Skip to main content

Table 3 Results of primary and secondary outcomes at T2 (n total = 579)

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

Composite primary outcome

IG

CG

Unadjusted OR (95% CI) §

p-value

Adjusted OR (95% CI) §

p-value

First non-elective hospital admission or death

n = 307

n = 272

    

ITT analysis (including patients lost to FU as having reached the outcome)

151

(49.2%)

102

(37.5%)

1.7

(1.13–2.54)

0.01 i

1.46

(0.99–2.18)

0.06 iii

First non-elective hospital admission or death

n = 281

n = 257

    

PP analysis (excluding patients lost to FU: IG n = 26, CG n = 15)

125

(44.5%)

87

(33.9%)

1.57

(1.01–2.43)

0.04 i

1.33

(0.87–2.04)

0.2 iii

Secondary outcomes

IG

CG

Unadjusted HR (95% CI) §

p-value

Adjusted HR (95% CI) §

p-value

Mortality

n = 281 §§

n = 257 §§

    

Post-interventional death (all-cause)

31

(11.0%)

22

(8.6%)

1.54

(0.74–3.25)

0.25 iii

1.34

(0.62–2.91)

0.46 iii

Secondary outcomes

IG

CG

Unadjusted OR (95% CI) §

p-value

Adjusted OR (95% CI) §

p-value

Mortality

n = 281 §§

n = 257 §§

    

Post-interventional death (all-cause)

31

(11.0%)

22

(8.6%)

1.32

(0.61–2.86)

0.5 i

1.18

(0.51–2.72)

0.7 iii

Non-elective hospital admissions

n = 281

n = 257

    

Patients with ≥1 hospital admission (%)

103

(36.7%)

68

(26.5%)

1.61

(1.03–2.51)

0.04 i

1.39

(0.95–2.03)

0.09 iii

Total number of hospital admissions

122

74

–

–

–

–

Median (IQR)

0 (0–1)

0 (0–1)

–

0.008 ii

–

–

Falls

n = 281

n = 257

    

Patients with ≥1 falls (%)

58

(20.6%)

73

(28.4%)

0.66

(0.35–1.21)

0.2 i

0.55

(0.31–0.98)

0.04 iii

Total number of falls

65

76

–

–

–

–

Median (IQR)

0 (0–0)

0 (0–1)

–

0.047 ii

–

–

Fractures

n = 281

n = 257

    

Patients with ≥1 fractures (%)

25

(8.9%)

13

(5.1%)

1.83

(0.87–3.86)

0.1 i

1.61

(0.8–3.2)

0.2 iii

Total number of fractures

26

13

–

–

–

–

Median (IQR)

0 (0–0)

0 (0–0)

–

0.08 ii

–

 

Number of drug prescriptions

n = 250 §§

n = 235 §§

 

p-value

–

p-value

Total number of drugs

2218

2140

–

–

–

–

Median number of drugs (IQR)

8 (7–10)

9 (8–10)

–

0.1 ii

–

–

Change in number of drugs from baseline: median reduction (IQR)

0 (−1–0)

0 (−2–0)

–

0.6 ii

–

–

EQ-5D-5L index

n = 250

n = 235

 

p-value

–

p-value

Median (IQR)

0.806

(0.698–0.909)

0.806

(0.701–0.909)

–

0.3 ii

–

–

EQ-VAS score

n = 250

n = 234

 

p-value

–

p-value

Median (IQR)

60 (50–75)

60 (50–70)

–

0.2 ii

–

–

5-GDS: Score ≥ 2 points

(affective impairment)

n = 250

n = 235

 

p-value

–

p-value

n patients (%)

105

(42.0%)

81

(34.5%)

1.38

(0.89–2.12)

0.2 i

1.41

(0.9–2.21)

0.1 iii

6-CIT: Score ≥ 8 points

(cognitive impairment)

n = 250

n = 235

 

p-value

–

p-value

n patients (%)

64

(25.6%)

61

(26.0%)

0.98

(0.57–1.7)

0.9 i

0.88

(0.48–1.62)

0.7 iii

  1. i Fisher exact test, ii Mann-Whitney U test, iii Wald test
  2. § Event occurred / not occurred within the observation period of 24 months; adjusted by the following baseline characteristics: sex, age, number of conditions, number of symptoms within 1 month before T0, number of falls, number of fractures and number of hospitalisations within 12 months before T0
  3. §§ IG n = 281, CG n = 257 after exclusion of pre-interventional deaths and withdrawals; IG n = 250, CG n = 235 after additional exclusion of post-interventional deaths due to missing values
  4. IG Intervention group, CG Control group, OR Odds ratio, CI Confidence intervals, ITT Intention-to-treat analysis, FU Follow-up, PP Per-protocol analysis, IQR Interquartile range, EQ-5D 5-Item questionnaire measuring health-related quality of life, VAS Visual analogue scale, 5-GDS 5-Item Geriatric Depression Scale, 6-CIT 6-Item Cognitive Impairment Test