Cut and Dry Insights to Prevent Surgical Site Infections
Centers for Disease Control and Prevention Guideline for the Prevention of Surgical Site Infection, 2017 JAMA Surgery by the Centers for Disease Control and Prevention
August 23, 2017 –PHILADELPHIA — Regardless of the place and procedure, undergoing surgery is often associated with anxiety and concerns. After all, how can a patient be certain their doctor is following best practices to ensure a safe and successful procedure?
Even in common procedures like hip and knee replacements, surgical site infections (SSIs) – an infection occurring at the site of the surgery – can occur. Almost 300,000 SSIs occur annually in the United States. Estimates suggest that up to half may be preventable with the use of current evidence-based strategies. Additionally, due to antimicrobial–resistant pathogens, the costs and challenges associated with treating SSIs is growing.
A guideline published this month in JAMA Surgery by the Centers for Disease Control and Prevention, and supported by Craig A Umscheid, MD, MSCE, vice chair for Quality and Safety at Penn Medicine and an associate professor in General Internal Medicine, and his team, provides the most up to date recommendations for clinicians and organizations about how to prevent SSIs in their care settings.
The guideline is based on a systematic literature review of 170 studies conducted by Umscheid and his colleagues, and examines 10 core domains that pertain to all surgical procedures and 10 additional areas that pertain strictly to orthopaedic surgery. For example, one core recommendation suggests providing a higher percentage of inspired oxygen to reduce the risk of surgical site infections for patients who are intubated (i.e. have a tube inserted into their throat to help them breathe) during their procedure. Other core recommendations advise surgeons about how to administer intravenous antibiotics during a procedure, and to limit antibiotics after a procedure when there is no benefit and only harm.
The section on joint replacement makes recommendations about the use of blood transfusions, what to do for patients who are on steroids to minimize infection risk during a surgical procedure, and biofilms on prosthetic joints. If a patient gets a joint infection, one of the biggest problems is that the inserted hardware can also get infected, and an impenetrable biofilm can form around the infected hardware such that antibiotics cannot clear the infection, thus forcing surgeons to remove the prosthetic joint.
In 1999, the Centers for Disease Control and Prevention published guidelines on surgical site infection prevention. The update to that guideline began over five years ago, but Ebola, Zika and other national and international healthcare emergencies delayed its completion.
The news blog checked in with Umscheid to see what the major takeaways are from this guideline and how it can improve the safety of surgical procedures.
Q: Why is this update timely and significant?
A: SSIs are increasing, and can be particularly devastating in relatively common procedures like joint surgery, where you can get an infection of your prosthetic joint, or in heart surgery, where you can get an infection of your sternotomy site, which is where an incision has been made through your chest bone to reach your heart. That said, when current evidence-based strategies are used SSIs are often preventable, so we have opportunity here to strengthen care.
Q: Can you give us an example of how one of these recommendations might change care?
A: One of the core recommendations is about keeping patients warm during surgery. If the patient gets cold in the operating room, this can increase the risk of surgical site infection. So the surgical team should use blankets and devices like bear huggers to keep patients warm during the operating room procedure to reduce the risk.
Q: In the study, the team discusses how best to administer intravenous antibiotics or prepare a surgical site before a surgeon makes an incision to prevent infection. You also provide recommendations about how to control blood sugar levels. These seem like standard practices, but is it concerning to you that some places have not implemented all of these?
A: Many health care organizations have implemented most or all of these practices, but we hope this work informs those who have room to improve – institutions that might have practice gaps between what we know works and what their practicing in the real world. Most importantly, we hope this guideline helps address the ongoing debates over some of the controversial issues in SSI prevention – such as how to prepare a surgical site, how long to give antibiotics after a procedure, how much oxygen to give patients during a procedure, whether to use triclosan coated sutures to prevent SSI, and so on.
Umscheid directs the Center for Evidence Based Practice, and his team has worked on quality and safety issues related to healthcare associated infections for years. The team tackled preventing catheter-associated urinary tract infections in a 2010 CDC guideline in Infection Control and Hospital Epidemiology. A year later, they co-authored a CDC guideline with recommendations to hospitals about how to prevent norovirus gastroenteritis outbreaks. They published another CDC guideline in 2013 on preventing infections during solid organ transplantation, and two years later, the Agency for Healthcare Research and Quality funded the group’s work to systematically review approaches to cleaning hospital room surfaces to prevent HAIs, a review later published in the Annals of Internal Medicine.
This latest work is more than five years in the making, and early signals suggest it may have great impact. The level of interest from peers – more than 1/2 million views, 75,000 downloads, and the most “tweeted,” “posted,” and “blogged” about JAMA Surgery article in history – gives the team hope that this momentum will continue, and the findings will inform surgical practice at the national and international level.
“Clinical practice and quality measures are informed by guidelines,” Umscheid says. “This is about ensuring all patients in all hospitals receive the best evidence-based care available.”
Penn Physician-Administrator Selected for Panel to Improve Healthcare Systems
Craig A. Umscheid, MD, MSCE, brings broad background to guide patient research priorities
August 23, 2016 –PHILADELPHIA — Craig A. Umscheid, MD, MSCE, an associate professor of Medicine and Epidemiology at the Perelman School of Medicine at the University of Pennsylvania, has been appointed by the Patient-Centered Outcomes Research Institute to serve on its Advisory Panel on Improving Healthcare Systems. Umscheid is also director of the Penn Medicine Center for Evidence-based Practice, which summarizes and disseminates scientific evidence for improving care delivery.
The Institute is an independent, Washington, D.C.-based nonprofit organization authorized by Congress to fund research that provides patients, caregivers, and clinicians with evidence-based information for making better-informed health care decisions.
During his three-year term, Umscheid and colleagues on the panel will help the Institute identify research funding priorities that reflect outcomes that matter most to patients and other health care decision makers.
Umscheid was selected “on the basis of his experience, expertise, and ability to contribute to the panel’s tasks and responsibilities.” Panel members represent a wide range of health care perspectives including patients, family members, clinicians, and researchers, as well as representatives of health systems and educational institutions.
The Advisory Panel on Improving Healthcare Systems is one of seven that advises the Institute. About 40 candidates from over 400 nominees were selected to serve on these seven panels. Eight out of 145 nominees were selected to serve on the Improving Healthcare Systems panel.
“I am honored to have been chosen to serve on this important advisory panel,” Umscheid said. “Whether as inpatients or outpatients, people receive vital, often life-extending and life-saving care in our nation’s hospitals and health care systems. Ensuring that these systems make use of the best, most up-to-date scientific evidence is crucial for maintaining patients’ health and saving lives.”
