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NKDEP Coordinating Panel Meeting
 Summary- December 16, 2013

NKDEP Coordinating Panel

  • Amy Barton Pai, PharmD, BCPS, FASN, FCCP
  • Elcedo Bradley, RN, MEd
  • Henry Brehm
  • Ann Bullock, MD
  • Anne Camp, MD
  • Jeanne Charleston, BSN, RN
  • Jane Chiang, MD
  • Susan Crowley, MD
  • Maria Ferris, MD
  • Richard Goldman, MD
  • Lois Hill, MS, RD, LD, CSR
  • Frederick Kaskel, MD, PhD
  • Derrick Latos, MD, MACP
  • Janice Lea, MD
  • Bennie Marshall, RN, EdD
  • Constance Mere, MD
  • Sarah Mott. MS, RD
  • Priscilla Murphy, RN, MS, NBCC
  • Eduardo Ortiz, MD, MPH
  • Uptal Patel, MD
  • Nilka Rios-Burrows, MPH, MT
  • Sylvia E. Rosas, MD, MSCE
  • Dori Schatell, MS
  • Kimberly Smith, MD, MS
  • Bernadette Thomas, APRN, DNP, MPH
  • Monique Whitney
  • Julie Wright-Nunes, MD MPH
  • Bessie Young, MD, MPH
  • Kim Zuber, PAC

NIDDK

  • Andrew Narva, MD, FACP
  • Eileen Newman, MS, RD
  • Tamara Bavendam, MD, MS
  • Delia Houseal, PhD, MPH
  • Joanne Karimbakas, MS, RD
  • Kathy Kranzfelder, MA
  • Pamela Morrison, RN, MSN
  • Marva Moxey-Mims, MD
  • Robert Star, MD
  • Diane Tuncer

Panelists and Presenters

  • Robert Cohen, MD, MSC

NKDEP Program Staff

  • Cara Crosby
  • Raquel Garcia-Pertusa
  • Anna Zawislanski, MPH
​​

I. Welcome and Introductions

Andrew Narva

Dr. Narva welcomed members and thanked them for their support of NKDEP’s activities over the last year.

New members on the Coordinating Panel were introduced:

  • Jane Chiang, American Diabetes Association
  • Constance Mere, Howard University Hospital
  • Priscilla Murphy, Chi Eta Phi Sorority
  • Nilka Rios-Burrows, Centers for Disease Control and Prevention
  • Uptal Patel, Duke University School of Medicine, Duke Clinical Research Institute
  • Monique Whitney, caregiver
  • Kim Zuber, American Academy of Physician Assistants

II. Enhancing Effective Communication Between Health Professionals and CKD Patients

Robert Cohen

Effective communication between health professionals and patients is critical to improving health outcomes for all conditions, including chronic kidney disease (CKD). In addition to improved health outcomes, research indicates that effective communication can lead to improved adherence to treatment plans, higher patient and physician satisfaction, and treatment that is more aligned with the patient’s goals and values. It can also reduce health care costs in terms of reduced malpractice claims, reduced diagnostic testing costs, and fewer hospital readmisions. CKD communication failures result in

  • poor adherence to treatment regimens;
  • delayed discussions about end-stage kidney disease (ESKD) options (e.g., pre-emptive kidney transplants, creation of permanent dialysis access, referral to palliative care); and
  • lack of understanding of patients’ preferences.

Providers encounter multiple obstacles in communicating effectively with their patients. Some of the obstacles relate to the patient, such as the level of health literacy and language and cultural differences. Others are systemic, such as time constraints, both real and perceived. Provider behavior may also limit communication. Providers can fail to devote enough time to listen to the patient’s needs and concerns or fail to respond to the patient’s emotions. Many providers are unprepared to deal with an emotional response from a patient or hesitate to have serious conversations out of concern that they may dash a patient’s hopes or cause undue worry. Failure to address a patient’s emotions can stand in the way of the necessary discussions related to the patient’s condition.

In addition to these general challenges, nephrology has some unique communication challenges. CKD can be an abstract concept for patients, especially since most patients have no symptoms until late in the disease course. In addition, there are variable kidney function trajectories and prognostic uncertainties associated with CKD, making it more difficult to give patients definitive answers about disease progression and outcomes. These challenges make it difficult for providers to know when they should have pivotal conversations with their patients. Many of these conversations deal with giving patients bad news. This can add a level of stress to these conversations for both patient and provider, further complicating communication. With practice and the right techniques, providers can learn to be better communicators. There are a number of strategies that have proven effective in enhancing provider/patient communication.

Important Communication Skills
  • Addressing emotions
  • Assessing understanding
  • Breaking bad news
  • Attentive listening
  • Motivational interviewing
  • Gaining patient or family member perspective
  • Making a recommendation

Ask-Tell-Ask

This strategy helps to ensure that the patient has understood the information that has been delivered. It begins with the provider asking a patient what his or her understanding is of a specific matter (e.g., What is your understanding of your kidney problem?). This allows the provider to know how to tailor the information to a given patient. The provider then offers information in small bits and in simple language. The exchange is concluded with the provider once again asking a question to assess whether the patient has understood the information provided and whether he or she has any additional questions. The provider should frame these questions in a way that it is not patronizing. A self-deprecating approach can be effective (i.e., “Sometimes I don’t do a great job of explaining. Can you tell me in your own words what you understand?”). Ask-Tell-Ask is an iterative tool, often used several times in a given encounter with a patient.

Active, Reflective Listening

This consists of attentive listening to the patient by carefully tracking words, meaning, and feelings. At the end of the exchange the provider “reflects” back what they have heard, providing a summary of both the meaning of the patient’s statements and the patient’s emotions.

Open-Ended Inquiry

Open-ended inquiry entails asking open-ended questions in order to learn more about what the patient is thinking and feeling. This strategy can be especially useful when discussing treatment goals.

NURSE Acronym
    Name: Identify the emotion
    Understand: the emotion
    Respect: the patient
    Support: the patient
    Explore: the emotion further

Empathy

Empathy is the awareness and understanding of the emotions of others. The NURSE strategy is designed to help providers recognize a patient’s emotions, help the patient process the emotions, and deliver the necessary information.

Framing Concepts and Supportive Statements

Framing concepts can help guide difficult conversations. An example of a framing concept is “Hope for the best, prepare for the worst.” This framework helps to align patient/physician hopes and at the same time acknowledges that things may not go as planned. It can guide discussions about the prognosis, allowing the physician to share concerns, and promote discussions that lead to a plan or recommendation.

