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Ay, H., Arsava, M., Rosand, J., and others (2008, May). "Severity of leukoaraiosis and susceptibility to infarct growth in acute stroke." (AHRQ grant HS11392). Stroke 39, pp. 1409-1413.

Leukoaraiosis (LA) volume at the time of acute ischemic stroke is a predictor of infarct growth, concludes this study. LA is a term used to describe neuroimaging findings of diffuse hemispheric white matter abnormalities mainly characterized by loss of myelin and/or ischemic injury. LA is associated with structural and functional vascular changes that may compromise tissue perfusion at the microvascular level. The authors of this study examined 61 patients with diffusion-weighted imaging-mean transit time mismatch, who were scanned twice within 12 hours of symptom onset and between days 4 and 30. Using a model with percentage mismatch lost as response and LA volume, and other factors, they found that LA volume was an independent predictor of infarct growth. The adjusted mismatch lost in the highest quartile of LA volume was nearly two times greater than the percentage mismatch lost in the lowest quartile.

Bader, J.D., Perrin, N.A., Maupomé, G., and others (2008). "Exploring the contributions of components of caries risk assessment guidelines." (AHRQ grant HS13339). Community Dentistry and Oral Epidemiology 36, pp. 357-362.

This study analyzed data from two dental insurance plans to determine how well a patient's current caries activity (tooth decay), caries experience in the past year (receipt of one or more caries-related restorative, endodontic, or surgical procedures), and their dentist's subjective assessment of the patient's caries risk was able to predict future risk of dental caries. In both plans, current caries activity alone had limited ability to predict who would develop later caries (sensitivity), but was good at identifying who would not develop them (specificity). Adding consideration of previous caries experience improved sensitivity, but at the cost of specificity. Sensitivity further improved when dentists' subjective assessment was included. However, overall accuracy suffered, due to the greater number of false-positives that resulted (prediction of more cavities than developed).

Badrick, E., Bobak, M., Britton, A., and others (2008, March). "The relationship between alcohol consumption and cortisol secretion in an aging cohort." (AHRQ grant HS06516). Journal of Clinical Endocrinology & Metabolism 93(3), pp. 750-757.

This study links alcohol consumption with activation of the hypothalamic-pituitary-adrenal (HPA) axis (elevated cortisol levels), which has been shown to increase blood pressure, impair immune function, and alter metabolism. The researchers examined alcohol consumption and cortisol secretion (based on several daily saliva samples) among 2,693 men and 977 women during the 2002-2004 phase of the Whitehall II study of British civil servants. Among men, there was a 3 percent increase in cortisol per unit of alcohol consumed each week. The slope of cortisol decline during the day in heavy drinkers was reduced, indicating less control of the HPA axis in heavy drinkers. Among women, the cortisol awakening response was greater in heavy than in moderate drinkers. These findings suggest chronic changes of the HPA axis among heavy drinkers.

Calderón, J.L., Fleming, E., Gannon, M.R., and others (2008, April). "Applying an expanded set of cognitive design principles to formatting the Kidney Early Evaluation Program (KEEP) longitudinal survey." (AHRQ grant HS14022). American Journal of Kidney Diseases 51(4, Suppl. 2), pp. S83-S92.

Health survey researchers must apply cognitive design principles to survey development to improve participation and response rates by populations with limited literacy skills, poor health literacy, and limited survey literacy, concludes this study. The researchers assessed the National Kidney Foundation's Kidney Early Evaluation Program (KEEP) followup form for adherence to six cognitive design principles: simplicity, consistency, organization, natural order, clarity, and attractiveness. They also looked at its readability and variation of readability across survey items. The form violated each cognitive design principle and readability principle, possibly contributing to item nonresponse and low followup rates in KEEP. The researchers revised the form to better reflect these principles and found it to be more user-friendly, simpler, better organized, more attractive, and easier to read.

