When the measure returns for maintenance (5 years), the measure developer should have:
- Aligned with any forthcoming CBE polices around pediatric population measures;
- Explored meaningfulness with patients/parents/caregivers that have direct lived experience in this measure area; and
- Explored the potential for risk adjustment based on patient age.
Percentage of patient months for all pediatric (<18 years old) in-center hemodialysis patients in which the delivered dose of hemodialysis (calculated from the last measurement of the month using the UKM or Daugirdas II formula) was spKt/V >= 1.2.
Measure Specs
General Information
In considering target spKt/V, the pediatric population should receive at least a spKt/V of 1.2, which is the minimum requirement for the adult population in order to allow for the increased nutritional needs of children. Analysis of CPM data further support this cut-off since adolescents with spKt/V below 1.2 were found to have significantly increased risk of hospitalization as compared to those with spKt/V of 1.2-1.4.
For 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.
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.
Numerator
Number of patient months from the denominator in which the delivered dose of hemodialysis (calculated from the last measurement of the month using the UKM or Daugirdas II formula) was spKt/V >= 1.2.
Months with spKt/V >=1.2 are counted in the numerator. Eligible spKt/V values are those >=1.2 during the reporting month. The last spKt/V value reported (from any facility), not including missing, expired, out-of-range, and not performed, is selected when multiple values are reported in the month. EQRS is the primary data source for obtaining Kt/V values, supplemented by Medicare claims when values are missing or out-of-range.
Missing, expired, out-of-range, and not performed are not counted as achieving the minimum spKt/V threshold.
Denominator
To be included in the denominator for a particular month, a patient must be on hemodialysis for the entire month, must 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, must be on thrice weekly in-center hemodialysis during the month, and must be assigned to that facility for the entire month.
A 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).
Exclusions
Exclusions that are implicit in the denominator definition include:
- Patients on home hemodialysis
- Patients on peritoneal dialysis
- Adult patients (>=18 years old)
- Patients on ESRD less than 91 days
- Patients not on thrice weekly dialysis
- Patients not assigned to the facility for the entire month
There are no additional exclusions for this measure.
There are no additional or explicit exclusions beyond what is embedded in the denominator's definition.
Measure Calculation
Denominator:
For the reporting month, patients are included in the denominator if:
- Patient modality is indicated as Hemodialysis during the entire month (in-center)
- Patient is dialyzing thrice weekly during the 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 is assigned to the facility for the entire month
Numerator:
For the reporting month, patient months from the denominator are also included in the numerator if they have a spKt/V >=1.2. The last spKt/V value reported (from any facility), not including missing, expired, out-of-range, and not performed, is selected when multiple values are reported in the month.
To obtain the measure score, the numerator is divided by the denominator to produce a rate of patients who meet the measure criteria.
The measure is not stratified.
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.
Measure Record
Point of Contact
N/A
Wil Agbenyikey
Woodlawn, MD
United States
Jennifer Sardone
University of Michigan
Ann Arbor, MI
United States
Importance
Evidence
The primary source of evidence for this measure is the KDOQI guidelines for pediatric hemodialysis prescription and adequacy. The guideline states:
“8.3.1 Children should receive at least the delivered dialysis dose as recommended for the adult population. (A)”
Clinical Practice Guidelines for Hemodialysis Adequacy: KDOQI Guideline 8. Pediatric Hemodialysis Prescription and Adequacy: 2006.
http://www2.kidney.org/professionals/KDOQI/guideline_upHD_PD_VA/hd_guide8.htm
KDOQI CPG 8.3.1 rating strength grade is ‘A’. The recommendation for Grade A guidelines states ‘It is strongly recommended that clinicians routinely follow the guideline for eligible patients. There is strong evidence that the practice improves health outcomes.’
In addition to the above guideline, the 2009 clinical pediatric dialysis adequacy TEP conducted a literature search, where we retrieved a total of 190 articles using several sources.
