Research Briefs

Research Activities, January 2010, No. 353

Alexander, G. and Staggers, N. (2009). "A systematic review of the designs of clinical technology. Findings and recommendations for future research." (AHRQ grant HS16862). Advances in Nursing Science 32(3), pp. 252-279.

Human factors studies have become more important as technology diffuses into clinical settings. These authors used human factors concepts—effectiveness, efficiency, and satisfaction—to review studies on the design of clinical technology. They identified 50 studies with an emphasis on nursing that met their relevance criteria. The majority of the studies evaluated the effectiveness of clinical technology interfaces, while studies about interface efficiency were fewest in number. The authors recommend more examinations that include unstudied nursing specialties to provide detailed accounts of experiences with clinical technology. They also support expanding the types, settings, and participants for usability testing, developing integrated displays, and expanding outcome variables in usability studies.

Ancker, J.S., Chan, C., and Kukafka, R. (2009). "Interactive graphics for expressing health risks: Development and qualitative evaluation." (AHRQ grant HS16333). Journal of Health Communications 14, pp. 461-475.

Communicating accurately about health risks is an important but difficult part of health promotion, decision support, informed consent, and other health communication activities. Dynamic, game-like graphics that permit user interaction may be an effective way of expressing quantitative risks for health communication. The researchers developed a prototype for a risk communication model, then designed the graphics after feedback from five focus groups. The interactive program was associated with more expressions of emotions by the focus group participants than the other graphics and visuals. Participants tended to describe quantitative information as impersonal and irrelevant. Most of them preferred a matrix of stick figures to a bar chart, because it was "clearer that you're talking about human beings and not statistics." Most participants also said they enjoyed the interactive aspect of being able to input personal information and get tailored output. The researchers concluded that interactive graphics appear to have potential for expressing risk magnitude as well as the feeling of risk.

Asarnow, J.R., Jaycox, L.H., Tang, L., and others (2009, September). "Long-term benefits of short-term quality improvement interventions for depressed youths in primary care." (AHRQ grant HS09908). The American Journal of Psychiatry 166(9), pp. 1002-1010.

The researchers evaluated a quality improvement intervention for depressed youths in primary care settings. The participants were 418 youths, 13-21 years of age, with current depressive symptoms. The intervention consisted of expert leader teams to oversee implementation of the intervention, clinical care managers trained in cognitive behavioral therapy for depression to support patient evaluation and treatment, and support for patient and provider choice of treatments. The researchers found that the intervention, relative to usual treatment enhanced by provider training, led to more rapid recovery, with a reduced likelihood of severe depression 6 months after the intervention. Over an 18-month period, they further observed a significant indirect intervention effect on rates of severe depression, depressive symptoms, and mental-health-related quality of life. The findings suggest an important direction for new research on improving outcomes for youth depression.

Barton, M.B. and Elmore, J.G. (2009). [Editorial] "Pointing the way to informed medical decision making: Test characteristics of clinical breast examination." Journal of the National Cancer Institute 101(18), pp. 1223-1225. Reprints (AHRQ Publication No. 10-R008) are available from the AHRQ Publications Clearinghouse.

Clinical breast examinations (CBEs) can detect lesions missed by mammography. Adding CBE to mammography can increase test sensitivity, but the cost of an improvement in sensitivity is a decrease in specificity. This editorial discusses a study in this issue of the journal that used data from the Ontario Breast Screening Program to discuss this cost in terms of the number of false-positive examinations for each additional cancer detected. The study authors found that in a theoretical population of 10,000 women between the ages of 50 and 60, the addition of CBE to mammography would result in the detection of breast cancer in only four additional women. This approach would also lead to false-positive results for an additional 219 women. These data suggest that CBE must be done well if it is to be done at all, with the acknowledgement that overall referrals and false-positive results will increase, note the authors of the editorial. They further conclude that more answers are needed on the role of CBE in breast cancer screening before definitive recommendations for or against its use can be made.

Chen, R.C., Clark, J.A., and Talcott, J.A. (2009, August). "Individualizing quality-of-life outcomes reporting: How localized prostate cancer treatments affect patients with different levels of baseline urinary, bowel, and sexual function." (AHRQ grant HS08208). Journal of Clinical Oncology 27(24), pp. 3916-3922.

