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Rheumatoid arthritis (RA) is a chronic disabling disease (1) that often is associated with the inability to conduct occupations, such as paid work and other daily activities. Ultimately, patients' daily activities may become limited and their societal participation restricted (2–9). People with RA experience a decrease in overall functional ability and quality of life (2) and a greater loss of their life activities than people without RA (7).
Assessing, exploring, and understanding the patients' daily functioning are essential when treating people with RA. Health professionals who specialize on rehabilitation focus on the daily functioning of the patient (10). Current recommendations regarding assessment of disease and disease consequences include recommendations to measure function, mainly referring to physical function (11). To map and assess daily functioning and disability from a holistic biopsychosocial perspective in rehabilitation, the framework of the World Health Organization International Classification of Functioning, Disability and Health (ICF) can be used. The overall aim of the ICF classification is to provide a unified and standard language for the description of health and health-related conditions in rehabilitation and a common framework for all health professions (12–14).
The ICF has 2 parts, each containing separate components. Part 1 covers functioning and disability and includes the components body functions (b) and structures (s) and activities and participation (d). Part 2 covers contextual factors and includes the components environmental factors (e) and personal factors (Figure 1). Each component consists of several chapters and within each chapter, categories, which are the units of the classification (14). Chapters represent health domains that are used to organize the classification. An example is Chapter 5: self-care within the component activities and participation.
Figure 1. The model of the International Classification of Functioning, Disability and Health (ICF). The model shows the relationship between the ICF components body functions (b) and structures (s) and activities and participation (d) and the contextual factors environmental factors (e) and personal factors. Each component consists of chapters that then consist of categories. Within the component activities and participation, Chapter 5: self-care includes the categories “d510 washing oneself” (second-level) and “d5100 washing body parts” (third level) among many others.
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To facilitate the application of the ICF in clinical practice, specific Comprehensive ICF Core Sets (abbreviated in this article as ICF Core Sets) for certain health conditions have been developed. ICF Core Sets are short lists of ICF categories that are important for patients with a specific disease. The ICF Core Set for RA is a short list of ICF categories that are important for patients with RA and is meant to include all relevant ICF categories by representing the typical spectrum in functioning of patients with RA (15).
The ICF RA Core Set was developed by rheumatology health professionals in a formal decision-making and consensus process. In this process, evidence was integrated from preliminary studies. These preliminary studies included a delphi exercise involving health professionals as experts, a systematic literature review, and an empiric data collection that was done quantitatively with a checklist (15). The consensus process revealed a current, preliminary version of the ICF RA Core Set. The current, preliminary version of the ICF RA Core Set now needs to be validated and further developed.
One aspect in this validation process is to explore the patient perspective. To explore the perspective of patients, a qualitative research approach was considered most appropriate. When measuring and assessing daily functioning in people with RA from a holistic biopsychosocial perspective in rehabilitation, it is important to include the patient perspective because personal values for outcomes vary between and within patients and professionals (16, 17). Qualitative methodology provides the possibility of exploring the perspective of those who experience the disease (the patient perspective) (16, 18, 19).
ICF Core Sets have been developed for other chronic diseases apart from RA, and preliminary versions have been established. The next step is validation. The ICF RA Core Set is the first to undergo validation. Therefore, the present study is also considered a methodologic pilot study for the validation and development of ICF Core Sets for other diseases and health conditions.
The objective of this study therefore was to validate the current, preliminary version of the ICF RA Core Set from the patient perspective using a qualitative approach. The specific aims were to 1) explore the aspects of functioning and health that are important to patients with RA, 2) examine how these aspects are represented by the current version of the ICF RA Core Set, 3) possibly identify aspects of functioning important for people with RA that are not included in the ICF RA Core Set, and 4) explore the qualitative methodology in this pilot study for further validation and development of ICF Core Sets for other diseases.
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In this qualitative study, the validity of the ICF RA Core Set was supported by the perspective of the individual patients. We could demonstrate that a large number of the categories included in the ICF RA Core Set address issues considered important to patients. However, some additional issues were raised in this study that are not covered in the current version of the ICF RA Core Set. An example is fatigue. Fatigue came up in our interviews and was linked to the “b130 energy and drive functions” as well as to the third-level category “b4552 fatiguability” because the patients' description of fatigue was related to the definitions of both ICF categories. Category “b130 energy and drive functions” is included in the ICF RA Core Set, but “b4552 fatiguability” is not included. Fatigue was identified at Outcome Measures in Rheumatology Clinical Trials VI as an area of particular importance to patients with RA (18). In a qualitative study on rheumatology outcomes important to patients with RA, the patients identified fatigue, pain, disability, and a general feeling of wellness as their major concerns (27). Thus, from the results obtained, we would suggest that the third-level category “b4552 fatiguability” should be included in the ICF RA Core Set to fully cover the concept of fatigue as experienced by the patients.
The categories “d8700 personal economic resources” and “e1650 financial assets” emerged from the interviews and are not included in the current version of the ICF RA Core Set. Economic consequences in relation to the loss of paid work due to physical disability were also found to be important issues to patients with RA in the literature (3–6).
