[Navicular bone fractures in horses: Prognosis after conservative and surgical treatment]. / Strahlbein-Frakturen beim Pferd: Prognose nach konservativer und chirurgischer Therapie.

INTRODUCTION: The aim of this retrospective study is to describe and compare conservative and surgical treatment of navicular fractures in horses. An attempt is made to identify critical points that can favorably influence the prognosis of this orthopedic disease. All horses treated for a navicular fracture at the Equine Clinic, Vetsuisse Faculty, University of Zurich between 2005 and 2017 were included in this study. The severity of lameness at initial examination, radiographic assessment, hoof conformation, treatment (conservative or surgical), complications and outcome were determined from the medical records. Conservative and surgical treatment consisted of stable rest, a controlled exercise program and therapeutic orthopedic shoeing. During surgical treatment, fracture reduction was also carried out with a cortical screw. Computer assisted surgery were used in five horses and computer tomography in three horses. Follow-up examinations included clinical and radiographic examinations. The outcome was divided into three categories: 1 = very good; 2 = good; 3 = poor. Twelve horses met the inclusion criteria; Four horses were treated conservatively and eight were treated surgically. After conservative treatment, two horses (50 %) had a very good outcome and two (50 %) had a good outcome. After surgical treatment, four horses (50 %) had a very good outcome and four (50 %) had a poor outcome. Overall, 67 % of horses had a very good or good outcome, although radiographic signs of bone healing was not present in any of these cases. Various complications were identified, such as the fracture of a screw, the fragmentation of the small navicular bone fragment, the development of osteoarthrosis in the coffin joint and progressive podotrochosis. This study shows that the prognosis of navicular fractures is generally cautious and that degenerative changes to the navicular apparatus worsen the prognosis. In the present study, surgical treatment did not improve the prognosis of navicular fractures despite the intrasurgical use of three-dimensional imaging. However, technical advances could reduce the complication rate in the future.

INTRODUCTION: Le but de cette étude rétrospective était de décrire et de comparer le traitement conservateur et chirurgical des fractures de l'os naviculaires chez le cheval. Une tentative est faite pour identifier les points critiques qui peuvent influencer favorablement le pronostic de cette maladie orthopédique. Tous les chevaux traités pour une fracture de l'os naviculaire à la Clinique équine de la Faculté Vetsuisse de l'Université de Zurich entre 2005 et 2017 ont été inclus dans cette étude. La gravité de la boiterie lors de l'examen initial, l'évaluation radiographique, la conformation du sabot, le traitement (conservateur ou chirurgical), les complications et le résultat ont été déterminés à partir des dossiers médicaux. Le traitement conservateur et chirurgical consistait en un repos au box, un programme d'exercice contrôlé et un ferrage orthopédique thérapeutique. Au cours du traitement chirurgical, une réduction de la fracture a également été effectuée à l'aide d'une vis corticale. La chirurgie assistée par ordinateur a été utilisée sur cinq chevaux et la tomographie assistée par ordinateur sur trois chevaux. Les examens de suivi comprenaient des examens cliniques et radiographiques. Les résultats ont été divisés en trois catégories: 1 = très bon; 2 = bon; 3 = mauvais. Douze chevaux répondaient aux critères d'inclusion ; quatre chevaux ont été traités de manière conservatrice et huit ont été traités chirurgicalement. Après un traitement conservateur, deux chevaux (50 %) ont eu un très bon résultat et deux (50 %) un bon résultat. Après le traitement chirurgical, quatre chevaux (50 %) ont eu un très bon résultat et quatre (50 %) un mauvais résultat. Dans l'ensemble, 67 % des chevaux ont eu un très bon ou un bon résultat, bien que les signes radiographiques de guérison osseuse n'aient été présents dans aucun de ces cas. Diverses complications ont été identifiées, telles que la fracture d'une vis, la fragmentation du petit fragment de l'os naviculaire, le développement d'une arthrose dans l'articulation interphalangienne distale et une podotrochlose progressive. Cette étude montre que le pronostic des fractures de l'os naviculaire est généralement réservé et que les modifications dégénératives de l'appareil naviculaire aggravent le pronostic. Dans la présente étude, le traitement chirurgical n'a pas amélioré le pronostic des fractures du naviculaire malgré l'utilisation intra-chirurgicale de l'imagerie tridimensionnelle. Cependant, les progrès techniques pourraient réduire le taux de complications dans le futur.

Towards a Common Understanding of the Health Sciences.

