Cost of clinical events in health economic evaluations in Germany: a systematic review.

Guidance from the Institute for Quality and Efficiency in Health Care (IQWiG) on cost estimation in cost-benefit assessments in Germany acknowledges the need for standardization of costing methodology. The objective of this review was to assess current methods for deriving clinical event costs in German economic evaluations. A systematic literature search of 24 databases (including MEDLINE, BIOSIS, the Cochrane Library and Embase) identified articles, published between January 2005 and October 2009, which reported cost-effectiveness or cost-utility analyses. Studies assessed German patients and evaluated at least one of 11 predefined clinical events relevant to patients with diabetes mellitus. A total of 21 articles, describing 199 clinical cost events, met the inclusion criteria. Year of costing and time horizon were available for 194 (97%) and 163 (82%) cost events, respectively. Cost components were rarely specified (32 [16%]). Costs were generally based on a single literature source (140 [70%]); where multiple sources were cited (32 [16%]), data synthesis methodology was not reported. Cost ranges for common events, assessed using a Markov model with a cycle length of 12 months, were: acute myocardial infarction (nine studies), first year, 4,618-17,556 €; follow-up years, 1,006-3,647 €; and stroke (10 studies), first year; 10,149-24,936 €; follow-up years, 676-7,337 €. These results demonstrate that costs for individual clinical events vary substantially in German health economic evaluations, and that there is a lack of transparency and consistency in the methods used to derive them. The validity and comparability of economic evaluations would be improved by guidance on standardizing costing methodology for individual clinical events.

Utilisation of patient perspective to validate clinical measures of outcome following spinal cord injury.

PURPOSE: The purpose of this article is to utilise the perspective of persons with a spinal cord injury (SCI), gained from focus groups, to validate recommended clinical measures of outcome. METHOD: Clinical measures of outcome as recommended by Wood-Dauphinee and the SCI Consensus Group were categorised using the World Health Organisation's International Classification of Functioning, Disability and Health (ICF). These were then cross-referenced to the problems of functioning identified by patients in 10 focus groups held in New Zealand as part of the International ICF Core Set project. The focus groups were performed separately for people in the post-acute situation and in the chronic situation to address different experiences since SCI. RESULTS: In the post-acute group, the recommended measures of functioning, the Functional Independence Measure (FIM), Hospital Anxiety and Depression Scale and Visual Analogue Scale for pain correlated well against the focus groups identification of problems of functioning. In the chronic group, the short-form Craig Handicap Assessment and Reporting Technique (sf-CHART), the SF-12 and the Life Satisfaction Questionnaire (LSQ) largely captured the problems of functioning identified. There were some categories that were common to both patient groups and were not changed by time since SCI. In addition, there were some problems of functioning identified by the patient groups that were not covered by the suggested measures. CONCLUSIONS: Utilisation of a battery of outcome measures based on a theoretical framework can quantify problems of functioning in the SCI population. Although the measures suggested by SCI Consensus Group largely capture the problems of functioning, other outcome measures have been shown to be more responsive to the changes in the SCI population and also incorporate more of the identified problems of functioning.

Validation of International Classification of Functioning, Disability, and Health (ICF) Core Sets for early postacute rehabilitation facilities: comparisons with three other functional measures.

OBJECTIVE: Short lists of International Classification of Functioning, Disability, and Health (ICF) categories, ICF Core Sets, have been developed as reference standards for clinical practice and research. The objective of this study was to validate the ICF Core Sets for early postacute rehabilitation facilities against the measures most commonly used in early postacute rehabilitation, the FIM instrument, the Functional Assessment Measure, and the Barthel index. DESIGN: Linking study matching the concepts of three commonly used outcome measures to corresponding ICF categories. RESULTS: Corresponding ICF categories could be found for all of the items of the FIM instrument + Functional Assessment Measure and Barthel index. The 40 items of these three measures were linked to 33 different ICF categories. Four items could be linked to ICF categories that were not part of any of the Postacute ICF Core Sets. CONCLUSIONS: The Postacute ICF Core Sets cover the concepts of the most frequently used measures in early postacute rehabilitation. Yet, many aspects of human functioning are not measured by the FIM instrument + Functional Assessment Measure and the Barthel index. If this information is considered relevant, these items would have to be added by using supplementary measures. Our comparison demonstrates the benefit of using a common language when comparing items using different wordings and concepts.

Systematic review of measures and their concepts used in published studies focusing on the treatment of acute inflammatory arthritis.

To identify outcome measures and concepts cited in published studies focusing on the treatment of acute inflammatory arthritis, and to identify and quantify the concepts contained in these measures using the International Classification of Functioning, Disability and Health (ICF) as a reference. This 'research perspective' is part of the development process for an ICF core set in acute arthritis. Electronic searches of Medline, Embase, Cumulative Index to Nursing and Allied Health Literature, Pedro and the Cochrane Library from January 2000 to July 2004 were carried out. Data on the outcome measures and patient characteristics for the included studies were extracted. The items of the identified questionnaires and their underlying concepts were specified and then linked to ICF categories using standardized linkage rules. From the 401 abstracts retrieved, 104 studies met the inclusion criteria. From these studies, 38 formal assessment instruments, 62 single clinical measures, 66 technical measures and 14 clinical criteria were identified. A total of 966 concepts were extracted, and 84.7% of these concepts could be linked to ICF categories. The concepts contained in measures named in more than 5% of the studies were represented by 34 second-level ICF categories. Ten (30%) of the 34 categories belong to the component "Body Functions", 3 (9%) to the component "Body Structures" and 21 (61%) to the component "Activities and Participation". The ICF provides a valuable reference to identify and quantify the concepts of outcome measures focusing on the management of patients with acute inflammatory arthritis. Our findings indicate there is good agreement on 'what should be measured' in acute inflammatory arthritis to allow for a comparison of patient populations.

