Independent thesis Advanced level (degree of Master (Two Years)), 20 credits / 30 HE credits
Development of a method to assess drug-related admissions
Introduction: To use drug-related admissions (DRAs) to hospital as an outcome measure in clinical trials, there is a need for a causality assessment method to assess such admissions that can be used by inexperienced professionals in order to save time for clinicians.
Aim: There is a need for an easy and quick method that early can exclude admissions which are ”unlikely” and ”certainly” drug-related, therefore, the aim of this study was to develop and test a reliable and applicable method to assess DRA, that can be used in a clinical trial setting by a medical student or a pharmacy student.
Materials and Methods: First a semi-structured literature research was conducted to identify existing methods to assess DRA´s. The second phase consisted of the development of a screening tool and a testing phase with five students and two experienced clinicians. Inter-rater reliability, positive- and negative predictive value, sensitivity and specificity were calculated to validate the screening tool.
Results: The most common methods used in previously published studies were explicit methods, e.g. the WHO causality assessment system. A screening tool was successfully developed and resulted in high inter-rater reliability, (Cohen´s kappa 0.92), positive- and negative predictive value and sensitivity and specificity were all high for ”unlikely” DRAs (resp. 94.1% and 54.6%, 51.6% and 94.7%), but for ”certain” DRAs positive predictive value (PPV) was insufficient (resp. 44.4% and 97.6%, 80.0% and 88.9%).
Conclusions: The screening tool results in high level of inter-rater reliability. Further development is needed in order to fully validate the tool for use in an RCT. For future purpose it is advised to only use the tool to screen for unlikely DRA´s.