Introduction

For most of the affected people, a spinal cord injury (SCI) has long-term consequences. Following an extended period of hospitalization with acute care and early post-acute rehabilitation, community reintegration is the main goal of rehabilitation.1 Successful community reintegration depends not only on a person's physical functioning, but also on many interrelated facilitators and barriers in the social and physical environment. Rehabilitation teams therefore need to consider aspects such as employment, mobility and transportation, family support and physical accessibility in the community when planning transition to the community.

Another challenge associated with the long-term care of people with SCI is the changing range of functional problems with increasing duration of injury. Studies report that the prevalence of pressure ulcers, autonomic dysreflexia, heterotopic ossification and need for help with activities of daily living increases per years after injury.2

Therefore, long-term care of people with SCI requires an in-depth understanding of the broad range and interaction of these functional problems that people may experience. The International Classification of Functioning, Disability and Health (ICF)3 provides a comprehensive and universally accepted framework to classify and describe functioning, disability and health in people with all kinds of diseases or conditions, including SCI. According to the ICF, the problems associated with a disease may involve Body Functions and Body Structures and the Activities and Participation in life situations. Health states and the development of disability are modified by contextual factors such as environmental and personal factors.3 Additional information on the ICF model can be found on the ‘Spinal Cord’ website. The ICF is structured hierarchically. Categories are divided into chapters, which constitute the first level of precision. Categories on higher levels (for example, third or fourth level) are more detailed. To give an example, the third-level ICF category, d5400 Putting on clothes, is one element of the second-level category, d540 Dressing. The second-level category, d540 Dressing, is an element of the chapter d5 Self-Care. Finally, the chapter d5 Self-Care is part of the ICF component d Activities and Participation. Further details can found on the website World Health Organization (http://apps.who.int/classifications/icfbrowser/).

As the ICF can serve as the basis for a comprehensive and detailed understanding of the functioning and disability, it is essential in the first step to identify what aspects of functioning and disability in people with SCI should be defined. This process is consistent with the approach that has been followed in other health conditions. Selections of ICF categories relevant for people with a specific health condition, the so-called ‘ICF Core Sets’, have already been developed for a number of health conditions.4 However, in SCI different contexts have to be taken into account.

As ‘ICF Core Sets for Neurological Conditions in the Acute Context’ were already developed5 and are currently validated for SCI, the project aimed at developing ICF Core Sets for SCI for the early post-acute context and for the long-term context.6 The early post-acute context covers the first comprehensive rehabilitation after the acute SCI. The long-term situation follows the early post-acute situation. This definition was regarded as being applicable throughout the world, irrespective of the different health systems.

The development process of the ICF Core Sets for SCI is divided in a preparatory phase in which information was gathered from different studies and from a final consensus conference.6 The objective of this paper is to report the results of the consensus process, integrating evidence from preparatory studies to develop the Comprehensive ICF Core Set for SCI in the long-term context and the Brief ICF Core Set for SCI in the long-term context.

Methods

A formal decision-making and consensus process integrating evidence gathered from preparatory studies and expert opinion was followed.

Preparatory studies

The conference was based on the data available as on 1 October 2007. The preparatory studies included an empiric data collection applying the second-level ICF categories in 387 people with chronic SCI from 14 countries, an Internet-based expert survey including 144 SCI health professionals worldwide, a systematic literature review on outcomes used in 281 SCI clinical trials and a qualitative study including 23 focus groups with people with SCI from six countries. On the basis of these preparatory studies, a pre-selection of ICF categories was performed using the modified scree test.7 The ICF categories most frequently named in all four preparatory studies made up the starting point of the decision-making and consensus process. Details of the preparatory studies are described in the reference publications.8, 9, 10, 11

Recruitment of conference participants

Health professionals who have expressed their interest in the project in advance as well as people who were suggested by the project steering committee built up a pool of potential participants. A total of 154 people (58 physicians, 24 physical therapists, 27 occupational therapists, 23 nurses, 12 psychologists and 10 social workers from 38 countries) made up this pool. Participants were selected randomly after consideration of the profession and the country of origin to assure a balanced representation of all important health professions and all world regions.

