Percentage of all patient months for adult patients (>= 18 years old) whose delivered peritoneal dialysis dose was a weekly Kt/V urea >= 1.7 (dialytic + residual).
Measure Specs
General Information
Evaluation of PD adequacy every four months for adults is critical to ensure timely dose adjustment as needed, and adequate dialysis doses (Kt/V urea > 1.7 for adult patients and Kt/V urea > 1.8 for pediatric patients) have been linked to improved patient outcomes. Therefore, continued implementation of this measure is needed to ensure frequent adequacy measurement and adequate dialysis dosing.
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].
- 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.
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. 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.
Numerator
Number of patient months in the denominator whose delivered peritoneal dialysis was a weekly Kt/Vurea >= 1.7 (dialytic + residual, measured in the last 4 months).
Reporting months with weekly Kt/V urea >=1.7 (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 3 months is applied to the calculation for that month.
Missing, expired, out-of-range, and not performed are not counted as achieving the minimum weekly Kt/V urea threshold.
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.
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 Medicare claims, as well as the Organ Procurement and Transplant Network (OPTN).
Exclusions
Exclusions that are implicit in the denominator definition include
- Patients not on peritoneal dialysis for the entire month
- Pediatric patients (<18 years old)
- Patients who have had ESRD for <91 days
- 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 PD during the entire month
- Patient age as of the beginning of the reporting month is at least 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 >= 1.7.
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 3 months is applied to the calculation for that month.
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.
Point of Contact
N/A
Wil Agbenyikey
7500 Security Boulevard
Woodlawn, ME 21244
United States
United States
Importance
Evidence
The primary evidence for this measure comes for the 2006 KDOQI Clinical Practice Guidelines and Clinical Practice Recommendations for 2006 Updates: Hemodialysis Adequacy, Peritoneal Dialysis Adequacy and Vascular Access. The guideline states:
Adult Kt/V target:
GUIDELINE 2. PERITONEAL DIALYSIS SOLUTE CLEARANCE TARGETS AND MEASUREMENTS
Data from RCTs suggested that the minimally acceptable small-solute clearance for PD is less than the prior recommended level of a weekly Kt/Vurea of 2.0. Furthermore, increasing evidence indicates the importance of RKF as opposed to peritoneal small-solute clearance with respect to predicting patient survival. Therefore, prior targets have been revised as indicated next. 2.1 For patients with RKF (considered to be significant when urine volume is > 100 mL/d): 2.1.1 The minimal "delivered" dose of total small-solute clearance should be a total (peritoneal and kidney) Kt/Vurea of at least 1.7 per week. (B)
2.1.2 Total solute clearance (residual kidney and peritoneal, in terms of Kt/Vurea) should be measured within the first month after initiating dialysis therapy and at least once every 4 months thereafter. (B)
2.1.3 If the patient has greater than 100 mL/d of residual kidney volume and residual kidney clearance is being considered as part of the patient ´s total weekly solute clearance goal, a 24-hour urine collection for urine volume and solute clearance determinations should be obtained at a minimum of every 2 months. (B) 2.2 For patients without RKF (considered insignificant when urine volume is =100 mL/d):
2.2.1 The minimal "delivered" dose of total small-solute clearance should be a peritoneal Kt/Vurea of at least 1.7 per week measured within the first month after starting dialysis therapy and at least once every 4 months thereafter. (B)”
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://www.kidney.org/professionals/KDOQI/guidelines_commentaries
Grade: The guidelines for adult patients were graded B. Grade B: It is recommended that clinicians routinely follow the guideline for eligible patients. There is moderately strong evidence that the practice improves health outcomes.
The body of evidence included 20 studies, ranging from 1998-2004. The KDOQI panel noted that the body of evidence shows a correlation between total solute clearance for urea and patient mortality and morbidity. Thus, this evidence supports that the delivered dose of dialysis should be measured frequently for assessment of adequate treatment, and treatment should be set accordingly. In particular, of the 20 studies considered in the body of evidence, the results from two randomized clinical trials were used to justify the KDOQI guidelines [2,3]. The results from additional observational studies also supported the KDOQI recommendations [see, e.g. 1,6].
