Qual Life Res DOI 10.1007/s11136-014-0622-y
Concept Analysis of the Patient Reported Outcomes Measurement Information System (PROMISÒ) and the International Classification of Functioning, Disability and Health (ICF) Carole A. Tucker • Alarcos Cieza • Anne W. Riley • Gerold Stucki • Jin Shei Lai • T. Bedirhan Ustun • Nenad Kostanjsek • William Riley David Cella • Christopher B. Forrest
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Accepted: 2 January 2014 Ó Springer Science+Business Media Dordrecht 2014
Abstract Purpose The Patient Reported Outcomes Measurement Information System (PROMISÒ) is a US National Institutes of Health initiative that has produced self-report outcome measures, using a framework of physical, mental, and social health defined by the World Health Organization in 1948 (WHO, in Preamble to the Constitution of the World Health Organization as adopted by the International Health Conference, New York, 1948). The World Health Organization’s International Classification of Functioning, Disability and Health (ICF) is a comprehensive classification system of health and health-related domains that was put forward in 2001. The purpose of this report is to compare and contrast PROMIS and ICF conceptual frameworks to support mapping of PROMIS instruments to the ICF classification system .
Methods We assessed the objectives and the classification schema of the PROMIS and ICF frameworks, followed by content analysis to determine whether PROMIS domain and sub-domain level health concepts can be linked to the ICF classification. Results Both PROMIS and ICF are relevant to all individuals, irrespective of the presence of health conditions, person characteristics, or environmental factors in which persons live. PROMIS measures are intended to assess a person’s experiences of his or her health, functional status, and well-being in multiple domains across physical, mental, and social dimensions. The ICF comprehensively describes human functioning from a biological, individual, and social perspective. The ICF supports classification of health and health-related states such as functioning, but is not a specific measure or assessment of health, per se.
C. A. Tucker (&) College of Health Professions and Social Work, Temple University, 3307 North Broad Street, Philadelphia, PA 19140, USA e-mail: [email protected]
J. S. Lai D. Cella Department of Medical Social Sciences, Northwestern University Feinberg School of Medicine, Chicago, IL, USA
A. Cieza Department of Psychology, University of Southampton, Southampton, UK A. Cieza G. Stucki ICF Research Branch of the WHO Collaborating Centre for the Family of International Classifications in Germany (DIMDI), Nottwil, Switzerland A. W. Riley Department of Population and Family Health Sciences, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA G. Stucki Swiss Paraplegic Research, Nottwil, Switzerland
T. Bedirhan Ustun N. Kostanjsek World Health Organization, CTS Team, Geneva, Switzerland W. Riley National Cancer Institute, National Institutes of Health, Bethesda, MA, USA C. B. Forrest The Children’s Hospital of Philadelphia, Philadelphia, PA, USA C. B. Forrest Department of Pediatrics, University of Pennsylvania School of Medicine, Philadelphia, PA, USA C. B. Forrest Leonard Davis Institute of Health Economics, University of Pennsylvania, Philadelphia, PA, USA
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PROMIS domains and sub-domain concepts can be meaningfully mapped to ICF concepts. Conclusions Theoretical and conceptual similarities support the use of PROMIS instruments to operationalize selfreported measurement for many body function, activity and participation ICF concepts, as well as several environmental factor concepts. Differences observed in PROMIS and ICF conceptual frameworks provide a stimulus for future research and development. Keywords Health PROMIS ICF Self-report Outcomes Functioning
Introduction Advances in the measurement of health, particularly selfreported health, have been stymied by the absence of theory to guide the creation of a comprehensive typology of health concepts that is internationally accepted across a wide variety of disciplines [2]. Health concept terminologies vary across scientific fields, disciplines, and professional groups. Thus, when person-reported outcome (PRO) measures are developed, most are not linked to any existing system, which has contributed to the challenges of PRO measurement. In recent years, the increase in multi-institutional and global clinical research trials along with the emergence of electronic health records have strengthened the imperative for standardized and interpretable shared terminology across health measurement systems. A unified health terminology and related typology or classification system would support the aggregation of results from multiple studies [2]. Integrating the many competing health frameworks can be accomplished by linking concepts in one system to concepts in another framework using common meaningful terms. Such mappings would improve understanding of the individual concepts upon which the frameworks are built as well as the respective over-arching frameworks. The most comprehensive attempt to classify health concepts is the World Health Organization’s (WHO) International Classification of Functioning, Disability and Health (ICF) [3, 4]. The ICF is a classification system (http://www.who.int/classifications/icf/en/) based on an integrative, biopsychosocial model of health, functioning, and disability [3]. The ICF has become an international standard for describing health and functioning, and a large number of health measures have been mapped to it [5, 6]. However, the largest PRO development effort in the world, the Patient Reported Outcomes Measurement Information System (PROMISÒ), has not been systematically linked to the ICF. PROMIS is an ambitious effort to provide a broad
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set of publicly available, person-reported outcomes of physical, mental, and social health [7, 8]. An individual’s development and quality of life are outcomes that reflect the dynamic interconnectedness of health, functioning, and person and environmental contextual factors [9]. Hence, quality of life, health, functioning, and development are critical concepts to classify and assess in all individuals as supported by both the ICF and PROMIS bodies of work. The purpose of this report is to compare the conceptual underpinnings of PROMIS and ICF and to determine how PROMIS assessment tools can be used to operationalize ICF concepts, and how the ICF can be used to describe PROMIS content. After contrasting the two conceptual frameworks and respective terminologies, we perform a lexical and semantic mapping of PROMIS instruments to ICF chapters and first level categories. We conclude with a discussion on areas of future growth and potential approaches to refinement of each framework generated by this harmonization.
Overview of PROMIS PROMIS (www.nihpromis.org) is an ongoing US National Institutes of Health initiative designed to create instruments that measure self-perceptions of adults and children about their experiences of health, functioning, and well-being [7, 8]. The initial focus of the network was the development of PRO instruments to assess common clinical research endpoints applicable across diseases, settings, and conditions. Although the PROMIS conceptual framework has greatly expanded since its inception in 2004, the purpose of the framework is to guide the development of distinct outcome constructs. As of 2013, PROMIS had developed dozens of unique instruments, which have been translated into multiple languages. PROMIS adopted the classic WHO tripartite definition in which health is described as consisting of physical, mental, and social health dimensions [3]. This decision was made because of the broad acceptance of this simple framework, and its relative flexibility to accommodate a wide array of self-reported health concepts. The 2013 version of the PROMIS health framework is shown in Fig. 1, and additional details can be found at http://www. nihpromis.org. PROMIS instruments are developed using a rigorous mixed-methods approach [10]. This process begins with qualitative studies to define the theoretical construct and methods and to ensure the comprehensibility and translatability of item concepts across languages and cultures. Psychometric methods, including factor and item response theory analyses, are used to develop item banks that provide precise and efficient measurement of the underlying concepts. Instruments are administered as either fixed-
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Fig. 1 Conceptual domain framework of PROMIS which can be accessed at http://www.nihpromis.org/measures/domainframework
length short forms or computer adaptive tests (CATs). For example, the PROMIS physical function item bank has over one hundred items. However, with CAT administration, only a small subset of items need to be completed (5–7 items typically) for a person’s physical functioning ability to be determined with a high degree of precision. PROMIS instruments are publically available and translated into multiple languages (www.nihassessmentcenter. org). Test users have the freedom to use the prespecified short forms, administer the items as a CAT, or derive custom instruments by choosing specific items from item banks. Regardless of method, the person’s score is placed on the same PROMIS metric. Moreover, by calibrating the items using IRT methods, PROMIS measures can be statistically linked to other measures of the same concept, placing non-PROMIS ‘‘legacy’’ measures on the PROMIS metric [11].
