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1 Lewis H. Walker Cystic Fibrosis Center January 1, 2010 Special Edition Inside this issue: Special Edition Explanation Identifying Pulmonary Exacerbations of CF: The Akron Pulmonary Exacerbation Score PES Scoring Information 4 Pulmonary Exacerbation Treatment Program: A New Standard to Improve Pulmonary Outcomes PeXT Outpatient Algorithm 6 PeXT Inpatient Algorithm 7 CF Inpatient Plan of Care: What a Conept! Cover Current Features SPECIAL EDITION Pulmonary Exacerbations Kimberly A. Spoonhower, MD I n this special edition of our newsletter, we discuss a topic that seems, at first glance, easy to figure out: When is a person with CF sick? In other words, what are the symptoms they might have when they have a flare-up, or exacerbation, of their lung problems? Once we figure that out, what should we do about it? Everyone is familiar with our aggressive use of antibiotics specific to the bacteria that grow in an individual s sputum or throat culture. However, in many years of CF research, few studies have determined how long we should give those antibiotics, and by what route (oral, intravenous, or nebulized). Thus, the CF care team at the Lewis H. Walker CF Center has been diligently working over the last several years to answer these questions, and this newsletter is dedicated to our quest to provide legendary care of pulmonary exacerbations for people with CF. In this issue, we highlight the use of antibiotics to treat pulmonary exacerbations. Although we rely on antibiotics to kill bacteria and make people better, we want to emphasize that all the antibiotics in the world may not make someone better without three additional, key elements: aggressive airway clearance, nutrition, and energy management. Airway clearance remains critically important to rid the airways of sticky mucus that can continue to trap bacteria faster than the antibiotics can work to clear it, and to prevent ongoing, irreversible lung damage. Additionally, maintaining a healthy body weight is always important for people with CF, but it becomes even more important when that body is trying to fight off an infection. Aggressive nutritional management with supplements and nutritious, high-calorie food remains critical to treating a pulmonary exacerbation as well. Finally, helping the body rest and use energy to fight infection while maintaining overall strength and endurance is important as well. This is why our physical therapists do what they do to help people best use their energy in the hospital. Although this issue highlights our decision process for prescribing antibiotics, please remember that antibiotics are only one of four key strategies to treat pulmonary exacerbations. For people admitted to the hospital for treatment, these strategies are reflected in the Inpatient Plan of Care. In this newsletter, Dr. Kraynack discusses how we figure out when someone is sick, and describes the success of the Pulmonary Exacerbation Score (PES). Finally, Dr. Spoonhower discusses our new Pulmonary Exacerbation Treatment (PExT) Program and how we decide to give antibiotics and for how long. Peggy Walder RN reviews the inpatient Plan of Care. We hope you find this special edition of our newsletter helpful.

