Comments on Functional Status Assessment and Target Setting for
Patients with Congestive Heart Failure
I applaud CMS for seeking to develop a quality measure that seeks to
measure the health status (symptoms, function and quality of life) of patients with
heart failure, as this represents a primary treatment goal for this condition.
Moreover, the literature is replete with examples of the inaccuracies of physicianassigned estimates (e.g. NYHA) of patients’ health status, making the elicitation of
this information directly from patients a huge advance. Therefore, the comments
provided seek to improve the initial design of the measure and, in no way, are to
undermine the importance of this effort.
Conceptual Design of the Measure:
As described, this measure seeks to define patient-level targets for
subsequent patient-reported outcome (PRO) scores. This is presumably an effort to
acknowledge that cross-sectional follow-up scores cannot be used because risk
adjustment methods have not been developed. However, the collection of the
proposed data will rapidly enable such risk adjustment models to be built and
would allow the last assessment in a reporting year to be risk-adjusted based upon
patients’ first assessments and associated demographic and clinical characteristics. I
believe that this would be a much more valid methodology for assessing the quality
of care, as judged by a provider’s patients’ health status. Moreover, some of the
proposed measures (e.g. the KCCQ) have available descriptive, clinically-relevant
interpretations of PRO scores and the results of cross-sectional assessment may be
more readily interpretable than the proportion of patients that met an individually
determined goal.
While intuitively the use of individually determined goals may seem
interpretable, how such goals are to be defined is unknown. It is not clear how a
clinician would engage patients in setting such a target, as all patients would
presumably want to have as few symptoms, physical and social limitations, and as
high a quality of life, as possible, even if not reasonably attainable. In addition,
recording such targets is challenging, particularly as providers and patients may
have limited familiarity with instrument’s scores and what different scores
represent, nor are providers necessarily trained or proficient at goal setting with
patients. An additional – and very important – limitation of this approach is that
targets may vary substantially across providers and among patients within a given
provider’s practice. This inconsistency increases the potential for ‘gaming’, by
encouraging providers to set as low a target as possible so as to achieve the measure.
In contrast, some of the proposed PROs have very clear standards to define
the clinical significance of changes in scores. For example, the Kansas City
Cardiomyopathy Questionnaire (KCCQ), has documented that a change of 5, 10 or 20
points represents small, but clinically important, moderate and large clinical
changes, respectively. This tool also has great symmetry, such that either an
improvement or deterioration in scores of 5, 10 or 20 points would reflect
clinical improvement or deterioration of the same magnitude. Using this tool, it
would be possible to set consistent goals across all providers, such as no
deterioration in patients’ heart failure-related health (e.g. change in scores over the
reporting year >-5 points on the KCCQ Overall Summary Score). This approach
would also have a very clear interpretation. Using this example, the interpretation
would be the proportion of patients who got no worse over the reporting period.
Alternatively, one could define a goal being the proportion of patients whose health
status improved over the reporting year (i.e. the proportion of patients whose KCCQ
Summary Scores improved by 5 points), although this would be a smaller
proportion of patients within a practice than the other target. Once risk-adjustment
models were in place, then it would be straightforward to benchmark the
performance of providers in maintaining or improving heart failure patients’ health
status.
Measure Type:
The proposed measure considers this to be a process measure, rather than
an outcome measure. While reporting of Functional Status Assessments (FSAs) is a
process, the results of the FSA are an outcome. In fact, this is one of the most
important outcomes from patients’ perspectives. I would encourage CMS to create a
clearer articulation of the importance of this measure by calling the results (e.g.
either obtaining an individually defined target (which I am not in favor of) or a
proportion of patients attaining an consensus-defined target) as an outcome, even if
the reporting of the FSAs is called a process measure.
Timing of Assessment:
I agree and applaud the intent of the measure developers to include scores
within 14 days of an FSA visit as an initial FSA score. This enables providers to send
questionnaires (physically or electronically) to patients so that they can be
completed before the visit and improve the efficiency of FSA visits.
