Relationship Between FEV1 and Patient-Reported Outcomes Changes: Results of a Meta-Analysis of Randomized Trials in Stable COPD.

Background: This meta-analysis assessed the relationship between change from baseline (CFB) in spirometric measurements (trough forced expiratory volume in 1 second [FEV1] and FEV1 area under the curve [AUC]) and patient-reported outcomes (St. George's Respiratory Questionnaire total score [SGRQ] CFB, Transition Dyspnea Index [TDI] and exacerbation rates) after 6-12 months' follow-up, using study treatment-group level data. Methods: A systematic literature search was performed for randomized controlled trials of ≥24 weeks duration in adults with chronic obstructive pulmonary disease (COPD). Studies reporting ≥1 spirometric measurement and ≥1 patient-reported outcome (PRO) at baseline and at study endpoint were selected. The relationships between PROs and spirometric endpoints were assessed using Pearson correlation coefficient and meta-regression. Results: Fifty-two studies (62,385 patients) were included. Primary weighted analysis conducted at the last assessment showed a large significant negative correlation (r, -0.68 [95% confidence interval (CI); -0.77, -0.57]) between trough FEV1 and SGRQ. Improvement of 100 mL in trough FEV1 corresponded to a 5.9 point reduction in SGRQ. Similarly, a reduction of 4 points on SGRQ corresponded to 40 mL improvement in trough FEV1 (p<0.001). The weighted correlation coefficients of trough FEV1 with TDI, exacerbation rate (all) and exacerbation rate (moderate/severe) at last assessment point were 0.57, -0.69 and -0.57, respectively (all p<0.05). For the analyses excluding placebo groups, the correlations of FEV1 with SGRQ and TDI were lower but significant. Conclusions: A strong association exists between changes in spirometric measurements and changes in PROs.

Inhaled ß-agonist does not modify sympathetic activity in patients with COPD.

BACKGROUND: Neurohumoral activation is present in COPD and might provide a link between pulmonary and systemic effects, especially cardiovascular disease. Because long acting inhaled ß-agonists reduce hyperinflation, they could reduce sympathoexcitation by improving the inflation reflex. We aimed to evaluate if inhaled therapy with salmeterol reduces muscle sympathetic nerve activity (MSNA) evaluated by microneurography. METHODS: MSNA, heart rate, blood pressure, and respiration were continually measured. After baseline recording of 20 minutes, placebo was administered; after further 45 minutes salmeterol (50 µg) was administered which was followed by a further 45 minutes of data recording. Additionally, lung function, plasma catecholamine levels, arterial pulse wave velocity, heart rate variability, and baroreflex sensitivity were evaluated. Following 4 weeks of treatment with salmeterol 50 µg twice daily, measurements were repeated without placebo administration. RESULTS: A total of 32 COPD patients were included. Valid MSNA signals were obtained from 18 patients. Change in MSNA (bursts/100 heart beats) following acute administration of salmeterol did not differ significantly from the change following placebo (-1.96 ± 9.81 vs. -0.65 ± 9.07; p = 0.51) although hyperinflation was significantly reduced. Likewise, no changes in MSNA or catecholamines were observed after 4 weeks. Heart rate increased significantly by 3.8 ± 4.2 (p < 0.01) acutely and 3.9 ± 4.3 bpm (p < 0.01) after 4 weeks. Salmeterol treatment was safe and well tolerated. CONCLUSIONS: By using microneurography as a gold standard to evaluate sympathetic activity we found no change in MSNA following salmeterol inhalation. Thus, despite an attenuation of hyperinflation, the long acting ß-agonist salmeterol does not appear to reduce nor incite sympathoexcitation. TRIAL REGISTRATION: This study was registered with the European Clinical Trials Database (EudraCT No. 2011-001581-18) and ClinicalTrials.gov ( NCT01536587 ).

Assessment of functional outcomes in patients with head and neck cancer according to the International Classification of Functioning, Disability and Health Core Sets from the perspective of the multi-professional team: results of 4 Delphi surveys.

BACKGROUND: The International Classification of Functioning, Disability and Health Core Set for Head and Neck Cancer (ICF-HNC) covers the typical spectrum of problems in functioning in head and neck cancer. This study is part of a multistep process to develop practical guidelines in Germany. The purpose of this study was to identify instruments for the assessment of functioning using the ICF-HNC as reference. METHODS: Four Delphi surveys with physicians, physiotherapists, psychologists, and social workers were performed to identify which aspects of the ICF-HNC are being treated and which assessment tools are recommended for the assessment of functioning. RESULTS: Ninety-seven percent categories of the ICF-HNC were treated by healthcare professionals participating in the current study. Altogether, 33 assessment tools were recommended for therapy monitoring, food intake, pain, further organic problems/laboratory tests, and psychosocial areas. CONCLUSION: Although the ICF-HNC is being currently implemented by the head and neck cancer experts, several areas are not covered regularly. Additionally, validated tools were rarely recommended.

