Percentage of pediatric (< 18 years old) peritoneal dialysis patient-months whose delivered peritoneal dialysis dose was a weekly Kt/Vurea >= 1.8 (dialytic + residual)
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1.5 Measure Type1.6 Composite MeasureNo1.7 Electronic Clinical Quality Measure (eCQM)1.8 Level Of Analysis1.9 Care Setting1.9b Specify Other Care SettingDialysis Facility1.10 Measure Rationale
The dose of dialysis is used to estimate the ability of peritoneal dialysis to clear the blood of accumulated toxins. In the adult population, outcome studies have shown an association between dose of hemodialysis in terms of small solute removal and clinical outcomes. Studies have shown a Kt/V of 1.8/week or greater in adult PD patients was associated with better serum albumin levels[1] and improved survival [2]. The ADEMEX did not show clinical benefit with weekly Kt/V doses exceeding 1.7/week in adult CAPD patients [1].
Pediatric PD adequacy targets should be no lower than existing adult PD adequacy targets since generally, pediatric patients’ greater metabolic demands require higher adequacy targets in terms of small solute clearance. No equivalent large scale clinical trials have been conducted in the pediatric peritoneal dialysis population, but smaller scale observational studies support the association between delivered peritoneal dialysis dose and patient outcomes including the potential for improved growth [3].
- Paniagua R, Amato D, Vonesh E, et al. “Effects of increased peritoneal clearances on mortality rates in peritoneal dialysis: ADEMEX, a prospective, randomized, controlled trial.” Journal of the American Society of Nephrology: JASN (2002) 13:1307-20. PMID: 11961019.
- Lo WK, Lui SL, Chan TM, et al. “Minimal and optimal peritoneal Kt/V targets: Results of an anuric peritoneal dialysis patient´s survival analysis.” Kidney international (2005) 67:2032-8. PMID: 15840054.
- Rees L, Feather S, Shroff R. “Peritoneal Dialysis Clinical Practice Guidelines for Children and Adolescents.” British Association of Pediatric Nephrology (2008).
1.11 Measure Webpage1.20 Testing Data Sources1.25 Data SourcesFor the analyses supporting this submission, the measure is calculated using EQRS as the primary data source for the Kt/V values used to determine the numerator. If a patient’s Kt/V data are missing in EQRS, Kt/V values from Medicare claims are used as an additional source for obtaining that information. Please see the attached data dictionary for a list of specific data elements that are used from each data source.
EQRS is the primary basis for placing patients at dialysis facilities and dialysis claims are used as an additional source. Information regarding first ESRD service date, death, age and incident comorbidities adjustments and transplant is obtained from EQRS (including the CMS Medical Evidence Form (Form CMS-2728) and the Death Notification Form (Form CMS-2746)) and Medicare claims, as well as the Organ Procurement and Transplant Network (OPTN) and the Social Security Death Master File.
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1.14 Numerator
Number of patient months in the denominator in which delivered peritoneal dialysis dose was a weekly Kt/V urea >= 1.8 (dialytic + residual, measured in the last 6 months)
1.14a Numerator DetailsReporting months with weekly Kt/V urea >=1.8 (dialytic + residual) are counted in the numerator. If no weekly Kt/V urea value is reported for a given patient in the reporting month, the most recent peritoneal dialysis weekly Kt/V urea value in the prior 5 months is applied to the calculation for that month.
Missing, expired, and not performed are not counted as achieving the minimum weekly Kt/V urea threshold.
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1.15 Denominator
To be included in the denominator for a particular reporting month, the patient must be on peritoneal dialysis for the entire month, be < 18 years old at the beginning of the month, must have had ESRD for greater than 90 days at the beginning of the month, and must be assigned to that facility for the entire month.
1.15a Denominator DetailsA treatment history file is the data source for the denominator calculation used for the analyses supporting this submission. This file provides a complete history of the status, location, and dialysis treatment modality of an ESRD patient from the date of the first ESRD service until the patient dies or the data collection cutoff date is reached. For each patient, a new record is created each time he/she changes facility or treatment modality. Each record represents a time period associated with a specific modality and dialysis facility. EQRS is the primary basis for placing patients at dialysis facilities and dialysis claims are used as an additional source of information in certain situations. Information regarding first ESRD service date, death, and transplant is obtained from EQRS (including the CMS Medical Evidence Form (Form CMS-2728) and the Death Notification Form (Form CMS-2746)) and Medicare claims, as well as the Organ Procurement and Transplant Network (OPTN).
