also prevalent in ESRD, such as lipoprotein(a). This study concludes that small apolipoprotein(a) [apo(a)] size, but not Lp(a) level, independently predicts total mortality risk in dialysis patients. The investigators prospectively followed 864 dialysis patients. They measured Lp(a) by an apo(a) size-independent ELISA test and apo(a) size by Western blot after SDS-agarose gel electrophoresis. They examined time to death and coexisting conditions. They performed survival analyses with adjustment for baseline demographics, comorbid conditions, albumin, and lipids. The median followup was 33.7 months, with 346 deaths, 162 kidney transplants, and 10 losses to followup. Regression analysis showed no association between Lp(a) level and mortality. However, an association was found between small apo(a) isoform size and mortality, after adjusting for other factors.

Machlin S.R., Valluzzi, J.L., Chevarley, F.M., and Thorpe, J.M. (2001). "Measuring ambulatory health care use in the United States: A comparison of 1996 estimates across four federal surveys." Journal of Economic and Social Measurement 27, pp. 57-69.

The U.S. Department of Health and Human Services currently sponsors a number of national surveys that have different primary objectives and methodologies, but all can be used in different ways to produce general estimates of the use of ambulatory care in the Untied States. Among these surveys are the Medical Expenditure Panel Survey (MEPS), the National Health Interview Survey (NHIS), the National Ambulatory Medical Care Survey (NAMCS), and the National Hospital Ambulatory Medical Care Survey (NHAMCS). Through a comparison of 1996 survey estimates, these authors describe important methodological and other technical considerations when using these different data sources for measuring ambulatory care use in office-based and hospital settings.

Reprints (AHRQ Publication No. 03-R020) are available from the AHRQ Publications Clearinghouse.

Editor's Note: Although the cover date of this journal is 2001, it was actually published and received by subscribers in January 2003.

Murphy, N.A. Irwin, M.C., and Hoff, C. (2002, December). "Intrathecal baclofen therapy in children with cerebral palsy: Efficacy and complications." (AHRQ grant HS11825). Archives of Physical Medicine and Rehabilitation 83, pp. 1721-1725.

Spasticity is a hallmark finding in 75 percent of children with cerebral palsy (CP). In some children, spasticity can be beneficial as a system of intrinsic bracing and as a means to support upright positioning and ambulation. In others, it can lead to loss of range of motion, functional impairments, pain, and deformity. The goals of spasmolytic interventions in children with CP must therefore be individualized and may include a combination of interdisciplinary therapies, local and systemic medications, orthopedic and neurosurgical procedures, and most recently, intrathecal baclofen (ITB). These investigators examined the efficacy of implanted ITB delivery systems in 23 children with CP during a 48-month period. The ITB therapy effectively reduced spasticity in children with CP. However, explantation was required in 44 percent of the children, with wound complications as the leading cause in 73 percent. Children of smaller size and younger age, as well as those with gastrostomy tubes and nonambulatory status, were more likely to encounter complications necessitating explantation.

Newgard, C.D., and Lewis, R.J. (2002, December). "The paradox of human subject protection in research: Some thoughts of and experiences with the federal-wide assurance program." (AHRQ National Research Service Award fellowship F32 HS00148). Emergency Medicine 9(12), pp. 1426-1429.

The Office for Human Research Protections (OHRP) of the U.S. Department of Health and Human Services recommends that all federally supported research projects have a Federal-wide Assurance for Protection for Human Subjects (FWA) secured at all participating institutions. These authors point out that they were recently awarded a grant from an HHS agency to validate an out-of-hospital pediatric trauma triage rule for children involved in motor vehicle crashes. Because of the new assurance system, all 29 hospitals receiving study subjects required an FWA. However, only six hospitals (large academic trauma centers) had an FWA in place; the 23 community hospitals did not. Although the authors applaud the streamlining of the FWA, they conclude that until a practical method for ensuring patient protections for research conducted in non-academic settings are devised, there will continue to be a barrier to effective outcomes-based research in the large patient population served by community and smaller private hospitals.

Peleg, M., Tu, S., Bury, J., and others (2003, January). "Comparing computer-interpretable guideline models: A case-study approach." (Joint support from AHRQ, the National Library of Medicine, and Department of the Army). Journal of the American Medical Informatics Association 10, pp. 52-68.

Many groups are developing computer-interpretable clinical guidelines (CIGs) for use during clinical encounters. CIGs use Task-Network Models for representation but differ in their approaches to addressing particular modeling challenges. These authors compared six models: Asbru, EON, GLIF, GUIDE, PRODIGY, and PROforma, according to eight components that capture the structure of CIGs. The components enable modelers to encode guidelines as plans that organize decision and action tasks in networks. They also enable the encoded guidelines to be linked with patient data, a key requirement for enabling patient-specific decision support. The researchers found agreement among the models on many guideline components that the CIG community could adopt as standards: plan organizations, expression language, conceptual medical record model, medical concept model, and data abstractions. Differences were most apparent in underlying decision models, goal representation, use of scenarios, and structured medical actions.

