PROMIS investigators developed a domain framework for self-reported health (see Appendix A). Domain definitions were created for global health, physical function, fatigue, pain, emotional distress (including depression, anxiety, and anger), and social health (social function and social support).
Global Health
Global health refers to evaluations of health in general rather than specific elements of health. The global health items include global ratings of the five primary PROMIS domains (physical function, fatigue, pain, emotional distress, social health) and general health perceptions that cut across domains. Global items allows respondents to weight together different aspects of health to arrive at a ‘bottom-line” indicator of their health status. Global health items have been found to be consistently predictive of important future events such as health care utilization and mortality.
The PROMIS global health items include the most widely used single self-rated health item (global01). Previous research has shown that the former item taps physical health and mental health about equally but it reflects physical health more than mental health, especially for those with low less of income2. PROMIS includes a single item that provides a pure rating of physical health (global03) and another item for mental health (global04). Also included is an overall quality of life item (global02) that is a very strong indicator of mental health15. The remaining items provide global ratings of physical function (global06), fatigue (global08), pain (global07), emotional distress (global10), and social health (global05 and global09).
Physical Health
Physical Function
Physical function is defined as one's ability to carry out various activities that require physical capability, ranging from self-care (activities of daily living) to more vigorous activities that require increasing degrees of mobility, strength, or endurance21, 11, 12, 24. Physical function items, when considered as an outcome endpoint for clinical research in chronic illness, generally have a "capability" stem and a corresponding "capability" set of response items (e.g., "Are you able to...normally, with some difficulty, with moderate difficulty, with great difficulty, unable to do"), and are given in the present tense. This specifically excludes some items that may have great utility in other settings, as with "performance" items that ask whether an activity was actually conducted during a specified time frame (with a "Did you?" type of stem). Such items require capability but also opportunity and motivation. The use of capability stems also excludes the concept of satisfaction (e.g., "How satisfied are you with your current level of function?"). Such questions address subjective appraisals of oneself that incorporate concepts such as coping or adjustment. Because many persons with a chronic disease will have more than one chronic condition and cannot distinguish the fraction of a problem attributable to each one, physical function items attempt to quantitate the sum of these effects, leaving the teasing out of relative contributions to the analysis stage. Physical function is conceptually multidimensional, with four related subdomains: mobility (lower extremity function), dexterity (upper extremity function), axial (neck and back function), and ability to carry out instrumental activities of daily living (IADL).
Symptoms
Fatigue at its highest level is defined as an overwhelming, debilitating, and sustained sense of exhaustion that decreases one's ability to carry out daily activities, including the ability to work effectively and to function at one's usual level in family or social roles22, 19, 10. Similar subjective feelings, yet fewer behavioral impacts, are associated with lower levels of fatigue. Fatigue is divided conceptually into the experience of fatigue (such as its intensity, frequency and duration), and the impact of fatigue upon physical, mental and social activities.
Pain is an unpleasant sensory and emotional experience associated with actual or potential tissue damage, or described in terms of such damage20, 17, 5, 18. Pain is what the patient says it is—that is, the "gold standard" of pain assessment is self-report. Pain is divided conceptually into components of quality (referring to the nature, characteristics, intensity frequency and duration of pain), impact upon physical, mental and social activities, and behaviors one engages in to avoid, minimize or reduce pain.
Sleep/Wake Function
Sleep and wakefulness are the two fundamental behavioral states of human beings. Sleep is a rapidly reversible, recurrent state of reduced (but not absent) awareness of and interaction with the environment. Wakefulness is a behavioral state of active engagement and interaction with the environment, including the perception and processing of stimuli and the production of cognitive, emotional, and behavioral responses. Sleep and wakefulness are both distinct from abnormal behavioral states such as delirium or coma. The generation of sleep and wakefulness is an endogenous phenomenon which is regulated by homeostatic and circadian physiological processes, but which can be influenced by internal (e.g., cognitive, emotional) and external (e.g., physical, environmental) stimuli. A considerable body of scientific data describes the neuroanatomy and neurophysiology of sleep and wakefulness. While the precise functions of sleep remain to be identified, there is little doubt that sleep is necessary for optimal mental and physical function during wakefulness. Alterations in the amount or quality of sleep have been associated with impaired alertness, cognitive and emotional function, and learning; disordered function of the central nervous system, cardiovascular, endocrine-metabolic, and immunesystems; and even with increased mortality.