1.15d Age GroupChildren (0-17 years)
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1.15b Denominator Exclusions
Exclusions that are implicit in the denominator definition include
- Patients not on peritoneal dialysis for the entire month
- Adult patients (>=18 years old)
- All patients who have had ESRD for <91 days, and
Patients not assigned to the facility for the entire month
There are no additional exclusions for this measure.
1.15c Denominator Exclusions DetailsThere are no additional or explicit exclusions beyond what is embedded in the denominator's definition.
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1.13 Attach Data Dictionary1.13a Data dictionary not attachedNo1.16 Type of Score1.17 Measure Score InterpretationBetter quality = Higher score1.18 Calculation of Measure Score
Denominator: For the reporting month, patients are included in the denominator if:
- Patient modality is indicated as peritoneal dialysis during the entire month
- Patient age as of the beginning of the reporting month is less than 18 years
- Patient has had ESRD for greater than 90 days at the beginning of the month
- Patient has been assigned to the facility for the entire month
Numerator:
For the reporting month, patients from the denominator are also included in the numerator if they have a weekly Kt/V urea >= 1.8.
If no weekly Kt/V urea value is reported for a given patient in a month, the most recent peritoneal dialysis weekly Kt/V urea value in the prior 5 months is applied to the calculation for that month.
1.18a Attach measure score calculation diagram1.19 Measure Stratification DetailsThe measure is not stratified.
1.26 Minimum Sample SizePublic reporting of this measure on DFCC or in the ESRD QIP would be restricted to facilities with at least 11 eligible patients for the measure to comply with restrictions on reporting of potentially patient identifiable information related to small cell size. We have applied this restriction to all the reliability and validity testing reported here.
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StewardCenters for Medicare & Medicaid ServicesSteward Organization POC EmailSteward Organization URLSteward Organization Copyright
N/A
Measure Developer Secondary Point Of ContactUnited States
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2.1 Attach Logic Model2.2 Evidence of Measure Importance
The primary source of evidence for this measure is the KDOQI Clinical Practice Guidelines and Clinical Practice Recommendations for 2006 Updates: Hemodialysis Adequacy, Peritoneal Dialysis Adequacy and Vascular Access.
Guideline recommendation:
6.3.2.1 The minimal “delivered” dose of total (peritoneal and kidney) small-solute clearance should be a Kt/Vurea of at least 1.8/week”
“For areas in which no pediatric-specific data exist, the CPGs and CPRs for adult patients should serve as a minimum standard for pediatric patients, but the overall clinical “wellness” of the individual pediatric patient should be the primary factor that influences the quantity and quality of the care provided.”
National Kidney Foundation. KDOQI Clinical Practice Guidelines and Clinical Practice Recommendations for 2006 Updates: Hemodialysis Adequacy, Peritoneal Dialysis Adequacy and Vascular Access. Am J Kidney Dis 48:S1-S322, 2006 (suppl 1).
http://www2.kidney.org/professionals/KDOQI/guideline_upHD_PD_VA/pd_rec6.html
The number of published clinical studies in the pediatric population is very small and includes small numbers of patients. PD adequacy studies among the pediatric population are largely observational studies; large scale clinical trials do not exist in the pediatric PD population because of the low prevalence of stage 5 CKD among pediatric patients, high transplantation rate, and difficulty of determining measurable study end points. Therefore, outcomes from the adult PD adequacy studies are evaluated, as experts agree that pediatric PD adequacy targets should be no lower than existing adult PD adequacy targets since generally, pediatric patients’ greater metabolic demands require higher adequacy targets in terms of small solute clearance.
Studies in the adult population and the small number of studies in the pediatric population generally support the relationship between improved solute clearance and clinical outcomes. The evidence supports a target Kt/V for peritoneal dialysis adequacy of between 1.7 and 1.8/week. There is evidence to support that the higher metabolic demands for growth in the pediatric population may require dialysis targets that are at least equal if not higher than in the adult population. There are no specific clinical studies evaluating frequency of adequacy measurements. However, dialysis adequacy would need to be measured in order to ensure that target adequacy doses are achieved.
The 2013 clinical TEP reviewed 30-40 studies on peritoneal dialysis adequacy for both the adult and pediatric populations. PD adequacy studies among the pediatric population are largely observational studies; large scale clinical trials do not exist in the pediatric PD population because of the low prevalence of stage 5 CKD among pediatric patients, high transplantation rate, and difficulty of determining measurable study end points. These include studies on solute clearance and clinical outcomes (such as the ADEMEX), the method of measurement of volume in the pediatric population (Morgenstern, et al. JASN 17:285-293, 2006), the importance of measurement of residual renal function (CANUSA study, Bargman JM, et al. JASN 2158-2162, 2001) and the importance of growth as an outcome measure in the pediatric population (Chadha V, et al. PDI 2001), among others.