Umscheid is also medical director of clinical decision support, where he helps develop and deploy informatics interventions and care pathways to facilitate high-value care. He also is vice chair for quality and safety in the department of Medicine at Penn, and a practicing physician in hospital medicine.
Externally, Umscheid’s roles include assisting the Centers for Disease Control and Prevention with guideline development, and leading the Penn portion of the ECRI Institute - Penn Medicine Agency for Healthcare Research and Quality funded Evidence-based Practice Center, one of 13 such centers funded to perform comparative effectiveness reviews to inform national healthcare policy. Umscheid received his undergraduate degree from Cornell, his medical degree from Georgetown, and a master’s of science in clinical epidemiology from Penn's Center for Clinical Epidemiology and Biostatistics.
More information about the Advisory Panel on Improving Healthcare Systems is available on the Patient-Centered Outcomes Research Institute website.
Study Suggests Reduced Immunosuppression Drug Dose May Be Best for Kidney Transplant Outcomes
Penn researchers analyze immunosuppressant strategies to determine most effective treatment for better, longer term renal function
March 15, 2016 –The kidney is the most commonly transplanted organ in the United States, with more than 17,000 transplants performed each year. Following kidney transplant, patients are routinely placed on a regimen of immunosuppressant medications to prevent organ rejection, which often includes calcineurin inhibitors (CNIs) as the backbone medication of this regimen. However, questions remain about the best use of these drugs to strike the balance between preventing rejection and avoiding drug-related complications. Researchers from the Perelman School of Medicine at the University of Pennsylvania, in partnership with ECRI Institute under the ECRI Institute-Penn Medicine Evidence-based Practice Center contract, investigated four immunosuppression strategies and found that many patients might benefit from a lower-than-standard dose of CNIs. Their findings are detailed in a study published this week in the American Journal of Transplantation, with additional research included online in an extended Agency for Healthcare Research and Quality (AHRQ) report.
One of the main hurdles in using immunosuppressant medications is finding the right balance between too little drug, which results in organ rejection, and too much drug, which can increase risk of infections, renal failure, cardiovascular disease and diabetes. As part of the larger AHRQ report, the team conducted an analysis of 105 studies from 1994 through 2015 to compare laboratory techniques for monitoring CNI drug levels, to examine the best times to collect CNI drug levels, and to evaluate alternatives to using standard dose CNIs as part of the immunosuppressant regimen in kidney transplant recipients.
“A big question in the field is whether there is a benefit to prescribing an alternative CNI dose, or even an entirely different immunosuppressant regimen for kidney recipients,” said Deirdre Sawinski, MD, an assistant professor in the division of Renal Electrolyte and Hypertension. “CNI dosing protocols have changed over time but the impact on clinical outcomes is unknown.”
The AHRQ report and publication in the American Journal of Transplantation focused on determining whether the standard CNI recommendations provide the best results for patients and their kidneys. Researchers evaluated four CNI strategies to determine which had the best long-term clinical impact. These strategies included:
- Minimization: using a lower-than-standard CNI dosage
- Conversion: switching to a different class of immunosuppressants after starting a standard dosage CNI
- Withdrawal: tapering off of a CNI regimen without adding a new immunosuppressant
- Avoidance: the use of a immunosuppressant regimen that does not include CNIs from the start of therapy
“To answer this specific dosage question, we evaluated 88 randomized controlled trials that examined one or more of the four CNI strategies,” said Craig A. Umscheid, MD, MSCE, an assistant professor of General Internal Medicine and Epidemiology and director of the Center for Evidence-based Practice. “Findings suggest that CNI minimization results in better clinical outcomes than standard dose CNI regimens. Evidence for the conversion and withdrawal strategies suggested trade-offs between improved renal function and higher risk of rejection, and the evidence for the avoidance strategy was insufficient to make conclusions.”
Researchers agree that there is more to be explored when it comes to CNI immunosuppression regimens and finding the best therapies for maintaining renal function over a longer period of time. The study notes that a majority of the research analyzed only evaluated low-risk patients and did not examine high-risk kidney recipients, such as those with second transplants, other organ transplants, or HIV. The available studies also tended to evaluate the older CNI cyclosporine, rather than the newer CNI tacrolimus, which is now more commonly used. In addition, there were limited data on patient outcomes after long-term use of CNI regimens, which is a critical evidence gap given that patients are living longer following transplants, and adverse events associated with CNIs can often take years to manifest.
Other Penn study authors include Jennifer Trofe-Clark, Pharm D, a clinical transplant pharmacist and adjunct associate professor in the division of Renal Electrolyte and Hypertension, Sony Tuteja, Pharm D, MS, a research associate in the division of Translational Medicine and Human Genetics, Brian Leas, MS, MA, a research analyst in the Center for Evidence-based Practice, and Benjamin C. French, PhD, an associate professor of Biostatistics. Authors from ECRI Institute include Stacey Uhl, MS, and Janice Kaczmarek, MS. Funding for the research has been provided by the Agency for Healthcare Research and Quality (AHRQ, U.S. Department of Health and Human Services, HHSA 290-2012-00011I).
Evidence-based Practice Model Can Help Hospitals Crunch Data to Deliver Best Care, Cut Costs, and Reduce Hospital Error
Penn Medicine Researchers Produce First Comprehensive Assessment of the Role of Evidence-Based Practice Centers in Decision-Making within a United States Hospital
November 4, 2015 – Amid continued pressures to minimize errors and cut costs, hospitals are continuing to scramble to find solutions to problems plaguing health systems nationwide.
A possible solution to many of those issues can be found in hospital evidence-based practice centers (EPCs), says a new Penn Medicine study suggesting EPCs can effectively inform decision-making in medical settings. In the first comprehensive assessment of the role of EPCS in decision-making in a United States hospital, study authors say EPCs can help clinical and administrative leaders understand problems and evaluate possible solutions by reviewing the available scientific literature when national guidelines are not available, thus filling a critical knowledge gap. By putting this published evidence into practice, these centers can improve quality, safety and value of medical care offered, and improve relationships between clinicians and administrators, all fostering a culture of evidence-based practice.
“Hospital EPCs are also uniquely equipped to identify and adapt national evidence-based guidelines and systematic reviews to benefit their local institutions,” says Craig A. Umscheid, MD, MSCE, an assistant professor of Medicine, director of Penn Medicine’s Center for Evidence-Based Practice (CEP), and senior author of the study, published online ahead of print last week in the Journal of Hospital Medicine. “By synthesizing this valuable data, EPCs can inform health care leaders on how to make decisions that improve care, cut costs, and achieve other positive changes throughout their operations.”
