Evidence map›Paper›PMID 28446127›Full record

ArticleBMC medical research methodology2017

Sample size and power determination when limited preliminary information is available.

Christine E McLaren, Wen-Pin Chen, Thomas D O'Sullivan, Daniel L Gillen, Min-Ying Su, Jeon H Chen, Bruce J Tromberg

Open access · goldAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in BMC medical research methodology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
0.4field-weighted citation impact, top 35% of its field
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

4 citing papers in PubMed, 9 citations in OpenAlex.

  1. Article
  2. Article
  3. Article
  4. 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

7 authors at 2 institutions in 1 country.

Christine E McLarenDepartment of Epidemiology, University of California, Irvine, 224 Irvine Hall, Irvine, CA, USA. cmclaren@uci.edu.
Wen-Pin ChenChao Family Comprehensive Cancer Center, University of California, Orange, CA, USA.
Thomas D O'SullivanLaser Microbeam and Medical Program, Beckman Laser Institute and Medical Clinic, University of California, Irvine, CA, USA.
Daniel L GillenDepartment of Statistics, University of California, Irvine, CA, USA.
Min-Ying SuTu & Yuen Center for Functional Onco-Imaging, Department of Radiological Sciences, University of California Irvine, Irvine, CA, USA.
Jeon H ChenTu & Yuen Center for Functional Onco-Imaging, Department of Radiological Sciences, University of California Irvine, Irvine, CA, USA.
Bruce J TrombergLaser Microbeam and Medical Program, Beckman Laser Institute and Medical Clinic, University of California, Irvine, CA, USA.
University of California, Irvine · USBeckman Laser Institute and Medical Clinic · US

Funding

Univ.of Calif., Irvine Cancer Center Support GrantP30CA062203 · NCI · UNIVERSITY OF CALIFORNIA-IRVINE · PI Christine Hui · 1994 to 2026
$57.9M
UC Irvine Alzheimer's Disease Research Center Induced Pluripotent Stem Cell CoreP50AG016573 · NIA · UNIVERSITY OF CALIFORNIA-IRVINE · PI LAFERLA, FRANK M · 2000 to 2019
$37.0M
Virtual Photonocs TechnologiesP41EB015890 · NIBIB · UNIVERSITY OF CALIFORNIA-IRVINE · PI DURKIN, ANTHONY · 2012 to 2017
$7.0M
Developing DOSI Technology for Monitoring Response To Breast Cancer ChemotherapyR01CA142989 · NCI · UNIVERSITY OF CALIFORNIA-IRVINE · PI DURKIN, ANTHONY J · 2010 to 2017
$4.1M
NCI NIH HHS P30 CA062203NCI NIH HHS R01 CA142989NIA NIH HHS P50 AG016573NIBIB NIH HHS P41 EB015890
6 · The paper itself

Abstract

backgroundWe describe a novel strategy for power and sample size determination developed for studies utilizing investigational technologies with limited available preliminary data, specifically of imaging biomarkers. We evaluated diffuse optical spectroscopic imaging (DOSI), an experimental noninvasive imaging technique that may be capable of assessing changes in mammographic density. Because there is significant evidence that tamoxifen treatment is more effective at reducing breast cancer risk when accompanied by a reduction of breast density, we designed a study to assess the changes from baseline in DOSI imaging biomarkers that may reflect fluctuations in breast density in premenopausal women receiving tamoxifen.

methodWhile preliminary data demonstrate that DOSI is sensitive to mammographic density in women about to receive neoadjuvant chemotherapy for breast cancer, there is no information on DOSI in tamoxifen treatment. Since the relationship between magnetic resonance imaging (MRI) and DOSI has been established in previous studies, we developed a statistical simulation approach utilizing information from an investigation of MRI assessment of breast density in 16 women before and after treatment with tamoxifen to estimate the changes in DOSI biomarkers due to tamoxifen.

resultsThree sets of 10,000 pairs of MRI breast density data with correlation coefficients of 0.5, 0.8 and 0.9 were simulated and generated and were used to simulate and generate a corresponding 5,000,000 pairs of DOSI values representing water, ctHHB, and lipid. Minimum sample sizes needed per group for specified clinically-relevant effect sizes were obtained.

conclusionThe simulation techniques we describe can be applied in studies of other experimental technologies to obtain the important preliminary data to inform the power and sample size calculations.

Indexed as

Antineoplastic Agents, HormonalBiomarkersBreast DensityBreast NeoplasmsComputer SimulationFemaleHumansMagnetic Resonance ImagingMammographyOptical ImagingSample SizeTamoxifenAntineoplastic Agents, HormonalBiomarkersTamoxifenBreast densityDiffuse optical spectroscopic imagingMagnetic resonance imagingPower and sample size calculationTamoxifen

Identifiers

PMID28446127
PMCPMC5406943
OpenAlexW2609385613

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.