In May 2014, an additional literature search was performed and additional pieces of evidence [11-14] are included in the citations below as a result of that search.
- Paniagua R, Amato D, Vonesh E, et al. “Effects of increased peritoneal clearances on mortality rates in peritoneal dialysis: ADEMEX, a prospective, randomized, controlled trial.” Journal of the American Society of Nephrology: JASN (2002) 13:1307-20. PMID: 11961019.
- Lo WK, Lui SL, Chan TM, et al. “Minimal and optimal peritoneal Kt/V targets: Results of an anuric peritoneal dialysis patient's survival analysis.” Kidney international (2005) 67:2032-8.
PMID: 15840054 - Holtta T, Ronnholm K, Jalanko H, Holmberg C. “Clinical outcome of pediatric patients on peritoneal dialysis under adequacy control.” Pediatric Nephrology (2000) 14: 889-97. PMID: 10975294
- National Kidney Foundation. KDOQI Clinical Practice Guidelines and Clinical Practice Recommendations for 2006 Updates: Hemodialysis Adequacy, Peritoneal Dialysis Adequacy and Vascular Access. Am J Kidney Dis 48:S1-S322, 2006 (suppl 1).
- Rees L, Feather S, Shroff R. “Peritoneal Dialysis Clinical Practice Guidelines for Children and Adolescents.” British Association of Pediatric Nephrology (2008).
- White CT, Gowrishankar M, Feber J et al. “Clinical practice guidelines for pediatric peritoneal dialysis.” Pediatric Nephrology: (2006) 21: 1059-66. PMID: 16819641
- European Best Practice Guideline Working Group. “European Best Practice Guidelines for Peritoneal Dialysis.” Nephrology Dialysis Transplantation (2005) 20:ix1-ix37.
- Chadha V, Blowey DL, Warady BA. “Is growth a valid outcome measure of dialysis clearance in children undergoing peritoneal dialysis?” Peritoneal dialysis international : journal of the International Society for Peritoneal Dialysis (2001) 21 Suppl 3:S179-84. PMID: 11887816
- Morgenstern BZ, Wuhl E, Nair KS, Warady BA, et al. “Anthropometric prediction of total body water in children who are on pediatric peritoneal dialysis.” Journal of the American Society of Nephrology: JASN (2006) 17:285-93. PMID: 16319190
- Bargman JM, Thorpe KE, Churchill DN et al. “Relative contribution of residual renal function and peritoneal clearance to adequacy of dialysis: a reanalysis of the CANUSA study.” Journal of the American Society of Nephrology (2001) 12(10):2158-62.
- Cho Y1, Johnson DW, Craig JC, Strippoli GF, Badve SV, Wiggins KJ. Biocompatible dialysis fluids for peritoneal dialysis. Cochrane Database Syst Rev. 2014 Mar 27;3:CD007554. doi: 10.1002/14651858.CD007554.pub2.
- Cadnapaphornchai MA1, Teitelbaum I. Strategies for the preservation of residual renal function in pediatric dialysis patients. Pediatr Nephrol. 2014 May;29(5):825-36; quiz 832. doi: 10.1007/s00467-013-2554-0. Epub 2013 Jul 19.
- Watanabe A1, Lanzarini VV, Filho UD, Koch VH. Comparative role of PET and Kt/V determination in pediatric chronic peritoneal dialysis.Int J Artif Organs. 2012 Mar;35(3):199-207. doi: 10.5301/ijao.5000070.
Baştuğ F1, Dursun I, Dursun J et al. Could mini-PET be used to instead of 4 h original-PET to assess peritoneal permeability in children on peritoneal dialysis? Ren Fail. 2014 May;36(4):562-6. doi: 10.3109/0886022X.2013.879368. Epub 2014 Jan 23.
An additional search was conducted to support the Fall 2024 Maintenance submission, but no additional relevant publications were identified.
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2.6 Meaningfulness to Target Population
Direct evidence: when CMS held a Star Ratings TEP (comprised of approximately equal numbers of providers and patients) to discuss the fate of Kt/V inclusion in the Star Ratings composite reported on DFCC, the patients overwhelmingly voted to retain Kt/V as one important determinant of quality care in the dialysis facilities. Many individually expressed a high degree of comfort in being able to see the Kt/V monthly, to be reassured that at least that component of their dialysis treatments was at or above a minimum standard.