As fundamental behavioral and brain states, sleep and wakefulness can be described at several levels of organization, including the activity of individual cells, neural systems, or the entire organism. Methods of measuring sleep at the organismic level in humans include physiological recordings, functional neuroanatomic studies, and patient-reported outcomes (PROs). The PROMIS Sleep Disturbances and Wake Disturbances scales are examples of the latter.
Multiple types of assessments are possible within the broad domain of sleep-wake PROs. For instance, some self-report assessments are used to diagnose specific sleep disorders; others (sleep-wake diaries or logs) are used to assess habitual sleep-wake quantities and patterns; and still others measure an individual’s perceptions of the quality and global experience of sleep and wakefulness. The PROMIS Sleep Disturbance and Wake Disturbance scales fall into the latter category. Both scales assess function and disturbances over a seven-day time frame.
Sleep Disturbances: The PROMIS Sleep Disturbances Scale focuses on perceptions of sleep quality, sleep depth, and restoration associated with sleep; perceived difficulties with getting to sleep or staying asleep; and perceptions of the adequacy of and satisfaction with sleep. The Sleep Disturbances Scale does not include symptoms of specific sleep disorders, nor does it provide subjective estimates of sleep quantities (e.g., the total amount of sleep, time to fall asleep, or amount of wakefulness during sleep).
Wake Disturbances: The PROMIS Wake Disturbances Scale focuses on perceptions of alertness, sleepiness, and tiredness during usual waking hours; and on functional impairments during wakefulness that are associated with sleep problems or impaired alertness. The Wake Disturbances Scale does not directly assess cognitive, affective, or performance impairments. The Wake Disturbances scale measures the level of waking alertness, sleepiness, and function within the context of overall sleep-wake function.
Mental Health
Emotional Health
Emotional distress commonly refers to unpleasant feelings or emotions that are experienced privately and, therefore, are good candidates for assessment as patient-reported outcomes. Emotional distress is comprised typically of aspects of anxiety, depression, and anger. Anxiety, depression, and anger represent risk factors that have been associated with both the incidence and progression of disease. The mechanisms by which these associations arise are not well understood, but they can be organized into two general families: direct effects via physiological pathways (e.g., the association between depression and risk factors for cardiovascular disease such as blood lipids and inflammation, which may be produced by shared causal variables) and indirect effects via the impact on health-related behaviors (e.g., increased use of tobacco and alcohol as a consequence of negative emotions).
Given the overlap among the symptoms of anxiety, depression, and anger, a number of conceptual models have been proposed to account for the shared versus unique variance captured in measures of negative affect. Watson and Clark6, 26 proposed a hierarchical structure to explain the relationships between self-reported symptoms of anxiety, depression, and anger. First, they described a second-order, nonspecific factor reflecting high levels of negative affect—or “general distress”—common to all these emotions. Anger tends to have smaller loadings on the general factor than anxiety and depression, but it still is a strong marker of the dimension. In addition, Watson and Clark’s model included first-order factors that are specific to, and help to differentiate, the three affects.
Depression: Symptoms specific to depression are those that reflect low levels of positive affect. In addition, depression is often characterized by the experience of loss and feelings of hopelessness, helplessness, and worthlessness. The PROMIS item bank for depression focuses on negative mood (e.g., sadness, guilt), decrease in positive affect (e.g., loss of interest), information-processing deficits (e.g., problems in decision-making), negative views of the self (e.g., self-criticism, worthlessness), and negative social cognition (e.g., loneliness, interpersonal alienation).
Anxiety: Symptoms that best differentiate anxiety are those that reflect autonomic arousal and the experience of threat. The PROMIS item bank for anxiety focuses on fear (e.g., fearfulness, feelings of panic), anxious misery (e.g., worry, dread), hyperarousal (e.g., tension, nervousness, restlessness), and somatic symptoms related to arousal (e.g., cardiovascular symptoms, dizziness).