2 P a ge 2 S pecial Edition Identifying Pulmonary Exacerbations of CF: The Akron Pulmonary Exacerbation Score (PES) Nathan C. Kraynack, MD M any of the symptoms of cystic fibrosis (CF) are related to the lungs. The airways in CF become obstructed by thick and sticky mucus. Unfortunately, this mucus is a great place for bacteria to live and grow. This chronic bacterial infection causes inflammation in the lung tissue which leads to lung damage. This cycle happens repeatedly over years, with periods of stable health mixed with episodes of increased respiratory symptoms. We call these episodes, with increased coughing or sputum production, "pulmonary exacerbations". This cycle of inflammation, bacterial infection, and exacerbation leads to worsening lung disease over time. Therefore, it is critically important to aggressively treat pulmonary exacerbations (PEx) because increased number and severity of exacerbations are associated with lung damage, decreased lung function, decreased quality of life, and increased health care costs. Exacerbations are very common and increase in frequency with age. Antibiotics intravenously (IV) and hospitalization are often needed to treat exacerbations effectively. Despite the critical role that a PEx plays in CF lung disease, no standard criteria for the diagnosis of a PEx have been universally accepted by CF specialists. Thus, the diagnosis of a PEx in a patient with CF remains up to the CF care provider and patient. A number of diagnostic criteria for a PEx exist and are in widespread use, including that from the Cystic Fibrosis Clinical Practice Guidelines, unfortunately these have not completely caught on. Many other definitions are used for research studies, but these define an exacerbation based on the patient receiving antibiotics. This is a potential problem because studies show that CF care providers practice slighlty differently, and one provider's idea of an exacerbation that requires antibiotics may be quite different from another provider's idea of an exacerbation that requires antibiotics. Therefore, using the decision to treat a patient as part of any definition of an exacerbation is a problem. In fact, by some estimates from CF centers around the country and the world, only 1/2 to 1/3 of patients who are having a PEx are treated with antibiotics within two weeks of the diagnosis. In studies that try to determine what defines a PEx, a number of signs and symptoms that are associated with treatment of an exacerbation "jump out" as important. These signs and symptoms include the following: increased cough, change in chest congestion or mucus, decreased exercise tolerance, decreased appetite, decreased weight, coughing up blood, change in chest sounds heard by the CF provider, and increased respiratory rate. So, why can't everyone just agree on a standard definition for a PEx? I don't know, but here is what we did about it! Our CF Center became interested in the criteria for treatment of pulmonary exacerbations in 2004 as part of the Cystic Fibrosis Foundation s Quality Improvement (QI) Initiative. At that time, our CF Registry data showed that our center s pediatric patients had pulmonary function that was well below the national average. We were not happy with this. Interestingly, the hospitalization rate of our pediatric patients was also below the national average. One possible explanation for this difference was a less aggressive approach to treating PEx in our pediatric patients. Another possibility was that the providers at our center used different definitions for a PEx, or that some providers were more likely to prescribe antibiotics early, while others may have waited to see if things got better. Using a series of clinical case scenarios (kind of like a multiple choice test) that described a typical patient with CF experiencing various signs and symptoms of a PEx, we determined that the CF care providers at our center did have different approaches to identifying a PEx and how to treat it. Currently, more than 13 CF centers have now taken this test (over 120 CF specialists) and we found that the same thing happens at most CF centers. One provider says, "Give antibiotics!", and another provider in the same centers says, "Don't give antibiotics". This is very confusing for CF patients, their families, and for the CF providers. We concluded from this study that a standard definition of a PEx was very much needed and could be used by other CF specialists. Using all the available medical studies on exacerbations, our CF center developed a Pulmonary Exacerbation Score (PES) to identify patients experiencing an exacerbation. The PES was designed to be comprehensive, include elements of previously published studies, practical, and convenient for providers to use. The score has fourteen elements and is divided into three clinical domains: systemic (meaning total body ) signs and symptoms, pulmonary signs and symptoms, and objective measurements (including lung function measurements). A minimum score on the PES for the presence of a pulmonary exacerbation was defined based on the available medical studies and an agreement of all CF care specialists (adult and pediatric CF physicians and nurse clinicians) at our care center. The PES was trialed for two years in all patients 6-18 years old at our CF center.

3 FEV1% Predicted S pecial Edition P a ge 3 Identifying Pulmonary Exacerbations of CF: The Akron Pulmonary Exacerbation Score (PES) Con t During that time, a PES was calculated for all patients seen at our center at every visit. We tracked the use of the PES on a weekly basis to see if the providers were using it and treating the pulmonary exacerbations for scores 5 or more. To see if using the PES made any improvement in the overall lung function at our center, we also kept track of lung function at our center on a quarterly basis using the CF registry database. Over the first two years of using the PES the lung function of our 6-18 year old patients increased dramatically. It improved by about 6% over the two-year period. It may sound small, but this is the same amount of improvement seen in studies when patients start a new medicine like TOBI (R) or Pulmozyme (R). The PES was incorporated into our clinic visit record in 2007 and is now the standard of care at our CF center. Since standardizing of the definition of a PEx at our center, average lung function continues to improve and is now about 9% higher than when we started using the PES! To put this in perspective, on the average someone with CF loses about 2% of their lung functionper year. A 9% increase in lung function could prolong someone's need for lung transplant for 3-4 years! Although the PES was initially studied in patients 6-18 years-old, it is used for all patients over age 6 years in our center since we started our project. A standard, modified version of the PES is used by the clinical nursing staff over the telephone to determine who needs to be seen in clinic for a "sick visit" or who needs antibiotics started right away. A similar, modified version of the PES is being developed for patients younger than 6 years or those unable to perform pulmonary function testing (the Pedi-PES). Using a standardized definition of a CF pulmonary exacerbation is associated with improved pulmonary function in pediatric patients at our CF center. This has never been done before! The PES is comprehensive, practical, and convenient Median FEV1% Predicted Furthermore, it does not require any additional information above what is typically gathered at a routine CF visit. Modifications of this tool have been useful for younger patients, those unable to perform pulmonary function testing, and for determining which patients may need to be seen in the clinic or treated for an exacerbation over the phone. Now that we have the PES as our standard definition, the next step is to standardize how we treat an exacerbation. What antibiotics should we use? Oral medicines at home or IV's in the hospital? How long should we treat for? The PES is very important, but just the beginning. The PExT is the NExT step! Please ask your CF provider to explain the PES in further detail at you next visit if you want to know more, and please see the "Pulmonary Exacerbations: Information for Patients and Families" page of this special issue of Current Features. 96 Figure 1: This graph shows 92 the lung function (FEV 1 % predicted) of all CF patients years at our center from We started using 88 the PES in October The 86 PES became our standard of care in January Since 84 instituting the PES, lung function has increased dramatically Implemented PES Standardized PES y Year

