Validation of a comprehensive classification tool for treatment-related problems

Objective Several drug-related problem classification systems can be found in the literature. However, it is generally agreed that a comprehensive, well constructed and validated instrument is currently lacking. The aim of this study is the development and validation of a comprehensive treatment-related problems assessment and classification tool for use in teaching, practicing and researching pharmaceutical care and to improve identification, resolving and preventing of treatment-related problems. Method The development and validation involved five steps starting with literature search to define a treatment related problem and also to form a database of treatment-related problems identified in the literature. In the next step, all problems that were identified in the first step and passed the evaluation of the three authors were pooled together and then divided into groups according to their common or shared construct, in the third step a suitable assessment method was developed according to the construct of the different problems, in the next step the developed instrument was validated for content, internal and external validity. Finally the tool was finalized and tested for reproducibility and inter-rater agreement. Results The final validated version included six main categories for treatment-related problems (Indication, Effectiveness, Safety, Knowledge, Adherence and Miscellaneous). These categories include a total of nine subcategories and a total of 29 treatment related problems. Conclusion The treatment-related problems assessment and classification tool introduced in this paper was applied to actual patient cases and proved to be valid. This tool also has several features that are new.