Indirect evidence: most US dialysis patients achieve a Kt/V above 1.2 (HD) and 1.7 (PD). This achievement requires the cooperation of the patient, as they MUST provide consent for the length of treatment and other ordered dialysis parameters involved in achieving these targets. It is well documented in the literature that shortened dialysis treatments, for example, often result in lower Kt/V results. Thus, implicit consent from the patient, a member of the CMS-defined Interdisciplinary Team responsible for dialysis plan of care, is required to complete dialysis as ordered by the provider and executed by the interdisciplinary dialysis team.
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2.4 Performance Gap
Among the 21 facilities that have at least 11 eligible patients, we generated the following statistics of their performance scores (based on the patient month) using the January – December 2022 EQRS and Medicare claims data: mean=76.01% (SD=14.32%); min=48.75%; max=100.0%; Mean scores by decile are shown in Table 1 below. These results indicate that, on average, facilities are meeting the Kt/V urea guidelines in 76% of PD patients.
Note about Table 1: Deciles were defined differently between Tables 1 and 2. In Table 1, facilities are grouped and ranked according to ascending performance score. In Table 2, ranking is calculated on the basis of ascending facility size.
Table 1. Performance Scores by DecilePerformance Gap Overall Minimum Decile_1 Decile_2 Decile_3 Decile_4 Decile_5 Decile_6 Decile_7 Decile_8 Decile_9 Decile_10 Maximum Mean Performance Score 76.01% 48.75% 50.73% 57.01% 64.84% 69.86% 75.33% 81.26% 85.26% 86.58% 89.90% 96.83% 100.0% N of Entities 21 1 2 2 2 2 2 3 2 2 2 2 1 N of Persons / Encounters / Episodes 363 11 26 56 34 24 29 50 28 31 56 29 11
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3.1 Feasibility Assessment
Data collection for Kt/V values is accomplished via EQRS, a web-based and electronic batch submission platform maintained and operated by CMS contractors. Measures reported on DFCC are reviewed on a regular basis by dialysis facility providers and rare instances of inaccurate or missing data are present based on comments reported in the DFCC ticketing system.
3.3 Feasibility Informed Final MeasureNo changes were made.
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3.4 Proprietary InformationNot a proprietary measure and no proprietary components
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4.1.3 Characteristics of Measured Entities
For the Fall 2024 maintenance submission, 21 facilities that had at least 11 eligible patients during January 2022 – December 2022 were included in the analyses. Public reporting of this measure on DFCC or in the ESRD QIP would be restricted to facilities with at least 11 eligible patients for the measure to comply with restrictions on reporting of potentially patient identifiable information related to small cell size. We have applied this restriction to all the reliability and validity testing reported here.
4.1.1 Data Used for TestingFor the Fall 2024 maintenance submission, 2022 EQRS and Medicare claims data were used.
4.1.4 Characteristics of Units of the Eligible Population362 patients who were from 21 facilities with at least 11 eligible patients were included in the analyses. Out of all included patients, 42.3% were female, 2.7% were Native American, 2.8% were Asian, 0.3% were Pacific Islander, 22.1% were Black, 69.1% were White, 2.8% were Other/Multi-Racial, and 23.5% were Hispanic. Please note, the number of patients listed here may not match the total number of patients in Tables 1 and 2 due to patients being counted multiple times if they switched providers during the year.
4.1.2 Differences in DataNone.
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4.2.1 Level(s) of Reliability Testing Conducted4.2.2 Method(s) of Reliability Testing
We used January 2022 – December 2022 EQRS and Medicare claims data to calculate the inter-unit reliability (IUR) for the overall 12 months, minimum, maximum, and within each decile to assess the reliability of this measure. The inter-unit reliability (IUR) measures the proportion of the measure variability that is attributable to the between-facility variance. The yearly based IUR was estimated using a bootstrap approach, which uses a resampling scheme to estimate the within facility variation that cannot be directly estimated by ANOVA. We note that the method for calculating the IUR was developed for measures that are approximately normally distributed across facilities. Since this measure is not normally distributed, the IUR value should be interpreted with some caution.
4.2.3 Reliability Testing ResultsThe annual IUR=0.734 across 12 reporting months, which suggests 73% of variation in the measure is attributed to between facility variation.
Note about Table 2: Deciles were defined differently between Tables 1 and 2. In Table 1, facilities are grouped and ranked according to ascending performance score. In Table 2, ranking is calculated on the basis of ascending facility size.