Overview of the International Classification of Functioning, Disability and Health (ICF) The ICF was officially endorsed in 2001 (resolution WHA 54.21) as an international standard to describe and classify health, functioning, and disability. It provides a
scientific basis for understanding and studying health and functioning, a classification system to improve communication between different users, and a systematic coding scheme for health information systems. The ICF fits within the Family of International Classification systems that include the International Classification of Disease (ICD) and the International Classification of Health Interventions (ICHI). The ICF is organized into components of body structure, body functions, activity and participation, personal and environmental contextual factors (Fig. 2) [3]. All components but the personal factors are further subclassified into categories, which are the units of the classification. The classification contains 32 first level categories. From each of these first level categories, second and third level categories are defined providing increasing level of detail. Several ‘‘core sets’’ of ICF categories have been identified as most important for describing health-related functioning associated with different health conditions, environmental factors and for varied intervention settings [12–14]. PROMIS could be used to operationalize core sets and measure related ICF concepts. The aim of the study was to compare and contrast PROMIS and ICF conceptual frameworks in order to support application of PROMIS instruments for measurement of components of the ICF classification system.
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Body Functions Component (b)
Activity and Participation Component (d)
Body Structures Component (s)
Environmental Component (e)
Personal Factors No named Component
Fig. 2 Conceptual framework of the International Classification of Functioning, Health and Disability (WHO 2002). The corresponding ICF defined components are provided and linked to the figures elements by dashed arrows
Methods Comparison of different health terminologies, classification and measurement systems can be accomplished through the analyses of the conceptual frameworks and the hierarchical arrangements of concepts, and at the individual item level (i.e., the most granular health concept) [15, 16]. Thus, to determine whether PROMIS and ICF have sufficient compatibility to justify using PROMIS measures to operationalize ICF concepts and to use ICF concepts to describe PROMIS content, we first identified and compared the intended purpose and guiding principles of each framework. Secondly, we systematically identified the meaningful concepts for PROMIS domains and analyzed both those PROMIS concepts and the ICF categories. Such an approach is essentially an equivalence mapping of concepts of the main trunk or primary branches of the frameworks. Our methods followed those from previous research that had shown for biomedical ontologies, simple lexical techniques, such as comparing preferred names of concepts and their synonyms, are effective in creating mappings [15]. Our team included scientists with extensive expertise in PROMIS and ICF. We performed concept mapping of the definitions and labels of the primary domains of PROMIS to the first- and second-level ICF codes to compare and contrast content and conceptual overlap. This process of concept mapping relies on identification of the key concepts based on the definitions, inclusions and exclusions, the placement within the framework, and the sub-concepts of the more granular levels (e.g., items, or third levels).
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Two investigators (CT, AR) independently completed the preliminary conceptual domain mapping and assignment of PROMIS domains to ICF categories and vice versa. On the rare occasion when the 2 reviewers disagreed about the preliminary assignment of PROMIS domains, consensus was achieved with input from a third reviewer (CBF). These primary conceptual domain mappings were subsequently reviewed by 9 experts who agreed with the mappings and final consensus achieved. Finally, to support the primary conceptual framework and domain mapping, we carried out a content analysis consisting of item-level mapping for all PROMIS items to ICF third-/fourth-level categories. The method used here is similar to conceptual mapping, but rather than the larger domains and related concepts being considered; each of the smallest conceptual units (e.g., items, fourth-level categories) is identified and mapped between the frameworks. Item-level mapping is accomplished by first identifying meaningful concepts based on lexical analysis and similarity of the words used within each item/subcategory that represent the simplest concepts [15]. Such incremental item-level mapping can be helpful to determine how sets of items in differently organized frameworks are grouped to represent the more general and complex health concepts. Previous reports of mapping to the ICF framework often use such a conceptual or similarity mapping at the item level as exemplified by Cieza’s work [15]. This more detailed item-level mapping process was used to support the primary conceptual framework mapping reported here and is described in detail elsewhere [17].
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Results Comparison of intended purpose and guiding principles Both PROMIS [7] and ICF [4] are intended for the entire population and applicable to all people, regardless of the presence of a health condition, personal characteristics, or environment in which they live. They are generic systems that provide standardized terminologies for describing health of individuals and populations. Even though the initial PROMIS research network consisted primarily of experts from a single country (USA), PROMIS has moved into the international health measurement arena with establishment of the International PROMIS organization in 2012. In addition, all PROMIS instruments undergo cultural harmonization and translatability review during their initial development. Experts in translation ensure that items developed in English will translate well into other languages, retaining cultural relevance, and PROMIS. Additional language translations are ongoing along with psychometric analyses of translated measures, and assessment of DIF is also completed and considers necessary standards as instruments mature. In contrast, the ICF was developed by a team of international experts and is being used worldwide. Neither PROMIS nor ICF provides an explicit definition or a comprehensive theoretical model of health. PROMIS use the differentiation of physical, mental, and social wellbeing from the 1948 WHO definition of health; ICF provides a framework for the conceptualization of health in terms of functioning. Although neither ICF nor PROMIS was developed to include disease-specific elements, both of them can be used to categorize or measure impairments, symptoms, and restrictions, as well as the impact of health conditions on life areas, such as self-care and personal relationships. For such condition-specific use, core sets derived from the most relevant ICF codes or administration of selected PROMIS instruments relevant to a given disease can be applied to provide more condition-focused measurement or categorization. The ICF provides a broad set of health and healthrelated functioning terms and concepts. PROMIS provides granularity within targeted areas of health outcomes useful for measurement in clinical research and practice applications. The ICF provides a system for organizing the components of the biological aspects of health (body structure and function), health-related functioning (activity and participation), and the non-health-related environmental aspects. PROMIS concepts more heavily focus on the subjective experience of health in terms of affective, cognitive, functioning, and well-being experiences. An important difference between these 2 frameworks is that ICF specifies and includes personal and environment
factors that influence person-level functioning in the context of everyday life. The PROMIS conceptual framework is designed to specify the content of self-reported health and does not include a model such as personal or environmental factors. The ICF clearly articulates the need to incorporate assessment of environmental contexts in understanding actual functioning. PROMIS does not include explicit assessment of the environment, as environmental assessment is not a health outcome. However, the impact of several ICF environmental categories (e.g., instrumental aids, social supports) can be assessed by some PROMIS item banks. For example, the PROMIS informational support item bank is conceptually consistent with the ICF environmental factor chapter E3—support and relationships. Though both PROMIS and ICF recognize the importance of person factors, neither provides a hierarchical framework or definitions concerning person contextual concepts. PROMIS primary domains of mapped to ICF We mapped the PROMIS instruments’ domain-level concepts to the ICF chapters and second-level categories (Table 1). The table describes whether one or more PROMIS tools provide good assessment of the ICF concept (Full), some coverage of the ICF concept but not completely (Partial), or do not assess the ICF concept (None). As a system of self-reported health, PROMIS does not include measures that correspond to any category in the ICF body structures (S categories). PROMIS does include many sub-domain concepts that overlap with the ICF body function (B categories) component. In particular, PROMIS provides a rich set of measures for ICF mental functions (b1), sensory functions and pain (b2), cardiovascular and respiratory functions (b4), reproductive functions (b6), and neuromusculoskeletal and movement-related functions (b7). While ICF refers to these as body functions, impairments in these ICF body function categories are often symptoms, a term used within the PROMIS framework. The PROMIS framework contains physical symptom subdomains (pain, fatigue) and physical functions (physical functioning and sexual functioning). PROMIS provides a high level of granularity in definition and measurement of certain mood and emotion outcomes, which are not well represented by ICF specific categories. For example, ICF emotional functions (b152) category includes codes for the appropriateness of emotion (b1520), regulation of emotion (b1521), and range of emotion (b1522). PROMIS anxiety, anger, depression concepts and corresponding instruments all map to a single ICF concept—range of emotion (b1522)—and PROMIS has minimal coverage of the 2 subconcepts of appropriateness and regulation.