4 P a ge 4 S pecial Edition Pulmonary Exacerbations: Information for Patient s & Families AND Do You Know That Lung infections (pulmonary exacerbations) are a main cause of lung damage in people with CF? Do you know that your CF provider uses these symptoms to determine a Pulmonary Exacerbation Score (pes) to help them decide if you or your child need antibiotics? fevers, even low grade, for a week or two can be a sign of a lung infection? being tired or just not feeling well for a week or two can be a sign of a lung infection? missing school or work, for any reason, may mean that you are getting sick? not eating well or just not feeling hungry for a week or two can be a sign of a lung infection? losing weight or not gaining weight (if a child) in between clinic visits can be a sign of a lung infection? any change in cough (more frequently, spells lasting longer, or increasing harshness ) for as little as a week can be a sign of a lung infection? any change in mucus coughed up (if it is new, if its more frequent, if there is more of it or if it changes color) for as little as a week can be a sign of a lung infection? even a little shortness of breath with any activity (walking, climbing stairs, or exercising) or feeling short of breath when sitting can be a sign of a lung infection? new noises made by the lungs (wheezes, crackles, mucus flopping in the airways ) or breathing faster or heavier is a sign of a lung infection? even small decreases in lung function (as little as ~ 10%) over 3-6 months can be a sign of a lung infection and a need for antibiotics? new findings on lung X-rays, even if they are small or minor, may mean that you are getting sick even if you don t feel bad? coughing up blood, even if it is a small amount in streaks or flecks in the mucus can mean that a lung infection is starting or worsening and may need antibiotics? YOUR FINAL PES SCORE EQUALS THE SUM OF ALL THE COMPONENTS PES=1pt PES=1pt PES=2pts PES=1pt PES=2pts MILD~PES=1pt, SIGNIFICANT~PES=2pts MILD~PES=1pt, SIGNIFICANT~PES=2pts PES=2pts PES=2pts PES=3pts IF DOWN 10%, PES=5pts IF DOWN 15% PES=1, 2 OR 5pts DEPENDING ON FINDING PES=3pts FOR BLOOD STREAKED MUCUS, PES=5pts JUST BLOOD =TOTAL PES SCORE A PES 5=A NEED FOR ANTIBIOTICS