Table 2. Accountable Entity–Level Reliability Testing Results by Denominator-Target Population SizeAccountable Entity-Level Reliability Testing Results Overall Minimum Decile_1 Decile_2 Decile_3 Decile_4 Decile_5 Decile_6 Decile_7 Decile_8 Decile_9 Decile_10 Maximum Reliability 0.734 0.639 0.639 0.649 0.659 0.668 0.693 0.728 0.738 0.767 0.798 0.842 0.846 Mean Performance Score 76.01% 74.38% 74.38% 75.39% 85.77% 74.29% 66.93% 71.49% 83.38% 88.17% 69.65% 72.92% 90.58% N of Entities 21 2 2 2 2 2 2 3 2 2 2 2 1 N of Persons / Encounters / Episodes 363 22 22 23 24 25 28 50 35 41 49 66 34 4.2.4 Interpretation of Reliability ResultsThe IUR suggests this measure is reliable. However, since the distribution of performance scores is skewed, the IUR value should be interpreted with some caution.
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4.3.1 Level(s) of Validity Testing Conducted4.3.2 Type of accountable entity-level validity testing conducted4.3.2a Why testing not conductedAccountable entity-level validity testing was not performed due to the small size of the pediatric population.4.3.3 Method(s) of Validity Testing
Data elements in EQRS for quality measures that are used in value-based purchasing undergo regular validity testing to ensure accuracy and results are publicly reported. This process involves a medical record review from 300 randomly selected dialysis facilities with up to 10 patients from each facility also being randomly selected. A total of 24 data elements were most recently reviewed from April – June 2023. A nurse review team compares these data elements from the patients chart to what is reported in EQRS. Patient-level data elements include: date of birth, date regular dialysis began, admission and discharge date to facility, type of dialysis treatment and date of death. Quality measure data elements include: Kt/V for hemodialysis, date of Kt/V collection, method used to calculate Kt/V, and modality type.
4.3.4 Validity Testing ResultsResults of this analysis are notable for the following:
- 96.5% correct matches with 1.6% of entries in either EQRS (0.2%) or Medical Records (1.4%) containing missing information.
- 1.9% incorrect matches
- Date elements showed error rates ranging from 0-2.3%
4.3.5 Interpretation of Validity ResultsThis analysis reveals a high degree of validity for the key data elements used in the measure. Additional details can be found at: https://qualitynet.cms.gov/esrd/data-validation#tab2
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4.4.1 Methods used to address risk factorsRisk adjustment approachOffRisk adjustment approachOffConceptual model for risk adjustmentOffConceptual model for risk adjustmentOff
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5.1 Contributions Towards Advancing Health Equity
We are not providing a response to this optional question.
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6.1.1 Current StatusYes6.1.3 Current Use(s)6.1.4 Program DetailsDialysis Facility Care Compare, http://www.medicare.gov, Dialysis Facility Care Compare helps patients find detailed information about Medicare-certified dialysis facilities. They can compare the services an, United States, All Medicare-certified dialysis facilities who are eligible for the measure and have at least 11 patients (due to public reporting requirements).
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6.2.1 Actions of Measured Entities to Improve Performance
Most U.S. chronic dialysis facilities perform quite well on both the hemodialysis Kt/V as well as the PD Kt/V metric. Given this performance, most dialysis facilities are not required to “do more” in order to avoid flagging as underperforming. The greatest utility of the Kt/V measure is as a minimum standard to provide ongoing information about the effectiveness of small solute clearance, one technical outcome of dialysis treatments that contributes to the overall assessment of dialysis success. As the ISPD Guidelines for PD adequacy point out, it is not the only metric that should be used to assess dialysis adequacy, but one important minimum standard for assessment of one aspect of the therapy. In addition to providing this minimum dialytic clearance of small metabolic solutes, the dialysis facility has multiple other aspects of holistic care to monitor and address for optimal dialysis care. Unfortunately, quality metrics that assess these components of dialysis adequacy are either in development , or not yet available based on the current standards of the underlying scientific evidence.
6.2.2 Feedback on Measure PerformanceWe reviewed the comments and questions submitted during the DFCC preview periods that have taken place since the last maintenance (2019-present). Outside of questions about facility-specific results (such as questioning the records for a particular patient), we receive a handful of questions regarding the measure specifications.
For DFCC, feedback can be provided any time through contacting the dialysisdata.org helpdesk. Preview periods allow for specific times for facilities review and comment on measure calculations and provide an opportunity to request a patient list.
6.2.3 Consideration of Measure FeedbackThe measure specifications have not been revised since the last maintenance cycle in 2019. Feedback received during DFCC preview periods has resulted in more detailed and accurate documentation available to the public, primarily via the ESRD Measures Manual and the Guide to the Quarterly Dialysis Facility Reports.