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Qual Life Res Table 1 Assignment of PROMIS item banks to ICF concepts ICF component
Body functions (B)
Body structures (S) Activity and participation (D)
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ICF chapter
ICF chapter concepts
B1
PROMIS coverage of specific ICF concepts (2012) Full
Partial
Comments
Mental functions
Addressed by multiple PROMIS mental health concepts of affect, behaviors, and cognition
Orientation (b114) and perceptual (b156) mental functions
B2
Sensory functions and pain
Pain—with PROMIS pain intensity and interference banks
Seeing and hearing
B3
Voice and speech functions
None
B4
Functions of the cardiovascular, hematological, immunological, and respiratory functions
ICF exercise tolerance concept is addressed by PROMIS physical function and fatigue concepts
B5
Functions of the digestive, metabolic, and endocrine systems
None
B6
Genitourinary and reproductive functions
Sexual function ICF concepts well addressed by PROMIS sexual function concepts
B7
Neuromusculoskeletal and movement-related functions
ICF muscle power functions within PROMIS physical function
B8
Functions of the skin and related structures
None
S1–S8
Body structures
None
D1
Learning and applying knowledge
These are fairly generic defined concepts in the ICF and are minimally addressed by PROMIS at the generic concept level
D2
General tasks and demands
D3
Communication
Minimal specific coverage by a single item bank
D4
Mobility
Well covered primarily by PROMIS physical function concepts
Transferring (d420), using transportation (d470), and driving (d475)
D5
Self-care
Well covered primarily by PROMIS physical function concepts
Toileting (d530), eating (d550), and drinking(d560) concepts
D6
Domestic life
Well covered primarily by PROMIS physical function and social roles concepts
D7
Interpersonal interactions and relationships
Well covered within the social health relationship concept
Formal and relating to strangers
D8
Major life areas
Education, work, and employment by PROMIS physical function and social role concepts
Other sub-concepts minimally or not addressed
D9
Community, social, and civic life
Primarily concepts of community life and recreation and leisure by PROMIS physical function and social role concepts
Other sub-concepts minimally or not addressed
No coverage for vestibular, taste, smell, touch, proprioception
Other ICF subconcepts minimally or not addressed
Urinary functions are not addressed Other ICF sub-concepts minimally or not addressed
Qual Life Res Table 1 continued ICF component
Environmental factors (E)
Personal factors
ICF chapter
ICF chapter concepts
E1
PROMIS coverage of specific ICF concepts (2012) Full
Partial
Products and technology
Distributed within concepts of transportation, sexual function, and communication
Other sub-concepts minimally or not addressed
E2
Natural environment and human-made changes to environment
None
E3
Support and relationships
Primarily related to e340 (personal care providers and personal assistants)
E4 E5
Attitudes Services, systems, and policies
None None
No additional sub-domains specified in the ICF
Comments
Other sub-concepts minimally or not addressed
PROMIS measures health outcomes, does not include measures of personal factors
PROMIS provides physical functioning item banks that can yield a general physical functioning score as well as sub-domain scores for upper extremity functioning and mobility. Though PROMIS does not have a specific selfcare instrument, many ICF self-care concepts are used to measure physical functioning, particularly within the upper extremity sub-domain. Many PROMIS items contain more than one concept; for example, an item includes assessment of the impact of one concept (e.g., fatigue, pain, depression) on other concepts (e.g., self-care and mobility). This is not the case in the ICF, since the ICF categories as part of a classification system are intended to be unambiguous, mutually exclusive and reflect individual constructs, independent from each other. Overall, PROMIS supports measurement of the majority of major concepts (chapters) in the ICF activity and participation component, though there are a few constructs not addressed deeply by PROMIS (Table 1). For example, the ICF concept for communication (D3) is not specifically or fully addressed by a PROMIS item bank; however, there are PROMIS item level concepts that address communication skills. In addition, concepts that are better assessed through clinical examination, laboratory assay, or imaging (e.g., body structures and some body functions) than through person-reported outcomes are not represented in PROMIS item banks. Given the focus of PROMIS on measurement of person health outcomes, there is minimal explication or item concepts that could be used to measure many ICF environmental factor concepts. ICF primary concepts mapped to PROMIS Several insights emerge from the mapping of ICF concepts to PROMIS instruments (Table 2). PROMIS sub-domains
are characterized by well-defined, clinically homogenous, and unidimensional constructs that are empirically supported by expert consensus, patient input, and psychometric analyses. Within each of the PROMIS item bank instruments, the related ICF concept maps effectively onto the PROMIS concepts of the amount or intensity of the underlying construct. The additional items within that PROMIS bank may assess the impact of the concept on experiences or behaviors in other related life areas, even though empirically all items factor into one dimension. For example, fatigue in PROMIS includes items that capture the intensity of fatigue as well as items that assess the impact of fatigue on daily functioning concepts such as self-care, mobility, and domestic life. In the corresponding ICF category for fatigue (b1300), the intensity or frequency of fatigue are the relevant concepts. Another health attribute for which PROMIS provides different specificity than the corresponding ICF category is pain. In the ICF, pain is included within the ‘‘b-level’’ or body function category with sub-domains explicated by pain location or body regions. PROMIS provides additional insight into pain with sub-concepts of quality, magnitude, related behaviors, as well as impact of pain on one’s functioning. In the ICF, specific mental functions including emotions are primarily classified at the body function level [Chapter 1] within single codes covering a variety of emotions as discussed above for emotional functions (b152). Similarly, ‘‘handling stress and other psychological demands,’’ including affect and behaviors, is also classified with a single ICF code (d240) in the Activity and Participation. PROMIS provides more granularity in measurement of these single ICF codes and has item banks for specific negative emotions, positive emotions, behaviors, and
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Qual Life Res Table 2 PROMIS item banks aligned with corresponding ICF concepts PROMIS item banks
Related ICF concepts
Comments
Physical health—functioning and symptoms Physical function
Physical function—mobility aids
Sexual function and satisfaction
Mobility (D4)
The PROMIS physical function banks provide comprehensive measure of functioning related to mobility
Self-care (D5)
PROMIS include concepts found in acquisition of goods and services (d610), household tasks (d630– d640), and caring for household objects (d650– d660)
Domestic life (D6) Major life areas (D8)
PROMIS include general physical function associated with work and employment (d840– d850)
Community, social, and civic life (D9)
PROMIS covers concepts primarily in recreation and leisure (d920)
Sexual functions (b640)
The PROMIS sexual function item banks provide comprehensive and granular measures of the corresponding ICF concepts
