Evidence map›Paper›PMID 21351116›Full record

Trial reportHepatology (Baltimore, Md.)2011

Peginterferon with or without ribavirin has minimal effect on quality of life, behavioral/emotional, and cognitive outcomes in children.

James R Rodrigue, William Balistreri, Barbara Haber, Maureen M Jonas, Parvathi Mohan, Jean P Molleston, Karen F Murray, Michael R Narkewicz, Philip Rosenthal, Lesley J Smith and 5 more

Registry-linked trialOpen access · bronzeAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Hepatology (Baltimore, Md.), 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00100659 (Pegylated Interferon +/- Ribavirin for Children With Hepatitis C), which is not on this map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
1.5field-weighted citation impact, top 18% 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.

NCT00100659 phase3completednot on this map

Pegylated Interferon +/- Ribavirin for Children With Hepatitis C

TypeinterventionalSponsorNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Ran2004 to 2010Enrolled114ConditionsChronic Hepatitis CArmsPegylated Interferon/ribavirin
3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 22 citations in OpenAlex.

  1. Trial
  2. Article
  3. Review
  4. Article
  5. Hepatitis C Virus Infection in Children.Gastroenterology & hepatology · 2017
    Article
  6. Article
  7. 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

15 authors at 14 institutions in 1 country.

James R RodrigueBeth Israel Deaconess Medical Center, Boston, MA. jrrodrig@bidmc.harvard.edu
William Balistreri
Barbara Haber
Maureen M Jonas
Parvathi Mohan
Jean P Molleston
Karen F Murray
Michael R Narkewicz
Philip Rosenthal
Lesley J Smith
Steven J Lobritto
Kathleen B Schwarz
Patricia R Robuck
Bruce Barton
Regino P González-Peralta
Columbia University · USBeth Israel Deaconess Medical Center · USBoston Children's Museum · USChildren's Hospital of Philadelphia · USCincinnati Children's Hospital Medical Center · USGeorge Washington University · USJohns Hopkins University · USNational Institute of Diabetes and Digestive and Kidney Diseases · USRiley Hospital for Children · USSeattle Children's Hospital · USUniversity of California, San Francisco · USUniversity of Colorado Denver · USUniversity of Florida · USUniversity of Massachusetts Chan Medical School · US

Funding

INSTITUTE FOR TRANSLATIONAL HEALTH SCIENCE (UL1): BPCAUL1RR025014 · NCRR · UNIVERSITY OF WASHINGTON · PI DISIS, MARY L. · 2007 to 2011
$51.5M
Pegylated Interferon +/- Ribavirin for Children with HCVU01DK067767 · NIDDK · JOHNS HOPKINS UNIVERSITY · PI SCHWARZ, KATHLEEN · 2003 to 2008
$3.9M
NCRR NIH HHS UL1 RR025014NIDDK NIH HHS 1UO1DK067767NIDDK NIH HHS U01 DK067767
6 · The paper itself

Abstract

unlabelledThe aim of this study was to prospectively assess the quality of life (QOL), behavioral/emotional functioning, and cognitive status of children undergoing treatment for hepatitis C virus (HCV) infection. In all, 114 children (5 to 18 years old) enrolled in a multisite randomized clinical trial (Peds-C) to evaluate peginterferon alpha 2a (PEG 2a) with ribavirin (RV) or with placebo (PL) completed several standardized measures prior to treatment and at 24 weeks, 48 weeks, 6 months following treatment, and at two annual follow-up visits. After 24 weeks of treatment, mean physical QOL scores declined significantly for both groups from baseline to 24 weeks of treatment (F = 5.8, P = 0.004), although scores remained in the average range. There were no significant time or group effects for behavioral/emotional or cognitive functioning. Three children (5%) in the PEG 2a + RV group and no children in the PEG 2a + PL group had a clinically significant increase in depression symptoms. For those children who received 48 weeks of treatment, there were no significant time or group effects on any of the outcome measures (P > 0.05). A majority of children in both the PEG 2a + RV and PEG 2a + PL groups experienced no clinically significant change in physical QOL, behavioral adjustment, depression, or cognitive functioning during or after treatment.

conclusionOverall QOL and psychosocial functioning are not deleteriously impacted by PEG 2a + RV or PL treatment of children with HCV.

Indexed as

Quality of LifeAdolescentAntiviral AgentsBehaviorChildChild, PreschoolCognitionDrug Therapy, CombinationEmotionsFemaleHepatitis CHumansInterferon-alphaInterferon alpha-2MalePolyethylene GlycolsAntiviral AgentsInterferon-alphaInterferon alpha-2peginterferon alfa-2aPolyethylene GlycolsRecombinant ProteinsRibavirin

Identifiers

PMID21351116
PMCPMC3082614
OpenAlexW2010426360

What OpenQuestion holds

Textmetadata
LicenceTDM
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.