OBJECTIVE: The aim of health sciences is to maintain and improve the health of individuals and populations and to limit disability. Health research has expanded astoundingly over the last century and a variety of scientific disciplines rooted in very different scientific and intellectual traditions has contributed to these goals. To allow health scientists to fully contextualize their work and engage in interdisciplinary research, a common understanding of the health sciences is needed. The aim of this paper is to respond to the call of the 1986 Ottawa Charter to improve health care by looking both within and beyond health and health care, and to use the opportunity offered by WHO's International Classification of Functioning, Disability and Health (ICF) for a universal operationalization of health, in order to develop a common understanding and conceptualization of the field of health sciences that account for its richness and vitality. METHODS: A critical analysis of health sciences based on WHO's ICF, on WHO's definition of health systems and on the content and methodological approaches promoted by the biological, clinical and socio-humanistic traditions engaged in health research. RESULTS: The field of health sciences is presented according to: 1) a specification of the content of the field in terms of people's health needs and the societal response to them, 2) a meta-level framework to exhaustively represent the range of mutually recognizable scientific disciplines engaged in health research and 3) a heuristic framework for the specification of a set of shared methodological approaches relevant across the range of these disciplines. CONCLUSION: This conceptualization of health sciences is offered to contextualize the work of health researchers, thereby fostering interdisciplinarity.

A guide on how to develop an International Classification of Functioning, Disability and Health Core Set.

International Classification of Functioning, Disability and Health (ICF) Core Sets are purpose-tailored shortlists of ICF categories from the whole ICF classification for describing functioning and disability. Although the 34 ICF Core Sets developed up to now already cover many health conditions, there may still be a need to develop additional ICF Core Sets that tackle other health conditions and address other purposes. This paper provides a detailed description of the standard process for developing ICF Core Sets that will serve as a guide for future ICF Core Set development projects. ICF Core Sets are developed by means of a three-phase, multi-method scientific process. The process involves four preparatory studies - an empirical multicentre study, a systematic literature review, a qualitative study and an expert survey. The results of the preparatory studies serve as the starting point for a structured decision-making and consensus process at an international conference, during which participating experts decide on the ICF categories to be included in the Comprehensive and Brief ICF Core Sets. The first version of the ICF Core Set may necessitate modifications for specific applications and implementation in specific settings.

Development of a health index in patients with ankylosing spondylitis (ASAS HI): final result of a global initiative based on the ICF guided by ASAS.

OBJECTIVES: The burden of disease in patients with ankylosing spondylitis (AS) can be considerable. However, no agreement has been reached among expert members of Assessment of SpondyloArthritis International Society (ASAS) to define severity of AS. Based on the International Classification of Functioning, Disability and Health (ICF), a core set of items for AS has been selected to represent the entire spectrum of possible problems in functioning. Based on this, the objective of this study was to develop a tool to quantify health in AS, the ASAS Health Index. METHODS: First, based on a literature search, experts' and patients' opinion, a large item pool covering the categories of the ICF core set was generated. In several steps this item pool was reduced based on reliability, Rasch analysis and consensus building after two cross-sectional surveys to come up with the best fitting items representing most categories of the ICF core set for AS. RESULTS: After the first survey with 1754 patients, the item pool of 251 items was reduced to 82. After selection by an expert committee, 50 items remained which were tested in a second cross-sectional survey. The results were used to reduce the number of items to a final set of 17 items. This selection showed the best reliability and fit to the Rasch model, no residual correlation, and absence of consistent differential item function and a Person Separation Index of 0.82. CONCLUSIONS: In this long sequential study, 17 items which cover most of the ICF core set were identified that showed the best representation of the health status of patients with AS. The ASAS Health Index is a linear composite measure which differs from other measures in the public domain.

Explanatory power does not equal clinical importance: study of the use of the Brief ICF Core Sets for Spinal Cord Injury with a purely statistical approach.

STUDY DESIGN: Psychometric study analyzing the data of a cross-sectional, multicentric study with 1048 persons with spinal cord injury (SCI). OBJECTIVE: To shed light on how to apply the Brief Core Sets for SCI of the International Classification of Functioning, Disability and Health (ICF) by determining whether the ICF categories contained in the Core Sets capture differences in overall health. METHODS: Lasso regression was applied using overall health, rated by the patients and health professionals, as dependent variables and the ICF categories of the Comprehensive ICF Core Sets for SCI as independent variables. RESULTS: The ICF categories that best capture differences in overall health refer to areas of life such as self-care, relationships, economic self-sufficiency and community life. Only about 25% of the ICF categories of the Brief ICF Core Sets for the early post-acute and for long-term contexts were selected in the Lasso regression and differentiate, therefore, among levels of overall health. CONCLUSION: ICF categories such as d570 Looking after one's health, d870 Economic self-sufficiency, d620 Acquisition of goods and services and d910 Community life, which capture changes in overall health in patients with SCI, should be considered in addition to those of the Brief ICF Core Sets in clinical and epidemiological studies in persons with SCI.