ICF Core Set for patients with musculoskeletal conditions in the acute hospital.

PURPOSE: The aim of this consensus process was to decide on a first version of the ICF Core Set for patients with musculoskeletal conditions in the acute hospital. METHODS: The ICF Core Set development involved a formal decision-making and consensus process integrating evidence gathered from preliminary studies including focus groups of health professionals, a systematic review of the literature and empiric data collection from patients. RESULTS: Twenty-one experts selected a total of 47 second-level ICF categories. The largest number of categories was selected from the ICF component Body Functions (17 categories or 36%). Nine (19%) of the categories were selected from the component Body Structures, 11 (23%) from the component Activities and Participation, and 10 (21%) from the component Environmental Factors. CONCLUSION: The Acute ICF Core Set for patients with musculoskeletal conditions provides all professionals with a clinical framework to comprehensively assess patients in the acute hospital. This first ICF Core Set will be further tested through empiric studies in German-speaking countries and internationally.

The ICF categories identified in nursing interventions administered to neurological patients with post-acute rehabilitation needs.

PURPOSE: The objectives of this study were (1) to determine whether the ICF covers the goals of nursing interventions and (2) to identify the areas of functioning, disability and health most relevant to nursing practice of neurological patients with early post-acute rehabilitation needs. METHODS: This cross-sectional study on nursing interventions is part of a larger multicentric cross-sectional study describing functioning, disability and health. The nursing interventions were recorded by nurses in charge of the patient. According to established rules, the recorded nursing interventions were linked to the ICF. RESULTS: One hundred and eighteen different nursing interventions were documented by the nursing staff. The intervention goals were linked to 67 different second-level ICF categories. Thirty belong to the component Body Functions, 19 to the component Body Structures, 13 to the component Activities and Participation, and five to the component Environmental Factors. CONCLUSIONS: The fact that all nursing interventions in early post-acute rehabilitation facilities could be linked to ICF categories supports the usefulness of the ICF in nursing. Initial problems in adapting profession-specific terminology to the ICF framework can be overcome, as shown by our linking exercise. Further analyses will be needed to show if these theoretical findings are supported by empirical evidence.

Systematic review of measures and their concepts used in published studies focusing on rehabilitation in the acute hospital and in early post-acute rehabilitation facilities.

PURPOSE: To identify outcome measures cited in published studies focusing on rehabilitation in the acute hospital and in early post-acute rehabilitation facilities, and to identify and quantify the concepts contained in these measures using the ICF as a reference. METHODS: Electronic searches of Medline, Embase, CINAHL, Pedro and the Cochrane Library from 1997 to March 2002 were carried out. In a first step, abstracts of the retrieved studies were checked and data on the outcome measures and certain characteristics of the included studies were extracted. In a second step, the items of the questionnaires and their underlying concepts were specified. These concepts were then linked to ICF categories using standardized linkage rules. RESULTS: From the 1,657 abstracts retrieved, 259 studies met the inclusion criteria. In a second step, 277 formal assessment instruments and 351 single clinical measures were retrieved. A total of 1,353 concepts were extracted from the clinical and technical measures. Ninety-six percent of these concepts could be linked to ICF categories. Fifty-six second-level ICF categories representing the concepts contained in the measures. Twenty-six (46%) of the 56 categories belong to the component Body Functions, five (9%) to the component Body Structures, and 25 (45%) to the component Activities and Participation. CONCLUSIONS: The ICF provides a valuable reference to identify and quantify the concepts of outcome measures focusing on rehabilitation in the acute hospital and in early post-acute rehabilitation facilities. Our findings indicate a need to define and to agree on 'what should be measured' in rehabilitation care to allow for a comparison of patient populations.

ICF Core Set for patients with musculoskeletal conditions in early post-acute rehabilitation facilities.

PURPOSE: The aim of this consensus process was to decide on a first version of the ICF Core Set for patients with musculoskeletal conditions in early post-acute rehabilitation facilities. METHODS: The ICF Core Set development involved a formal decision-making and consensus process integrating evidence gathered from preliminary studies including focus groups of health professionals, a systematic review of the literature and empiric data collection from patients. RESULTS: Fifteen experts selected a total of 70 second-level categories. The largest number of categories was selected from the ICF component Body Functions (23 categories or 33%). Seven (10%) of the categories were selected from the component Body Structures, 22 (31%) from the component Activities and Participation, and 18 (26%) from the component Environmental Factors. CONCLUSION: The Post-acute ICF Core Set for patients with musculoskeletal conditions is a clinical framework to comprehensively assess patients in early post-acute rehabilitation facilities, particularly in an interdisciplinary setting. This first ICF Core Set will be further tested through empiric studies in German-speaking countries and internationally.