Established in 2006, Penn Medicine’s CEP is staffed by a hospitalist director, three research analysts, six physician and nurse liaisons, a health economist, a biostatistician, administrator, and librarians. To accomplish its mission of strengthening quality, safety, and value of care delivered at the Health System, the CEP performs rapid systematic reviews of published research, translates evidence into practice using computer-based interventions in electronic health records, and educates trainees, staff, and faculty on evidence-based decision making.
While the number of hospital EPCs has grown worldwide, there are few known EPCs doing this work in the U.S. Also, the limited research available on EPCs focuses on their evaluations of technology, neglecting to take a comprehensive look at the role hospital EPCs play in integrating evidence into clinical practice.
In this study, the researchers analyzed an internal database of evidence reviews performed by the University of Pennsylvania Health System’s CEP for internal requestors between July 2006 (when the CEP was established) and June 2014. The team then conducted an anonymous web survey of all of those who requested a report during the last four of the Center’s eight fiscal years.
The study found that nearly 250 reports were produced in the Center’s first eight years. Clinical departments, chief medical officers, and purchasing committees were the most common requestors of reports. Drugs and devices were the two most commonly reviewed types of technologies, but topics ranging from care processes, organizational systems and policies, and medical and surgical procedures were also commonly reviewed. Examples of reviews include evaluations of the effectiveness and safety of:
Drugs (for example, celecoxib for pain in joint replacement)
Devices (for example, automated systems to monitor hand hygiene of hospital staff)
Care processes (for example, how to best manage patients experiencing gastrointestinal bleeding)
Reports were completed within two to three months on average, and more than 10 percent of reports were used to develop computerized interventions in the electronic health record.
The survey data of 46 respondents found that 98 percent of report requestors said the scope of the review and level of detail was “about right,” and 77 percent said reports confirmed their tentative decision.
When asked whether the report informed their decision, 79 percent of requestors “agreed” or “strongly agreed,” underlining the vital role of the evidence reviews. Respondents also found the reports easy to request, easy to use, timely, and relevant, resulting in high requestor satisfaction.
The most common reasons cited for requesting a report was the CEP’s skills in identifying and synthesizing the available evidence, and the Center’s objectivity. Authors add that this credibility underscores the value of a neutral center in an environment where clinical departments and hospital committees may have competing interests, and where politics and external influences (including industry) may otherwise negatively influence institutional decision making.
The study’s other co-authors were Kishore L. Jayakumar, Julia Lavenberg, Matthew D. Mitchell, Jalpa A. Doshi, Brian Leas, David R. Goldman, Kendal Williams, and Patrick J. Brennan, all of Penn Medicine.
Funding for this research was provided by the National Center for Research Resources (UL1RR024134), which is now at the National Center for Advancing Translational Sciences (UL1TR000003).
Penn Study Finds Important Gaps in Evidence for Best Methods for Cleaning Hospital Rooms to Prevent Healthcare-associated Infections
Additional research needed to help lower risk for patients
August 10, 2015 – Tray tables, bed rails, light switches, and toilets: All are common vectors for swapping germs between patients and health care workers. While a new systematic overview in this week’s Annals of Internal Medicine points to several promising cleaning tactics of these “high-touch surfaces,” there’s a lack of evidence as to which is the most effective at reducing healthcare-associated infections (HAIs). Few studies measured patient outcomes or focused on newer technologies, and even less compared cleaning tactics against one another — important gaps to fill as the U.S. health care system works to reduce the 75,000 HAI-related deaths that occur annually.
The systematic overview was led by Craig A. Umscheid, MD, MSCE, an assistant professor of Medicine and Epidemiology in the Perelman School of Medicine at the University of Pennsylvania, and Senior Associate Director at the ECRI Institute-Penn Medicine Agency for Healthcare Research and Quality (AHRQ)-funded Evidence-Based Practice Center (EPC), Jennifer Han, MD, MSCE, an assistant professor of Medicine and Epidemiology, and Brian Leas, MS, MA, and Nancy Sullivan, research analysts in the ECRI-Penn AHRQ EPC, and revealed major gaps in existing evidence for the best practices for cleaning hospital room surfaces to prevent HAIs, including Clostridium difficile, MRSA, andVRE.
“The cleaning of hard surfaces in hospital rooms is critical for reducing healthcare-associated infections,” said Han, the study’s lead author. “We found that the research to date does provide a good overall picture of the before and after results of particular cleaning agents and approaches to monitoring cleanliness. Researchers now need to take the next step and compare the various ways of cleaning these surfaces and monitoring their cleanliness in order to determine which are the most effective in driving down the rate of hospital-acquired infections.”
While studies examining HAIs have increased over the last 15 years, infections acquired in the hospital remain a leading cause of death and morbidity. In 2011, there were over 721,000 HAIs in the U.S., according to the most recently available data from the U.S. Centers for Disease Control and Prevention (CDC). What’s more, many experts believe that only 50 percent of surfaces are typically disinfected during cleaning of a patient’s room.
Examining 80 studies published between 1998 and 2014, the research team found that comparative effectiveness studies were uncommon. Such studies would have directly compared different ways of cleaning, disinfecting, and monitoring the cleanliness of hard surfaces in order to determine which were most effective. There were also relatively few studies that focused on measuring outcomes of most interest to patients, such as changes in HAI rates or the presence of pathogens on patients. Only five of the studies were randomized controlled trials.
Instead, the existing studies were largely before and after experiments, comparing the magnitude of surface contamination after cleaning with a particular agent to the magnitude of contamination before cleaning. Over 65 percent of the studies assessed surface contamination, such as bacterial burden and colony counts, as the primary outcome. Less than 35 percent reported on patient-centered outcomes, such as HAI rates or acquisition of a specific organism in the body, known as colonization.
The ECRI-Penn EPC team looked at three broad categories of evidence: 1) which agents and methods were used to clean hard surfaces; 2) what approaches were available to monitor the effectiveness of cleaning; and 3) what systems-level factors are needed for cleaning and monitoring to be successful. In addition to its literature review, the researchers interviewed a number of national experts.
“Our goal was to provide a comprehensive review of evidence in all three domains,” said Umscheid, the study’s senior author. “While there is a clear need for more patient-centered and comparative effectiveness research, the findings that do exist provide a good place to start in terms of a hospital or health care entity seeking information on ways to mitigate healthcare-associated infections.”
