ORIGINAL ARTICLE
DEVELOPMENT OF ICF CORE SETS FOR HEAD
AND NECK CANCER
Uta Tschiesner, MD,1Simon Rogers, BDS MBChB (Hon.), FSD RCS, FRCS, MD,2Andreas Dietz, MD, PhD,3Bevan Yueh, MD, MPH,4Alarcos Cieza, PhD, MPH5
1
Department of Otorhinolaryngology Head and Neck Surgery at Ludwig Maximilian University, Munich, Germany. E-mail: [email protected]
2
Regional Maxillofacial Unit, Merseyside Head and Neck Cancer Centre, University Hospital Aintree, Liverpool, United Kingdom
3
Department of Otorhinolaryngology Head and Neck Surgery at Leipzig University, Leipzig, Germany 4
Department of Otolaryngology, Head and Neck Surgery, University of Minnesota, Minneapolis, MN 5
ICF Research Branch of the WHO FIC Collaborating Center (DIMDI), IHRS, Ludwig Maximilians University, Munich, Germany
Accepted 17 April 2009
Published online 1 July 2009 in Wiley InterScience (www.interscience.wiley.com). DOI: 10.1002/hed.21172
Abstract: Background. Based on the International Classifi-cation of Functioning (ICF)—Disability and Health, participants from different professional and cultural backgrounds were invited to achieve consensus on a first version of ICF Core Set for head and neck cancer (HNC). It was designed to set standards for the assessment of functioning in HNC.
Methods. The ICF was adopted by the World Health Orga-nization (WHO) in 2001 and was used as the frame of refer-ence. Preselection of potential ICF categories was based on 4 different preparatory studies: patient interviews, health profes-sional surveys, literature review, and multicenter study apply-ing ICF-nomenclature. After trainapply-ing on the ICF, the results of preparatory studies were presented to 21 invited participants to vote in a formal consensus process on both the Brief and Comprehensive ICF Core Set for HNC. Participants came from all 6 WHO world regions, covering 12 different countries. Pro-fessional backgrounds included otorhinolaryngologists, maxillo-facial surgeons, medical/radiation oncologists, psychologists, physiotherapists, nurses, and social workers.
Results. The Comprehensive ICF Core Set for HNC included 112 categories (8% of entire ICF) and the Brief ICF Core Set for HNC included 19 categories (1% of ICF).
Conclusion. A first version of ICF Core Sets for HNC was defined. Further validation is in process. VVC 2009 Wiley Peri-odicals, Inc.Head Neck32:210–220, 2010
Keywords:International Classification of Functioning Disability and Health; head and neck cancer; functional rehabilitation; WHO; quality of life
H
ead and neck cancer (HNC) and its treatment has strong tumor- and treatment-related impact on the patients’ functioning in everyday life, including eating and speaking as well as pain and disfigurement. Patients with head and neck cancer have a lower quality of life than age-matched controls1 and they even seem to have lower quality of life than patients with other common cancers.2The assessment of functioning and quality of life both have become increas-ingly relevant in outcome measurement of head and neck cancer.3–15Correspondence to:U. Tschiesner V
VC 2009 Wiley Periodicals, Inc.
A literature review, including articles in Eng-lish in MEDLINE between 2000 and 2006, reveals a low degree of standardization in the use of outcome measures in head and neck can-cer.16 This also shows how difficult it is pres-ently to draw practical and clinically relevant conclusions out of different studies that assess functioning in the field of head and neck cancer. Also, reporting methods differ according to the need of end user, for example, different clini-cians, regulators, or sponsors, and apply differ-ent foci, methods, and study endpoints. This
creates high data redundancy and costs.17
Therefore, Trotti et al suggested a uniform lan-guage and methods in the context of a given dis-ease to improve the utility of safety information in oncology.
Weymuller and Bhama18 have pointed out, in present head and neck cancer research, that there is very little information on the impact of interventions on the patient’s functioning in life, such as pain regimens, benefit of tracheotomy or percutaneous endoscopic gastrostomy tubes, and palliative radiotherapy or chemotherapy.
