11/18/2013 Based on the largest comprehensive systematic review to date, researchers at the Perelman School of Medicine at the University of Pennsylvania concluded that available evidence does not support an association between statins and memory loss or dementia. The new study, a collaborative effort between faculty in Penn Medicine’s Preventive Cardiovascular Program, the Penn Memory Center, and the Penn Center for Evidence-Based Practice, will be published in Annals of Internal Medicine.
“Statins are prescribed to approximately 30 million people in the United States, and these numbers may increase as a result of the national cholesterol guidelines recently released,” said senior study author Emil deGoma, MD, assistant professor of Medicine and medical director of the Preventive Cardiovascular Program at Penn. “A wealth of data supports a benefit of these cholesterol-lowering medications among individuals at risk for cardiovascular disease in terms of a reduction in the risk of heart attack and stroke; however, potential side effects of statins are less well understood. In February 2012, largely based on anecdotal reports, the U.S. Food and Drug Administration (FDA) issued a safety statement warning patients of possible adverse cognitive effects associated with statin use. Many concerned patients have asked if there is a relationship between statins and memory problems. Their concerns, along with the FDA statement, prompted us to pursue a rigorous analysis of all available evidence to better answer the question – are statins associated with changes in cognition?”
The research team conducted a systematic review of the published literature and identified 57 statin studies reporting measures of cognitive function. Dr. deGoma and colleagues found no evidence of an increased risk of dementia with statin therapy. In fact, in cohort studies, statin users had a 13 percent lower risk of dementia, a 21 percent lower risk of Alzheimer’s disease, and a 34 percent lower risk of mild cognitive impairment compared to people who did not take statins.
Most importantly, cognitive test scores were not adversely affected by statin treatment in randomized controlled trials. In these trials, roughly half of the study participants received statins and the other half received placebo. All study participants underwent formal testing of memory and other cognitive domains through tests such as the ability to recall a set of numbers. The analysis of 155 cognitive tests spanning eight categories of cognitive function, including 26 tests of memory, revealed no differences between study participants treated with statins and those provided placebo.
The research team additionally performed an analysis of the FDA post-marketing surveillance databases and found no difference in the frequency of cognitive adverse event reports between statins and two commonly prescribed cardiovascular medications that have not been associated with cognitive impairment, namely, clopidogrel and losartan.
“Overall, these findings are quite reassuring. I wouldn’t let concerns about adverse effects on cognition influence the decision to start a statin in patients suffering from atherosclerotic disease or at risk for cardiovascular disease. I also wouldn’t jump to the conclusion that statins are the culprit when an individual who is taking a statin describes forgetfulness. We may be doing more harm than good if we withhold or stop statins – medications proven to reduce the risk of heart attack and stroke – due to fears that statins might possibly cause memory loss,” said Dr. deGoma.
The team acknowledges that while their analysis is reassuring, large, high-quality randomized controlled trials are needed to confirm their findings.
“For many of the cognitive outcomes that we examined, the identified studies were small, were at risk for bias, used varying diagnostic tests to assess cognitive domains, and did not include patients on high-dose statins, which is important given the increasing use of high-dose statins for secondary prevention,” noted study co-author Craig Umscheid, MD, MSCE, assistant professor of Medicine and Epidemiology and director of the Penn Center for Evidence-based Practice. “Thus, additional trials addressing these limitations would strengthen our conclusions. Despite this, the totality of the evidence does reassure us that there’s unlikely to be a significant link between statins and cognitive impairment.”
Additional Penn authors include Marisa Schoen, BA, Benjamin French, PhD, Matthew D. Mitchell, PhD, Steven E. Arnold, MD, and Daniel J. Rader, MD.
UPHS Team Awarded for Using Information Technology to Reduce Catheter—Associated Urinary Tract Infections
12/04/2012 A Penn Medicine team led by Craig Umscheid, MD, MSCE, FACP, assistant professor of medicine and epidemiology and director of the Center for Evidence-based Practice has won the first place 2012 Health Care Improvement Foundation's (HCIF) "Patient Safety and Quality Award” for its work leveraging information technology to decrease catheter-associated urinary tract infections (CAUTIs).
Established in 2002, the annual honor recognizes "innovative contributions in advancing patient care" and comes with a $5,000 grant to support future efforts in patient safety research. The award was announced at yesterday's annual meeting of the Delaware Valley Healthcare Council of the Hospital & Healthsystem Association of Pennsylvania.