Among its findings, the EPC team identified several studies showing that rates of C. difficile (or “C. diff”),the most common cause of hospital-acquired gastrointestinal infections, fell with the use of bleach-based disinfectants but that a chlorine dioxide-based product was ineffective in reducing C. diff contamination and infection rates. Patients taking antibiotics are at special risk of becoming infected with C. diff because antibiotics can disrupt the normal bacteria of the bowel. According to the CDC, C. diff caused almost half a million infections in the United States in 2011.
In addition, six studies integrating various wipes moistened with hydrogen peroxide and other chemicals into preventive strategies reported positive outcomes, including sustained reductions in HAIs. Seventeen studies implementing “no-touch” modalities to clean hard surfaces – such as devices that emit ultraviolet light or hydrogen peroxide vapor – reported positive findings, with three specifically demonstrating reductions in infection rates. Seven of eight studies evaluating enhanced coatings on hospital room surfaces, such as copper-coated bed rails, reported positive findings. Surfaces made of solid, copper-based metals or alloys continuously kill bacteria that cause infections.
The EPC team also highlighted several priority areas for future research, based on their review of the evidence and interviews with leading experts. Questions to emphasize in future studies include: what surfaces present the greatest infection risk to patients, what benchmarks should be established for measuring cleanliness, and what factors affect the quality of routine disinfection practices? Further research is also needed on recently emerging disinfection strategies.
“In addition to expanding the use of comparative effectiveness research and placing greater emphasis on patient-centered outcomes, future research should investigate the effectiveness of a number of promising new technologies and approaches,” said Han. “These include self-disinfecting coatings and increasingly used surface markers for monitoring the presence of pathogens. Other challenges include identifying high-touch surfaces that confer the greatest risk of pathogen transmission and developing standard thresholds for defining cleanliness.”
Other co-authors include David A. Pegues, MD, from Penn, and Janice L. Kaczmarek, MS from ECRI Institute.
Penn Study Shows Computer-Assisted Diagnosis Tool Helps Physicians Assess Skin Conditions Without Aid from Dermatologists: Tool Harnesses Photo Database to Improve Diagnostic Accuracy
April 22, 2015 – In the first major study to examine the use of a computer-assisted, photo-driven differential diagnosis generator for skin conditions, researchers at the Perelman School of Medicine at the University of Pennsylvania found physicians routinely used the tool, without an increase in calling for inpatient dermatology consultations. The software diagnostic tool, VisualDx, aids in diagnosing dermatologic conditions by allowing physicians to enter information such as the type and location of a rash, and associated symptoms such as pain or itching, and then generating a range of possible diagnoses accompanied by photographs. This enables users to rapidly compare the rash of an individual patient to a database of more than 1,300 pediatric and adult skin conditions represented by nearly 30,000 images, with the aim of improving diagnostic accuracy reducing misdiagnosis-related harm.
The study, published early online in Diagnosis (http://www.degruyter.com/view/j/dx.ahead-of-print/dx-2014-0058/dx-2014-0058.xml), found that the rate of dermatologic consultations at the Hospital of the University of Pennsylvania, the flagship hospital of Penn Medicine, did not change for the 18 months after VisualDx was introduced compared to the 12 months before it was introduced.
“This is important because these tools by design suggest numerous potential diagnoses, which could result in an increase in unnecessary testing and specialty consultation, and associated costs and harms, particularly in the hands of less experienced clinicians,” says the study’s senior author, Craig A. Umscheid, MD, MSCE, assistant professor of Medicine and Epidemiology and director of the Penn Medicine Center for Evidence-based Practice. “Conversely, if there were a significant reduction in dermatologic consultations, it would have suggested that general internists, emergency room physicians, family doctors and pediatricians, all of whom by definition are not specialists in dermatology, may have relied on the tool to make dermatologic diagnoses, rather than consulting a dermatologist for help.”
The Penn team examined the use of VisualDx throughout the University of Pennsylvania Health System by month for the 18 months following its introduction in September 2012. Researchers found a median of 474 unique monthly VisualDx sessions by users, a rate that continued throughout the time period under study. The researchers found that, overall, VisualDx was accessed through mobile devices (35 percent); inpatient (34 percent), outpatient (11 percent), and emergency department (one percent) electronic health records; and via searches in UpToDate, a point-of-care evidence summary resource (19 percent).
“Technology like this has great promise, but it can’t help patients unless it’s actually used,” says Umscheid. “Previous studies have been primarily simulations, where researchers take variables from case studies and input them into the software to retroactively assess the diagnostic accuracy of the software. However, our purpose was to determine if a differential diagnosis generator like VisualDx would actually be used by providers if implemented in a hospital, and we found that it is — most often on mobile devices and by inpatient providers.”
Differential diagnosis generators have been suggested as a potential way of reducing misdiagnosis, which is estimated to result in 40,000 to 80,000 deaths in U.S. hospitals annually. “The technology can help users overcome cognitive shortcomings such as availability bias, in which providers diagnose patients with conditions they’ve recently seen or can easily recall, rather than those conditions that are most likely to occur. It can also reduce fund of knowledge deficiencies by directing users to diagnoses they might not have otherwise considered,” commented the study’s lead author John Barbieri, MD, MBA, a 2014 graduate of the Perelman School of Medicine and The Wharton School.
The other Penn co-author was Benjamin French, PhD. The study was supported in part by the National Institutes of Health (UL1RR024134 and UL1TR000003).The ECRI Institute-Penn Medicine Evidence-based Practice Center (EPC) was recently redesignated by the Agency for Healthcare Research and Quality (AHRQ) to serve as an EPC through 2019. ECRI Institute has maintained this designation since the inception of the EPC program in 1997. The ECRI Institute-Penn Medicine EPC was established in 2012.
AHRQ Redesignates ECRI Institute-Penn Medicine as Evidence-based Practice Center
New 5-year contract supports the Agency for Healthcare Research and Quality in its efforts to disseminate scientific research of important healthcare topics
January 30, 2015 — The ECRI Institute-Penn Medicine Evidence-based Practice Center (EPC) was recently redesignated by the Agency for Healthcare Research and Quality (AHRQ) to serve as an EPC through 2019. ECRI Institute has maintained this designation since the inception of the EPC program in 1997. The ECRI Institute-Penn Medicine EPC was established in 2012.