Anger: Anger is distinguished by attitudes of hostility and cynicism and is often associated with experiences of frustration impeding goal-directed behavior. Specific components relate to verbal and nonverbal evidence of interpersonal antagonism. The PROMIS item bank for anger focuses on angry mood (e.g., irritability, reactivity), negative social cognition (e.g., interpersonal sensitivity, envy, vengefulness), verbal aggression, and efforts necessary to control angry mood.
In general, our PROMIS item banks emphasize the cognitive and affective components of these concepts. Both psychometric considerations (e.g., skewed distributions for high threshold behavioral items, the need to fit item response theory models to coherent unidimensional concepts) and considerations regarding validity (e.g., potential confounding between somatic symptoms of emotional distress and markers of physical disease) have led us to this emphasis.
Social Health
Social health is defined as perceived well-being regarding social activities and relationships, including the ability to relate to individuals, groups, communities and society as a whole. The term “social health” is used here synonymously with "social function" and refers to a higher-order domain, with measurable subdomains. Components of social functioning include understanding and communication, getting along with people, participation in society and performance of social roles. Additional conceptualizations of social functioning focus on the quality, reciprocity and size of an individual’s social network1, 4. Although social role participation was the initial focus of PROMIS investigation, several other aspects of social health are noteworthy. These include social support and interpersonal attributes independent of particular roles, such as intimacy, assertiveness, sociability, submissiveness and interpersonal control13. The two broad patient-reported outcomes under social function within the PROMIS framework are Social Function and Social Support.
Social Function
Social function is defined by PROMIS as involvement in, and satisfaction with, one’s usual social roles in life’s situations and activities. These roles may exist in marital relationships, parental responsibilities, work responsibilities and social activities9, 16. Social function has also been referred to with terms such as role participation and social adjustment16. Qualitative and quantitative analysis of PROMIS data collected from 2005-2007 have resulted in a conceptual division of social function into “ability to participate” and “satisfaction with participation.” Each of these two components has sub-components that divide social roles such as work and family responsibilities, and more discretionary social activities such as leisure activity and relationships with friends.
Social Support
There are two broad types of social support: quantitative and qualitative7, 23, 25. Quantitative social support refers to the existence of, and interconnections between, social ties, e.g., marital status, number of relationships, frequency of contacts with friends and relatives, church membership, and volunteer participation. Qualitative social support refers to functional aspects of supportive relationships, i.e., interpersonal relationships that serve particular functions. This includes the interactive process by which emotional, instrumental, informational or motivational support is obtained from one's social network3. It also includes feeling cared for and valued as a person, communication with others, and feelings of belonging and trust14, 16. Measures of social support generally seek information about a person’s perception of the availability or adequacy of resources provided by other persons7. In this context, perceived social support is a subdomain of social health.
1) Beels, C.C., Gutwirth, L., Berkeley, J., & Struening, E. (1984). Measurements of social support in schizophrenia. Schizophrenia Bulletin, 10(3):399-411.
2) Bjorner, J.B., Fayers, P.M., & Idler, E.L. (2005). Self-rated health. In P.M. Fayers. & R.D. Hays (eds), Assessing Quality of Life (pp. 309-323). Oxford: Oxford University Press.
3) Bowling, A., & Farquhar, M. (1991). Associations with social networks, social support, health status and psychiatric morbidity in three samples of elderly people. Social Psychiatry and Psychiatric Epidemiology, 26(3):115-26.
4) Brekke, J.S., Long, J.D., & Kay, D.D. (2002). The structure and invariance of a model of social functioning in schizophrenia. Journal of Nervous and Mental Disorders, 190(2):63-72.
5) Chang, H. (1999). Cancer pain management. Medical Clinics of North America, 83(3):711-736.
6) Clark, L.A., & Watson, D. (1991). Tripartite model of anxiety and depression: Psychometric evidence and taxonomic implications. Journal of Abnormal Psychology, 100, 316-336.
7) Cohen, S., & Syme, S.L. (1985). Issues in the study and application of social support. In S. Cohen & S.L. Syme (eds). Social Support and Health (pp. 3-22). Orlando, FL: Academic Press, Inc.