5 S pecial Edition P a ge 5 Pulmonary Exacerbation Treatment Program: A New Standard to Improve Pulmonary Outcomes Kimberly A. Spoonhower, MD I n the history of medicine, few improvements have made as great an impact as the development of antibiotics. Antibiotics were developed at a critical time in the understanding of cystic fibrosis and its treatment. Penicillin was first given to patients with CF in the early 1950 s, and at the time, small doses led to great responses and significantly improved survival for people with cystic fibrosis. Although we still give antibiotics, the means by which we deliver antibiotics have improved. Many physicians and nurses remember when intravenous catheters (IV s) were primarily used to administer fluids, and people with CF were admitted to the hospital for painful, intra-muscular shots of antibiotics every eight hours. Although the number of antibiotics available and their power to kill harmful bacteria has grown and continues to grow almost every year, CF care providers still have little information to guide their use. We rationally choose antibiotics based on the throat and sputum cultures we get in clinic, but there are few studies to tell us how long to give those well-chosen antibiotics, if it is better to give them by mouth or IV or inhaled, and how to decide if someone is sick enough for antibiotics. In other words, we need studies to define a pulmonary exacerbation, and how best to treat it. Dr. Kraynack and the Akron team were nationally recognized for our work in developing the Pulmonary Exacerbation Score (PES) described previously in this newsletter. Following the success of the PES, Dr. Kraynack and his team were awarded a grant from the Cystic Fibrosis Foundation to use the PES to continue to improve treatment for pulmonary exacerbations (PEx). After preliminary work, the team developed the PExT program, or the Pulmonary Exacerbation Treatment algorithm to outline standardized care for a CF pulmonary exacerbation. Using data collected through the PES project, we outlined a standardized care algorithm for both the outpatient treatment and inpatient treatment of a PEx as outlined below (see figures 1 and 2). The PExT program aims to define an exacerbation using the PES and to assist CF care providers and patients to determine the appropriate duration of antibiotic therapy, the most appropriate route of antibiotic delivery, and the time to follow-up to ensure resolution of the PEx. Standardized treatment is meant to provide the most aggressive care possible, and to improve the overall health and pulmonary function of patients at the Lewis H. Walker CF Center. Overall, our treatment of pulmonary exacerbations will not be terribly different. We will continue to identify an exacerbation using the PES for patients age 6 years and older (we hope to develop a Pedi-PES" for our younger patients soon). We will continue to choose antibiotics based on the results of throat and sputum cultures to pick the antibiotics to which the bacteria are most susceptible. One potential difference is how aggressive we will be using IV antibiotics. After reviewing hundreds of exacerbations over the last several months, we noticed that if the PES was > 12, patients were almost always given IV antibiotics. Therefore, we picked a PES of 12 as a cutoff for a severe exacerbation that requires aggressive therapy with IV antibiotics, either in the hospital or at home as the safety of the antibiotic allows. If the PES is 10-12, the exacerbation is considered moderate, and either oral or IV antibiotics can be used. We outlined several considerations that may influence a provider and patient to choose one route over the other. For example, if someone has received several courses of oral antibiotics in the last month, although the current exacerbation may not be severe, oral antibiotics are less likely to work, so IV antibiotics could be used instead. The most noticeable difference for the outpatient management of exacerbations will be the follow-up. In an effort to ensure that people obtain the maximal benefit from treatment, people receiving IV antibiotics will need to follow-up weekly to monitor for toxicity as well as improvement in lung function and symptoms, and those receiving oral antibiotics will need to follow-up in 2-3 weeks after the start of the exacerbation. This not only helps us make sure that people get better but also allows us to act quickly to change course or consider alternate treatments if we do not see the expected improvement. For people admitted to the hospital for IV antibiotics, care will remain much the same but with the addition of more frequent assessments with pulmonay function tests (PFTs). As noted on figure 2, PFTs will be done on hospital day 6, 9, 13, and if needed day 17. This results in approximately one extra PFT during an average two-week admission. Previously, it was our practice to obtain PFTs on Mondays. With the PExT program, PFTs may not necessarily fall on a Monday. In conclusion, we hope that our new algorithm will improve the overall lung function at our center, but also improve the quality of care for individual people with CF experiencing a pulmonary exacerbation. We anticipate this program will not only help patients in our community but will also lead to benefits for people with CF throughout the country. Using standard treatment approaches to improve patient outcomes is not new; in fact there are standard, nationally recognized treatment protocols for heart attacks and strokes that have improved survival for these conditions. We hope our PExT program will do the same for pulmonary exacerbations in CF.