6.2.4 Progress on ImprovementThe following reports the performance scores for this measure at the yearly level for 2015 - 2022. This analysis demonstrates a general increase in performance across seven years for the measure as implemented on DFCC. Calendar year 2020 was not reported due to CMS's COVID Extraordinary Circumstances Exception (ECE) data policy that restricted the use of EQRS clinical data from a portion of that year.
Year 2015: N = 27, Mean = 55.6%, Std Dev =29.7%, Min = 3.6%, Max = 97.3%
Year 2016: N = 30, Mean =60.6%, Std Dev = 26.9%, Min = 7%, Max = 95.8%
Year 2017: N = 31, Mean = 71.3%, Std Dev = 17.5%, Min = 17.5%, Max = 95.3%
Year 2018: N = 32, Mean = 73.2%, Std Dev = 17.9%, Min = 24.4%, Max = 98.3%
Year 2019: N = 28, Mean = 75.9%, Std Dev = 25.6%, Min = 4.1%, Max = 100.0%
Year 2021: N = 11, Mean = 81.5%, Std Dev = 11.6%, Min = 64.0%, Max = 100.0%
Year 2022: N = 21, Mean = 76.0%, Std Dev = 14.3%, Min = 48.8%, Max = 100.0%
6.2.5 Unexpected FindingsWe have been encouraged by the magnitude of improvement in measure results after implementation noted in 6.2.4 above.
We have not been notified of documented unintended impacts on patients as a result of measure implementation.
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ASPN Comments on CBE #2706
OrganizationAmerican Society of Pediatric NephrologyPediatric Peritoneal Dialysis Adequacy: Achievement of Target Kt
ASN supports the continued endorsement of both the pediatric dialysis adequacy measures: CBE #1423: Minimum spKt/V for Pediatric Hemodialysis Patients and CBE #2706: Pediatric Peritoneal Dialysis Adequacy: Achievement of Target Kt/V. Both of these measures align with the current Kidney Disease Outcomes Quality Initiative (KDOQI) guidelines for dialysis adequacy for pediatric patients. The validity and reliability testing demonstrates that these measures are appropriate for continued inclusion in the ESRD QIP. Realizing these measures may be topped out, we believe having an outcomes measure focused on dialysis adequacy for hemodialysis and peritoneal dialysis supports accountability for facilities treating pediatric patients.
OrganizationAmerican Society of NephrologyComments on CBE #2706: Pediatric Peritoneal Dialysis Adequacy
Kidney Care Partners (KCP) appreciates the opportunity to comment on four of the measures that are part of the Partnership for Quality Measurement’s Fall 2024 Measure Cycle. KCP is a coalition of members of the kidney care community that includes the full spectrum of stakeholders related to dialysis care—patient advocates, healthcare professionals, dialysis providers, researchers, and manufacturers and suppliers—organized to advance policies that improve the quality of care for individuals with chronic kidney disease and end stage renal disease (ESRD). We greatly appreciate the PQM undertaking this important work and offer the following comments the ESRD facility-level measures under review.
CBE #2706: Pediatric Peritoneal Dialysis Adequacy: Achievement of Target Kt/V
KCP supports the continued endorsement of both the pediatric dialysis adequacy measures: CBE #1423: Minimum spKt/V for Pediatric Hemodialysis Patients and CBE #2706: Pediatric Peritoneal Dialysis Adequacy: Achievement of Target Kt/V. Both of these measures align with the current KDOQI guidelines for dialysis adequacy for pediatric patients. The validity and reliability testing demonstrate that these measures are appropriate for continued inclusion in the ESRD QIP. We continue to believe that even though these measure may be topped out, having an outcomes measure focused on dialysis adequacy for hemodialysis and peritoneal dialysis supports accountability for facilities treating pediatric patients.
KCP again thanks you for the opportunity to comment on this these measures. If you have any questions, please do not hesitate to contact Kathy Lester, JD, MPH.
OrganizationKidney Care Partners
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CBE #2706 Staff Assessment
Importance
ImportanceStrengths:
- Logic Model: A clear logic model is provided, depicting the relationships between inputs (interdisciplinary team identifies patients with weekly Kt/Vurea < 1.8, identifies the root causes of low Kt/Vurea), activities (managing dialysis dose), and desired outcomes (decreased likelihood of hospitalizations and death, improved quality of care and quality of life). This model demonstrates how the measure's implementation will lead to the anticipated outcomes.