Cooper, W.O., Hernandez-Diaz, S., Gideon, P., and others (2008). "Positive predictive value of computerized records for major congenital malformations." (AHRQ grant HS10384). Pharmacoepidemiology and Drug Safety 17, pp. 455-460.

Depending on the congenital defect affecting an infant, computerized infant and maternal claims data linked to vital records may help identify birth defects in populations of vulnerable persons. However, for many defects, medical record confirmation will probably be required to validate occurrence of the defect. Those are the conclusions of this study drawn from cases from three studies of congenital malformations in the Tennessee Medicaid population. Among 1,430 potential congenital malformations identified from either birth certificates or inpatient claims, more than two-thirds (68 percent) were confirmed by medical record review. The positive predictive value (PPV) varied considerably depending on the data source and the organ system. For example, cardiac defects had a very low PPV when identified from birth certificates, but somewhat higher PPV when identified from inpatient claims. Orofacial defects had a 91 percent PPV from birth certificates and inpatient claims.

Devine, S., West, S.L., Andrews, E., and others (2008). "Validation of neural tube defects in the full featured-General Practice Research Database." (AHRQ grant HS10397). Pharmacoepidemiology and Drug Safety 17, pp. 434-444.

This study found that the General Practice Research Database (GPRD), the world's largest longitudinal patient electronic medical records database, was useful in identifying three of four neural tube defects (anencephaly, encephalocele, and meningocele), but more information was needed to accurately identify cases of spina bifida. The GPRD provides clinical information based on general practitioner records. The authors first created algorithms to identify 217 potential neural tube defect (NTD) cases in either a child's or a mother's record, and validated cases by querying general practitioners via a questionnaire. They validated an NTD diagnosis for 117 cases, for an overall positive predictive value (PPV) of 0.71 (71 percent of cases predicted to have an NTD did). The PPVs varied by NTD type: 0.81 for anencephaly, 0.83 for cephalocele, 0.64 for meningocele, but only 0.47 for spina bifida.

Galliher, J.M., Stewart, T.V., Pathak, P.K., and others (2008). "Data collection outcomes comparing paper forms with PDA forms in an office-based patient survey." (AHRQ grant HS11182). Annals of Family Medicine 6, pp. 154-160.

The collection and management of survey data in office-based clinical research is challenging. According to these authors, handheld computers produce more complete data than the paper method for the returned survey forms. However, they are not superior, because of the large amount of missing data due to technical difficulties with the handheld computers or loss and theft. Other hardware solutions, such as tablet computers or cell phones linked via a wireless network directly to a Web site, may be better electronic solutions for the future, note the researchers. They asked each of 19 medical assistants and nurses in family practices to administer a survey about pneumococcal immunizations to 60 older adults, 30 using paper forms and 30 using electronic forms on handheld computers. They then analyzed the completeness of data obtained by both groups.

Gibbons, R.D., Segawa, E., Karabatsos, G., and others (2008, May). "Mixed-effects Poisson regression analysis of adverse event reports: The relationship between antidepressants and suicide." (AHRQ grant HS16973). Statistics in Medicine 27(11), pp. 1814-1833.

These authors developed a new statistical methodology to analyze postmarketing surveillance data from the Food and Drug Administration's (FDA) Adverse Event Reporting System (AERS) to examine the relationship between antidepressants and suicide. The statistical method involved both empirical Bayes and full Bayes estimation of rate multipliers for each drug within a class of drugs, for a particular adverse event (AE), based on a mixed-effects Poisson regression model. Using this approach, they found that the newer antidepressants (selective serotonin reuptake inhibitors) were associated with lower rates of suicide AE reports compared with older antidepressants. They suggest several improvements to the existing AERS to improve its public health value as an early warning system.

Gorman, J.R., Madlensky, L., Jackson, D.J., and others (2007, December). "Early postpartum breastfeeding and acculturation among Hispanic women." (AHRQ grant HS07161). BIRTH 34(4), pp. 308-315.