Radwin, L., and Fawcett, J. (2002). "A conceptual model-based programme of nursing research: Retrospective and prospective applications." (AHRQ grant K08 HS11625). Journal of Advanced Nursing 30(3), pp. 355-360.

A conceptual model implicitly or explicitly guides research. Some researchers identify the conceptual model prior to conducting their studies. Other researchers may eventually come upon a conceptual model that provides a context for the research already completed and direction for future studies. These authors explain how collaboration with a theoretician enabled them to find a conceptual model that provided a frame of reference to past, present, and future studies. Further, the model allows the studies, previously considered to be disparate, to be viewed as a more coherent program of research.

Sambamoorthi, U., Olfson, M., Walkup, J.T., and Crystal, S. (2002, January). "Diffusion of new generation antidepressant treatment among elderly diagnosed with depression." (AHRQ grants HS11825, HS9566). Medical Care 41(1), pp. 180-194.

In 1997, nearly two-thirds of the 1.1 million community-dwelling elderly Medicare beneficiaries with depression were treated with antidepressants. Among those treated with antidepressants, the use of new-generation antidepressants, such as selective serotonin reuptake inhibitors (SSRIs), increased from 35 percent in 1992 to 77 percent in 1997. These new-generation antidepressants are more costly, but have fewer side effects, than earlier drugs. The researchers analyzed the use of new generation antidepressants from 1992 to 1997 among depressed elderly Medicare patients using survey data, Medicare fee-for-service claims, and detailed self-reports from the Medicare Current Beneficiary Survey. They found that from 1992 to 1994, when SSRIs were being introduced, 63 percent of college-educated elderly were treated with new generation antidepressants compared with 47 percent of those with a high school education. Also, 42 percent of low-income elderly people compared with 54 percent of those with incomes above 200 percent of Federal poverty guidelines were treated with new generation antidepressants over the same period. These differences disappeared by the end of 1997. The findings agree with other studies which show that early users of new treatments, especially costly ones, are likely to disproportionately represent those of higher socioeconomic status.

Solomon, M.D., Lee, P.P., Mangione, C.M., and others (2002, December). "Characteristics of eye care practices with managed care contracts." (AHRQ grant HS09942). American Journal of Managed Care 8(12), pp. 1057-1067.

Managed care has influenced the organization, financing, and delivery of health care for nearly every medical specialty. To examine the variation in practice structure, financial structure, and utilization and quality management systems for eye care practices with managed care contracts, these researchers surveyed 88 group and 56 solo eye care practices that contracted with six health plans affiliated with a national managed care organization. They found that few practices bore substantial financial risk, and nearly all practices used quality management tools that could help improve the quality of care. For example, fee-for-service payments were the primary source of group practice revenue, although 60 percent of groups derived some revenues from capitation payments. Group practices paid their physicians almost exclusively with fee-for-service payments or salary arrangements. Most practices received practice profiles and three-fourths were subject to utilization review, which mainly consisted of preauthorization for procedures, tests, or referrals. The majority of practices used clinical guidelines, protocols, or pathways. Nearly all group practices used computerized information systems to assist in delivering care, and most had provider education programs.

Tsai, A.C., Lurie, P., and Sehgal, A.R. (2002, October). "An outbreak of Web sites selling ciprofloxacin following an outbreak of anthrax by mail." (NRSA training grant T32 HS00059). American Journal of Medicine 113, pp. 424-427.

The Centers for Disease Control and Prevention reported the first case of an anthrax outbreak transmitted by mail on October 4, 2001. At the time, ciprofloxacin was the only FDA-approved agent to prevent anthrax infection after exposure. Following the reported outbreak, at least 59 Web sites sold ciprofloxacin without prescription, 23 of these Web sites were created within 2 weeks after the anthrax outbreak was reported. These researchers used 11 Internet search engines to identify English-language Web sites that sold any generic or branded form of ciprofloxacin without requiring buyers to mail or fax written prescriptions from their physicians. Of the 59 Web sites identified, none were certified by the Verified Internet Pharmacy Practice Sites program. Only 51 percent of the sites sold other medications in addition to ciprofloxacin; only 37 percent provided a telephone number for customers with questions; 29 percent displayed no information about potential adverse drug effects; and 27 percent did not mention contraindicated use in patients with a history of hypersensitivity to quinolone antibiotics like ciprofloxacin. In addition, 19 percent did not require the customer to fill out a medical questionnaire for purchase, and 14 percent had false or misleading clinical claims and warnings. Only 68 percent of sites stated that a full dosing course for postexposure anthrax prophylaxis is 60 days; only 12 percent of these sites even sold the 60-day package. The median lowest per-tablet price was $6.95, a 50 percent markup over the U.S. wholesale price at the time of $4.67. By September 10, 2002 only 13 sites were still selling ciprofloxacin.

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Current as of March 2003
AHRQ Publication No. 03-0024

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