- First, we retrieved 79 articles using a PubMed search of articles with human subjects, published in English since January 1, 2005. The search terms were: [(pediatric OR pediatrics OR children) and (dialysis OR hemodialysis OR peritoneal dialysis) and (adequacy OR "dialysis dose" OR "dose monitoring" OR "residual renal function" OR "urea clearance" OR "solute clearance" OR "phosphate clearance" OR "amino acid clearance" OR "folate clearance" OR "Kt/V" OR "peritoneal equilibration test" OR ("ultrafiltration" and peritoneal)) and NOT (cvvhd OR "continuous veno venous" OR transplant OR "kidney transplant" OR transplantation)].
- Second, we reviewed 61 citations from the Kidney Disease Outcomes Quality Initiative Guidelines on pediatric peritoneal dialysis and hemodialysis. Third, we reviewed the tables of contents of the journal Pediatric Nephrology and retrieved two articles from early on-line publishing that had not yet been included in PubMed. Finally, we reviewed the citations in 14 articles previously identified; this found an additional 65 articles for review. Duplicate articles were excluded.
- A total of 124 articles were found to be relevant for measure development. Four pieces of evidence listed below [1-4] were determined to be relevant to this specific measure.
An additional literature search was conducted in May 2014 and additional evidence has been added to the list of citations [5-8].
- Lowrie EG, et al. Effect of the hemodialysis prescription of patient morbidity: report from the National Cooperative Dialysis Study. N Engl J Med 305:1176–1181, 1981.
- Owen WF Jr, et al. The urea reduction ratio and serum albumin concentration as predictors of mortality in patients undergoing hemodialysis. N Engl J Med 329:1001–1006, 1993.
- Gorman G, et al. Clinical outcomes and dialysis adequacy in adolescent hemodialysis patients. Am Journal Kidney Dis; 47: 285-93, 2006.
- Fischbach M, et al. Intensified and daily hemodialysis in children might improve statural growth. Pediatr Nephrol 21:1746–1752, 2006.
- Daugirdas JT. Dialysis dosing for chronic hemodialysis: beyond Kt/V. Semin Dial. 2014 Mar;27(2):98-107.
- Kaur A, Davenport A. Hemodialysis for infants, children, and adolescents. Hemodial Int. 2014 Apr 14. doi: 10.1111/hdi.12163. [Epub ahead of print]
- Dunne N, Campbell M, Fitzpatrick M, Callery P. Comparison of Kt/V and urea reduction ratio in measuring dialysis adequacy in paediatric haemodialysis in England.J Ren Care. 2014 Jun;40(2):117-24. doi: 10.1111/jorc.12059. Epub 2014 Mar 20.
- Cadnapaphornchai MA, 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.
An additional literature search was performed for the Fall 2024 maintenance review but no relevant publications were identified.
Measure Impact
In response to the question, we provide two examples:
- 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.
Performance Gap
Among the 15 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=85.4% (SD=16.8%); min=41.7%; 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 guidelines in 85.4% of pediatric HD 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.
| 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 | 85.42% | 41.67% | 64.27% | 76.92% | 86.91% | 89.92% | 91.81% | 95.23% | 97.47% | 98.85% | 100% | 100% | 100% |
| N of Entities | 15 | 1 | 1 | 2 | 1 | 2 | 1 | 2 | 2 | 1 | 1 | 2 | 2 |
| N of Persons / Encounters / Episodes | 220 | 15 | 15 | 27 | 14 | 33 | 21 | 26 | 36 | 11 | 13 | 24 | 24 |
Equity
Equity
We are not providing a response to this optional question.
Feasibility
Feasibility
Data collection is accomplished primarily via EQRS, a web-based and electronic batch submission platform maintained and operated by CMS contractors, supplemented by Medicare claims. Publicly reported measures like this one are reviewed on a regular basis by dialysis facility providers and rare instances of inaccurate or missing data are present (based on comments received during facility previews).
No changes were made.
