This report was conducted to provide objective evidence and recommendations to inform the work of the American Thoracic Society, in collaboration with the American Academy of Family Practitioners, the American College of Physicians, and the American Academy of Pediatrics Spirometry Task Force in clarifying usage of spirometry as part of the management of COPD. A systematic literature review was undertaken to address four questions:

1. What is the prevalence of COPD and airflow obstructions in various adult populations as defined by 1) spirometry and 2) clinical examination?

2. Can use of spirometry lead to increased smoking cessation rates?

3. Does the effectiveness of COPD specific therapies to improve clinically relevant outcomes vary based on baseline severity or change in spirometry?

4. Is prediction of future COPD status based on spirometry, with or without clinical indicators, more accurate than prediction based on clinical indicators alone?

The Minnesota EPC was asked to answer the following questions related to elective treatment of nonruptured AAA that were nominated by America’s Health Insurance Plans:

1. What are the comparative effectiveness and adverse effects of treatment options of AAA including active surveillance, open repair, and endovascular repair?

2. What is the relationship of volume, both hospital and physician, to the benefits and harms of endovascular procedures to repair AAA?

3. How do the characteristics of the aneurysm (size/location/shape) and the patient (age/gender) affect the benefits and harms of endovascular and open-surgical repair?

4. What are the costs-benefits for each of the procedures?

A shortage of registered nurses, in combination with increased workload, has the potential to threaten quality of care. Increasing the nurse to patient ratios has been recommended as a means to improve patient safety. However, the cost effectiveness of increasing RN staffing is controversial. This systematic review analyzes associations between hospital nurse staffing and patient outcomes with consideration of variables that could influence the primary association. The basic research questions were:

1. How is a specific nurse to patient ratio associated with patient outcomes (i.e., mortality; adverse drug events, nurse quality outcomes, length of stay; patient satisfaction with nurse care)? How does this association vary by patient characteristics, nurse characteristics, organizational characteristics, and nursing outcomes?

2. How is a measure of nurse work hours (hours per patient or patient day) associated with the same patient outcomes?

3. What factors influence nurse staffing policies?

4. What nurse staffing strategies are effective for improving the patient outcomes listed in question 1?

5. What gaps in research on nurse staffing and patient outcomes can be identified to address in future studies?

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Prevention of Fecal and Urinary Incontinence in Adults (AHRQ Evidence Report/Technology Assessment Number 161
December 2007

Investigators
   Tatyana Shamliyan, MD, MS
   Jean Wyman, PhD
   Donna Z. Bliss, PhD, RN, FAAN
   Robert L. Kane, MD
   Timothy J. Wilt, MD, MPH

This systematic review was commissioned as background material for an NIH/OMAR State of-the-Science Conference on the Prevention of Fecal and Urinary Incontinence in Adults. The aims of this review are to synthesize the published evidence of effective methods to identify individuals at risk and patients with undiagnosed UI and FI in the community and in LTC settings and to compare the effectiveness of different clinical interventions to prevent the occurrence and progression of UI and FI in adults. The following questions were developed for this review:

1. What are the prevalence and incidence of urinary and fecal incontinence in the community and long-term care settings? How does prevalence differ in race, ethnicity, and gender groups?

2. What are the independent contributions of risk factors for urinary and fecal incontinence, including age, functional impairment, institutionalization, parity, childbirth, and postpartum state, menopause, dietary factors, smoking, obesity, genetic factors, prostate disorders, dementia, psychiatric disorders, specifically depression, diabetes, urinary tract infection, chronic gastrointestinal conditions, cardiovascular and pulmonary diseases, gastrointestinal, gynecologic, and urological procedures, neurological disorders, such as stroke and spinal cord problems?

3. What is the evidence to support specific clinical interventions to reduce the risk of urinary and fecal incontinence?

4. What are the strategies to improve the identification of persons at risk and patients who have urinary and fecal incontinence?

5. What are the research priorities for identifying effective strategies to reduce the burden of illness in these conditions?

This report summarizes evidence comparing the relative effectiveness and safety of treatment options for clinically localized prostate cancer. The report addresses the following questions:

1. What are the comparative risks, benefits, short- and long-term outcomes of therapies for clinically localized prostate cancer?

2. How do specific patient characteristics, e.g., age, race/ethnicity, presence or absence of comorbid illness, preferences (e.g., tradeoff of treatment-related adverse effects vs. potential for disease progression), affect the outcomes of these therapies, overall and differentially?

3. How do provider/hospital characteristics affect outcomes overall and differentially (e.g., geographic region and volume)?

4. How do tumor characteristics, e.g., Gleason score, tumor volume, screen vs. clinically detected tumors, affect the outcomes of these therapies, overall and differentially?