However, it appears that this proposed measurement is to be used with only
a 3-month window. The logic for this is not clear. It would seem more practical to
enable longer periods of time, within a reporting year, to be eligible. A short window
may mandate more frequent visits than would be clinically indicated, increasing
both costs and patient inconvenience. Moreover, it may take some time to improve
patients’ health status and 3 months may be too narrow of a window, particularly if
more major interventions, such as cardiac resynchronization therapy, slow
uptitration of medications, or cardiac rehabilitation are needed. I would encourage
the developers to consider any 2 FSAs within the reporting year as being acceptable,
with the first one serving as baseline and the best post-baseline measure serving as
the benchmark for assessing performance (heart failure is an undulating disease
and enabling the highest post-baseline scores gives providers credit for the best
health status that they were able to achieve for their patients). Of course, the next
reporting year would establish a new baseline for that subsequent year.
Proposed FSA/PRO Measures:
This measure proposes to use either generic (VR-12 or PROMIS 10) or
disease-specific measures as FSAs. This is very problematic for a symptomatic
disease, like heart failure, in which patients often also have other comorbid
conditions that can impair their generic health status, but may be less relevant to
their heart failure. In treating patients with heart failure, providers are specifically
trying to minimize their patients’ heart failure symptoms (shortness of breath,
fatigue and edema) to improve their physical/social functioning and to optimize
their quality of life. Generic measures are downstream of these therapeutic targets
and have been repeatedly shown to be very insensitive, as compared with diseasespecific instruments (See Am Heart J 2005;150:707-15), and may not capture
meaningful improvements in patients’ heart failure – the purported goal of this
measure. For example, a patient with severe arthritis and dyspnea due to heart
failure may derive substantial benefit from optimal diuresis and diet in terms of
their heart failure, but their generic health status (limited by their arthritis) might
not change and would falsely suggest that the provider has not improved the
patient’s heart failure.
Beyond the insensitivity of generic measures, for this measure to be accepted
by the clinical community, it should also be actionable and helpful in improving care.
This requires having the measure provide clinically interpretable domains, which
global generic measures do not. In contrast the KCCQ distinctly measures patients’
symptoms, functional and social limitations and their quality of life. Clinicians will
be able to leverage such a refined measurement to know whether or not they need
to target additional therapy to controlling symptoms, engage the patient in exercise
to improve physical functioning or consider counseling for a patient with good
symptom control and function, but poor quality of life. This resolution of clinically
relevant domains is also an advantage of the KCCQ over the Minnesota Living with
Heart Failure Questionnaire (MLHFQ), which only provides a physical and mental
health scale.
Given the clear superiority of disease-specific instruments over generic ones,
the authors should consider if it is desirable to propose a single measure or both the
KCCQ and MHLFQ. The advantages of the KCCQ are its greater clinical relevancy (see
above), its much clearer standards for interpretability (Am Heart J 2005;150:70715), its greater sensitivity to clinical change (J Am Coll Cardiol. 2000:35(5):1245-55),
its established psychometric properties in multiple heart failure etiologies (heart
failure due to both reduced and preserved left ventricular function and valvular
heart disease), and its greater feasibility. The MLHFQ has 21 items. In contrast, the
KCCQ has recently been shortened to be only 12 items, while maintaining all of the
psychometric properties of the original tool (Circ Cardiovasc Qual Outcomes.
2015;8:469-476). It requires only 2-3 minutes for patients to complete. Minimizing
the response burden to patients (and to clinicians who will have to transcribe the
scores into a scoring program to score the instruments) is an enormous benefit and
increases the feasibility of data collection. While I understand the sensitivities
around recommending a single instrument for performance assessment, it would be
advantageous to consider endorsing the KCCQ-12 so that a consistent measure is
used with which to compare performance across providers and which will enable
more providers to develop familiarity with a tool that is being increasingly used as
an outcome in clinical trials. This would also enable the results of these trials to be
more readily interpreted and translated to the clinical setting. However, if more
than 1 instrument is to be proposed, I strongly suggest that only the disease-specific
KCCQ-12 and MLHFQ be supported.