Winter 2011 Member e–Newsletter

Table of Contents

• Evidence–Based Medicine: Why We Should Care About Clinical Research
• End–Stage Renal Disease (ESRD) Quality Incentive Program
• Chair’s Corner
• 2011 CAP Awards
• 2011 NKF Spring Clinical Meetings
• Membership Update
• Update: Sydney the Kidney

Evidence–Based Medicine: Why We Should Care About Clinical Research

Beth Wilkening, PA–C

When you use an algorithm, committee recommendations or published guidelines to evaluate or treat a patient, do you know why you trust them to guide your decision-making process?

Evidence based medicine (EBM) was originally defined by Dr. David Sackett in 1996 as “the conscientious, explicit, and judicious use of current best evidence in making decisions about the care of individual patients.” This practice is now generally called evidence based practice (EBP), understood to be a systematic approach to clinical problem solving. EBP is a dynamic process involving the integration of our clinical expertise, the patients’ values, and the results of the best available research into decisions about patient care. Clinical expertise includes our education, clinical skills, and collective experience. Patients we encounter bring their own values and expectations to the interaction with us. Clinical recommendations and guidelines are designed using the best evidence extracted from clinically relevant research conducted using sound methodology.

Medical and scientific information, clinical skills, and active listening/cultural sensitivity training generally are well–taught in our advanced practice programs. However, the EBP process also involves learning what question needs to be asked, how to effectively search the literature, and how to apply criteria (“rules of evidence”). This process needs to occur in order to evaluate research findings and appropriately extrapolate results for the particular patient issue.

The five A’s of EBP start and end with the patient:

1. ASSESS. Do as thorough an assessment of the patient as possible and identify the problem.
2. ASK. Take problem that you have identified and ask a question. It should be relevant to the patient’s case and expressed to enable you to find an answer. Use the mnemonic “PICO” to identify the components of an appropriately focused question. The question should identify the main problem of the patient, what treatment(s) are being considered, what alternative treatment (if any) might be available, and what outcome is desired or should be avoided.
   

   P = Patient or Problem
   Consider the important characteristics of the patient that might be relevant to the diagnosis or treatment: primary problem/disease/co–existing conditions, gender, age, race, current medications

   I = Intervention, Prognostic Factor, or Exposure
   Consider the main intervention needed: medical/surgical management, medication, tests
   Consider what factors might influence the prognosis
   Consider patient exposure to substance (as the etiology of the problem or the treatment)
   

   C = Comparison
   Consider an alternative to the potential intervention (there may not be one)

   O = Outcomes
   Consider the goal for the patient: will you improve or otherwise affect the outcome by relieving or eliminating symptoms, reducing treatment adverse events, or improving function/test scores?

3. ACQUIRE. The type of question will help you determine what type of evidence to acquire and review.

   TYPE OF QUESTION	CLINICAL TASK	SUGGESTED BEST TYPE OF STUDY
   Diagnosis	how to select and interpret diagnostic tests	prospective, blind comparison to a gold standard
   Therapy	how to select treatments that do more good than harm and are worth the efforts and costs of use	*RCT > cohort > case control > case series
   Prognosis	how to estimate the patient’s likely clinical course and anticipate possible complications	cohort study > case control > case series
   Harm/Etiology	how to identify causes for disease including iatrogenic	RCT > cohort > case control > case series
   Prevention		RCT > cohort study > case control > case series
   Clinical Exam		prospective, blind comparison to gold standard
   Cost Benefit		economic analysis

   *RCT = Randomized Controlled Trial

   Case Series and Case Report: Collections of reports on the treatment of individual patients or a report on a single patient. Since no control groups are used for comparing outcomes, neither is statistically valid.

   Case Control Study: A study that starts with patients who already have the outcome and looks backwards to possible exposures. It compares patients who already have a specific condition to people who do not have that condition by looking back at factors or exposures that might be associated with the condition. Medical record review and patient recall typically are used. It often is less reliable than a randomized controlled trial or a cohort study; showing a statistical relationship between factors does not always imply causality.