Latent Class Factor Analysis of the Functional Independence Measure confirmed four distinct dimensions in patients undergoing neurological rehabilitation.

AIM: The FIM instrument is broadly applied in varying rehabilitation services for outcome assessment. Thus, it is important to examine its applicability for services which may differ from the situations and patients for which it was originally developed. The aims of the present study were to examine 1) whether the four FIM dimensions "activities of daily living", "sphincter management", "mobility", and "executive function" can be retrieved by Latent Class Factor Analysis (LCFA); and 2) whether the four dimensions show floor effects in patients with acquired brain injuries undergoing intensive post-acute rehabilitation. METHODS: We analyzed the FIM data of 269 patients with acquired brain injuries undergoing intensive post-acute rehabilitation. To examine the dimensional structure of the FIM instrument we carried out LCFA. Cronbach's alpha was used to measure the internal consistency. We examined the distribution of the dimension scores to identify floor effects. RESULTS: LCFA confirmed the postulated four dimensions. The explained variance of items assigned to the four dimensions ranged from 46% to 89%. Cronbach's alpha coefficients of the four subscales ranged from 0.94 to 0.96. The percentage of patients scoring the minimum possible score in each of the retrieved dimensions ranged from 22.3% to 47.9%. CONCLUSION: When applying the FIM instrument to patients undergoing intensive neurological rehabilitation its dimensionality should be kept in mind. For some patients this outcome measure might not be discriminative enough due to floor effects.

The comprehensive ICF core sets for spinal cord injury from the perspective of occupational therapists: a worldwide validation study using the Delphi technique.

OBJECTIVE: To validate the International Classification of Functioning, Disability and Health (ICF) core sets for individuals with spinal cord injury (SCI) in the early post-acute and long-term context from the perspective of occupational therapists (OTs). SETTING: International. METHODS: OTs experienced in the treatment in SCI were asked about problems, resources and aspects of the environment treated by them, in a three-round electronic mail survey using the Delphi technique. Responses were linked to the ICF by two researchers; kappa coefficient was calculated as statistical measure of agreement. RESULTS: In total, 67 experts from 27 countries named 2586 different concepts. For the early post-acute context, 223 concepts were linked to ICF categories. Three ICF categories from the component body function, three ICF categories from the component body structures and five ICF categories from the component activities and participation were not represented in the ICF core set for the early post-acute context with an expert agreement of more than 75%. For the long-term context, 205 concepts were linked to ICF categories. Two ICF categories from the component body function, four ICF categories from the component body structures and two ICF categories from the component activities and participation were not represented in the ICF core set with an expert agreement of more than 75%. CONCLUSION: OTs addressed a vast variety of problems that they take care of in their interventions in persons with SCI. The Comprehensive ICF core sets covered a high percentage of these problems. Further research is necessary on a few aspects that are not included in the ICF core sets for SCI.

The comprehensive ICF core sets for spinal cord injury from the perspective of physical therapists: a worldwide validation study using the Delphi technique.

OBJECTIVE: To validate the International Classification of Functioning, Disability and Health (ICF) Core Set for individuals with spinal cord injury (SCI) in the early post-acute and long-term context from the perspective of physical therapists. SETTING: International. METHODS: Physical therapists experienced in the treatment of SCI were asked about problems, resources and aspects of the environment treated by them, in a three-round electronic mail survey using the Delphi technique. Responses were linked to the ICF by two researches; κ-coefficient was calculated as statistical measure of agreement. RESULTS: In all, 81 experts from 27 countries named 3694 concepts. They were linked to 187 ICF categories for the early post-acute context. Three ICF categories from the component body function, five ICF categories from the component body structures and two ICF categories from the component activities and participation were not represented in the ICF Core Set for the early post-acute context. In all, 207 ICF categories were linked for the long-term context. Four ICF categories from the component body function, five ICF categories from the component body structures and two ICF categories from the component activities and participation were not represented in the ICF Core Set for the long-term context. CONCLUSION: Physical therapists addressed a vast variety of problems that they take care of in their interventions in patients with SCI. The Comprehensive ICF Core Sets covered a high percentage of these problems. Further research is necessary on several responses not covered in the ICF.

