AHRQ Annual Highlights, 2010 (continued)

Patient-Centered Outcomes Research/Comparative Effectiveness Portfolio

AHRQ's Effective Health Care Program is a Federal leader in the growing field of comparative effectiveness research. Research that evaluates the benefits and harms of different health care interventions and ways to deliver health care helps clinicians and patients work together to choose the most appropriate treatment for an illness or condition.

The Effective Health Care Program, created by Congress in Section 1013 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, produces rigorous reviews of existing scientific evidence for different health care interventions, funds new research to help fill gaps in our knowledge about effectiveness of different health care options, and provides concise, plain language guides for several audiences, including Spanish-speaking patients. Additional products are intended to specifically reach clinicians, nurses, pharmacists, and medical students include continuing education activities, training modules, downloadable presentations, Webcasts, videos, and podcasts in English and Spanish.

In FY10, the Effective Health Care Program released a total of 51 comparative effectiveness research reviews, original research findings, and summary guides for clinicians and patients. These publications included comparative effectiveness reviews of treatment options for common conditions such as nonoperative and operative treatments for rotator cuff tears, comparing core needle and surgical excision biopsy for diagnosing breast lesions, and radiotherapy treatments for patients with head and neck cancer. For emerging treatment options, the program released a technical report on percutaneous heart valve replacement. The program also published new research findings on using electronic medical records and administrative claims data for assessing type 2 diabetes care and quality measures for end-of-life care. In 2010, consumer summary guides and clinician guides remained the most popular products disseminated through http://www.effectivehealthcare.ahrq.gov and the AHRQ publications clearinghouse.

Comparative Effectiveness Research Reviews (CERs)

Evidence-based Practice Centers (EPCs) thoroughly review existing scientific studies to compare treatments and health strategies to characterize benefits and harms of different options to identify where more research is needed.

Three of the CERs published in FY10 are briefly summarized here:

• Comparative Effectiveness of Core-Needle and Open Surgical Biopsy for the Diagnosis of Breast Lesions. Breast cancer is the second most common malignancy of women, with approximately 250,000 new cases diagnosed each year. More than 180,000 of these cases are invasive breast cancer. Early detection and treatment improves survival. Routine screening with physical examination and mammography is widely used in the United States. Suspicious findings on mammography may require a biopsy for diagnosis. Over 1 million women have breast biopsies each year in the United States. Between 20 and 30 percent of these biopsies yield a diagnosis of breast cancer. This review compares traditional surgical biopsies with various types of core-needle biopsies, which involve removing tissue through a hollow-core needle inserted through the skin. The researchers found that certain core-needle biopsies could distinguish between malignant and benign lesions approximately as accurately as open surgical biopsy, which is commonly considered the "gold standard" method of evaluating suspicious lesions. The report indicates that women who are initially diagnosed with breast cancer by surgical biopsy are more likely to undergo multiple surgical procedures during treatment than women who are initially diagnosed with breast cancer by core needle biopsy. Because it is less invasive, core-needle biopsy costs less than open surgical biopsy, consumes fewer resources, and generally is preferred by patients, according to the report.
• Comparative Effectiveness and Safety of Radiotherapy Treatments for Head and Neck Cancer. According to the National Cancer Institute, head and neck cancer accounts for nearly 3 to 5 percent of all cancer in the United States. These types of cancer are more common in men and in people older than age 50. Around 47,560 men and women in this country develop head and neck cancer every year. Tobacco and alcohol use are common risk factors for this cancer. This review found that intensity-modulated radiation therapy (IMRT) reduces side effects when treating head and neck cancers. IMRT employs three-dimensional imaging and other technological and treatment enhancements that tightly control and target the amount of radiation delivered to the target area. The researchers found that IMRT leads to fewer cases of xerostomia (dry mouth) than traditional two-dimensional or three-dimensional radiation therapies. However, the researchers did not find evidence that IMRT is more successful than any other kind of radiation therapy in reducing tumors. In examining the evidence regarding proton beam radiation therapy, a technology that some clinicians believe targets radiation even more precisely than IMRT, the researchers did not find enough evidence to draw conclusions regarding its benefits or potential side effects.
• Comparative Effectiveness of Angiotensin-Converting Enzyme Inhibitors or Angiotensin II Receptor Blockers Added to Standard Medical Therapy for Treating Stable Ischemic Heart Disease. This review found that two medications—angiotensin-converting enzyme (ACE) inhibitors and angiotensin II receptor blockers (ARBs)—commonly used to treat high blood pressure appear to be effective in treating stable ischemic heart disease. Researchers found that treatment with these two medications can lead to a reduction in death, risk of heart attack, risk of stroke, and fewer hospitalizations for heart failure for patients suffering from stable ischemic heart disease. However, the drugs have risks. The risks associated with ACE inhibitors include a persistent cough, sudden fainting, too much potassium in the blood, and dangerously low blood pressure. Risks associated with ARBs include too much potassium in the blood and low blood pressure. Patients with stable ischemic heart disease who take an ACE inhibitor in addition to standard treatment can reduce their likelihood of death from heart attack or heart failure, non-fatal heart attacks, hospitalization for heart failure, and revascularization. Patients who take an ARB in addition to standard medications can reduce their risk of death from a heart-related cause, heart attack, or stroke.

