Abstract
Introduction
The Comprehensive International Classification of Functioning, Disability and Health (ICF) Core Set for Hand Conditions has been developed as a tool to describe functioning in individuals with hand conditions. The purpose of this study was to validate the ICF Core Set in a multicentre study in Germany.
Methods
We conducted a cross-sectional multicentre study involving individuals with various types of hand injuries or disorders from hand trauma units and rehabilitation facilities in Germany. We performed structured patient interviews using the Comprehensive ICF Core Set for Hand Conditions to investigate whether all of its categories are necessary to describe patients' functioning. Patients additionally completed the Disabilities of the Arm, Shoulder and Hand Questionnaire (DASH).
Results
The study sample comprised 260 individuals (65% men) with a mean age of 46 years. Participants had a mean DASH score of 42.7 (22.25 SD) and a median time since injury or diagnosis of 106 days. Most frequent diagnoses were fractures at forearm, wrist and hand level. We identified patients' problems in all ICF categories of the Comprehensive ICF Core Set for Hand Conditions with a prevalence of at least 10%. Two ICF categories were perceived as missing: ‘b4352 – functions of lymphatic vessels’ and ‘b298 – sensory functions and pain, other specified – neuralgia in upper extremity’.
Discussion
The Comprehensive ICF Core Set for Hand Conditions has been validated in this national multicentre study. All of its categories could thereby be confirmed. Further validation is needed, involving different study samples in different countries worldwide.
Keywords
Introduction
Hand problems may originate from conditions of the hand considered as disorders or diseases as well as injuries located directly at hand, wrist or forearm level, such as carpal tunnel syndrome, Dupuytren's disease or fractures. Furthermore, the hand can be limited due to conditions involving the hand considered as diseases or injuries originating external to the hand but affecting the hand, such as rheumatoid arthritis, stroke, Parkinson's disease or brachial plexus injuries, etc. Regardless the type of disease or injury, there are substantial challenges to daily functioning associated with hand conditions. The challenges, patients with hand conditions have to cope with, are not only related to functions of body systems such as mobility of joints, but may also impact on daily routine activities as for example in self-care, work and leisure activities. 1–7
There is an extensive amount of outcome measures to be used in clinical studies and evaluation on hand patients, and no clear consensus exists on which are the most appropriate. 8–11 To guide health professionals working in multidisciplinary teams, in terms of what should be measured in patients with hand conditions, the Comprehensive International Classification of Functioning, Disability and Health (ICF) Core Set for Hand Conditions can serve as a practical tool. 12,13
The Comprehensive ICF Core Set for Hand Conditions has been adopted at the International ICF Consensus Conference convened in Switzerland in May 2009. 14 Twenty-three experts in the field of hand conditions, from 22 different countries, attended the formal decision-making and consensus process, and decided on the selection of ICF categories to be included in the Comprehensive ICF Core Set for Hand Conditions. The Comprehensive ICF Core Set is an agreed-on list of ICF categories grouped into the following components: body functions (b), body structures (s), activities and participation (d), and environmental factors (e) (Figure 1). 15 It aims to describe functioning and disability of patients with hand conditions and to guide multidisciplinary assessments in treatment and rehabilitation of hand patients. The current version of the Comprehensive ICF Core Set contains a set of 117 ICF categories. 16 The Comprehensive ICF Core Set for Hand Conditions has been tested and validated in this national, cross-sectional multicentre study.

The structure of the International Classification of Functioning, Disability and Health (ICF)
The objective of the study was to validate the Comprehensive ICF Core Set for Hand Conditions. The specific aims were (1) to investigate whether all categories of the Comprehensive ICF Core Set for Hand Conditions are necessary to describe functioning of patients with hand conditions; and (2) to explore if there should be other categories included.
Methods
Study design
The study was conducted as a multicentre cross-sectional study collecting patient data in four study centres in Germany. The study protocol and consent forms were approved by the Ethics Committee of the Medical Association, Hamburg and the Ethics Committee of the Ludwig-Maximilians-Universität, Munich. The study was conducted based on the principles of the Declaration of Helsinki.
Sample
Patients were included, if they (1) suffered from a hand condition (as described previously); (2) were at least 18 years of age; (3) had no mental disorder; (4) understood the purpose of the study and (5) signed the informed consent after the whole study was explained to them. To gather information from a wide spectrum of hand conditions, many different diagnoses were included.
