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 ischemic 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 by so called “linking rules” to the ICF. Results: 166 trials on chronic ischemic heart disease, 227 trials on diabetes mellitus, 428 trials on obesity and 253 trials on obstructive pulmonary disease were included. 10 different health status questionnaires were extracted in chronic ischemic heart disease, 19 in diabetes mellitus, 47 in obesity, 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 ‘respiratory functions’ (b440) and in chronic ischemic heart disease ‘heart functions’ (b410). Conclusions: In all four 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 measures used in clinical trials

Content comparison of osteoporosis-targeted health status measures in relation to the International Classification of Functioning, Disability and Health (ICF)

The most frequently used instruments for health-related quality of life (HRQL) in patients with osteoporosis are the Quality of Life Questionnaire of the European Foundation for Osteoporosis (QUALEFFO-41) and the Osteoporosis Assessment Questionnaire (OPAQ 2.0 and OPAQ SV). Since HRQL- and International Classification of Functioning, Disability and Health (ICF)-based approaches have both strengths and weaknesses, it is expected that they will be used simultaneously in clinical practice and research. Therefore, we investigated the relationship between osteoporosis-targeted instruments and the ICF. All three selected instruments cover body functions, including pain in back and emotional functions. Sleep functions and energy are represented in the QUALEFFO-41 and OPAQ 2.0 but not in the OPAQ SV. Body structures and environmental factors are covered only by the OPAQ 2.0 and OPAQ SV. The ICF provides an excellent framework when comparing the content of osteoporosis-targeted HRQL instruments and may be useful when selecting health status instruments for clinical studies

Content comparison of low back pain specific measures based on the International Classification of Functioning, Disability and Health (ICF)

Objectives: The objective of this study was to compare the content covered by the North American Spine Society Lumbar Spine Outcome Assessment Instrument, the Oswestry Low Back Disability Questionnaire, and the Roland-Morris Disability Questionnaire based on the International Classification of Functioning, Disability and Health (ICF).Methods: The linkage of items of the three measures to the ICF involved three steps, which were performed by two different health professionals and in which 10 different linking rules were applied.Results: In the 48 items of the three instruments, a total of 123 concepts were identified and linked to the ICF. The concepts contained in the items were linked to 10 ICF categories of the component "body functions," 27 of the component "activities and participation," and 4 of the component "environmental factors." The estimated kappa coefficients ranged from 0.67 to 1.00.Conclusion: Comparison based on the ICF provides insight into both the breadth of health dimensions measured as well as the thoroughness and depth of measurement. Therefore, it can be a useful tool when selecting specific measures for a study. Compared with other types of qualitative review, the most important advantage of the content comparison of measures based on the ICF is the use of an external and independent reference to which all the instruments can be linked and by which all the instruments can be compared. The three back-specific measures are comparable, with their common focus on physical aspects of body functions and activities and participation

Identifying the concepts contained in outcome measures of clinical trials on musculoskeletal disorders and chronic widespread pain 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 low back pain, chronic widespread pain, osteoarthritis, osteoporosis and rheumatoid arthritis using the International Classification of Functioning, Disability and Health (ICF) as a reference.Methods: Randomized controlled trials carried out between 1991 and 2000 were identified using 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: One hundred and twenty-nine trials on low back pain, 42 trials on chronic widespread pain, 176 trials on osteoarthritis, 107 trials on osteoporosis and 382 trials on rheumatoid arthritis were included. Fifty-nine different health status questionnaires were extracted in low back pain, 29 in chronic widespread pain, 29 in osteoarthritis, 3 in osteoporosis and 48 in rheumatoid arthritis. Across conditions at least 77% (range 77-88%) of the extracted concepts could be linked to the ICF. In low back pain, chronic widespread pain and osteoarthritis the most used ICF-categories were sensation of pain (b280), in osteoporosis structure of trunk (s760) and in rheumatoid arthritis additional musculoskeletal structures related to movement (s770). The most used category across conditions was sensation of pain (b280) except for osteoporosis.Conclusion: The ICF provides a useful reference to identify and quantify the concepts contained in outcome assessment used in clinical trials

Cores sets for osteoporosis

Objective: To report on the results of the consensus process integrating evidence from preliminary studies to develop the first version of a Comprehensive International Classification of Functioning, Disability and Health (ICF) Core Set and a Brief ICF Core Set for osteoporosis.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 239 ICF categories at the second, third and fourth ICF levels with 72 categories on body functions, 41 on body structures, 81 on activities and participation, and 45 on environmental factors. Fifteen experts from 7 different countries attended the consensus conference on osteoporosis. Altogether 67 second-level and 2 third-level categories were included in the Comprehensive ICF Core Set with 15 categories from the component body functions, 7 from body structures, 21 from activities and participation, and 26 from environmental factors. The Brief ICF Core Set included a total of 22 second-level categories with 5 on body functions, 4 on body structures, 6 on activities and participation, and 7 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 osteoporosis. Both the Comprehensive ICF Core Set and the Brief ICF Core Set were defined

Calling for Help—Peer-Based Psychosocial Support for Medical Staff by Telephone—A Best Practice Example from Germany

Background: A telephone support hotline (PSU-HELPLINE) was established at the beginning of the pandemic due to the burden on health professionals and the lack of support at the workplace. The aim of this study was to evaluate the telephone support service for health professionals in terms of its burden, benefits, and mechanisms of action. Methods: Data collection was conducted during and after calls by PSU-HELPLINE counsellors. In addition to the socio-demographic data evaluation, burdens of the callers and the benefits of the calls were collected. The content-analytical evaluation of the stresses as well as the effect factors were based on Mayring’s (2022). Results: Most of the callers were highly to very highly stressed. The usefulness of the conversation was rated as strong to very strong by both callers and counsellors. The PSU-HELPLINE was used primarily for processing serious events and in phases of overload. The support work was carried out through the following aspects of so-called effect factors, among others: psychoeducation, change of perspective, resource activation, problem actualization, connectedness, information, problem solving, self-efficacy, and preservation of resources. Conclusions: The expansion of local peer support structures and the possibility of a telephone helpline are recommended. Further research is needed