Sensations associated with genital and reproductive functions (b670) Sleep disturbance
Sleep functions (b134)
PROMIS bank provides comprehensive and granular measure of ICF-related sleep functions
Sleep-related impairment
Energy and drive functions (b130)
The PROMIS sleep-related impairment bank includes item related to energy functions as well as impact on a range of ICF concepts such as mobility, self-care, and mental functions
Fatigue
Energy and drive functions (b130)
PROMIS bank provides comprehensive measure of fatigue in terms of intensity and quality of the fatigue experience, as well as behaviors and impact on functioning of fatigue
Pain intensity
Sensation of pain (b280)
The operationalization of pain is different between the 2 frameworks. ICF pain domains relate most directly to location of pain. PROMIS pain domains provide a more comprehensive characterization of intensity, behaviors, and impact on functioning with greater specificity and granularity than explicated in the ICF While these item concepts relate to ICF b280 sensation of pain, the PROMIS pain concept is broader and provides measurement of the common behaviors observed or performed by individuals in pain. Such reactions are probably related to intensity as well as the individual’s tolerance and coping
Pain behavior
Sensation of pain (b280) Communicating–producing (d330–349)
Pain interference
Sensation of pain (b280) Mental functions (b1) Mobility (D4) Self-care (D5) Domestic life (D6) Community, civic, and social life (D9)
Pain quality
Sensation of pain (b280)
Pain intensity
Sensation of pain (b280)
GI symptoms
Functions related to the digestive system (b510–b539)
PROMIS mental health—affect, behaviors, and cognition
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There is no single ICF code that maps directly to this PROMIS bank, rather the secondary meaningful concepts correspond to specific functions such as walking, occupation. While these item concepts relate to ICF b280 sensation of pain, the PROMIS pain concept is broader and provides measurement of the impact of the individual’s pain on healthrelated functioning PROMIS uses a 10-point rating scale of pain intensity
Qual Life Res Table 2 continued PROMIS item banks
Related ICF concepts
Comments
Emotional distress—anxiety
Emotional functions (b152)
Emotional distress—depression
Emotional functions (b152)
Emotional distress—anger Psychosocial illness impact (positive and negative)
Emotional functions (b152) Temperament and personality functions (b126)
PROMIS provides quite granular measures of several distinct emotions that the ICF categorized under the b152 code
Cognitive function
Global mental functions (b110–139) Specific mental functions (b140–189)
Alcohol use—problem drinking
Energy and drive functions (b130) Emotional functions (b152)
Alcohol use—consequences (positive and negative) Alcohol use—expectancies (positive and negative)
Energy and drive functions (b130) Emotional functions (b152) Energy and drive functions (b130) Emotional functions (b152)
PROMIS provides measures of several temperament concepts, related to positive and negative affect, that are less granular in the ICF b126 code The cognitive function bank may cover many of these ICF concepts quite comprehensively Substance abuse corresponds to a very specific ICF code b1303 (craving) as a primary code, however, PROMIS banks explore experiential, behavioral, and impact of the substance use across physical, social, and mental health areas. The PROMIS alcohol-use banks provide granular and comprehensive measurement of one specific type of substance use/abuse—alcohol. These banks could provide a basis for development of similar measures of other substance use/abuse concepts
PROMIS social health—relationships and function Ability to participate in roles and activities Satisfaction with roles and activities
Self-care (D5) Domestic life (D6) Interpersonal interactions and relationships (D7) Major life areas (D8) Community, social and civic life (D9)
The PROMIS bank provides a breadth of coverage consistent with several participation related ICF chapter concepts This PROMIS item bank maps to these ICF-related concepts based on the included role or activity, however, ‘‘satisfaction with’’ as reflected in the PROMIS banks is not a concept included within these specific ICF concepts
Companionship
Interpersonal interactions and relationships (D7)
Conceptually quite similar, though PROMIS does not include the concept of interactions with strangers specifically
Emotional support
Support and relationships (E3)
These three PROMIS item banks all map to ICF E3 and provide a breath of conceptual coverage
Instrumental support
Support and relationships (E3)
Informational support
Support and relationships (E3)
Attitudes (E4)
cognition, thereby providing a highly granular system for describing the psychological experiences of health.
Discussion PROMIS provides a measurement system that can be used to describe and assess many aspects of the ICF, and the ICF can serve as a typology for classifying the content of PROMIS. This is the primary conclusion of our analysis of the two health frameworks. Additionally, our analyses identified important differences between PROMIS and ICF. PROMIS was broadly envisioned as a means to standardize and advance patient-reported outcomes (PROs), and in the areas targeted by PROMIS, provide significant opportunities for measurement of related ICF concepts. The ICF was developed to meet the need for a common, international
means of describing human functioning, disability, and health by means of health, health-related, and non-healthrelated domains that make possible the comprehensive description of functioning and disability. Nonetheless, both systems are intended to be used in all individuals and populations, regardless of health condition, personal characteristics, or environment in which persons live. PROMIS is a measurement system that will continue to evolve and expand over time, as does the ICF classification system through updates and revisions to the ICF platform. Our work linking PROMIS to the ICF has identified several domains that may be useful to consider for further development (e.g., communication concepts) of PROMIS domains. Similarly, PROMIS has empirically demonstrate that some concepts represented by a single ICF code may be more multi-dimensional than represented by a single code, and be better characterized by definition of additional
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ICF categories or levels. The PROMIS framework to date has been shaped, in part, by health domains that have been or are being developed to assess specific latent traits of self-perceived health outcomes. At present, the ICF guides clinicians in describing functioning and disability at multiple levels across all body systems and body functions, limitations in activities, and restrictions in participation within the necessary environmental contexts. As both PROMIS and ICF continue to mature, such differences may promote additional synergy between the 2 efforts. Both PROMIS and ICF have advanced the measurement and understanding of health and functioning. There is sufficient comparability of the ICF and PROMIS frameworks to justify the use of PROMIS as a measurement system for several of the ICF concepts, and for PROMIS to consider the value of ICF to contribute to broadening its conceptual framework. Similarly, ICF can potentially turn to efforts like PROMIS to provide empirical support of its framework. Detailed mapping between PROMIS instruments at the item level with ICF second- and third-level categories can further help clarify the measurement opportunities [17]. Ultimately, such complementary efforts will lead to improved systems for comprehensive health outcome measures.
