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Measure Summary
Title
Advanced chronic kidney disease (CKD): percent of patients prescribed vitamin D2.
Source(s)
Renal Physicians Association. Appropriate patient preparation for renal replacement therapy. Rockville (MD): Renal Physicians Association; 2002 Oct 1. 78 p. (Clinical Practice Guideline; no. 3).

Measure Domain

Primary Measure Domain
Clinical Quality Measures: Process
Secondary Measure Domain
Does not apply to this measure

Brief Abstract

Description

This measure assesses the percent of patients prescribed vitamin D2 among patients with advanced chronic kidney disease (CKD) and immunoreactive parathyroid hormone (iPTH) greater than 100 pg/mL (or greater than 1.5 times the upper limit of normal for each assay used) and vitamin D level less than 30 ng/mL.

Rationale

Renal osteodystrophy is a complex and multifaceted disease process that begins early in the course of chronic kidney disease (CKD) and is a major, long-term complication associated with high rates of morbidity. The metabolic and skeletal derangements associated with renal osteodystrophy are not easily reversed and, therefore, early interventions are crucial.

Serum levels of 1,25(OH)2D correlate with 25(OH)D in CKD stage 3 and 4, indicating that the generation of 1,25(OH)2D in CKD patients depends on supply of 25(OH)D. Patients with CKD are more likely than non-CKD patients to have 25(OH)D levels less than 30 ng/mL. Levels of 25(OH) vitamin D less than 30 ng/mL but within the normal range have been associated with elevated immunoreactive parathyroid hormone (iPTH) levels in the elderly, and levels less than 15 ng/mL have been associated with a greater severity of secondary hyperparathyroidism (HPTH) in end-stage renal disease (ESRD) patients. Therapy may reduce fracture risk in the elderly.

Evidence for Rationale
Ghazali A, Fardellone P, Pruna A, Atik A, Achard JM, Oprisiu R, Brazier M, Remond A, Moriniere P, Garabedian M, Eastwood J, Fournier A. Is low plasma 25 (OH) vitamin D a major risk factor for hyperparathyroidism and Looser's zones independent of calcitriol?. Kidney Int. 1999 Jun;55(6):2169-77. PubMed External Web Site Policy

Ishimura E, Nishizawa Y, Inaba M, Matsumoto N, Emoto M, Kawagishi T, Shoji S, Okuno S, Kim M, Miki T, Morii H. Serum levels of 1,25-dihydroxyvitamin D, 24,25-dihydroxyvitamin D, and 25-hydroxyvitamin D in nondialyzed patients with chronic renal failure. Kidney Int. 1999 Mar;55(3):1019-27. PubMed External Web Site Policy

Reichel H, Deibert B, Schmidt-Gayk H, Ritz E. Calcium metabolism in early chronic renal failure: implications for the pathogenesis of hyperparathyroidism. Nephrol Dial Transplant. 1991;6(3):162-9. PubMed External Web Site Policy

Renal Physicians Association. Appropriate patient preparation for renal replacement therapy. Rockville (MD): Renal Physicians Association; 2002 Oct 1. 78 p. (Clinical Practice Guideline; no. 3).

Thomas MK, Lloyd-Jones DM, Thadhani RI, Shaw AC, Deraska DJ, Kitch BT, Vamvakas EC, Dick IM, Prince RL, Finkelstein JS. Hypovitaminosis D in medical inpatients. N Engl J Med. 1998 Mar 19;338(12):777-83. PubMed External Web Site Policy
Primary Health Components

Advanced chronic kidney disease; renal osteodystrophy; immunoreactive parathyroid hormone; 25(OH) vitamin D; vitamin D insufficiency

Denominator Description

The number of adult patients with advanced chronic kidney disease (CKD), not currently receiving renal replacement therapy, with immunoreactive parathyroid hormone (iPTH) greater than 100 pg/mL (or greater than 1.5 times the upper limit of normal for each assay used) and vitamin D level less than 30 ng/mL

Numerator Description

The number of patients from the denominator prescribed vitamin D2

Evidence Supporting the Measure

Type of Evidence Supporting the Criterion of Quality for the Measure
  • A clinical practice guideline or other peer-reviewed synthesis of the clinical research evidence
  • A formal consensus procedure, involving experts in relevant clinical, methodological, public health and organizational sciences
  • A systematic review of the clinical research literature (e.g., Cochrane Review)
Additional Information Supporting Need for the Measure

Levels of 25(OH) vitamin D less than 30 ng/mL but within the normal range have been associated with elevated immunoreactive parathyroid hormone (iPTH) levels in the elderly, and levels less than 15 ng/mL have been associated with a greater severity of secondary hyperparathyroidism (HPTH) in end-stage renal disease (ESRD) patients.