Assessment of functional outcomes in head and neck cancer.

The goals of the present publication are (a) to identify standardised methods and tools applied in clinical trials and cohort studies to assess key functional aspects in HNC, using the Brief ICF Core Set for head and neck cancer (ICF-HNC) as a reference and (b) to propose a set of sound standardised methods and tools suitable to assess functional problems in HNC. This work contributed to the development of practical ICF-HNC based guidelines targeting the standardised measurement of functional outcomes in HNC follow-up and clinical research in Germany. A systematic review of randomised and clinical controlled trials, and observational studies in HNC were carried out to identify standardised methods and tools. Suitable methods and tools were then selected based on pre-defined criteria. 210 assessment methods and tools were identified in 136 studies: 146 patients reported outcomes (PRO) and 64 tools rated by health professionals. Altogether 59 tools were considered suitable to be included in guidelines: four side effects classifications, two performance status scales, 31 PROs, 10 assessment criteria for clinical examinations, seven assessment methods and tools for the evaluation of technical, equipment-based procedures and five technical, equipment-based procedures. It was possible to identify and select sound and standardised assessment methods and tools for almost all functioning areas defined in the ICF-HNC. Since no tool sufficiently covers support provision by immediate family and by health professionals as well as economic self-sufficiency, we recommend a corresponding update of existing tools.

Priorities of head and neck cancer patients: a patient survey based on the brief ICF core set for HNC.

The International Classification of Functioning, Disability and Health Core Set for Head and Neck Cancer (ICF-HNC) covers the typical spectrum of problems in functioning experienced by patients with head and neck cancer (HNC). The major goal of the present work was to evaluate patients' priorities using the brief ICF-HNC as a starting point. A priorities assessment checklist consisting of 15 statements was created based on the 14 validated categories of the brief ICF-HNC. In a cross-sectional study, patients were requested to select up to 5 items that were especially important to them. The checklist was sent by mail to 465 patients at different time points of cancer follow-up and handed out to 56 patients with recent HNC diagnosis. Altogether 300 (64.51 %) patients returned the checklist. The top priority of our sample was "I want to survive the cancer", followed by "I want that all the expenses for cancer treatment, cancer care and any additional follow-up treatments be covered by my health insurance or by the welfare system", "I want to be able to continue performing all daily life tasks well", "I want to have trusting relationships with my doctors, nurses and therapists" and "I want to be able to speak clearly". Although survival was, as expected, the top priority for patients enrolled in the study, we show that the weight given to survival and further symptoms or daily life activities meaningfully changes when the biopsychosocial perspective proposed in the ICF is adopted.

Phase I clinical study of vascular targeting fluorescent cationic liposomes in head and neck cancer.

The aim of this first-time-in-human non-randomized dose-escalating prospective phase I clinical trial was to analyze safety of two doses of fluorescent rhodamine-labeled cationic liposomes (LDF01) in head and neck squamous cell carcinoma (HNSCC). Patients had resectable UICC stadium I-IV A HNSCCs. LDF01 was administered before tumor resection under general anesthesia as an intravenous infusion with effective lipid doses of 0.5 or 2 mg/kg b.w., respectively. In addition to clinical monitoring for safety assessment, tumor biopsies were taken during the surgical procedure for fluorescence histological analysis. Eight patients were assigned to the two dose groups. During safety follow-up no clinically relevant adverse events occurred. Fluorescence histology revealed some evidence of favorable selectivity of LDF01 for tumor microvessels in the high-dose group. LDF01 is safe applied as infusion at both tested dose levels. Furthermore, LDF01 can be detected in the vicinity of tumor cells and could be assigned to the microvessel target in individual HNSSC cases. Detailed analysis of targeting properties of LDF01 has to be performed in upcoming clinical phase II trials.

What domains of the International Classification of Functioning, Disability and Health are covered by the most commonly used measurement instruments in traumatic brain injury research?

