Health-Related Quality of Life

One class of PRO measures health-related quality of life (HRQL). HRQL is a multidimensional¹⁹ construct encompassing physical, social, and emotional well-being associated with illness and its treatment.²⁰ Different types of HRQL measures^21,22 are useful for different purposes.²³ Numerous generic health status measures, such as the Medical Outcomes Study Short Form SF-36 (and related measures) and the Sickness Impact Profile are classic examples.^24–27 This type of PROM is useful in assessing individuals both with and without a health condition. Such data allow researchers, clinicians, and others to compare groups with and without a specific condition and to estimate population norms.

A health utility or preference measure is also not disease-specific. It provides a score ranging from 0 (death) to 1 (perfect health) that represents the value that a patient places on his or her own health.²⁸ Experts can use scores from these types of measures to calculate quality-adjusted life years or compare information to population norms.

Many PROMs are intended for use in populations with chronic illnesses.^29–31 Over the past 8 years, the PROMIS network has developed a considerable number of PROMs in physical, mental, and social health for adults and infants, children, and adolescents with chronic conditions.^32,33 Neuro-QOL is another measurement effort focused on capturing important areas of functioning and well-being in neurologic diseases.³⁴ These measurement efforts do not reference a specific disease in the items; thus, they permit comparisons across conditions.

Other PROMs are targeted on a specific disease (e.g., spinal cord injury) or treatment (e.g., chemotherapy).^35,36 Often these instruments are developed so that investigators can demonstrate responsiveness to treatment in a clinical trial rather than compare data against population norms or information on other conditions.³⁷ Condition-specific PROMs often provide additional, complementary information about a patient’s HRQL.^30,38–40

Functional Status

Another type of PROM is a functional status measure. Functional status refers to a patient’s ability to perform both basic and more advanced (instrumental) activities of daily life.⁴¹ Examples of functional status include physical function, cognitive function, and sexual function. As with HRQL instruments, a large number of functional status measures exist, but they vary widely in quality.⁴² Some may address a very specific type of function (e.g., Upper Limb Functional Index) or be developed for use in a specific disease population (e.g., patients with multiple sclerosis), whereas others may be appropriate for use across chronic conditions.^43–49

Symptoms and Symptom Burden

Symptoms such as fatigue and pain intensity are key domains for PROMs. Symptoms are typically negative, and their presence and intensity are best assessed through patient report.⁵⁰ Scales characterize the severity of the symptoms. The impact of symptoms, such as the degree to which pain interferes with usual functioning, is also a common focus of PROMs. Symptom burden captures the combination of both symptom severity and impact experienced with a specific disease or treatment.⁵⁰

Common symptom and symptom burden measures include the Functional Assessment of Chronic Illness Therapy—Fatigue scale, which is not targeted on any one condition. By contrast, disease-focused symptom indexes include the symptom indexes for various cancer types set out by the National Comprehensive Cancer Network and a dyspnea-specific instrument for chronic obstructive pulmonary disease.^51,52 PROMIS investigators developed the PROMIS Pain Interference measure, which quantifies the impact of pain on functioning.⁵³

Health Behaviors

Yet another category of PROMs assesses health behaviors. Although health behaviors may be considered predictors of health outcomes, they are also health outcomes in their own right in the sense that health care interventions can have an impact on them. Information from health behavior PROMs serves several important clinical purposes. Clinicians can use it to monitor risk behaviors with potentially deleterious health consequences. This information enables practitioners to identify areas for risk reduction and health promotion interventions among their patients. Health behavior PROMs can also be used to assess patients’ response to health promotion interventions and to monitor health behaviors over time.

Health risk assessments (HRAs) illustrate how health behavior PROMs can be incorporated into health promotion and disease prevention programs. Defined by the US Centers for Disease Control and Prevention (CDC) as tools to measure individual health, HRAs may consist of clinical examination or laboratory test results as well as health behavior PROMs.⁵⁴ A recent report from the US Agency for Healthcare Research and Quality (AHRQ) identified three key components in the process of implementing HRAs in health promotion: (1) patient self-reported information to identify risk factors for disease, (2) individualized health-specific feedback to patients based upon the information they reported, and (3) at least one health promotion recommendation or intervention.⁵⁵

Although HRAs have been implemented in community settings, universities, and health maintenance organizations, they have been most commonly implemented in workplace settings.⁵⁵ An extensive review of HRA program outcomes concluded that, in many cases, implementing HRA programs improved health behaviors and intermediate health outcomes (e.g., blood pressure); however, the evidence did not demonstrate whether using HRAs affected disease incidence or health outcomes over the medium to long term.⁵⁵

As the emphasis on the importance of health behaviors has increased, so has the number of available PROs developed to assess health behaviors across multiple domains. Health behavior PROs may assess general health by measuring risk factors without a focus on a specific disease or behavioral category. Two examples of health behavior PROMs measuring multiple risk factors that the National Committee for Quality Assurance has certified are the Personal Wellness Profile⁵⁶ and the Insight Health Risk Appraisal Survey.⁵⁷