   Cohort Study: A study that starts by identifying or knowing the exposure and follows patients forward to an outcome. It uses a large population already taking a particular treatment or having an exposure, follows them forward over time, and compares their outcomes to a similar group that has not been affected by the treatment or exposure being studied. This is an observational study. It is not as reliable as a randomized controlled study; the two groups may differ in other ways than the treatment or exposure being studied.

   Randomized Controlled Clinical Trial (RCT): A study that randomly assigns patients to the exposure(s) or intervention(s) and then follows them forward to an outcome. It is designed to introduce a treatment or exposure in order to study its effect on real patients. The study design includes methodologies to reduce the potential for bias (randomization and blinding) but still allow for comparison between intervention groups and control groups (no intervention). It can provide sound evidence of cause and effect.

   Systematic Review: Focuses on a clinical topic to answer a specific question. An extensive literature search identifies studies with sound methodology. The studies are reviewed and assessed; the results are summarized according to predetermined criteria of the review question.

   Meta–analysis: a thorough examination of valid studies on a topic. Results are combined using accepted statistical methodology and reported as if it were one large study.

   There is an evidence pyramid, a guideline to the hierarchy of study design. When we search for evidence, we should look for the highest level of studies to answer the question we have posed.

   At the base of the pyramid is the base of information – an idea or laboratory research. As theory becomes a therapy or a diagnostic tool, it is tested first in laboratory/computer models, then in animals, and then in humans.

   Within the pyramid, the amount of published literature decreases as the study design becomes more rigorous and statistically valid toward the apex. However, what is published generally becomes more relevant to a clinical question.

   

   Some helpful websites include PubMed (the US National Library of Medicine) and The Cochrane Database of Systematic Reviews.

4. APPRAISE. Evaluate the evidence for validity and applicability:
   
   

   Validity: Were intervention and control groups equal at baseline? Was randomization sequence hidden from researchers? Were patients randomized to intervention? Was the study blinded? Was follow–up completed? Were patients’ data analyzed in the treatment group to which they were assigned (“intent to treat”)?

   Applicability: Treatment effect, relative and absolute risk reduction. Ask were study patients similar to your patient of interest, were all clinically important outcomes considered, are intervention benefits greater than the potential for harm?

   Grading Systems and Recommendations:

   SORT: Strength of Recommendation Taxonomy

   Uses Codes A, B, C:

   A = Consistent, good–quality patient-oriented evidence*
   B = Inconsistent or limited–quality patient-oriented evidence*
   C = Consensus, disease-oriented evidence**, usual practice, expert opinion, or case series for studies of diagnosis, treatment, prevention, or screening

   * Patient–oriented evidence measures outcomes that matter to patients such as morbidity, mortality, symptom improvement, cost reduction, and quality of life.

   **Disease–oriented evidence measures immediate, physiologic, or surrogate end points that may or may not reflect improvements in patient outcomes (e.g. blood pressure, blood test results, physiologic function, and pathologic findings).

   GRADE: Grading of Recommendations Assessment, Development and Evaluation

   Uses Strong / Weak

5. APPLY. Finally, take it back to the patient. Integrate the information and your evaluation of the evidence, the patient’s preferences, and your clinical expertise; and apply it to your practice.

A health policy does not just happen. The way we care for patients and the procedures we follow are backed by study and evidenced gathered from practice.