Technical Briefs

A Technical Brief provides an overview of key issues related to a clinical intervention or health care service—for example, current indications for the intervention, relevant patient population and subgroups of interest, outcomes measured, and contextual factors that may affect decisions regarding the intervention. Technical Briefs generally focus on interventions for which there are limited published data and too few completed protocol-driven studies to support definitive conclusions. The emphasis, therefore, is on providing an early objective description of the state of the science, a potential framework for assessing the applications and implications of the new interventions, a summary of ongoing research, and information on future research needs. The Technical Brief published in FY10 is summarized below:

• Percutaneous Heart Valve Replacement. A newer, less invasive method of heart valve replacement shows promise and may be appropriate for patients who cannot tolerate traditional open heart surgery, but more research is needed to understand its potential risks and benefits. Percutaneous heart valve replacement is a realistic option for some patients with heart valve disease, especially older or sicker patients. Approximately 92 percent of patients who received a percutaneous valve survived the procedure; of those, 86 percent survived for at least 30 days. However, information is lacking on the potential long-term benefits and risks of this procedure, particularly compared with open heart valve replacement surgery. The report did not conclude that any of the seven replacement valves studied is safer or more effective than another.

Technical brief topics expected to be published in FY11 include:

• Evaluation of Suspicious Skin Lesions Using Noninvasive Diagnostic Techniques.
• Stereotactic Radiosurgery for Extracranial Solid Tumors.
• Wheeled Mobility (Wheelchair) Service Delivery.
• Neurothrombectomy Devices for Treatment of Acute Ischemic Stroke.
• Use and Safety of Positional Magnetic Resonance Imaging in the Management of Patients with Musculoskeletal Pain.
• Fetal Surgery.

New Research Reports

These reports are based on clinical research and studies that use health care databases and other scientific resources and approaches to explore practical questions about the effectiveness, safety, and appropriateness of health care items and services. They are produced by research centers that are part of AHRQ's Developing Evidence to Inform Decisions about Effectiveness (DEcIDE) Network and AHRQ's Centers for Education and Research on Therapeutics (CERTs).

In FY10, the Effective Health Care Program released 14 new research reports, two of which are summarized below:

• Who Uses Exenatide for Glucose Control in Diabetes Mellitus? A Retrospective Cohort Study of a New Therapy. Exenatide was approved by the Food and Drug Administration (FDA) in April 2005 as adjunctive therapy for type 2 diabetes mellitus (DM). Researchers evaluated whether early use of this drug was consistent with the FDA-approved indications for use. Beginning in June 2005, 3,225 people filled a prescription for exenatide. Of these, 22 percent of users were obese, compared to 11 to 15 percent using other medications. Fourteen percent of users had used no other medication for DM in the preceding year, suggesting that exenatide was their initial therapy. Thirty percent filled a thiazolidinedione prescription within 60 days of filling exenatide. The researchers concluded that exenatide was used frequently early after its approval as monotherapy or with a thiazolidinedione (neither is an FDA-approved indication). Exenatide users had a higher prevalence of obesity than patients using other therapies, suggesting that its weight-lowering benefits may be widely known.
• Effectiveness of Isosorbide Dinitrate and Hydralazine in Racial/Ethnic Subgroups With Heart Failure. Researchers assessed the associations between treatment with hydralazine-isosorbide dinitrate (H-ISDN) and mortality or heart failure hospitalization in veterans with heart failure. Their findings showed that H-ISDN prescription was not associated with risk of death in five of nine subgroups predefined by race/ethnicity (black, white, Hispanic) and time of initiation of H-ISDN (1 to 4, 5 to 12, or more than 12 months following heart failure diagnosis), but was associated with an increased risk of death in the four subgroups with longer times to initiation. H-ISDN was associated with a significantly increased risk of heart failure hospitalization in all but one subgroup. H-ISDN was associated with significantly lower risk for both mortality and hospitalization in blacks than in Hispanics or whites. Other evidence-based heart failure therapies (e.g., angiotensin converting enzyme inhibitors, beta-blockers, and combinations) had a strong association with reduced mortality. The researchers concluded that H-ISDN was not associated with significant reduction in mortality or hospitalization for heart failure in any subgroups analyzed. Blacks had lower risks of adverse outcomes with H-ISDN than Hispanics or whites.