Evidence for Additional Information Supporting Need for the Measure
Ghazali A, Fardellone P, Pruna A, Atik A, Achard JM, Oprisiu R, Brazier M, Remond A, Moriniere P, Garabedian M, Eastwood J, Fournier A. Is low plasma 25 (OH) vitamin D a major risk factor for hyperparathyroidism and Looser's zones independent of calcitriol?. Kidney Int. 1999 Jun;55(6):2169-77. PubMed External Web Site Policy
Extent of Measure Testing

Unspecified

State of Use of the Measure

State of Use
Current routine use
Current Use
Internal quality improvement

Application of the Measure in its Current Use

Measurement Setting
Ambulatory/Office-based Care
Hospital Outpatient
Professionals Involved in Delivery of Health Services
Physicians
Least Aggregated Level of Services Delivery Addressed
Individual Clinicians or Public Health Professionals
Statement of Acceptable Minimum Sample Size
Unspecified
Target Population Age

Age greater than or equal to 18 years

Target Population Gender
Either male or female

National Strategy for Quality Improvement in Health Care

National Quality Strategy Aim
Better Care
National Quality Strategy Priority
Prevention and Treatment of Leading Causes of Mortality

Institute of Medicine (IOM) National Health Care Quality Report Categories

IOM Care Need
Living with Illness
IOM Domain
Effectiveness

Data Collection for the Measure

Case Finding Period

Unspecified

Denominator Sampling Frame
Patients associated with provider
Denominator (Index) Event or Characteristic
Clinical Condition
Patient/Individual (Consumer) Characteristic
Denominator Time Window
Does not apply to this measure
Denominator Inclusions/Exclusions

Inclusions
Adult patients age 18 years and older with chronic kidney disease stage 4 or 5 (glomerular filtration rate [GFR] less than or equal to 30 mL/min/1.73 m2), not currently receiving renal replacement therapy, with immunoreactive parathyroid hormone (iPTH) greater than 100 pg/mL (or greater than 1.5 times the upper limit of normal for each assay used) and vitamin D level less than 30 ng/mL

Exclusions
Unspecified

Exclusions/Exceptions
Unspecified
Numerator Inclusions/Exclusions

Inclusions
The number of patients from the denominator prescribed vitamin D2*

*Prescribed vitamin D dosage is vitamin D2 50,000 units orally every month for six months.

Exclusions
Unspecified

Numerator Search Strategy
Episode of care
Data Source
Administrative clinical data
Laboratory data
Paper medical record
Pharmacy data
Type of Health State
Does not apply to this measure
Instruments Used and/or Associated with the Measure

Unspecified

Computation of the Measure

Measure Specifies Disaggregation
Does not apply to this measure
Scoring
Rate/Proportion
Interpretation of Score
Desired value is a higher score
Allowance for Patient or Population Factors
Unspecified
Standard of Comparison
Internal time comparison

Identifying Information

Original Title

Number of patients prescribed vitamin D2 / number of patients with advanced CKD and iPTH greater than 100 pg/mL (or greater than 1.5 times the upper limit of normal for each assay used) and vitamin D level less than 30 ng/mL.

Submitter
Renal Physicians Association - Medical Specialty Society
Developer
Renal Physicians Association - Medical Specialty Society
Funding Source(s)

Ortho Biotech Products, LP

Composition of the Group that Developed the Measure

W. Kline Bolton, MD, Working Group Chair, University of Virginia School of Medicine, Charlottesville, VA; William F. Owen, Jr., MD, President, RPA, Duke University School of Medicine Durham, NC; Baxter Healthcare Corp., McGaw Park, IL; Dale Singer, MHA, Executive Director, RPA.

Content Experts: Jack Coburn, MD, UCLA School of Medicine, West Los Angeles V.A. Healthcare Center, West Los Angeles, CA; William Haley, MD, Mayo Clinic, Jacksonville, FL; Annamaria Kausz, MD, New England Medical Center, Boston, MA; Adeera Levin, MD, St. Paul's Hospital, Vancouver, BC; William Mitch, MD, University of Texas Medical Branch, Galveston, TX; Patricia Painter, PhD, University of California, San Francisco, CA; Michael Rocco, MD, MSCE, Wake Forest University School of Medicine, Winston-Salem, NC.