CAUTIs are the most common type of healthcare-associated infection. As much as 70 percent of CAUTIs may be preventable with recommended infection control measures; resulting in as many as 380,000 fewer infections and preventing as many as 9,000 deaths each year. To help eliminate these infections, the Penn Medicine Center for Evidence-based Practice (CEP) worked with the Centers for Disease Control and Prevention to revise the national guidelines on preventing CAUTIs. Then, leaders from Nursing, Infection Control, Quality and Safety, and Information Technology at Penn Medicine collaborated with CEP to integrate the guidelines into computerized clinical decision support to reduce CAUTIs locally.
Over about a year of using this system, the group found that the intervention helped physicians decide whether their patients needed urinary catheters, and alerted physicians when catheters needed to be removed (reducing the days they were used overall).
The life-saving technology, together with other health system interventions, reduced CAUTIs by about 50 percent over about one year. Estimates suggest this effort also led to an estimated financial savings of approximately $140,000 annually.
HCIF is an independent, nonprofit corporation that fosters healthcare initiatives aimed at improving the safety, outcomes, and care experiences in health care facilities across the five-county Philadelphia region.
Penn Medicine Partners with ECRI to Win Evidence-Based Practice Center Designation from the Agency for Healthcare Research and Quality
9/18/2012 The University of Pennsylvania Health System’s Center for Evidence-based Practice, in partnership with the ECRI Institute, a nonprofit organization dedicated to researching approaches to improve patient care, has been selected by the Agency for Healthcare Research and Quality (AHRQ) as one of its 11 Evidence-based Practice Centers (EPCs). This new EPC designation will allow ECRI Institute and Penn Medicine clinicians and researchers to bid for projects through AHRQ to review and synthesize literature on preventive, therapeutic and diagnostic interventions to assess which are most beneficial to patients. The work informs clinical practice guidelines for physicians and educational materials for patients, as well as health-care-related decisions by the federal government, states, and national medical societies, such as those related to the development of new measures of clinical effectiveness and quality.
“We are extremely excited to partner with ECRI on the synthesis of those research findings most important to our patients’ health,” says Craig A. Umscheid, MD, MS, a hospitalist at the Hospital of the University of Pennsylvania, director of the Penn Medicine Center for Evidence-based Practice, and Senior Associate Director of the newly formed ECRI Institute-Penn Medicine EPC. “ECRI’s objectivity and methodologic soundness set the standard for the field of research synthesis. Combined with the breadth and depth of our faculty’s clinical and research expertise, and our Center’s local experience in supporting patient care through research synthesis and dissemination, we’ll be positioned to make a real difference.”
There are no specific dollar amounts that are guaranteed from winning this designation, but the designation itself allows the ECRI-Penn EPC as well as the other 10 AHRQ EPCs to compete for up to $50 million worth of contracts from AHRQ in the next five years.
“We are pleased and honored to hold the trust of AHRQ and the healthcare system more broadly in advancing the science of systematic review to assess the effectiveness of healthcare interventions and practices based on outcomes that matter to patients,” says Karen Schoelles, MD, SM, director of the ECRI Institute-Penn Medicine EPC.
CEP Abstract Wins First Place in National Evidence-Based Quality Improvement Conference
7/20/2012 Julia Lavenberg, PhD, RN, a research analyst at the Penn Medicine Center for Evidence-based Practice, won First Place at the 2012 Summer Institutes on Evidence-Based Quality Improvement conference for her abstract submission entitled “Evidence-based QI: The first six years of a hospital-based HTA center.” The abstract received the highest score out of 120 abstracts submitted. It focused on CEP’s model of integrating evidence into clinical practice across a multi-hospital academic health system. The national conference is an annual one that is offered jointly by the Academic Center for Evidence-Based Practice (ACE) and the Improvement Science Research Network (ISRN) at the University of Texas Health Science Center in San Antonio, Texas. There were 600 registrants for the conference, and attendees included nurses, advance practice nurses, clinicians, researchers, educators, physicians, pharmacists, librarians, and administrators. For more information about Dr. Lavenberg’s abstract, see the Penn Media release here: http://www.uphs.upenn.edu/news/News_Releases/2012/09/lavenberg/. For more information about the conference, click here: http://www.acestar.uthscsa.edu/
Poster Presented at IHI Meeting in Orlando
12/26/2012 Joel Betesh, M.D., F.A.C.P., the Pennsylvania Hospital liaison to the Penn Medicine Center for Evidence-based Practice, presented a poster at the 24th Annual Institute for Healthcare Improvement National Forum in Orlando in December 2012. The poster was entitled “An Evidence Based Practice Center in an Academic Medical Center Supports Continuous Quality Improvement. .” It focused on CEP’s model of integrating evidence into clinical practice across a multi-hospital academic health system, and described the recent collaboartion between CEP and the ECRI Institute as one of eleven AHRQ Evidence-based Practice Centers. The poster highlighted two evidence reviews that were used as the basis for major informatics projects within the health system: the blood transfusion order set and the early warning system for sepsis. The IHI national conference is an annual event. There were 5500 registrants for the conference, and attendees included physicians, nurses, advance practice nurses, researchers, educators, and administrators.