References
Sackett DL, Rosenberg WMC, Gray JAM, Haynes RB, Richardson WS. Evidence based medicine: what it is and what it isn’t. BMJ 1996; 312: 71–2

Sackett DL, Strauss SE, Richardson WS, et al. Evidence–based medicine: how to practice and teach EBM. London: Churchill–Livingstone, 2000

Helpful Websites:
Duke University Medical Center Library EBM Tutorial
Centre for Evidence Based Medicine, Oxford (with link to CATmaker download)
Centre for Evidence Based Medicine, Toronto
JAMAevidence
GRADE Working Group

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End-Stage Renal Disease (ESRD) Quality Incentive Program

Lynn Poole, FNP–BC
NKF–CAP Legislative Chair

The Medicare Improvements for Patients and Providers Act (MIPPA), legislation passed by Congress in 2008, mandated the creation of a prospective payment system for ESRD (bundling) and included a requirement for CMS to create an ESRD Quality Incentive Program (QIP). Further, MIPPA included a requirement that CMS “develop a QIP that will result in payment reductions to providers of dialysis services and dialysis facilities that do not meet or exceed an established total performance score with respect to performance standards established for certain specified measures.” The reduction in payment may be up to two percent (2%) of payments to dialysis providers and facilities.

The proposed rule was published on August 12, 2010 with the period for public comment ending on September 24, 2010. NKF submitted comments during the public comment period. The final rule was published on December 29, 2010, and QIP will be implemented on January 1, 2012.

Monitoring the quality of care for those with ESRD has long been a component of the Medicare ESRD payment system. The process has evolved over the years via monitoring initiatives by the ESRD Networks, the Core Indicators Project, the Clinical Performance Measures Project (CPM), Dialysis Facility Compare (DFC), the ESRD Conditions for Coverage (CfC) and most recently implementation of the CROWNWeb system. However, at no time in the past has performance been associated with reductions in payment from Medicare. That alone elevates the stakes and the level of attention to the QIP.

Initially there will be three measures included in the QIP, two for anemia management and one for adequacy of hemodialysis. Future measures will be determined as the QIP progresses and are to be established via an informal rulemaking process.

The measures are:

• Percentage of Medicare patients with an average hgb <10.0 g/dl
• Percentage of Medicare patients with an average hgb >12.0 g/dl
• Percentage of Medicare patients with an average URR* > 65% for patients dialyzing 3x per week
  *It is the plan eventually to replace the URR measure with a Kt/V measure

Performance rates are:

• Hgb < 10.0 g/dl, the national performance rate is 2%
• Hgb > 12.0 g/dl, the national performance rate is 26%
• Hemodialysis Adequacy, the national performance rate is 96% for patients dialyzing 3x per week

Calendar year 2011 is the initial performance period which affords the agency adequate time to collect and analyze the data and calculate the performance scores.

Performance Scores: Ten points will be assigned to each performance measure. CMS will subtract two points for every one percentage point below the standard. Performance measures are weighted according to their clinical significance, thus hgb < 10.0 g/dl is weighted at 50 percent of the total and each of the other two measures are weighted at 25 percent of the total. CMS plans to reevaluate weighting as new measures are added to the QIP. Reductions in payment will be in 0.5 percent increments up to a total of 2 percent. Payment reductions will apply to the monthly payment with applicable adjustments included in the calculation such as case-mix, wage index, outliers, etc.

CMS plans to utilize CROWNWeb, claims data, patient activity reports, dialysis provider forms and other quantitative and qualitative data sources for the QIP.

Public Reporting: There are new requirements for reporting and for public disclosure. Facilities will be required to prominently display certificates sent by CMS disclosing performance scores for the individual facility and additional information will be available on Dialysis Facility Compare. CMS aspires to make this information available closer to real-time rather than from the distant past.

Future Plans: CMS plans to add additional performance measures to the QIP and are developing measures in the areas of patient satisfaction, iron management, vascular access, access infection, bone mineral metabolism, Kt/V, fluid/weight management and other measures specific for the pediatric dialysis population, but with plans to make the measures applicable to all modalities.

The implementation of the QIP will move providers and practitioners into areas that heretofore have been conceptual rather than real. To assure the best performance for the QIP measures, now and in the future, providers and practitioners will be required to work together so that all can benefit, especially the patients who entrust their complicated care and lives to those of us committed to providing them the best care possible. There will be challenges and likely some missteps but if we stay focused on the goals and outcomes, all will benefit and at in the end we will be proud of what we have accomplished.

