Evidence map›Paper›PMID 23227880›Full record

ArticleTrials2012

Removing barriers to participation in clinical trials, a conceptual framework and retrospective chart review study.

Norma F Kanarek, Marty S Kanarek, Dare Olatoye, Michael A Carducci

Abstract read
In one paragraph

Article in Trials, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed, 4 pooled it
–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

19 citing papers in PubMed, 4 syntheses or guidelines pooled it.

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  10. Are We Scared of Clinical Trials if Not Sufficiently Informed and Educated?Advances in medical education and practice · 2022
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  13. Barriers to non-small cell lung cancer trial eligibility.Contemporary clinical trials communications · 2018
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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

4 authors.

Norma F KanarekDepartment of Environmental Health Sciences, Johns Hopkins Bloomberg School of Public Health, 615 North Wolfe Street, Baltimore, MD 21205, USA. nkanarek@jhsph.edu
Marty S Kanarek
Dare Olatoye
Michael A Carducci

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundEnrollment in interventional therapeutic clinical trials is a small fraction of all patients who might participate given reasonable access.

methodsA hierarchical approach is utilized in measuring staged participation from trial availability to patient enrollment. Our framework suggests that concern for justice comes in the design and eligibility criteria for clinical trials; attention to beneficence is given in the eligibility and physician triage stages. The remaining four stages rely on respect for persons. An example is given where reasons for nonparticipation or barriers to participation in prostate cancer clinical trials are examined within the framework. In addition, medical oncology patients with an initial six month consultation are tracked from one stage to the next by race using the framework to assess participation comparability.

resultsWe illustrated seven transitions from being a patient to enrollment in a clinical trial in a small study of prostate cancer cases who consulted SKCCC Medical Oncology Department in early 2010. Pilot data suggest transition probabilities as follows: 65% availability, 84% eligibility, 92% patient triage, 89% trials discussed, 45% patient interested, 63% patient consented, and 92% patient enrolled. The average transition probability was 77.7%. The average transition probability, patient-trial-fit was 50%; opportunity was 51%, and acceptance was 66.7%. Trial availability, patient interest and patient consented were three transitions that were below the average; none were statistically significant.

conclusionsThe framework may serve to streamline comprehensive reporting of clinical trial participation to the benefit of patients and the ethical conduct of clinical trials.

Indexed as

Patient SelectionAttitude of Health PersonnelBeneficenceChi-Square DistributionClinical Trials as TopicEligibility DeterminationHealth Knowledge, Attitudes, PracticeHumansInformed ConsentMalePatient Acceptance of Health CarePatientsPrognosisProstatic NeoplasmsRetrospective StudiesSocial Justice

Identifiers

PMID23227880
PMCPMC3551829

What OpenQuestion holds

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Registered trials

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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.