Cost-effectiveness of cognitive-behavioral group therapy for dysfunctional fear of progression in cancer patients.

Anxiety and fear are often associated with chronic conditions such as cancer. This paper targets the cost-effectiveness analysis of a cognitive-behavioral group therapy (CBT) in comparison to a client-centered, supportive-experiential group therapy (SET) in cancer patients with dysfunctional fear of progression. An incremental cost-effectiveness analysis was performed using data from a randomized controlled trial among cancer patients receiving inpatient rehabilitation. The means, 95% confidence intervals [95% CI], incremental cost-effectiveness graphic and acceptability curve were obtained from 1,000 bootstrap replications. A total of 174 patients were included in the economic evaluation. The estimated means [95% CI] of direct costs and reduction of fear of progression were 9,045.03 [6,359.07; 12,091.87] and 1.41 [0.93; 1.92] for patients in the SET and 6,682.78 [4,998.09; 8,440.95] and 1.44 [1.02; 1.09] for patients in the CBT. The incremental cost-effectiveness ratio [95% CI] amounts to minus 78,741.66 [-154,987.20; 110,486.32] for an additional unit of effect. Given the acceptability curve, there is a 92.4% chance that the CBT, compared with the SET, is cost-effective without the need of additional costs to payers. Our main result is the superior cost-effectiveness of the cognitive-behavioral intervention program in comparison to the non-directive encounter group for our sample of cancer patients with high levels of anxiety.

The ICF Core Set for stroke from the perspective of physicians: a worldwide validation study using the Delphi technique.

BACKGROUND: The ICF Core Set for stroke is an application of the International Classification of Functioning, Disability and Health (ICF) and represents the typical spectrum of problems in functioning of patients with stroke. AIM: The aim of this study was to validate the ICF Core Set for stroke from the perspective of physicians. DESIGN: Observational. SETTING: Other. POPULATION: Physicians experienced in stroke treatment. METHODS: Physicians experienced in stroke treatment were asked about the patients' problems, patients' resources and aspects of environment that physicians take care of in a three-round electronic mail survey using the Delphi technique. The responses were linked to the ICF by two persons. The degree of agreement was calculated using Kappa statistic. RESULTS: Eighty-eight physicians in 30 countries named 2142 patients' problems that covered all ICF components. Two hundred seventy-seven ICF categories were linked to these. Kappa statistic for agreement reached 0.68 with a 95% confidence interval of 0.66-0.69. Although 28 ICF categories were not represented in the ICF Core Set for stroke, only four of them were considered as important by at least 75% of the participants. Those categories addressed sensations associated with cardiovascular and respiratory functions, urinary excretory functions, involuntary movement functions and sensations related to muscle and movement functions. CONCLUSION: The validity of the ICF components Body structures, Activities and Participation, and Environ-mental Factors was fully supported. Only some body functions were identified that were not covered and need to be investigated further.

Factors explaining limitations in activities and restrictions in participation in rheumatoid arthritis.

AIM: The objectives of this study were to examine which factors, according to the International Classification of Functioning, Disability and Health (ICF) framework contribute to the explanation of activity limitations measured by the Health Assessment Questionnaire (HAQ - model I) and which factors contribute to the explanation of participation restrictions measured by the Social Function Scale of SF-36 (model II) in patients with rheumatoid arthritis (RA). METHODS: Cross-sectional data collection of variables concerning the health status of 239 consecutively included patients with RA at the outpatient Departments of Physical Medicine and Rehabilitation of the University Hospital of Zurich and of the University Hospital of Munich was conducted. Measures included: disease activity score (DAS-28), Rheumatoid Arthritis Disease Activity Index (RADAI), HAQ, Short-form-36 (SF-36), Sociodemo-graphy Questionnaire, Comorbidity Questionnaire (SCQ), Muscle Strength Index (MSI), range of motion (EPM-ROM), grip strength, Sequentional Occupational and Dexterity Assessment (SODA), radiologic score (Ratingen Score). Multivariate regression analyses were conducted building models of explanation. RESULTS: Model I included vitality, RADAI, DAS, SODA PAIN Score, MSI and EPM-ROM as explaining variables with a globally explained variance of 53%. Model II included vitality, mental health, the HAQ and living alone as explaining variables with a globally explained variance of 42.4%. CONCLUSION: Activity limitations in RA were mainly explained by vitality and disease activity factors. Restrictions in participation in RA were mainly explained by vitality and mental health.