Supportive Statements

Supportive statements can help patients get through a difficult time (e.g., I wish it were different and your kidney function had not worsened.), especially when discussing bad news or when a patient has difficulty accepting poor prognostic information. Such statements can serve to connect the physician with the patient and transform the conversation. When delivered at appropriate moments, supportive statements build the provider-patient relationship and promote trust.

Teaching Communication Skills to Nephrologists in Training

Nephrologists receive very little training in effective communication. Even though the Accreditation Council for Graduate Medical Education requires competency in this domain, training in communication skills is not routinely part of the curriculum for nephrologists, as it is with other subspecialties (e.g., oncology, geriatrics).

Case-Based Simulations
  • Breaking Bad News/Responding to Emotion
  • Dialysis Decision-Making
  • Transitions in Care/End-of-Life

During their training, nephrology fellows engage in activities that require effective communication skills, such as the care for complex patients and providing care as part of a clinical team. Research indicates that many of these trainees feel unprepared to engage in these necessary complex conversations. The Harvard Nephrology Fellows’ Communication Skills Workshop is designed to teach communication skills. The training uses some didactics but primarily relies on practice of skills in a small group setting, i.e., it is more process than content oriented. Using small groups provides the learners an opportunity to practice the skills in a learner-centered, interactive format. Use of simulated patients provides learners experience with situations where feedback is provided by the facilitators, fellow trainees, and the simulated patients in the moment.

The full-day training is conducted by four facilitators. In the first year, 14 fellows from three Boston-area hospitals completed the training. Pre- and post-training surveys were administered to the fellows to assess their sense of preparedness in terms of communicating with patients. In each of the eight domains assessed (e.g., giving bad news, responding to emotions, eliciting patient goals/preferences, discussing prognostic uncertainty, discussing aspects of dialysis, and end of treatment/end-of-life issues), the sense of preparedness increased significantly after the workshop. The fellows also reported extremely high satisfaction with the training.

Recommendations for NKDEP

Based on his experience, Dr. Cohen recommended that NKDEP build on existing efforts to enhance the communication skills of providers. NKDEP could develop materials that focus on

  • assessing patient understanding of complex issues;
  • conducting challenging conversations;
  • how to make it more likely that the patient is understood; and
  • how to make it more likely that the patient’s emotions are acknowledged.

In particular, NKDEP could produce training videos for clinicians, similar to OncoTalk, that demonstrate specific situations clinicians encounter. These include

  • assessing a patient’s understanding of kidney impairment;
  • breaking bad news to a CKD patient about progression to ESKD; and
  • gaining an understanding of patient’s preferences.

Response of CP Members

Monique Whitney

Based on her experience as a caregiver, Ms. Whitney discussed certain situations that can be particularly challenging for patients. She emphasized the responsibility of the physician to effectively communicate information to patients. Given that it can be hard for patients to process information, especially when it is bad news, patients should be encouraged to bring a caregiver or advocate to appointments. In addition, she emphasized that gender and age can play a role in communication. Men and women have different ways of communicating. Caregivers may be younger than the clinicians and favor different styles of communication. Respect is critical in all circumstances. Also, dealing with the medical team can be difficult for patients, especially if members do not communicate effectively across the team. It can be extremely frustrating for patients if they have to coordinate communication across team members.

  • Dr. Cohen stated that while it does not always happen, it is always optimal to have someone accompany patients and serve as an extra set of “eyes and ears.” Clinicians can invite the patient to bring an additional person if they know difficult information will be provided during an appointment. He added that these conversations are ongoing, not a one-time occurrence. There are multiple opportunities to involve family members and caregivers in the conversation.
  • Dr. Cohen agreed that there are cultural and gender issues but that many of the communication skills presented help to address these issues. In addition to the skills presented, there are other skills that can help clinicians determine the communication preferences of patients and their families and how to navigate cultural differences while still ensuring that patients receive critical information.

Jeanne Charleston

Ms. Charleston emphasized the importance of clinicians having a unified message. Many CKD patients do not know that they have kidney disease. Primary care physicians need to be more effective in communicating with patients when they refer them to nephrologists. Using videos and role playing can be valuable tools. Training in motivational interviewing—for all staff—can help to improve communication skills. Another way to frame the dialogue could be to add a pre-CKD diagnosis. This approach has worked well with diabetes and hypertension. It could help patients accept the diagnosis and prepare for the hard discussions.

  • Dr. Cohen added that building the skills of physicians to deal with prognostic uncertainty can also be an effective way to help patients cope with their diagnosis and process the related emotions and fears. Framing concepts can be useful for such discussions.

Ann Bullock

Dr. Bullock stated that primary care physicians are conducting the necessary conversations with patients. However, it is a difficult concept for patients to process, especially when they do not feel sick, which may impact how they interact in their initial contacts with nephrologists. Based on her experience with Indian Health Services (IHS) patients, many patients know a family member that has been on dialysis. They often have a traumatic response to the diagnosis because of their past experience. In these circumstances, having a caregiver/family member present can be beneficial. One advantage to treating CKD in the primary care setting is that providers often have long-term relationships with patients and can begin discussions about kidney health early on and provide patients choices (e.g., home dialysis, transplants).

With Native populations, it is important to understand and be sensitive to cultural issues. Physicians also must be careful to not blame the patient for his or her condition. This can result in adding a sense of guilt and shame to an already bad diagnosis.