Summary Guides

These short, plain-language guides—tailored to clinicians, consumers and patients, or policymakers—summarize research reviews' findings on the effectiveness and risks of treatment options. Patient guides provide background on health conditions, while clinician and policymaker guides rate the strength of evidence behind a report's conclusions. The guides on medications also contain basic wholesale price information.

Among the new consumer and clinical guides released in FY10 were:

• Thinking About Having Your Labor Induced?—This guide provides women with information about elective induction and helps answer questions, including: What are the possible problems with elective induction? What don't we know yet about elective induction?
• Elective Induction of Labor: Safety and Harms—This guide for clinicians summarizes evidence comparing the safety of elective induction of labor (induction at term without a medical indication) with expectant management (waiting for spontaneous labor in a term pregnancy). It also includes information about maternal and fetal outcomes when elective induction of labor is used.
• Adding ACEIs and/or ARBs to Standard Therapy for Stable Ischemic Heart Disease: Benefits and Harms—This guide summarizes evidence for clinicians to help address this question: "Should standard medical therapy in patients with stable ischemic heart disease be augmented with an ACEI (angiotensin-converting enzyme inhibitor) or an ARB (angiotensin II receptor blocker)?"
• "ACE Inhibitors" and "ARBs" To Protect Your Heart?—By providing simple text with a diagram, chart, and graph, this guide helps patients with stable coronary heart disease compare the benefits and possible side effects of ACEIs and ARBs.
• Having a Breast Biopsy—This guide for patients provides information about the different kinds of biopsies, what to expect during a breast biopsy, possible side effects, and research about how well different kinds of biopsies work to find cancer.
• Core-Needle Biopsy for Breast Abnormalities—This clinician guide compares core-needle biopsy with open surgical biopsy for diagnosing breast lesions. It also summarizes the accuracy and possible harms of various core-needle biopsy methods.

Slide Sets and CME/CE Credit

In FY10, AHRQ created the Effective Health Care Program Slide Library, which contains lectures created for faculty engaged in educating clinicians, researchers, and other health professionals in training. The lectures have slides, talking points, references that are linked to PubMed®, and key words to find additional slides on a similar topic. Each slide can be individually viewed and downloaded, or the library can be searched by key word to assemble a customized presentation. In addition, presentations can be downloaded for faculty who are instructing clinicians, researchers, and other health professionals. Presentations can be downloaded in their entirety or searched by key word to assemble a customized presentation.

• Comparative Effectiveness of Angiotensin-Converting Enzyme Inhibitors and/or Angiotensin II Receptor Blockers Added to Standard Medical Therapy for Treating Patients With Stable Ischemic Heart Disease and Preserved Left Ventricular Systolic Function. This slide set is based on a CER of this topic.
• Management of the Patient with Stable Ischemic Heart Disease and Preserved Left Ventricular Systolic Function. This slide set is based on the CER Clinician and Consumer Guides for Comparative Effectiveness of Angiotensin-Converting Enzyme Inhibitors (ACEIs) or Angiotensin II-Receptor Blockers (ARBs) Added to Standard Medical Therapy for Treating Stable Ischemic Heart Disease (IHD).
• AHRQ Training Modules for the Systematic Reviews Methods Guide. This collection of 27 presentations was developed for instructors teaching clinical researchers and students about the science of systematic reviews and for Evidence-based Practice Center directors to use in mentoring and teaching new investigators. The presentations and quizzes are based on the Methods Guide for Effectiveness and Comparative Effectiveness Reviews and other resources.

AHRQ also developed continuing medical education (CME) and continuing education (CE) modules for health practitioners as well as continuing pharmacy education (CPE).

EHC Program Webcasts

Effective Health Care Program Webcasts are offered periodically to bring methodologists, researchers, and clinicians together to discuss research findings and the impact on future research needs.

