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Table 1 Primary and secondary outcomes

From: Expert-based medication reviews to reduce polypharmacy in older patients in primary care: a northern-Italian cluster-randomised controlled trial

Composite primary outcome

Outcome

Measuring method

Description

Non-elective hospitalisations or all-cause mortality

Recorded by the GP in the case report form (CRF) at FU1, FU2, T2 (final data analysis)

Hospitalisations: number of episodes

(referral to any acute care facility, either emergency department or hospital; elicited by the GP, by any other physician or by the patient himself)

Death: number of patients

Secondary outcomes

Outcome

Measuring method

Description

All-cause mortality

All events were recorded by the GPs in the CRF at T0, FU1, FU2, T2

Number of patients

Non-elective hospital admissions

All events were recorded by the GPs in the CRF at T0, FU1, FU2, T2

Number of episodes (see primary endpoint)

Falls

All events were recorded by the GPs in the CRF at T0, FU1, FU2, T2

Number of falls requiring medical care

Fractures

All events were recorded by the GPs in the CRF at T0, FU1, FU2, T2

Number of fractures occurred within the observation period

Number of drug prescriptions

Recorded by the GPs in the CRF at T0, FU1, FU2, T2

Total number of prescribed drugs

Health-related quality of life

EQ-5D-5L and EQ-VAS [35]

The questionnaire was handed out to the patients by the GPs at T0 and T2 (prior to / after the intervention)

- Five items addressing health-related QoL (mobility, self-care, usual activities, anxiety / depression, pain) and resulting in an index value (maximum = 1 = full health)

- Visual analogue scale EQ-VAS (range 0–100)

Affective status

5-Item Geriatric Depression Scale (5-GDS) [36]

The questionnaire was handed out to the patients by GPs at T0 and T2

- Five items addressing satisfaction, tediousness, helplessness, social withdrawal, self-esteem

- ≥2 points → presence of depressive symptoms

(range 0–5)

Cognitive performance

6-Item Cognitive Impairment Test (6-CIT) [37]

The questionnaire was handed out to the patients by GPs at T0 and T2

- Six items evaluating cognitive function

- ≥10 points → significant cognitive impairment

(range 0–28)