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measures used in stroke based on the international classification of functioning, disability and health (ICF): A systematic review. Quality of Life Research, 16(5), 833–851. Riley, W. T., Rothrock, N., Bruce, B., et al. (2010). Patientreported outcomes measurement information system (PROMIS) domain names and definitions revisions: Further evaluation of content validity in IRT-derived item banks. Quality of Life Research, 19(9), 1311–1321. Cella, D., Yount, S., Rothrock, N., et al. (2007). The PatientReported Outcomes Measurement Information System (PROMIS): progress of an NIH Roadmap cooperative group during its first two years. Medical Care, 45(5 Suppl 1), S3–S11. McDougall, J., Wright, V., & Rosenbaum, P. (2010). The ICF model of functioning and disability: Incorporating quality of life and human development. Developmental Neurorehabilitation, 13(3), 204–211. doi:10.3109/17518421003620525. PROMISÒ Instrument Development and Psychometric Evaluation Scientific Standards. http://www.nihpromis.org/Documents/ PROMIS_Standards_050212.pdf. Accessed 19 Dec 2012. Carle, A. C., Cella, D., Cai, L., Choi, S. W., Crane, P. K., Curtis, S. M., et al. (2011). Advancing PROMIS’s methodology: Results of the third Patient-Reported Outcomes Measurement Information System (PROMIS(Ò)) Psychometric Summit. Expert Rev Pharmacoecon Outcomes Res, 11(6), 677-84. doi: 10.1586/erp. 11.74. Oberhauser, C., Escorpizo, R., Boonen, A., Stucki, G., & Cieza, A. (2012). A statistical validation of the Brief ICF Core Set for osteoarthritis based on a large international sample of patients with osteoarthritis. Arthritis Care Res (Hoboken). 2012 Jun 28. doi: 10.1002/acr.21775. Kus, S., Oberhauser, C., Cieza, A. (2012). Validation of the brief International Classification of Functioning, Disability, and Health (ICF) core set for hand conditions. Journal of Hand Therapy, 25(3), 274–286; quiz 287. doi: 10.1016/j.jht.2012.02.003. Glocker, C., Kirchberger, I., Glaessel, A., Fincziczki, A., Stucki, G., & Cieza, A. (2012). Content validity of the comprehensive international classification of functioning, disability and health (ICF) core set for low back pain from the perspective of physicians: a Delphi survey. Chronic Illness. [Epub ahead of print] PubMed PMID: 22689356. Cieza, A., Brockow, T., Ewert, T., et al. (2002). Linking healthstatus measurements to the international classification of functioning, disability and health. Journal of Rehabilitation Medicine, 34, 205–210. Ghazvinian, A., Noy, N. F., & Musen, M. A. (2009). Creating mappings for ontologies in biomedicine: Simple methods work. In AMIA annual symposium (AMIA 2009), San Francisco, CA. Tucker, C.A., Escorpizo, R., Cieza, A., Lai, J. S., Stucki, G., Ustun, T.B., et al. (2013). Describing the Content of the Patient Reported Outcomes Measurement Information System (PROMISÒ) Using the International Classification of Functioning, Health and Disability (in review 12/2013).
Concept Analysis of the Patient Reported Outcomes Measurement Information System (PROMISÒ) and the International Classification of Functioning, Disability and Health (ICF) Carole A. Tucker • Alarcos Cieza • Anne W. Riley • Gerold Stucki • Jin Shei Lai • T. Bedirhan Ustun • Nenad Kostanjsek • William Riley David Cella • Christopher B. Forrest
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Accepted: 2 January 2014 Ó Springer Science+Business Media Dordrecht 2014
Abstract Purpose The Patient Reported Outcomes Measurement Information System (PROMISÒ) is a US National Institutes of Health initiative that has produced self-report outcome measures, using a framework of physical, mental, and social health defined by the World Health Organization in 1948 (WHO, in Preamble to the Constitution of the World Health Organization as adopted by the International Health Conference, New York, 1948). The World Health Organization’s International Classification of Functioning, Disability and Health (ICF) is a comprehensive classification system of health and health-related domains that was put forward in 2001. The purpose of this report is to compare and contrast PROMIS and ICF conceptual frameworks to support mapping of PROMIS instruments to the ICF classification system .
Methods We assessed the objectives and the classification schema of the PROMIS and ICF frameworks, followed by content analysis to determine whether PROMIS domain and sub-domain level health concepts can be linked to the ICF classification. Results Both PROMIS and ICF are relevant to all individuals, irrespective of the presence of health conditions, person characteristics, or environmental factors in which persons live. PROMIS measures are intended to assess a person’s experiences of his or her health, functional status, and well-being in multiple domains across physical, mental, and social dimensions. The ICF comprehensively describes human functioning from a biological, individual, and social perspective. The ICF supports classification of health and health-related states such as functioning, but is not a specific measure or assessment of health, per se.
C. A. Tucker (&) College of Health Professions and Social Work, Temple University, 3307 North Broad Street, Philadelphia, PA 19140, USA e-mail: [email protected]
J. S. Lai D. Cella Department of Medical Social Sciences, Northwestern University Feinberg School of Medicine, Chicago, IL, USA
A. Cieza Department of Psychology, University of Southampton, Southampton, UK A. Cieza G. Stucki ICF Research Branch of the WHO Collaborating Centre for the Family of International Classifications in Germany (DIMDI), Nottwil, Switzerland A. W. Riley Department of Population and Family Health Sciences, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA G. Stucki Swiss Paraplegic Research, Nottwil, Switzerland
T. Bedirhan Ustun N. Kostanjsek World Health Organization, CTS Team, Geneva, Switzerland W. Riley National Cancer Institute, National Institutes of Health, Bethesda, MA, USA C. B. Forrest The Children’s Hospital of Philadelphia, Philadelphia, PA, USA C. B. Forrest Department of Pediatrics, University of Pennsylvania School of Medicine, Philadelphia, PA, USA C. B. Forrest Leonard Davis Institute of Health Economics, University of Pennsylvania, Philadelphia, PA, USA
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PROMIS domains and sub-domain concepts can be meaningfully mapped to ICF concepts. Conclusions Theoretical and conceptual similarities support the use of PROMIS instruments to operationalize selfreported measurement for many body function, activity and participation ICF concepts, as well as several environmental factor concepts. Differences observed in PROMIS and ICF conceptual frameworks provide a stimulus for future research and development. Keywords Health PROMIS ICF Self-report Outcomes Functioning
Introduction Advances in the measurement of health, particularly selfreported health, have been stymied by the absence of theory to guide the creation of a comprehensive typology of health concepts that is internationally accepted across a wide variety of disciplines [2]. Health concept terminologies vary across scientific fields, disciplines, and professional groups. Thus, when person-reported outcome (PRO) measures are developed, most are not linked to any existing system, which has contributed to the challenges of PRO measurement. In recent years, the increase in multi-institutional and global clinical research trials along with the emergence of electronic health records have strengthened the imperative for standardized and interpretable shared terminology across health measurement systems. A unified health terminology and related typology or classification system would support the aggregation of results from multiple studies [2]. Integrating the many competing health frameworks can be accomplished by linking concepts in one system to concepts in another framework using common meaningful terms. Such mappings would improve understanding of the individual concepts upon which the frameworks are built as well as the respective over-arching frameworks. The most comprehensive attempt to classify health concepts is the World Health Organization’s (WHO) International Classification of Functioning, Disability and Health (ICF) [3, 4]. The ICF is a classification system (http://www.who.int/classifications/icf/en/) based on an integrative, biopsychosocial model of health, functioning, and disability [3]. The ICF has become an international standard for describing health and functioning, and a large number of health measures have been mapped to it [5, 6]. However, the largest PRO development effort in the world, the Patient Reported Outcomes Measurement Information System (PROMISÒ), has not been systematically linked to the ICF. PROMIS is an ambitious effort to provide a broad
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set of publicly available, person-reported outcomes of physical, mental, and social health [7, 8]. An individual’s development and quality of life are outcomes that reflect the dynamic interconnectedness of health, functioning, and person and environmental contextual factors [9]. Hence, quality of life, health, functioning, and development are critical concepts to classify and assess in all individuals as supported by both the ICF and PROMIS bodies of work. The purpose of this report is to compare the conceptual underpinnings of PROMIS and ICF and to determine how PROMIS assessment tools can be used to operationalize ICF concepts, and how the ICF can be used to describe PROMIS content. After contrasting the two conceptual frameworks and respective terminologies, we perform a lexical and semantic mapping of PROMIS instruments to ICF chapters and first level categories. We conclude with a discussion on areas of future growth and potential approaches to refinement of each framework generated by this harmonization.
