Evidence map›Paper›PMID 36979665›Full record

ArticleBiomedicines2023

Sample Size Analysis for Machine Learning Clinical Validation Studies.

Daniel M Goldenholz, Haoqi Sun, Wolfgang Ganglberger, M Brandon Westover

2 registry-linked trialsFull text read
In one paragraph

Article in Biomedicines, 2023. 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 35 papers.

0numbers the graph read from it
0cells of the map it votes in
35citing papers in PubMed
–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.

NCT07427927 enrolling by invitationnot on this mapstarted 2024, after this paper: background citation

Data-driven Clustering in Hemorrhoid Surgery: Retrospective Monocentric Study for the Identification of Clinical Phenotypes

TypeobservationalSponsorIRCCS Policlinico S. DonatoRan2024 to 2026Enrolled100ConditionsHemorrhoid, Hemorrhoid ProlapseArmsAny surgical procedure for hemorrhoidal disease
NCT07695376 recruitingnot on this mapstarted 2026, after this paper: background citation

CArdiovascular Risk Assessment Via Multimodal Data Analysis Enabling Personalised Prevention Strategies Targeting MEnopausaL Women - Observational Study

Typeobservational_patient_registrySponsorBiogipuzkoa Health Research InstituteRan2026 to 2028Enrolled3,000ConditionsPerimenopause, Menopause, Cardiovascular (CV) Risk, Women (Between 30 to 60 Years Old)
3 · Its place in the literature

Who cites it

35 citing papers in PubMed.

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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

4 authors.

Daniel M GoldenholzDepartment of Neurology, Beth Israel Deaconess Medical Center, Boston, MA 02215, USA.ORCID 0000-0002-8370-2758
Haoqi SunDepartment of Neurology, Beth Israel Deaconess Medical Center, Boston, MA 02215, USA.
Wolfgang GanglbergerDepartment of Neurology, Beth Israel Deaconess Medical Center, Boston, MA 02215, USA.ORCID 0000-0002-6029-2450
M Brandon WestoverDepartment of Neurology, Beth Israel Deaconess Medical Center, Boston, MA 02215, USA.

Funding

Institutional Career Development CoreKL2TR002542 · NCATS · HARVARD MEDICAL SCHOOL · PI BREDELLA, MIRIAM ANTOINETTE, RUTKOVE, SEWARD B. · 2018 to 2022
$8.7M
Data-Driven Sleep Biomarkers of Brain Health, Heart Health, and MortalityR01HL161253 · NHLBI · BETH ISRAEL DEACONESS MEDICAL CENTER · PI CLIFFORD, GARI DAVID, MIGNOT, EMMANUEL J · 2022 to 2025
$8.3M
Integrative Motor Activity Biomarker for the Risk of Alzheimer's RiskRF1AG064312 · NIA · BRIGHAM AND WOMEN'S HOSPITAL · PI HU, KUN · 2019 to 2019
$3.6M
Multimodal Network Connectivity Architecture (MOCA) of the Brain and its Role in the Recovery of Consciousness in Comatose Cardiac Arrest PatientsR01NS102574 · NINDS · MASSACHUSETTS GENERAL HOSPITAL · PI GREER, DAVID MATTHEW, WU, ONA · 2018 to 2022
$3.4M
Investigation of Sleep in the Intensive Care Unit (ICU-SLEEP)R01NS102190 · NINDS · MASSACHUSETTS GENERAL HOSPITAL · PI WESTOVER, MICHAEL BRANDON · 2018 to 2022
$3.2M
Prospective Validation of Neurophysiologic Outcome Prediction in Acute Brain InjuryR01NS126282 · NINDS · BETH ISRAEL DEACONESS MEDICAL CENTER · PI Aaron F Struck, Michael Brandon Westover · 2023 to 2026
$2.9M
Big Data and Deep Learning for the Interictal-Ictal-Injury ContiuumR01NS107291 · NINDS · MASSACHUSETTS GENERAL HOSPITAL · PI WESTOVER, MICHAEL BRANDON · 2018 to 2022
$2.8M
Establishing a Brain Health Index from the Sleep ElectroencephalogramRF1NS120947 · NINDS · MASSACHUSETTS GENERAL HOSPITAL · PI CASH, SYDNEY S, THOMAS, ROBERT JOSEPH · 2021 to 2021
$2.4M
Non-Invasive Seizure Forecasting System Using E-Diaries, Internal and External FactorsK23NS124656 · NINDS · BETH ISRAEL DEACONESS MEDICAL CENTER · PI Daniel M Goldenholz · 2022 to 2026
$954k
NCATS NIH HHS KL2 TR002542NHLBI NIH HHS R01 HL161253NIA NIH HHS RF1 AG064312NIH HHS 5KL2TR002542NIH HHS K23NS124656NIH HHS R01AG062989NIH HHS R01NS102190NIH HHS R01NS102574NIH HHS R01NS107291NIH HHS RF1AG064312NINDS NIH HHS K23 NS124656NINDS NIH HHS R01 NS102190NINDS NIH HHS R01 NS102574NINDS NIH HHS R01 NS107291NINDS NIH HHS R01 NS126282NINDS NIH HHS RF1 NS120947
6 · The paper itself

Abstract

backgroundBefore integrating new machine learning (ML) into clinical practice, algorithms must undergo validation. Validation studies require sample size estimates. Unlike hypothesis testing studies seeking a

methodsOur open-source method, Sample Size Analysis for Machine Learning (SSAML) was described and was tested in three previously published models: brain age to predict mortality (Cox Proportional Hazard), COVID hospitalization risk prediction (ordinal regression), and seizure risk forecasting (deep learning).

resultsMinimum sample sizes were obtained in each dataset using standardized criteria. DISCUSSION: SSAML provides a formal expectation of precision and accuracy at a desired confidence level. SSAML is open-source and agnostic to data type and ML model. It can be used for clinical validation studies of ML models.

Indexed as

machine learningpower calculationstatistics

Identifiers

PMID36979665
PMCPMC10045793

What OpenQuestion holds

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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 OpenQuestion graph.