Table 3.

Initial and Revised PROMIS Domain Definitions

Domain Name	Initial Definition	Revised Definition
Global Health	Global health refers to evaluations of health in general. 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 allow respondents to weigh together different aspects of health to arrive at a “bottom-line” indicator of their health. These 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 lower levels of income. 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). The remaining items provide global ratings of physical function (global06), fatigue (global08), pain (global07), emotional distress (global10), and social health (global05 and global09).	The PROMIS Global Health items assess health in general (i.e. overall health). The global health items include global ratings of the five primary PROMIS domains (physical function, fatigue, pain, emotional distress, social health) as well as perceptions of general health that cut across domains. Global items allow respondents to weigh together different aspects of health to arrive at a “bottom-line” indicator of their health. Similar global health items have been found predictive of future health care utilization and mortality. The PROMIS Global Health items include the most widely used single self-rated health item (“In general, would you say your health is …”). Previous research has shown that this item taps physical and mental health about equally but reflects physical health more than mental health among respondents at lower income levels. PROMIS Global Health items include specific ratings of physical health and mental health, as well as a rating of overall quality of life. The remaining items provide global ratings of physical function, fatigue, pain, emotional distress, and social health. There is no reporting period specified for these items; current status is inferred. The PROMIS Global Health items can be administered as individual items or combined to produce separate physical and mental health summary scores (see Hays, Bjorner, Revicki, Spritzer, & Cella, 2009).
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).	The PROMIS Physical Function item bank assesses one’s ability to carry out activities that require physical actions, ranging from self-care (activities of daily living) to more complex activities that require a combination of skills, often within a social context. “Physical Function” is inclusive of the term “disability” and includes the full spectrum of physical functioning from severe impairment to exceptional physical abilities. The PROMIS Physical Function items assess capability to perform a variety of physical activities, and often begin with the stem “Are you able to …” Items assessing performance of these activities (the frequency with which physical activities were performed within a specified timeframe), may have great utility for some purposes, but are not included in the physical function item bank. Performance requires not only capability but also opportunity and motivation. The use of capability stems in the PROMIS Physical Function item bank also excludes satisfaction items (e.g., “How satisfied are you with your current level of functioning?”). Such questions address subjective appraisals of oneself that incorporate concepts such as coping or adjustment. Additionally, because many persons with a chronic disease will have more than one chronic condition and often are unable to distinguish the proportion of physical limitation attributable to each condition, the PROMIS physical function items assess physical capabilities and limitations without causal attribution. 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. There is no reporting period specified for these items; current status is inferred.
Pain Intro	Pain is an unpleasant sensory and emotional experience associated with actual or potential tissue damage, or described in terms of such damage. 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, or social activities, and behaviors one engages in to avoid, minimize, or reduce pain.	Pain is an unpleasant sensory or emotional experience associated with actual or potential tissue damage, or described in terms of such damage. 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 (e.g. the nature, characteristics, intensity, frequency, and duration of pain), behaviors (e.g. verbal and nonverbal actions that communicate pain to others) and interference (e.g. impact of pain on physical, mental, and social activities).
Pain Behavior	Pain behaviors are behaviors that usually communicate to others that a person is experiencing pain. The include observable displays such as sighing or crying, as well as verbal reports of pain or pain severity behaviors such as resting, guarding, facial expressions, asking for help, and taking medications.	The PROMIS Pain Behavior item bank assesses external manifestations of experiencing pain. These actions or reactions can be verbal or nonverbal, involuntary or deliberate. Pain behaviors usually communicate to others that a person is experiencing pain. They include observable displays such as sighing or crying, and pain severity behaviors such as resting, guarding, facial expressions, and asking for help, as well as verbal reports of pain. The item bank uses a “past 7 days” reporting period.
Pain Interference (previously Pain Impact)	Pain Impact refers to the consequences of pain on relevant aspects of persons’ lives and may include impact on social, cognitive, emotional, physical, and recreational activity as well as sleep and enjoyment of life.	The PROMIS Pain Interference item bank assesses the consequences of pain on relevant aspects of persons’ lives and may include the impact of pain on social, cognitive, emotional, physical, and recreational activities as well as sleep and enjoyment in life (Note that Pain Interference bank includes only one sleep item). The item bank uses a “past 7 days” reporting period.
Fatigue	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 roles. 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.	The PROMIS Fatigue item bank assesses fatigue from mild subjective feelings of tiredness to an overwhelming, debilitating, and sustained sense of exhaustion that is likely to decrease 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 roles. Fatigue is divided conceptually into the experience of fatigue (such as its frequency, duration, and intensity), and the impact of fatigue upon physical, mental and social activities. The item bank uses a “past 7 days” reporting period.