For more information about the conference, click the link below:
Cost/ Benefit Analysis
07/06/2012 Matthew Mitchell and Craig Umscheid of the Center for Evidence-based Practice at Penn Medicine have studied different cardiac stenting locations based on effectiveness, safety and cost.
CEP Work Recognized in Two UPHS Quality and Patient Safety Awards for 2011
01/31/2012 Contributions by the Penn Center for Evidence- based Practice were recognized in two UPHS Quality and Safety Awards for 2011. These awards are designed to acknowledge faculty and staff of UPHS departments who have exhibited leadership and innovation in activities that ensure high quality clinical outcomes, patient satisfaction, patient safety and cost efficiency. CEP team members Terese Kornet, Ingi Lee, Neil Fishman and Craig Umscheid were recognized for their contributions to the submission that was the "Overall Winner" for the UPHS Quality and Patient Safety Award. The submission was titled “The Impact of Computerized Decision Support on Indwelling Urinary Catheter Use at UPHS”. CEP Directors Craig Umscheid and Kendal Williams were also part of a team that received the "Operational Award" for the UPHS Quality and Patient Safety Award. The submission was entitled “Standardizing Identification Of Patients’ Covering Provider Throughout UPHS Hospitals To Improve Communication And Patient Safety”. The list of all of those who collaborated on each project as well as all of the project submissions and award winners is included in the link below.
CEP Introduces a New Product to Communicate Our Most Clinically Relevant Reports to Penn Providers
10/06/2011 - CEP introduces a new format to communicate our most clinically relevant evidence reviews to Penn providers. The synopses are called Penn Reviews Of Valid Evidence – or PROVE. The first of these reviews will address gastrointestinal bleeding prophylaxis for high risk critical care patients, and will include a “bottom line”, results table, commentary by a clinician and an analyst, and a link to the full report.
09/30/2011 - The Center for Evidence-based Practice recently co-authored with the Centers for Disease Control and Prevention (CDC) a guideline for the prevention of norovirus gastroenteritis outbreaks in health care settings. The guideline can be found on the CDC website at http://www.cdc.gov/hicpac/index.html
09/29/2010 Contributions by the Penn Center for Evidence- based Practice were recognized in two UPHS Quality and Safety Awards for 2010. These awards are designed to acknowledge faculty and staff of UPHS departments who have exhibited leadership and innovation in activities that ensure high quality clinical outcomes, patient satisfaction, patient safety and cost efficiency. CEP team members David Goldmann and Brian Leas were recognized for their contributions to the submission that was the "CPUP Overall Winner" for the UPHS Quality and Patient Safety Award. The submission was titled “Introducing best practices for reducing aberrant behavior in patients prescribed opiates for non-cancer pain”. CEP Directors Craig Umscheid and Kendal Williams received "Honorable Mention" for the UPHS Quality and Patient Safety Award for their submission detailing the results of their updated VTE prophylaxis computerized clinical decision support. The submission was entitled “The Impact of an Updated Computerized Clinical Decision Support on Venous Thromboembolism Prophylaxis at UPHS”. The list of all of those who collaborated on each project as well as all of the project submissions and award winners is included in the link below.
1/1/10 - The Center for Evidence-based Practice recently partnered with the Healthcare Infection Control Practices Advisory Committee (HICPAC) to update their guideline methodology and publish new guidelines. HICPAC is a federal advisory committee made up of 14 external infection control experts who provide advice and guidance to the Centers for Disease Control and Prevention (CDC) and the Secretary of the Department of Health and Human Services (HHS) regarding the practice of health care infection control, strategies for surveillance and prevention and control of health care associated infections in United States health care facilities.
CEP was instrumental in updating their guideline methodology and publishing the first guideline using these new methods: "The 2009 Guideline for Prevention of Catheter-associated Urinary Tract Infections". Links to the Methodology Update and the UTI guideline can be found at HICPAC's website.
