Evidence map›Paper›PMID 27694262›Full record

Trial reportNeurology2016

Quality of life at 6 months in the Idiopathic Intracranial Hypertension Treatment Trial.

Beau B Bruce, Kathleen B Digre, Michael P McDermott, Eleanor B Schron, Michael Wall, NORDIC Idiopathic Intracranial Hypertension Study Group

Registry-linked trialOpen access · bronzeAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Neurology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01003639 (A Multicenter, Double-blind, Randomized, Placebo-controlled Study of Weight-Reduction and/or Low Sodium Diet Plus Acetazolamide vs Diet Plus Placebo in Subjects With Idiopathic Intracranial Hypertension With Mild Visual Loss), which is not on this map. Cited by 17 papers.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed
1.8field-weighted citation impact, top 15% of its field
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.

NCT01003639 phase2 / phase3completednot on this map

A Multicenter, Double-blind, Randomized, Placebo-controlled Study of Weight-Reduction and/or Low Sodium Diet Plus Acetazolamide vs Diet Plus Placebo in Subjects With Idiopathic Intracranial Hypertension With Mild Visual Loss

TypeinterventionalSponsorSt. Luke's-Roosevelt Hospital CenterRan2010 to 2014Enrolled165ConditionsIdiopathic Intracranial HypertensionArmsAcetazolamide, Placebo, Formal weight loss counselling program
3 · Its place in the literature

Who cites it

17 citing papers in PubMed, 44 citations in OpenAlex.

  1. Observational
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  8. Review
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  10. How do presentation age and CSF opening pressure level affect long-term prognosis of pseudotumor cerebri syndrome in children? Experience of a single tertiary clinic.Child's nervous system : ChNS : official journal of the International Society for Pediatric Neurosurgery · 2022
    Article
  11. Article
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  15. Pseudotumor Cerebri Syndrome in Children.Current pain and headache reports · 2019
    Review
  16. Idiopathic intracranial hypertension: consensus guidelines on management.Journal of neurology, neurosurgery, and psychiatry · 2018
    Article
  17. 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

6 authors at 2 institutions in 1 country.

Beau B BruceFrom the Departments of Ophthalmology, Neurology, and Epidemiology (B.B.B.), Emory University, Atlanta, GA; Departments of Neurology and Ophthalmology (K.B.D.), Moran Eye Center, University of Utah, Salt Lake City; Departments of Biostatistics and Computational Biology and Neurology (M.P.M.), University of Rochester Medical Center, NY; Division of Extramural Research (E.B.S.), National Eye Institute, Bethesda, MD; and Department of Ophthalmology and Visual Sciences (M.W.), University of Iowa Carver College of Medicine, Iowa City. bbbruce@emory.edu.
Kathleen B DigreFrom the Departments of Ophthalmology, Neurology, and Epidemiology (B.B.B.), Emory University, Atlanta, GA; Departments of Neurology and Ophthalmology (K.B.D.), Moran Eye Center, University of Utah, Salt Lake City; Departments of Biostatistics and Computational Biology and Neurology (M.P.M.), University of Rochester Medical Center, NY; Division of Extramural Research (E.B.S.), National Eye Institute, Bethesda, MD; and Department of Ophthalmology and Visual Sciences (M.W.), University of Iowa Carver College of Medicine, Iowa City.
Michael P McDermottFrom the Departments of Ophthalmology, Neurology, and Epidemiology (B.B.B.), Emory University, Atlanta, GA; Departments of Neurology and Ophthalmology (K.B.D.), Moran Eye Center, University of Utah, Salt Lake City; Departments of Biostatistics and Computational Biology and Neurology (M.P.M.), University of Rochester Medical Center, NY; Division of Extramural Research (E.B.S.), National Eye Institute, Bethesda, MD; and Department of Ophthalmology and Visual Sciences (M.W.), University of Iowa Carver College of Medicine, Iowa City.
Eleanor B SchronFrom the Departments of Ophthalmology, Neurology, and Epidemiology (B.B.B.), Emory University, Atlanta, GA; Departments of Neurology and Ophthalmology (K.B.D.), Moran Eye Center, University of Utah, Salt Lake City; Departments of Biostatistics and Computational Biology and Neurology (M.P.M.), University of Rochester Medical Center, NY; Division of Extramural Research (E.B.S.), National Eye Institute, Bethesda, MD; and Department of Ophthalmology and Visual Sciences (M.W.), University of Iowa Carver College of Medicine, Iowa City.
Michael WallFrom the Departments of Ophthalmology, Neurology, and Epidemiology (B.B.B.), Emory University, Atlanta, GA; Departments of Neurology and Ophthalmology (K.B.D.), Moran Eye Center, University of Utah, Salt Lake City; Departments of Biostatistics and Computational Biology and Neurology (M.P.M.), University of Rochester Medical Center, NY; Division of Extramural Research (E.B.S.), National Eye Institute, Bethesda, MD; and Department of Ophthalmology and Visual Sciences (M.W.), University of Iowa Carver College of Medicine, Iowa City.
NORDIC Idiopathic Intracranial Hypertension Study Group
Emory University · USUniversity of Rochester Medical Center · US

Funding

Neuro-Ophthalmology Research Disease Investigator Consortium (NORDIC) NetworkU10EY017281 · NEI · ST. LUKE'S-ROOSEVELT INST FOR HLTH SCIS · PI KUPERSMITH, MARK J · 2009 to 2014
$10.2M
Data Coordination and Biostatistics Center for the NORDIC NetworkU10EY017387 · NEI · UNIVERSITY OF ROCHESTER · PI KIEBURTZ, KARL D. · 2009 to 2013
$7.0M
NEI NIH HHS U10 EY017281NEI NIH HHS U10 EY017387
6 · The paper itself

Abstract

objectiveTo examine the changes in vision-specific and overall health-related quality of life (QOL) at 6 months in participants with idiopathic intracranial hypertension (IIH) and mild visual loss enrolled in the Idiopathic Intracranial Hypertension Treatment Trial (IIHTT) and to determine the signs and symptoms of IIH that mediate the effect of acetazolamide on QOL.

methodsWe assessed QOL using the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25), the 10-Item NEI-VFQ-25 Neuro-Ophthalmic Supplement, and the 36-Item Short Form Health Survey (SF-36). We examined associations among changes in QOL measures over 6 months, treatment status, and changes in signs and symptoms using linear and structural equation models.

resultsAmong the 165 participants with IIH (86 randomized to acetazolamide, 79 to placebo), beneficial effects of acetazolamide were seen on all QOL scales evaluated, as well as on the Near Activities (5.60 points, p = 0.03), Social Functioning (3.85 points, p = 0.04), and Mental Health (9.82, p = 0.04) subscales of the NEI-VFQ-25. Positive acetazolamide-related effects on QOL appeared to be primarily mediated by improvements in visual field, neck pain, pulsatile tinnitus, and dizziness/vertigo that outweighed the side effects of acetazolamide.

conclusionsThe marked reductions in baseline QOL seen among patients with mild visual loss from IIH are improved by treatment with acetazolamide. When combined with acetazolamide-associated improvements in visual field and other aspects of IIH, our findings with respect to QOL provide further support from the IIHTT in favor of acetazolamide to augment a dietary intervention in the treatment of IIH with mild visual loss (clinicaltrials.gov: NCT01003639).

Indexed as

AcetazolamideAdolescentAdultCarbonic Anhydrase InhibitorsFemaleFollow-Up StudiesHumansMaleMiddle AgedPseudotumor CerebriQuality of LifeSurveys and QuestionnairesVisual AcuityYoung AdultAcetazolamideCarbonic Anhydrase Inhibitors

Identifiers

PMID27694262
PMCPMC5100710
OpenAlexW2526698382

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.