Some additional categories were interpreted to be related to side effects. The patients explicitly assigned some categories from the ICF component body functions to side effects of medication, such as “b1400 sustaining attention,” “b5106 regurgitation and vomiting,” and “b5252 frequency of defecation.” This information provided by the patients was documented without further valuation. Some of these causal relationships can also be found in the literature. Among the additional categories that emerged from the interviews, “b1263 psychic stability,” “b1400 sustaining attention,” “b820 repair functions of the skin,” and “b840 sensations related to the skin” could be related to side effects of steroids (28); “b5252 frequency of defecation” could be related to gastrointestinal side effects due to nonsteroidal antiinflammatory drugs (29) and disease-modifying antirheumatic drugs (30). This information was attributed by the researchers according to the existing literature. Side effects were only found in the ICF component body functions.
The degree of agreement between health professionals was found to be moderate according to the Kappa coefficient. However, the lower limits of confidence intervals exceed 0.5. Additionally, the calculation of agreement did not only involve the linking of concepts to the ICF, but the whole process of the qualitative analysis that was done by 2 researchers for 15% of the transcribed data. This includes the division of the transcribed interview data into meaning units, the identification of the concepts, and the linking to the ICF, which was all done independently by the 2 researchers. From the qualitative research perspective, the limitation of calculating the Kappa coefficient might still be that it is a quantitative measure.
We conducted interviews to validate the ICF RA Core Set from the patient perspective. In our study, interviews were chosen to explore the life context of the patients. Frequently, the patients reported specific problems from their own life context by giving specific examples. These specific examples may represent their individual perspective, compared with a more general perspective of the experts. For example, for the second-level category “d445 hand and arm use,” the following 4 specifications were documented: opening a milk package, using a coffee machine, using one's hand while sailing, and using hand and arm to lean on something. The specifications were not presented in this study, but an additional analysis would be highly valuable. Patients thus may find their individual problems not always acknowledged, but nevertheless a more general category or component might be covered. On the other hand, experts might have in mind the typical or general patient, whereas patients focus on their own individual problems in everyday life.
Most difficult to understand for the patients were the technical terms in the ICF component environmental factors, for example Chapter 1: products and technology. This could be a limitation of interview type 2 in which patients were presented the titles and terms of the ICF chapters instead of the open questions in interview type 1. Problems with the ICF terms thus only turned up in type-2 interviews. However, 26 ICF categories emerged in the type-2 interviews, compared with 15 in the type-1 interviews. It might have been important to present the ICF chapters to the patients—as it was done in the type-2 interviews—to facilitate that the patients would talk about their problems in daily life. However, saturation was reached after 8 interviews in the type-2 interviews, compared with 13 in the type-1 interviews. However, a limitation of the type-2 interviews might have been that the questions related closely to the ICF terms. In contrast, the open-ended questions in type-1 interviews facilitated that the patients focused on their life experiences and revealed concepts not covered by the ICF.
However, some patients were able to clearly follow the ICF terminology of all chapters during the type-2 interviews. These patients related problems in their daily life to either problems in body functions and structures, activities and participation, or environmental factors. They were able to identify causes and effects according to the ICF model that they were presented prior to the interview. Patient N identified problems with her teeth and related that to a change in the body structure teeth (“s3200 teeth”) with a temporal relation to RA, as well as to her decreased ability to care for the teeth because brushing her teeth caused pain in her hands (“d5201 caring for teeth”). Further in the interview, she reported another cause for her teeth problems: frequent vomiting and nausea, which were side effects from the drugs she had to take (“b1506 regurgitation and vomiting”), increased during brushing of her teeth; therefore, she had to terminate teeth brushing.
Among the personal factors, “lying as a strategy to deal with RA” emerged from one interview. The patient had to lie that she did not have a chronic disease to reach her personal goals. She wanted to become and work as a nurse. She had to lie to the nursing school she applied to and later had to lie to her employer to get a job as a nurse. This person also indicated that the employer's policy was an important issue to be considered. In her employer's organization it was not possible for her to ask other employees or her boss for help when she, for example, had to handle and carry heavy objects or when she had to walk long distances. Thus, the organizational policy of her employer is a barrier for her in her work environment.
Our study followed a qualitative methodology. Problems of all participants were treated as equally important without implying a quantitative perspective, such as frequencies or increasing importance if an issue was mentioned more often. In qualitative research, sample sizes typically remain small because intensive data analysis is required. However, this aspect allowed us to include and explore individual perspectives of patients in the validation of the ICF RA Core Set. Further research from an epidemiologic perspective is suggested with the aim to test out the frequency and importance of the issues that were identified as problematic and relevant areas to patients with RA in our qualitative study. A limitation of our study is that the sample included only patients from Austria, although patients were from different sex and age groups and professional backgrounds. Additional studies with patients from other cultures are suggested that could use the same methodology as the present study.
From a methodologic perspective, this study may serve as a model for further validation studies and ongoing development of other ICF Core Sets in other countries and in other diseases.
In this qualitative study, the validity of the ICF RA Core Set was supported by the perspective of individual patients. However, some additional issues raised in this study but not covered in the current ICF RA Core Set need to be investigated.