6/12/09 - Congratulations to Jalpa Doshi, PhD on winning the 2009 Department of Medicine Austrian Award for Health Evaluation Research. Dr. Doshi, Director of CEP's Economic Evaluations Unit, presented a poster titled "Assessing the Financial Impact of a Unit Based Clinical Leadership Model at a University Hospital: A Case Study of Reductions in Central Line-Associated Bloodstream Infections ." The poster estimated the impact of the University of Pennsylvania Health System's Unit Based Clinical Leadership quality infrastructure on catheter associated blood stream infections at Penn. The study was performed by Dr. Doshi along with colleagues in the Center for Evidence-based Practice and the Department of Medicine, and was recently presented as an oral abstract by CEP Co-Director Dr. Craig Umscheid at the Annual Society for Healthcare Epidemiology in America Meeting in San Diego. Besides finding reductions in blood stream infections and costs savings resulting from the novel quality infrastructure, the study also provides an example of the challenges faced and approaches used while evaluating healthcare interventions in the presence of multifaceted quality improvement processes in real-world hospital settings.
6/8/08 - CEP hosted a multidisciplinary forum entitled "Improving the Quality, Safety and Value of Patient Care through Evidence-based Practice" on the Penn campus in Houston Hall's hall of Flags. The purpose was to explore how payors, providers, researchers, policymakers and the biomedical industry can work together to improve the quality, safety and value of patient care in the Philadelphia region through evidence-based practice. Highlights included a keynote address by Brent James, MD, Executive Director, Institute for Healthcare Delivery Research, Intermountain Health Care on collaborative opportunities for applying evidence. Other presenters included:
- Carolyn Clancy, MD, Director, Agency for Healthcare Research and Quality
- L. Gregory Pawlson, MD, MPH, Executive Vice President, National Committee for Quality Assurance
- Donald F. Schwarz, MD, MPH, MBA, Deputy Mayor of Health and Opportunity and Health Commissioner for the City of Philadelphia
- Harold C. Sox, MD, Editor, Annals of Internal Medicine
- I. Steven Udvarhelyi, MD, Senior Vice President and Chief Medical Officer, Independence Blue Cross
- Newell McElwee, PharmD, MSPH, Senior Director, Pfizer
- Steven Teutsch, MD, MPH, Executive Director, Outcomes Research and Management, Merck
.For more information and a link to a full video of Conference proceedings, please visit our Conferences section.
5/23/08 - Congratulations to Dr. Jeff Miller on winning the 2008 Edward W. Holmes Research Award for Residents and Students in Evaluative Research. Dr. Miller, a third year resident in the Department of Medicine, presented a poster titled "Chlorhexidine versus Povidone-Iodine in Skin Antisepsis: A Systematic Review and Cost Analyses to Inform Initiatives to Reduce Hospital Acquired Infections." It describes the work he performed during his resident elective with Dr. Rajender Agarwal at the Center for Evidence-based Practice. Drs. Miller and Agarwal found that chlorhexidine was more cost-effective than betadine at reducing surgical site infections. Their work informed purchasing decisions and policy changes in UPHS operating rooms.
CEP has a new office location...
3/12/08 - Formerly located on 1 Founders in the Hospital of the University of Pennsylvania at 3400 Spruce Street, the Center for Evidence-based Practice has moved to:
3535 Market Street
CEP Sponsors Evidence-based Medicine Resource for UPHS Clinicians
11/1/07 - Beginning November 1, 2007, the UPHS Center for Evidence-based Practice began sponsoring the emailing of InfoPOEMs® to primary care physicians at UPHS, including CPUP and CCA clinicians in Internal Medicine, Gynecology, Family Medicine, and Emergency Medicine. InfoPOEMs® are published by Wiley InterScience®, and are concise daily email summaries of the latest most clinically relevant published peer-reviewed research. After an InfoPOEM® is emailed, it is accessible at all times using the search engine InfoRetriever®. InfoRetriever® also allows you to search other resources like clinical calculators, ICD-9 codes, and abstracts of Cochrane Systematic Reviews. These products were purchased with the hope that the concise, clinically relevant and evidence based information they provide will help UPHS clinicians meet the continual challenge of keeping up to date with the latest study findings that matter most to their patients. The product should also improve accessibility to these findings at and beyond the point of care.
6/25/07 - The Center for Evidence-based Practice recently received an award from the University Research Foundation of the University of Pennsylvania to support our upcoming conference entitled “Improving the Quality, Safety and Value of Patient Care through Evidence-based Practice: A Multidisciplinary Regional Forum”. The conference is being scheduled for Summer 2008. Please check back for more details on the conference.