Participants were recruited at (1) the Department of Hand Surgery, Plastic and Microsurgery at the BG Trauma Hospital, Hamburg, (2) the Department of Plastic and Hand Surgery, Burns Unit at the BG Clinic Bergmannstrost, Halle, (3) the Department of Hand, Replantation and Microsurgery at the Trauma Hospital, Berlin and (4) at the Institute for Health and Rehabilitation Sciences of the Ludwig-Maximilians-Universität, Munich.
Measures
Health professionals (physicians, physical therapists, occupational therapists and nurses from the respective study centres who were involved in patients' care, as well as a researcher (SK) from the ICF Research Branch) conducted the interviews using the Comprehensive ICF Core Set for Hand Conditions. The Comprehensive ICF Core Set lists 117 ICF categories of which 27 (23%) refer to body functions, 10 (9%) to body structures, 38 (32%) to activities and participation, and 42 (36%) to contextual environmental factors. It has been developed as a tool to describe functioning and disability of individuals with hand conditions, based on a biopsychosocial view. Various types of hand conditions were thereby considered differentiated into (1) conditions of the hand and (2) conditions involving the hand. While the former include disorders or diseases as well as injuries located directly at hand, wrist or forearm level (such as carpal tunnel syndrome, Dupuytren's disease or fractures, etc.), the latter cover diseases or injuries originating external to the hand but affecting the hand (such as rheumatoid arthritis, stroke, Parkinson's disease or brachial plexus injuries, etc.).
The scale to quantify the degree of the patients' problems was a Visual Analogue Scale (VAS) ranging from 0 (no problem) to 100 (total problem). In addition, health professionals were asked to document the specific aspects of functioning that they considered as missing in the Comprehensive ICF Core Set. Sociodemographic data regarding gender, age, marital status, living situation, education status, occupation and setting (inpatient/outpatient) were collected. Disease-related data included type of hand condition, affected side, handedness and grip strength. The patients filled in the Disabilities of the Arm, Shoulder and Hand Questionnaire (DASH). 17
Data collection
The health professionals conducted the one-to-one interviews in the previously mentioned study centres using the Comprehensive ICF Core Set for Hand Conditions. 16 Health professionals involved in the study were trained in a one-day workshop on the structure and terminology of the ICF and the methods of the data collection. Further, a case example was presented to the health professionals during this workshop, based on which the interview situation was trained in a role-play. Additionally, they were provided with an interview manual, which contained a detailed description of how to perform the interviews as well as examples of how to question the patient during the interview.
Before the interview, the health professionals obtained demographic and clinical data from patients' medical records. The interview itself was conducted in a structured format, i.e. the interviewer rated the degree of patients' problems in every single ICF category from the Comprehensive ICF Core Set for Hand Conditions. For the components body functions and body structures, health professionals' appraisal was solely based on the clinical information retrieved from the medical charts and on their knowledge of the patient (with the exception of the categories referring to the chapter ‘b1 – Mental Functions’, which were rated in dialogue with the patients). Regarding the component activities and participation as well as the contextual environmental factors, the health professionals took into consideration the information derived from the patients. However, the interviewers rated the amount of limitation (or restriction) in activities and participation and the degree of environmental factors being a facilitator or a barrier, from their clinical experience. During the interview, the patients were not provided with the category list. Patients filled in the self-reported DASH questionnaire after the interview.
Analysis
Sociodemographic and disease-related data were analysed using descriptive statistics. The DASH score is thereby reported.
Regarding the ICF categories, absolute and relative frequencies (prevalence) are reported along with their 95% confidence intervals (CI). The level of problem in the different ICF categories of the components body functions, body structures, and activities and participation was dichotomized considering 0 as no problem and values >0 as problem.
Descriptive data analyses were performed with SAS 9.1 (SAS Institute Inc, Cary, NC, USA).
Results
A total study population of 260 participants (169 men, 65%) was recruited in the BG Trauma Hospital, Hamburg (n = 148), the BG Clinic Bergmannstrost, Halle (n = 45), the Trauma Hospital, Berlin (n = 50) and at the Institute for Health and Rehabilitation Sciences in Munich (n = 17). From 260 interviews, 199 (76.6%) were conducted by physicians, 30 (11.5%) by occupational therapists, 12 (4.6%) by physical therapists and two (0.8%) interviews were conducted by nurses. All clinical interviewers were closely involved in patients' care in the respective study centres. A researcher from the ICF Research Branch (SK) conducted 17 (6.5%) interviews as well. Age at interview ranged from 19 to 82 years (mean 46 years). Selected sociodemographic and disease-related data are listed in Table 1.