Under the new contract, known as EPC V, the ECRI Institute-Penn Medicine EPC will work with clinicians, policymakers, patients, consumers, and other scientific partners to develop topics and questions for systematic review of the literature, and to promote the synthesis, translation, and dissemination of research evidence. The EPC has reported on a variety of topics, many in the area of cancer, genetic testing, and imaging tests (access free reports).
As part of the new contract, all 13 Evidence-based Practice Centers will be eligible to bid on work to support the U.S. Preventive Services Task Force (USPSTF), an independent, volunteer panel of experts in prevention and evidence-based medicine dedicated to improving the health of Americans.
“Since we began working together, we’ve been able to utilize ECRI Institute’s independent, evidence-based research and Penn Medicine’s clinical and academic leadership to advance research to improve patient care,” says Karen Schoelles, MD, SM, director of the ECRI Institute-Penn Medicine EPC. “This new contract inspires us to build on our previous collaborations and break into new research territory.
”“We look forward to continuing our efforts to transform patient care delivery as we work alongside ECRI Institute and AHRQ,” says Craig A. Umscheid, MD, MSCE, director of the Penn Medicine Center for Evidence-based Practice and senior associate director of the ECRI Institute-Penn Medicine EPC.
The EPC will work with Insight Policy Research, a small woman-owned disadvantaged business.
To learn more about ECRI Institute’s work in evaluating health technologies through the Evidence-based Practice Center, membership in the Health Technology Assessment Information Service, and customized consultation and support for clinical practice guideline development, e-mail firstname.lastname@example.org, or call (610) 825-6000, ext. 5519.
Penn Medicine Experts Urge Expansion of Federal Incentives to Improve Patient Care Quality and Safety
Focusing on structural changes in addition to individual clinical outcomes would bring greater gains
January 13, 2015 — In an invited commentary published online by JAMA Internal Medicine, Patrick J. Brennan, MD, chief medical officer of the University of Pennsylvania Health System, and Craig A. Umscheid, MD, MSCE, director of Penn’s Center for Evidence-based Practice, recommend that the Centers for Medicare and Medicaid Services shift its use of financial incentives from an exclusive focus on preventing specific clinical outcomes toward encouraging the creation of hospital-wide structures that promote the translation of research evidence into clinical practice to improve the quality and safety of patient care.
In 2008, Medicare implemented the Hospital-Acquired Conditions Initiative, a policy denying incremental payment for eight complications of hospital care, also known as “never events.” Another study published in JAMA Internal Medicine led by Teresa Waters, PhD, of the University of Tennessee Health Science Center, found that after the new federal policy was introduced, central line-associated bloodstream infections fell by 11 percent and catheter-associated urinary tract infections fell by ten percent. But there was no significant reduction in hospital-acquired pressure ulcers and serious inpatient falls.
The study authors suggested that the difference in the policy’s effects on infections as compared to falls and pressure ulcers were the result of the evidence available at the time to guide hospitals to improve these outcomes.
But the Penn authors disagreed. Instead, they suggested that the difference in the policy’s effect had more to do with the challenge of improving complex quality outcomes such as pressure ulcers and inpatient falls, when compared to the easier-to-improve outcome of infections. Unlike infection prevention efforts, which often target care providers and involve changes to a limited set of procedures such as catheter insertion and occur in closely monitored settings such as intensive care units, efforts at reducing falls and pressure ulcers are much more complex. They require multidisciplinary, patient-centered collaboration across the entire spectrum of care, not just critical care.
“Incentives are indeed important,” says Brennan. “But they must be the right incentives. There was good-quality evidence available to underpin fall and pressure ulcer prevention efforts when the CMS initiative was launched. Yet neither of these measures has significantly improved. This may be because it’s simply not possible to reduce falls and pressure ulcers by taking a few clear-cut steps, as in the case of reducing infections. Instead, broader and more comprehensive structural changes within hospitals should be considered. Such efforts would reduce an even larger number of never events than by simply tackling them one at a time.”
Hospitals should aim to bridge what’s called the “knowing-doing gap,” Umscheid says. “That’s the disconnect between what we know works based on the best available evidence and what we actually practice. To bridge the gap, we are not advocating abandoning incentives that focus on individual clinical outcomes. Instead we are urging federal regulators to also encourage institution-wide structural changes. We believe these changes can create the necessary conditions for solving difficult problems such as falls and pressure ulcers -- and others as well.”
The structural changes suggested by Brennan and Umscheid are the fabric of Penn Medicine’s successful quality improvement program. They include:
- establishing unit-based leadership, where physicians, nurses, and quality administrators work together on their local wards or clinics to ensure that quality standards are met
- creating data stores that can provide local evidence for which quality initiatives are effective
- investing in staff education on evidence-based quality improvement, including in-house learning academies
- opening local evidence-based practice centers, where experts can identify and adapt national evidence and best practices to address local problems identified by staff
Penn Medicine's "Sepsis Sniffer" Generates Faster Sepsis Care and Suggests Reduced Mortality: Early identification and intervention lead to better results for hospital inpatients
October 9, 2014 — An automated early warning and response system for sepsis developed by Penn Medicine experts has resulted in a marked increase in sepsis identification and care, transfer to the ICU, and an indication of fewer deaths due to sepsis. A study assessing the tool is published online in the Journal of Hospital Medicine.
Sepsis is a potentially life-threatening complication of an infection; it can severely impair the body’s organs, causing them to fail. There are as many as three million cases of severe sepsis and 750,000 resulting deaths in the United States annually. Early detection and treatment, typically with antibiotics and intravenous fluids, is critical for survival.
The Penn prediction tool, dubbed the “sepsis sniffer,” uses laboratory and vital-sign data (such as body temperature, heart rate, and blood pressure) in the electronic health record of hospital inpatients to identify those at risk for sepsis. When certain data thresholds are detected, the system automatically sends an electronic communication to physicians, nurses, and other members of a rapid response team who quickly perform a bedside evaluation and take action to stabilize or transfer the patient to the intensive care unit if warranted.
The study developed the prediction tool using 4,575 patients admitted to the University of Pennsylvania Health System (UPHS) in October 2011. The study then validated the tool during a pre-implementation period from June to September 2012, when data on admitted patients was evaluated and alerts triggered in a database, but no notifications were sent to providers on the ground. Outcomes in that control period were then compared to a post-implementation period from June to September 2013. The total number of patients included in the pre and post periods was 31,093.
