Evidence map›Paper›PMID 29787333›Full record

ArticleJournal of oncology practice2018

Investigator Disclosure and Advanced Cancer Patient Understanding of Informed Consent and Prognosis in Phase I Clinical Trials.

Fay J Hlubocky, Nancy E Kass, Debra Roter, Susan Larson, Kristen E Wroblewski, Jeremy Sugarman, Christopher K Daugherty

Erratum issued Registry-linked trialOpen access · bronzeAbstract readMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Article in Journal of oncology practice, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT04407676 (A Randomised Controlled Trial of Enhanced Informed Consent Compared to Standard Informed Consent To Improve Patient Understanding of Early Phase Oncology Clinical Trials), which is not on this map. Cited by 8 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 2 pooled it
2.3field-weighted citation impact, top 12% 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.

NCT04407676 naunknown statusnot on this mapstarted 2020, after this paper: background citation

A Randomised Controlled Trial of Enhanced Informed Consent Compared to Standard Informed Consent To Improve Patient Understanding of Early Phase Oncology Clinical Trials

TypeinterventionalSponsorRoyal Marsden NHS Foundation TrustRan2020 to 2023Enrolled34ConditionsSolid NeoplasmsArmsSummary PIS and Online Video Modules
3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 2 syntheses or guidelines pooled it, 19 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Article
  5. JAMIA open · 2022
    Article
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

7 authors at 2 institutions in 1 country.

Fay J HlubockyUniversity of Chicago, Chicago, IL; and Johns Hopkins University, Baltimore, MD.
Nancy E KassUniversity of Chicago, Chicago, IL; and Johns Hopkins University, Baltimore, MD.
Debra RoterUniversity of Chicago, Chicago, IL; and Johns Hopkins University, Baltimore, MD.
Susan LarsonUniversity of Chicago, Chicago, IL; and Johns Hopkins University, Baltimore, MD.
Kristen E WroblewskiUniversity of Chicago, Chicago, IL; and Johns Hopkins University, Baltimore, MD.
Jeremy SugarmanUniversity of Chicago, Chicago, IL; and Johns Hopkins University, Baltimore, MD.
Christopher K DaughertyUniversity of Chicago, Chicago, IL; and Johns Hopkins University, Baltimore, MD.
University of Chicago · USJohns Hopkins University · US

Funding

Ethics and Clinical Trials in Advanced Cancer CareR01CA087605 · NCI · UNIVERSITY OF CHICAGO · PI DAUGHERTY, CHRISTOPHER K · 2001 to 2009
$2.0M
NCI NIH HHS R01 CA087605
6 · The paper itself

Abstract

purposeAdvanced cancer patients (ACPs) who participate in phase I clinical trials often report a less-than-ideal understanding of the required elements of informed consent (IC) and unrealistic expectations for anticancer benefit and prognosis. We examined phase I clinical trial enrollment discussions and their associations with subsequent ACP understanding.

methodsClinical encounters about enrollment in phase I trials between 101 ACPs and 29 oncologists (principal investigators [PIs] and fellows) at three US academic medical institutions were recorded. The Roter Interaction Analysis System was used for analysis. ACPs completed follow-up questionnaires to assess IC recall.

resultsPIs disclosed the following phase I IC elements to ACPs in encounters: trial purpose in 40%; specific physical risks in 60%; potential specific medical benefits gained by trial participation (eg, disease stabilization) in 48.2%; and alternatives to phase I trial participation in 47.1%, with 1.1% of encounters containing palliative and 2.3% hospice information. PIs provided ACP-specific prognoses in 29.0% of encounters but used precise terms of death in only 4.7% and terminal in 1.2%. A significant association existed between PI disclosure of the trial purpose as dosage/toxicity, and ACPs subsequently correctly recalled trial purpose versus PIs who did not disclose it (85% v 13%; P < .05).

conclusionMany oncologists provide incomplete disclosures about phase I trials to ACPs. When disclosure of certain elements of IC occurs, it seems to be associated with better recall, especially with regard to the research purpose of phase I trials.

Indexed as

ComprehensionDisclosureInformed ConsentResearch PersonnelAcademic Medical CentersClinical Trials, Phase I as TopicFemaleFollow-Up StudiesHumansMaleNeoplasmsOncologistsPrognosisSurveys and Questionnaires

Identifiers

PMID29787333
PMCPMC6002254
OpenAlexW2804360119

What OpenQuestion holds

Textmetadata
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.