Table 1.
Parameters | Re-examine POPI trial | Generic sample size calculation | Source | |||
---|---|---|---|---|---|---|
Baseline values | Range | Baseline values | Range | |||
Sample size calculation | ||||||
inc | PID incidence (per year) | 1) 2 % & 2) 3 %a | calculated† | POPI trial [14] | ||
RR | Relative risk | 1) 0.48 & 2) 0.44a | calculateda | POPI trial [14] | ||
t | Follow-up time (in days) | 365 | 365 | 90–540‡ | POPI trial [14] | |
α | Significance level | 5 % | 5 % | POPI trial [14] | ||
1-β | Power | 80 % | 10–90 %† | 80 % | POPI trial [14] | |
Infection parameter | ||||||
λ | Force of infection (per day) | calculated§ | calculated§ | |||
1/r | Duration of infection (in days) | 365 | 365 ± 75 | 365 | 365 ± 75 | Model [17]¶ |
p | Prevalence of infection | 7 % | 3–10 %‡ | 7 % | 3–10 %‡ | POPI trial [14] |
Progression to PID | ||||||
f | Fraction of women with chlamydia who progress to PID in absence of testing | calculated† | 10 % | 7–13 % | Model [16]¶ | |
1/γ | Infection progression (in days) | calculated# | calculated# |
aFor the three types of progression, PID incidence is used for the control group and RR is calculated per type
†The fraction f and the PID incidence inc in the control group satisfy the equation: fprt = inc
‡Range determined by agreement among authors
§In the absence of the trial, to observe chlamydia prevalence p at steady state:
¶Results of a mathematical model which used published trial data
#To achieve the same cumulative PID incidence in all three processes in absence of the trial:
PID, pelvic inflammatory disease; RR, relative risk