Armin Stucki

Identifying the concepts contained in outcome measures of clinical trials on four internal disorders using the International Classification of Functioning, Disability and Health as a reference.

OBJECTIVES To systematically identify and compare the concepts contained in outcome measures of clinical trials on chronic ischaemic heart disease, diabetes mellitus, obesity, and obstructive pulmonary disease, including asthma using the International Classification of Functioning, Disability and Health (ICF) as a reference. METHODS Randomized controlled trials between 1993 and 2003 were located in MEDLINE and selected according predefined criteria. The outcome measures were extracted and the concepts contained in the outcome measures were linked to the ICF. RESULTS 166 trials on chronic ischaemic heart disease, 227 trials on diabetes mellitus, 428 trials on obesity, and 253 trials on obstructive pulmonary disease were included. Ten different health status questionnaires (fulfilling the inclusion criteria) were extracted in chronic ischaemic heart disease, 19 in diabetes mellitus, 47 in obesity, and 39 in obstructive pulmonary disease. Across conditions at least 75% (range 75-92%) of the extracted concepts could be linked to the ICF. In diabetes mellitus and obesity the most used ICF categories were general metabolic functions (b540), in obstructive pulmonary disease respiration functions (b440) and in chronic ischaemic heart disease heart functions (b410). CONCLUSION In all 4 health conditions the majority of studies were drug trials focusing on clinically relevant parameters and not on functioning. The ICF provides a useful reference to identify and quantify the concepts contained in outcome assessment used in clinical trials.

ICF CORE SETS FOR OBESITY

OBJECTIVE To report on the results of the consensus process integrating evidence from preliminary studies to develop the first version of the Comprehensive ICF Core Set and the Brief ICF Core Set for obesity. METHODS A formal decision-making and consensus process integrating evidence gathered from preliminary studies was followed. Preliminary studies included a Delphi exercise, a systematic review and an empirical data collection. After training in the ICF and based on these preliminary studies relevant ICF categories were identified in a formal consensus process by international experts from different backgrounds. RESULTS The preliminary studies identified a set of 219 ICF categories at the second, third and fourth ICF levels with 87 categories on body functions, 34 on body structures, 53 on activities and participation and 45 on environmental factors. Twenty-one experts attended the consensus conference on obesity (18 physicians with various sub-specializations and 3 physical therapists). Altogether 109 categories (108 second-level and one third-level categories) were included in the Comprehensive ICF Core Set with 30 categories from the component body functions, 18 from body structures, 28 from activities and participation and 33 from environmental factors. The Brief ICF Core Set included a total of 9 second-level categories with 3 on body functions, 4 on activities and participation and 2 on environmental factors. No body-structures categories were included in the Brief ICF Core Set. 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 obesity. Both the Comprehensive ICF Core Set and the Brief ICF Core Set were defined.

ICF Core Sets for chronic ischaemic heart disease

OBJECTIVE To report on the results of the consensus process integrating evidence from preliminary studies to develop the first version of a Comprehensive ICF Core Set, and a Brief ICF Core Set for chronic ischaemic heart disease. METHODS A formal decision-making and consensus process integrating evidence gathered from preliminary studies was followed. Preliminary studies included a Delphi exercise, a systematic review and an empirical data collection. After training in the ICF and based on these preliminary studies relevant ICF categories were identified in a formal consensus process by international experts from different backgrounds. RESULTS The preliminary studies identified a set of 253 ICF categories at the second, third and fourth ICF levels with 89 categories on body functions, 25 on body structures, 82 on activities and participation and 57 on environmental factors. Sixteen experts attended the consensus conference on CIHD (11 physicians with various sub-specializations and 3 physical therapists). Altogether 61 second-level categories were included in the Comprehensive ICF Core Set with 14 categories from the component body functions, one from body structures, 17 from activities and participation and 29 from environmental factors. The Brief ICF Core Set included a total of 36 second-level categories with 10 on body functions, one on body structures, 13 on activities and participation and 12 on environmental factors. 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 CIHD. Both the Comprehensive ICF Core Set and the Brief ICF Core Set were defined.