Proprietary Information
Scientific Acceptability
Testing Data
For the Fall 2024 maintenance submission, calendar year 2022 EQRS and Medicare claims data were used.
For the Fall 2024 maintenance submission, 15 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.
For the Fall 2024 maintenance submission, 15 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.
For the Fall 2024 maintenance submission, 218 pediatric hemodialysis dialysis patients were included. Out of all included patients, 100.0% were aged < 18, 48.6% were female, 2.3% were Native American, 3.7% were Asian, 0.5% were Pacific Islander, 43.1% were Black, 49.5% were White, 0.9% were Other/Multi-Racial, and 26.2% 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.
Reliability
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.
For the Fall 2024 maintenance submission, the annual IUR=0.873 across 12 reporting months, which suggests 87% of variation in the measure is attributed to between facility variations.
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.
For the Fall 2024 maintenance submission, the IUR again suggests this measure is reliable. However, since the distribution of performance scores is skewed, the IUR value should be interpreted with some caution.
| | Overall | Minimum | Decile_1 | Decile_2 | Decile_3 | Decile_4 | Decile_5 | Decile_6 | Decile_7 | Decile_8 | Decile_9 | Decile_10 | Maximum |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Reliability | 0.873 | 0.838 | 0.838 | 0.849 | 0.849 | 0.859 | 0.859 | 0.864 | 0.872 | 0.876 | 0.902 | 0.919 | 0.919 |
| Mean Performance Score | 85.42% | 97.47% | 97.47% | 96.99% | 100.00% | 82.95% | 91.30% | 76.89% | 59.59% | 86.84% | 88.45% | 96.48% | 96.48% |
| N of Entities | 15 | 1 | 1 | 2 | 1 | 2 | 1 | 2 | 2 | 1 | 2 | 1 | 1 |
| N of Persons / Encounters / Episodes | 220 | 11 | 11 | 24 | 12 | 26 | 13 | 27 | 29 | 15 | 39 | 24 | 24 |
Validity
Validity testing could not be conducted due to small patient population.
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.
Results 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%
This 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
Risk Adjustment
Use & Usability
Use
All Medicare-certified dialysis facilities who are eligible for the measure, and have at least 11 patients (due to public reporting requirements).
All Medicare-certified dialysis facilities who are eligible for the measure, and have at least 11 patients (due to public reporting requirements).
Usability
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.
We reviewed the comments and questions submitted during the DFC preview periods that have taken place since the last maintenance (2019-present). Outside of questions about facility-specific results (such as questioning the Kt/V value on record for a particular patient), we receive a handful of questions each preview period regarding the measure specifications, such as the determination of thrice weekly dialysis.
Note that since UM-KECC is not the contractor responsible for the ESRD Quality Incentive Program, we do not have access to the detailed comments/requested that are submitted during the annual preview period for that program.
Since PY 2019, the ESRD QIP has been reporting a combined Kt/V measure in order to allow for more reporting of data for pediatric and peritoneal dialysis patients. Most of the recent comments addressed in the rule have to do with that decision, and a desire to return to reporting the four measures separately. The ESRD QIP NPRM for PYX includes a proposal to return to the four separate measures.
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.
For the ESRD QIP, feedback can be provided any time through contacting the QIP helpdesk. Preview periods allow for specific times for facilities review and comment on measure calculations. Comments can also be submitted in response to the Notice of Proposed Rulemaking for each QIP payment year.
The 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.
The following table reports the performance scores for this measure at the yearly level for 2015 - 2022. This analysis suggests an early increase in performance followed by a period of decline for the measure as implemented on DFCC, however these trends are based on small numbers of facilities and will, therefore, exhibit more variability. 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 = 17 Mean = 88.0%, Std Dev =8.6%, Min = 71.3%, Max = 100.0%
Year 2016: N = 14, Mean =90.3%, Std Dev = 7.8%, Min = 74.8%, Max = 100.0%
Year 2017: N = 14, Mean = 95.2%, Std Dev = 4.6%, Min = 85.4%, Max = 100.0%
Year 2018: N = 18, Mean = 92.2%, Std Dev = 7.7%, Min = 73.6%, Max = 100.0%
Year 2019: N = 14, Mean = 92.5%, Std Dev = 6.5%, Min = 75.7%, Max = 100.0%
Year 2021: N = 11, Mean = 88.8%, Std Dev = 12.2%, Min = 63.5%, Max = 100.0%
Year 2022: N = 15, Mean = 85.4%, Std Dev = 16.8%, Min = 41.7%, Max = 100.0%
We have not been notified of documented unintended impacts on patients as a result of measure implementation.