In both the pre- and post-implementation periods, four percent of patient visits triggered the alert. Analysis revealed 90 percent of those patients received bedside evaluations by the care team within 30 minutes of the alert being issued. In addition, the researchers found that the tool resulted in:
• A two to three-fold increase in orders for tests that could help identify the presence of sepsis
• A 1.5 to two-fold increase in the administration of antibiotics and intravenous fluids
• An increase of more than 50 percent in the proportion of patients quickly transferred to the ICU
• A 50 percent increase in documentation of sepsis in the patients’ electronic health record
The study found a lower death rate from sepsis and an increase in the number of patients successfully discharged home, although these findings did not reach statistical significance.
“Our study is the first we’re aware of that was implemented throughout a multihospital health system,” said lead author Craig A. Umscheid, MD, MSCE, director of Penn’s Center for Evidence-based Practice. “Previous studies that have examined the impact of sepsis prediction tools at other institutions have only taken place on a limited number of inpatient wards. The varied patient populations, clinical staffing, practice models, and practice cultures across our health system increases the generalizability of our findings to other health care settings.”
Umscheid also noted that the tool could help triage patients for suitability of ICU transfer. “By better identifying those with sepsis requiring advanced care, the tool can help screen out patients not needing the inevitably limited number of ICU beds.”
In addition to Umscheid, the other Penn co-authors are Joel Betesh, MD; Christine Vanzandbergen, PA, MPH; Asaf Hanish, MPH; Gordon Tait, BS; Mark E. Mikkelsen, MD, MSCE; Benjamin French, PhD; and Barry D. Fuchs, MD, MS.
Dr. Umscheid’s contribution to this project was supported in part by the National Institutes of Health, National Center for Advancing Translational Sciences, grant # UL1TR000003.
Penn Study: Electronic Alerts Significantly Reduce Catheter-Associated Urinary Tract Infections - Design of alerts crucial in achieving benefits for patients
August 22, 2014 — A Penn Medicine team has found that targeted automated alerts in electronic health records significantly reduce urinary tract infections in hospital patients with urinary catheters. In addition, when the design of the alert was simplified, the rate of improvement dramatically increased.
The alerts help physicians decide whether their patients need urinary catheters in the first place and then alert them to reassess the need for catheters that have not been removed within a recommended time period. The electronic alert, developed by medical researchers and technology experts at the Perelman School of Medicine at the University of Pennsylvania, is the subject of a study published in the September issue of Infection Control and Hospital Epidemiology.
Approximately 75 percent of urinary tract infections acquired in the hospital are associated with a urinary catheter, which is a tube inserted into the bladder through the urethra to drain urine. According to the Centers for Disease Control and Prevention, 15 to 25 percent of hospitalized patients receive urinary catheters during their hospital stay. As many as 70 percent of urinary tract infections in these patients may be preventable using infection control measures such as removing no longer needed catheters resulting in up to 380,000 fewer infections and 9,000 fewer deaths each year.
“Our study has two crucial, applicable findings,” said the Penn study’s lead author Charles A. Baillie, MD, an internal medicine specialist and fellow in the Center for Clinical Epidemiology and Biostatistics at Penn Medicine. “First, electronic alerts do result in fewer catheter-associated urinary tract infections. Second, the design of the alerts is very important. By making the alert quicker and easier to use, we saw a dramatic increase in the number of catheters removed in patients who no longer needed them. Fewer catheters means fewer infections, fewer days in the hospital, and even, fewer deaths. Not to mention the dollars saved by the health system in general.”
In the first phase of the study, two percent of urinary catheters were removed after an initial “off-the-shelf” electronic alert was triggered (the stock alert was part of the standard software package for the electronic health record). Hoping to improve on this result in a second phase of the study, Penn experts developed and used a simplified alert based on national guidelines for removing urinary catheters they had previously published with the CDC. Following introduction of the simplified alert, the proportion of catheter removals increased more than seven-fold to 15 percent.
The study also found that catheter associated urinary tract infections decreased from an initial rate of .84 per 1,000 patient days to .70 per 1,000 patient-days following implementation of the first alert and .50 per 1,000 patient days following implementation of the simplified alert. Among other improvements, the simplified alert required two mouse clicks to submit a remove-urinary-catheter order compared to seven mouse clicks required by the original alert.
The study was conducted among 222,475 inpatient admissions in the three hospitals of the University of Pennsylvania Health System between March 2009 and May 2012. In patients’ electronic health records, physicians were prompted to specify the reason (among ten options) for inserting a urinary catheter. On the basis of the reason selected, they were subsequently alerted to reassess the need for the catheter if it had not been removed within the recommended time period based on the reason chosen.
Women’s health units had the highest proportion of alerts that led to a remove-urinary-catheter order and critical care units saw the lowest proportion of alerts leading to a remove order.
“As more hospitals adopt electronic health records, studies such as ours can help point the way toward improved patient care,” said senior author Craig Umscheid, MD, MSCE, assistant professor of Medicine and Epidemiology and director of Penn’s Center for Evidence-based Practice. “Thoughtful development and deployment of technology solutions really can make a difference. In this study, we learned that no two alerts are alike, and that changes to an alert’s usability can dramatically increase its impact.”
Several studies have already shown that reminder systems to limit the use and duration of urinary catheters can lower catheter infection rates. However, the majority of these have used non-computerized reminders, such as written reminders or stickers. The current Penn study is one of the largest to examine the impact of electronically generated alerts. In addition to the size of the study, a second strength is its multi-year duration. Most prior studies relied on a brief study period, and several studies observed an increase in catheter use when the relatively brief intervention had ended.
In addition to Baillie and Umscheid, other Penn Medicine co-authors are Mika Epps, MSN, RN; Asaf Hanish, MPH; Neil O. Fishman, MD; and Benjamin French, PhD.
Link Between Ritual Circumcision Procedure and Herpes Infection in Infants Examined by Penn Medicine AnalysisJuly 24, 2014 — A rare procedure occasionally performed during Jewish circumcisions that involves direct oral suction is a likely source of herpes simplex virus type 1 (HSV-1) transmissions documented in infants between 1988 and 2012, a literature review conducted by Penn Medicine researchers and published online in the Journal of the Pediatric Infectious Diseases Society found. The reviewers, from Penn’s Center for Evidence-based Practice, identified 30 reported cases in New York, Canada and Israel.
The practice—known as metzitzah b’peh—and its link to HSV-1 infections have sparked international debate in recent years, yet no systematic review of the literature has been published in a peer-reviewed journal examining the association and potential risk. During metzitzah b’peh, the mohel, a Jewish person trained to perform circumcisions, orally extracts a small amount of blood from the circumcision wound and discards it.