The relationship between pathophysiological or anatomical changes and restrictions in the participation of everyday life can in turn be influenced by the disease process itself and by individually different contextual factors includ-ing social support and job demands.19 For clini-cal practice and further research it would be valuable to have a practical framework that cov-ers the entire spectrum of disabilities and guides all aspects of rehabilitation.
To achieve this goal, we need a comprehen-sive framework on how to address the disabil-ities and a matching classification to group them effectively, which serves as a universal language understood by health professionals, researchers, patients, patient organizations, and insurance companies at the same time. The con-cepts, classifications, and measurements of func-tioning and health are accordingly becoming an important key to structured assessment of functioning.20
THE INTERNATIONAL CLASSIFICATION OF FUNCTIONING—DISABILITY AND HEALTH
The approval of the International Classification of Functioning (ICF)—Disability and Health by the World Health Assembly in May 2001 can be considered a landmark event on this respect.21
The ICF stands next to the well-known Interna-tional Classification of Disease (ICD-10), but applies a different focus on health. Although the ICD-10 classifies different medical diagnoses, the ICF classifies patient functioning. Function-ing is influenced not only by the medical diagno-ses but also by a variety of different individual contextual factors. The ICF establishes the beginning of a new era of patient-oriented clini-cal practice, research, and teaching.22
The ICF is based on the integrative bio-psychosocial model of functioning, disability, and health of the World Health Organization (WHO). Based on this model, functioning, with its components body functions and structures and activities and participation, is viewed in relation to the health condition (which often
means the medical diagnosis), as well as
patient-specific personal and environmental fac-tors.21 This integrative biopsychosocial model does not confine itself to a medical diagnosis, but targets functioning in the context of the given environment and modifiable personal fac-tors.23,24 Moreover, in different clinical contexts like in rehabilitation and ambulatory care func-tioning represents not only an outcome but also the starting point of the clinical assessment, the intervention management, and the evaluation and quality management.25,26 The components of biopsychosocial model, as well as the under-standing of their interactions, can be seen in Figure 1.
ICF CORE SETS
The ICF contains more than 1400 categories, making it a highly comprehensive classification. This comprehensiveness is a major advantage
FIGURE 1. The bio-psycho-social model included in the Inter-national Classification of Functioning, Disability and Health (ICF).
and strength of the ICF. However, it is also the major challenge to its practicability and feasibility.
To enhance the applicability of the classi-fication, ICF-based tools must be tailored to the needs of the users, without weakening the strengths of the ICF.27 One approach is the development of ICF Core Sets.
ICF Core Sets are a selection of categories out of the entire ICF classification, which are relevant for a specific disease process.22 So far, ICF Core Sets have been developed in a stand-ardized process for 12 health conditions includ-ing chronic ischemic heart disease,28 obstructive pulmonary disease,29 stroke,30 diabetes melli-tus,31 and rheumatoid arthritis,32 depression,33 and breast cancer.34
The ICF Core Sets for HNC is the first head and neck condition and the second malignancy linked to the ICF framework and classification as adopted by the WHO in 2001.
The goal of the ICF Core Sets for head and neck cancer is to select sets of categories out of the whole classification that can serve as mini-mal standards for the assessment and documen-tation of functioning and health of patients with head and neck cancer in clinical studies, clinical encounters, and multiprofessional comprehen-sive assessment.35
ICF Core Set for HNC head and neck cancer should include a single or a group of diagnoses with similar effects on functioning, disability, and health. It was decided to combine malignan-cies located in the oral cavity, pharynx, larynx, and the salivary glands. The comparably small group of carcinomas of the nose and paranasal sinuses, 3% of all carcinomas of the upper aero-digestive tract,36are not included because of the significant differences in clinical presentation and effects on functioning.
