Table 2.
Discrimination power of the tool
| Health care setting/Medicines | True positives a (n) | False positives b (n) | Cut-off level (scores) of 100: Sensitivity/Specificity (%) (Confidence intervalsc: Lower 95% CL; Upper 95% CL); Positive/Negatived Likelihood ratios (LR+/LR-) | |||
|---|---|---|---|---|---|---|
| Ambulatory Yerevan (Armenia)/Antibiotics | 1 | 10 | ≥40: | |||
| Sensitivity | 100 | (2.5 | 100) | |||
| Specificity | 79.95 | (65.66 | 89.76) | |||
| LR+ | 4.9 | |||||
| LR- | 0 | |||||
| 0 | 2 | ≥60 | ||||
| Sensitivity | NaN | (0 | 100) | |||
| Specificity | 96 | (86.29 | 99.51) | |||
| LR+ | N/A | |||||
| LR- | NaN | |||||
| Ambulatory Zagreb & Pula (Croatia)/Anti-obesity Preparations, Anabolic Agents for Systemic use, Diuretics, Sex Hormones and Modulators of the Genital System, Urologicals, Psycho-analeptics | 1 | 20 | ≥40 | |||
| Sensitivity | 100 | (2.5 | 100) | |||
| Specificity | 71.01 | (58.84 | 81.31) | |||
| LR+ | 3.5 | |||||
| LR- | 0 | |||||
| 1 | 13 | ≥60 | ||||
| Sensitivity | 100 | (2.5 | 100) | |||
| Specificity | 81.16 | (69.94 | 89.57) | |||
| LR+ | 5.3 | |||||
| LR- | 0 | |||||
|
Ambulatory Rome (Italy)/ Anabolic Agents for Systemic use, Diuretics, Sex Hormones and Modulators of the Genital System, Urologicals |
3 | 0 | ≥40; ≥60 | |||
| Sensitivity | 100 | (29.24 | 100) | |||
| Specificity | 100 | (93.73 | 100) | |||
| LR+ | - | |||||
| LR- | 0 | |||||
|
All ambulatory sub-studies
Yerevan (Armenia), Zagreb & Pula (Croatia), Rome (Italy) |
||||||
| 5 | 30 | ≥40 | ||||
| Sensitivity | 100 | (47.82 | 100) | |||
| Specificity | 82.86 | (76.44 | 88.12) | |||
| LR+ | 5.8 | |||||
| LR- | 0 | |||||
|
Ambulatory sub-studies
Yerevan (Armenia), Zagreb & Pula (Croatia), Rome (Italy) |
||||||
| ≥40 | ||||||
| Sensitivity | 100 | (39.76 | 100) | |||
| Specificity | 84.13 | (76.56 | 90.03) | |||
| LR+ | 6.3 | |||||
| LR- | 0 | |||||
| ≥60 | ||||||
| Sensitivity | 100 | (39.76 | 100) | |||
| Specificity | 89.68 | (83 | 94.39) | |||
| LR+ | 9.7 | |||||
| LR- | 0 | |||||
| In-patient Aalst (Belgium)/Anti-obesity Preparations, Anabolic Agents for Systemic Use, Diuretics, Sex Hormones and Modulators of the Genital System; Urologicals, Psychoanaleptics | 0 | 33 | ≥40 | |||
| Sensitivity | 0 | 100 | ||||
| Specificity | 21.43 | (10.3 | 36.81) | |||
| LR+ | N/A | |||||
| LR- | ||||||
| 0 | 11 | ≥60 | ||||
| Sensitivity | 0 | 100 | ||||
| Specificity | 73.81 | (57.96 | 86.14) | |||
| LR+ | N/A | |||||
| LR | ||||||
|
In-patient Reykjavík (Iceland)/ Anti-obesity Preparations |
0 | 13 | ≥40 | |||
| Sensitivity | 0 | 100 | ||||
| Specificity | 92.52 | (87.01 | 96.21) | |||
| LR+ | N/A | |||||
| LR- | ||||||
| 0 | 5 | ≥60 | ||||
| Sensitivity | 0 | 100 | ||||
| Specificity | 96.64 | (92.34 | 98.9) | |||
| LR+ | N/A | |||||
| LR- | ||||||
Legend
The cut-off level which classified correctly the cases of harm at a minimum of false classifications is highlighted in bold letters
a“True positive”: The initial classification of the patient by the tool as “probably being at risk of health damage caused by FFC medicines” was maintained after the retrospective assessment of the medical record (“reference method”)
b“False positive”: The initial classification of the patient by the tool as probably being at risk of health damage caused by FFC medicines” was rejected after the retrospective assessment of the medical records (“reference method”)
cThe sensitivity and specificity of the tool were expressed as “exact two-sided 95% confidence intervals” according to the method of Clopper and Pearson for the presence of 2 and 3 of 5 risk indicators
dPositive/negative likelihood ratios: the ability of a test to discriminate between people likely to have a disorder and those less likely to have a disorder is determined by the test’s likelihood ratio (LR)
The ratio of true positives to false positives (LR+) is the likelihood ratio for a positive test result being correct
The ratio of false negatives to true negatives (LR-) is the likelihood ratio for a negative test result being correct