Lead author Brian F. Leas, MS, MA, a research analyst in the Center for Evidence-based Practice at the University of Pennsylvania Health System, identified six relevant studies for the systematic review. All six studies were descriptive case reports or case series that documented neonatal HSV-1 infections after circumcision with direct oral suction.
“There is sufficient clinical evidence to suggest the practice is a source of infection and therefore a risk exists—though the extent or magnitude of that risk is not well defined and warrants further investigation,” said Leas. All of the studies, the authors report, presented clinical findings consistent with the transmission of infection from mohel to infant, including the location of HSV lesions, timing of symptoms, and HSV type. Two infants died, whereas others experienced mild to severe symptoms of the virus.
More than half of American adults are infected with HSV-1, which frequently presents itself as oral lesions, or cold sores, though many people never or rarely develop symptoms. Newborns infected with HSV-1, on the other hand, can become very sick quickly with high fever and seizures, and it can even cause death. Herpes simplex virus type 2 is a sexually-transmitted disease and is characterized by genital lesions, and is less common, affecting about 16 percent of adults.
The practice of metzitzah b’peh has been used in some ultra-Orthodox Jewish circles; however, the researchers note it is unclear how many metzitzah b’pehs take place in the United States per year.
The New York City Department of Health and Mental Hygiene instituted regulations in the fall of 2012, after a number of babies contracted herpes following the practice. Mohels in New York City are required to obtain written consent from parents before performing metzitzah b’peh. New York City has a relatively higher population of those who identify as ultra-Orthodox compared to the rest of the country.
In a 2012 report, an American Academy of Pediatrics task force concluded that circumcision is safe and provides overall health benefits, including reducing the risk of HIV, but advised against direct oral suction due to risk of infection.
“Neonatal herpes infection can cause severe morbidity and potentially death, so mitigating potential risks for infection is critical,” the authors write. “More research using cohort or case-control designs to fully capture all the relevant data is needed to clarify the real-world risk of HSV-1 infection associated with metzitzah b’peh.”Craig A. Umscheid, MD, MSCE, an assistant professor of Medicine and Epidemiology at the Perelman School of Medicine and Director of Penn Medicine’s Center for Evidence-based Practice, was the senior author on the study.
Major Gaps in Hepatitis C Care Identified As New Drugs and Screening Efforts Emerge, Penn Study Finds.
Less than 10 percent of People Infected with Hepatitis C are Cured
In the largest study of its kind, the team examined data culled from 10 studies between 2003 and 2013 and found that less than 10 percent of people infected with hepatitis C in the United States — 330,000 of nearly 3.5 million people — were cured (achieved viral suppression) with antiviral hepatitis C treatment. The researchers also found that only 50 percent of people were diagnosed and aware of their infection; 43 percent of those with the disease had access to outpatient care; and only 16 percent were prescribed treatment.
“This study puts forth a good baseline of hepatitis C care in the United States over the last 10 years—which will be useful in monitoring the success and impact of new screening efforts and advances in antiviral therapy,” said the study’s first author,Baligh Yehia, MD, MPP, MSHP, an assistant professor of Medicine in Penn’s division of Infectious Diseases. “There are many people who don’t know that they have the infection, don’t have access to hepatitis C care and medications, and who haven’t been treated. With this data, we can see these gaps more clearly. This information will be useful for ensuring better access to hepatitis c care and treatment in the coming years.”
In June, the Centers for Medicare and Medicaid Services began reimbursing for hepatitis C virus screenings for two target populations, including baby boomers (those born between 1945 through 1965) and those at high risk for the infection. Six months prior, the U.S. Food & Drug Administration (FDA) approved sofosbuvir, an oral medication shown to cure most cases of hepatitis C infection, with fewer side effects than the current treatment options. Other drugs — which have shown success in clinical trials, some conducted at Penn Medicine—are expected to gain FDA approval within the year.
“The new regimens will be game changers in the treatment of chronic hepatitis C,” said senior author Vincent Lo Re III, MD, MSCE, assistant professor of Medicine and Epidemiology in the division of Infectious Diseases and department of Biostatistics and Epidemiology at Penn. “Given the high prevalence of this infection, particularly in baby boomers who didn’t know they were infected, having new, highly-effective treatment options to eradicate the virus will be a tremendous benefit to patients that will ultimately help us to reduce liver-related complications and re-infection rates.”
Such advances are expected to increase the number of patients treated for the disease. In the 1990s, HIV treatment turned a monumental corner with the advent of antiretroviral therapy. “It’s a very similar situation that we can learn from,” said Yehia. “With those advances, came challenges with access to and engagement in care. As hepatitis C therapy continues to advance, a focus on improving diagnosis, linkage to care, and insurance coverage will be more critical.”
The team screened close to 10,000 articles before identifying 10 studies that address one or more steps in the cascade of care, ranging from diagnosis to viral suppression. Some of the data came from the National Health and Nutrition Examination Survey and the Chronic Hepatitis B and C Cohort study. The researchers addressed seven key steps along this cascade and estimated the following based off the data analyzed:
- Number of people with chronic hepatitis C infection—3.5 million
- Diagnosed and aware of their infection—1.7 million (50% of those with infection)
- Those with access to outpatient care –1.5 million (43% of those with infection)
- Hepatitis C RNA confirmed—950,000 (27% of those with infection)
- Disease staged by liver biopsy—580,000 (17% of those with infection)
- Prescribed treatment—550,000 (16% of those with infection)
- Achieved sustained virologic response—330,000 (9% of those with infection)
Co-authors of the study, which was funded by the National Institutes of Health, include Craig A. Umscheid, MD, MSCE, and Asher J. Schranz, MD.
Penn Experts Urge Focus on Reducing Preventable Hospital Readmissions, Estimated to Constitute Just 25 Percent of All Readmissions.
Current efforts may hinder quality improvement and unfairly penalize hospitals
Under the Affordable Care Act, hospitals must report readmission rates for heart attack, heart failure, and pneumonia to CMS. CMS then imposes financial penalties on institutions having an excessive number of readmissions that take place within 30 days following patient discharge. Additional medical conditions will be added in 2015. Many patients with these conditions suffer from additional illnesses that are complex and come with many co-morbid conditions.