Please email me if you would like a copy of the final rules.

Chair’s Corner

Kim Zuber, PA–C, MSPS

The year has flown by. I am halfway through my tenure as CAP Chair and I can’t believe we are already in 2011…The Year of Bundling. Last year at this time, we were excited about starting Kidney Disease Education for our patients and we were all awaiting the “Your Treatment, Your Choice” CD from NKF. This year, we feel like old hands at teaching treatment options and now await the consequences (both good and bad) from the changeover to bundling. Since more than 90 percent of all dialysis units moved to bundling on 1/1/11, January was a real eye–opener for all of us. I expect that when we all meet in Vegas for the CAP Town Hall Meeting that we will have both cheers and jeers to share about the transition to bundling. Lynn Poole, CAP’s Legislative Chair, has graciously agreed to keep us up–to–date with items on the listserv revolving around the change in billing practices. Personally, I am interested to see how bone management changes. CMS is not collecting data on bone health and the units are not being graded on renal osteodystrophy. Injectable drugs will cost the units money, and so I am worried. I hope to be pleasantly surprised, but time will tell.

CMS also added the requirement for APs to personally sign each lab order. We already do this in D.C. area hospitals…by clicking on an icon that adds our signature to the order. However, we need to log in, click on each lab and click OK. The advantage is we can do it from home. The disadvantage is the hospitals in our area refuse to allow APs to sign orders. I can only hope the LDOs (large dialysis organizations) make sure that APs have access to their computer programs. I have heard from APs over the years that were not given their own access to the LDOs computer programs. Perhaps this will be the carrot that allows us our own personal computer tracking IDs. As we go to electronic health records, most organizations do not quite know what to do with us. I think a solution is obvious: issue APs an ID, just like physicians are given.

So, I look forward to seeing, and hearing from you, on Thursday April 28^th from 4:00–5:30 for the CAP Town Hall Meeting in Las Vegas. It will be a chance to network with your colleagues, learn what is working (and what is not) and discover what you can do to bring ‘best practices’ to your nephrology group. See you in April!

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2011 CAP Awards

The following awards will be given at the NKF Spring Clinical Meetings, during the CAP Networking Luncheon on Wednesday, April 27 from 12:00–2:00. Congratulations to this year’s awardees!

The 2011 Tim Poole Award will be given to Deb Hain, PhD, APRN, GNP–BC. Dr. Hain, a nephrology nurse since 1987, is currently a Nephrology Nurse Practitioner, Nurse Researcher and Assistant Professor at the Florida Atlantic University Christine Lynn College of Nursing. She also works as a nephrology NP for the Cleveland Clinic, Florida. She is an active member of both CAP and the American Nephrology Nurses Association (ANNA).

Tim Poole, PA–C, exemplified the qualities of the ideal Advanced Practitioner. He served his patients, was active in his community and devoted to his family. Deb, too, balances her professional and personal life. In addition to her professional obligations as an NP and nursing instructor, she finds time to participate in NKF KEEP Screenings, to volunteer with the elderly in her community and to keep up with the demands of an active family.

Deb is the “go–to person“ for nephrology in her area. Whether it is counseling patients approaching kidney failure or instructing nephrology fellows on the basics of dialysis, Deb always stays patient focused. CAP is proud to give this award to an Advanced Practitioner who represents the best in all of us.

If CAP had a cheerleading team, Charles J. Foulks, MD, FACP, FACN, would be the head cheerleader. Charlie, as we know him, is the recipient of the 2011 Nostradamus Award. The award is presented annually to an individual or organization which promotes nephrology Advanced Practitioners.

Charlie has been a long–time supporter of Advanced Practitioners, and he is no stranger to NKF. Since the inception of the AP track at the NKF Spring Clinical Meetings, he has been one of the speakers we have relied on. He has devoted his professional and personal life to helping others and training the next generation of medical professionals.