In addition, several large-scale health behavior assessment systems provide additional context for the use of general health behavior PROMs. The Behavioral Risk Factor Surveillance System (BRFSS), created in 1984 by the CDC as a state-based system, uses a standardized questionnaire to measure health risk and health promotion behaviors. These include health awareness, tobacco use, consumption of fruits and vegetables, physical activity, seatbelt use, immunization, and alcohol consumption.⁵⁸ The National Health and Nutrition Examination Survey (NHANES) constitutes another large-scale implementation of health behavior PROMs. Established by the CDC in the 1960s, NHANES includes health behavior surveys in addition to clinical examinations to assess health status at the population level.⁵⁹

The health behavior survey portion of NHANES assesses a wide range of health risk and health promotion behaviors, including smoking, drug use, alcohol use, sexual practices, physical activity, dietary intake, and reproductive health practices.⁵⁹ Health behavior PROMs can also assess risk factors associated with specific diseases (e.g., smoking) or those related to specific behavioral categories (e.g., physical activity, seatbelt use, food consumption). The health risk survey, an interactive computer-based survey assessing alcohol consumption and smoking,⁶⁰ is one example. Another is the CAGE-Adapted to Include Drugs (CAGE-AID) questionnaire, a self-reported screening measure of substance use disorder among treatment-seeking adolescents. Its name derives from its four main questions (Cutting down, being Annoyed if people criticize drinking, feeling Guilty about drinking, and needing an Eye-opener).⁶¹

A subset of health behavior PROMs assesses health-promoting behaviors. Examples of such PROM instruments include “Starting the conversation,” a brief measure of dietary intake;⁶² “Exercise as the fifth vital sign,” a brief measure of physical activity;⁶³ School Health Action, Planning and Evaluation System (SHAPES), a school-based self-report physical activity measure;⁶⁴ and the Morisky Medication Adherence Scale (8-item).⁶⁵

Patient Experience of Care

Patient ratings of health care are an integral component of patient-centered care. In its definition of the essential dimensions of patient-centered care, the Institute of Medicine (now known as the National Academy of Medicine) includes shared decision making among clinicians, patients, and families; self-efficacy and self-management skills for patients; and the patient’s experience of care.^66,67 Measurement of patient ratings is a complex concept that is related to perceived needs, expectations of care, and experience of care.^68–75 Patient ratings can cover the spectrum of patient engagement, from experience to shared decision making to self-management to full activation.

Clinicians’ recognition of patient preferences and values can help health care professionals tailor treatments based on informed decisions that their patients might make based on those preferences. In fact, improving decision quality is one critically important step that the nation can take to improve the quality (processes and outcomes) of health care and thus enhance value for health care expenditures. For this reason, patients’ ratings of their experiences with care not only provide information very salient to patients and families, but they also have considerable policy implications. Each safe practice in the updated NQF consensus report includes a section titled “Opportunities for Patient and Family Involvement.”⁷⁶

The three major types of patient health care ratings relate to evaluations of patient satisfaction, patient motivation and activation, and patient reports of their actual experiences. Patient satisfaction is a multidimensional construct that includes patient concerns about the disease and its treatment, issues of treatment affordability and financial burden for the patient, communication with health care providers, access to services, satisfaction with treatment explanations, and confidence in the physician.^77–83 Shikiar and Rentz proposed a three-level hierarchy of satisfaction: (1) satisfaction with health care delivery, including issues of accessibility, clinician-patient communication, and quality of facilities; (2) satisfaction with the treatment regimen, including medication, dietary and exercise recommendations, and similar elements of therapies; and (3) satisfaction with the medication itself, rather than the broader treatment.⁷³ Patient satisfaction has important implications for clinical decision making and enhancing the delivery of health care services; it is increasingly the focus of research and evaluation of medical treatments, services, and interventions.⁸⁴ It is an important indicator of future adherence to treatment.^72,85–90 Satisfaction has a long history of measurement, and numerous instruments are available.^{70,75,91–99}

One potentially important predictor of health outcomes is patient activation, or the degree to which patients are motivated and have the relevant knowledge, skills, and confidence to make optimal health care decisions.^100-102 Hibbard and colleagues¹⁰² developed a 13-item scale, the Patient Activation Measure (PAM),^103,104 which demonstrated favorable psychometric properties in several cross-sectional and some longitudinal studies.¹⁰¹ Although appreciation of the benefits of activated patients is increasing,¹⁰⁵ commensurate support is lacking to help patients become more activated with respect to their health care decision making.¹⁰⁴ Although research supports the claim that improvements in patient activation are associated with improvements in self-reported health behaviors,^101,105 additional research is necessary to better understand both these relationships and their relevance to actual behavior. Patient activation, as measured by the PAM or otherwise, may be a useful moderator or mediator of PROs that will in turn contribute to performance measurement.

An important contemporary focus is on measuring patient reports of their actual experiences with health care services.¹⁰⁶ Reports about care are often regarded as more specific, actionable, understandable, and objective than general ratings alone.^107,108 The Consumer Assessment of Healthcare Providers and Systems (CAHPS) program is a multiyear AHRQ initiative to support and promote the assessment of consumers’ experiences with health care. The CAHPS program has two main goals: (1) to develop standardized patient questionnaires and (2) to generate tools and resources that produce understandable and usable comparative information for both consumers and health care providers. The CAHPS project has become a leading mechanism for the measurement of patient perspectives on health care access and quality.