The American Academy of Pediatrics recommends exclusive breastfeeding for the first 6 months of life. Although Hispanic and white mothers in the United States have similar breastfeeding rates, more acculturated Hispanic mothers have lower rates of breastfeeding than their less acculturated counterparts. This study went one step further and linked higher acculturation among Hispanic women with lower odds of exclusive postpartum breastfeeding after hospital discharge. The researchers examined medical record data from 1,635 low-income, low-risk women at one birth center. After adjusting for other factors, Hispanic women in the low-acculturation group (who spoke Spanish) were 36 percent more likely and white women were 49 percent more likely to breastfeed exclusively at hospital discharge than Hispanic women in the high-acculturation group (who spoke English).

Hearld, L.R., Alexander, J.A., Fraser, I., and Jiang, H.J. (2008, June). "How do hospital organizational structure and processes affect quality of care?: A critical review of research methods." Medical Care Research and Review 65(3), pp. 259-299.

Interest in the role of organizational factors in the delivery of care has risen in recent years. This article reviews studies that examine the relationship between the structural characteristics and organizational processes of hospitals and quality of care, using Donabedian's structure-process-outcome and level of analysis frameworks. The authors found that most of the studies are conducted at the hospital level of analysis and are typically focused on the organizational structure-quality outcome relationship. They conclude with recommendations of how health services researchers can expand their investigations to better illuminate the understanding of the relationship between organizational characteristics and quality of care.

Reprints (AHRQ publication no. 08-R083) are available from the AHRQ Publications Clearinghouse.

Kao, L.S. and Thomas, E.J. (2008, April). "Navigating towards improved survival safety using aviation-based strategies." (AHRQ grant HS11544). Journal of Surgical Research 145(2), pp. 327-335.

Despite the apparent similarities between surgery and aviation, there are several differences between the two fields that should be considered before universally adopting and instituting aviation-based strategies in health care, concludes this review of studies on the topic. The health care system is more complicated than aviation in terms of the regulatory structure. Surgery and aviation also differ in terms of interpersonal relationships between professionals. Also, a flight is one interval in time, while patient care involves multiple caregivers and locations without clear beginnings and endings. New technologies are developed and incorporated more rapidly in health care than in aviation, resulting in challenges in determining and assessing competency. Finally, people are far more complex than airplanes.

McGowan, J.J., Cusack, C.M., and Poon, E.G. (2008, May-June). "Formative evaluation: A critical component in EHR implementation." (AHRQ Contract No. 290-04-0016). Journal of the American Medical Informatics Association 15(3), pp. 297-301.

This viewpoint paper evolved from a presentation at the American College of Medical Informatics 2007 Winter Symposium, the ensuing discussion, and activities related to implementation of electronic health records (EHR) outside of academia or research institutions. The authors assert that successful EHR implementation is facilitated and sometimes determined by formative evaluation that typically focuses on process rather than outcomes. They note that with more Federal funding to implement EHR systems in health care organizations unfamiliar with research protocols, the need for formative evaluation assistance (in the form of tools and protocols) is growing. It should be provided by practicing medical informaticians.

Neumann, P.J., Palmer, J.A., Daniels, N., and others (2008, April). "A strategic plan for integrating cost-effectiveness analysis into the US healthcare system." (AHRQ Contract No. 290-2005-0006). The American Journal of Managed Care 14(4), pp. 185-188.

This commentary outlines a strategic plan for policymakers to address obstacles and to integrate cost-effectiveness analysis (CEA) into health policy decisions, drawing on stakeholders as part of the solution. The plan was developed by the Panel on Integrating Cost-Effectiveness Considerations into Health Policy Decisions, which is composed of medical and pharmacy directors at public and private health plans. The strategic plan involves a series of activities to advance the use of CEA in the United States. These include research and demonstration projects to illustrate potential gains from using the technique and ongoing consensus-building steps (for example, workshops, conferences, and town meetings) involving a broad coalition of stakeholders. The panel calls for funding and leadership from policymakers and nonprofit foundations, active engagement of legislators and business and consumer groups, and leadership by the Medicare program.