OBJECTIVE: To identify the most frequently used outcome measurement instruments reported in clinical studies on TBI and to provide a content comparison in the framework of the International Classification of Functioning, Disability and Health (ICF). PATIENTS AND METHODS: A systematic literature review of clinical studies in TBI was performed using Medline, EMBASE and PsychINFO. The items of the measurement instruments present in more than 20% of the studies were linked to the ICF language. RESULTS: 193 papers fulfilled the eligibility criteria. The frequency analysis identified six instruments: Functional Independence Measure (50%), Glasgow Outcome Scale (34%), Disability Rating Scale (32%), Wechsler Adult Intelligence Scale (29%), Trail Making Test (26%) and Community Integration Questionnaire (22%). The analysed instruments focus on different aspects of body functions (especially DRS, WAIS and TMT) and aspects of activities and participation in life (especially CIQ and FIM). Inter-researcher agreement for the ICF linking process was 0.83. CONCLUSIONS: Translating the items of different measurement instruments into the ICF language provides a practical tool to facilitate content comparisons among different outcome measures. The comparison can assist clinical researchers to integrate information acquired from different studies and different tools.

Preservation of organ function in head and neck cancer.

Preservation of function is a crucial aspect for the evaluation of therapies applied in the field of head and neck cancer. However, preservation of anatomic structures cannot automatically be equated with preservation of function. Functional outcome becomes increasingly important particularly for the evaluation of alternative treatment options with equivalent oncological outcomes.AS A RESULT, PRESENT STUDIES TAKE INTO ACCOUNT THREE TOPIC AREAS WITH VARYING EMPHASIS: (1) the effects of cancer therapy on essential physiological functions, (2) additional therapy-induced side-effects and complications, and (3) health-related quality of life. The present article summarizes vital aspects of clinical research from recent years. Functional outcomes after surgical and non-surgical treatment approaches are presented according to tumor localization and staging criteria. Additional methodological aspects relating to data gathering and documentation as well as challenges in implementing the results in clinical practice are also discussed.

Perspective of physicians within a multidisciplinary team: content validation of the comprehensive ICF core set for head and neck cancer.

BACKGROUND: The Comprehensive International Classification of Functioning, Disability and Health Core Set for Head and Neck Cancer (ICF-HNC) is an application of the ICF and guides multidisciplinary cancer follow-up and rehabilitation in patients with head and neck cancer. The objective of this study was to understand the role of physicians within the multidisciplinary team and to explore the content validity of the ICF-HNC from the perspective of physicians. METHODS: In a 3-round Delphi survey, physicians experienced in the treatment of head and neck cancer were asked what patients' problems, resources, and aspects of environment they treat. The responses of the first round were linked to the ICF. In the second round the participants received a list of identified ICF categories and were asked if these ICF categories represent patients' problems, resources, and aspects of the environment they treat. Round 3 required a reconsideration of the given answers in accord with the group response. The agreement of the linking process between 2 health care professionals was calculated using kappa statistics. RESULTS: In all, 55 physicians from 25 countries gave 781 statements; 83 ICF categories were linked to the statements after the first round; 55 ICF categories reached consensus of ≥ 75% after the third round. Of these, 46 categories (84%) are already included in the ICF-HNC. Within the entire ICF-HNC, physicians treat most categories from body structures (88%) and functions (76%) and some categories from activities and participation (15%) and environmental factors (21%). The kappa coefficient for linking ICF categories was 0.988 (95% bootstrapped confidence interval: 0.95-0.99). CONCLUSIONS: The content validity of the ICF-HNC was supported by the perspective of physicians. This study supports the need for a multidisciplinary team. The aspects of functioning which are not treated by physicians should be addressed by timely involvement of other health professions.

Functional outcome in patients with advanced head and neck cancer: surgery and reconstruction with free flaps versus primary radiochemotherapy.

The objective was to compare functional outcome in patients with advanced head and neck cancer (HNC) treated with (a) surgical resection and reconstruction with microvascular free flaps (MVFF) followed by radiochemotherapy versus (b) primary radiochemotherapy (RCT) on the basis of the International Classification of Functioning, Disability and Health (ICF) from WHO. This was a cross-sectional, multi-institutional study. The outcome measures included ICF Core Sets for HNC, the EORTC-QLQ, modules c30 + hn35 and the University of Washington-Quality of life Questionnaire (UW-QOL). Analyses included descriptive statistics, ranking exercises, and regression analyses in a cumulative logit model; 27 patients were treated with MVFF and 22 with RCT. Global Quality of life scores suggested a slightly better functional outcome for the surgical approach. The majority of ICF categories (81/93, 87%) did not show a difference in functional outcome between the two treatment approaches. In the remaining 12 ICF categories, n = 3 body structures were more affected in the MVFF group, while n = 3 body functions, and n = 6 activities/participations were more problematic in the RCT group. This included oral swallowing and weight maintenance functions as well as social relationships, acquiring a job, and economic self-sufficiency. In addition, nine contextual environmental factors were more relevant to the RCT group. Both treatment approaches seemed appropriate to advanced HNC from the perspective of functional outcome. The influence of treatment modalities on the social and economic lives of cancer survivors needs to be explored further. In order to guide rehabilitation according to patients' needs, the ICF offers a multidimensional view comprising body structures, body functions, and activities and participation in life.