Emotional Distress Intro	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.	Emotional distress typically refers to unpleasant feelings or emotions. Emotional distress is often reflected in reports of anxiety, depression, and anger. Given the overlap among the experiences and 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 or emotional distress. For example, Watson (2005) proposed a hierarchical structure with first order factors of anxiety, depression, and anger subsumed under a second- order, nonspecific factor reflecting high levels of negative affect or “general distress”. Anger tends to have smaller loadings than anxiety and depression on the general distress factor, but it still is an important component of general distress.
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 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.	The PROMIS Anger item bank assesses angry mood (e.g., irritability, frustration), negative social cognitions (e.g., interpersonal sensitivity, envy, disagreeableness), verbal aggression, and efforts to control 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. Physical aggression items were excluded from the PROMIS Anger item bank based on psychometric properties and poor fit of these items to the other items in the bank. The item bank uses a “past 7 days” reporting period.
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 (cardiovascular symptoms, dizziness).	The PROMIS Anxiety item bank assesses 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., racing or pounding heart, dizziness). Symptoms that best differentiate anxiety are those that reflect autonomic arousal and the experience of threat. Only one behavioral avoidance item (e.g. “I avoided public places and activities”) is included in the PROMIS Anxiety item bank. Other behavioral avoidance items were excluded based on psychometric properties and poor fit with the item bank. Therefore, this item bank does not comprehensively tap behavioral fear avoidance. The item bank uses a “past 7 days” reporting period.
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 self (e.g. self-criticism, worthlessness), and negative social cognition (e.g. loneliness, interpersonal alienation).	The PROMIS Depression item bank assesses negative mood (e.g., sadness, guilt), negative views of the self (e.g., self-criticism, worthlessness), negative social cognition (e.g., loneliness, interpersonal alienation), and decreased positive affect and engagement (e.g., loss of interest, loss of meaning and purpose). Depression is reflected in high levels of negative affect and low levels of positive affect. It is often characterized by the experience of loss and feelings of hopelessness, helplessness, and worthlessness. Somatic symptoms items (e.g. changes in appetite, sleep, psychomotor functioning) were excluded from the PROMIS Depression item bank based on psychometric properties and poor fit of these items to the other items in the bank. Therefore, the PROMIS Depression item bank does not reflect the full range of symptoms commonly considered in a diagnosis of Major Depressive Disorder, but the exclusion of somatic items from this bank eliminates the confounding effects of these items when assessing depression in patients with comorbid physical conditions. The item bank uses a “past 7 days” reporting period.
Sleep Intro	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 immune systems; 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 for measuring sleep at the organismic level in humans include physiological recording, 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 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 Disturbances and Wake Disturbances Scales fall into the latter category. Both scales assess function and disturbances over a seven-day time frame.	Sleep and wakefulness are the two fundamental neurobehavioral 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. As fundamental neurobehavioral states, sleep and wakefulness can be described on several levels, ranging from single neuronal activity to patient-reported outcomes (PROs) of sleep experience and quality. Multiple types of assessments are possible within the broad domain of sleep-wake PROs. Some self-report assessments are used to diagnose specific sleep disorders; others 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 Sleep-Related Impairment item banks fall into the latter category.
Sleep Disturbance	The PROMIS Sleep Disturbance 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 Disturbance 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).	The PROMIS Sleep Disturbance item bank assesses perceptions of sleep quality, sleep depth, and restoration associated with sleep; perceived difficulties and concerns with getting to sleep or staying asleep; and perceptions of the adequacy of and satisfaction with sleep. The PROMIS Sleep Disturbance 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). The item bank uses a “past 7 days” reporting period.
Sleep-Related Impairment (previously Wake Disturbance)	The PROMIS Wake Disturbance 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 Disturbance Scale does not directly assess cognitive, affective, or performance impairments. The Wake Disturbance Scale measures the level of waking alertness, sleepiness, and function within the context of overall sleep function.	The PROMIS Sleep-Related Impairment item bank assesses perceptions of alertness, sleepiness, and tiredness during usual waking hours, and the perceived functional impairments during wakefulness associated with sleep problems or impaired alertness. The Sleep- Related Impairment item bank measures the level of waking alertness, sleepiness, and function within the context of overall sleep- wake function, but does not directly assess cognitive, affective, or performance impairments. The item bank uses a “past 7 days” reporting period.