Information on a patient's level of urinary, bowel, or sexual function before treatment for localized prostate cancer (baseline function) may allow for more individualized counseling about the long-term effects on quality of life (QOL) of a particular type of treatment. That's the conclusion of this study of 409 men treated for localized prostate cancer. It found that different baseline levels of function prior to treatment produced distinct patterns of functional changes at 36 months after treatment. The group studied included 127 patients who underwent radical prostatectomy (RP)—74 who received nerve-sparing surgery and 53 who received non-nerve-sparing surgery, 190 patients who underwent external-beam radiation therapy (EBRT), and 92 patients who underwent brachytherapy (BP). All treatment modalities produced large increases in sexual dysfunction. However, patients with normal sexual function at baseline and who underwent BT seemed to preserve function better than other patients with normal sexual function at baseline. As expected, RP increased urinary incontinence more than EBRT or BT, but patients with intermediate levels of incontinence at baseline showed large improvement in function following BT. Patients with a high level of urinary obstruction or irritation at baseline benefited from treatment, particularly when undergoing RP. Patients who underwent either type of radiation therapy (EBRT or BT) exhibited greater loss of bowel function after treatment than patients treated with RP.

Clancy, C.M. (2009, September/October). "New patient safety culture survey helps medical offices assess awareness." American Journal of Medical Quality 24(5), pp. 441-443. Reprints (AHRQ Publication No. 10-R001) are available from the AHRQ Publications Clearinghouse.

A new survey tool is available for medical offices to help improve clinician and staff awareness of patient safety culture, notes the director of the Agency for Healthcare Research and Quality (AHRQ) in this commentary. A 2004 study of medical errors among family physicians found errors and preventable adverse events in 24 percent of outpatient visits. Harm occurred to patients in 24 percent of the errors and potential harm in an additional 70 percent of the errors. An increase in outpatient treatment for chronic conditions, including cancer chemotherapy, underscores the need for consciousness of patient safety in medical offices, notes the author. The AHRQ Medical Office Survey on Patient Safety Culture, designed for offices with at least three providers, was released in June 2009. This survey parallels the 5-year-old AHRQ Hospital Survey on Patient Safety Culture, which has been used by hundreds of hospitals in the United States. Before being publicly released, the survey was pilot tested in more than 200 medical offices, including primary care, specialty, and multispecialty practices. The major differences between the medical office and hospital surveys reflect their respective organizational structures.

Clancy, C. (2009, August). "Other voices. Energetic about improving quality." Hospitals & Health Networks, pp. 12-13.

Considerable progress has been made in improving care quality and safety, but much more needs to be done, according to the Director of the Agency for Healthcare Research and Quality (AHRQ). For example, there is not yet a gold standard benchmark for patient harm telling us how we are doing as a nation. AHRQ and the Centers for Medicare and Medicaid Services are working on this problem now and expect to have a kind of gold standard reference developed within the next year. There is already something close to this now for Medicare patients. The proliferation of reporting programs and quality measures ultimately need to converge on at least one core set of measures that all payers and creditors use, notes the author. Reducing potentially avoidable hospital readmissions is also a challenge. Patients in vulnerable populations and subgroups tend to be underrepresented in clinical studies that assess efficacy. Addressing this challenge is important given the emerging majorities in this country. Finally, comparative effectiveness and health IT are essential counterparts to go with all of the advances in biomedicine in recent decades.

Clancy, C. (2009, August). "Quality in the OR: The new AHRQ reports." AORN Journal 90(2), pp. 269-271. Reprints (AHRQ Publication No. 10-R005) are available from the AHRQ Publications Clearinghouse.

Keeping patients safe in the operating room (OR) may be the perioperative nurse's highest calling. It cannot hearten perioperative nurses to learn that U.S. health care quality continues to lag and that patient safety problems actually are getting worse, according to the Director of the Agency for Healthcare Research and Quality (AHRQ). The Agency's 2008 National Healthcare Disparities Report and National Healthcare Quality Report document that health care quality remains suboptimal and continues to improve at a slow pace, while disparities persist in quality and access. Certain measures demand our attention, notes the author. These include: appropriate timing of antibiotics, the rate of accidental puncture or laceration during a procedure, postoperative pneumonia or a thrombolytic event, and postoperative abdominal wound separation. We are engaged in a multi-front national effort to improve on some of these measures. A significant investment in quality improvement is being made through the American Reinvestment and Recovery Act of 2009. As nurses know, quality improvement will be real and sustained when they are empowered to apply the knowledge they already have at every opportunity.

Haggerty, C.L., Totten, P.A., Ferris, M., and others (2009). "Clinical characteristics of bacterial vaginosis among women testing positive for fastidious bacteria." (AHRQ grant HS08358). Sexually Transmitted Infections 85, pp. 242-248.