ICF use to identify common problems on a TBI neurorehabilitation unit in Spain.

OBJECTIVE: To describe functioning and health of individuals with traumatic brain injury (TBI) based on the International Classification of Functioning, Disability and Health (ICF). METHODS: A cross-sectional, prospective study was conducted in a neurorehabilitation hospital. Data collection included socio-demographic factors, single interviews based on the extended ICF Checklist 2.1 for TBI, patient ratings on general health and functioning status, WHOQoL, EQ5D and the Comorbidity Questionnaire. RESULTS: 103 patients (81%males) were included in the study. The mean of age was 34 yrs. 24% were inpatients whereas 76% were outpatients. 130 out of 150 categories (87%) of the extended checklist were relevant in > 10% of patients. Differences in functioning and disability between patients in the shorter versus long term situation were noted to be predominantly in the ICF domains of Activities and Participation as well as in Body Functions. Correlations between EQ5D and ICF-based data collections were all p < 0.01. CONCLUSIONS: This study identified the most common problems in patients with TBI receiving Neurorehabilitation services based on the ICF. Results emphasize the need to describe disability and rehabilitation standards from a comprehensive perspective that not only includes Body Functions and Structures but also the ICF domains of Activities and Participation and Environmental factors.

ICF Core Set for head and neck cancer: do the categories discriminate among clinically relevant subgroups of patients?

The multidisciplinary assessment of functioning in patients with head and neck cancer (HNC) according to the ICF Core Set for Head and Neck Cancer (ICF-HNC) was developed in an international and multi-disciplinary approach. The ICF-HNC is an application of the ICF that was adopted by the World Health Organization. The objective of this study was to test whether categories of the ICF-HNC can discriminate among clinically relevant differences in patients. This was a cross-sectional multicentre study in which 267 patients with HNC from 11 different countries participated. All categories were tested within a cumulative logit model to identify which ICF-categories show differences in tumour location, staging, treatment modalities and time since treatment. In the comprehensive ICF-HNC, 84 of the tested categories (76%) reflect differences in at least one of the given parameters. In the Brief ICF Core Sets for HNC (ICF-HNC), all 19 categories (100%) reflect differences. Two categories (social relationships and economic self-sufficiency) showed significant differences among all tested criteria. Most categories of the ICF-HNC are sensitive to clinically relevant differences in the study population. Especially, the ICF component 'activities and participation' holds categories with high discriminative ability for clinically relevant differences. These aspects should be carefully included into rehabilitation plans for HNC.

Does laryngopharyngeal reflux cause intraoral burning sensations? A preliminary study.

Intraoral burning sensations are a common problem in the otolaryngological practice. The aim of this study was to evaluate if laryngopharyngeal reflux can cause intraoral burning sensations by measuring oropharyngeal acid reflux. Patients with recurring intraoral burning sensations underwent oropharyngeal pH monitoring in our outpatient clinic. The pH catheter was placed at the level of the uvula. The catheter contained an externally worn transmitter, which wirelessly sent the data to a monitor. In addition, patients were instructed to indicate meals or the occurrence of burning sensations by pressing provided buttons on the monitor. Corresponding events of burning sensations and a significant decrease in oropharyngeal pH values should be visualized. Twenty two patients suffering from recurring intraoral burning sensations underwent oropharyngeal pH measurement for 21-25 h. We could find oropharyngeal reflux episodes in 11 patients. However, we could not detect any episodes of burning sensations in the mouth corresponding with a decrease in oropharyngeal pH values. Our results suggest that there is no causal connection between LPR episodes and the occurrence of intraoral burning sensations in the examined patients. Although further studies with more patients are necessary in the future, we conclude from our findings that recurring intraoral burning sensations are not an indication for proton pump inhibitor therapy.

Graphical modeling can be used to illustrate associations between variables describing functioning in head and neck cancer patients.