Overview of PROMIS PROMIS (www.nihpromis.org) is an ongoing US National Institutes of Health initiative designed to create instruments that measure self-perceptions of adults and children about their experiences of health, functioning, and well-being [7, 8]. The initial focus of the network was the development of PRO instruments to assess common clinical research endpoints applicable across diseases, settings, and conditions. Although the PROMIS conceptual framework has greatly expanded since its inception in 2004, the purpose of the framework is to guide the development of distinct outcome constructs. As of 2013, PROMIS had developed dozens of unique instruments, which have been translated into multiple languages. PROMIS adopted the classic WHO tripartite definition in which health is described as consisting of physical, mental, and social health dimensions [3]. This decision was made because of the broad acceptance of this simple framework, and its relative flexibility to accommodate a wide array of self-reported health concepts. The 2013 version of the PROMIS health framework is shown in Fig. 1, and additional details can be found at http://www. nihpromis.org. PROMIS instruments are developed using a rigorous mixed-methods approach [10]. This process begins with qualitative studies to define the theoretical construct and methods and to ensure the comprehensibility and translatability of item concepts across languages and cultures. Psychometric methods, including factor and item response theory analyses, are used to develop item banks that provide precise and efficient measurement of the underlying concepts. Instruments are administered as either fixed-
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Fig. 1 Conceptual domain framework of PROMIS which can be accessed at http://www.nihpromis.org/measures/domainframework
length short forms or computer adaptive tests (CATs). For example, the PROMIS physical function item bank has over one hundred items. However, with CAT administration, only a small subset of items need to be completed (5–7 items typically) for a person’s physical functioning ability to be determined with a high degree of precision. PROMIS instruments are publically available and translated into multiple languages (www.nihassessmentcenter. org). Test users have the freedom to use the prespecified short forms, administer the items as a CAT, or derive custom instruments by choosing specific items from item banks. Regardless of method, the person’s score is placed on the same PROMIS metric. Moreover, by calibrating the items using IRT methods, PROMIS measures can be statistically linked to other measures of the same concept, placing non-PROMIS ‘‘legacy’’ measures on the PROMIS metric [11].
Overview of the International Classification of Functioning, Disability and Health (ICF) The ICF was officially endorsed in 2001 (resolution WHA 54.21) as an international standard to describe and classify health, functioning, and disability. It provides a
scientific basis for understanding and studying health and functioning, a classification system to improve communication between different users, and a systematic coding scheme for health information systems. The ICF fits within the Family of International Classification systems that include the International Classification of Disease (ICD) and the International Classification of Health Interventions (ICHI). The ICF is organized into components of body structure, body functions, activity and participation, personal and environmental contextual factors (Fig. 2) [3]. All components but the personal factors are further subclassified into categories, which are the units of the classification. The classification contains 32 first level categories. From each of these first level categories, second and third level categories are defined providing increasing level of detail. Several ‘‘core sets’’ of ICF categories have been identified as most important for describing health-related functioning associated with different health conditions, environmental factors and for varied intervention settings [12–14]. PROMIS could be used to operationalize core sets and measure related ICF concepts. The aim of the study was to compare and contrast PROMIS and ICF conceptual frameworks in order to support application of PROMIS instruments for measurement of components of the ICF classification system.
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Body Functions Component (b)
Activity and Participation Component (d)
Body Structures Component (s)
Environmental Component (e)
Personal Factors No named Component
Fig. 2 Conceptual framework of the International Classification of Functioning, Health and Disability (WHO 2002). The corresponding ICF defined components are provided and linked to the figures elements by dashed arrows
Methods Comparison of different health terminologies, classification and measurement systems can be accomplished through the analyses of the conceptual frameworks and the hierarchical arrangements of concepts, and at the individual item level (i.e., the most granular health concept) [15, 16]. Thus, to determine whether PROMIS and ICF have sufficient compatibility to justify using PROMIS measures to operationalize ICF concepts and to use ICF concepts to describe PROMIS content, we first identified and compared the intended purpose and guiding principles of each framework. Secondly, we systematically identified the meaningful concepts for PROMIS domains and analyzed both those PROMIS concepts and the ICF categories. Such an approach is essentially an equivalence mapping of concepts of the main trunk or primary branches of the frameworks. Our methods followed those from previous research that had shown for biomedical ontologies, simple lexical techniques, such as comparing preferred names of concepts and their synonyms, are effective in creating mappings [15]. Our team included scientists with extensive expertise in PROMIS and ICF. We performed concept mapping of the definitions and labels of the primary domains of PROMIS to the first- and second-level ICF codes to compare and contrast content and conceptual overlap. This process of concept mapping relies on identification of the key concepts based on the definitions, inclusions and exclusions, the placement within the framework, and the sub-concepts of the more granular levels (e.g., items, or third levels).
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Two investigators (CT, AR) independently completed the preliminary conceptual domain mapping and assignment of PROMIS domains to ICF categories and vice versa. On the rare occasion when the 2 reviewers disagreed about the preliminary assignment of PROMIS domains, consensus was achieved with input from a third reviewer (CBF). These primary conceptual domain mappings were subsequently reviewed by 9 experts who agreed with the mappings and final consensus achieved. Finally, to support the primary conceptual framework and domain mapping, we carried out a content analysis consisting of item-level mapping for all PROMIS items to ICF third-/fourth-level categories. The method used here is similar to conceptual mapping, but rather than the larger domains and related concepts being considered; each of the smallest conceptual units (e.g., items, fourth-level categories) is identified and mapped between the frameworks. Item-level mapping is accomplished by first identifying meaningful concepts based on lexical analysis and similarity of the words used within each item/subcategory that represent the simplest concepts [15]. Such incremental item-level mapping can be helpful to determine how sets of items in differently organized frameworks are grouped to represent the more general and complex health concepts. Previous reports of mapping to the ICF framework often use such a conceptual or similarity mapping at the item level as exemplified by Cieza’s work [15]. This more detailed item-level mapping process was used to support the primary conceptual framework mapping reported here and is described in detail elsewhere [17].