Pierre-Jacques, M., Safran, D.G., Zhang, F., and others (2008, April). "Reliability of new measures of cost-related medication nonadherence." (AHRQ grant HS16955). Medical Care 46(4), pp. 444-448.

The new Medicare prescription drug benefit increases the need for reliable ways to monitor beneficiaries' medication use, spending, and access. Most previous research on this subject had been cross-sectional, so there was no research reporting the test-retest reliability of commonly used measures of cost-related medication nonadherence. These researchers developed a questionnaire to test the reliability of three measures of cost-related medication nonadherence (skipping doses, taking smaller doses, and not filling or delaying refills of prescriptions) and five general cost-reduction strategies for a group of Medicare HMO members in eastern Massachusetts who were surveyed twice (30-60 days apart). The cost reduction strategies were using generic drugs; purchasing drugs via mail, Internet, or from outside the United States; using prescription samples from a physician; sharing medicines with another person; and spending less on other basic needs. The estimated test-retest reliability of the measures of nonadherence was high, and they have been integrated into the Medicare Current Beneficiary Survey. Researchers and policymakers will now be able to identify changes in cost-related nonadherence among Medicare beneficiaries.

Pylypchuk, Y. and Selden, T.M. (2008, July). "A discrete choice decomposition analysis of racial and ethnic differences in children's health insurance coverage." Journal of Health Economics 27(4), pp. 1109-1128.

Children of different racial and ethnic groups vary substantially with respect to health insurance coverage. In order to get a better understanding of how much a given characteristic contributes to coverage differences, these researchers adapted a recently developed matching decomposition method for use with sample-weighted data from the 2004-2005 Medical Expenditure Panel Survey. They also developed a full nonparametric approach that implements decomposition through weight adjustments. Using these approaches, they determined that observable characteristics such as poverty, parent educational level, family structure (for black children), and immigration-related factors (for Hispanic children) account for 70 percent or more of the coverage differences among white, black, and Hispanic children (who have the highest uninsurance rates). The most important immigration-related factor for Hispanic children is the disproportionate prevalence of native-born children with noncitizen parents. These results suggest that the lower coverage levels among ethnic and racial minorities are due to the fact that uninsurance is concentrated among socioeconomically disadvantaged children who happen to be minorities.

Rivera, A.J. and Karsh, B. (2008). "Human factors and systems engineering approach to patient safety for radiotherapy." (AHRQ grant HS13610). International Journal of Radiation Oncology, Biology, and Physics 71 (Supplement 1), pp. S174-S177.

Since the publication of the Institute of Medicine report "To Err is Human," there has been a call to use human factors and systems engineering methods and principles to solve patient safety problems. These authors discuss three tools for better understanding how systems and human factors engineering can be used to improve patient safety. The first is work system analysis, the outcome of which is typically a graphic map depicting the inputs, transform-ations, and outputs of the system under study. The second tool is the Systems Engineering Initiative for Patient Safety (SEIPS) model of work system and patient safety. This model categorizes interactions between the person and the system and identifies interactions that can be improved. The system itself is divided into five main components (person, tools and technologies, organization, physical environment, and tasks). To show processes and outcomes, the SEIPS model integrates the work system model and Donabedian's structure-process-outcome framework. A third tool, developed from the SEIPS model by Karsh, et al., focuses on demonstrating how the structure of the health care system can influence provider performance and patient and provider safety.

Rosen, A.K., Gaba, D.M., Meterko, M., and others (2008, May). "Recruitment of hospitals for a safety climate study: Facilitators and barriers." (AHRQ grant HS13920). The Joint Commission Journal on Quality and Patient Safety 34(5), pp. 275-284.