6 P a ge 6 S pecial Edition Figure 1

7 S pecial Edition P a ge 7 Figure 2

8 P a ge 8 S pecial Edition CF Inpatient Patient Plan of Care: What a Concept! Peggy Walder, RN I n July of 2007, the CF Team at the Lewis H. Walker Cystic Fibrosis Center announced the creation of an individualized Inpatient Plan of Care to be used during hospital admissions. The realization that the CF daily regimen can be overwhelming, especially when a patient and family are taken out of the comfort of their home, brought together a group of multi-disciplinary staff here at Akron Children s Hospital. Together we established a list of routine daily practices that are considered to provide the best and safest management of cystic fibrosis in accordance with the standards of the CF Foundation. The group included doctors, nurses, child life specialists, physical and respiratory therapists, nutritionists, educators and case managers who shared the same goal: to ensure that all of the medications and therapies needed to promote good CF health would be given in a beneficial, timely manner. In other words, the patient and family would experience the best possible benefit from their hospital stay. What exactly is the Individualized Plan of Care? It is a schedule, an agenda of sorts, which accommodates the complexities of the CF regimen. We realize that our patients are individuals and that circumstances of illness require any plan of care to be flexible while supporting the 4 key strategies used to treat a pulmonary exacerbation: 1) aggressive use of antibiotics, 2) efficient airway clearance, 3) good nutrition and 4) energy management. Therefore, our system is designed to be written and re-written as needed to provide the best quality medical care tailored to a patient s specific needs. With this in mind, patients and parents can expect the following components of the plan of care shortly after arrival to the hospital: PExT A member of the nursing staff presents the Inpatient Plan of Care. It starts as a basic schedule representing the level of care provided to all patients. It shows the times of day to expect things like vital signs (temperature, blood pressure, weight, etc.) and daily physical assessments, as well as time for personal hygiene, meals/ snacks and age-appropriate bedtimes. Medications are reviewed and dosing times are added to the plan of care according to the home schedule whenever possible. This allows us to verify medications make corrections as needed. Allergies are also noted for the record and ID bracelet. The doctor s orders are reviewed, including any additional medications, aerosols and IV infusions that have been ordered. These are added to the care plan at the appropriate intervals, for example, at mealtimes. The orders may also include blood sugar checks, tube feedings and procedures such as x-rays or other special tests. Other CF therapies are reviewed, such as nutritional counseling, airway clearance, and physical therapy sessions. These will be planned as much as possible with your personal preferences in mind, within the availability of the healthcare provider. Exclusion from these sessions will require an order from the physician. Child Life activities, tutoring and free time are also placed on the care plan according to availability. Keep in mind that some days will be busier than others depending on tests or procedures that need to be done. Current hospital and CF isolation policies are reviewed on an individual basis. Rules concerning going off the nursing unit are also be reviewed. Refusals of medications and therapies without legitimate reason are reported to the physician on a daily basis. Three or more refusals are also reported to parents and plans to correct the situation will be discussed. The Inpatient Plan of Care is posted in the room so that the patient and family are aware of expectations and can be involved with changes that need to be made. Age-appropriate action plans are used to provide direction and to teach healthy CF practices to our younger patients who are becoming accustomed to hospital visits. Members of the CF Team will make contact with you at intervals during the hospital stay to assist with adjustments and questions. As you can see, the Inpatient Plan of Care is designed with the your child s/ your individual needs in mind. The expectation is that choosing healthy self-care practices and planning the daily schedule will promote involvement of each patient in his or her care. To accomplish this, we need your cooperation and patience. We invite you to partner with us to achieve good outcomes. After all, we are all on the same team! Everyone s doing it... So should you

9 S pecial Edition P a ge 9 But I Thought it is Winter Kimberly A. Spoonhower, MD Is the CF Team behind in their newsletter again? Why the fall theme with multicolored leaves? Although thinking we are late is a safe bet, the leaves symbolize change, which is key to improving quality through standardized care. Many people worry that standardized care means impersonal treatment. However, just as our patients and care providers are remarkable, unique individuals, each tree has brilliantly colored, diverse leaves. However, it is the collective brilliance of those varied leaves that brings awe and stunning beauty in the fall. Thus, together, we can change our individual practices to produce a system that provides legendary care for people living with cystic fibrosis.

10 Lewis H. Walker Cystic Fibrosis Center Purpose: To provide legendary care and service to our patients and families with cystic fibrosis. Lewis H. Walker Cystic Fibrosis Center Mission: To develop cutting edge, comprehensive, individualized care programs for cystic fibrosis though the use of Quality Improvement principles and the adaptation of the newest clinical research. The Lewis H. Walker Cystic Fibrosis Center has cared for individuals with CF for more than 60 years. We have been a leader in Quality Improvement in CF for over 5 years. Many team members are considered national and international QI experts, helping spread the use of QI principles to other CF care centers. We currently serve over 200 patients diagnosed with CF. There are 78 individuals seen in our adult CF program, and 144 children and adolescents in our pediatric center. We are one of six programs dedicated to CF care in the state of Ohio. Lewis H. Walker Cystic Fibrosis Center Division of Pulmonary Medicine One Perkins Square Akron, Ohio Phone Fax We re on the web, check it out!

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