Discussion

  • Dr. Young stated that the increased use of computers during appointments has had a negative impact on communication. Clinicians need to take the time to engage the patient and, most importantly, establish eye contact, if effective communication is to take place.
  • Dr. Latos stated that primary care physicians try to have these conversations but they are overwhelmed (e.g., limited time for appointments, treating multiple chronic conditions). Building communication needs to start during a clinicians’ initial training and is critical for all health care providers (e.g., physicians, nurses, physician assistants, etc.). However, he noted that primary care physicians often do not feel comfortable providing detailed information about kidney disease to patients—they want nephrologists to conduct these discussions. Providing training at such venues as the American Society of Nephrology (ASN) pre-conferences is a good start. Program directors of the nephrology fellowships need to buy into this process. It is also important to look at the role of other clinicians in the process. Nurse practitioners can play an important role in patient education. Dr. Cohen added that there has been interest in more training in communications skills among the fellowship programs.
  • Dr. Goldman stated that nephrology fellows need training on how to open a discussion about patient goals, treatment options, and prognosis. The patient’s health literacy needs to be taken into consideration in these discussions. Tools are available to help providers frame the discussion for patients. The National Patient Safety Foundation’s patient-focused “AskMe3” program focuses on three questions: 1) what is my main problem; 2) what do I need to do; and 3) why is this important to me. These address the most important questions for patients. In addition, clinicians need training in reflective listening. This is a nonjudgmental technique that recognizes feelings and is an opportunity to be empathetic.
  • Dr. Goldman stated that clinicians need training on effective communication techniques while using electronic health records (EHRs). Dr. Cohen stated that this need has been recognized but more work is necessary in this area.
  • Dr. Marshall stated that NKDEP has very useful resources, especially “Make the Kidney Connection,” which focuses on diabetes and CKD and explains the various risk factors. This is useful in community education. In addition, patients can be very useful in educating others by telling their own story.
  • Ms. Zuber stated that findings from a survey of kidney patients (CKD 4) indicated that 90 percent of patients that had been in a nephrology practice for over a year did not believe they had kidney disease—there is significant denial.
  • Ms. Zuber asked about addressing the needs of patients with low cognition—those that cannot engage in discussions. Dr. Cohen stated that cognition challenges are a major challenge and caregivers/advocates need to be involved as soon as possible.
  • Dr. Wright-Nunes stated that she has conducted research in nephrology clinics that indicated patients did not understand their diagnosis of CKD, even though the programs thought that they were doing a good job with patient education and there was a patient educator on staff. The research also showed that the more patients understood their condition as a result of information from the provider, the less they were satisfied with their care. This needs to be explored further to determine whether it is the way information is conveyed or just the process of dealing with a chronic disease. Dr. Cohen stated that there needs to be more research in this area. The findings also emphasize the importance of having these dialogs on an ongoing basis. Dr. Wright-Nunes stated that patients do want to know and learn—the challenge is identifying the right tools.
  • Dr. Goldman stated that the Renal Physicians Association has developed guidelines related to shared decision making. The toolkit is available free of charge.
  • Ms. Schatell stated that while there is little research to support it, the key message to convey to patients is hope. Hope has to be the fundamental focus, whether the discussion is focused on transplant, home dialysis, or something else. Besides the treatment options, the dialogue needs to focus on quality of life—what the patient wants his or her life to look like.
  • Dr. Ferris commented that in the Oncotalk videos the provider do not use visual aids. Visual aids can help both providers and patients discuss an issue.
  • Dr. Ferris stated that the Oncotalk videos did not feature culturally diverse individuals—both patients and providers want to see someone that looks like them and sounds like them.
  • Ms. Thomas stated that resources for primary care providers would be very welcome and it is important to present how CKD relates to other chronic conditions. CKD treatment should be put in the context of the primary care team and other conditions that the team is addressing.
  • Ms. Murphy stated there are many people that do not have access to gyms, health-related information, and other resources. It is necessary to reach out to this population and also give them hope.
  • Dr. Narva stated that NKDEP can play a role in training providers on how to be effective communicators. An advisory group from the CP would be helpful.

III. What Interventions should NKDEP Promote?

CKD: So Many Guidelines, So Little Evidence

Andrew Narva

There are a range of guidelines for the screening and monitoring of CKD. This has created a great deal of confusion among providers on when and how to treat CKD and when to refer patients to nephrologists. Given the paucity of evidence, NKDEP faces challenges in providing recommendations to clinicians about appropriate interventions related to CKD screening and monitoring.

To add to the confusion, there is a great deal of uncertainty in the results provided by the various eGFR formulas (e.g., Modification of Diet in Renal Disease [MDRD] formula, Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] formula). For example, for a patient with an eGFR of 59, with the MDRD there is a 77.2 percent chance of having a measured GFR between 42 and 78. With the CKD-EPI there is a 79.9 percent chance of having a measured GRF between 42 and 78 percent. Given this variability, clinicians face difficulty in conveying the meaning and significance to patients and in making a diagnosis of CKD.

The second common test that is used to identify people with CKD is urine albumin, which indicates kidney damage. Urine albumin is not only important for screening patients at risk of CKD but it is also helpful in treating and monitoring CKD. Forty (40) percent of the patients identified with CKD in the National Health and Nutrition Examination (NHANES) survey were identified on the basis of increased urine albumin—their eGFR was normal. A urine albumin-to-creatinine ratio (UACR) of over 30 milligrams per gram is generally considered abnormal. Currently, the urine albumin test is not standardized. NKDEP’s Laboratory Working Group conducted a study that found median variation of 40% in results on the same specimens across the most common assays.

With such uncertainty in the tests used to diagnose CKD, it is difficult to estimate the prevalence of CKD. NHANES data indicate that more than 20 million people in the United States may have an eGFR of less than 60 and/or evidence of kidney damage based on a UACR of greater than 30 milligrams per gram.

In addition, the value of screening for and monitoring CKD has recently been questioned. A U.S. Preventive Services Task Force (USPSTF) evidence review conducted in 2012 found that the evidence was insufficient to determine if systematic screening of high-risk adults and monitoring of patients with CKD stages 1-3 had a direct effect on clinical outcomes or adverse effects. The indirect evidence suggested that screening populations at high risk of developing CKD and monitoring patients with early signs of kidney disease for albuminuria and eGFR may help to identify patients with CKD stages 1-3 who might benefit from early treatment with angiotensin-converting-enzyme (ACE) inhibitors, angiotensin II receptor antagonists (ARBs), or statins.

To add even more confusion, recommendations are being made by a number of organizations that are contradictory. In August 2013, the National Kidney Foundation (NKF) reported that 59 percent of Americans will develop kidney disease in their lifetime and recommended annual urine screenings for those 60 years of age and older. A 2010 study by the Centers for Disease Control and Prevention (CDC) concluded that urine screening is only cost effective for patients with diabetes or hypertension. Also, in 2013, the American College of Physicians (ACP) developed guidelines based on the USPSTF evidence review that recommend against screening asymptomatic adults without risk factors for CKD. ASN released a statement objecting to these recommendations and supporting routine screening of elderly people.

