Evidence map›Paper›PMID 26884390›Full record

Trial reportDrugs & aging2016

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

Esther M M van de Glind, Hanna C Willems, Saeid Eslami, Ameen Abu-Hanna, Willem F Lems, Lotty Hooft, Sophia E de Rooij, Dennis M Black, Barbara C van Munster

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in Drugs & aging, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed, 4 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

18 citing papers in PubMed, 4 syntheses or guidelines pooled it.

  1. A cost-saving analysis of pharmacologic management in osteoporotic fracture prevention among postmenopausal women.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2025
    Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Article
  6. Article
  7. Age is just a number: the concept of time to benefit in older adults.European journal of hospital pharmacy : science and practice · 2023
    Article
  8. Controversies in Osteoporosis Treatment of Nursing Home Residents.Journal of the American Medical Directors Association · 2022
    Review
  9. Article
  10. Observational
  11. Does treatment with bisphosphonates protect against fractures in real life? The HUNT study, Norway.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2021
    Article
  12. Review
  13. Observational
  14. Clinical Management of Osteoporotic Fractures.Current osteoporosis reports · 2018
    Review
  15. Article
  16. Individualizing Prevention for Older Adults.Journal of the American Geriatrics Society · 2018
    Article
  17. Article
  18. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors.

Esther M M van de GlindGeriatrics Section, Department of Internal Medicine, Academic Medical Center, Amsterdam, The Netherlands. emmvandeglind@gmail.com.
Hanna C WillemsGeriatrics Section, Department of Internal Medicine, Academic Medical Center, Amsterdam, The Netherlands.
Saeid EslamiDepartment of Medical Informatics, Academic Medical Center, Amsterdam, The Netherlands.
Ameen Abu-HannaDepartment of Medical Informatics, Academic Medical Center, Amsterdam, The Netherlands.
Willem F LemsDepartment of Rheumatology, VU Medical Center, Amsterdam, The Netherlands.
Lotty HooftDutch Cochrane Centre, University Medical Center, Utrecht, The Netherlands.
Sophia E de RooijGeriatrics Section, Department of Internal Medicine, Academic Medical Center, Amsterdam, The Netherlands.
Dennis M BlackDepartment of Epidemiology and Biostatistics, University of California San Francisco, San Francisco, CA, USA.
Barbara C van MunsterGeriatrics Section, Department of Internal Medicine, Academic Medical Center, Amsterdam, The Netherlands.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundFor physicians dealing with patients with a limited life expectancy, knowing the time to benefit (TTB) of preventive medication is essential to support treatment decisions.

objectiveThe 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.

methodsWe 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.

resultsFor 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 <70 years, it was 19 months (ARR = 0.7%).

conclusionSPC is a clear and understandable graphical method to determine the TTB. Its main advantage is that there is no need to define a prespecified time point, as is the case in traditional survival analyses. Prescribing alendronate to patients who are aged ≥70 years is useful because the TTB shows that they will benefit after 8 months. Investigators should report the TTB to simplify clinical decision making.

Indexed as

AlendronateBone DensityFemaleFractures, BoneHumansMiddle AgedOsteoporosis, PostmenopausalRiskSpinal FracturesSurvival AnalysisTime FactorsAlendronate

Identifiers

PMID26884390
PMCPMC4837200

What OpenQuestion holds

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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.