Bacterial vaginosis (BV) is a common lower genital tract infection that may lead to pelvic inflammatory disease (PID) and other conditions. Although no single agent is known to cause BV and its etiology is not well understood, various bacteria such as Gardnerella vaginalis, ureaplasmas, Mycoplasma hominis, and anaerobic bacteria are commonly isolated from BV patients. The researchers sought to determine the associations among various fastidious pathogens and BV defined by Gram stain and Amsel's criteria among a population of women with PID. Their analysis was conducted using stored specimens from 50 randomly selected women with histologically confirmed non-gonococcal, non-chlamydial endometritis. The researchers concluded that L. sanguinegens/amnionii, A. vaginae, and BV-associated bacteria 1 are associated with BV defined by Gram stain and Amsel's criteria among women with histologically confirmed PID. Consistent results using varying BV definitions suggest robust findings.

Haukoss, J.S., Hopkins, E., Byyny, R.L., and others (2009). "Design and implementation of a controlled clinical trial to evaluate the effectiveness and efficiency of routine opt-out rapid human immunodeficiency virus screening in the emergency department. (AHRQ grant HS17526). Academic Emergency Medicine 16, pp. 800-808.

In 2006, the Centers for Disease Control and Prevention published revised recommendations for performing nontargeted rapid HIV testing in health care settings, including emergency departments (EDs). Limited research has been performed to define the most effective approach to performing HIV testing in EDs. The researchers designed this study to evaluate the clinical effectiveness, clinical efficiency, cost effectiveness, and patient and staff acceptance of performing nontargeted opt-out rapid HIV screening when compared to physician-directed diagnostic testing in the ED of a large, urban teaching hospital. The article provides a conceptual framework for health services researchers and the broader public health community for the performance of comparative effectiveness research in EDs. It describes the design and implementation of a large prospective controlled clinical trial and three nested observational studies. Due to the unique scope of the article, and because it was written prior to the conclusion of the study, no results are provided.

Kennedy, K.M., Rodriguez, K.M., Head, D., and others (2009, July). "Neuroanatomical and cognitive mediators of age-related differences in perceptual priming and learning." (AHRQ grant HS13819). Neuropsychology 23(4), pp. 475-491.

Identification of a word or object (perceptual identification) is a skill that can be acquired by people of all ages. However, it is unclear whether older observers improve at the same rate as their younger counterparts. The authors of this study examined the effects of age-related differences in brain structure and cognitive resources on perceptual priming and perceptual skill acquisition. They chose a fragmented picture identification task to gauge simultaneously the age, neural, and cognitive effects on both perceptual repetition priming and perceptual learning in the same task. They assessed the working memory and fluid intelligence of 169 healthy adults (ages 18-80) and, using MRI scans, measured brain volumes of regions that were deemed relevant to those cognitive skills. The results of the study indicate that, although neither item-specific repetition priming nor more general skill learning of fragmented pictures identification are immune to aging, age effects on performance are largely mediated by multiple and dissociable neuroanatomical and cognitive factors.

Lanham, H.J., McDaniel, R.R., Crabtree, B.F., and others (2009, September). "How improving practice relationships among clinicians and nonclinicians can improve quality in primary care." (AHRQ grant HS08776). The Joint Commission Journal on Quality and Patient Safety 35(9), pp. 457-466.

The researchers used data from four large National Institutes of Health-funded studies, an iterative analytic strategy, and a grounded theory approach to understanding the characteristics of relationships within primary care practices. The broad range of data included direct observation of practices during work activities and patient-client interactions, in-depth interviews with physicians and other key staff members, surveys, structured checklists of office environments, and chart reviews. Analyses focused on characteristics of practice relationships that exhibited a range of success in achieving practice improvement. The analyses were based on complex adaptive systems theory, which emphasizes the role of interdependencies in system outcomes. The seven characteristics identified as important in practice improvement were trust, mindfulness, heedfulness, respectful interaction, diversity, social/task relatedness, and rich/lean communication. The researchers developed a model depicting the relationship between these seven characteristics of practice relationships and other factors such as reflection, sensemaking and learning, and practice outcomes.

Lo Re, V., Haynes, K., Forde, K.A., and others (2009). "Validity of The Health Improvement Network (THIN) for epidemiologic studies of hepatitis C virus infection." (AHRQ grant HS10694). Pharmacoepidemiology and Drug Safety 18, pp. 807-814.

