Abstract

The aim of this study was to systematically analyze outcome measures in head and neck cancer trials using the International Classification of Functioning. Disability, and Health (ICF) as reference. Clinical trials 2000 to 2006 in MEDLINE were selected according to predefined criteria. Outcome measures were extracted, and concepts contained in the outcome measures were translated into ICF. A total of 254 publications showed 4203 concepts that translate into 117 different, second-level ICF-categories. Just 2 of 117 outcome measures apply regularly: e580 (health_services) in 58% publications and b510 (ingestion_function) in 46% publications. Any other outcome measure applies to < 33% publications. In the differentiation of outcome measures among tumor locations, staging, or treatment options, no systematic use of specific outcome measures was identified in any subgroup. The ICF provides a useful reference to identify and quantify outcome measures in head and neck cancertrials. Applying the ICF classification reveals little standardization in the use of outcome-measures by different authors. However, this is not related to the heterogeneity of head and neck cancer in terms of tumor locations, staging, or treatment options. Systematic use of the ICF might increases comparability of study results and decrease data silos.

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