• New and Improved: Registries for Evaluating Patient Outcomes and HIT. In this live Webcast from the AHRQ 2010 Annual Conference, the Registries for Evaluating Patient Outcomes: A User's Guide: 2nd Edition, was introduced. Following the presentations, participants discussed potential topics for future updates of this handbook.
• Carotid Revascularization: Present Patterns of Use, What Will the Future Hold? This Web conference featured speakers who described a DEcIDE study with two main objectives: (1) to evaluate temporal trends and geographical variation in the use of diagnostic imaging for carotid artery disease; and (2) to examine geographic variation in and predictors of carotid treatments and treatments for carotid artery disease. Medicare claims—one of the richest, most comprehensive sources of publicly available health care information—were used to gather retrospective data for analysis.

For more information on AHRQ's Effective Health Care Program, go to http://www.effectivehealthcare.ahrq.gov.

Evidence-based Practice Centers

Under the Evidence-based Practice Center (EPC) Program, institutions in the United States and Canada receive multiyear contracts to systematically review and critically appraise all relevant scientific literature on clinical, behavioral, organizational, and financing topics; methodology of systematic reviews; and other health care delivery issues. They also produce Evidence Reviews, Technical Briefs, and Updates (also see Research Reviews under Comparative Effectiveness Portfolio). The information in these reports is used by Federal and State agencies; private sector professional societies; health delivery systems; providers; payers; and others committed to evidence-based health care for informing and developing coverage decisions, quality measures, educational materials and tools, guidelines, and research agendas.

Recent Research Findings From the EPC Program

Some of the new evidence reports and technology assessments released by the 14 EPCs include:

• Alzheimer's Disease and Cognitive Decline. This report concluded there is insufficient evidence to identify which factors or interventions may increase or decrease the risks of developing Alzheimer's disease (AD) or other cognitive declines. Some studies suggest that diabetes, certain alleles of the apolipoprotein E gene, smoking, and depression increase the risk of AD and cognitive decline. Other studies suggest cognitive engagement and physical activity decrease risks. With the exception of the apolipoprotein E gene, however, evidence supporting these findings tended to be weak. The researchers noted that the data were often limited and the quality of evidence was low. The degree to which these factors modified risk was typically small to moderate for AD and small for cognitive decline.
• Enhancing Use and Quality of Colorectal Cancer Screening. This review found that factors such as low income or less education, being uninsured or of Hispanic or Asian descent, not being acculturated into the United States, and having less or reduced access to health care are associated with lower screening rates for colorectal cancer (CRC). Factors that are associated with higher screening rates include being insured, of higher income or education, being non-Hispanic white, participating in other cancer screenings, having a family history of CRC or personal history of another cancer, and receiving a physician's recommendation to be screened. Interventions that effectively increased CRC screening with high strength of evidence include patient reminders, one-on-one interactions, eliminating structural barriers, and system-level changes. The largest magnitude of improvement came from one-on-one interactions and eliminating barriers. Purely educational small-media interventions did not improve screening rates.
• Impact of Consumer Health Informatics Applications. This review found that certain consumer health informatics (CHI) applications may effectively engage consumers, enhance traditional clinical interventions, and improve both intermediate and clinical health outcomes. In terms of the impact of CHI on intermediate health outcomes, the researchers found a significant positive impact for at least one intermediate health outcome for breast cancer, diet, exercise, alcohol abuse, smoking cessation, obesity, diabetes, mental health, asthma/chronic obstructive pulmonary disease (COPD) studies, and menopause/hormone replacement therapy (HRT) utilization. Five out of the eight studies demonstrated a significant positive impact of CHI on at least one aspect of the doctor-patient relationship. In terms of the impact of CHI on clinical outcomes, significant positive impact was demonstrated in at least one clinical outcome for breast cancer, diet, exercise, or physical activity, mental health, and diabetes. No studies included in this review found any evidence of consumer harm attributable to a CHI application.
• Vaginal Birth After Cesarean: New Insights. Researchers synthesized studies on vaginal birth after cesarean (VBAC) and found evidence that, while rare for both trial of labor and elective repeat cesarean, maternal mortality was significantly higher for elective repeat cesarean delivery. Risks for uterine rupture and perinatal death remain rare but elevated for trial of labor. Hispanic and black women were less likely than their white counterparts to have a vaginal delivery. The researchers found insufficient evidence on nonmedical factors such as medical liability, economics, hospital staffing, and structure and setting, which all appear to be important drivers for VBAC.