In the adult population, among the studies showing any improvement in mortality in high total clearance versus low total clearance, relative risks ranged from 0.6 to 0.99. In one study, Kt/V was measured as continuous and found a relative risk of 0.94 per 0.1 mL/min increase in Kt/V (95% CI = 0.88, 1.02). The majority of the studies showed a benefit of higher total clearance in PD patients.
- Bargman JM, Thorpe KE, Churchill DN: Relative contribution of residual renal function and peritoneal clearance to adequacy of dialysis: A reanalysis of the CANUSA Study. J Am Soc Nephrol 12:2158-2162, 2001
- 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. J Am Soc Nephrol 13:1307-1320, 2002
- Lo WK, Ho YW, Li CS, et al: Effect of Kt/V on survival and clinical outcome in CAPD patients in a randomized prospective study. Kidney Int 64:649-656, 2003
- Szeto CC, Wong TY, Leung CB, et al: Importance of dialysis adequacy in mortality and morbidity of Chinese CAPD patients. Kidney Int 58:400-407, 2000
- Diaz-Buxo JA, Lowrie EG, Lew NL, Zhang SM, Zhu X, Lazarus JM: Associates of mortality among peritoneal dialysis patients with special reference to peritoneal transport rates and solute clearance. Am J Kidney Dis 33:523-534, 1999
- Rocco MV, Frankenfield DL, Prowant B, Frederick P, Flanigan MJ: Risk factors for early mortality in U.S. peritoneal dialysis patients: Impact of residual renal function. Perit Dial Int 2002 22:371-379
- Termorshuizen F, Korevaar JC, Dekker FW, van Manen JG, Boeschoten EW, Krediet RT: The relative importance of residual renal function compared with peritoneal clearance for patient survival and quality of life: An analysis of the Netherlands Cooperative Study on the Adequacy of Dialysis (NECOSAD)-2. Am J Kidney Dis 41:1293-1302, 2003
- Chung SH, Heimburger O, Stenvinkel P, Qureshi AR, Lindholm B: Association between residual renal function, inflammation and patient survival in new peritoneal dialysis patients. Nephrol Dial Transplant 18:590-597, 2003
- Jager KJ, Merkus MP, Dekker FW, et al: Mortality and technique failure in patients starting chronic peritoneal dialysis: Results of The Netherlands Cooperative Study on the Adequacy of Dialysis. NECOSAD Study roup. Kidney Int 55:1476-1485, 1999
- Ates K, Nergizoglu G, Keven K, et al: Effect of fluid and sodium removal on mortality in peritoneal dialysis patients. Kidney Int 60:767-776, 2001
- Wang AY, Wang M, Woo J, et al: Inflammation, residual kidney function, and cardiac hypertrophy are interrelated and combine adversely to enhance mortality and cardiovascular death risk of peritoneal dialysis patients. J Am Soc Nephrol 15:2186-2194, 2004
- Szeto CC, Wong TY, Chow KM, Leung CB, Law MC, Li PK: Independent effects of renal and peritoneal clearances on the mortality of peritoneal dialysis patients. Perit Dial Int 24:58-64, 2004
- Szeto CC, Wong TY, Chow KM, et al: Impact of dialysis adequacy on the mortality and morbidity of anuric Chinese patients receiving continuous ambulatory peritoneal dialysis. J Am Soc Nephrol 12:355-360, 2001
- Bhaskaran S, Schaubel DE, Jassal SV, et al: The effect of small solute clearances on survival of anuric peritoneal dialysis patients. Perit Dial Int 20:181-187, 2000
- Rocco M, Soucie JM, Pastan S, McClellan WM: Peritoneal dialysis adequacy and risk of death. Kidney Int 58:446-457, 2000
- Lo WK, Tong KL, Li CS, et al: Relationship between adequacy of dialysis and nutritional status, and their impact on patient survival on CAPD in Hong Kong. Perit Dial Int 21:441-447, 2001
- Davies SJ, Phillips L, Russell GI: Peritoneal solute transport predicts survival on CAPD independently of residual renal function. Nephrol Dial Transplant 13:962-968, 1998
- Perez RA, Blake PG, Spanner E, et al: High creatinine excretion ratio predicts a good outcome in peritoneal dialysis patients. Am J Kidney Dis 36:362-367, 2000
- Park HC, Kang SW, Choi KH, Ha SK, Han DS, Lee HY: Clinical outcome in continuous ambulatory peritoneal dialysis patients is not influenced by high peritoneal transport status. Perit Dial Int 21:S80-S85, 2001 (suppl 3)
- Aslam N, Bernardini J, Fried L, Piraino B: Peritoneal dialysis clearance can replace residual renal function. Perit Dial Int 21:263- 268, 2001
In May 2014, an additional literature search was performed. Additional pieces of evidence supporting the relationship between PD clearance and outcomes are included in the citations below as a result of that search.