Training and information exchange

During the conference, the first meeting consisted of a 3-h training, in which all participants were familiarized with the ICF framework and classification.4 In a series of successive meetings described elsewhere, the decision process of the ICF Core Sets for SCI in the early post-acute context took place,12 followed by the presentation of the evidence from the preparatory studies of the ICF Core Sets for the long-term context. Thus, the participants were very aware of the decision process to be followed for the ICF Core Sets for SCI in the long-term context. Participants received the summary sheets containing both the pre-selected ICF categories and the results of the preparatory studies during this presentation (see Table 1).

Table 1 Fraction of the list including the results of the preparatory studies for each ICF category as presented to the participants of the consensus conference

Iterative decision-making process

The ICF Core Set categories were identified in an iterative decision-making process with discussions and voting in working groups and plenary sessions. The process was guided by a member of the ICF Research Branch. In the process, ICF categories that were either clearly relevant or irrelevant according to preset decision rules were excluded from further discussion. The focusing on the remaining controversial categories was thereby facilitated. The decision-making process consisted of two major activities.

In the first activity, the participants were asked to select ICF categories to be included in the Comprehensive ICF Core Set, that is, a list of ICF categories long enough to describe the prototypical spectrum of limitations in the functioning and health of individuals with SCI in the long-term context, but at the same time short enough to be practical in comprehensive, multidisciplinary assessments.

In the second activity, the participants were requested to select the Brief ICF Core Set from the list of ICF categories included in the Comprehensive ICF Core Set by means of a two-round ranking exercise and a final vote. The Brief ICF Core Set is a list of ICF categories long enough to describe the prototypical spectrum of limitations in the functioning and health of people with SCI in the long-term context, but at the same time short enough to be practical in clinical studies.

The data resulting from the voting and ranking processes were continuously entered in MS Excel 2003 throughout the conference.

Results

Preparatory studies

In the empirical study, 258 second-level categories were identified. The qualitative study, the expert survey and the systematic review revealed 344, 392 and 424 second-, third- and fourth-level categories, respectively. In total, a list of 262 different second-level categories resulted from the preparatory studies. Using modified scree test, the 198 most frequently reported categories were selected.7 The list of ICF categories finally presented at the conference to the participants included 595 ICF categories at the second, third or fourth level (164 on Body Functions, 89 on Body Structures, 212 on Activities and Participation and 130 on Environmental Factors).

ICF consensus conference

The consensus process took place from 15 November to 18 November 2007 at the Swiss Paraplegic Research, Nottwil, Switzerland. Although 33 health professionals participated in the development of the ICF Core Sets for the early post-acute context, an additional health professional was recruited during the process to develop the ICF Core Sets for the long-term context. In total, 12 physicians with various sub-specializations, 6 physical therapists, 5 occupational therapists, 6 nurses, 3 psychologists and 2 social workers from 31 different countries attended the consensus process for SCI in the long-term context.

The decision-making process involved five working groups with 6–7 health professionals in each. The process was facilitated by the moderator of the plenary sessions and the five working-group leaders.

Comprehensive ICF Core Set

Tables 2, 3, 4 and 5 show the ICF categories included in the Comprehensive ICF Core Set. The number of second-, third- and fourth-level categories in the Comprehensive ICF Core Set is 168, with 116 categories on the second level, 41 categories on the third level and 11 categories on the fourth level. The 52 third- and fourth-level categories are a further specification of 11 categories on the second level. The 168 categories of the Comprehensive ICF Core Set are made up of 44 (26.2%) categories from the component Body Functions, 19 (11.3%) from the component Body Structures, 64 (38.1%) from the component Activities and Participation and 41 (24.4%) from the component Environmental Factors.