OBJECTIVE: To examine the associations between variables of functioning measured by the International Classification of Functioning, Disability and Health (ICF) in head and neck cancer (HNC) patients by means of graphical modeling. STUDY DESIGN AND SETTING: Graphical modeling was used on a data set of a cross-sectional multicentric study of 145 patients with HNC. Functioning was qualified using the extended ICF checklist. Multiple imputation was used to handle missing data. The least absolute shrinkage and selection operator for generalized linear models was used to identify conditional associations between the ICF categories. Bootstrap aggregating was used to enhance the accuracy and validity of model selection. RESULTS: The resulting graph shows largely meaningful associations between the ICF categories. One central point could be visualized consisting of a circular path of d330 Speaking, d350 Conversation, b510 Ingestion functions, s320 Structure of mouth, and b310 Voice functions. Another important structure in the graph were the bow-shaped associations beginning with d335 Producing nonverbal messages to b130 Energy and drive functions. CONCLUSION: Graphical modeling can be used to describe associations between different areas of functioning in HNC patients. They found associations can be the basis for improved rehabilitation and gives a deeper understanding of functioning in HNC patients.

Changing the perspective: current trends in the assessment of functional outcome in patients with head and neck cancer.

Functional outcome and quality of life have become frequent outcome measures in head and neck cancer (HNC) clinical trials. Many thoroughly validated outcome measures are available. Still, there is a low degree of standardization and comparability among measures. It seems difficult to fully translate the new insights into clinical routine. The aims of this paper are 1) to acknowledge the diversity of outcome measures and many of the past milestones that have been reached, but also 2) to capture a growing need to concentrate and reach consensus. The hypothesis is to gain more benefit from changing the perspective toward consensus rather than diversity in functional outcome assessment. The next steps are to adopt a unique "language" to describe functional outcome and implement clear end points that assist clinical decision making. The International Classification of Functioning, Disability, and Health was adopted by the WHO and offers an internationally accepted classification to describe disability in HNC.

Content validation of the international classification of functioning, disability and health core sets for head and neck cancer: a multicentre study.

OBJECTIVE: the International Classification of Functioning, Disability and Health (ICF) Core Sets for head and neck cancer (HNC) structure the assessment of functioning and guide rehabilitation. They are an application of the ICF that was adopted by the World Health Organization. They exist in a first version as a Comprehensive Core Set (CCS) with 112 categories for multidisciplinary assessment and clinical studies and as a Brief Core Set (BCS) with 19 categories for data collection in clinical routine. The BCS is a selection of the most important categories from the CCS. The objective of this study was to test whether the CCS and BCS are relevant in patients with HNC treated in different departments and countries across the world. DESIGN: a multicentre, cross-sectional study was conducted with 276 patients at 14 international study-centres. Data collection included departments of otolaryngology, maxillofacial surgery, hemato-oncology, psychiatry, speech therapy, and physiotherapy. METHODS: questionnaires on the CCS, the University of Washington Quality of Life questionnaire (UW-QOL version 4), and European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ) modules c30 and hn35 were completed by patients and health professionals. Frequency analyses and Spearman correlations were applied. RESULTS: for the CCS, 105 of 112 categories (94%) were confirmed. New categories were not identified. For the BCS, 14 of 19 categories (74%) were confirmed, whereas several additional categories of the CCS have qualified for upgrading and inclusion in the BCS. Correlations between the UW-QOL and EORTC-QLQ (modules c30 and hn35) to the ICF-based data collection were satisfactory (mostly p < .01). CONCLUSION: the CCS proved to be exhaustive and covers a broader range of aspects than any of the tested questionnaires. Final selection of categories out of the CCS into the BCS requires further studies.

Health professional perspective on disability in head and neck cancer.