Sociodemographic and disease-related characteristics of the participants (n = 260)
The majority of the patients suffered from injuries of the hand (70.4%). Most frequent diagnoses were fractures at wrist and hand level (19%), fracture at forearm (17%), dislocation, sprain and strain of joints and ligaments (12%), injury of muscle and tendon (12%), and traumatic amputation of wrist and hand (10%) (Table 2). Median time from injury to interview was 103 days for patients having an injury located directly at the hand (n = 233), 97 days for patients having a disorder/disease located directly at the hand (n = 58) and 1040 days (34 months) for patients with an injury/disease originating external to the hand but affecting the hand (n = 19). Table 3 shows time since injury or disease and the mean DASH-Score by type of hand condition. Sixty-seven per cent of the patients were inpatients. No patients were excluded from the analysis.
Diagnosis of the participants (n = 260)
Note: Multiple diagnoses per participant possible
Time since injury or diagnosis and DASH-Score, stratified for type of hand condition
DASH = Disabilities of the Arm, Shoulder and Hand Questionnaire
†Data analysed, n = 254
‡Data analysed, n = 250
Health professionals reported for all ICF categories of the Comprehensive ICF Core Set for Hand Conditions either impairments, limitations (or restrictions) or noted environmental factors as facilitators or barriers in at least 10% of the study population. Table 4 shows the ICF categories of the Comprehensive ICF Core Set for Hand Conditions in which patients' problems were documented in more than 70% of the study population. ICF categories of the Comprehensive ICF Core Set for Hand Conditions showing the highest prevalence were: e310 ‘Immediate family’ (93.1%), e355 ‘Health professionals’ (91.5%), s7302 ‘Structure of the hand’ (91.2%), b730 ‘Muscle power functions’ (86.2%) and b7100 ‘Mobility of a single joint’ (84.6%). Only six of the ICF Core Set categories were affected with percentages <20.0% (Table 5). Table 6 lists the ICF categories showing a prevalence of <70.0% and ≥20.0%.
ICF Core Set categories being relevant in >70% of patients
ICF Core Set categories being relevant in <20.0% of patients
ICF Core Set categories being relevant in <70.0% and ≥20.0% of the patients
Note: ICF categories showing a prevalence ≥50.0% are in bold
Health professionals documented the following specific aspects of functioning as missing in the Comprehensive ICF Core Set for Hand Conditions: swelling in arms and hands, problems due to protective posture, increased hair growth, neuralgia in upper extremity and lymph functions in upper extremity. Consequently, the ICF categories ‘b4352, – Functions of lymphatic vessels’ and ‘b298 – Sensory functions and pain, other specified – neuralgia in upper extremity’ were added to the Comprehensive ICF Core Set of Hand Conditions. Table 7 shows the validated version of the Comprehensive ICF Core Set for Hand Condition.
Validated version of the comprehensive ICF Core Set for Hand Conditions
Note: Additionally included ICF categories are in bold
Discussion
The first version of the Comprehensive ICF Core Set for Hand Conditions, adopted in May 2009 has been validated in this national cross-sectional study. Thereby, all ICF categories of the Comprehensive ICF Core Set for Hand Conditions were confirmed. Thus, it has been shown by this study that the Comprehensive ICF Core Set for Hand Conditions does not contain any redundant ICF category. The results of this study further illustrate that among the included study population, only six ICF categories of the Comprehensive ICF Core Set for Hand Condition were less frequently affected. Nevertheless, with a prevalence of impairment or limitation in 10–20% of the study population, these ICF categories remain as confirmed in the Comprehensive ICF Core Set for Hand Conditions.
Half of the 22 ICF categories in which patients' problems were documented with a prevalence of more than 70% refer to the component activities and participation. Aspects predominantly affected were related to (fine) hand use, domestic life activities, employment and leisure activities. Difficulties in these areas have also been found in other studies that explored the consequences of various types of hand conditions. 1–4,18,19 The majority of our study population experienced injuries of the hand, and the structures primarily affected were joints, bones, muscles, tendons and ligaments. Therefore, it is less surprising that mobility of joints, muscle power and endurance as well as structure of the hand were the central aspects identified among the components body functions and structures.
