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Table 2 Final core outcome set with definitions of the outcomes

From: International core outcome set for clinical trials of medication review in multi-morbid older patients with polypharmacy

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
  1. Abbreviations: HRQoL Health-related quality of life, DDI drug-drug interaction