Evidence map›Paper›PMID 35488744›Full record

ReviewEuropean journal of clinical investigation2022

Informed consent and biological agents in rheumatology and internal medicine.

Gabriele Mandarelli, Florenzo Iannone, Stefano Ferracuti, Ignazio Grattagliano, Marcello Benevento, Biagio Solarino, Davide Ferorelli, Roberto Catanesi

Open access · hybridAbstract readReview
In one paragraph

Review in European journal of clinical investigation, 2022. 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
0.4field-weighted citation impact, top 39% 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

8 authors at 2 institutions in 1 country.

Gabriele Mandarelli"Aldo Moro" University of Bari, Bari, Italy.ORCID https://orcid.org/0000-0003-4887-5108
Florenzo Iannone"Aldo Moro" University of Bari, Bari, Italy.ORCID https://orcid.org/0000-0003-0474-5344
Stefano Ferracuti"Sapienza" University of Rome, Rome, Italy.
Ignazio GrattaglianoItalian College of General Practitioners and Primary Care, Florence, Italy.ORCID https://orcid.org/0000-0002-3472-9364
Marcello Benevento"Aldo Moro" University of Bari, Bari, Italy.ORCID https://orcid.org/0000-0002-4895-0182
Biagio Solarino"Aldo Moro" University of Bari, Bari, Italy.
Davide Ferorelli"Aldo Moro" University of Bari, Bari, Italy.
Roberto Catanesi"Aldo Moro" University of Bari, Bari, Italy.
University of Bari Aldo Moro · ITSapienza University of Rome · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe need for highly effective therapies in rheumatologic diseases has led to the widespread and growing use of a heterogeneous class of molecules called biological agents. The increasing experience with biological agents has raised concerns about safety and efficacy issues that need to be discussed in the informed consent acquisition process.

methodsThe authors performed a review of the literature on biological agents focusing on their most important characteristics concerning the informed consent procedures.

resultsNo studies specifically addressed the issue of informed consent in patients receiving biological agents. Several studies reported data about off-label use of biological agents usually with no obvious attention to informed consent shortcomings.

conclusionThe reported association between biological agents and serious infections or malignancies, including reactivation of latent tuberculosis, needs specific disclosure in informed consent acquisition, together with information about the possible efficacy in clinical contexts often characterized by resistance to previous treatments. Ethical and clinical issues bound to the need for experimenting with new agents with potentially serious adverse effects deserve specific attention. Studies aimed at evaluating mental capacity to consent in subjects receiving biological agents are required.

Indexed as

RheumatologyBiological FactorsDisclosureHumansInformed ConsentBiological Factorsbiological agentsinformed consentmental capacityrheumatology

Identifiers

PMID35488744
PMCPMC9539695
OpenAlexW4225115571

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

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.