The ICF as such has been designed to facili-tate a multiprofessional teamwork approach, which is required when dealing with head and neck cancer. The treatment for head and neck cancer often requires a coordinated longitudinal care involving physicians (for example otorhi-nolaryngologists, maxillofacial specialists, and medical and clinical oncologists) as well as psy-chologists, physical therapists, speech and swal-lowing therapists, nurses, and social workers.
The ICF Core Sets allow clinicians and
researchers to classify and describe patients’ functioning using widely accepted terminology. Shared terminology and common definitions
facilitate multiprofessional approaches, inter-national studies, and ease the comparison of outcomes.
The main task of the ICF consensus confer-ence for head and neck cancer was to develop internationally accepted ICF Core Sets that are still practical and feasible to apply. This was done in 2 levels: a Brief ICF Core Set to define categories as minimal standards to assess and report on functioning and health in any patient with HNC, and a Comprehensive ICF Core Set applicable to multidisciplinary assessment. Although the Comprehensive ICF Core Set for HNC should include the full spectrum of prob-lems in functioning in patients with head and neck cancer, the Brief ICF Core Set aims to include just the most important categories across countries and health professions.
The ICF Core Set development project for HNC is a cooperation between the Department of Otorhinolaryngology at the Ludwig Maximi-lian University (Munich, Germany), the ICF Research Branch of the WHO Collaboration Centre of the Family of International Classifica-tions (DIMDI, Munich, Germany), the Classifi-cation, Assessment and Terminology team, and partner institutions across the world.37 The ICF Core Set development project for HNC is funded
by the Deutsche Krebshilfe e.V. (nonprofit
organization).
Figure 2 summarizes the time schedule for the ICF Core Set development for head and neck cancer.
The aim of the publication is to present the results of the ICF consensus conference for head and neck cancer: The Comprehensive and Brief ICF Core Sets for HNC.
FIGURE 2. Time schedule of the development process of ICF Core Sets for head and neck cancer.
MATERIALS AND METHODS
The development of ICF Core Sets for HNC must be based on 2 foundations: evidence and consensus. Evidence was created by preparatory studies including the different perspectives involved in head and neck cancer treatment: the perspective of patients as well as the perspec-tives of different health professions involved in treatment and rehabilitation. The preparatory studies identified a preselection of categories and created the basis on which the decision-making process started.
The concept of consensus was initiated by informing as many representatives of the scien-tific community involved in the treatment of head and neck cancer as possible. This has been attempted by publishing a protocol paper to out-line the upcoming process and to call for inter-national cooperation.35 During the process, consensus was reached by involving experienced representatives in good reputation of the dif-ferent health professions involved in head and neck cancer and from all 6 WHO world regions. They were brought together at an ICF consen-sus conference in Switzerland to decide in a multistep consensus process on a first version of ICF Core Sets for HNC.
Preparatory Studies. The preparatory studies were performed to preselect ICF categories that are relevant to head and neck cancer out of the entire ICF classification. The preparatory stud-ies tried to cover the different perspectives rele-vant in head and neck cancer treatment. (1) The patient perspective, which was captured in semistructured patient interviews along 6 pre-defined open questions covering the ICF compo-nents.38 (2) The health professional perspective, which was collected with the same set of ques-tions as applied in the patient interviews. The survey included participants from all WHO-world regions and from the following health professionals: physicians, dentists, psycholo-gists, physical therapists, speech and swallow-ing therapists, nurses, and social workers. (3) An empirical multicenter study at 9 different study centers in 4 European countries to check for the applicability of ICF nomenclature and ICF categories in the field of head and neck can-cer.39,40 (4) The perspective of researchers was covered by a systematic literature review in MEDLINE 2000 to 2006.16,41
Any category that was relevant in at least 5% of the patients in 1 of the preparatory studies qualified for entering the consensus conference. Altogether, the preparatory studies identified 370 categories (25%) of 1454 ICF cate-gories of the entire classification as relevant to head and neck cancer and were presented to the participants. Of these categories, 120 (32%) were from the component body functions, 80 (22%) from body structures, 95 (26%) from activ-ities and participation, and 76 (21%) from contextual environmental factors. These 370 cat-egories were presented to the participants at the conference and built the starting point for the decision-making process.
