The Renal Physicians Association (RPA) is the professional organization of nephrologists whose goals are to ensure optimal care under the highest standards of medical practice for patients with kidney disease and related disorders. RPA acts as the national representative for physicians engaged in the study and management of patients with kidney disease.

We appreciate the opportunity to provide comment on PCQM-683 - Hospital Harm - Acute Kidney Injury (AKI). RPA strongly encourages the adoption of strategies to minimize AKI risk. However, RPA does not believe the measure as written is a meaningful quality measure. The RPA's concerns are as follows:

1. The measure as written reflects the incorrect presumption that that all increases in creatinine are clinically significant and represent AKI with tubular injury. The use of the 50% increase in serum creatinine definition does not consider the heterogeneity of AKI. What should be targeted are severe episodes of AKI associated with tubular injury, not small fluctuations in serum creatinine (e.g., those associated with appropriate and intended diuresis of volume overload) that might not be clinically significant.

Secondly, changes in actual renal function as estimated by glomerular filtration rate (GFR) are not linear and proportional to each mg/dl change in serum creatinine such that a 50% increase in a normal creatinine represents greater loss of GFR than a 50% increase in an abnormal creatinine. Thus, even with the use of a baseline from which to measure the event, the measure as written does not consider the clinical significance (or insignificance) of the change in number.
As written, a creatinine of greater than 4 is the "severe " CKD exclusion value planned for this measure. In many cases, patients with less advanced CKD and underlying medical conditions such as heart failure, or volume expansion are treated with diuretics and have a significant but transient increase in the serum creatinine to values over 1.5 times their baseline. Although we understand that this may be a long-term risk factor for other undesirable outcomes, currently, there are very few other appropriate treatment options and most nephrologists would NOT consider those changes to be a reasonable surrogate for POOR QUALITY of care on the part of the clinicians in the hospital.

The numerator would need to be revised to reflect nuances of care, such as: rise in creatinine for patients WITH NORMAL (i.e., under 0.9) baseline creatinine should be at least a 1.5 times increase and the change should be a sustained change for over 48 hours without a downward trend. Since AKI can occur anytime during a hospitalization, it should not necessarily be the admission creatinine. Instead, the creatinine during the baseline period 5 days prior to the so-called episode of AKI should be the relevant creatinine Situations where this would be the case include any of the following:
• Patients with a baseline creatinine of 1.0 to 1.5 with CHF, volume expansion, and the change should be over 2-fold and sustained without a downward trend for over 48 hours;
• patients with more severe CKD, where the serum creatinine should increase over 3 times baseline and the change should be sustained without a downward trend for over 48 hours; or
• in elderly frail patients and other patients with low muscle mass and therefore lower baseline creatinines, where a different approach may be needed.

2. At a minimum, RPA recommends that the threshold be modified from KDIGO stage 1 AKI to at least stage 2 AKI (a doubling of serum creatinine), if not stage 3 AKI. Although even stage 1 AKI is associated with increased mortality risk, it is not clear that this is modifiable risk due to the AKI rather than reflective of underlying comorbidities.

3. Another major concern relates to underlying risk adjustment, as comparing rates of AKI between hospitals, even if it included adjustment for comorbidities, is likely to result in disparities between hospitals because of case mix.

4. The timing of blood draws relative to hospital events will influence how such a measure is assessed. In order to be standardized across patients and hospitals, there would need to be a mandate to draw BUN and creatinine on a set frequency or time period - which is not necessarily centered on the individual patient, nor is this appropriate medical care.

5. As this is a eCQM measure, there will be no clinical context. As such, only data in structured fields are captured. Most electronic health records do not have structured fields reliably entered for every co-morbidity, meaning that data elements may not be reliably captured. Even when structured fields exist, they may not be populated unless there is a "hard stop" forcing them to do so. To program a "hard stop" for every data point would be too disruptive to the work flow.

6. As written, this measure has high potential for unintended consequences. Since patients with underlying chronic kidney disease are at increased risk for AKI after procedures such as angiography and surgery, the implementation of an AKI measure might have the unintended consequence of limiting care to this vulnerable population. It has already been demonstrated that "renalism," the failure to perform appropriate diagnostic and therapeutic procedures for a patient because of fear of AKI, occurs. For example, patients with underlying chronic kidney disease who are hospitalized with symptoms of acute coronary syndrome (ACS), including ST-elevation myocardial infarction, are less likely to undergo coronary angiography and revascularization procedures. This failure to perform interventions due to fear of AKI has been associated with increased mortality risk. The present measure may institutionalize "renalism" as an unintended consequence.

In summary, RPA believe a meaningful AKI measure should capture patterns of care, such as appropriately adjusting drug doses in patients with CKD or avoiding nephrotoxic agents in patients with CKD or with a changing creatinine and not be designed in a way that that it negatively impacts clinical decision making and discourages appropriate care. As written, the measure does not meaningfully improve quality of care and may have unintended consequences