- Evidence and Literature Review: The measure is supported by a comprehensive literature review including systematic reviews and clinical practice guidelines that demonstrate a clear net benefit in terms of improved outcomes for peritoneal dialysis patients. The primary source of evidence is the National Kidney Foundation KDOQI Clinical Practice Guidelines and Clinical Practice Recommendations for 2006 Updates, which apply to both adult and pediatric populations.
- Performance Gap: Data from January – December 2022 EQRS and Medicare claims data shows a performance gap, with decile ranges from 48.75% to 100%, indicating variation in measure performance across the target population. The overall average performance score is 76.01%, showing significant room for improvement.
- Anticipated Impact: If implemented, the developer posits the measure’s anticipated impact on important outcomes is expected to be improved growth and quality of life, based on smaller observational studies and patient input from a CMS Star Ratings TEP.
- Business Case: Overall, the developer provides strong evidence of significant improvements in patient outcomes due to effective management of peritoneal dialysis, with a well-documented, strong business case for the measure’s relevance and necessity in improving health care outcomes.
- Existing Measures: The proposed measure addresses a healthcare need not sufficiently covered by existing measures, offering advantages in terms of addressing peritoneal dialysis in the pediatric population.
- Patient Input: Description of patient input supports the conclusion that the measured outcome is meaningful with at least moderate certainty. Patient input was obtained through a CMS Star Ratings TEP, where patients voted to retain Kt/V as an important determinant of quality care in dialysis facilities.
Limitations:
- Evidence: The developer did not provide information on the grading of the clinical guidelines cited. The evidence supporting this measure is fairly old. This is most likely due to the lack of updated guidelines.
- The previous iteration (2019) of the measure included performance scores from about 31 facilities (2017 data) while the current version of the measure provides performance scores from 21 facilities (2022 data). The difference in sample sizes adds uncertainty about whether peritoneal dialysis care improved between 2017 and 2022.
- Performance gap: Although performance scores by decile range from 48.8% to 100%, indicating variation in measure performance across facilities, the performance gap data is based on 21 facilities and 363 eligible patients. This low number of facilities and patients limits the generalizability of the performance gap results.
Rationale:
- This maintenance measure includes a robust evidence base, clear business case, documented performance gap, significant anticipated impact, well-articulated logic model, and its superiority over existing measures, making it essential for addressing peritoneal dialysis in pediatric populations. However, grading was not provided for the clinical guidelines cited, and the provided evidence is fairly dated (potentially due to a lack of updated clinical guidelines).
Feasibility Acceptance
Feasibility AcceptanceStrengths:
- Feasibility Assessment: A comprehensive feasibility assessment has been conducted. Testing data are derived from EQRS, with Kt/V values from Medicare claims used as an additional source if a patient’s Kt/V data are missing in EQRS.
- Adjustments Based on Feasibility: There were no adjustments to the measure’s development from the feasibility assessment.
- Data Collection Strategy: Required data are routinely generated and used during care, are available in EQRS and Medicare claims, and the data collection strategy can be implemented effectively. Measures reported on Dialysis Facility Care Compare (DFCC) are reviewed regularly by dialysis facility providers for inaccurate or missing data.
- Licensing and Fees: This is not a proprietary measure and there are no proprietary components. There are no fees to use any aspect of the measure.
Limitations:
- None.
Rationale:
- This maintenance measure meets all criteria for 'Met' due to its well-documented feasibility assessment, clear and implementable data collection strategy, and transparent handling of licensing and fees, ensuring practical implementation within the health care system.
Scientific Acceptability
Scientific Acceptability ReliabilityStrengths:
- Data Sources and Dates: Data used for testing were sourced from EQRS and Medicare claims data during the period 1/2022-12/2022. The entities included in the analysis were characterized by facilities with 11 or more eligible patients.
- Accountable Entity-Level Reliability: The developer conducted inter-unit reliability testing (IUR) at the accountable entity-level. A bootstrap approach was used to estimate within-entity variance. More than 70% of accountable entities meet the expected threshold of 0.6.
Limitations:
- None.
Rationale:
- The results demonstrate sufficient reliability at the accountable entity level.
Scientific Acceptability ValidityStrengths:
- The developer provided person- or episode-level validity testing from 300 randomly selected facilities for 10 patients per facility (April-June 2023) for key data elements (date of birth, date regular dialysis began, admission and discharge date to facility, type of dialysis treatment and date of death. Quality measure data elements include: Kt/V for hemodialysis, date of Kt/V collection, method used to calculate Kt/V, and modality type). The results demonstrated high agreement and low missing values.
Limitations:
- The developer stated that accountable-entity level validity testing was not conducted due to small sample sizes for pediatric patients. In addition, face validity was not systematically assessed. Finally, the absence of material variation of an intermediate outcome measure among entities in the Importance Table (Table 1) also does not support a validity claim.
