National Quality Measures Clearinghouse | Expert Commentaries: Quality Measures: Patient-Reported Outcomes for Quality Improvement of Clinical Practice
By: Kathleen N. Lohr, PhD
May 14, 2012
For more than 40 years, beginning with the seminal work of Avedis Donabedian and continuing to the present, outcomes have had a central role in how high-quality health care is conceptualized. (1-5) In an era in which individualized or personalized care, patient-centered care, patient-centered medical homes, and "patient-important" outcomes are increasingly invoked as critical aims for the U.S. health care system, using patient-reported outcomes (PROs) in quality assessment and improvement schemes seems crucial.
The significance of this view has not yet, it would seem, reached any substantial level of practical application. For example, in 2009, in a commentary written for the National Quality Measures Clearinghouse (NQMC), Persell called attention to some limitations of quality measures for ambulatory care. (6) He noted that most measures deal with process of care (e.g., the proportion of eligible patients who received a laboratory test or prescription medication) or at best intermediate (proxy) outcomes (e.g., the proportion of eligible patients who achieved a specific level of control for hypertension or diabetes during some specified period). Missing, however, are health outcomes of direct relevance to patients, such as emotional health, pain, or physical functioning.
Broadly, PROs constitute information from patients about a health condition, its management, and impact on well-being. The core element of PROs is health-related quality of life (HRQOL)—"aspects of a person's overall well-being...affected by health status or health care." (7) As Persell noted, "Outcomes are often what patients and other stakeholders care about the most." (6) However, even though NQMC has more than 360 outcome measures (as of early 2012), the Clearinghouse has very few patient-reported outcome measures—those directly salient to and reported by patients about the end results of health care.
Are they not available? Are they insufficiently well developed to meet NQMC's Inclusion Criteria (a set of four detailed requirements)? The answer to both these questions is "No." Literally thousands of PROs exist. Several Web sites are devoted to them: examples for specific measures include http://www.euroqol.org/ for the EQ-5D or http://www.sf-36.org/ for the Medical Outcomes Trust Short Forms; sites such as http://www.proqolid.org or http://www.mapi-institute.com/ provide information about or access to hundreds of questionnaires. Quality of Life Research, the official journal of the International Society of Quality of Life (ISOQOL, now in its 20th year of publication), is a key source of information on the reliability, validity, responsiveness, feasibility, and other attributes of PROs. Are they known but not being submitted to NQMC? The answer to this question appears to be "Very likely."
Locating PROs on NQMC
As of summer 2011, NQMC had published just over 2,000 health-related measures on its Web site. The relevant domain framework (for measures related to health) branches to measures for health care delivery and then to clinical quality measures. Within this classification are five domains (process, access, outcome, structure, and patient experience).
The outcome domain, defined in NQMC as "… a health state of a patient resulting from health care," can cover a wide range of variables: death, morbidity, diagnoses, results from laboratory tests, utilization measures, and HRQOL (at least in theory). This domain, however, is potentially so broad and expansive that it is not an ideal route to navigate to NQMC's PRO measures. It yields more than 100 measure summaries for a user to sift through, of which perhaps one-third would reflect content typical of self-reported HRQOL assessments.
A better approach for identifying PROs at the NQMC Web site entails using the Advanced Search feature. From this page, a user can select "Clinical Quality Measure: Outcome" from the Measure Domain selection box and then choose one or more options in the Data Source box. The most obvious Data Source choice is "Patient/Individual Survey." The combination of "Outcome" and "Patient/Individual Survey" yields about 20 measures involving PROs. Examples include various measures in the Activity Measure for Post-acute Care (AM-PAC) set (from the Boston University Health & Disability Research Institute), and the BASIS-24® survey (i.e., the 24-item Behavior and Symptom Identification Scale from McLean Hospital in Virginia).
A more extensive set of potential PRO measures can be identified via an Advanced Search using the combination of "Outcome," "Patient/Individual Survey," and "Special or Unique Data." This approach retrieves more than 90 possible measures. Only a minority, however, appear to be based on self-report questionnaires (e.g., Depression: percent of clinically significant depression patients with a 50 percent or greater reduction in Patient Health Questionnaire [PHQ]). Instead, many involve outcomes observed by clinicians or others, such as home health care measures reflecting Activities of Daily Living (ADLs) or those of the Functional Communications Measures of the American Speech-Language-Hearing Association. In short, although these are important outcomes measures, most will not be specifically PRO measures.
Finally, using "Patient/Individual Survey" with "Registry Data" will produce about 40 entries. Some overlap with yields from other searches. However, this approach also identifies PROs that use data from the PHQ-9 (9-item Patient Health Questionnaire) developed through the HRSA (Health Resources and Services Administration) Health Disparities Collaboratives (for depression).
The NQMC measures that provide information about a recognized dimension of a self-reported outcome—e.g., mean changes in a PRO scale score—can be identified by use of the Advanced Search feature, but nonetheless they seem to be relatively few in number. More measures provide counts or percentages of patients meeting certain criteria derived from a self-reported measure—e.g., proportion of patients in a given practice or nursing home reporting performance of an ADL. Far more, however, give such data for clinician-reported outcome measures. Interestingly, some quality measures are not classified as "outcome" measures but rather as "process" measures, yet they reflect some form of outcome measurement (e.g., a quantitative symptom assessment tool such as the PHQ-9) used in determining whether care has met authoritative practice guidelines.