Charlie’s involvement with NKF and his work as a nephrologist has spanned more than 30 years. During that time, he has been an active member of many committees and work groups. He has published numerous articles and participated in many groups to establish guidelines for practice. Among his many awards and honors, Charlie is perhaps the most proud of being the recipient of the 2009 Paragon Award, the highest honor of the American Association of Physician Assistants (AAPA).

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2011 NKF Spring Clinical Meetings

The Advanced Practice track at the NKF Spring Clinical Meetings is a winning proposition. Where else can you network with colleagues from all over the United States, sharpen your clinical skills, learn new techniques and approaches to issues we face every day, earn educational credits and HAVE FUN?

You can experience all this for only $250. Don’t wait another minute – register for this premier event today. Starting with Nephrology 201 on Tuesday, April 26, and going through until Saturday, April 30, every day is packed with meetings and opportunities to chat with practitioners from the mountains to the beaches and all points in between.

Want to express yourself about bundling? Come to the CAP Town Hall meeting. Thinking about a research project for your unit or maybe you are going back to school? The Strut Your Stuff session highlights research by other Advanced Practitioners. Are your PowerPoint presentations looking just a little blah? Rev up your laptop and come to the lunch session with a PowerPoint guru.

Topics range from the serious, Diagnostic Urinalysis, to the fun, but informative Renal Anatomy Game Show. There will be a CAP luncheon, Healthcare Practitioners’ reception and an extensive Exhibit Hall.

Don’t let this pass you by. Register today and pack your bags for Vegas!

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Membership Update

Attention CAP Members!! The 2011 NKF Spring Clinical Meetings are fast approaching and this is a very good time to renew your NKF–CAP membership. We are a young Council and smaller than most, but we offer huge benefits. These include:

• An active listerv email discussion group to guide us through the challenges of bundling, give support to our practice styles, and discuss questions or issues we face in our practice
• Results from the 2010 Nephrology AP Salary and Benefits survey, which we can bring to our place of work and garner more benefits, including a salary increase or our name on the door or practice letterhead.
• Nephrology Essentials: an online education program to enhance nephrology knowledge. Although originally developed for the practitioner new to nephrology, it has been an excellent go–to source for even the most seasoned AP.
• Dialysis Essentials: An excellent program to fin–tune our dialysis knowledge and education. This has been a year–long collaboration of APs all over the country who have met through telephone conferences and e–mail to produce what will be an educational and reference tool for Dialysis APs. An extra bonus – it will have CE and CEU credits. Coming soon!
• The opportunity to apply for educational stipends to attend the NKF Spring Clinical Meetings.
• Working on your PA or DNP? The NKF Spring Clinical Meetings is a great place to present your poster.

In addition, we present two annual awards: The Tim Poole Award to an outstanding CAP member and the Nostradamus Award to the person or organization who has contributed to the goals of CAP. If that’s not enough, we also get substantial discounts on educational programs, NKF Spring Clinical Meetings registration and opportunities to network, participate in public policy and support NKF programs and activities.

Renew your membership today or share the news about CAP with a friend or colleague.

If you are having any membership issues, please contact CAP’s Membership Chair Barbara Weis Malone or Denise Dilley, NKF’s Professional Council Activities Director.

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Update: Sydney the Kidney

He’s Back! After being missing for several months, Sydney the Kidney is back and anxious to hit the road to promote kidney awareness and health. He is very closed–mouth about his whereabouts since he was last seen. One thing for sure—he is on steroids (see picture).

Sydney wants to pick up his travels. Contact Deb Hain, his travel agent to reserve Sydney for your area. He will travel to New York in April in time to spruce up for NKF’s Spring Clinical Meetings in Las Vegas. Make sure you visit the CAP booth in the Exhibition Hall to meet Sydney and welcome him back.

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