Evidence map›Paper›PMID 33576742›Full record

ArticleJMIR mHealth and uHealth2021

Investigator Experiences Using Mobile Technologies in Clinical Research: Qualitative Descriptive Study.

Kevin Christopher McKenna, Cindy Geoghegan, Teresa Swezey, Brian Perry, William A Wood, Virginia Nido, Steve L Morin, Brigid K Grabert, Zachary P Hallinan, Amy L Corneli

Abstract read
In one paragraph

Article in JMIR mHealth and uHealth, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing 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.

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

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

  1. Guideline
  2. Article
  3. Article
  4. Article
  5. Article
  6. Article
  7. Article
  8. 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

10 authors.

Kevin Christopher McKenna *Department of Population Health Sciences, Duke University, Durham, NC, United States.ORCID 0000-0003-3983-1306
Cindy Geoghegan *Patient and Partners LLC, Madison, CT, United States.ORCID 0000-0003-0992-3728
Teresa Swezey *Department of Population Health Sciences, Duke University, Durham, NC, United States.ORCID 0000-0002-2493-3089
Brian Perry *Department of Population Health Sciences, Duke University, Durham, NC, United States.ORCID 0000-0002-4648-7673
William A Wood *Department of Medicine, Division of Hematology, University of North Carolina at Chapel Hill, Chapel Hill, NC, United States.ORCID 0000-0001-7439-2543
Virginia Nido *Genentech, Inc., San Francisco, CA, United States.ORCID 0000-0002-0044-2736
Steve L Morin *Office of Health and Constituent Affairs, US Public Health Service, US Food and Drug Administration, Silver Spring, MD, United States.ORCID 0000-0003-0955-2066
Brigid K Grabert *Lineberger Comprehensive Cancer Center, School of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC, United States.ORCID 0000-0003-0556-1563
Zachary P Hallinan *Clinical Trials Transformation Initiative, Durham, NC, United States.ORCID 0000-0003-2922-6313
Amy L Corneli *Department of Population Health Sciences, Duke University, Durham, NC, United States.ORCID 0000-0002-4629-4329

Funding

Increasing the Quality and Efficiency of Clinical Trials (R18)R18FD005292 · FDA · DUKE UNIVERSITY · PI LI, JENNIFER S · 2014 to 2019
$26.8M
Increasing the Quality and Efficiency of Clinical Trials (U18)U18FD005292 · FDA · DUKE UNIVERSITY · PI John H Alexander · 2019 to 2026
$26.1M
Cancer Control Education ProgramT32CA057726 · NCI · UNIV OF NORTH CAROLINA CHAPEL HILL · PI Melissa B Gilkey, Melissa A. Troester · 2017 to 2026
$3.7M
FDA HHS R18 FD005292FDA HHS U18 FD005292NCI NIH HHS T32 CA057726
6 · The paper itself

Abstract

backgroundThe successful adoption of mobile technology for use in clinical trials relies on positive reception from key stakeholders, including clinical investigators; however, little information is known about the perspectives of investigators using mobile technologies in clinical trials.

objectiveThe aim of this study was to seek investigators' insights on the advantages and challenges of mobile clinical trials (MCTs); site-level budgetary, training, and other support needs necessary to adequately prepare for and implement MCTs; and the advantages and disadvantages for trial participants using mobile technologies in clinical trials.

methodsUsing a qualitative descriptive study design, we conducted in-depth interviews with investigators involved in the conduct of MCTs. Data were analyzed using applied thematic analysis.

resultsWe interviewed 12 investigators who represented a wide variety of clinical specialties and reported using a wide range of mobile technologies. Investigators most commonly cited 3 advantages of MCTs over traditional clinical trials: more streamlined study operations, remote data capture, and improvement in the quality of studies and data collected. Investigators also reported that MCTs can be designed around the convenience of trial participants, and individuals may be more willing to participate in MCTs because they can take part from their homes. In addition, investigators recognized that MCTs can also involve additional burden for participants and described that operational challenges, technology adoption barriers, uncertainties about data quality, and time burden made MCTs more challenging than traditional clinical trials. Investigators stressed that additional training and dedicated staff effort may be needed to select a particular technology for use in a trial, helping trial participants learn and use the technology, and for staff troubleshooting the technology. Investigators also expressed that sharing data collected in real time with investigators and trial participants is an important aspect of MCTs that warrants consideration and potentially additional training and education.

conclusionsInvestigator perspectives can inform the use of mobile technologies in future clinical trials by proactively identifying and addressing potential challenges.

Indexed as

Research PersonnelTechnologyHumansQualitative Researchclinical researchclinical trialdigital healthdigital health technologymHealthmobile applicationsmobile clinical trialsmobile devicesmobile technology

Identifiers

PMID33576742
PMCPMC7910119

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.