Invitation Process. The recruitment strategy for participants had to balance the needs for inter-national expertise without compromising a feasi-ble decision-making process. Expert participants were suggested by (1) international and regional societies and (2) clinicians involved in the pre-paratory studies. All names were collected in a matrix covering all professional backgrounds considered relevant (see earlier) and all 6 WHO world regions and random samples were drawn for invitation. If an invitee rejected the invita-tion or did not answer to the invitainvita-tion and its reminder after 2 weeks, a new person was cho-sen and invited.
Consensus Procedure. The ICF consensus con-ference for head and neck cancer involved health professionals from different parts of the world. Twenty-one experts attended the confer-ence and were divided into 3 groups of 7 experts each. Each group consisted of different health
professionals from different countries who
worked actively together for 3 days in a team-work technique called the ‘‘Nominal Group Tech-nique.’’42 The language at the conference was English.
At the beginning of the conference, partici-pants were trained on (1) the structure, princi-ples, and nomenclature of the ICF in general and; (2) the results from the preparatory stud-ies; and (3) the principles of the consensus pro-cess applied during the conference.
The categories to be included in the ICF Core Sets were chosen in 2 different types of sessions: in working groups and in the plenary. Each working group consisted of 7 voting partic-ipants, including a working group leader (BY, SR, AD). Additionally, in each group there was a
nonvoting working group assistant to document group results. In the plenary, working group leaders presented and argued their group deci-sions. However, all participants were allowed to argue during the plenary session. The plenary sessions were moderated by an independent health professional (AC) with circumstantial experience in the ICF but without any personal involvement in head and neck cancer treatment and rehabilitation. She did not vote herself on the inclusion of ICF categories.
The decision-making process included 3 con-secutive steps: (1) selection of ICF categories for the Comprehensive ICF Core Set on second level; (2) selection of categories that require further detailization at higher ICF-levels, ie, third and fourth level; and (3) selection of categories out of the Comprehensive ICF Core Set that should be included in the Brief ICF Core Set for HNC.
The categories for the Brief ICF Core Set for HNC were chosen out of the Comprehensive ICF Core Set by means of a ranking exercise. The cutoff line for the ranking was determined in a separate vote after the ranking.
RESULTS
The Consensus conference on ICF Core Sets for HNC took place on November 22 to 24, 2007, at Nottwil, Switzerland.
Thirty-three international experts were
selected by the invitation and contact criteria. All of them were contacted by mail, informed about the ICF Core Set development project for head and neck cancer, and invited to the confer-ence with a formal letter of invitation. Twenty-one experts (64%) participated in the conference. Of the other 12 who did not agree to participate, 4 of them never answered the invitation mail or the reminder and 8 of them cancelled the invita-tion because of other professional commitments or private reasons.
The 21 participants covered different cul-tural and professional backgrounds (Table 1).
The expert consensus conference agreed a Comprehensive ICF Core Set for HNC and includes 112 different ICF categories: 34 (30%) are from body functions 33 (29%) from body structures, 26 (23%) from activities and partici-pation, and 19 (17%) from contextual environ-mental factors. These 112 categories are just 8% of all categories included in the ICF classifica-tion. They were selected at different levels as
follows: 75 at second level, 30 at third level, and 7 at fourth level. At first, ICF categories were selected on the second level. This level of detaili-zation was satisfactory for the activities and participations and the environmental factors. However, some categories from body structures and body functions required further detailiza-tion into the third and fourth level. For exam-ple, b510, ingestion function, was subdivided into 10 different categories including biting, chewing, sucking, manipulating food in the mouth and different types of swallowing, includ-ing oral, pharyngeal, and esophageal swallow-ing. The category b1801, body image, was chosen instead of the higher, less specific cate-gory b180, experience of self and time.