Methods need to be developed to identify, correctly classify, and follow for extended periods of time large numbers of patients infected with hepatitis C virus (HCV). The Health Improvement Network (THIN) may fill this need. THIN is a primary care medical records database in the United Kingdom that contains electronic medical records of over 1,500 general practitioners. Before THIN can be used for epidemiologic research, the validity of the diagnosis of HCV infection in the database must be determined. The researchers sought to determine the accuracy of THIN's HCV diagnostic codes compared to general practitioner confirmation of documented diagnosis. After identifying 150 patients in the THIN database with initial diagnosis codes for HCV infection and nonspecific viral hepatitis, the researchers surveyed physicians in the database. They found that the HCV-specific diagnostic codes in the THIN were highly predictive of HCV infection. Also, manual review of THIN's records reduced misclassification of HCV infection as viral hepatitis (not otherwise specified).

Maro, J.C., Platt, R., Holmes, J.H., and others (2009, September). "Design of a national distributed health data network." (AHRQ Contract No. 290-05-0033). Pace, W.D., Cifuentes, M., Valuck, R.J., and others. "An electronic practice-based network for observational comparative effectiveness research." (AHRQ Contract No. 290-05-0033) Annals of Internal Medicine 151(5), pp. 341-344 and 338-340.

These two articles describe, respectively, the general design of a national distributed health data network and the construction and initial use of a smaller geographically distributed data network for comparative effectiveness research. In the first paper, the general structure of a national distributed health data network is discussed. This network would support both observational and interventional studies, but permit the local data holders to maintain control over acces to and use of data from their local database of electronic health records. Relevant data for a study would be shared, while retaining protected health information locally. The authors discuss policy issues, including the funding necessary for a truly national network, and the usefulness of this proposed network to multiple Federal agencies. The second paper describes the Distributed Ambulatory Research in Therapeutics Network (DARTnet), which connects eight geographically and organizationally distinct databases of electronic health records (EHRs) representing more than 500 clinicians and more than 400,000 patients. The network allows researchers to query the federated databases to obtain information for use in studies related to comparative effectiveness of prescription drugs and medical devices. Rather than being a one-way transfer of standardized information from the federated databases, DARTnet can prompt clinicians to obtain specific clinical information during a patient encounter. This gives the researchers the ability to combine the elements of observational research and those of a clinical trial.

Plantinga, L.C., Fink, N.E., Finkelstein, F.O., and others (2009). "Association of peritoneal dialysis clinic size with clinical outcomes." (AHRQ grant HS08365). Peritoneal Dialysis International 29, pp. 285-291.

Few studies have examined the relationship between peritoneal dialysis (PD) clinic size and outcomes in patients who are well characterized with respect not only to demographics but also to comorbid disease status and other clinical and laboratory characteristics. Using a national prospective cohort study, the researchers examined whether being treated at a larger PD clinic was associated with better patient outcomes, including fewer switches to hemodialysis (HD), fewer cardiovascular (CV) events, lower CV mortality, and lower all-cause mortality. Their study included 236 PD patients, who were treated at 26 outpatient dialysis clinics in 13 States throughout the United States. The researchers found that PD patients treated at clinics with more than 50 patients were at lower risk of switching to HD and at lower risk of CV events. This was true regardless of adjustments for demographic factors, other illnesses, body size, albumin and creatinine levels, and clinic years of operation. There was no association of PD clinic size with CV mortality or all-cause mortality.

Sittig, D.F. and Singh, H. (2009, September 9). "Eight rights of safe electronic health record use." (AHRQ grant HS017820). Journal of the American Medical Association 302(10), pp. 1111-1113.

To avoid medical errors resulting from electronic health records (EHR) use and to achieve the promise of EHRs, the authors propose eight rights of safe EHR use. EHR hardware and software must be adequately sized, configured, and maintained. Content must be evidence-based, carefully constructed, monitored, complete, and error-free. The user interface should present all the relevant patient data in a format allowing clinicians to rapidly perceive problems, formulate responses, and document their actions. Trained and knowledgeable personnel are essential for safe use as are software designers, developers, trainers, and implementation and maintenance staff. Clinical decision support interventions should be streamlined with clinicians' electronically enabled workflow through a standard set of functions. A culture of innovation, exploration, and continual improvement are key organizational factors for safe EHR use. State and Federal rules, regulations, and policies must address the safety and effectiveness of health information exchange across organizational boundaries. Finally, organizations must continually evaluate the usability and performance of their systems after implementation, reliably measure benefits, and assess potential iatrogenic effects.