NKDEP takes a conservative approach to screening and monitoring. It recommends screening at-risk individuals with the following conditions:

  • Diabetes mellitus type 1 or type 2
  • Hypertension
  • Cardiovascular disease
  • Family history of kidney failure

NKDEP has adopted the following approach:

  • NKDEP only makes recommendations for clinical management that are supported by high-quality evidence.
  • NKDEP does not promote outside guidelines.
  • NKDEP does not include staging algorithms based on eGFR alone.
  • NKDEP does not encourage referral based solely on eGFR.
Systemic Evidence Review and Guidelines Development Process
  • Identify Topic Areas
  • Establish Panel/Support Staff
  • Develop Questions
  • Develop Inclusion/Exclusion Criteria
  • Conduct Literature Search
  • Identify Eligible Studies
  • Rate Quality of Studies
  • Abstract Data
  • Create Evidence Tables
  • Summarize Evidence
  • Grade Evidence
  • Develop and Grade Recommendations
  • Draft Report
  • External Review of Report
  • Finalize Report
  • Release of Report
  • Implementation of Guidelines

Evaluating Evidence and Clinical Practice Guidelines

Eduardo Ortiz, MD, MPH

The Institute of Medicine (IOM) released two important reports in 2011 that should inform current guideline development. Finding What Works in Health Care: Standards for Systematic Reviews and Clinical Practice Guidelines We Can Trust are designed to promote the development of evidence-based guidelines.

The IOM reports emphasize that a systematic review of the evidence is critical to guideline development and that guideline developers should use explicit and standard methodology to rate the evidence quality for individual studies as well as to grade the overall body of evidence that will drive the recommendations. This rating of the evidence quality of individual studies combined with grading of the overall body of evidence indicates to users the level of confidence they should have in the evidence and recommendations. It is important that recommendations be clearly aligned with and supported by the evidence.

Dr. Ortiz described the process to produce Evidence-Based Guideline for the Management of High Blood Pressure in Adults, which was developed by the Panel Appointed to the Eighth Joint National Committee (JNC 8). The guideline was released online in the Journal of the American Medical Association in December 2013.

Development of clinical guidelines is a multistep process, which can be extremely time consuming. One of the keys to the overall success of the process is the selection of panel members. Panel members should bring different expertise, skills, and perspectives to the process. In addition to having expertise in the guideline topic (e.g., hypertension or nephrology), other areas of expertise should also be represented (primary care, pharmacology, nursing, informatics, guideline development and implementation, etc.). Members should also represent different settings (academic institutions, community practice, rural and urban areas, etc.). There must be adequate representation of members in the various domains so that representation is fair, balanced, and meaningful. Conflicts of interests and possible biases should also be considered when selecting members. There must be an established process for handling conflicts of interest as the panel reviews the evidence. The selection of leaders (i.e., co-chairs) is also extremely important to the process.

Formulating Questions
Asking the right questions is a key component of the evidence-based process. The PICOTSS process focuses on the following variables.

  • Person, Patient, or Population
  • Intervention
  • Control/Comparator
  • Outcomes
  • Time (study duration)
  • Setting
  • Study Design

Inclusion/Exclusion Criteria
The criteria define the parameters for conducting the literature search for each question. It ensures that the selection of articles is objective and comprehensive. Panel members should work collaboratively with the methodology team to establish the criteria so that the relevant clinical questions are addressed and the criteria are applied consistently throughout the literature review.

Literature Review
The literature review is a systematic search for each question using the inclusion/exclusion criteria. It is essential to ensure that all relevant articles are included. For JNC 8, each article was reviewed independently by two trained reviewers (not panel members). In the event the reviewers did not agree about including an article, a third reviewer adjudicated. If a consensus could not be reached the article was included.

Quality Rating
The methodology team rated each article for quality using a standardized tool with 14 items. As with the literature review, each article was reviewed by two independent reviewers, with a third reviewer adjudicating if the reviewers did not agree. Articles were rated good, fair, or poor. Articles that were rated good or fair were included.

Data Abstraction/Evidence Tables
This process provides access to the pertinent data. Important elements from each included articles that were abstracted and compiled in a database. Evidence tables were created that contain detailed information about each study. Summary tables were also created, which are more succinct versions of the evidence tables that facilitate the panel’s review of the overall body of evidence.

Grading of Overall Quality of Evidence
Grading the overall quality of evidence is very important. There are many systems that have been developed to grade evidence. The JNC 8 process reviewed these systems, including GRADE (Grading of Recommendations, Assessment, Development, and Evaluations), USPSTF, American College of Cardiology/American Heart Association, and several others. GRADE is the most frequently used of these systems, but it is usually modified to facilitate use, so there are many versions of “modified GRADE” in use. The panel found that none of them fully met their needs, so they developed their own hybrid version that attempted to consolidate the best features of each. The result was a system that was most similar to USPSTF, albeit a modified version.

Levels of Evidence The overall quality of evidence should drive the recommendations and will indicate to users of the guideline the level of confidence they should have in the recommendations. Depending on the type of study (and how well it was conducted), there are various levels of evidence. For example, well-designed, well-conducted randomized controlled trials yield the highest level of evidence. For JNC 8 the quality of evidence was rated as high, moderate, or low.

Many systems for grading evidence include expert opinion as a level of evidence, which is usually categorized as low evidence. However, expert opinion does not actually constitute evidence; expert opinion is, by definition, an opinion and not evidence. An expert’s opinion can be based on evidence, but it is still an opinion that is formed and influenced by factors such as knowledge, training, experience, and bias.

Grading the Strength of Recommendations
The panel must make recommendations based on the evidence while taking into consideration the trade-offs between the benefits, risks, burdens, and costs. Recommendations should be closely aligned with the evidence and graded on the strength of the evidence that supports the recommendation. For JNC8, recommendations were graded with the following scale:

  • A: strong recommendation
  • B: moderate recommendation
  • C: weak recommendation
  • D: recommendation against
  • E: expert opinion
  • N: no recommendation for or against.

Outcomes
In developing questions, conducting the literature search, assessing and summarizing the evidence, and crafting recommendations, it is important for the panel to focus on important health-related outcomes that people actually experience and care about, such as mortality, myocardial infarctions, strokes, renal failure, and amputations. Guideline developers should be cautious about using intermediate or surrogate outcomes, such as biochemical, physiologic, or laboratory measures. This is a concern because use of intermediate or surrogate outcomes may not result in real benefits on important outcomes that actually affect people’s lives or they may even result in harm. There are many examples in the biomedical literature where this has been the case, including: • Use of Class I anti-arrhythmic agents in patients presenting to the hospital with heart attacks. They decreased arrhythmias (an intermediate outcome) but increased mortality (a more important health outcome). • Use of clofibrate to reduce cholesterol resulted in decreased levels of serum cholesterol (an intermediate outcome) but increased mortality (a more important health outcome).