8) [This reference does not pertain to the domain definitions] DeWalt, D.A., Rothrock, N., Yount, S., & Stone, A. on behalf of the PROMIS Cooperative Group (2007). Evaluation of item candidates: The PROMIS qualitative item review. Medical Care, 45: S12-S21.
9) Dijkers, M. P., Whiteneck, G., & El-Jaroudi, R. (2000). Measures of social outcomes in disability research. Archives of Physical Medicine and Rehabilitation, 81(12, suppl 2):S63-S80.
10) Glaus, A. (1998). Fatigue in Patients With Cancer: Analysis and Assessment. Heidelberg,
Germany: Springer-Verlag Berlin.
11) Haley, S.M., Coster, W.J., & Binda-Sundberg, K. (1994). Measuring physical disablement: The contextual challenge. Physical Therapy, 74(5):443-451.
12) Haley, S.M., McHorney, C.A., & Ware, J.E., Jr. (1994). Evaluation of the MOS SF-36 physical functioning scale (PF-10): I. Unidimensionality and reproducibility of the Rasch item scale. Journal of Clinical Epidemiology, 47(6):671-684.
13) Horowitz, L.M., Rosenberg, S.E., Baer, B.A., Ureno, G., & Villasenor, V.S. (1988). The inventory of interpersonal problems: Psychometric properties and clinical applications. Journal of Consulting and Clinical Psychology, 56, 885-892.
14) Larson, J.S. (1993). The measurement of social well-being. Social Indicators Research, 28:285-296.
15) Lorenz, K.A., Cunningham, W.E., Spritzer, K.L., & Hays, R.D. (2006). Changes in symptoms and health-related quality of life in a nationally representative sample of adults in treatment for HIV. Quality of Life Research, 15, 951-958.
16) McDowell, I., & Newell, C. (1996). Measuring Health: A Guide to Rating Scales and Questionnaires, second edition. New York, NY: Oxford University Press.
17) Merskey H., & Bogduk, N. (eds.) (1994). Classification of Chronic Pain: Descriptions of Chronic Pain Syndromes and Definitions of Pain Terms, second edition. Seattle, WA: IASP Press.
18) Meuser, T., Pietruck, C., Radbruch, L., Stute, P., Lehmann, K. A., & Grond, S. (2001). Symptoms during cancer pain treatment following WHO-guidelines: A longitudinal follow-up study of symptom prevalence, severity, and etiology. Pain, 93(3):247-257.
19) North American Nursing Diagnosis Association (1996). Nursing Diagnoses: Definition and Classification, 1997-1998. Philadelphia, PA: McGraw-Hill.
20) Sherbourne, C. D. (1992). Pain measures. In A. L. Stewart & J.E. Ware (eds.) Measuring Functional Status and Well-Being: The Medical Outcomes Study Approach (pp. 230-234). Durham, NC: Duke University Press.
21) Stewart, A. L., & Kamberg, C. (1992). Physical functioning. In A.L. Stewart & J.E. Ware (eds.) Measuring Functional Status and Well-Being: The Medical Outcomes Study Approach (pp. 86-142). Durham, NC: Duke University Press.
22) Stewart, A. L., Hays, R. D., & Ware, J. E. (1992). Health perceptions, energy/fatigue, and health distress measures. In A.L. Stewart & J.E. Ware (eds.) Measuring Functional Status and Well-Being: The Medical Outcomes Study Approach (pp. 143-172). Durham, NC: Duke University Press.
23) Wills, T.A. (1985). Supportive functions of interpersonal relationships. In S. Cohen & S.L. Syme (eds). Social Support and Health (pp. 61-82). Orlando, FL: Academic Press, Inc.
24) Wilson, I.B., & Cleary, P.D. (1995). Linking clinical variables with health-related quality of life. A conceptual model of patient outcomes. Journal of the American Medical Association, 273(1):59-65.
25) Wortman, C.B., & Conway, T.L. (1985). The role of social support in adaptation and recovery from physical illness. In S. Cohen & S.L. Syme (eds). Social Support and Health (pp. 281-302). Orlando, FL: Academic Press, Inc.
26) Watson, D., & Clark, L.A. (1992). Affects separable and inseparable: On the hierarchical arrangement of the negative affects. Journal of Personality and Social Psychology, 62, 489-505.