Evidence map›Paper›PMID 38623880›Full record

ArticlePediatric transplantation2024

Approach for defining human adenovirus infection and disease for central review adjudication in clinical studies.

Brian T Fisher, Jesse Blumenstock, Craig L K Boge, Sydney Shuster, Alix E Seif, Michael Green, Marian G Michaels, Jessie L Alexander, Monica I Ardura, Tamara P Miller and 7 more

Open access · hybridAbstract read
In one paragraph

Article in Pediatric transplantation, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
1.1field-weighted citation impact, top 21% 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.

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

2 citing papers in PubMed, 2 citations in OpenAlex.

  1. Article
  2. Review
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

17 authors at 11 institutions in 1 country.

Brian T FisherDivision of Infectious Diseases, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, USA.ORCID 0000-0002-8224-4281
Jesse BlumenstockDivision of Infectious Diseases, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, USA.
Craig L K BogeDivision of Infectious Diseases, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, USA.
Sydney ShusterDivision of Infectious Diseases, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, USA.
Alix E SeifSection of of Cellular Therapy and Transplantation in the Division of Oncology, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, USA.
Michael GreenDivision of Infectious Diseases, UPMC Children's Hospital of Pittsburgh, Pittsburgh, Pennsylvania, USA.ORCID 0000-0002-6011-2894
Marian G MichaelsDivision of Infectious Diseases, UPMC Children's Hospital of Pittsburgh, Pittsburgh, Pennsylvania, USA.
Jessie L AlexanderDivision of Pediatric Stem Cell Transplantation and Cellular Therapies, UPMC Children's Hospital of Pittsburgh, Pittsburgh, Pennsylvania, USA.
Monica I ArduraNationwide Children's Hospital, Columbus, Ohio, USA.
Tamara P MillerChildren's Healthcare of Atlanta, Atlanta, Georgia, USA.
Diego R HijanoSt. Jude Children's Research Hospital, Memphis, Tennessee, USA.ORCID 0000-0002-2903-666X
William J MullerAnn & Robert H. Lurie Children's Hospital of Chicago, Chicago, Illinois, USA.ORCID 0000-0001-7690-0695
Jennifer E SchusterChildren's Mercy Kansas City, Kansas City, Missouri, USA.ORCID 0000-0001-6365-566X
Abby M GreenWashington University School of Medicine, St. Louis, Missouri, USA.
Daniel E DulekMonroe Carell Jr. Children's Hospital at Vanderbilt, Nashville, Tennessee, USA.ORCID 0000-0002-1821-6657
Adriana E KajonInfectious Disease Program, Lovelace Biomedical Research Institute, Albuquerque, New Mexico, USA.
Lara Danziger-IsakovCincinnati Children's Hospital Medical Center, Cincinnati, Ohio, USA.ORCID 0000-0002-5691-5221
Children's Hospital of Philadelphia · USChildren's Hospital of Pittsburgh · USChildren's Mercy Hospital · USCincinnati Children's Hospital Medical Center · USEmory University · USLovelace Respiratory Research Institute · USMonroe Carell Jr. Children's Hospital · USNationwide Children's Hospital · USNorthwestern University · USSt. Jude Children's Research Hospital · USWashington University in St. Louis · US

Funding

FDA HHS 7540120C00135NIAID NIH HHS HHSN272201600014C
6 · The paper itself

Abstract

backgroundPediatric allogeneic hematopoietic cell transplant (allo-HCT) recipients are at risk for morbidity and mortality from human adenovirus (HAdV). HAdV can be detected in an asymptomatic state, referred to as infection or with signs or symptoms of illness, referred to as disease. Standardized case definitions are needed to distinguish infection from disease and allow for consistent reporting in both observational cohort studies and therapeutic clinical trials.

methodsA working group of experts in virology, transplant infectious disease, and HCT was assembled to develop HAdV infection and disease definitions with the degree of certainty (i.e., possible, probable, and proven). Definitions were further refined through an iterative process and independently applied by two central review committees (CRCs) to 20 pediatric allo-HCT recipients with at least one HAdV-positive PCR.

resultsInitial HAdV infection and disease definitions were developed and updated through an iterative process after reviewing clinical and virological details for 81 subjects with at least one positive HAdV PCR detected in a clinical specimen. Independent application of final definitions to 20 HAdV positive allo-HCT recipients by two CRCs yielded similar number of HAdV infection or disease events but with variation of degree of certainty for some events.

conclusionsApplication of definitions by a CRC for a study of HAdV infection and disease is feasible and can provide consistency in the assignment of outcomes. Definitions need further refinement to improve reproducibility and to provide guidance on determining clinical improvement or worsening after initial diagnosis of HAdV infection or disease.

Indexed as

Adenoviruses, HumanAdenovirus Infections, HumanHematopoietic Stem Cell TransplantationChildCohort StudiesHumansReproducibility of ResultsTransplantation, Homologoushematopoietic cell transplantationhuman adenoviruspediatrics

Identifiers

PMID38623880
PMCPMC11031616
OpenAlexW4394853565

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.