“Reducing hospital readmissions is clearly important on many levels,” says lead author Julia G. Lavenberg, PhD, RN, a research analyst at Penn’s Center for Evidence-based Practice. “Patients prefer to remain at home, payers save money, and hospitals avoid financial penalties for having high readmission rates. But while current policy assumes that a significant proportion of readmissions are preventable, research tells us that this is simply not so. Moreover, there is no consensus in the medical and policy communities on how to define preventable readmissions, which is essential for taking action to reduce them.”
Other payers, such as private insurers, are likely to follow the federal lead and withhold funding for high readmission rates. As a result, hospitals and health systems nationwide are devoting significant time, effort, and money to reducing readmissions. Steps include increasing patient education before discharge, introducing or expanding home health visits, and working more closely with nursing homes and rehabilitation centers.
“Current research tells us that only about 25 percent of hospital readmissions are preventable,” says senior author Sunil Kripalani, MD, MSc, chief of the Section of Hospital Medicine at Vanderbilt University. “We urge a focus on preventing these readmissions, so that hospitals can enhance efforts in areas where it will have the greatest effect as well as ensure fair and equitable reporting of hospital performance.”
Until a validated measure of preventability is developed, the authors recommend several steps. First, the readmission time horizon should be reduced from the current 30 days to seven or 15 days, as research suggests that early readmissions – those within seven to 15 days of discharge -- are more likely preventable than those occurring later. Second, policymakers should take the socioeconomic status of patients into account by only comparing hospitals serving similar patient communities when determining penalties for excess readmission rates. Finally, adjusting for other community factors such as practice patterns and access to care is necessary to more accurately reflect factors under a hospital’s control.
“We’re encouraging a major shift in perspective,” adds co-author Craig A Umscheid, MD, MSCE, a hospitalist and Director of the Center for Evidence-based Practice at Penn. “We want policymakers to acknowledge that hospitals should not be penalized for factors beyond their control which may play an important role in readmissions, such as inadequate community health resources or severity of the patient’s illness.”
Such a shift would require agreement among healthcare researchers and policymakers on how to identify and measure preventable or potentially preventable readmissions. While there are existing methods for doing so, there is no consensus on which is best. Furthermore, some of these methods are proprietary and thus unavailable for evaluation by others. These methods use such techniques as identifying readmission for conditions closely related to the original diagnosis or complications arising from the original admission.
To rectify this gap, the authors urge healthcare researchers and policymakers to come to agreement on a transparent, universal method for defining preventable or potentially preventable readmissions. This could include algorithms -- based on insurance claims data -- that recognize patterned relationships between original and readmission diagnoses for a variety of medical conditions. Then, clinicians at individual hospitals could use these standards to evaluate whether individual readmissions were potentially preventable or not. In time, researchers could codify these individual decisions into best-practice standards to serve as guides for subsequent assessments.
In addition to Lavenberg and Umscheid, Penn co-authors include Brian Leas; Kendal Williams, MD; and David R. Goldmann, MD.
Dr. Umscheid was supported in part by the National Center for Research Resources and the National Center for Advancing Translational Sciences (UL1TR000003). Dr. Kripalani receives funding from the National Heart, Lung and Blood Institute (R01HL109388), and from CMS (1C1CMS331006-01 and 1C1CMS330979-01).
Penn Study Shows Automated Prediction Alert Helps Identify Patients at Risk for 30-Day Readmission11/27/2013 An automated prediction tool which identifies newly admitted patients who are at risk for readmission within 30 days of discharge has been successfully incorporated into the electronic health record of the University of Pennsylvania Health System. The tool, developed by researchers at the Perelman School of Medicine, is the subject of a study published in the December issue of the Journal of Hospital Medicine.
The all-Penn team found that having been admitted to the hospital two or more times in the 12 months prior to admission is the best way to predict which patients are at risk for being readmitted in the 30 days after discharge. As a result of this finding, the automated tool is now able to identify patients as being “high risk” for readmission and creates a “flag” in their electronic health record. Upon admission of a high-risk patient, the flag appears next to the patient’s name in a column titled “readmission risk.” The flag can be double-clicked to display detailed information relevant to discharge planning including inpatient and emergency department visits over the previous 12 months, as well as information about the care teams, lengths of stay, and problem(s) associated with those prior admissions.
“The results we’ve seen with this tool show that we can predict, with a good deal of accuracy, patients who are at risk of being readmitted within 30 days of discharge,” said lead author Charles A. Baillie, MD, an internal medicine specialist and fellow in the Center for Clinical Epidemiology and Biostatistics at Penn Medicine. “With this knowledge, care teams have the ability to target these patients, making sure they receive the most intensive interventions necessary to prevent their readmission.”
Interventions proven to help reduce 30-day readmissions include enhanced patient education and medication reconciliation on the day of discharge, increased home services to provide a safe landing, follow up appointments soon after discharge, and follow-up phone calls to ensure an extra level of protection. In the process of medication reconciliation, pharmacists compare a patient's current hospital medication orders to all of the medications that the patient was taking at home prior to their hospital admission. This is done to avoid medication errors such as omissions, duplications, dosing errors, or drug interactions.
In support of the study, the Penn Medicine Center for Evidence-based Practice identified in the published literature a number of variables associated with readmission to the hospital, including: prior admissions, visits to the emergency department, previous 30-day readmissions, and the presence of multiple medical disorders.
Using two years of retrospective data, the team examined these variables using their own local data and found that a single variable – prior admission to the hospital two or more times within a span of 12 months – was the best predictor of being readmitted in the future. This marker was integrated into the electronic health record and was studied prospectively for the next year. During that time, patients who triggered the readmission alert were subsequently readmitted 31 percent of the time. When an alert was not triggered, patients were readmitted only 11 percent of the time.
“By automating the process of readmission risk prediction, we were able to provide risk assessment quickly and efficiently in real time, enabling all members of the inpatient team to carry out a coordinated approach to discharge planning, with special attention paid to those identified as being at the highest risk for readmission,” said Craig A Umscheid, MD, MSCE, assistant professor of Medicine and Epidemiology, director of the Penn Medicine Center for Evidence-based Practice, and senior author on the study.
The risk assessment tool is part of a series of steps taken by Penn Medicine to reduce readmissions.
“Readmission rates should improve over time as the risk flag is used more routinely and the interventions necessary to reduce readmission rates for those identified as high risk are implemented,” said Baillie.
In addition to Baillie and Umscheid, other Penn Medicine co-authors include Christine VanZandbergen, Gordon Tait, Asaf Hanish, Brian Leas, Benjamin French, C. William Hanson, and Maryam Behta.
Penn Medicine Review Finds Statin Use Not Linked to a Decline in Cognitive Function
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.