Response of CP Members

Susan Crowley

Dr. Crowley stated she is involved in creating guidelines for the VA and that it is helpful to understand the process used by other groups. A challenge that the VA has experienced is that there are multiple existing guidelines. NKDEP could play a role in vetting or prioritizing these guidelines.

  • Dr. Narva responded that NKDEP does not endorse guidelines but does promote specific evidence-based approaches. Much more research related to kidney disease is necessary and this message needs to be conveyed to the general public. In addition, it is necessary to educate providers about what constitutes evidence-based care and how to assess guidelines to determine if the recommendations are based on evidence.
  • Dr. Ortiz added that it is important to balance depth and breadth when assessing existing research. It is difficult to be comprehensive if adhering rigorously to an evidence-based approach, so it is important to focus on a defined topic area and develop specific recommendations that are based on a literature search driven by questions developed using the PICOTTS format.

Kim Smith

The Centers for Medicare and Medicaid (CMS) is committed to achieving value in the delivery of health care services. To do this it has focused on performance measures and health outcomes. The challenge is that in many areas there is only minimal evidence related to effectiveness. Also, CMS solicits comments from a wide range of stakeholders, including the public, and must process and incorporate this input. Given the lack of evidence in certain areas, some stakeholders want to lower the level of evidence required. In developing its own performance measures, CMS needs to consider all the existing guidance. In addition, CMS must take into consideration statutes related to the care that must be provided.

  • Dr. Smith asked how care can be moved forward for patients with kidney disease given the limited evidence. Dr. Ortiz stated that it would be ideal to drive performance measures based on hard outcome data (ideally from RCTs), but the data to support this often do not exist. He added that performance measures should not be developed based on expert opinion. However, if there is no other evidence, one might have to defer to expert opinion. If guidelines or performance measures are being developed based on limited evidence and/or expert opinion it is important that the make-up of panel members and reviewers is such that they represent an appropriate balance of expertise and perspectives.
  • Dr. Smith added that CMS relies on technical expert panels to develop performance measures. This is an open process and providers and the public are encouraged to participate.
  • Dr. Star added that this is a long-term approach and that the Coordinating Panel could help identify issues that need further study (and then support for the studies could be provided by NIH and the Patient-Centered Outcomes Research Institute [PCORI]). NIH is working with groups of investigators to identify topics for study by PCORI.

Uptal Patel

Dr. Patel stated that it is important to acknowledge the evidence gaps and develop recommendations only where there is evidence. All organizations need to focus on disseminating information that is in line with the current knowledge base and reflective of the current body of evidence. The challenge for NKDEP is communicating this uncertainty to patients, as well as providers.

Jane Chiang

Dr. Chiang stated that subpopulations should also be considered. For example, there is very little research related to the pediatric population. This results in a guideline development process that is significantly different. In these circumstances expert–level evidence is important. In addition, guidelines should result in protocols that are practical and easy to implement by providers, especially generalists, to facilitate uptake in the field. Research has shown that with diabetes guidelines, there is poor adherence by providers when the guidelines are broad and more complicated.

  • Dr. Ortiz added that it is important to go through the systematic review process. This identifies areas where more research is necessary. It also provides transparency to recommendations based on expert opinion (i.e., it acknowledges the lack of evidence). It provides more information to stakeholders such as performance measure developers and payers about the level of evidence behind the recommendations.

Discussion

  • Dr. Narva asked whether there is evidence to support the ACP guideline related to tracking urine albumin for people on ACE inhibitors. Dr. Ortiz agreed that given the available evidence it appears that it might have been more appropriate to make an evidence statement as opposed to a recommendation.
  • Dr. Narva asked about the steps for creating performance measures once the body of evidence has been identified and assessed. Dr. Ortiz replied that it is important for guideline developers and performance measurement groups to work together. Guideline developers should remain engaged in the development of performance measures to ensure that the measures are reflective of the evidence and recommendations. It also helps to ensure that the groups developing the performance measures have the information they need. In the past, there has not always been the collaboration necessary to ensure appropriate performance measures. Well-crafted performance measures are important because they can impact reimbursement in addition to health outcomes.
  • Dr. Latos stated that all guidelines should be developed using the same rigorous process described by Dr. Ortiz. However, organizations that develop guidelines also have their own priorities and agendas, which results in multiple guidelines that are often not aligned. This creates a great deal of confusion for providers in the field.
  • Dr. Ortiz stated that the challenge of multiple guidelines has been recognized for a long time and there have been many efforts to try to standardize and improve the approach to guideline development. The Agency for Healthcare Research and Quality (AHRQ) and ECRI Institute (which supports the National Guidelines Clearinghouse), has been working on this issue.
  • Dr. Star asked if there is an organization that rates guidelines. Dr. Ortiz said that he is not aware of anyone doing it at this time but that the ECRI Institute has been exploring the possibility of doing this.
  • Dr. Bullock stated the many randomized controlled trials, from which the evidence is drawn, explicitly exclude patients with various conditions or for other reasons. The guidelines are generalized and the performance measures are then based on this evidence. This makes it extremely difficult for providers—they must balance caring for the individual patient with the performance measures that are based on the general population.
  • Dr. Goldman asked if it is feasible to combine the processes of developing guidelines and performance measures (i.e., including performance measure methodologist in the process of identifying research questions and drafting guidelines). Dr. Ortiz stated that it would be good for guideline developers to include panel members with expertise in performance measurement, and it would be good for performance measurement groups to include guideline developers on their panels. JNC 8 made attempts to collaborate with performance measure developers; for example, in the beginning of the project, the JNC 8 panel met with three performance measurement organizations to learn more about the performance measurement process and get their input. However, due to limited resources and other constraints, there was not ongoing collaboration throughout the project. While it would be good to include performance measurement experts on the panel, it may not always be feasible to do this. It is also important for panel members to be involved in the review of performance measures so that they can ensure that the evidence and guidelines have been accurately interpreted and applied.
  • Dr. Narva stated that NKDEP will continue to inform clinicians about assessing guidelines and the process used to develop guidelines.