Some structures beyond the head and neck region were also included. Besides the shoulder region, there were also s7301 (forearm), s760 (the trunk), and s750 (lower extremities). They were mainly chosen to monitor the outcome af-ter flap reconstruction.
Table 1.Participants by professional and cultural background.
Background Participants,n
Professional background Physicians
Otolaryngologists 8
Maxillofacial surgeons 3
Radiation and medical oncologists 4
Psychologists 2
Physiotherapists 2
Nurses 1
Social worker 1
Sum 21
Country, listed by WHO region Africa
South Africa 1
Americas
USA 2
Eastern Mediterranean region
Oman 1 Europe Belgium 2 Germany 5 Israel 1 The Netherlands 1 Poland 1 United Kingdom 3
Eastern Pacific region
Australia 1
South East Asia
India 2
Korea 1
Sum 21
The process of preselection of categories in the preparatory studies was satisfactory for the participants of the conference. No new catego-ries were included in the ICF Core Sets for HNC.
However, 2 faults of the ICF have been iden-tified. In the category s340, structures of larynx, just the vocal cord is specified in the ICF, whereas the supra or subglottic region are not mentioned in the classification. In the category s330, structure of pharynx, just the nasal and oral pharynx are subclassified but not the hypo-pharynx. Therefore, ‘‘other specified’’ categories were included in the Comprehensive ICF Core Set for HNC to cover the missing anatomical regions, and the category ‘‘unspecified’’ was included for cases in which the concrete anatom-ical location might not be available or applicable (Table 2).
The expert consensus conference agreed a Brief ICF Core Set for HNC of 19 different ICF categories: 6 (32%) are from body functions; 4 (21%) from body structures; 6 (32%) from activ-ities and participation; and 3 (16%) from contex-tual environmental factors. These 19 categories account for just 1% of all categories included in the ICF classification (Table 3).
DISCUSSION
A formal consensus process integrated evidence from preparatory studies and expert appraisal and led to the definition of a first version of ICF Core Sets for HNC: (1) a Brief ICF Core Set as minimal standards to describe functioning and (2) a Comprehensive ICF Core Sets for multidis-ciplinary assessment to formulate rehabilitation goals and to evaluate progress.
In a clinical setup, the ICF Core Set for HNC may not be seen in competition to established tools to collect information (for example, vali-dated patient questionnaires, video swallow, speech intelligibility testing), but rather as a
comprehensive framework to structure the
obtained information following the biopsychoso-cial view of the ICF and to guide rehabilitation accordingly.
So far, there is no systematic framework available that covers the broad range of head and neck cancer–related symptoms and limita-tions in functioning. However, all aspects cov-ered by the National Comprehensive Cancer Network43 or the concepts of functioning found in the items of validated head and neck cancer–
specific questionnaires, for example, the UW-QoL,44 EORTC-QLQ-HN35 modules,45 or FACT-HN module,6 are all covered by the Comprehen-sive ICF Core Set for HNC as defined at the ICF Consensus conference.
The process of preselection of categories through 4 different types of preparatory studies was satisfactory for the expert participants at the conference. No new categories were included in the Core Sets. However, in some cases of body structures, the participants identified a deficient anatomical classification in the ICF. For example, some important structures like the supra and subglottic region or the hypopharynx are not adequately represented in the present version of the ICF.
Body functions may indeed be the most im-portant component in patients with head and neck cancer. This is reflected not only by the fact that most categories of the Comprehensive ICF Core Set for HNC are body functions (n ¼ 34) but also by the fact that all chapters avail-able for body functions in the ICF are repre-sented in the Comprehensive ICF Core Set (8/8). When compared with other ICF Core Sets on other major health conditions, for example, breast cancer,34 chronic ischemic heart dis-ease,28 chronic obstructive pulmonary disease,29 stroke,30 diabetes mellitus,31 rheumatoid arthri-tis,32 or depression,33 the Comprehensive ICF Core Set for HNC with more than 100 categories is one of the longer Comprehensive Core Sets so far. However, when compared with other Brief ICF Core Sets, the Brief ICF Core Set for HNC is relatively short and crisp with just 19 catego-ries. Only stroke30 and chronic obstructive pul-monary disease29 have fewer categories with 18 and 17 categories, respectively. This underlines the far-reaching, complex effects on functioning and disability and the numerous interactions with contextual environmental factors caused by head and neck cancer as assessed in comprehen-sive, multidisciplinary assessment necessary for some patients. The breadth of ICF chapters (26/ 30) contained in the Comprehensive ICF Core Set for HNC reflects the important and compre-hensive impairments of patients with head and neck cancer across the 4 ICF components. On the other hand, a relatively short Brief ICF Core Set for HNC shows a well-defined group of core aspects that are relevant in most patients with head and neck cancer.