Table 2 ICF categories of the component body functions included in the Comprehensive ICF Core Set for spinal cord injury in the long-term context
Table 3 ICF categories of the component body structures included in the Comprehensive ICF Core Set for spinal cord injury in the long-term context
Table 4 ICF categories of the component activities and participation included in the Comprehensive ICF Core Set for spinal cord injury in the long-term context
Table 5 ICF categories of the component environmental factors included in the Comprehensive ICF Core Set for spinal cord injury in the long-term context

All chapters of the component Body Functions and Activities and Participation are represented in the Comprehensive ICF Core Set. From the component Body Structures, chapter 2 The eye, ear and related structures, chapter 3 Structures involved in voice and speech and chapter 5 Structures related to the digestive, metabolic and endocrine systems are not represented in the Comprehensive ICF Core Set. From the Environmental Factors, all chapters are represented in the Comprehensive ICF Core Set except chapter 2 Natural environment and human-made changes of environment.

Brief ICF core set

Table 6 shows the second-level ICF categories ordered by rank that were selected for the Brief ICF Core Set. The Brief ICF Core Set includes a total of 33 second-level categories that represents 28.4% of all second-level categories that were selected for the Comprehensive Core Set. In total, nine categories were chosen from the component Body Functions (representing 28.1% of selected second-level categories in the Comprehensive Core Set), four from Body Structures (representing 100% of selected second-level categories in the Comprehensive Core Set), 11 from Activities and Participation (representing 28.2% of selected second level-categories in the Comprehensive Core Set) and nine from Environmental Factors (representing 22.0% of selected second-level categories in the Comprehensive Core Set).

Table 6 ICF categories included in the Brief ICF Core Set for spinal cord injury in the long-term context

Discussion

The formal consensus process integrating evidence from preparatory studies and expert knowledge at the ICF Core Set conference for SCI led to the definition of a Comprehensive ICF Core Set for SCI in the long-term context for multidisciplinary assessment and a Brief ICF Core Set for SCI in the long-term context for clinical studies.

The 168 categories (116 second-level categories) that were included in the Comprehensive Core Set reflect the numerous functional changes that occur in people with SCI in the long-term context. As the Core Set should be applied for all levels of spinal cord lesions, a wide range of functional problems was included in the Comprehensive Core Set. Despite keeping in mind that the Comprehensive ICF Core Set should include as many categories as necessary to comprehensively describe functioning in patients with SCI, but as few as possible to be practical, the participants frequently felt that a specific description of a problem is necessary. Thus, they included many third and even fourth-level categories that provide specifications of second-level categories, such as b280 Pain, s120 Spinal cord and related structures or d445 Hand and arm use.

With respect to the four main components of the ICF, the following issues were raised:

Approximately one-third of the second-level ICF categories of the component Body functions were included in the first vote with a high agreement among the participants. These categories include functions typically problematic in people with SCI in the long-term context, such as procreation functions and weight maintenance functions.13, 14

The inclusion of the category b164 Higher level cognitive functions was discussed and found to be related primarily to co-morbid traumatic brain injury, which was not the focus of the SCI Core Sets.

It was not clear for the participants whether problems with depression and anxiety are covered by b126 Temperament and personality functions or b152 Emotional functions. Finally, they agreed that these important aspects may be covered by b152 Emotional functions and should be included in the Core Set.15

In addition, the inclusion of b180 Experience of self and time functions was discussed controversially. The participants who recognized that this category includes problems related to alteration of the body image of a person stressed its importance. However, the majority of participants voted for an exclusion of this category.

b310 Voice functions was excluded after discussion; 41% of the participants who wanted to include the category pointed out that persons with high spinal cord lesions frequently have problems with voice functions in the long-term phase.16

Some participants wanted to include b535 Sensations associated with the digestive system to cover abdominal distension that is frequent in persons with SCI.17 However, in the final vote the majority of the participants voted against an inclusion of this category.

Regarding neuromusculoskeletal functions, all candidate second-level categories were included except two categories addressing involuntary movement functions.

The selection of all four candidate ICF categories related to functions of skin underlines the importance of impaired skin function in patients with SCI in the long-term context.18

In the selection process of Body Structures, several categories were included in the first voting round with a high agreement. Besides the structures of the spinal cord and urinary system, categories were selected that include trunk, upper extremities and shoulder region that address problems typically found in persons with SCI in the long-term situation.19 In addition, the high prevalence of pressure sores in the chronic phase was taken into consideration by selecting four third-level categories that refer to structural alterations of specific areas of the skin.18 The structures of the sympathetic and parasympathetic nervous system were finally excluded as the functional problems associated with these systems seemed to be more important than the structural impairments.