Little is known about factors affecting hospital participation in hospital safety assessment studies. These researchers studied factors affecting recruitment of 30 Department of Veterans Affairs (VA) hospitals into a study to evaluate perceptions of safety culture. To minimize selection bias, hospitals were recruited that represented the spectrum of safety performance on the basis of scores derived from the Agency for Healthcare Research and Quality's Patient Safety Indicators. Despite attempts to optimize recruitment, it was necessary to contact more than 90 hospitals to obtain a 30-hospital sample. Hospitals with a more entrepreneurial culture (associated with risk-taking, innovation, and quality improvement) were recruited more quickly. Also, hospitals with better safety performance were more likely to be recruited than lower-performing hospitals. The researchers concluded that it was important to recruit representative samples of hospitals based on measures of safety performance rather than just accepting the first hospitals that applied to participate.

Schootman, M., Jeffe, D.B., Gillanders, W.E., and others (2007, May). "The effects of radiotherapy for the treatment of contralateral breast cancer." (AHRQ grant HS14095). Breast Cancer Research Treatment 103, pp. 77-83.

Radiation therapy following breast-conserving surgery (BCS) for primary breast cancer is the widely used standard of care. Although radiation therapy undisputedly reduces the risk of breast cancer recurrence in the first breast, it has only a small overall survival benefit. In contrast, omission of radiation therapy following BCS for a primary cancer that later develops in the second breast, doubles the risk of dying, according to this study. Researchers used population-based data from the 1985-2000 Surveillance, Epidemiology, and End Results program to identify women with stage 0-III cancer that occurred in a second breast at least 6 months after a stage 0-III primary cancer in the first breast. The women's tumors were typically grade I-II, less than 1 cm in size, invasive ductal or lobular cancers, and without lymph node involvement. The researchers compared mortality rates of women aged 40-69 years who did not receive radiation therapy following BCS for the second breast cancer with those who did. Overall, 43 percent of 1,083 women who later developed cancer in the second breast did not receive radiation therapy after BCS. This group of women had 2.2 times greater risk of dying from breast cancer and 1.7 times greater risk of dying from all causes.

Singh-Manoux, A., Britton, A., Kivimaki, M., and others (2008, April). "Socio-economic status moderates the association between carotid intima-media thickness and cognition in midlife: Evidence from the Whitehall II study." (AHRQ grant HS06516). Atherosclerosis 197(2), pp. 541-548.

Cerebrovascular disease has been linked to dementia in older patients and also, to a lesser extent, to reduced cognitive function in middle-aged patients. These researchers, using intima-media thickness (IMT) of the carotid artery as a measure of generalized atherosclerosis, sought to determine how IMT's relationship to cognitive function was affected by socioeconomic status (SES) and whether IMT was more strongly associated with specific aspects of cognitive function. The subject population consisted of 4,112 middle-aged adult British civil servants enrolled in the Whitehall II study. Their cognitive function was assessed with a battery of six standard tasks and SES by civil service grade of employment at baseline. The researchers found that carotid artery IMT in stroke-free middle-aged individuals (average age: 60.9) was associated with reduced cognition only among those with the most socioeconomic disadvantage. IMT in this group was not associated with short-term visual memory or global cognitive status but, after adjustment for prevalent coronary heart disease, vascular, and behavioral risk factors, it was significantly associated with inductive reasoning, vocabulary, and phonemic fluency.

Silenas, R., Akins, R., Parrish, A.R., and Edwards, J.C. (2008, January-March). "Developing disaster preparedness competence: An experiential learning exercise for multiprofessional education." (AHRQ grant HS13715). Teaching and Learning in Medicine 20(1), pp. 62-68.