IV. Optimizing CKD Medication Management: Opportunities to Partner with Pharmacists

Amy Barton Pai

The growing number of patients with CKD and the increased emphasis on multidisciplinary care present opportunities for pharmacists to become more engaged in the treatment of CKD. Increasing the role of pharmacists in direct patient care has been shown to improve clinical outcomes and reduce the total cost of care. However, integrating pharmacists onto the clinical team presents challenges in terms of compensation, billing, and for establishing an optimal return on investment (e.g., pharmacist-to-patient ratio). There can also be turf issues with other providers, such as physicians, especially when it comes to controlling patients’ medications. In addition, most pharmacists practicing today are limited in the direct-patient care services they can provide and do not have the opportunity to optimally practice the patient care skills they learned during their training.

Evidence supports the involvement of pharmacists in the care of patients with CKD. Dr. Pai and colleagues published an invited review related to medication reconciliation and therapy management in dialysis-dependent patients that was published in 2013. It reviews existing evidence and presents strategies for involving pharmacists in the care of dialysis patients in a financially viable way. Other studies explore optimizing pharmacotherapy in CKD and medication-related problems and the outcomes of pharmacists care in CKD. A 2011 Surgeon General Report, Improving Patient and Health System Outcomes through Advanced Pharmacy Practice, cites the evidence that has been accumulated across Federal health care agencies.

Pharmacists are trained to systematically approach medication management—using a holistic approach to managing medication profiles. The process involves assessment, development of a care plan, follow-up, and tracking of patient outcomes. However, this systematic approach has many different labels (e.g., pharmaceutical care, comprehensive medication management, medication therapy management), which creates confusion regarding the role of pharmacists in providing direct patient care.

In addition to the confusion related to practice terminology, there is also a misinterpretation of the specific tasks that pharmacists perform. For example, many see the primary role of pharmacist as medication reconciliation, which is to ensure the accuracy of the medications. Medication reconciliation does not ensure that the medications are appropriate and safe. Medication management involves other patient-focused tasks such as care transitions, adherence, self-care behaviors, and kidney disease-specific issues.

Involving Pharmacists in Treatment of CKD

Research indicates that CKD patients are receptive to engaging with pharmacists regarding their treatment. A survey by the Northeast Kidney Foundation asked patients about whether they would like to have a pharmacist available during dialysis treatment and what other services they would like to see provided by pharmacists. Patients were very receptive to having pharmacistsinvolved in their care to ensure the coordination of medication and to answer questions. However, pharmacists may need additional training to assume this role. While Pharm.D. graduates are practice ready to provide medication management services for the general population, additional training, such as a residency or certificate program, is most likely necessary to manage special populations like patients with CKD.

The NKDEP Pharmacy Working Group (PhWG) is identifying areas where pharmacists can increase their involvement in the care of patients with CKD.

Patient Education

The PhWG is working to incorporate the reporting of eGFR on e-prescriptions. This will allow pharmacists to identify patients that may need additional information about CKD or raise issue of kidney disease with individuals that are at risk (pre-CKD). The PhWG has been working with the NKDEP IT Working Group and other health information technology stakeholders to further explore this issue. The PhWG is also exploring State-level restrictions. The PhWG is developing a white paper on this issue.

Medication Literacy

Research indicates that many patients have difficulty understanding the information on medication labels. To introduce pharmacists to this issue and provide them strategies for interacting with patients, the PhWG launched an initiative focused on nonsteroidal anti-inflammatory drugs (NSAID) avoidance counseling at the point of purchase. The PhWG is developing a continuing education (CE) training for pharmacists that uses an innovative, multimedia approach, including a video of a patient counseling session. Additional CE credits will be available for documenting patient interaction regarding NSAID avoidance. The PhWG will discuss their efforts in this area at the American Pharmacists Association’s CKD Symposium in March 2014 and will have an article in Pharmacy Today in January 2014. The PhWG is also working to include information about NSAID-related adverse kidney effects in resource materials used by pharmacists such as the Handbook of Nonprescription Drugs.

Communication

Pharmacists can play a role in answering questions patients have about their treatment and medications and resolve conflicting information patients may receive (e.g., having an occasional glass of wine while on certain medications). The PhWG is working to increase pharmacists’ confidence in addressing CKD-related issues so that they can serve as a resource to patients. This is being done though the CE activities, symposia, and the educational materials discussed above.

Model for Involving Pharmacists in Patient Care: U.S. Department of Veterans Affairs

The U.S. Department of Veterans Affairs (VA) is at the forefront of expanding the role of pharmacists in patient care. The scope of work for pharmacists has been expanded to include collaborative drug therapy management (CDTM). With CDTM the pharmacist enters into a protocol with a physician and has prescriptive authority as well as the ability to order labs and consults. In the VA, the pharmacist must be credentialed, have clinical privileges, and be a licensed, independent practitioner. Nearly all States have some form of CDTM but there are different requirements.

In the VA, clinical pharmacy specialists (CPS) are mid-level providers. Their focus is on improving medication safety. CPS provide comprehensive medication management in primary and specialty care. They minimize the patient’s need to see multiple providers for medication assessments and evaluation, allowing the physician to focus on evaluation of disease progression and identification of new illnesses. The services provided by CPS improve medication safety, health outcomes, access to care, and overall health. Studies have shown that for each dollar invested in clinical pharmacy services there is more than $4 in benefit.

Of the 7,050 VA pharmacists, over 40 percent are CPS. Of the CPS, 72 percent have completed both residency training and certification. However, only 55 CPS have an advanced scope of practice in nephrology.

Community-Level Pharmacies

An area of opportunity to engage pharmacists in patient care is at the community pharmacy level. There are 7,600 Walgreens stores in the United States that employ 70,000 providers, mostly pharmacists. Walgreens is moving the pharmacist from behind the counter to allow more interaction with patients and also expanding service. For example, 26,000 pharmacists are certified in immunizations. Other pharmacy and super market chains are taking similar approaches.

