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Table 4 Final COS for effectiveness studies in optimising prescribing in older adults in care homes

From: Development of a core outcome set for effectiveness trials aimed at optimising prescribing in older adults in care homes

Category

Outcome domain

• Outcome

Definition from Delphi questionnaire

Medication-related

1. Medication appropriateness (potentially inappropriate prescribing)

Potentially inappropriate prescribing ‘encompasses the use of medicines that introduce a significant risk of an adverse drug-related event where there is evidence for an equally or more effective but lower-risk alternative therapy available for treating the same condition…also includes the use of medicines at a higher frequency and for longer than clinically indicated, the use of multiple medicines that have recognised drug-drug interactions and drug-disease interactions, and importantly, the under-use of beneficial medicines that are clinically indicated but not prescribed for ageist or irrational reasons’ [53]

• Number of prescribed medicines

Number of medications prescribed for a care home resident

• Duplicate drugs

’Duplicate drugs’ described a situation where an individual is prescribed two medicines of the same pharmacological class, e.g. the prescribing of two concurrent opiates [54]

• Use of antipsychotics

The prescription of antipsychotic medicines in care home residents. ‘Antipsychotic drugs are also known as “neuroleptics” and (misleadingly) as “major tranquillisers”. In the short term they are used to calm disturbed patients whatever the underlying psychopathology… The balance of risks and benefits should be considered before prescribing antipsychotic drugs for elderly patients’ [55]

• Harmful interactions

A ‘harmful interaction’ in a care home resident may describe the prescription of a medication which causes or has the potential to cause a clinically significant drug-drug or drug-disease interaction. A drug-drug interaction is when a medicine affects the pharmacological effect of another medicine. A drug-disease interaction is when a medicine, which may be used to treat or prevent one disease, can have a detrimental effect on another existing disease/condition in the individual [56]

• Anticholinergic burden

The anticholinergic burden associated with care home residents’ medication regimens. Medicines with anticholinergic effects are commonly prescribed for various conditions; however, increased overall exposure to anticholinergics has been associated with an increased risk of cognitive impairment, falls and all-cause mortality in older adults [57]

2. Adverse drug events

Adverse drug events experienced by care home residents. ‘An adverse drug event is any undesirable event experienced by a patient whilst taking a medicine, including physical harm, mental harm, or loss of function’ [58]

3. Prescribing errors

Prescribing errors in care home residents’ medication regimens. A prescribing error is ‘a prescribing decision that results in an unintentional, significant: (1 reduction in the probability of treatment being timely and effective, or (2 Increase in the risk of harm, when compared to generally accepted practice’ [59]

Patient-related

4. Falls

Falls occurring amongst care home residents. A fall is ‘an event which results in a person coming to rest inadvertently on the ground or floor or other lower level’ [60]

5. Quality of life

A measure of care home residents’ quality of life (QoL). QoL is ‘a ubiquitous concept that has different philosophical, political and health-related definitions. Health-related QoL includes the physical, functional, social and emotional well-being of an individual’ [61]

6. All-cause mortality

All deaths of care home residents

Healthcare utililisation-related

7. Admissions to hospital (and associated costs)

The number of care home residents having a hospital admission/number of hospital admissions per resident (and the associated costs)

• Accident and emergency (A&E) visits to hospital (and associated costs)

The number of care home residents attending A&E departments/number of A&E visits per resident (and the associated costs)