The EPCs are currently researching the following topics:

• Safety of Probiotics Used to Reduce Risk and Prevent or Treat Disease.
• Management of Acute Otitis Media, Update.
• Enabling Health Care Decisionmaking Through the Use of Health IT.
• Assessment of Thiopurine Methyltransferase Activity in Patients Prescribed Azathioprine or Other Thiopurine-based Drugs.
• Alcohol Consumption and Cancer Risk.
• Inhaled Nitric Oxide in Preterm Infants.
• Comparative Effectiveness of Treatments for Carotid Artery Stenosis.
• Effectiveness of Cochlear Implants.
• Lifestyle Interventions for Four Conditions: Breast Cancer, Prostate Cancer, Type 2 Diabetes Mellitus, and Metabolic Syndrome.

For more information about the EPC Program, go to .

Centers for Education and Research on Therapeutics

The Centers for Education and Research on Therapeutics (CERTs) is a national program that conducts research and provides education to advance the optimal use of drugs, biologicals, and medical devices. The CERTs program, funded and overseen by AHRQ in consultation with the U.S. Food and Drug Administration (FDA), was originally authorized by Congress in 1997 to examine the benefits, risks, and cost effectiveness of therapeutic products; educate patients, consumers, doctors, pharmacists, and other clinical personnel; and improve quality of care while reducing unnecessary costs by increasing the appropriate use of therapeutics and preventing adverse effects and their medical consequences.

Clinician-Consumer Health Advisory Information Network (CHAIN)

Launched in 2009, this educational Web site offers expert perspectives, advice, and guidance on drugs, biological products, and medical devices. The Clinician-Consumer Health Advisory Information Network (CHAIN) links clinicians and consumers with information on therapeutics to assist in clinical practice and health care decisionmaking in areas where evidence is undergoing significant and rapid changes. The site also provides access to educational and informational resources developed from research conducted by CERTs. An educational section includes an online medication record and materials to assist consumers with clinician-patient conversations and decisionmaking. Resources for clinicians include a slide library that can be adapted to educate clinical audiences and educational materials that provide continuing medical education credit. For more information, go to http://www.chainonline.org.

Recent Research Findings From the CERTs Program

• Proton-pump inhibitors and preventing bleeding ulcers. Heart patients who took a stomach acid-suppressing proton-pump inhibitor along with clopidogrel—a drug that prevents blood clots—were only half as likely to be hospitalized for upper digestive tract bleeding than those who used clopidogrel alone, according to a study by researchers from the Vanderbilt University Medical Center CERT (Annals of Internal Medicine, March 2010).
• Team-based care interventions for hypertension. Adding pharmacists and nurses to the teams that help patients control their blood pressure (BP) improves outcomes, according to a systematic review of intervention studies by researchers at the University of Iowa CERT. Although nurses, pharmacists within primary care clinics, and community pharmacists all served to improve BP control, the greatest impact was seen for interventions that involved community pharmacists. The researchers found that team-based interventions that provided education about blood pressure medications were associated with a reduction in mean systolic BP (SBP) of 8.75 mm Hg and diastolic BP of 3.6 mm Hg. Pharmacist treatment recommendations were associated with a mean SBP reduction of 9.30 mm Hg; intervention by nurses a 4.80 mm Hg SBP mean reduction; and use of a treatment algorithm, 4.00 mm Hg mean SBP reduction. Compared with patients who received no intervention, patients who received a nurse intervention were nearly twice as likely to have controlled BP. Patients who received interventions from pharmacists in primary care clinics and community pharmacists were two to nearly three times more likely to have controlled BP (Archives of Internal Medicine, October 2009).
• Antibiotic prescriptions and increased patient satisfaction with emergency department visits. Even though antibiotics are ineffective in treating viral conditions and contribute to antibiotic resistance, some patients give higher satisfaction ratings to emergency departments (EDs) that provide prescriptions for antibiotics, according to researchers from the University of Pennsylvania CERT. Surveying 463 patients who received care at 8 Veterans Administration (VA) EDs and 496 patients seen at 8 non-VA EDs, researchers found that patients at the non-VA hospitals were more satisfied with their visits when they received a prescription for antibiotics. In fact, 64 percent of patients at non-VA hospitals who received antibiotics reported high levels of overall satisfaction compared with 50 percent of patients who did not receive prescriptions. Receiving antibiotics did not affect satisfaction levels for patients seen at VA sites. The authors suggest that because EDs may be located at the same VA site where patients receive their primary care services, followup care may be easier to obtain (Academic Emergency Medicine, October 2009).

More information about the CERTs program can be found at http://certs.hhs.gov.

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