Evidence map›Paper›PMID 22565583›Full record

ArticleJournal of empirical research on human research ethics : JERHRE2012

Negotiating decisions during informed consent for pediatric Phase I oncology trials.

Patricia A Marshall, Ruth V Magtanong, Angela C Leek, Sabahat Hizlan, Amy D Yamokoski, Eric D Kodish

Open access · greenAbstract read
In one paragraph

Article in Journal of empirical research on human research ethics : JERHRE, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 1 pooled it
0.4field-weighted citation impact, top 23% 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

6 citing papers in PubMed, 1 synthesis or guideline pooled it, 17 citations in OpenAlex.

  1. Pooled it
  2. Review
  3. Article
  4. Review
  5. Review
  6. 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.

Patricia A MarshallCenter for Genetic Research Ethics and Law, Department of Bioethics, School of Medicine, Case Western Reserve University, Cleveland, Ohio, USA.
Ruth V Magtanong
Angela C Leek
Sabahat Hizlan
Amy D Yamokoski
Eric D Kodish
Cleveland Clinic · USCase Western Reserve University · US

Funding

Informed Consent in Pediatric Phase I Cancer TrialsR01CA122217 · NCI · CLEVELAND CLINIC LERNER COM-CWRU · PI KODISH, ERIC D. · 2007 to 2011
$3.3M
NCI NIH HHS 1R01CA122217NCI NIH HHS R01 CA122217
6 · The paper itself

Abstract

During informed consent conferences (ICCs) for Phase I trials, oncologists must present complex information while addressing concerns. Research on communication that evolves during ICCs remains largely unexplored. We examined communication during ICCs for pediatric Phase I cancer trials using a stratified random sample from six pediatric cancer centers. A grounded theory approach identified key communication steps and factors influencing the negotiation of decisions for trial participation. Analysis suggests that during ICCs, families, patients, and clinicians exercise choice and control by negotiating micro-decisions in two broad domains: drug logic and logistics, and administration/scheduling. Micro-decisions unfold in a four-step communication process: (1) introduction of an issue; (2) response; (3) negotiation of the issue; and (4) resolution and decision. Negotiation over smaller micro-decisions is prominent in ICCs and merits further study.

Indexed as

CommunicationDecision MakingNegotiatingNeoplasmsChildChoice BehaviorClinical Trials, Phase I as TopicHumansInformed ConsentPatient SelectionThird-Party Consent

Identifiers

PMID22565583
PMCPMC3472642
OpenAlexW2015012938

What OpenQuestion holds

Textmetadata
LicenceTDM
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.