The Comprehensive ICF Core Set for HNC has the highest percentage of categories that
Table 2.Comprehensive ICF Core Set for head and neck cancer.
ICF code Title
Body functions,n¼34
b117 Intellectual functions
b126 Temperament and personality functions b130 Energy and drive functions
b134 Sleep functions b152 Emotional functions b1801 Body image b230 Hearing functions
b240 Sensations associated with hearing and vestibular function b250 Taste function b255 Smell function b280 Sensation of pain b310 Voice functions b320 Articulation functions
b435 Immunological system functions b440 Respiration functions
b455 Exercise tolerance functions b5100 Sucking
b5101 Biting b5102 Chewing
b5103 Manipulation of food in the mouth b5104 Salivation b51050 Oral swallowing b51051 Pharyngeal swallowing b51052 Esophageal swallowing b51058 Swallowing, other b51059 Swallowing, unspecified b530 Weight maintenance functions b535 Sensations associated with the
digestive system b555 Endocrine gland functions b640 Sexual functions
b710 Mobility of joint functions b730 Muscle power functions b810 Protective functions of the skin b820 Repair functions of the skin Body structures,n¼33
s1106 Structure of cranial nerves s3200 Teeth s3201 Gums s32020 Hard palate s32021 Soft palate s3203 Tongue s3204 Structure of lips
s3208 Structure of mouth, other specified s3209 Structure of mouth, unspecified s3300 Nasal pharynx
s3301 Oral pharynx
s3308 Structure of pharynx, other specified s3309 Structure of pharynx, unspecified s3400 Vocal folds
s3408 Structure of larynx, other than vocal fold s3409 Structure of larynx, unspecified s410 Structure of cardiovascular system s420 Structure of immune system s4300 Trachea
s4301 Lungs
s510 Structure of salivary glands s520 Structure of esophagus s7101 Bones of face
s7103 Joints of head and neck region
ICF code Title
Body structures (continued)
s7104 Muscles of head and neck region
s7105 Ligaments and fasciae of head and neck region s7108 Structure of head and neck region, other specified s7109 Structure of head and neck region, unspecified s720 Structure of shoulder region
s7301 Structure of forearm s750 Structure of lower extremity s760 Structure of trunk
s810 Structure of areas of skin Activities and participationn¼26
d230 Carrying out daily routine
d240 Handling stress and other psychological demands d330 Speaking
d350 Conversation
d360 Using communication devices and techniques d415 Maintaining a body position
d430 Lifting and carrying objects d460 Moving around in different locations d470 Using transportation
d475 Driving
d510 Washing oneself d520 Caring for body parts d550 Eating
d560 Drinking
d570 Looking after one’s health d640 Doing housework
d710 Basic interpersonal interactions d720 Complex interpersonal interactions d750 Informal social relationships d760 Family relationships d770 Intimate relationships
d845 Acquiring, keeping and terminating a job d870 Economic self-sufficiency
d910 Community life d920 Recreation and leisure d930 Religion and spirituality Environmental factors,n¼19
e1100 Food e1101 Drugs
e115 Products and technology for personal use in daily living
e125 Products and technology for communication e165 Assets
e310 Immediate family e320 Friends
e340 Personal care providers and personal assistants e355 Health professionals
e410 Individual attitudes of immediate family members e460 Societal attitudes
e525 Housing services, systems and policies e535 Communication services, systems and policies e555 Associations and organizational services,
systems and policies
e570 Social security services, systems and policies e575 General social support services, systems
and policies
e580 Health services, systems and policies e585 Education and training services, systems
and policies
e590 Labor and employment services, systems and policies
belong to the ICF component of body structures (n ¼ 33, 29%). In other comprehensive Core Sets, the percentage of body structures ranges between 0% in depression to 19% in rheumatoid arthritis. This can partly be explained with sur-gery being a major part of treatment in head and neck cancer. When compared with drug medication, surgery is bound to bring about a change in body structures. In breast cancer, the percentage of relevant body structures in the comprehensive Core Set is 11%. In the group of voting participants, there has been predomi-nance of surgically oriented physicians (otorhi-nolaryngologists and maxillofacial surgeons,n¼ 11). It is up to the validation studies to confirm or deny the relatively strong importance of body structures in the assessment of functioning in patients with head and neck cancer.
