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.
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: 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.