Tan, C., Hsia, R., Shou, H., and others (2009, August). "Chlamydia trachomatis-infected patients display variable antibody profiles against the nine-member polymorphic membrane protein family." (AHRQ grant HS08358). Infection and Immunity 77(8), pp. 3218-3226.

Chlamydia trachomatis, a prevalent human pathogen, infects the ocular and genital mucosa. The complete sequence analysis of the C. trachomatis genome has revealed a multigene family encoding nine predicted polymorphic membrane proteins (Pmps). The researchers tested the hypothesis that the Pmp gene repertoire is the basis of a previously undetected mechanism of antigenic variation by examining variations in the Pmp-specific antibody response in different patient populations with confirmed C. trachomatis genital infection. The researchers found varied anti-Pmp antibody profiles in patients from four geographically distinct C. trachomatis-infected populations. They also demonstrated Pmp subtype-specific and gender-specific antibody responses. These observations imply variable expression of the Pmp gene family during infection, suggesting that the C. trachomatis Pmp gene family is the basis of a mechanism of antigenic variation for the purpose of immune evasion.

Weiner, M.G. and Embi, P.J. (2009, September). "[Editorial] Toward reuse of clinical data for research and quality improvement: The end of the beginning?" (AHRQ grant HS17099). Annals of Internal Medicine 151(5), pp. 359-360.

The authors of this editorial discuss the current status of health information technology (health IT) as a source of data for health care research. They observe that social and organizational challenges have been more important than technological issues in the success and failure of health IT initiatives. Similarly, adequate funding cannot ensure success of regional health IT organizations without effective governance structures. Advances in data capture, the speed and standardization of data transfer between systems, and the ability to draw on data from multiple sources has reduced researchers' reliance on administrative and billing data. However, achieving interoperability between data systems and ensuring adherence to common data standards will be necessary to make research uses of clinical data collected for patient records successful, the authors note. They conclude that current technology and successful models of distributed data systems suggest that we are closer to achieving the promise of health IT for research.

Winthrop, K.L. and Chiller T. (2009, June). "[Perspectives] Preventing and treating biologic-associated opportunistic infections." (AHRQ grant HS17552). Nature Reviews: Rheumatology 5, pp. 405-410.

A group of new drugs for the treatment of rheumatoid arthritis and other autoimmune diseases act by inhibiting tumor necrosis factor (TNF), a critical factor in the functioning of the immune system. While these FDA-approved drugs (infliximab, etanercept, adalimumab, and certolizumab) have exhibited great clinical efficacy against autoimmune diseases, their action in suppressing TNF places the patient at higher risk of developing a wide variety of bacterial, fungal, parasitic, and mycobacterial infections. The authors discuss the importance of testing patients for latent tuberculosis infection, infection with nontuberculous mycobacteria, endemic fungal diseases such as histoplasmosis, and diseases caused by intracellular bacterial pathogens such as Listeria monocytogenes or Salmonella. For latent tuberculosis infection, the authors recommend using interferon gamma release assays in patients who are likely to give a positive tuberculin skin test because of childhood vaccination. They suggest courses of treatment for patients found to have latent or active tuberculosis infections to allow them to begin anti-TNF therapy. The authors also suggest approaches for dealing with fungal infections and intracellular bacterial infections in patients given anti-TNF agents. Finally, they recommend postmarketing vigilance for any new anti-TNF biologics that come into clinical use.

Yawn, B.P., Graham, D.G., Bertram, S.L., and others (2009). "Practice-based research network studies and institutional review boards: Two new issues." (AHRQ grant HS14744). Journal of the American Board of Family Medicine 22, pp. 453-460.

Investigators of practice-based research network (PBRN) studies must interact with a number of Institutional Review Boards (IRBs), many of which are not familiar with PBRN research. The authors discuss two issues involving IRBs that arose during the second and third year of a 5-year PBRN study on postpartum depression. The study included 32 sites in 20 different States. The first issue was related to the use of site-specific and dated approval stamps for patient consent forms. This led to the need to obtain multiple patient consent forms for the same study and consequent delays. The second issue related to the retraining of local practice staff about working with human subjects, which many IRBs required to be performed either yearly or every two years. Eight of the 19 IRBs repeated the retraining course with exactly the same course materials as before. This resulted in approximately 200 hours of unreimbursed physician and nursing staff time. The authors believe that the cost of implementing such requirements, which lack evidence supporting their usefulness, must be balanced against the potential for improving human subject protection.

Current as of January 2010
Internet Citation: Research Briefs: Research Activities, January 2010, No. 353. January 2010. Agency for Healthcare Research and Quality, Rockville, MD.