Evidence map›Paper›PMID 33192414›Full record

ReviewFrontiers in human neuroscience2020

Publication of Study Exit Procedures in Clinical Trials of Deep Brain Stimulation: A Focused Literature Review.

Lauren R Sankary, Akila M Nallapan, Olivia Hogue, Andre G Machado, Paul J Ford

Abstract readReview
In one paragraph

Review in Frontiers in human neuroscience, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing 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

4 citing papers in PubMed.

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

5 authors.

Lauren R SankaryNeuroethics Program, Cleveland Clinic, Cleveland, OH, United States.
Akila M NallapanSchool of Graduate Studies, Case Western Reserve University, Cleveland, OH, United States.
Olivia HogueDepartment of Quantitative Health Sciences, Lerner Research Institute, Cleveland Clinic, Cleveland, OH, United States.
Andre G MachadoDepartment of Quantitative Health Sciences, Lerner Research Institute, Cleveland Clinic, Cleveland, OH, United States.
Paul J FordNeuroethics Program, Cleveland Clinic, Cleveland, OH, United States.

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

Considerable variability exists in the publication of clinical research study procedures related to study enrollment and participant exit from clinical trials. Despite recent efforts to encourage research data sharing and greater transparency regarding research outcomes, reporting of research procedures remains inconsistent. Transparency about study procedures has important implications for the interpretation of study outcomes and the consistent implementation of best practices in clinical trial design and conduct. This review of publications from clinical trials of deep brain stimulation (DBS) using the MEDLINE database examines the frequency and consistency of publication of research procedures and data related to exit from DBS research. Related considerations, such as device explant or continued use, battery and other device hardware replacements, and post-trial follow-up care are also reviewed. This review finds significant variability in the publication and reporting of study exit procedures. Of the 47 clinical trials included in this review, 19% (9) disclosed procedures related to exit from research. Reporting of other exit-related data and study procedures examined in this review was identified in fewer than half of the included clinical trials. The rate of participant retention and duration of follow-up was reported more than any other category of data included in this review. Results inform efforts to improve consistency in research design, conduct, and publication of results from clinical trials in DBS and related areas of clinical research.

Indexed as

deep brain stimulationneuroethicsneuromodulationneuro-psychiatric disordersresearch ethicsreview

Identifiers

PMID33192414
PMCPMC7609884

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.