Based on a topic and key questions nominated by the Consortium for Spinal Cord Medicine, we conducted a systematic review of published evidence to address the following questions:

1a. What proportion of adult patients with chronic posttraumatic spinal cord injuries have been diagnosed with:          a. Insulin resistance syndrome, metabolic syndrome          b. Diabetes mellitus Type 2, impaired glucose tolerance          c. Dyslipidemia          d. Obesity      1b. Is the prevalence of carbohydrate and lipid disorders higher in the subgroups of patients by age, race, and gender compared to the general population? Does the prevalence of carbohydrate and lipid disorders differ by the time after trauma, the level of trauma, and functional impairment?      2. Regarding risk of cardiovascular disease for people with SCI:          a. What is cardiovascular prevalence and mortality in adults with chronic posttraumatic spinal cord injuries?          b. Does cardiovascular incidence and mortality in adults with chronic posttraumatic spinal cord injuries differ compared to the general population based on age, race, and gender categories?          c. What is the strength of the association between cardiovascular incidence and mortality and abnormalities in lipid and glucose metabolism including Type 2 diabetes mellitus after adjustment for possible confounding factors?          d. Does association vary depending on age, gender, race, the duration after SCI, the level of SCI, and functional impairment?      3. What are the effects on carbohydrate or lipid-related outcomes in adults with SCI of:          a. Exercise          b. Dietary and pharmacologic interventions

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Integration of Mental Health/Substance Abuse and Primary Care (AHRQ Evidence Report/Technology Assessment Number 173)
October 2008

Investigators
   Mary Butler, PhD, MBA
   Robert L. Kane, MD
   Donna McAlpine, PhD
   Roger G. Kathol, MD
   Steven S. Fu, MD, MSCE
   Hildi Hagedorn, PhD
   Timothy J. Wilt, MD, MPH

This comprehensive systematic review addresses the evidence for integration of mental health services into primary care settings and primary services into specialty outpatient settings. The research questions were:

1. What models of integration have been used?          a. What theoretical models support these programs?          b. What is the evidence that integrated care leads to better outcomes?      2. To what extent does the impact of integrated care programs on outcomes vary for different populations (e.g., specific mental illness conditions, chronically ill, racial/ethnic groups, elderly/youth)?      3. What are the identified barriers to successful integration?          a. How were barriers overcome?          b. What are the barriers to sustainability?      4. To what extent did successful integration programs make use of health information technology (IT)?      5. What financial and/or reimbursement structure was employed in successful integration programs? Is there evidence to suggest that any specific financial/reimbursement strategy is superior to another?      6. What are the key elements of programs that have been successfully implemented and sustained in large health systems? To what extent do they follow, or how do they differ from, models that have been studied in published research studies?

The Minnesota EPC conducted a systematic review to address the following questions for a National Institutes of Health (NIH) Consensus Conference related to Management of Chronic Hepatitis B in Adults.

Consensus conference question 1. What is the natural history of Hepatitis B?      EPC question 1. What is the evidence that the following population characteristics or clinical features associated with hepatitis B are predictive of hepatocellular carcinoma, liver failure, cirrhosis, liver-related death, and all-cause mortality?      Consensus conference question 2. What are the benefits and risks of the current therapeutic options for hepatitis B with defined or continuous courses of treatment?      EPC question 2a. What is the efficacy (or effectiveness) of interferon therapy, oral therapy, and various combinations in treating hepatitis B with defined or continuous courses of treatment?      EPC question 2b. What are the known harms of interferon therapy, oral therapy, and various combinations in treating hepatitis B with defined or continuous courses of treatment? Surrogate outcomes of interest. Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) levels, HBV viral load, change in Hepatitis B e antigen (HBeAg) status, hepatitis B surface antigen (HBsAg) conversion, liver biopsy findings (necroinflammatory activity or stage of fibrosis), and drug resistance. Clinical outcomes of interest. hepatocellular carcinoma, liver failure, cirrhosis, liverrelated death, all-cause mortality.      Consensus conference question 3. Which persons with hepatitis B should be treated?      EPC question 3a. Are there differences in efficacy/effectiveness of treatments for treatment naïve versus drug-resistant patients, chronic HBeAg-positive versus HBeAg-negative patients, or for other subpopulations (as defined previously)?      EPC question 3b. Is there evidence that specific subpopulations do not require treatment for hepatitis B (i.e., that the surrogate and/or clinical outcomes are equivalent or superior when not exposed to treatment?)      Consensus conference question 4. What measures are appropriate to monitor therapy and assess outcomes?      EPC question 4. What is the evidence that changes in surrogate endpoints in response to treatment are reliable predictors of long-term resolution or slowed progression of disease? Patient Population: Adults (≥ 18 years of age), including elderly and members of racial/ethnic minority populations.

PROJECTS CURRENTLY BEING CONDUCTED BY THE MINNESOTA EPC: