Evidence map›Paper›PMID 30105163›Full record

ReviewNeurology. Clinical practice2018

Reflections on translation: Views of participants in a multisite Canadian CCSVI clinical trial.

Shelly Benjaminy, Cody Lo, Judy Illes, Anthony Traboulsee

Registry-linked trialAbstract readReview
In one paragraph

Review in Neurology. Clinical practice, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01864941 (Phase I/II Interventional Clinical Trial of Balloon Venoplasty for Chronic Cerebrospinal Venous Insufficiency in Multiple Sclerosis Patients), which is not on this map. Not yet cited in PubMed.

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

NCT01864941 phase1 / phase2completednot on this map

Phase I/II Interventional Clinical Trial of Balloon Venoplasty for Chronic Cerebrospinal Venous Insufficiency in Multiple Sclerosis Patients

TypeinterventionalSponsorUniversity of British ColumbiaRan2013 to 2017Enrolled104ConditionsMultiple SclerosisArmsCatheter venography with balloon venoplasty, Catheter venography with balloon venoplasty and balloon
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

4 authors.

Shelly BenjaminyNeuroethics Canada (SB, CL, JI) and Division of Neurology, Department of Medicine (SB, CL, JI, AT), University of British Columbia, Vancouver, Canada. SB is currently affiliated with AbilityLab, Chicago, IL.
Cody LoNeuroethics Canada (SB, CL, JI) and Division of Neurology, Department of Medicine (SB, CL, JI, AT), University of British Columbia, Vancouver, Canada. SB is currently affiliated with AbilityLab, Chicago, IL.
Judy IllesNeuroethics Canada (SB, CL, JI) and Division of Neurology, Department of Medicine (SB, CL, JI, AT), University of British Columbia, Vancouver, Canada. SB is currently affiliated with AbilityLab, Chicago, IL.
Anthony TraboulseeNeuroethics Canada (SB, CL, JI) and Division of Neurology, Department of Medicine (SB, CL, JI, AT), University of British Columbia, Vancouver, Canada. SB is currently affiliated with AbilityLab, Chicago, IL.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundWe sought to characterize the perspectives of participants in Canada's phase I/II chronic cerebrospinal venous insufficiency (CCSVI) clinical trial prior to and after the disclosure of trial results.

methodsThis was a researcher-administered survey of individuals who participated in Canada's CCSVI trial (Clincialtrials.gov, NCT01864941) about their (1) motivations for participating, (2) understanding of the trial process, and (3) perspectives on the social value of the trial.

resultsA total of 63 participants completed the survey. Participants were motivated to participate by altruism (mean score = 4.56 out of 5) and a desire to access the intervention in Canada (mean score = 3.63 out of 5). Many participants expected medical benefits, such as partial disease reversal (mean score = 3.32 out of 5). Participants felt strongly that the crossover trial design promoted fairness (mean score = 4.65 out of 5). Participants' familiarity with the CCSVI controversy increased significantly after the results were revealed (

conclusionsThere is a strong movement in science today to ensure that research agendas reflect the perspectives of multiple stakeholders, including research participants. While previous work suggests that negative findings adversely affect trust in science, the perspectives of participants in this study demonstrate that good trial design and resilience can prevail over expected tensions.

Identifiers

PMID30105163
PMCPMC6075987

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.