Discussion

  • Dr. Latos stated that pharmacists do not use the eGFR calculation—they use the Cockcroft -Gault calculation. When incorporating information into the EHR it is important to make sure that it is information pharmacists recognize and can act on. Dr. Pai stated that Cockcroft -Gault is used for drug dosing but pharmacists are also familiar with eGFR. The purpose for including eGFR is not for diagnosis. It is to give pharmacist information that they can use to engage patients in discussions about CKD.
  • Ms. Zuber asked if pharmacists have malpractice insurance. Dr. Pai responded that they do and that the college also has coverage.
  • Ms. Whitney stated that as a caregiver, she did not realize the important role that pharmacists can play in patient care. Caregivers should also be engaged in conversations between pharmacists and patients.
  • Dr. Goldman stated that many dialysis organizations have their own pharmacies or are in the process of developing them. He asked about the role of pharmacists in these organizations and whether there are performance measures related to these services. Dr. Pai stated that the goal is to provide medication management services with pharmacists engaging patients in various ways (e.g., phone, Skype, etc.). In terms of performance measures, adherence rates are the easiest to measure. There are no measures related to billing.

V. NKDEP Program Developments

NKDEP Summary Report

Eileen Newman

The newly revised report summarizes the burden of CKD in the United States, NKDEP’s efforts to address disparities and improve care using the Chronic Care Model as a framework, and the program’s future directions. The report also presents the chronic care model. The previous summary report was released in 2009.

NKDEP Scientific Evaluation Board

Andrew Narva

The newly-convened Scientific Evaluation Board (SEB) is intended to evaluate the activities of NKDEP. Its eight members represent various organizations and institutions within and outside of the kidney community. The SEB met in March 2013.

SEB Assesses:
  • Alignment of programs high-level objectives, strategies, and associated tactics
  • How program results are measured and whether they are meaningful
  • Impact of NKDEP on the kidney community and individuals
  • Appropriateness of the NKDEP Strategic Plan (i.e., it addresses all important areas and exclude unimportant areas)

In assessing NKDEP’s activities, the SEB identified the following strengths:

  • NKDEP has been highly successful and is making an impact in many ways.
  • The Chronic Care Model is an excellent framework for identifying audiences/targets and NKDEP has been effective in targeting these audiences, especially in terms of outreach to providers, pharmacists, and the clinical lab community.
  • Materials are of high quality and have achieved distinction despite significant competition in this area.
  • NKDEP’s activities are based on strong evidence.
  • Convening the Kidney Interagency Coordinating Committee has been highly beneficial.
  • NKDEP has been very innovative (e.g., engagement with Chi Eta Phi Nursing Sorority, HIT efforts).

The SEB made the following recommendations about NKDEP’s efforts:

  • Maintain a narrow focus (i.e., do not focus on a broad range of activities and issues).
  • Continue to monitor website metrics, as they provide important data.
  • Keep materials up-to-date.
  • Work to establish NKDEP as the primary resource for physician and patient education.
  • Systematize dissemination efforts.

The SEB made the following suggestions for NKDEP’s future directions:

  • Expand partnership efforts, using consistent messaging, to new organizations such as PCORI, ASN, the North American Primary Care Research Group, and the National Diabetes Education Program.
  • Collaborate with stakeholders to identify which products have been most effective.
  • Expand collaborative activities with CMS.
  • Act as a curator for CKD-related information and resources.
  • Convene researchers to encourage grant application in the areas of greatest need.
  • Coordinate with similar programs in other countries.
  • Conduct a pilot study to determine best way to share patients’ eGFR with pharmacists (e.g., use of EHR).
  • Conduct long-term follow-up of patient progress.
  • Solicit feedback from partner organizations.

Discussion

  • Dr. Star stated that the purpose of the evaluation was to assess whether the focus of the NKDEP program is appropriate, whether the program is meeting its objectives, and whether the results are meaningful. Similar evaluations are done for all of NIDDK’s large programs. NKDEP is more than an education program—it is the integration of new knowledge from research into clinical care.. The results of the SEB show that the program is consistent with this direction.

NKDEP CKD Diet Initiative

Eileen Newman

NKDEP has been working with the Academy of Nutrition and Dietetics (the Academy) for the past seven years to educate dietitians about CKD. The initial focus was on general practice dietitians. NKDEP developed the Assessment, Management, and Treatment Guide for CKD, which is designed to be a desk reference for dietitians and covers dietary interventions and medical nutrition therapy. NKDEP also developed five online training modules that have been included in the Academy’s certificate training program. To date, over 700 dietitians have completed at least one module. In addition, patient education materials were developed including patient factsheets. These address dietary interventions for CKD and how to read food labels.

The current focus of the initiative is on dietetic educators (both at the undergraduate level and for internships) so that they can incorporate CKD-related information into the training of future dietitians. NKDEP conducted a focus group and found that dietetic educators were not comfortable teaching about CKD and had little clinical experience. Focus group participants said they needed training tools to use in their classes. Based on the findings of the focus group NKDEP developed a slide deck and out-patient case studies. The slide deck provides an overview of kidney function and kidney disease, diet information, and information on medical nutrition therapy. Each case study provides background information, presents the case, including information about diet, presents test results, and includes a series of questions. Student worksheets are included. NKDEP is collaborating with the Academy’s Nutrition and Dietetics Educators and Preceptors Practice Group to train educators on how to use the materials. The case studies will also be included in the practice group’s simulated electronic medical record program.

Case Studies
  • Prediabetes, hypertension, and CKD
  • Albuminuria and type 2 diabetes
  • Hyperlipidemia, vitamin D, and anemia
  • Complications of CKD
  • Approaching kidney failure/Puerto Rican diet
  • Ethiopian diet (in development)

NKDEP is working with the Academy’s Nutrition and Dietetics Educators and Preceptors Practice Group to launch the new materials. Educators are being encouraged to complete the five training modules (self-study). NKDEP will provide members of the practice group an overview presentation and follow up webinars on how to implement the materials in the classroom and with interns.

Discussion

  • Ms. Hill asked if NKDEP is working with the Food and Drug Administration (FDA) to include information related to phosphorus on food labels. Dr. Smith stated that FDA has experienced barriers in terms of labeling for phosphorus and is not pursuing it at this time.
  • Ms. Hill stated that she has used the case studies with her students and they are very helpful.
  • Dr. Star asked if the training materials could be adapted for pharmacists. Ms. Newman said that they could be used for a wide range of providers and that they are already being adapted for primary care providers.

