Estimating the Time to Benefit for Preventive Drugs with the Statistical Process Control Method: An Example with Alendronate

Background For physicians dealing with patients with a limited life expectancy, knowing the time to benefit (TTB) of preventive medication is essential to support treatment decisions. Objective The aim of this study was to investigate the usefulness of statistical process control (SPC) for determini...

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Bibliographic Details
Published in:Drugs & aging 2016-05, Vol.33 (5), p.347-353
Main Authors: van de Glind, Esther M. M., Willems, Hanna C., Eslami, Saeid, Abu-Hanna, Ameen, Lems, Willem F., Hooft, Lotty, de Rooij, Sophia E., Black, Dennis M., van Munster, Barbara C.
Format: Article
Language:English
Subjects:
Alendronate - therapeutic use
Bone Density
Female
Fractures, Bone - prevention & control
Geriatrics/Gerontology
Humans
Internal Medicine
Medicine
Medicine & Public Health
Middle Aged
Original
Original Research Article
Osteoporosis, Postmenopausal - drug therapy
Pharmacology/Toxicology
Pharmacotherapy
Risk
Spinal Fractures - prevention & control
Survival Analysis
Time Factors
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Summary:Background For physicians dealing with patients with a limited life expectancy, knowing the time to benefit (TTB) of preventive medication is essential to support treatment decisions. Objective The aim of this study was to investigate the usefulness of statistical process control (SPC) for determining the TTB in relation to fracture risk with alendronate versus placebo in postmenopausal women. Methods We performed a post hoc analysis of the Fracture Intervention Trial (FIT), a randomized, controlled trial that investigated the effect of alendronate versus placebo on fracture risk in postmenopausal women. We used SPC, a statistical method used for monitoring processes for quality control, to determine if and when the intervention group benefited significantly more than the control group. SPC discriminated between the normal variations over time in the numbers of fractures in both groups and the variations that were attributable to alendronate. The TTB was defined as the time point from which the cumulative difference in the number of clinical fractures remained greater than the upper control limit on the SPC chart. Results For the total group, the TTB was defined as 11 months. For patients aged ≥70 years, the TTB was 8 months [absolute risk reduction (ARR) = 1.4 %]; for patients aged
ISSN:1170-229X
1179-1969
DOI:10.1007/s40266-016-0344-7