- Risk adjustment: This intermediate outcome measure is not risk adjusted. While a risk adjustment evaluation is not required for intermediate outcome measures (and in this case does not affect the rating), a discussion of risk adjustment would strengthen the submission.
Rationale:
- The developer conducted person- or episode-level validity testing on key data elements from 300 facilities, showing high agreement and low missing values, but did not perform accountable-entity level validity testing due to small pediatric sample sizes and did not systematically assess face validity. The absence of material variation of an intermediate outcome measure among entities in the Importance Table (Table 1) also does not support a validity claim. Going forward, a more robust logic model substantiated with face validity from the TEP would provide some modest support for a validity claim.
Equity
EquityThe developer did not address this optional domain
Use and Usability
Use and UsabilityStrengths:
- Use: The measure is currently used in Dialysis Facility Care Compare.
- Actions for Improvement: The developer provides a summary of how accountable entities can use the measure results to improve performance. Specifically, facilities can use the Kt/V measure to assess the effectiveness of small solute clearance, a technical outcome of dialysis treatments, which contributes to the overall assessment of dialysis success.
- Feedback Mechanism: Feedback and questions about the measure can be provided through the dialysisdata.org helpdesk. Additionally, specific preview periods allow facilities to review and comment on measure calculations and request a patient list. These interactions, along with literature reviews and engagement with clinical experts, are considered for updating the measure.
- Measure Updates: The developer notes that feedback was taken into consideration and resulted in more detailed and accurate documentation available to the public through updates to the ESRD Measures Manual and the Guide to the Quarterly Dialysis Facility Reports.
- Performance Trends: The developer reports changes in performance from 2015 to 2022, in which the overall performance generally increased, supporting the argument that this measure is usable. Calendar year 2020 was not reported due to CMS's COVID Extraordinary Circumstances Exception (ECE) data policy that restricted the use of EQRS clinical data from a portion of that year.
- Unexpected Findings: The developer reports no unexpected findings or documented unintended impacts on patients as a result of measure implementation.
Limitations:
- Missing data due to CMS's COVID Extraordinary Circumstances Exception (ECE) data policy. While the developer provides an explanation for the omitted 2020 data, the implications of the missing data on trend analysis are not explicitly addressed.
- There is an increase in performance followed by a period of decline in CY 2022. Trends in improvement are based on a small number of facilities; 11 facilities for 2021 and 21 facilities for 2022 compared to earlier years.
Rationale:
- For maintenance, the measure is actively used in at least one accountability application, with a clear feedback approach that allows for continuous updates based on stakeholder feedback. The measure also demonstrates a positive trend in performance results, affirming its ongoing usability. The developer reports no unexpected findings.
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Summary
Importance
ImportanceEvidence is dated, and sample size for gap analysis is quite small
Feasibility Acceptance
Feasibility Acceptanceagree with staff
Scientific Acceptability
Scientific Acceptability Reliabilityagree with staff
Scientific Acceptability Validitysmall sample size, little variation in this intermediate outcome, no risk adjustment, no assessment face validity
Equity
Equityagree with staff---optional
Use and Usability
Use and Usabilityagree with staff
Summary
needs attention to several areas
There are several areas that…
Importance
ImportanceAgree with staff recommendations.
Feasibility Acceptance
Feasibility AcceptanceAgree with staff recommendations.
Scientific Acceptability
Scientific Acceptability ReliabilityAgree with staff recommendations.
Scientific Acceptability ValidityThere should have been a larger sample size to conduct accountable-entity level validity testing.
Equity
EquityI agree with the staff recommendations.
Use and Usability
Use and UsabilityI agree with staff recommendations.
Summary
There are several areas that need to be address like more recent literature review and a larger sample size for accountable-entity level validity testing.
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ASPN supports the continued endorsement of both the pediatric dialysis adequacy measures: CBE #1423: Minimum spKt/V for Pediatric Hemodialysis Patients and CBE #2706: Pediatric Peritoneal Dialysis Adequacy: Achievement of Target Kt/V. It is critical that there be a clinical measure that is applicable for pediatrics, and the Kt/V measures are reasonable although there is a limited ability for improvement. We recommend continuing to align with the KDOQI recommendations of a pediatric PD Kt/V goal of 1.7; we do not recommend changing the goal to align with the adult recommendation. Measures do not apply to pediatric and adult ESRD patients in the same way, given the meaningful differences in these two patient populations, and we believe that keeping the pediatric Kt/V measure will allow for more accurate comparisons across patient populations and modalities.