Evidence map›Paper›PMID 38320487›Full record

Trial reportNEJM evidence2024

Smart Start - Designing Powerful Clinical Trials Using Pilot Study Data.

Johannes O Ferstad, Priya Prahalad, David M Maahs, Dessi P Zaharieva, Emily Fox, Manisha Desai, Ramesh Johari, David Scheinker

Registry-linked trialAbstract readClinical Trial
In one paragraph

Trial report in NEJM evidence, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04336969 (Teamwork, Targets, Technology, and Tight Control in Newly Diagnosed Pediatric T1D - 4T Study), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing 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.

NCT04336969 nacompletednot on this map

Teamwork, Targets, Technology, and Tight Control in Newly Diagnosed Pediatric T1D - 4T Study

TypeinterventionalSponsorStanford UniversityRan2020 to 2025Enrolled316ConditionsType1diabetesArms4T Education and Care
3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Article
  2. Article
  3. 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

8 authors.

Johannes O FerstadDepartment of Management Science and Engineering, Stanford University School of Engineering, Stanford, CA.
Priya PrahaladDivision of Pediatric Endocrinology, Stanford University School of Medicine, Stanford, CA.
David M MaahsDivision of Pediatric Endocrinology, Stanford University School of Medicine, Stanford, CA.
Dessi P ZaharievaDivision of Pediatric Endocrinology, Stanford University School of Medicine, Stanford, CA.
Emily FoxDepartment of Statistics, Stanford University, Stanford, CA.
Manisha DesaiQuantitative Sciences Unit, Department of Medicine, Stanford University School of Medicine, Stanford, CA.
Ramesh JohariDepartment of Management Science and Engineering, Stanford University School of Engineering, Stanford, CA.
David ScheinkerDepartment of Management Science and Engineering, Stanford University School of Engineering, Stanford, CA.

Funding

Stanford Center for Clinical & Translational Education and Research (Spectrum)UL1TR003142 · NCATS · STANFORD UNIVERSITY · PI O'HARA, RUTH M · 2019 to 2023
$45.0M
Teamwork, Targets, Technology, and Tight Control in Newly Diagnosed Pediatric T1D: 4T StudyR18DK122422 · NIDDK · STANFORD UNIVERSITY · PI MAAHS, DAVID MATTHEW · 2020 to 2024
$3.2M
NCATS NIH HHS UL1 TR003142NIDDK NIH HHS R18 DK122422
6 · The paper itself

Abstract

backgroundDigital health interventions may be optimized before evaluation in a randomized clinical trial. Although many digital health interventions are deployed in pilot studies, the data collected are rarely used to refine the intervention and the subsequent clinical trials.

methodsWe leverage natural variation in patients eligible for a digital health intervention in a remote patient-monitoring pilot study to design and compare interventions for a subsequent randomized clinical trial.

resultsOur approach leverages patient heterogeneity to identify an intervention with twice the estimated effect size of an unoptimized intervention.

conclusionsOptimizing an intervention and clinical trial based on pilot data may improve efficacy and increase the probability of success. (Funded by the National Institutes of Health and others; ClinicalTrials.gov number, NCT04336969.)

Indexed as

Research DesignHumansPilot ProjectsRandomized Controlled Trials as Topic

Identifiers

PMID38320487
PMCPMC13077730

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.