Increasing Engagement with the Hispanic Community

Eileen Newman, Anna Zawislanski, Raquel Garcia-Perusa

NKDEP has developed the “Riñones, Tesoros. Cuídalos” (“Kidneys, Treasures. Take Care of Them.”) outreach program to address the education gap about kidney disease in the Hispanic community. An important component of the program is the use of promotores, or community health workers, to educate Hispanics living with diabetes about CKD and kidney failure. To inform the development of the promotores program NKDEP conducted research (communication audit and expert interviews) in 2011. During 2012-2013, NKDEP worked to develop the promotores program. A pilot study of the promotores program will be conducted in 2014 prior to the national launch of the program.

Based on the findings of the research, NKDEP designed the promotores program and developed materials. This was a multi-step process. Initially, NKDEP sought guidance from promotores programs supported by other Federal Agencies (e.g., CDC, National Heart, Lung, and Blood, Institute) and also reached out to Hispanic-serving organizations such as the National Council of La Raza and Vision y Compromiso in California. In providing advice, these programs stressed the importance of obtaining community input throughout the entire development and implementation process. They also recommended using photos of real people instead of illustration and limiting the text in the materials for the target audience.

Comprehensive educational content was developed in both Spanish and English. The content and format was then tested in both Spanish and English with various audiences. The materials include a training manual with the training content, activities, and questions for participants. The flipchart, which will be used in educational sessions, is designed to be a visual aid for the participants with information to guide the promotores’ presentation on the backside. Additional materials to distribute to participants during the class were also developed. The materials were developed “in language.” They are not translations.

The materials were reviewed by the NKDEP Hispanic Clinical Group, which includes Spanish speaking nephrologists, nurses, and a dietitian. This group provided additional guidance in terms of revising the materials, such as simplifying the messages and maintaining a friendly tone (i.e., no scare tactics). The materials were further tested in focus groups made up of promotores and patients in Los Angeles and New York City. This feedback emphasized the need to have materials both in Spanish and English since some Hispanics prefer to communicate in English. In addition, the flipchart was tested by promotores in a diabetes class.

The pilot study evaluation program was developed in conjunction with the overall program. Advice on evaluation design was provided by the Office of the Assistant Secretary for Planning and Evaluation and evaluation experts within NIH. This advice helped NKDEP navigate the process of gaining Office of Management and Budget clearance to survey pilot study participants. This clearance is required for any Federal Agency conducting a survey of more than nine subjects.

NKDEP has engaged an independent research team experienced in working with promotores programs. The team will conduct a quantitative evaluation (e.g., collecting information on knowledge gain) as well as a qualitative evaluation to assess the quality of the intervention and what can be done to improve it for the national roll out. Based on advice from the evaluation team, the promotores will be collecting the data since they are in the field and have the ties to the target audience.

The pilot study will include 100 clients and their promotores at sites in Los Angeles and New York City (organizations with existing diabetes education programs). The findings from the pilot study will be used to revise the program for national dissemination and evaluation. During the pilot study, NKDEP will continue to work to build interest among promotores in programs across the country. Already, over 180 promotores have expressed interest in the program.

Discussion

  • Ms. Zuber asked about the difference between the control group and the experimental group in the pilot study. Ms. Newman stated that it is a time-series design. The study group will include a pretest, intervention, and posttest. The control group will include a pretest and two posttests, one with the experimental group and one after their intervention. The intervention will be provided to the control group following the experimental group study.

National Kidney Month 2014

Eileen Newman

NKDEP will participate in multiple activities during National Kidney Month (March). NKDEP will again partner with the American Diabetes Association Live Empowered Program and Chi Eta Phi Sorority for a national Kidney Sunday event on March 2, 2014. Chi Eta Phi has mandated that all chapters participate in the event. This year, the event will focus on churches in the “Diabetes Belt.” Individual “kidney champions” will be encouraged to host additional events, especially for churches that cannot hold an event on March 2. Also as part of National Kidney Month, NKDEP will work with State Diabetes Prevention and Control Programs to distribute materials via their websites and will release a World Kidney Day joint statement with the National Institute on Aging.

HIT Working Group Paper on including CKD Data in EHRs

Andrew Narva

The paper, to be submitted in early 2014, will

  • discuss the type and structure of data needed within EHRs in order to improve CKD care, surveillance, and research;
  • establish CKD as a model that proves the feasibility of EHRs for improving the care of patients with other chronic conditions; and
  • encourage providers to support implementation of accessible, interoperable CKD data into EHRs.

Developing Curriculum for Diabetes Educators

Andrew Narva

NKDEP is partnering with the American Association of Diabetes Educators (AADE) to develop CE modules, similar to the online training modules developed for dietitians. NKDEP will develop the content and AADE will host the modules and provide the CE credits. The modules will be presented at the AADE’s 2014 conference.

Kidney Interagency Coordinating Committee

Andrew Narva

Topics addressed at recent KICC meetings included:

  • VA efforts to improve CKD care;
  • CDC National Center for Health Statistics’ addition of serum creatinine collection to the Ambulatory Medical Care Survey;
  • AHRQ Effective Health Care Program’s evidence review on CKD screening and management;
  • USPSTF’s Recommendation on Screening for CKD; and
  • Future Federal CKD research and CMS End Stage Renal Disease initiative.

VI. Member Updates

Centers for Disease Control and Prevention

Nilka Rios-Burrows

Infection Prevention: CDC’s Division of Healthcare Quality Promotion has developed infection prevention interventions for dialysis centers. A series of tools (e.g., poster, pocket guide) and a training video have been developed. The materials address hand hygiene and practices for catheters and fistulas/graphs. The CDC’s Bloodstream Infection Prevention Collaborative is a partnership aimed at preventing bloodstream infections in hemodialysis patients. Information on both is available at: cdc.gov/dialysis.

CDC Fact Sheet on CKD: This fact sheet contains basic information about the risk of CKD, progression of the disease, and what can be done to prevent CKD. It is available at cdc.gov/ckd

NephCure Foundation

Henry Brehm

The NephCure Foundation has developed a Spanish language track for its patient education program. While it was challenging to find a nephrologist who spoke Spanish, the resulting product is much more effective than if a translator had been used.

VA Puget Sound Health Care System

Bessie Young

The VA has launched Specialty Care Access Network – Extension for Community Healthcare Outcomes (SCAN-ECHO). The program uses telehealth technology to provide specialty, comprehensive care. This will include partnerships with primary care to provide education on CKD through telenephrology outreach.

VII. Closing Remarks

Andrew Narva

Dr. Narva thanked the panel members for their participation.

April 2, 2014

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