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Results Comparison of intended purpose and guiding principles Both PROMIS [7] and ICF [4] are intended for the entire population and applicable to all people, regardless of the presence of a health condition, personal characteristics, or environment in which they live. They are generic systems that provide standardized terminologies for describing health of individuals and populations. Even though the initial PROMIS research network consisted primarily of experts from a single country (USA), PROMIS has moved into the international health measurement arena with establishment of the International PROMIS organization in 2012. In addition, all PROMIS instruments undergo cultural harmonization and translatability review during their initial development. Experts in translation ensure that items developed in English will translate well into other languages, retaining cultural relevance, and PROMIS. Additional language translations are ongoing along with psychometric analyses of translated measures, and assessment of DIF is also completed and considers necessary standards as instruments mature. In contrast, the ICF was developed by a team of international experts and is being used worldwide. Neither PROMIS nor ICF provides an explicit definition or a comprehensive theoretical model of health. PROMIS use the differentiation of physical, mental, and social wellbeing from the 1948 WHO definition of health; ICF provides a framework for the conceptualization of health in terms of functioning. Although neither ICF nor PROMIS was developed to include disease-specific elements, both of them can be used to categorize or measure impairments, symptoms, and restrictions, as well as the impact of health conditions on life areas, such as self-care and personal relationships. For such condition-specific use, core sets derived from the most relevant ICF codes or administration of selected PROMIS instruments relevant to a given disease can be applied to provide more condition-focused measurement or categorization. The ICF provides a broad set of health and healthrelated functioning terms and concepts. PROMIS provides granularity within targeted areas of health outcomes useful for measurement in clinical research and practice applications. The ICF provides a system for organizing the components of the biological aspects of health (body structure and function), health-related functioning (activity and participation), and the non-health-related environmental aspects. PROMIS concepts more heavily focus on the subjective experience of health in terms of affective, cognitive, functioning, and well-being experiences. An important difference between these 2 frameworks is that ICF specifies and includes personal and environment
factors that influence person-level functioning in the context of everyday life. The PROMIS conceptual framework is designed to specify the content of self-reported health and does not include a model such as personal or environmental factors. The ICF clearly articulates the need to incorporate assessment of environmental contexts in understanding actual functioning. PROMIS does not include explicit assessment of the environment, as environmental assessment is not a health outcome. However, the impact of several ICF environmental categories (e.g., instrumental aids, social supports) can be assessed by some PROMIS item banks. For example, the PROMIS informational support item bank is conceptually consistent with the ICF environmental factor chapter E3—support and relationships. Though both PROMIS and ICF recognize the importance of person factors, neither provides a hierarchical framework or definitions concerning person contextual concepts. PROMIS primary domains of mapped to ICF We mapped the PROMIS instruments’ domain-level concepts to the ICF chapters and second-level categories (Table 1). The table describes whether one or more PROMIS tools provide good assessment of the ICF concept (Full), some coverage of the ICF concept but not completely (Partial), or do not assess the ICF concept (None). As a system of self-reported health, PROMIS does not include measures that correspond to any category in the ICF body structures (S categories). PROMIS does include many sub-domain concepts that overlap with the ICF body function (B categories) component. In particular, PROMIS provides a rich set of measures for ICF mental functions (b1), sensory functions and pain (b2), cardiovascular and respiratory functions (b4), reproductive functions (b6), and neuromusculoskeletal and movement-related functions (b7). While ICF refers to these as body functions, impairments in these ICF body function categories are often symptoms, a term used within the PROMIS framework. The PROMIS framework contains physical symptom subdomains (pain, fatigue) and physical functions (physical functioning and sexual functioning). PROMIS provides a high level of granularity in definition and measurement of certain mood and emotion outcomes, which are not well represented by ICF specific categories. For example, ICF emotional functions (b152) category includes codes for the appropriateness of emotion (b1520), regulation of emotion (b1521), and range of emotion (b1522). PROMIS anxiety, anger, depression concepts and corresponding instruments all map to a single ICF concept—range of emotion (b1522)—and PROMIS has minimal coverage of the 2 subconcepts of appropriateness and regulation.
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Qual Life Res Table 1 Assignment of PROMIS item banks to ICF concepts ICF component
Body functions (B)
Body structures (S) Activity and participation (D)
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ICF chapter
ICF chapter concepts
B1
PROMIS coverage of specific ICF concepts (2012) Full
Partial
Comments
Mental functions
Addressed by multiple PROMIS mental health concepts of affect, behaviors, and cognition
Orientation (b114) and perceptual (b156) mental functions
B2
Sensory functions and pain
Pain—with PROMIS pain intensity and interference banks
Seeing and hearing
B3
Voice and speech functions
None
B4
Functions of the cardiovascular, hematological, immunological, and respiratory functions
ICF exercise tolerance concept is addressed by PROMIS physical function and fatigue concepts
B5
Functions of the digestive, metabolic, and endocrine systems
None
B6
Genitourinary and reproductive functions
Sexual function ICF concepts well addressed by PROMIS sexual function concepts
B7
Neuromusculoskeletal and movement-related functions
ICF muscle power functions within PROMIS physical function
B8
Functions of the skin and related structures
None
S1–S8
Body structures
None
D1
Learning and applying knowledge
These are fairly generic defined concepts in the ICF and are minimally addressed by PROMIS at the generic concept level
D2
General tasks and demands
D3
Communication
Minimal specific coverage by a single item bank
D4
Mobility
Well covered primarily by PROMIS physical function concepts
Transferring (d420), using transportation (d470), and driving (d475)
D5
Self-care
Well covered primarily by PROMIS physical function concepts
Toileting (d530), eating (d550), and drinking(d560) concepts
D6
Domestic life
Well covered primarily by PROMIS physical function and social roles concepts
D7
Interpersonal interactions and relationships
Well covered within the social health relationship concept
Formal and relating to strangers
D8
Major life areas
Education, work, and employment by PROMIS physical function and social role concepts
Other sub-concepts minimally or not addressed
D9
Community, social, and civic life
Primarily concepts of community life and recreation and leisure by PROMIS physical function and social role concepts
Other sub-concepts minimally or not addressed
No coverage for vestibular, taste, smell, touch, proprioception
Other ICF subconcepts minimally or not addressed
Urinary functions are not addressed Other ICF sub-concepts minimally or not addressed
Qual Life Res Table 1 continued ICF component
Environmental factors (E)
Personal factors
ICF chapter
ICF chapter concepts
E1
PROMIS coverage of specific ICF concepts (2012) Full
Partial
Products and technology
Distributed within concepts of transportation, sexual function, and communication
Other sub-concepts minimally or not addressed
E2
Natural environment and human-made changes to environment
None
E3
Support and relationships
Primarily related to e340 (personal care providers and personal assistants)
E4 E5
Attitudes Services, systems, and policies
None None
No additional sub-domains specified in the ICF
Comments
Other sub-concepts minimally or not addressed
PROMIS measures health outcomes, does not include measures of personal factors
PROMIS provides physical functioning item banks that can yield a general physical functioning score as well as sub-domain scores for upper extremity functioning and mobility. Though PROMIS does not have a specific selfcare instrument, many ICF self-care concepts are used to measure physical functioning, particularly within the upper extremity sub-domain. Many PROMIS items contain more than one concept; for example, an item includes assessment of the impact of one concept (e.g., fatigue, pain, depression) on other concepts (e.g., self-care and mobility). This is not the case in the ICF, since the ICF categories as part of a classification system are intended to be unambiguous, mutually exclusive and reflect individual constructs, independent from each other. Overall, PROMIS supports measurement of the majority of major concepts (chapters) in the ICF activity and participation component, though there are a few constructs not addressed deeply by PROMIS (Table 1). For example, the ICF concept for communication (D3) is not specifically or fully addressed by a PROMIS item bank; however, there are PROMIS item level concepts that address communication skills. In addition, concepts that are better assessed through clinical examination, laboratory assay, or imaging (e.g., body structures and some body functions) than through person-reported outcomes are not represented in PROMIS item banks. Given the focus of PROMIS on measurement of person health outcomes, there is minimal explication or item concepts that could be used to measure many ICF environmental factor concepts. ICF primary concepts mapped to PROMIS Several insights emerge from the mapping of ICF concepts to PROMIS instruments (Table 2). PROMIS sub-domains