- Krediet RT1, Struijk DG. Peritoneal changes in patients on long-term peritoneal dialysis. Nat Rev Nephrol. 2013 Jul;9(7):419-29. doi: 10.1038/nrneph.2013.99. Epub 2013 May 14.
- Fissell R1, Schulman G, Pfister M, Zhang L, Hung AM. Novel dialysis modalities: do we need new metrics to optimize treatment? J Clin Pharmacol. 2012 Jan;52(1 Suppl):72S-8S. doi: 10.1177/0091270011414576.
For the Fall 2024 maintenance submission, we conducted an additional literature review. We note that there are updated Guidelines from the International Society for Peritoneal Dialysis (ISPD) with commentary from KDOQI shortly thereafter [1, 2] which called for a holistic approach to determination of PD adequacy, documenting both philosophical and technical concerns with an adequacy definition solely focused on small solute-based calculations (e.g. Kt/V). However, they do recommend regular collection and analysis of those results as part of their recommendations (ungraded).
- Nourse P, Cullis B, Finkelstein F, Numanoglu A, Warady B, Antwi S, McCulloch M. ISPD guidelines for peritoneal dialysis in acute kidney injury: 2020 Update (paediatrics). Perit Dial Int. 2021 Mar;41(2):139-157. doi: 10.1177/0896860820982120. Epub 2021 Feb 1. PMID: 33523772.
- Teitelbaum I, Glickman J, Neu A, Neumann J, Rivara MB, Shen J, Wallace E, Watnick S, Mehrotra R. KDOQI US Commentary on the 2020 ISPD Practice Recommendations for Prescribing High-Quality Goal-Directed Peritoneal Dialysis. Am J Kidney Dis. 2021 Feb;77(2):157-171. doi: 10.1053/j.ajkd.2020.09.010. Epub 2020 Dec 16. PMID: 33341315.
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
Analysis of EQRS and Medicare claims data from January to December 2022 indicated the mean percentage of patients with PD adequacy measurements that achieved the target was 91.5% (SD=10.5%, N=2504 Mean scores by decile are shown in Table 1 below.. These results indicate that, on average, facilities are meeting the weekly Kt/V urea guidelines in 91% 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.
| 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 | 91.54% | 0% | 67.86% | 85.57% | 89.71% | 92.19% | 93.86% | 95.13% | 96.18% | 97.18% | 98.26% | 99.43% | 100% |
| N of Entities | 2504 | 2 | 250 | 250 | 250 | 252 | 250 | 252 | 249 | 252 | 249 | 250 | 77 |
| N of Persons / Encounters / Episodes | 77765 | 31 | 8202 | 7273 | 8059 | 8294 | 7842 | 8016 | 8616 | 8823 | 7356 | 6284 | 1378 |
Equity
Equity
We are not providing a response to this optional question.
Feasibility
Feasibility
Data collection for Kt/V values is accomplished via EQRS, web-based and electronic batch submission platform maintained and operated by CMS contractors. 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 necessary.
Proprietary Information
Scientific Acceptability
Testing Data
For the Fall 2024 maintenance submission, calendar year 2022 EQRS and Medicare claims data were used.
None
For the Fall 2024 maintenance submission, 2,504 facilities that had at least 11 eligible adult peritoneal dialysis 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 sample size.
For the Fall 2024 maintenance submission, 75,135 adult peritoneal dialysis patients were included. Out of all included patients, 55.4% were aged 18 - 65, 44.6% were aged 65 or older, 42.7% were female, 1.3% were Native American, 7.8% were Asian, 1.4% were Pacific Islander, 24.5% were Black, 64.7% were White, 0.3% were Other/Multi-Racial, and 17.7% 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 was 0.876 across 12 reporting months, which is high and suggests 88% of variation in the measure is attributed to between facility variation and approximately 12% to within 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.