The consensus process at the conference was based on the English language. To facilitate group discussions during the conference, non-English-speaking health professionals had been excluded. This might contain a structural bias for countries where English in not taught exten-sively. The issue of the extent and relevance of such a bias will also be addressed in the valida-tion phase following the consensus conference.
For all the aforementioned reasons, the first version of the ICF Core Sets for HNC is only recommended for validation or pilot studies.
Obviously, not all aspects of the Comprehen-sive ICF Core Set can be assessed and treated by 1 health profession alone. Dealing with HNC often requires a coordinated longitudinal care involving otolaryngologists, maxillofacial surgeons, radiation and medical oncologists, dentists, speech and language therapists, psy-chologists, nurses, physical therapists, social workers, etc. Because the ICF provides shared terminology for all health professions it is a promising tool to facilitate the multidisciplinary working approach in head and neck cancer. Shared terminology might also facilitate inter-national multicenter studies and ease the com-parison of study outcomes. To identify which aspects of functioning covered in the ICF Core sets can be collected by which health profes-sions, Delphi exercises have been started in the validation phase. Each Delphi exercise includes participants from all WHO world regions, but only from 1 health profession. The study ques-tion for each of the Delphi exercises is which problems are treated by this health profession.
The general objective of the validation phase is to study the validity and feasibility of the Brief and Comprehensive ICF Core Sets for HNC. In addition, it will be tested to what extend there are typical profiles for the different cancer locations, namely oral carcinoma, sali-vary glands, oro and hypopharynx, and larynx. This will be done in a multicenter cohort study at a network of cooperating organizations world-wide. The specific aim will be to examine the frequencies of patients problems in subsets including age, sex, nationality, socioeconomic factors, comorbidities, etc., to identify the cate-gories with most variance of external standards and to analyze to what extend of the whole spec-trum of disabilities is represented in the Core Set. Rasch analyses will help to understand what extent of the whole spectrum of problems in functioning and disability is represented in the ICF Core Set for HNC.
It is important to note that ICF Core Sets for HNC are not a health status measure themselves. In principle, they are just a comprehensive, agreed-on list of aspects that are relevant for the given disease. They define what should be meas-ured, but not how. They can be seen as a frame-work to guide comprehensive, multidisciplinary follow-up and rehabilitation.
Table 3.Brief ICF Core Set for head and neck cancer.
