Evidence mapPaperPMID 16972704Full record

ReviewBiometrical journal. Biometrische Zeitschrift2006

Sample size recalculation in internal pilot study designs: a review.

Tim Friede, Meinhard Kieser

2 registry-linked trialsAbstract readReview
PubMed Publisher
In one paragraph

Review in Biometrical journal. Biometrische Zeitschrift, 2006. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 59 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
59citing papers in PubMed, 1 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.

NCT04056039 phase2completedstarted 2018, after this paper: background citation

Efficacy of Atorvastatin vs Colchicine in Decrease of Troponin I of High Sensitivity as a Biomarker of Myocardial Damage in Patients With Rheumatoid Arthritis With Severe Activity.

Ran2018Enrolled60Registered outcomes3Posted comparisons0ConditionsArthritis, Rheumatoid, Cardiovascular DiseasesArmsAtorvastatin, Colchicine
Open the trial in the graph
NCT05122793 naactive not recruitingnot on this mapstarted 2021, after this paper: background citation

"HerzCheck" - Erkennung Und Prävention Einer Frühen Herzinsuffizienz Mittels Telemedizinischer Verfahren in Strukturschwachen Regionen

TypeinterventionalSponsorGerman Heart InstituteRan2021 to 2034Enrolled4,509ConditionsHeart Failure with Preserved Ejection FractionArmsPrevention offer
3 · Its place in the literature

Who cites it

59 citing papers in PubMed, 1 synthesis or guideline pooled it.

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  5. Epigallocatechin Gallate in Progressive MS: A Randomized, Placebo-Controlled Trial.Neurology(R) neuroimmunology & neuroinflammation · 2021
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

2 authors.

Tim FriedeNovartis Pharma AG, Biostatistics and Statistical Reporting, Basel, Switzerland. tim.friede@novartis.com
Meinhard Kieser

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The adequacy of sample size is important to clinical trials. In the planning phase of a trial, however, the investigators are often quite uncertain about the sizes of parameters which are needed for sample size calculations. A solution to this problem is mid-course recalculation of the sample size during the ongoing trial. In internal pilot study designs, nuisance parameters are estimated on the basis of interim data and the sample size is adjusted accordingly. This review attempts to give an overview on the available methods. It is written not only for biometricians who are already familar with the the topic and wish to update their knowledge but also for users new to the subject.

Indexed as

Clinical Trials as TopicConfidence IntervalsData Interpretation, StatisticalPilot ProjectsResearch DesignSample Size

Identifiers

PMID16972704

What Socratic holds

Textmetadata
Read underepoch 390

Registered trials

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 Socratic graph.