For the Fall 2024 maintenance submission, the IUR 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 | 0.876 | 0.714 | 0.724 | 0.753 | 0.785 | 0.808 | 0.830 | 0.853 | 0.873 | 0.894 | 0.914 | 0.953 | 0.953 |
| Mean Performance Score | 91.54% | 92.17% | 90.96% | 90.57% | 90.72% | 90.17% | 91.03% | 93.06% | 92.81% | 92.26% | 92.42% | 91.30% | 96.54% |
| N of Entities | 2504 | 126 | 261 | 204 | 305 | 201 | 293 | 231 | 258 | 245 | 262 | 244 | 1 |
| N of Persons / Encounters / Episodes | 77765 | 1386 | 3006 | 2741 | 4892 | 3715 | 6276 | 5870 | 7820 | 9080 | 12739 | 21626 | 259 |
Validity
Validity was assessed by calculating the Spearman correlation between this measure (using January 2022 – December 2022 EQRS and Medicare Claims data) and the 2022 SMR and SHR. Correlations were calculated to assess the association of this measure with clinical outcome quality measures expected to be markers of quality care. The measures represent an important subset of core clinical quality measures for this patient population.
We expected the following correlations with this measure:
- SMR: We anticipated a negative correlation with this measure
- SHR: We anticipated a negative correlation with this measure
Kt/V is a marker of dialysis adequacy; if targets are not being met, one would anticipate this being reflected in worse patient outcomes such as morbidity and mortality.
The Spearman correlation between the PD Kt/V measure and SMR is -0.00291, and statistically insignificant (p=0.89). The Spearman correlation between PD Kt/V measure and SHR is -0.131, and statistically significant (p<.0001).
The Spearman correlation coefficients indicate higher facility level percentages of patients that achieve the Kt/V target is associated with lower standardized mortality and hospitalization. The direction of the association was as expected and the association for SHR was statistically significant. Although a very weak association between facility level percentages of patients achieving the Kt/V target and lower standardized mortality was observed, it is in the expected direction. The lack of statistical significance with SMR is likely related to the relatively small number of PD patients that are in a given facility, relative to the number of patients who receive in-center hemodialysis.
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 reports the performance scores for this measure at the yearly level for 2015 - 2022. This analysis shows a slight 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 = 1799, Mean = 84.0%, Std Dev =13.4%, Min = 0.0%, Max = 100.0%
Year 2016: N = 1898, Mean =89.0%, Std Dev = 11.9%, Min = 0.0%, Max = 100.0%
Year 2017: N = 1984, Mean = 90.8%, Std Dev = 10.9%, Min = 0.0%, Max = 100.0%
Year 2018: N = 2085, Mean = 91.3%, Std Dev = 11.1%, Min = 0.0%, Max = 100.0%
Year 2019: N = 2217, Mean = 91.3%, Std Dev = 10.2%, Min = 0.0%, Max = 100.0%
Year 2021: N = 1894, Mean = 93.1%, Std Dev = 9.3%, Min = 0.0%, Max = 100.0%
Year 2022: N = 2504, Mean = 91.5%, Std Dev = 10.5%, Min = 0.0%, Max = 100.0%
We 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.
Comments
Staff Preliminary Assessment
CBE #0318 Staff Assessment
Importance
Strengths:
- Logic Model: A clear logic model is provided, depicting the relationships between inputs (interdisciplinary team identifies patients with spKt/V < 1.7, 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 adult peritoneal dialysis patients. High total clearance is associated with decreased mortality in adult populations. The developer also references the National Kidney Foundation KDOQI Clinical Practice Guidelines and Clinical Practice Recommendations for 2006 Updates, which apply to both adult and pediatric populations. Guidelines listed address minimum dosage and solute clearance targets; these guidelines are graded "B" ("It is recommended that clinicians routinely follow the guideline for eligible patients. There is moderately strong evidence that the practice improves health outcomes."). The measure specifications align with the dosage guideline. For the Fall 2024 maintenance submission, the developer conducted an additional literature review and found updated ISPD Guidelines, supported by KDOQI commentary, advocating for a holistic approach to determining peritoneal dialysis (PD) adequacy beyond just small solute-based calculations like Kt/V, though they still recommend regular collection and analysis of these results.
