The continuous quality improvement (CQI) process has been shown to improve clinical outcomes in many disciplines, including CKD. It presently is conducted at both the facility level and local network level.
7.1 For HD adequacy, each dialysis clinic should continue to monitor the processes related to the delivery of dialysis, such as Kt/V, reuse standards, etc. (A)
7.2 Consideration should be given to providing resources and training for expanding the assessment of clinical outcomes beyond mortality to include hospitalization rates, QOL, patient satisfaction, and transplantation rates, recognizing that without adequate resources and training, these outcomes are unlikely to be valid, and the efforts to collect such information may adversely affect patient care. (B)
7.3 Quality improvement programs should include representatives of all disciplines involved in the care of HD patients, including physicians, physician assistants, nurse practitioners, nurses, social workers, dietitians, and administrative staff. (B)
The CQI process has been shown to improve process and clinical outcomes in many disciplines, including CKD and particularly CKD stage 5.236
Improvement in both QOL and longevity are goals of Healthy People 2010, the strategic plan for the nation's health (accessed May 1, 2006).236A Kidney disease is 1 of 18 focus areas for Healthy People 2010. For patients with CKD stage 5 receiving dialysis therapy, the ongoing process to improve clinical outcomes is linked inextricably to the assessment of dialysis adequacy, and the need for programs to continuously assess and improve care remains as great as ever.237
With regard to HD adequacy guidelines, data from the HEMO Study support a plateau at the level of the existing recommended HD adequacy targets for the current practice of thrice-weekly treatments. There is no compelling evidence that additional increases in dialysis dose within the presently recommended range improve such clinical outcomes as patient mortality, hospitalization rates, QOL, patient satisfaction, and/or transplantation rates.1 However, as the global care for dialysis patients evolves, it is reasonable to assume that so may the most effective thresholds for delivery of dialysis. Therefore, continuing monitoring of outcomes—including not only delivered dose of dialysis, but also other key aspects of established and emerging factors that impact on both QOL and longevity of life for dialysis patients—will be critical for the continuing improvement of care for the dialysis patient.
Domains of clinical outcomes to be monitored (in addition to mortality) when sufficient resources exist and validated standards have been created might include:
Key to this process is the commitment to an evidence-based approach that will build upon, and not detract from, the existing limited resources.237 This would contribute to the creation of a system in which clinical outcome trends could be tracked and then meaningfully compared with regional outcome data (eg, from the CKD Stage 5 Network), national data, international data, and historical data from the facility itself. These findings could build upon the existing evidence-based recommendations for PD and HD, anemia management, and vascular access.
Comparison with regional or national data may be difficult because of limitations in adjusting for the case-mix of patients at individual centers and variations in quality of data collection to capture the adequate case-mix description. Thus, facilities that have fewer resources and less trained staff and/or more linguistically diverse patient populations are more likely to be unable to capture a complete clinical profile and more likely to underestimate case-mix severity, providing an overestimate of adjusted mortality or hospitalization rates.
For the overall care of dialysis patients, there likely will be value in tracking selected associated clinical outcomes to assess the role of HD, such as those related to reuse systems and frequent dialysis strategies. Many investigators and facilities already assess the former (eg, mortality) and the NIH is assessing the latter in a prospective study (accessed May 1, 2006)237A-239 The establishment of highly functional systems and well-trained dedicated staff (including those listed next) to ensure the quality and uniformity of data collection, as well as the ability to extract which component(s) contribute to clinical outcomes, will be critical to this process.
Quality improvement program representatives should include:
The large number of patients hospitalized at multiple facilities creates a tremendous task in the collection of accurate and valid data. Moreover, differences in similar procedures performed in an inpatient and outpatient setting vary geographically and across health care systems. This information would need to be clarified and/or appropriately adjusted to capture meaningful data.
Quality of Life
One of the more commonly used tools to assess health-related QOL (HRQOL) for patients with CKD stage 5 is the Kidney Disease and Quality of Life Short Form™ (KDQOL-SF).240 There is evidence that the physical, psychological, and/or mental components of HRQOL predict death and hospitalization among HD patients.32,241-243 Unfortunately, the area of QOL assessment is still limited by the use of multiple tools, challenging attempts at maintaining uniformity in QOL data collection. Although the KDQOL-SF has been translated and used in culturally, geographically, and linguistically diverse populations, it does not appear to have been validated in these settings. This is critical because there may be significant sex, generational, and/or racial/ethnic variations in perceived—and therefore, reported—QOL.244-247 In addition, many of the interventions shown to improve QOL have not been validated simultaneously to decrease the risk for adverse clinical outcomes.
Multiple factors influence patient satisfaction. Specific to HD, one key factor influencing patient satisfaction, time on dialysis therapy, is related inversely to achieving a higher dose of dialysis, higher phosphate clearance, less rapid volume removal, and other factors linked to improved clinical outcomes. This may place facilities in the situation in which patient satisfaction and clinical outcomes are in conflict, and there are no national standards for arbitrating this situation.248
Similar to QOL assessments, there also are multiple tools actively being used for assessing patient satisfaction that vary across and even within facilities. Without standard tools and validation of the tools, the utility of such surveys at present is insufficient to meet a clinical guideline standard. However, the continuing development and refinement of these tools is crucial to the continued improvement of care and the foundation of future guidelines.
There are no data linking the delivery of dialysis doses within the recommended range to renal transplantation. Multiple factors influence transplantation rates, including, but not limited to, case-mix, geography, insurance status, and patient and provider bias.249,250 While the monitoring of trends is valuable, assessment of the impact of these factors needs to be isolated, standardized, and validated into an appropriate analytical model before including dialysis transition rates to renal transplantation as a potential standard.
These guidelines for achieving the broad clinical outcome goals of improved QOL and enhanced longevity are a summation of ongoing “best practices” that supplement the existing KDOQI HD Guidelines. These best practices and the robust evidence required to support the rigor of a CPG are still evolving. This will require a methodologically sound foundation with standards that are generalizable. Future data collection will require assessments using prespecified approaches to data analysis that include all these factors and other related confounders (eg, demographics, case-mix, and medical therapeutics) into a clinically valid multivariable statistical model. Otherwise, the ability to ascertain the evidence of the contribution of existing clinical outcome best practices versus the achievement of recommended guidelines becomes a statistical/logistical impossibility. Such a consideration is an intense undertaking and should not be initiated without total commitment to the resources needed to address each of these issues and create the valid models needed to monitor improved care in a meaningful way. If this is not done, interpretation of partially collected or invalid data would: (1) be unable to determine the root cause of changes in clinical outcomes, (2) not be valid across and/or within facilities, and (3) add limited value above the present outcome analyses.