OBSERVATIONAL STUDIES | |||||||
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Study | Sample selection criteria | Comparability | Outcome & evaluation | Summary score/10 | |||
Representativeness sample: 2 points if the sample is a truly representative of the average in the target population; 1 point if the sample is somewhat representative of target population; no points if unclear or no description | Sample size: 1 point is sample size is justified by using power analysis; no points if not justified | Ascertainment of disease state or diagnosis: 2 points if validated or accepted tool was used; 1 point if non-validated or non-accepted, but well described; no points if unclear or no description | Comparability: 1 point if group design and groups are comparable; no points when groups are not comparable, 1 point when no comparative design was used; 1 point if the study controls for possible confounders | Assessment outcomes: 1 point if appropriate blood collection/drug concentration measurement and laboratory procedures used; No points if unclear or no description of procedure | Statistical test (analysis of outcomes): 2 points if population pharmacokinetic modelling with co-variate analysis or conventional 2-stage method with co-variate analysis or non-compartmental analysis with rich sampling (≥3/dosing interval); 1 point if outcome variables summarized while expressing variability; no points if the statistical test is unclear, incomplete or not described | ||
Bohte, 1995 [21] | ★ | – | – | ★ | – | ★ | 3/10: low |
Davies, 1986 [23] | – | – | – | ★ | – | ★★ | 3/10: low |
Davies, 1984 [24] | – | – | – | ★ | – | – | 1/10: low |
Davies, 1979 [22] | – | – | – | ★ | – | – | 1/10: low |
Farid, 1975 [25] | ★ | – | ★ | ★ | – | ★ | 4/10: low |
Guay, 1987 [29] | ★ | – | – | ★★ | ★ | ★★ | 6/10: high |
Offman, 2000 [26] | ★ | ★ | ★★ | ★★ | ★ | ★★ | 9/10: high |
Patel, 1995 [27] | ★ | ★ | ★ | ★★ | ★ | ★★ | 8/10: high |
Ramirez, 1985 [28] | ★ | – | ★★ | ★ | – | – | 4/10: low |