Table 2 Final core outcome set with definitions of the outcomes
Domain | Outcome | Definition |
|---|---|---|
Adverse events | Drug-related hospital admissions | Hospitalization due to an adverse drug event: harm due to an adverse drug reaction or a medical error related to overuse, underuse, or misuse of prescription and non-prescription medications and which is the main reason for or contributes to hospital admission of a patient |
Medication use | Overuse | The use or prescription of more drugs than clinically needed, including (1) any drug prescribed or used without an evidence-based clinical indication; (2) therapeutic duplication; (3) medication prescribed or used beyond the recommended duration |
Underuse | A failure to prescribe drugs that are indicated, including (1) omission of an evidence-based drug; (2) too short a duration | |
Potentially inappropriate medications | Drugs with risk of adverse drug reactions exceeding their expected clinical benefit to patients, particularly when safer therapeutic alternatives are available to treat the same condition [40] | |
Clinically significant DDI | A clinically significant DDI is defined as having a significant severity rating according to the drug interaction compendia used in the study (e.g. Drug Interaction Facts or Micromedex) [41] | |
Patient-reported outcomes | Health-related quality of life | Personal health status: HRQoL usually refers to aspects of our lives that are dominated or significantly influenced by our mental or physical well-being |
Pain relief | Whether pain has improved over the course of the trial |