Evidence map›Paper›PMID 38993767›Full record

ArticleFrontiers in transplantation2024

The value of organ and tissue biovigilance: a cross-sectional analysis.

Aurora Navarro, Oscar Len, Eduardo Muñiz-Diaz, Joan-Lluis Vives Corrons, Beatriz Dominguez-Gil, Anna Vilarrodona, Jaume Tort

Abstract read
In one paragraph

Article in Frontiers in transplantation, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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

1 citing paper in PubMed.

  1. 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

7 authors.

Aurora NavarroOganització Catalana de Trasplantaments (OCATT), Barcelona, Spain.
Oscar LenInfectious Diseases Department, Hospital Universitari Vall d'Hebron, Barcelona, Spain.
Eduardo Muñiz-DiazBanc de Sang i Teixits, Barcelona, Spain.
Joan-Lluis Vives CorronsProfessor emeritus, Hospital Clínic de Barcelona, Barcelona, Spain.
Beatriz Dominguez-GilGeneral Direction, Organización Nacional de Trasplantes, Madrid, Spain.
Anna VilarrodonaBarcelona Tissue Bank, Banc de Sang i Teixits, Barcelona, Spain.
Jaume TortOganització Catalana de Trasplantaments (OCATT), Barcelona, Spain.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Introduction: Biovigilance (BV) systems aim to improve the quality and safety of tissues and organs for transplantation. This study describes the Catalan BV system and analyzes its utility. Methods: It is a retrospective analysis of notifications on serious adverse events (SAEs) and reactions (SARs) since the implementation of the BV system (2008 for tissues and 2016 for organs) until 2020. Variables are presented to describe the most common critical steps of the pathway and complications associated with the quality and safety of tissues and organs. Results: A total of 154 and 125 notifications were reported to the Tissue and the Organ BV systems, respectively. Most SAEs were related to unexpected donor diseases and implemented actions were assured on those deemed preventable. Regarding SARs, donor-transmitted infections and malignancies (only organs) were the most common, followed by graft failure (tissues) and process-related (organs). The incidence of SAEs and SARs related to tissue was 3.44‰ and 0.22‰, respectively. The corresponding figures for organs were 31.48‰ and 8.8‰, respectively. Discussion: The analysis of the notifications to the Catalan BV systems has provided useful information about existing risks associated with the quality and safety of tissues and organs, and enabled the implementation of actions targeted to diminish risks and mitigate damage.

Indexed as

biovigilance systemquality and safetyretrospective analysisserious adverse eventsserious adverse reactionstissue–organ cross-sectional analysistransplantation

Identifiers

PMID38993767
PMCPMC11235277

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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.