- Performance Gap: Data from January – December 2022 End Stage Renal Disease Quality Reporting Program (EQRS) and Medicare claims data shows a performance gap, with decile ranges from 67.86% to 99.43% and an overall mean performance score of 91.54%, indicating variation in measure performance across facilities and less than optimal performance overall.
- 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 peritoneal dialysis among adults, with a well-documented, strong business case for the measure’s relevance and necessity in improving health care outcomes for adult peritoneal dialysis patients.
- Existing Measures: The proposed measure addresses a healthcare need not sufficiently covered by existing measures, offering advantages in terms of addressing peritoneal dialysis among adults.
- 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 measure is based on 2006 guidelines from KDOQI with additional evidence from a 2014 literature review showing the relationship between PD clearance and outcomes. This is most likely due to the lack of updated guidelines.
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 peritoneal dialysis among adults.
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 healthcare 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 at least 11 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:
- To substantiate the validity claim, the developer must demonstrate a causal association between the facility response [known and effective] to the measure and the measure focus. The developer provides empirical evidence of a facility-level co-variation between the measure focus and two material outcomes (mortality and hospitalization) in the causal chain. The suggested inference is that facility actions are causing the increase in the measure focus because those same actions are causing (or contributing to) a decrease in material outcomes across various populations and settings.
Limitations:
- Causal claims based on association (correlation) studies alone are prone to bias (i.e., confounding due to a common cause cannot be ruled-out). However, associations in the hypothesized direction (positive or negative) across various populations and settings is indirect confirmation of the existence of a suitable (plausible) mechanism capable of accounting for the observed correlation. However, in this instance the association is not statistically significant for mortality, but is statistically significant for hospitalization. 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 provides empirical evidence of a facility-level co-variation between the measure focus and two material outcomes, mortality (not statistically significant) and hospitalization (statistically significant) in the causal chain. Going forward, additional studies that either rule-out potential confounding or describe features of potential mechanisms will strengthen causal claims.
Equity
Strengths:
- The developer did not address this optional domain
Limitations:
- The developer did not address this optional domain
Rationale:
- 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 (for DFCC) and the QIP helpdesk (for ESRD QIP). 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 an upward trend in performance scores from 2015 to 2022, demonstrating an increase in performance overall through 2022 (84.0% to 91.5%), with a peak in 2021 (93.1%), 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.
Feedback Mechanisms: The developer notes that a limitation is that they do not have access to detailed comments that are submitted during the annual review period for ESRD QIP.
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. The developer reports no unexpected findings.
Committee Independent Review
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
no additional comments
Summary
Importance
I agree with staff recommendations.
Feasibility Acceptance
I agree with staff recommendations.
Scientific Acceptability
I agree with staff recommendations.
I agree with staff recommendations.
Equity
I agree with staff recommendations.
Use and Usability
I agree with staff recommendations.
Summary
I agree with staff recommendations. No additional comments.
support
Importance
this is met.
Feasibility Acceptance
Feasibility is demonstrated.
Scientific Acceptability
Reliability is demonstrated
validity is demonstrated
support comments from staff regarding their adjustment recommendations
Equity
Submission did not provide response to this optional variable
Use and Usability
use/usability is met
Summary
no comments.
support
Importance
demonstrated
Feasibility Acceptance
feasibility was met
Scientific Acceptability
this was met.
support staff comments
Equity
This was optional, excluded.
Use and Usability
This was met.
Summary
this is supported by this reviewer
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
Support
Importance
Agree with staff
Feasibility Acceptance
Easy to measure and report
Scientific Acceptability
Agree with staff
Agree with staff
Equity
Not addressed
Use and Usability
Agree with staff
Summary
Have no concerns beyond those discussed by 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
no comment
See above
Importance
Literature review should be summarized, not just cited. Guidelines old but clear. Sufficient performance validation.
Direct patient evidence lacking detail around vote. Indirect evidence not sufficient.
Feasibility Acceptance
No concerns.
Scientific Acceptability
Additional data on resampling scheme would be useful.
Measures chosen for correlation were sensible. Spearman was an appropriate choice. Correlations directions were as expected, but one was negligible and the other was weak. No face validity was provided. Overall, this is pretty weak evidence of validity.
Equity
No comment.
Use and Usability
No concerns.
Summary
See above
Public Comments
No public comments received.
No public comments received.