Comments
Staff Preliminary Assessment
CBE #1423 Staff Assessment
Importance
Strengths:
- Logic Model: A clear logic model is provided, depicting the relationships between inputs (interdisciplinary team identifies patients with spKt/V < 1.2, identifies the root causes of low Kt/Vurea), activities (manages 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 and clinical practice guidelines that demonstrate a clear net benefit in terms of improved outcomes for pediatric hemodialysis 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 41.7% to 100%, indicating variation in measure performance across facilities. The overall average performance score is 85.42% , showing room for improvement.
- Anticipated Impact: If implemented, the developer posits the measure’s anticipated impact on important outcomes is expected to be a decreased likelihood of hospitalizations and death, ultimately resulting in improved quality of care and an increase in the patient's quality of life.
- Business Case: Overall, the developer provides strong evidence of significant improvements in patient outcomes due to effective management of pediatric hemodialysis, with a well-documented, strong business case for the measure’s relevance and necessity in improving health care outcomes for pediatric hemodialysis patients.
- Existing Measures: The proposed measure addresses a healthcare need not sufficiently covered by existing measures, offering advantages in terms of addressing pediatric hemodialysis.
- 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 evidence supporting this measure is fairly old. This is most likely due to the lack of updated guidelines.
- Performance gap: Although decile ranges in performance range from 41.7% to 100%, indicating variation in measure performance across facilities, the performance gap data is based on 15 facilities and 220 eligible patients. This low number of facilities and patients limits the generalizaibilty of the performance gap results.
Rationale:
- This maintenance measure meets all criteria for "Met" due to its robust, well-graded evidence base, clear business case, documented performance gap, and meaningfulness to patients, making it essential for addressing hemodialysis in pediatric populations.
Feasibility Acceptance
Strengths:
- 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
Strengths:
- 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.
Strengths:
- 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
The developer did not address this optional domain.
Use and Usability
Strengths:
- Use: The measure is currently used in Dialysis Facility Care Compare and ESRD Quality Incentive Program (QIP).
- 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 and the QIP 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. Feedback was received about facility-specific results and measure specifications, such as the determination of thrice weekly dialysis.
- 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 there was an increase in performance followed by a period of decline, 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. As acknowledged by the developer, trends in improvement are based on a small number of facilities, which exhibits variability.
- The minimum and maximum performance scores for each year show a wide range, especially in 2022, where the minimum is 41.7% and the maximum is 100.0%.
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. From the initial implementation, the measure demonstrated an increase in performance results, affirming its ongoing usability. This was followed by a decline in performance; however, the developer noted that the number of reporting facilities is very small, which can impact stability of performance scores over time. Despite this fluctuation, the developer reports no unexpected findings.
Committee Independent Review
Agree
Importance
Met
Feasibility Acceptance
Met
Scientific Acceptability
Met
Met
Equity
Not met.
Use and Usability
Met
Summary
Agree with our professional societies.
support
Importance
agree with staff
Feasibility Acceptance
agree with staff
Scientific Acceptability
agree with staff
small sample sizes, no accountable entity level validity testing
Equity
optional
Use and Usability
agree with staff
Summary
Accept the recommendations of the major kidney and dialysis groups which support this measure. This is a well-accepted measure of dialysis adequacy.
Summary
Importance
Agree with staff recommendations.
Feasibility Acceptance
Agree with staff recommendations.