ICF Core Sets for individuals with spinal cord injury in the long-term context.

STUDY DESIGN: A formal decision-making and consensus process integrating evidence gathered from preparatory studies was followed. OBJECTIVES: The objective of the study was to report on the results of the consensus process to develop the first version of a Comprehensive International Classification of Functioning, Disability and Health (ICF) Core Set, and a Brief ICF Core Set for individuals with spinal cord injury (SCI) in the long-term context. SETTING: The consensus conference took place in Switzerland. Preparatory studies were performed worldwide. METHODS: Preparatory studies included an expert survey, a systematic literature review, a qualitative study and empirical data collection involving people with SCI. Relevant ICF categories were identified in a formal consensus process by international experts from different backgrounds. RESULTS: The preparatory studies identified a set of 595 ICF categories at the second, third or fourth level. A total of 34 experts from 31 countries attended the consensus conference (12 physicians, 6 physical therapists, 5 occupational therapists, 6 nurses, 3 psychologists and 2 social workers). Altogether, 168 second-, third- or fourth-level categories were included in the Comprehensive ICF Core with 44 categories from body functions, 19 from body structures, 64 from activities and participation and 41 from environmental factors. The Brief Core Set included a total of 33 second-level categories with 9 on body functions, 4 on body structures, 11 on activities and participation and 9 on environmental factors. CONCLUSION: A formal consensus process integrating evidence and expert opinion based on the ICF led to the definition of the ICF Core Sets for individuals with SCI in the long-term context. Further validation of this first version is needed.

Identification of the most common problems in functioning of individuals with spinal cord injury using the International Classification of Functioning, Disability and Health.

STUDY DESIGN: Cross-sectional, multicenter study. OBJECTIVES: To identify the most common problems of individuals with spinal cord injury (SCI) in the early post-acute and the long-term context, respectively, using the International Classification of Functioning, Disability and Health (ICF) as a frame of reference. SETTING: International. METHODS: The functional problems of individuals with SCI were recorded using the 264 ICF categories on the second level of the classification. Prevalence of impairment was reported along with their 95% confidence intervals. Data were stratified by context. RESULTS: Sixteen study centers in 14 countries collected data of 489 individuals with SCI in the early post-acute context and 559 in the long-term context, respectively. Impairments in thirteen ICF categories assigned to Body functions and Body structures were more frequently reported in the long-term context, whereas limitations/restrictions in 34 ICF categories assigned to Activities and Participation were more frequently found in the early post-acute context. Eleven ICF categories from the component Environmental Factors were more frequently regarded as barriers, facilitators or both by individuals with SCI in the early post-acute context as compared with individuals with SCI in the long-term context. Only two environmental factors were more relevant for people with SCI in the long-term context than in the early post-acute context. CONCLUSION: The study identified a large variety of functional problems reflecting the complexity of SCI and indicated differences between the two contexts. The ICF has potential to provide a comprehensive framework for the description of functional health in individuals with SCI worldwide.

ASAS/WHO ICF Core Sets for ankylosing spondylitis (AS): how to classify the impact of AS on functioning and health.

OBJECTIVE: To report on the results of a standardised consensus process agreeing on concepts typical and/or relevant when classifying functioning and health in patients with ankylosing spondylitis (AS) based on the International Classification of Functioning and Health (ICF). METHODS: Experts in AS from different professional and geographical backgrounds attended a consensus conference and were divided into three working groups. Rheumatologists were selected from members of the Assessment of SpondyloArthritis international Society (ASAS). Other health professionals were recommended by ASAS members. The aim was to compose three working groups with five to seven participants to allow everybody's contribution in the discussions. Experts selected ICF categories that were considered typical and/or relevant for AS during a standardised consensus process by integrating evidence from preceding studies in alternating working group and plenary discussions. A Comprehensive ICF Core Set was selected for the comprehensive classification of functioning and a Brief ICF Core Set for application in trials. RESULTS: The conference was attended by 19 experts from 12 countries. Eighty categories were included in the Comprehensive Core Set, which included 23 Body functions, 19 Body structures, 24 Activities and participation and 14 Environmental factors. Nineteen categories were selected for the Brief Core Set, which included 6 Body functions, 4 Body structures, 7 Activities and participation and 2 Environmental factors. CONCLUSION: The Comprehensive and Brief ICF Core Sets for AS are now available and aim to represent the external reference to define consequences of AS on functioning.