ICF code Title
Body functions,n¼6
b130 Energy and drive functions b152 Emotional functions b280 Sensation of pain b310 Voice functions b440 Respiration functions b510 Ingestion functions Body structures,n¼4 s320 Structure of mouth s330 Structure of pharynx s340 Structure of larynx
s710 Structure of head and neck region Activities and participation,n¼6
d230 Carrying out daily routine d330 Speaking d550 Eating d560 Drinking d760 Family relationships d870 Economic self-sufficiency Environmental factors,n¼3
e110 Products or substances for personal consumption (ie, food, drugs)
e310 Immediate family e355 Health professionals
In terms of selection of health status meas-ures, they add value by comparing the aspects covered by any measurement tool to the compre-hensive view of the ICF Core Set. The applica-tion range of a given health status measures and its place in the entire rehabilitation process can be easily demonstrated. ICF Core Sets can also be used to rate the content validity of health status measures and, thereby, select appropriate instruments for the specific needs of the patient.23,41,46–48
Comparability of functioning across different conditions, for example, between different can-cer types, can be based on the communalities and differences in ICF categories. Multivariate
models can explain variance and establish
anchor points.49 Different from generic or dis-ease-specific health status measures, the ICF Core Sets include not only patient-reported aspects but also important body functions and structures as well as contextual factors. This enables a far more comprehensive and therefore valid description of functioning. Although there are a number of generic and disease-specific health status measures for a disease, there is just 1 ICF classification in the world.
The use of defined ICF responder categories also provides an important step toward im-proved communication between heath profes-sionals and healthcare providers and will enable patients and their families to understand and communicate with health professionals about their functioning in life and connected treat-ment goals. The consistent use of ICF categories to describe patients’ functioning and standardize reporting on ICF intervention target categories might be a major step toward better interpret-ability and comparinterpret-ability of studies. This is especially true for multidisciplinary interven-tions, where we are currently often faced with a black box regarding both intervention targets and outcomes.49Last, but not least, the ICF and the ICF Core Sets can be a tool for teaching stu-dents and young colleagues staring their careers in any medical field and may facilitate multipro-fessional learning.50,51
The development of a globally acceptable frame of reference to describe functioning in head and neck cancer is a tremendous task requiring several small, incremental steps. A first step is to define which aspects of function-ing should be assessed. We now have a first ver-sion of an agreed-on list of relevant aspects in the format of ICF Core sets for HNC. However,
they are still object to further validation and ongoing improvements.
To anchorage the comprehensive biopsycho-social perspective included in the ICF into head and neck cancer treatment and follow-up, mea-surement tools have to be selected that collect information on the different aspects covered by the categories of the ICF Core Set for HNC. Many of the health status measures available in this research are seriously validated and might be well applicable to many aspects of the ICF Core Sets for HNC. However, still there has to be agreement on which instruments and scales are relevant for which aspects in the rehabilita-tion process. Addirehabilita-tionally, there might still be a ‘‘diagnostic gap’’ in a way that for some relevant aspects, as defined in the ICF Core Set for HNC, there is no appropriate health status mea-sure available. Possibly, for these aspects new ICF-based health status measures need to be developed. An alliance of items of the ICF Core Set with corresponding health status measures and assessment of their clinical applicability in terms of delivering clear answers to the clini-cian will be a next step and demands multidisci-plinary collaboration.
In conclusion, the development of a first ver-sion of ICF Core Sets for head and neck cancer is just a first step in the development of a world-wide accepted and standardized tool for the assessment of functional impairment of head and neck cancer. Establishing standardized ICF Core Sets for head and neck cancer in the long run should be useful for clinical practice, teach-ing, medical research, and cooperation between the various players in a modern healthcare system.
Acknowledgments. The authors thank all patients, clinicians, and scientists involved in the preparatory studies for their contributions. Especially, they thank the organizing team of the conference at the ICF research branch in Munich: Sven Becker, Michaela Coenen,
Heinrich Gall, Sandra Kus, and Elisabeth
Linseisen.
The authors are grateful for the creative and enthusiastic contributions made by the fol-lowing experts attending the conference: Kirsten Becker-Bikowski, Viktor Bonkowski, Andreas Dietz, Johan Fagan, Gerry Funk, Ulrich Har-reus, Suhel Hasan, Gerry Humphris, Shulamith Kreitler, Arun Maiya, Gerson Mast, Megan
Nutt, Christopher Nutting, Sandra Nuyts, Keunchil Park, Simon Rogers, Marek Rogowski, Nick Slevin, Jan Vermorken, Gert Walrave, Bevan Yueh.
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