Content comparison of health status measures for obesity based on the international classification of functioning, disability and health

Objective:To compare the content covered by twelve obesity-specific health status measures using the International Classification of Functioning, Disability and Health (ICF).Design:Obesity-specific health status measures were identified and then linked to the ICF separately by two trained health professionals according to standardized guidelines. The degree of agreement between health professionals was calculated by means of the kappa (κ) statistic. Bootstrapped confidence intervals (CI) were calculated. The obesity-specific health-status measures were compared on the component and category level of the ICF.Measurements:Twelve condition-specific health-status measures were identified and included in this study, namely the obesity-related problem scale, the obesity eating problems scale, the obesity-related coping and obesity-related distress questionnaire, the impact of weight on quality of life questionnaire (short version), the health-related quality of life questionnaire, the obesity adjustment survey (short form), the short specific quality of life scale, the obesity-related well-being questionnaire, the bariatric analysis and reporting outcome system, the bariatric quality of life index, the obesity and weight loss quality of life questionnaire and the weight-related symptom measure.Results:In the 280 items of the eight measures, a total of 413 concepts were identified and linked to the 87 different ICF categories. The measures varied strongly in the number of concepts contained and the number of ICF categories used to map these concepts. Items on body functions varied form 12% in the obesity-related problem scale to 95% in the weight-related symptom measure. The estimated κ coefficients ranged between 0.79 (CI: 0.72, 0.86) at the component ICFs level and 0.97 (CI: 0.93, 1.0) at the third ICFs level.Conclusion:The ICF proved highly useful for the content comparison of obesity-specific health-status measures. The results may provide clinicians and researchers with new insights when selecting health-status measures for clinical studies in obesity.

Part 1. International Classification of Functioning, Disability and Health (ICF) Core Sets for persons with sleep disorders: Results of the consensus process integrating evidence from preparatory studies

BACKGROUND/OBJECTIVES The International Classification of Functioning, Disability and Health (ICF) provides a comprehensive and universally accepted framework to classify changes in functioning related to health conditions. Comprehensive and Brief Core Sets have been defined for various disorders but not for sleep disorders. Such a Core Set would greatly enhance the techniques available to describe the impact of sleep disorders on patients. The overarching purpose of this paper is to report on phase 1 of the international and World Health Organization (WHO) endorsed consensus process in identifying ICF Core Sets for sleep disorders. METHODS A formal decision-making and consensus process which integrated evidence gathered from preparatory studies was carried out. Relevant ICF categories were selected by a sample of international experts from different backgrounds using the nominal group technique. RESULTS Twenty-six experts from 22 countries and different professional backgrounds attended the consensus conference. Altogether 120 second- or third-level ICF categories were included in the Comprehensive ICF Core Set with the following ICF component split: 49 categories from body functions, 8 from body structures, 31 from activities and participation and 32 from environmental factors. The Brief ICF Core Set included a total of 15 second-level categories: 5 body functions (sleep, energy and drive, attention, consciousness, respiration functions); 3 body structures (brain, respiratory system, pharynx); 4 activities and participation (focusing attention, driving, handling stress and other psychological demands, carrying out daily routine); and 3 environmental factors (immediate family; health services, systems, and policies; and health professionals). CONCLUSION A formal consensus process integrating evidence and expert opinion led to the first version of the ICF Core Sets for persons with sleep disorders. Further validation of the Core Set is needed.

Content Validity of the Comprehensive ICF Core Set for Chronic Obstructive Pulmonary Diseases:An International Delphi Survey

Introduction: The “Comprehensive ICF Core Set for Chronic Obstructive Pulmonary Diseases (COPD)“ 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 COPD. The objective of this study was to validate this ICF Core Set from the perspective of physicians. Materials and Methodology: Physicians experienced in COPD treatment were asked about the patients’ problems treated by physicians in patients with COPD in a three-round electronic mail survey using the Delphi technique. Responses were linked to the ICF. Results: Seventy-six physicians in 44 countries gave a total of 1330 responses that were linked to 148 different ICF categories. Nine ICF categories were not represented in the Comprehensive ICF Core Set for COPD although at least 75% of the participants have rated them as important. Nineteen concepts were linked to the not yet developed ICF component personal factors and seventeen concepts were not covered by the ICF. Conclusion: The high percentage of ICF categories represented in the ICF Core Set for COPD indicates satisfactory content validity from the perspective of the physicians. However, some issues were raised that were not covered and need to be investigated further.