Association Representatives: Carolyn Atkins, RN, BS, CCTC, National Kidney Foundation, Medical City Dallas Hospital, Dallas, TX; Shelley Clark, RN, National Renal Administrators Association, FMC North Roanoke Dialysis, Roanoke, VA; Paul Eggers, PhD, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Bethesda, MD; Lori Fedje, RD, LD, NKF Council on Renal Nutrition, Pacific Northwest Renal Services, Portland, OR; Richard Goldman, MD, Renal Physicians Association, Renal Medicine Associates, Emeritus Albuquerque, NM; Joel Greer, PhD, Centers for Medicare and Medicaid Services, Baltimore, MD; Richard Lafayette, MD, American Society of Nephrology, Stanford University School of Medicine, Stanford, CA; Eugene Z. Oddone, MD, American College of Physicians - American Society of Internal Medicine, Durham VA Medical Center, Durham, NC; Victoria Norwood, MD, American Society of Pediatric Nephrology, University of Virginia, Charlottesville, VA; Paul M. Palevsky, MD, Forum of ESRD Networks, University of Pittsburgh School of Medicine, VA Pittsburgh Health Care System, Pittsburgh, PA; Sandy Peckens, MSW, NKF Council of Nephrology Social Workers, Merrimack Valley Nephrology, Methuen, MA; Venkateswara Rao, MD, American Society of Transplantation, Hennepin County Medical Center, Minneapolis, MN; Charlotte Thomas Hawkins, PhD, RN, CNN, American Nephrology Nurses Association, Rutgers, The State University of New Jersey, Burlington, NJ; Joseph White, American Association of Kidney Patients.

Methodologists: David B. Matchar, MD, FACP, Director, Duke Center for Clinical Health Policy Research and Co-Director, Duke Evidence-based Practice Center, Durham, NC; Douglas C. McCrory, MD, MHS, Co-Director Duke Evidence-based Practice Center, Durham, NC; Joseph A. Coladonato, MD, Duke Institute of Renal Outcomes Research & Health Policy, Durham, NC; Preston S. Klassen, MD, MHS, Duke Institute of Renal Outcomes Research & Health Policy, Durham, NC; Meenal B. Patwardhan, MD, MHSA, Duke Center for Clinical Health Policy Research and Duke Evidence-based Practice Center, Durham, NC; Donal N. Reddan, MD, MHS, Duke Institute of Renal Outcomes Research & Health Policy, Durham, NC; Olivier T. Rutschmann, MD, MPH, Duke Center for Clinical Health Policy Research, Durham, NC; William S. Yancy, Jr., MD, MHS, Duke University Medical Center, Durham, NC.

Medical Editor: Rebecca N. Gray, DPhil, Duke Evidence-based Practice Center, Durham, NC.

Project Manager and Editor: Emily G. Shurr, MA, Duke Evidence-based Practice Center, Durham, NC.

Financial Disclosures/Other Potential Conflicts of Interest

There were none disclosed.

Adaptation

This measure was not adapted from another source.

Date of Most Current Version in NQMC
2002 Oct
Measure Maintenance

Unspecified

Date of Next Anticipated Revision

Unspecified

Measure Status

This is the current release of the measure.

The measure developer reaffirmed the currency of this measure in April 2014.

Source(s)
Renal Physicians Association. Appropriate patient preparation for renal replacement therapy. Rockville (MD): Renal Physicians Association; 2002 Oct 1. 78 p. (Clinical Practice Guideline; no. 3).
Measure Availability

The individual measure, "Number of patients prescribed vitamin D2 / number of patients with advanced CKD and iPTH greater than 100 pg/mL (or greater than 1.5 times the upper limit of normal for each assay used) and vitamin D level less than 30 ng/mL," is published in "Renal Physicians Association Clinical Practice Guideline #3: Appropriate Patient Preparation for Renal Replacement Therapy."

For more information, contact RPA at 1700 Rockville Pike, Suite 220, Rockville, MD 20852; phone: 301-468-3515; fax: 301-468-3511; Web site: www.renalmd.org External Web Site Policy; e-mail: rpa@renalmd.org.

NQMC Status

This NQMC summary was completed by ECRI on May 23, 2003. The information was verified by the Renal Physicians Association on June 17, 2003. This NQMC summary was retrofitted into the new template on May 6, 2011. The information was reaffirmed by the measure developer on April 7, 2014.

Copyright Statement

This NQMC summary is based on the original measure, which is subject to the measure developer's copyright restrictions.

For more information, contact RPA at 1700 Rockville Pike, Suite 220, Rockville, MD 20852; phone: 301-468-3515; fax: 301-468-3511; Web site: www.renalmd.org External Web Site Policy; e-mail: rpa@renalmd.org.

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