Evidence map›Paper›PMID 37921867›Full record

ArticleAJOB empirical bioethics

Informed Consent among Clinical Trial Participants with Different Cancer Diagnoses.

Connie M Ulrich, Sarah J Ratcliffe, Camille J Hochheimer, Qiuping Zhou, Liming Huang, Thomas Gordon, Kathleen Knafl, Therese Richmond, Marilyn M Schapira, Victoria Miller and 3 more

Abstract read
In one paragraph

Article in AJOB empirical bioethics. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing 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

4 citing papers in PubMed.

  1. Article
  2. Article
  3. Review
  4. 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

13 authors.

Connie M UlrichUniversity of Pennsylvania School of Nursing, Philadelphia, Pennsylvania, USA.ORCID 0000-0001-5681-3463
Sarah J RatcliffeUniversity of Virginia, Charlottesville, Virginia, USA.ORCID 0000-0002-6644-8284
Camille J HochheimerUniversity of Virginia, Charlottesville, Virginia, USA.
Qiuping ZhouGeorge Washington University, Washington, District of Columbia, USA.
Liming HuangUniversity of Pennsylvania School of Nursing, Philadelphia, Pennsylvania, USA.
Thomas GordonUniversity of Massachusetts Lowell, Lowell, Massachusetts, USA.
Kathleen KnaflUniversity of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.
Therese RichmondUniversity of Pennsylvania School of Nursing, Philadelphia, Pennsylvania, USA.
Marilyn M SchapiraUniversity of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania, USA.
Victoria MillerChildren's Hospital of Philadelphia, Philadelphia, Pennsylvania, USA.
Jun J MaoMemorial Sloan Kettering Cancer Center, New York, New York, USA.
Mary NaylorUniversity of Pennsylvania School of Nursing, Philadelphia, Pennsylvania, USA.
Christine GradyNational Institutes of Health, Clinical Center Department of Bioethics, Bethesda, Maryland, USA.ORCID 0000-0002-9093-4450

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Hongbiao Carl Lekaye · 1985 to 2026
$347.4M
Retention in Cancer Clinical Trials: Modeling Patients' Risk Benefit AssessmentsR01CA196131 · NCI · UNIVERSITY OF PENNSYLVANIA · PI ULRICH, CONNIE MARIE · 2015 to 2019
$2.0M
Challenges in Research EthicsZIACL090111 · CLC · CLINICAL CENTER · PI GRADY, CHRISTINE P · 2024 to 2024
$0k
NCI NIH HHS P30 CA008748NCI NIH HHS R01 CA196131
6 · The paper itself

Abstract

importanceInformed consent is essential to ethical, rigorous research and is important to recruitment and retention in cancer trials.

objectiveTo examine cancer clinical trial (CCT) participants' perceptions of informed consent processes and variations in perceptions by cancer type. DESIGN AND SETTING AND

participantsCross-sectional survey from mixed-methods study at National Cancer Institute-designated Northeast comprehensive cancer center. Open-ended and forced-choice items addressed: (1) enrollment and informed consent experiences and (2) decision-making processes, including risk-benefit assessment. Eligibility: CCT participant with gastro-intestinal or genitourinary, hematologic-lymphatic malignancies, lung cancer, and breast or gynecological cancer (

main outcome measuresPercentages satisfied with consent process and information provided; and assessing participation's perceptions of risks/benefits. Multivariable logistic or ordinal regression examined differences by cancer type.

resultsMost patient-participants felt well informed by the consent process (more than 90% overall and by cancer type) and. most (87.4%) reported that the consent form provided all the information they wanted, although nearly half (44.8%) reported that they read the form somewhat carefully or less. More than half (57.9%) said that talking to research staff (i.e., the consent process) had a greater impact on participation decisions than reading the consent form (2.1%). A third (31.1%) were very sure of joining in research studies before the informed consent process (almost half of lung cancer patients did-47.1%). Most patients personally assessed the risks and benefits before consenting. However, trust in physicians played an important role in the decision to enroll in CCT. CONCLUSIONS AND RELEVANCE: Cancer patients rely less on written features of the informed consent process than on information obtained from the research staff and their own physicians. Research should focus on information and communication strategies that support informed consent from referring physicians, researchers, and others to improve patient risk-benefit assessment and decision-making.

Indexed as

Clinical Trials as TopicDecision MakingInformed ConsentNeoplasmsAdultAgedComprehensionCross-Sectional StudiesFemaleHumansMaleMiddle AgedPatient ParticipationPatient SatisfactionPatient SelectionResearch SubjectsCancer clinical trialsdecision makinginformed consenttiming

Identifiers

PMID37921867
PMCPMC11492203

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.