The Center for Evidence-Based Practice Announces its New Resident Evidence-based Medicine (EBM) Elective
3/1/07 - The Center for Evidence-based Practice recently introduced its Resident Evidence-based Medicine (EBM) elective to the Graduate Medical Education Committee. Created by co-directors Kendal Williams and Craig Umscheid in collaboration with the Biomedical Library, the curriculum applies EBM precepts to real world problems facing the health system. It is open to residents from all services, and will give practical experience in conducting systematic reviews and meta-analyses. Through the elective, participants have the opportunity to take part in one of CEP’s ongoing reviews of healthcare technologies at the University of Pennsylvania Health System, including evaluations of medical and surgical drugs, devices and processes of care. To learn more about the CEP Resident EBM elective, please click here.
Penn Announces New, Unique “Center for Evidence-Based Practice” To Answer Important Clinical Questions by Examining the Evidence
Center to Offer Evidence-Based Guidelines to Health System to Support Healthcare Quality
7/1/06 - The University of Pennsylvania Health System (UPHS) is launching a new “Center for Evidence-Based Practice” in July 2006. Its purpose is to provide, throughout the entire health system, recommendations -- based on scientific methodology -- on clinical practices and policies. The center will evaluate drugs, as well as non-drug technologies like medical devices and equipment, and processes of care by examining research findings and drawing on the expertise of clinicians and industry experts.
“We wanted to create a forum to develop clinical practices and policies that would span the whole health system. The ultimate goal with this new center is to significantly improve patient safety and clinical outcomes and to reduce occurrences,” states P.J. Brennan, MD, Chief Medical Officer at UPHS, who will ultimately oversee the new center. “We want to take a proactive approach to evaluate new drugs on the market and the processes we use -- to have the evidence to support its use. We will methodically examine the data using scientific standards of analysis, and allow a rigorous review, to bring us to a logical conclusion.”
Once a specific medical issue is identified, the center will form a task force consisting of clinician experts from within UPHS to work alongside the center to examine the issue. The review process may last up to a few months for each issue, with multiple reviews occurring simultaneously. The process of review will start with a comprehensive search and evaluation of the world’s medical literature on the issue at hand. Then, the task force will obtain further input from thought leaders, institutional experts, and industry as appropriate.
When all of the evidence is analyzed, the task force will develop a set of recommended guidelines, which will be disseminated to each hospital’s chief medical officer for further review and application. This effort includes all of UPHS: the Hospital of the University of Pennsylvania, Penn Presbyterian Medical Center and Pennsylvania Hospital, all in Philadelphia.
Brennan adds, “The recommendations these task forces make will stem from a language and process that the medical community at Penn knows and respects. The intention here is to create a center that gathers, examines, and analyzes evidence and then brings clinical experts and industry into the process for their input. It’s a way to honestly analyze what we’re using and doing here at Penn. I know of no other center like this in existence at an academic medical center. We will directly apply evidence to clinical practice.”
Kendal Williams, MD, MPH and Craig Umscheid, MD, both Assistant Professors in the Department of Medicine with formal training in public health and epidemiology respectively, will serve as the center’s co-directors.
“Our main mission is to apply the best research findings from around the globe to our patient population. Penn has the ability to do this well,” comments Williams. "With this new center, we’re also tackling the important issue of clinician-industry relations and quality of care. Often many ‘special interests’ involved in patient care are in-line with our goals as healthcare professionals, but not always. It is the responsibility of a health system to promote the health and protect the safety of its patients. The health system leadership is showing, through this new center, that they take this duty very seriously."
In fact, Williams views the new center as a positive way to create a proactive, collaborative, patient-centered relationship between the health system and the pharmaceutical and medical device industry, based on science.
“This will encourage more scientific dialogue with industry rather than marketing dialogue,” adds Umscheid. “We want to be a resource to help our physicians to make decisions and practice medicine based on findings from valid clinical studies. The topic of our first review is the use of aprotinin, a drug used by anesthesiologists during cardiac surgery to reduce blood loss. Recently, its safety has come into question. We assembled a group of clinical experts from within Penn to help us conduct a clinically relevant, systematic review of the pertinent studies on the topic and we hope to recommend guidelines for its use within the next month.”
Also, the new center is in the process of developing a website to post its recommended guidelines so that they can serve as a resource beyond Penn, to the public and to other healthcare professionals who may be dealing with the same issues in similar patient populations.