A broad range of categories of the ICF component Activities and Participation was selected by the participants, reflecting the diversity of problems associated with SCI. The inclusion of many third-level categories of chapter 4 Mobility highlights the need for a detailed description of mobility problems by health professionals.

The discussion of the inclusion of d480, Riding animals for transportation, clearly showed cultural differences regarding the relevance of single ICF categories. Although the participants from India and Nepal pointed out that this category represents an important aspect of mobility in their countries, the majority finally decided not to include this ICF category in the Core Set.

It stands out that all candidate categories addressing education as well as work and employment were included in the Core Set. This decision reflects the essential role employment has in long-term adaptation to the injury and participation within a community. It is supported by the results of several studies reporting relatively low employment rates in people with SCI and identifying a number of facilitators and barriers that are associated with returning to work.20

A large number of Environmental Factors was included in the Comprehensive ICF Core Set, which is consistent with studies reporting on the importance of environmental factors for the adjustment of people with SCI.21 Systems, services and policies available for people with SCI within their country were regarded as major facilitators or barriers by the participants. Thus, most of the ICF categories of the component Environmental factors included in the Comprehensive ICF Core Set pertain to this chapter 5.

Furthermore, products and technology for different uses, including mobility, daily living or employment, were regarded as important. Consequently, all candidate categories of chapter 1 Products and Technology, except products and technology for the practice of religion and spirituality, were included in the Comprehensive ICF Core Set. The remaining categories that were included in the Comprehensive ICF Core Set address the support specifically provided by the family, friends and care providers as well as their attitudes.

The Brief ICF Core Set includes 33 second-level categories that were selected out of the second-level categories of the Comprehensive ICF Core Set, using a two-step ranking procedure and a final cutoff decision. The reduction in the number of categories, however, brought about the loss of presentation of several chapters. Depending on the component, up to five chapters per component are not represented in the Brief ICF Core Set.

The component Activities and Participation is represented by a considerable number of categories that predominantly pertain to the chapters 4 Mobility and 5 Self-Care. In contrast to the ICF Core Set for SCI in the early post-acute context, the category d465 Moving around using equipment, which refers to wheelchair driving, is included.12 It is also interesting that the Brief ICF Core Set for SCI in the long-term context has nearly twice the number of categories assigned to the component environmental factors compared with the Core Set for the early post-acute context. Again, this emphasizes the importance that the environment gains when people are being prepared to go back to the community life.

Validation studies will show whether specific subsets of people, for example, those with paraplegia versus tetraplegia or complete versus incomplete lesions will differ. Besides validation, strategies for the implementation of the ICF Core Sets for SCI in clinical practice are currently being developed. Using case studies of individuals with SCI, the application of the ICF Core Sets for SCI in rehabilitation practice is presented on an Internet website (http://www.ICF-casestudies.org). In addition, a handbook for users will be developed. Finally, as the ICF Core Sets for SCI indicate which areas of functioning should be measured but not how they should be measured, an operationalization of the ICF categories included in the ICF Core Sets for SCI would be useful. The International SCI Data Sets may complement the ICF Core Sets for SCI on this point because they provide specific information about how the relevant information could be assessed.22

In conclusion, a formal consensus process integrating evidence and expert opinion based on the ICF framework and classification led to the definition of ICF Core Sets for SCI in the long-term context. Both the Comprehensive Core Set for multi-disciplinary, comprehensive assessment and the Brief Core Set for research and clinical practice are preliminary and need to be tested and validated in the coming years with the ultimate goal of finally defining a universal, valid and accepted tool for clinical practice, clinical studies and health reporting.

Postscript

Professor Haim Ring (Julio Ring), our friend and colleague and author of this paper died on 15 September 2008. Haim always supported and motivated the process of developing ICF Core Sets. He built bridges among disciplines and health professions. He also brought world regions and countries to work together. We will always be endlessly thankful of having the opportunity of being close to this inspiring spirit.