ICF Core Sets for individuals with spinal cord injury in the early post-acute context.

STUDY DESIGN: A formal decision-making and consensus process integrating evidence gathered from preparatory studies was followed. OBJECTIVES: The aim of this study was to report on the results of the consensus process to develop the first version of a Comprehensive International Classification of Functioning, Disability and Health (ICF) Core Set and a Brief ICF Core Set for individuals with spinal cord injury (SCI) in the early post-acute context. SETTING: The consensus conference took place in Switzerland. Preparatory studies were performed worldwide. METHODS: Preparatory studies included an expert survey, a systematic literature review, a qualitative study and empirical data collection involving people with SCI. ICF categories were identified in a formal consensus process by international experts from different backgrounds. RESULTS: The preparatory studies identified a set of 531 ICF categories at the second, third and fourth levels. From 30 countries, 33 SCI experts attended the consensus conference (11 physicians, 6 physical therapists, 5 occupational therapists, 6 nurses, 3 psychologists and 2 social workers). Altogether 162 second-, third- or fourth-level categories were included in the Comprehensive ICF Core Sets with 63 categories from the component Body Functions, 14 from Body Structures, 53 from Activities and Participation and 32 from Environmental Factors. The Brief Core Set included a total of 25 second-level categories with 8 on Body Functions, 3 on Body Structures, 9 on Activities and Participation, and 5 on Environmental Factors. CONCLUSION: A formal consensus process-integrating evidence and expert opinion based on the ICF led to the ICF Core Sets for individuals with SCI in the early post-acute context. Further validation of this first version is needed.

Identification of similarities and differences in functioning in persons with rheumatoid arthritis and ankylosing spondylitis using the International Classification of Functioning, Disability and Health (ICF).

OBJECTIVE: The objective of this study is to identify similarities and differences in functioning in AS and RA using the ICF as the framework for the description of functioning. METHODS: The Comprehensive ICF Core Sets for RA and AS were compared qualitatively regarding their content. A comparison study of common second-level ICF categories from both ICF Core Sets collected in two different cross-sectional studies in the Netherlands was performed. Significant differences regarding the level of impairments, limitations or restrictions were analyzed within the Mann-Whitney U-Test. To study whether the common ICF categories have different meaning for the two populations the Rasch model for dichotomous response option was used. RESULTS: The Comprehensive ICF Core Set for AS includes 74 ICF categories in 19 chapters and the Comprehensive ICF Core Set for RA includes 96 ICF categories in 22 chapters. Interviews among 87 patients with AS and 143 patients with RA on 24 of the common ICF categories revealed significant differences regarding the extent of problems. DIF analyses reflect that the meaning of some ICF categories, such as 'd410 Changing basic body positions' is different in relation to functioning depending on the health condition. CONCLUSION: This study was the first to compare functioning in AS and RA based on the ICF. The results confirmed to a large extend the experiences well known from other studies and thereby showed that the ICF is useful to describe and compare functioning. Some aspects could be identified which are not easy to understand with existing evidence and need to be explained in the future.

Validation of the International Classification of Functioning, Disability and Health (ICF) core set for diabetes mellitus from the patient perspective using focus groups.

AIMS: The Comprehensive ICF Core Set for diabetes mellitus (DM) is a specific application of the International Classification of Functioning, Disability and Health (ICF) of the World Health Organization for clinical and research purposes involving the disorder. It represents the typical spectrum of functional problems in patients with DM. The objective of the study was to validate the Comprehensive ICF Core Set for DM from the perspective of patients. The specific aims were to explore the aspects of function and health important to patients with DM using focus group methodology and to examine to what extent these aspects are represented by the Comprehensive ICF Core Set for DM. METHODS: A qualitative study using focus group methodology was conducted. Sampling of patients followed the maximum variation strategy. Sample size was determined by saturation. The focus group discussions were digitally recorded and transcribed verbatim. The meaning condensation procedure was used for data analysis. The resulting meaningful concepts were linked to ICF categories according to established linking rules. RESULTS: Forty patients participated in eight focus groups. Seventy-five of the 85 ICF categories contained in the Comprehensive ICF Core Set for DM were identified by the patients. Forty-seven additional categories that are not covered by the Comprehensive ICF Core Set for DM were identified. CONCLUSIONS: The Comprehensive ICF Core Set for DM could be largely confirmed by the focus groups. Categories currently not covered by the Comprehensive ICF Core Set for DM should be investigated further.