Scientific Acceptability
Agree with staff recommendations.
Agree with staff recommendations.
Equity
Agree with staff recommendations.
Use and Usability
Agree with staff recommendations.
Summary
The sample size is too small for validility testing. Agree with professional societies on the importance of the measure.
Support
Importance
agree with staff
Feasibility Acceptance
Agree with staff
Scientific Acceptability
agree with staff
agree with staff
Equity
optional
Use and Usability
Agree with staff
Summary
Agree with staff
Support
Importance
Agree with staff
Feasibility Acceptance
Agree with staff
Scientific Acceptability
Agree with staff
Agree with staff
Equity
Agree with staff
Use and Usability
Agree with staff
Summary
Agree with staff. We need this data and understand the sample size for pediatric patients is small.
Overall
Importance
Solid guideline base, although old. Additional studies should be summarized, not just cited.
Agree with others that the fact that the treatment itself requires cooperation from the patient is not evidence of meaningfulness. No vote counts on patient input.
Gap looks somewhat limited - 30p is already at 86%, and I would expect high volatility given how small the sample sizes are.
Feasibility Acceptance
No concerns.
Scientific Acceptability
More info on bootstrapping/resampling needed.
Unclear why small sample sizes prevent any type of validity testing such as predictive or convergent/divergent validity at the facility level - would think if scores are considered reliable enough, those would be options. No face validity testing.
Equity
No concerns.
Use and Usability
Are there concerns about a measure whose measurable population is so small being used in an accountability program like QIP?
Summary
Pediatric quality in this space is important, but small samples remain challenging especially if this is used in payment applications like QIP.
Support
Importance
Important area of pediatric health needing attention
Feasibility Acceptance
Easy to collect and report
Scientific Acceptability
Meets standard
Agree with staff
Equity
But should be investigated
Use and Usability
Would like to see use increase
Summary
Agree with overall staff rating
Synthesis
Importance
Same issue: 2006 outdated guidelines
Measure specs state:
In considering target spKt/V, the pediatric population should receive at least a spKt/V of 1.2, which is the minimum requirement for the adult population in order to allow for the increased nutritional needs of children. Analysis of CPM data further support this cut-off since adolescents with spKt/V below 1.2 were found to have significantly increased risk of hospitalization as compared to those with spKt/V of 1.2-1.4.
Is this study cited?
4 papers identified as relevant to measure development (1981, 1993, 2006, 2006).
In 2014, identified four more publications.
Reports no new relevant publications between 2014 and 2024. Really?
Measure impact: based only on TEP ratings supportive of retaining Kt/V as indicator of quality of care. Did not address this minimum level for spKT/V. Did they vote on this measure?
Overall, relatively high mean performance of 85.42% Only decile 1 and minimum fall below 76% (Decile 2)
Feasibility Acceptance
Data collection is accomplished primarily via EQRS, a web-based and electronic batch submission platform maintained and operated by CMS contractors, supplemented by Medicare claims.
Non-proprietary
Scientific Acceptability
Only 15 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
Age distribution of sample of 218 patients not provided.
IUD=.873 with little variation by deciles
Validity testing not conducted.
Again, reports extent of matching between chart and EQRS data elements which is an indicator of quality of data collection.
Equity
not done
Use and Usability
Use: Same issue, public reporting, payment program link to locate facility for patients.
Usability: Same issue, most facilities perform well even when looking back as far as 2015. Cannot assess variation by year given small sample sizes. (85.4% and as high as 95.2%)
Summary
Outdated guidelines, little robust evidence to support clinical validity, if topped off and little change/7 years, why measure?
Public Comments
ASPN Comments on CBE #1423
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.
CBE #1423: Minimum spKt/V for Pediatric Hemodialysis Patients
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.
Comments on CBE #1423: Minimum spKt/V for Pediatric Hemodialysis
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 addressing the four ESRD facility-level measures under review.
CBE #1423: Minimum spKt/V for Pediatric Hemodialysis Patients
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 .