The Comprehensive ICF Core Set for Hand Conditions lists 42 different environmental factors potentially relevant to individuals with hand conditions. Environmental factors, in general, closely interact with functioning and disability, and its impact on a person's performance might either be in a facilitating or restricting way. 15 In our study, at least one-fourth of the participants stated 81% of these environmental factors as relevant (either as a facilitator or a barrier, or both) with respect to the health disorder they experienced. Thereof, support and attitudes of immediate family members, friends and health professionals were documented as most relevant, which is in line with other studies, describing attitudes and support of family, friends, colleagues or health professionals, as essential for a person's ability to cope with the effects of the disease. 20–22 Thus, to provide high-quality patient care, environmental factors' impact needs to be considered when planning a patient's rehabilitative treatment process. 23
The health professionals were asked to report the areas of functioning they consider as missing in the Comprehensive ICF Core Set. From the aspects documented by the health professionals, lymph functions and neuralgia in upper extremity could be taken into account by including the ICF categories ‘b4352 – Functions of lymphatic vessels’ and ‘b298 – Sensory functions and pain, other specified – neuralgia in upper extremity’ to the list of categories contained in the Comprehensive ICF Core Set for Hand Condition. Increased hair growth (similar as increased pigmentation) refers to ‘b810 – Protective functions of the skin’, which is already included in the Comprehensive ICF Core Set. Even though increased hair growth might lead to aesthetic complaints from the patients' point of view, we do not consider ‘b1801 – Body image’ as the adequate ICF category to choose for this aspect. The category ‘b1801 – Body image’ refers to chapter b1 Mental functions and according to its description, this category includes ‘Specific mental functions related to the representation and awareness of one's body’. 15 Increased hair growth, however, does not cover the mental aspect and therefore the authors reached consent that it would be best attributed to ‘b810 – Protective functions of the skin’. The aspects swelling in arms and hands, and problems due to protective posture are not covered by the ICF.
Another reason for considering the ICF Core Sets for Hand Conditions as helpful in clinical patient evaluation is their assistance when deciding on the appropriate outcome measure. The content of outcome measures frequently used can be analysed by linking its items to the ICF. As a consequence, different outcome measures become comparable. 24 Comparing the content of the outcome measures with the categories included in the ICF Core Set (informing about what should be measured) tells us which of the important functioning areas are captured, and which are not captured in a certain outcome measure, and thus facilitates the decision on the adequate outcome measure to choose.
Study limitations
Some issues need to be considered when interpreting these results. First, a convenience sampling procedure combined with a stratified sampling procedure was used. Therefore, the results of the study may not be representative. For example, there is a high proportion of inpatients included in our study sample, which indicates that the population had severe hand conditions. This is related to the study centres involved in the study, which were mainly trauma hospitals. Future studies need to address this issue by including different health and care institutions.
Second, the majority of the study population (70%) of this national validation study were individuals with injuries of the hand. The proportion of patients suffering from injuries or conditions originating external to the hand but affecting the hand is under-represented. Thus, we underline that additional testing of the ICF Core Sets for Hand Conditions is required in study populations with different distributions regarding the health conditions included.
Third, we solely used the DASH Score to describe the patient population and though this instrument was developed to ‘measure physical function and symptoms in people with […] musculoskeletal disorders of the upper limb’, 25 seven per cent of our study population with neurological conditions also filled in the DASH Questionnaire. The DASH Score potentially might be of use in further statistical data analyses.
Last, this study has only been performed in Germany. Therefore, other results could be found in other countries and settings as well as from different perspectives (e.g. patient perspective).
Conclusion
The Comprehensive ICF Core Set for Hand Conditions has been tested and validated in this multicentre study conducted in Germany. Based on our findings, all ICF categories of the Comprehensive ICF Core Set were confirmed, and two more ICF categories were added to the list of categories. Further validation studies are needed to gain representative results with respect to different cultures and hand conditions.
Concerning the future use of the Comprehensive ICF Core Set of Hand Condition, it is envisaged that the ICF Core Set serves as a reference tool for selecting potentially relevant aspects of functioning and disability to be drawn upon if necessary, to describe functioning for a specific patient with a specific hand condition in a specific situation.
Footnotes
Acknowledgements
We thank all physicians, nurses, physical therapists and occupational therapist who performed the patient interviews in the participating study centres. Our additional thanks go to Monika Dangers from the BG Trauma Hospital, Hamburg for her encouragement during data collection.
We also thank Caroline Bauer, Fares Day, Michaela Hönig, Silke Joachimsthaler and René Mittrach for supporting us in the patient recruitment process and Michaela Coenen for reviewing the manuscript.
Our special thanks go to Werner Plinske from the Institution for Statutory Accident Insurance and Prevention in the Health and Welfare Services (BGW) for his support during the whole project and to the German Social Accident Insurance (DGUV) for funding this project.