are characterized by well-defined, clinically homogenous, and unidimensional constructs that are empirically supported by expert consensus, patient input, and psychometric analyses. Within each of the PROMIS item bank instruments, the related ICF concept maps effectively onto the PROMIS concepts of the amount or intensity of the underlying construct. The additional items within that PROMIS bank may assess the impact of the concept on experiences or behaviors in other related life areas, even though empirically all items factor into one dimension. For example, fatigue in PROMIS includes items that capture the intensity of fatigue as well as items that assess the impact of fatigue on daily functioning concepts such as self-care, mobility, and domestic life. In the corresponding ICF category for fatigue (b1300), the intensity or frequency of fatigue are the relevant concepts. Another health attribute for which PROMIS provides different specificity than the corresponding ICF category is pain. In the ICF, pain is included within the ‘‘b-level’’ or body function category with sub-domains explicated by pain location or body regions. PROMIS provides additional insight into pain with sub-concepts of quality, magnitude, related behaviors, as well as impact of pain on one’s functioning. In the ICF, specific mental functions including emotions are primarily classified at the body function level [Chapter 1] within single codes covering a variety of emotions as discussed above for emotional functions (b152). Similarly, ‘‘handling stress and other psychological demands,’’ including affect and behaviors, is also classified with a single ICF code (d240) in the Activity and Participation. PROMIS provides more granularity in measurement of these single ICF codes and has item banks for specific negative emotions, positive emotions, behaviors, and
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Qual Life Res Table 2 PROMIS item banks aligned with corresponding ICF concepts PROMIS item banks
Related ICF concepts
Comments
Physical health—functioning and symptoms Physical function
Physical function—mobility aids
Sexual function and satisfaction
Mobility (D4)
The PROMIS physical function banks provide comprehensive measure of functioning related to mobility
Self-care (D5)
PROMIS include concepts found in acquisition of goods and services (d610), household tasks (d630– d640), and caring for household objects (d650– d660)
Domestic life (D6) Major life areas (D8)
PROMIS include general physical function associated with work and employment (d840– d850)
Community, social, and civic life (D9)
PROMIS covers concepts primarily in recreation and leisure (d920)
Sexual functions (b640)
The PROMIS sexual function item banks provide comprehensive and granular measures of the corresponding ICF concepts
Sensations associated with genital and reproductive functions (b670) Sleep disturbance
Sleep functions (b134)
PROMIS bank provides comprehensive and granular measure of ICF-related sleep functions
Sleep-related impairment
Energy and drive functions (b130)
The PROMIS sleep-related impairment bank includes item related to energy functions as well as impact on a range of ICF concepts such as mobility, self-care, and mental functions
Fatigue
Energy and drive functions (b130)
PROMIS bank provides comprehensive measure of fatigue in terms of intensity and quality of the fatigue experience, as well as behaviors and impact on functioning of fatigue
Pain intensity
Sensation of pain (b280)
The operationalization of pain is different between the 2 frameworks. ICF pain domains relate most directly to location of pain. PROMIS pain domains provide a more comprehensive characterization of intensity, behaviors, and impact on functioning with greater specificity and granularity than explicated in the ICF While these item concepts relate to ICF b280 sensation of pain, the PROMIS pain concept is broader and provides measurement of the common behaviors observed or performed by individuals in pain. Such reactions are probably related to intensity as well as the individual’s tolerance and coping
Pain behavior
Sensation of pain (b280) Communicating–producing (d330–349)
Pain interference
Sensation of pain (b280) Mental functions (b1) Mobility (D4) Self-care (D5) Domestic life (D6) Community, civic, and social life (D9)
Pain quality
Sensation of pain (b280)
Pain intensity
Sensation of pain (b280)
GI symptoms
Functions related to the digestive system (b510–b539)
PROMIS mental health—affect, behaviors, and cognition
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There is no single ICF code that maps directly to this PROMIS bank, rather the secondary meaningful concepts correspond to specific functions such as walking, occupation. While these item concepts relate to ICF b280 sensation of pain, the PROMIS pain concept is broader and provides measurement of the impact of the individual’s pain on healthrelated functioning PROMIS uses a 10-point rating scale of pain intensity
Qual Life Res Table 2 continued PROMIS item banks
Related ICF concepts
Comments
Emotional distress—anxiety
Emotional functions (b152)
Emotional distress—depression
Emotional functions (b152)
Emotional distress—anger Psychosocial illness impact (positive and negative)
Emotional functions (b152) Temperament and personality functions (b126)
PROMIS provides quite granular measures of several distinct emotions that the ICF categorized under the b152 code
Cognitive function
Global mental functions (b110–139) Specific mental functions (b140–189)
Alcohol use—problem drinking
Energy and drive functions (b130) Emotional functions (b152)
Alcohol use—consequences (positive and negative) Alcohol use—expectancies (positive and negative)
Energy and drive functions (b130) Emotional functions (b152) Energy and drive functions (b130) Emotional functions (b152)
PROMIS provides measures of several temperament concepts, related to positive and negative affect, that are less granular in the ICF b126 code The cognitive function bank may cover many of these ICF concepts quite comprehensively Substance abuse corresponds to a very specific ICF code b1303 (craving) as a primary code, however, PROMIS banks explore experiential, behavioral, and impact of the substance use across physical, social, and mental health areas. The PROMIS alcohol-use banks provide granular and comprehensive measurement of one specific type of substance use/abuse—alcohol. These banks could provide a basis for development of similar measures of other substance use/abuse concepts
PROMIS social health—relationships and function Ability to participate in roles and activities Satisfaction with roles and activities
Self-care (D5) Domestic life (D6) Interpersonal interactions and relationships (D7) Major life areas (D8) Community, social and civic life (D9)
The PROMIS bank provides a breadth of coverage consistent with several participation related ICF chapter concepts This PROMIS item bank maps to these ICF-related concepts based on the included role or activity, however, ‘‘satisfaction with’’ as reflected in the PROMIS banks is not a concept included within these specific ICF concepts
Companionship
Interpersonal interactions and relationships (D7)
Conceptually quite similar, though PROMIS does not include the concept of interactions with strangers specifically
Emotional support
Support and relationships (E3)
These three PROMIS item banks all map to ICF E3 and provide a breath of conceptual coverage
Instrumental support
Support and relationships (E3)
Informational support
Support and relationships (E3)
Attitudes (E4)
cognition, thereby providing a highly granular system for describing the psychological experiences of health.
Discussion PROMIS provides a measurement system that can be used to describe and assess many aspects of the ICF, and the ICF can serve as a typology for classifying the content of PROMIS. This is the primary conclusion of our analysis of the two health frameworks. Additionally, our analyses identified important differences between PROMIS and ICF. PROMIS was broadly envisioned as a means to standardize and advance patient-reported outcomes (PROs), and in the areas targeted by PROMIS, provide significant opportunities for measurement of related ICF concepts. The ICF was developed to meet the need for a common, international
means of describing human functioning, disability, and health by means of health, health-related, and non-healthrelated domains that make possible the comprehensive description of functioning and disability. Nonetheless, both systems are intended to be used in all individuals and populations, regardless of health condition, personal characteristics, or environment in which persons live. PROMIS is a measurement system that will continue to evolve and expand over time, as does the ICF classification system through updates and revisions to the ICF platform. Our work linking PROMIS to the ICF has identified several domains that may be useful to consider for further development (e.g., communication concepts) of PROMIS domains. Similarly, PROMIS has empirically demonstrate that some concepts represented by a single ICF code may be more multi-dimensional than represented by a single code, and be better characterized by definition of additional
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ICF categories or levels. The PROMIS framework to date has been shaped, in part, by health domains that have been or are being developed to assess specific latent traits of self-perceived health outcomes. At present, the ICF guides clinicians in describing functioning and disability at multiple levels across all body systems and body functions, limitations in activities, and restrictions in participation within the necessary environmental contexts. As both PROMIS and ICF continue to mature, such differences may promote additional synergy between the 2 efforts. Both PROMIS and ICF have advanced the measurement and understanding of health and functioning. There is sufficient comparability of the ICF and PROMIS frameworks to justify the use of PROMIS as a measurement system for several of the ICF concepts, and for PROMIS to consider the value of ICF to contribute to broadening its conceptual framework. Similarly, ICF can potentially turn to efforts like PROMIS to provide empirical support of its framework. Detailed mapping between PROMIS instruments at the item level with ICF second- and third-level categories can further help clarify the measurement opportunities [17]. Ultimately, such complementary efforts will lead to improved systems for comprehensive health outcome measures.
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