Where, then, among the many measures represented in NQMC and elsewhere, can we find the "voice of the patient?" If administrators and clinicians working to improve the quality of care do not assess self-reported PRO data, they are missing a major component of considerable salience to patients and their families. Could their access to authoritative quality measures, identified via the Clearinghouse, be constrained because such approaches are not yet widely included in standard quality measure sets?
What Are the Strengths and Limitations of PRO Measurement for Quality Improvement Purposes?
Developers and users of HRQOL instruments have generally been optimistic about applying PROs in clinical practice. Numerous benefits have been claimed for measuring PROs: enhancing patient care by identifying key concerns that the health professionals most qualified and trained to address these concerns can subsequently address; advancing understanding of individual patients' experiences and responses to therapy; strengthening patient autonomy through improved communication and better shared decisionmaking; and enabling documentation of disparities in the delivery and end results of health care.
Admittedly, PRO measurement in a quality improvement context raises feasibility problems. Users need clear linkages between processes and outcomes of care; well-understood measures; sensible data collection mechanisms (paper and pencil, computer-based, web-based) that work in their settings; and effective ways to report results. Possibly most important for quality improvement, users need to understand how to apply psychometric or statistical models, and the "average" results they produce, to the care of individual patients. Those engaged in quality improvement need knowledge of and access to reliable, valid measures; access to data or norms for interpreting scores; ways to minimize administrative burdens; approaches to risk adjustment techniques or information to enhance interpretations; and means of dealing with all the attendant costs.
These are big hurdles, but they are not insurmountable. Thus, if providers and quality improvement programs want to give greater emphasis to the voice of the patient, then they need to find assessment tools that accomplish several goals. These include being able to assign individual patients, and their outcomes, appropriately to different members of the clinical team; take adequate account of patients' values and preferences; control for sociocultural characteristics; and help resolve important conflicts among the core ethical principles of patient autonomy, provider autonomy vs. paternalism, and beneficence vs. nonmaleficence.
Can NQMC Alter This Picture?
Can NQMC contribute to this vision in which outcome assessments reported by patients, rather than clinicians, become a critical part of quality improvement efforts in the 21st century? I believe the answer is "Yes, in several ways."
First, as NQMC continues to grow and establish new criteria for measures and measure sets, it can help make clear that PROs can be successfully embedded in clinical practice. (8-9) Commissioning expert commentaries illustrating their use in clinical settings for patient care purposes may be one step that NQMC can take.
Second, NQMC can encourage developers to create, test, and validate accepted PRO measures and to submit them to the Clearinghouse; one example is the Patient-Reported Outcomes Measurement Information System (PROMIS ). (10-12) In addition, NQMC might consider relaxing its second inclusion criterion concerning current use or pilot testing of the measure specifically to evaluate or report on quality of care, because the measures may have been used more directly in patient care, not quality reporting per se. In the fourth criterion, putting more emphasis on information from developers on measurement properties (e.g., reliability and validity) reported in peer-reviewed media and less emphasis on the organizational affiliation where the measure was developed may also be helpful.
Third, if more outreach is needed—as it probably is—to convince developers of the desirability of submitting PRO measure sets, NQMC and the Agency for Healthcare Research and Quality (AHRQ) can collaborate on such communications. These might entail designing specific mailings to PRO developers and organizations, posting commentaries on the AHRQ Web site and in the NQMC, and making more information available at meetings or other venues for PRO developers and users (such as ISOQOL, the International Society of Quality in Health Care , or the International Network of Agencies for Health Technology Assessment ).
By taking steps to solicit and include more PROs in the Clearinghouse and, thereby, promoting use of PROs in quality assessment and improvement schemes, NQMC contributes in a meaningful way to the case that outcome assessments reported by patients must, soon, become a critical part of contemporary quality improvement programs.
Kathleen N. Lohr, PhD
RTI International, Research Triangle Park, NC
The views and opinions expressed are those of the author and do not necessarily state or reflect those of the National Quality Measures Clearinghouse™ (NQMC), the Agency for Healthcare Research and Quality (AHRQ), its contractor, ECRI Institute, or RTI International.
Potential Conflicts of Interest
Dr. Lohr reports professional affiliations with the PROMIS Health Organization, a nonprofit foundation. In addition, she is a member of the Core Editorial Board for the National Quality Measures Clearinghouse and the National Guideline Clearinghouse.
Editorial Note: NQMC editors share the author's appraisal of the value of patient-reported outcomes (PROs) and their potential utility in quality measurement. As health status assessment instruments, PROs fall short of NQMC's inclusion criteria, which require "a description of the denominator and numerator of the measure (including specific variables for inclusion or exclusion of cases/events from either the denominator or numerator)". However, PRO developers are uniquely well positioned to develop specifications for quality measures derived from their instruments. We encourage developers to do so and would welcome the submission of PRO-derived quality measures to NQMC.
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