Evidence map›Paper›PMID 25847579›Full record

Trial reportContemporary clinical trials2015

Use of mobile devices and the internet for multimedia informed consent delivery and data entry in a pediatric asthma trial: Study design and rationale.

Kathryn Blake, Janet T Holbrook, Holly Antal, David Shade, H Timothy Bunnell, Suzanne M McCahan, Robert A Wise, Chris Pennington, Paul Garfinkel, Tim Wysocki

2 registry-linked trialsAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Contemporary clinical trials, 2015. 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 17 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
17citing 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.

NCT02061280 phase4completednot on this map

Use of Mobile Devices and the Internet to Streamline an Asthma Clinical Trial

TypeinterventionalSponsorNemours Children's ClinicRan2013 to 2017Enrolled108ConditionsAsthmaArmsfluticasone/salmeterol 250/50 Dry Powder Inhaler, fluticasone/salmeterol 100/50 Dry Powder Inhaler, fluticasone 100mcg Dry Powder Inhaler
NCT05880147 nacompletednot on this mapstarted 2023, after this paper: background citation

App-based Consent for Participation in Pediatric Clinical Research: a Feasibility Study

TypeinterventionalSponsorUniversity of British ColumbiaRan2023 to 2024Enrolled120ConditionsConsentArmsConsent App, Traditional paper-based consent
3 · Its place in the literature

Who cites it

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

  1. Pooled it
  2. Trial
  3. Trial
  4. Article
  5. Article
  6. Article
  7. Article
  8. Article
  9. Replacing Paper Informed Consent with Electronic Informed Consent for Research in Academic Medical Centers: A Scoping Review.AMIA Joint Summits on Translational Science proceedings. AMIA Joint Summits on Translational Science · 2020
    Article
  10. Article
  11. Article
  12. Article
  13. Article
  14. Review
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  17. Review
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

10 authors.

Kathryn BlakeCenter for Pharmacogenomics and Translational Research, Nemours Children's Specialty Care, 807 Children's Way, Jacksonville, FL 32207, USA. Electronic address: kathryn.blake@nemours.org.
Janet T HolbrookCenter for Clinical Trials and Evidence Synthesis, Johns Hopkins University, 415 N Washington Street, Baltimore, MD 21205, USA. Electronic address: janet.holbrook@jhu.edu.
Holly AntalDivision of Psychiatry and Psychology, Nemours Children's Specialty Care, 807 Children's Way, Jacksonville, FL 32207, USA. Electronic address: holly.antal@nemours.org.
David ShadeCenter for Clinical Trials and Evidence Synthesis, Johns Hopkins University, 415 N Washington Street, Baltimore, MD 21205, USA. Electronic address: dshade1@jhu.edu.
H Timothy BunnellBioinformatics Core Facility, Nemours/Alfred I. duPont Hospital for Children, 1600 Rockland Road, Wilmington, DE 19803, USA. Electronic address: tim.bunnell@nemours.org.
Suzanne M McCahanBioinformatics Core Facility, Nemours/Alfred I. duPont Hospital for Children, 1600 Rockland Road, Wilmington, DE 19803, USA. Electronic address: Suzanne.mccahan@nemours.org.
Robert A WiseJohns Hopkins University School of Medicine, Baltimore, MD 21205, USA. Electronic address: rwise@jhmi.edu.
Chris PenningtonBioinformatics Core Facility, Nemours/Alfred I. duPont Hospital for Children, 1600 Rockland Road, Wilmington, DE 19803, USA. Electronic address: chris.pennington@nemours.org.
Paul GarfinkelNemours Office of Human Subjects Protection, Nemours Foundation, 10140 Centurion Parkway North, Jacksonville, FL 32256, USA. Electronic address: paul.garfinkel@nemours.org.
Tim WysockiCenter for Health Care Delivery Science, Nemours Children's Specialty Care, 807 Children's Way, Jacksonville, FL 32207, USA. Electronic address: tim.wysocki@nemours.org.

Funding

Use of Mobile Devices and the Internet to Streamline an Asthma Clinical Trial (MIR01HL114899 · NHLBI · NEMOURS CHILDREN'S CLINIC · PI BLAKE, KATHRYN V · 2012 to 2015
$1.9M
NHLBI NIH HHS R01 HL114899NHLBI NIH HHS R01HL114899
6 · The paper itself

Abstract

introductionPhase III/IV clinical trials are expensive and time consuming and often suffer from poor enrollment and retention rates. Pediatric trials are particularly difficult because scheduling around the parent, participant and potentially other sibling schedules can be burdensome. We are evaluating using the internet and mobile devices to conduct the consent process and study visits in a streamlined pediatric asthma trial. Our hypothesis is that these study processes will be non-inferior and will be less expensive compared to a traditional pediatric asthma trial. MATERIALS/

methodsParents and participants, aged 12 through 17 years, complete the informed consent process by viewing a multi-media website containing a consent video and study material in the streamlined trial. Participants are provided an iPad with WiFi and EasyOne spirometer for use during FaceTime visits and online twice daily symptom reporting during an 8-week run-in followed by a 12-week study period. Outcomes are compared with participants completing a similarly designed traditional trial comparing the same treatments within the same pediatric health-system. After 8 weeks of open-label Advair 250/50 twice daily, participants in both trial types are randomized to Advair 250/50, Flovent 250, or Advair 100/50 given 1 inhalation twice daily. Study staff track time spent to determine study costs.

resultsParticipants have been enrolled in the streamlined and traditional trials and recruitment is ongoing.

conclusionsThis project will provide important information on both clinical and economic outcomes for a novel method of conducting clinical trials. The results will be broadly applicable to trials of other diseases.

Indexed as

Computers, HandheldInformed ConsentInternetResearch DesignAdolescentAsthmaBronchodilator AgentsChildData CollectionDose-Response Relationship, DrugDouble-Blind MethodFemaleFluticasoneFluticasone-Salmeterol Drug CombinationHumansMaleBronchodilator AgentsFluticasoneFluticasone-Salmeterol Drug CombinationClinical trialInformed consentInternetMobile devicesMultimediaPediatric

Identifiers

PMID25847579
PMCPMC4450122

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.