Evidence map›Paper›PMID 34255614›Full record

ArticleAJOB neuroscience

Exit from Brain Device Research: A Modified Grounded Theory Study of Researcher Obligations and Participant Experiences.

Lauren R Sankary, Megan Zelinsky, Andre Machado, Taylor Rush, Alexandra White, Paul J Ford

Abstract read
In one paragraph

Article in AJOB neuroscience. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers.

0numbers the graph read from it
0cells of the map it votes in
16citing 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.

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

16 citing papers in PubMed.

  1. Article
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  4. Review
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  9. Post-trial access to implantable neural devices: an exploratory international survey.BMJ surgery, interventions, & health technologies · 2024
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

6 authors.

Lauren R SankaryNeuroethics Program, Cleveland Clinic.ORCID 0000-0002-9698-3616
Megan ZelinskyNeuroethics Program, Cleveland Clinic.
Andre MachadoNeurological Institute, Cleveland Clinic.
Taylor RushNeurological Institute, Cleveland Clinic.
Alexandra WhiteCleveland Clinic Lerner College of Medicine.
Paul J FordNeuroethics Program, Cleveland Clinic.ORCID 0000-0002-5423-8845

Funding

Ethical Safeguards for Exit and Withdrawal from Implanted Neurotechnology ResearchF32MH115419 · NIMH · CLEVELAND CLINIC LERNER COM-CWRU · PI SANKARY, LAUREN · 2017 to 2019
$152k
NIMH NIH HHS F32 MH115419
6 · The paper itself

Abstract

As clinical trials end, little is understood about how participants exiting from clinical trials approach decisions related to the removal or post-trial use of investigational brain implants, such as deep brain stimulation (DBS) devices. This empirical bioethics study examines how research participants experience the process of exit from research at the end of clinical trials of implanted neural devices. Using a modified grounded theory study design, we conducted semi-structured, in-depth interviews with 16 former research participants from clinical trials of DBS and responsive neurostimulation (RNS). Open-ended questions elicited motivations for joining the trial, understanding of study procedures at the time of initial informed consent, the process of exiting from research, and decisions about device removal or post-trial device use. Thematic analysis identified categories related to: limited preparedness for the end of research participation, straightforwardness of decisions to explant or keep the device, reconciling with the end of research participation, reconciling post-trial expectations, and achieving a sense of closure after exit from research. A preliminary theoretical model describes contextual factors influencing the process and experience of exit from research. Experiences of clinical trial participants should guide research practices to enhance the ethical design and conduct of clinical trials in DBS and other brain devices.

Indexed as

Deep Brain StimulationResearch PersonnelBrainGrounded TheoryHumansInformed ConsentDeep brain stimulationinformed consentneuroethicspost-trial obligationsresearch ethics

Identifiers

PMID34255614
PMCPMC10570922

What OpenQuestion holds

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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.