OBJECTIVES: To evaluate problems after head and neck cancer (HNC) from the multidisciplinary team perspective; to classify the results using the International Classification of Functioning, Disability, and Health (ICF); and to compare the results with a patient perspective. DESIGN: Internet-based survey. PARTICIPANTS: There were 103 participants from 27 countries: 50 physicians (otolaryngologists, maxillofacial specialists, and radiation and medical oncologists) and 53 nonphysicians (dentists, psychologists, physiotherapists, speech swallowing therapists, nurses, and social workers). INTERVENTIONS: Health professionals involved in the treatment of HNC were asked about relevant problems. The survey was Internet based and included 5 questions, 1 for each of the ICF components: Body Functions, Body Structures, Activities and Participation, and contextual Environmental and Personal factors. Answers were translated into ICF categories by 2 independent researchers, and frequencies were calculated. The results were compared with the outcomes of patient interviews based on similar questions. RESULTS: A total of 3643 different answers translated into the ICF using 160 different second-level ICF categories. Less than 1% of answers were not covered by the ICF. There was high consistency in the ratings of food ingestion, pain, and the relevance of the immediate family. In general, health professionals tended to emphasize aspects of anatomical defects and body image, whereas areas of speech and exercise tolerance functions were more often named by patients. CONCLUSIONS: The ICF seems to be a comprehensive tool for classifying problems after HNC from the multidisciplinary health professional perspective. There are important differences between the health professional and patient perspectives. We should be aware of this during cancer follow-up sessions and in the creation of rehabilitation plans.

Content validation of the Comprehensive ICF Core Set for Head and Neck Cancer (HNC): the perspective of psychologists.

OBJECTIVE: The 'Comprehensive ICF Core Set for Head and Neck Cancer (HNC)' 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 HNC. The objective of this study was to explore the content validity of this Core Set from the perspective of psychologists. METHODS: Psychologists experienced in HNC treatment were asked about the patients' problems, resources and aspects of environment they treat in HNC patients in a three-round Delphi survey. First round responses were linked to the ICF. In round two a list of all identified ICF categories was sent to the participants and they were asked whether the listed ICF categories represent the patients' problems, resources and the aspects of the environment psychologists treat in HNC patients. In round three the participants were requested to reconsider their decisions based on the group response. Kappa statistics was used to describe the agreement between the two health care professionals who performed the linking. RESULTS: 34 psychologists from 15 countries named 728 concepts covering all ICF components. 98 ICF categories were linked to these answers. 27 concepts were linked to the not yet developed ICF component 'personal factors'. Kappa coefficient reached 0.71 (95% bootstrapped CI 0.64-0.77). CONCLUSION: The validity of the Comprehensive ICF Core Set for HNC was largely supported by the perspective of psychologists. However, some categories considered relevant for psychologists but currently not covered by the Comprehensive ICF Core Set for HNC require further investigation.

Development of ICF core sets for head and neck cancer.

BACKGROUND: Based on the International Classification 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 Organization (WHO) in 2001 and was used as the frame of reference. Preselection of potential ICF categories was based on 4 different preparatory studies: patient interviews, health professional surveys, literature review, and multicenter study applying ICF-nomenclature. After training 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. Professional backgrounds included otorhinolaryngologists, maxillofacial 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.

Assessment of functioning in patients with head and neck cancer according to the International Classification of Functioning, Disability, and Health (ICF): a multicenter study.

OBJECTIVES: To assess the level of functioning in patients with head and neck cancer (HNC) using the the International Classification of Functioning, Disability, and Health (ICF). METHODS: Multicenter study at nine different study centers in four European countries. Data collection included structured interviews according to the extended ICF checklist with 145 HNC patients and completion of the European Organization for Research and Treatment of Cancer-Quality of Life Questionnaires (EORTC-QLQ). The generic ICF checklist was extended by additional HNC-specific categories identified in six HNC-specific questionnaires: EORTC, University of Washington Quality of Life (UW-QOL), Functional Assessment of Cancer Therapy scale (FACT), Performance Status Scale for Head and Neck cancer patients (PSS-HN), Head and Neck Quality of Life instrument (HN-QOL), and Voice Handicap Index (VHI). The ICF qualifier system was applied on a scale from 0 (not impaired) to 4 (completely impaired), as well as "ns, na" (not specified, not applicable) and "c" (impaired due to comorbidity). ICF categories impaired due to HNC (1-4) in > or = 10% of patients were reported. RESULTS: One hundred fifteen (80%) of 144 categories of the extended ICF checklist were identified to be at least mildly impaired or restricted in > or = 10% of patients. The four areas that were relevant to most of the patients were "immediate family" (91%), "friends" (86%), "health services and policies" (85%) and "health professionals" (85%), all belonging to the ICF component of environmental factors. The most often identified categories were "ingestion" (75%) for body functions and "speaking" (76%) for activities and participation. The summary score of all answers correlated well with the overall level of health and quality of life as assessed in the EORTC questionnaires (0.59, 0.61, respectively). CONCLUSIONS: The ICF identifies problems in functioning in patients with HNC comprehensively. The results emphasize the importance of contextual environmental factors. In particular, environmental factors referring to interpersonal support should be more strongly included in rehabilitation plans for HNC.