Concerns about bioterrorism, hurricane disasters, and outbreaks of pandemic infectious diseases compel medical educators to develop emergency preparedness training for medical and other health care professional students. The researchers describe an experiential tabletop exercise for learning general core competencies discussed in the Association of American Medical Colleges 2003 report on "Training Future Physicians about Weapons of Mass Destruction." The 3-hour exercise was preceded by 4 half-days of lectures given to 69 second-year medical students and 20 veterinary students. The scenario involved an emerging zoonotic disease (highly pathogenic avian influenza). The students were expected to develop an understanding of community emergency response systems, learn about unusual clinical scenarios, and become informed about the major concepts of disease reporting. All students were pre- and post-tested on their knowledge of these and other areas included in the course. The post-test revealed students improved knowledge in eight of nine areas. These results confirmed the findings from a previous study that a short interactive exercise is sufficient to improve physicians' knowledge about bioterrorism preparedness.

Tolomeo, P., Wheeler, M., Metlay, J.P., and others (2008, February). "Patient attitudes regarding participation in studies of antimicrobial resistance." (AHRQ grant HS10399). Infection Control and Hospital Epidemiology 29(1), pp. 155-159.

Some recent studies of antimicrobial resistance have focused on the role of antimicrobial-resistant pathogens that colonize the intestinal tract. Participation rates in such studies, which involve perirectal swabs, have been low (less than 60 percent). The researchers sought to determine patients' attitudes and beliefs regarding such studies and why a substantial proportion of eligible study participants refuse to participate. The 90-person study group of hospital inpatients was almost evenly divided between a group that had just participated in a fluoroquinolone-resistant E. coli study, a group that had refused to participate in that study, and a third group that had not been asked to participate. The study found that 31 of the individuals surveyed believed that the researchers might run additional tests without informing them, and 25 individuals believed that someone other than the researchers might gain access to the results. People who had previously refused to participate in the earlier study were significantly more likely to believe that a person could get sicker as a result of the study.

Whitney, S.N., Alcser, K., Schneider, C. E., and others (2008, April). "Principal investigator views of the IRB system." (AHRQ grant HS11289). International Journal of Medical Sciences 5(2), pp. 68-72.

The human subjects protection system is constantly expanding, yet its quality and efficiency are cast in doubt by experts, review bodies, and field- or discipline-specific committees. These researchers decided to survey federally funded principal investigators for their views of this system. Their study had a 14 percent response rate, with 28 investigators submitting their views. Respondents disagreed about how well the system is functioning. Some supporters of the system endorsed it without reservation, while others expressed frustration but believed that their local institutional review board (IRB) did its best to make a difficult system work well. Those investigators who were most critical mentioned multiple flaws in the system, such as inappropriate and incomprehensible consent forms, an emphasis on minutiae, and concern with protecting the institution more than the research subject. The IRB system was viewed as particularly burdensome in the areas of neurology, emergency medicine, repositories, and social sciences.

Zatzick, D.F., Russo, J., Rajotte, E., and others (2007, Fall). "Strengthening the patient-provider relationship in the aftermath of physical trauma through an understanding of the nature and severity of posttraumatic concerns." (AHRQ grant HS11372). Psychiatry, 70(3), pp. 260-273.

Researchers used open-ended, semi-structured questions to elicit up to three major concerns from each patient hospitalized injury survivor (18 years of age or older) within an average of 3 days following hospital admission. The injury survivors had endured either unintentional (e.g., motor vehicle accidents) or intentional (e.g., assault) injuries; patients with self-inflicted injuries were excluded. To measure post-traumatic stress disorder (PTSD) symptoms at 1, 3, 6, and 12 months following injury, the researchers used the PTSD Checklist (PCL), a 17-item self-report questionnaire. Of 120 hospitalized injury survivors, 84 percent expressed 1 or more severe concerns and 14.3 percent expressed 3 severe concerns. Physical health concerns (68 percent) were predominant, with the patients focusing on extent of their injury, pain, and worries about being able to take care themselves. These concerns were followed by work and finance (59 percent); social, such as the impact of the trauma on family and friends (44 percent); medical (8 percent); and legal (5 percent) concerns. Patients with three severe concerns had significantly elevated PCL scores compared with the other groups.

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