The current refocus of healthcare cost and effectiveness has almost everyone talking about outcomes. Even the IT department has developed an interest in clinical outcomes as evidenced by the shift in programming priorities to include clinical measures of effectiveness for reporting concurrently with patient billing submissions. About 10 years ago, a CIO for a rehabilitation organization asked me for the eight or nine data points that would be significant in measuring clinical quality; anticipating this information could be added to the patient’s billing profile as an addendum to what was being charged. Recently, I was asked by another IT visionary, “What are the top ten clinical measures needed for an outcomes reporting system?” My response to both has not changed much in the 10 years.
A clinical outcome assessment (COA) directly or indirectly measures how patients feel or function and can be used to determine whether a treatment has demonstrated a benefit. COAs can also measure a safety benefit (e.g., fewer side effects, complications or squelae of impairment) compared to other or no treatments. COA qualification is based on a review of the evidence to support the conclusion that the COA is a well-defined, valid and reliable assessment for use in clinical care settings. COAs measure a specific concept in a specific context of use.
The context of use typically includes the following elements:
- Disease, injury, impairment or condition being treated
- Patient population demographics (e.g., age, disease severity, language, culture, education)
- Clinical treatment objectives and plan of care
Now, in addition to the best practice standards application of COAs, we can add payment for the services provided as a use context for outcome quantification as value-based purchasing of healthcare moves to reality.
We should anticipate that in the future providing patient care will need to demonstrate effectiveness and COAs to be considered for qualification must include only those intended to support primary or secondary endpoints of treatment, patient goals or expectations define these endpoints of care. The COA utilizes a measure(s) that produces a score, plus clearly defined methods and instructions for administration or responding, a standard format for data collection, and well-documented methods for scoring, analysis and interpretation of results in the targeted patient population. COAs can measure treatment benefit directly or indirectly. For COAs that measure treatment benefit indirectly, measurement also includes a review of the evidence that the concept assessed is an adequate replacement for how patients feel or function in daily life (change in AM-PAC™ score is indicative of patient functional status improvement or decline).
COAs differ by who is doing the reporting of the outcome, i.e., the patient, a clinician or another observer.
Patient-reported outcome (PRO) assessments measures come directly from the patient’s perception of the status of particular aspects of events related to his/her health or functional ability. PROs are recorded without interpretation of the patient’s response by a clinician or other observer. The patient can record a PRO measurement directly, or an interviewer can record the patient’s response exactly as communicated.
Observer reported outcome (ObsRO) assessments are determined by an observer who does not necessarily have a background of professional training that is relevant to the measurement being made, i.e., a parent, teacher or caregiver. This type of assessment is often used when the patient is unable to self-report (e.g., infants, young children, cognitively incapacitated). An ObsRO assessment should only be used in the reporting of observable concepts (e.g., signs or behaviors). ObsRO assessments cannot be validly used to directly assess symptoms (e.g., pain) or other unobservable concepts.
An observer with some recognized professional training relevant to the measurement being made performs clinician-reported outcome (ClinRO) assessments. ClinRO assessments cannot be used to assess symptoms (e.g., pain, dizziness, nausea, fatigue) or other unobservable concepts. However, ClinRO assessments may include an evaluation and interpretation of the patient’s condition based on the clinician’s judgement.
For COAs, within the stated context of use, results of outcome assessments can be relied upon to measure a specific concept and have a specific interpretation and application in clinical treatment efficacy and regulatory decision-making. And we should anticipate that these measurements will be primary determinants of the value of patient care.