Evidence map›Paper›PMID 33003175›Full record

ArticleJournal of patient safety2021

Improvement Initiative to Develop and Implement a Tool for Detecting Drug-Drug Interactions During Oncology Clinical Trial Enrollment Eligibility Screening.

Lauren A Marcath, Taylor D Coe, Faisal Shakeel, Edward Reynolds, Mike Bayuk, Steven Haas, Bruce G Redman, Siu-Fun Wong, Daniel L Hertz

Open access · greenAbstract read
In one paragraph

Article in Journal of patient safety, 2021. 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
0.2field-weighted citation impact, top 44% 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, 1 citations in OpenAlex.

  1. Review
  2. 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

9 authors at 4 institutions in 1 country.

Lauren A MarcathFrom the Department of Pharmacotherapy, College of Pharmacy and Pharmaceutical Sciences, Washington State University, Spokane, Washington.
Taylor D CoeDepartment of Clinical Pharmacy, College of Pharmacy, University of Michigan, Ann Arbor, Michigan.
Faisal ShakeelDepartment of Clinical Pharmacy, College of Pharmacy, University of Michigan, Ann Arbor, Michigan.
Edward Reynolds©PEPID, LLC, Phoenix, Arizona.
Mike Bayuk©PEPID, LLC, Phoenix, Arizona.
Steven Haas©PEPID, LLC, Phoenix, Arizona.
Bruce G RedmanDepartment of Internal Medicine-Hematology/Oncology, Michigan Medicine, University of Michigan, Ann Arbor, Michigan.
Siu-Fun WongChapman University School of Pharmacy, Irvine, California.
Daniel L HertzDepartment of Clinical Pharmacy, College of Pharmacy, University of Michigan, Ann Arbor, Michigan.
University of Michigan–Ann Arbor · USChapman University · USMichigan Medicine · USWashington State University Spokane · US

Funding

SWOG Network Group Operations Center of the NCTNU10CA180888 · NCI · UNIVERSITY OF CALIFORNIA AT DAVIS · PI PRIMO N. LARA · 2014 to 2026
$152.1M
UM LAPs -UG1 GrantUG1CA233160 · NCI · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI ANNE F SCHOTT · 2019 to 2026
$5.4M
NCI NIH HHS U10 CA180888NCI NIH HHS UG1 CA233160
6 · The paper itself

Abstract

objectivesScreening subjects for drug-drug interactions (DDIs) before enrollment in oncology clinical trials is integral to ensuring safety, but standard procedures or tools are not readily available to screen DDI in this setting. Our objectives were to develop a DDI screening tool for use during oncology clinical trial enrollment and to test usability in single-center and multicenter pilot studies.

methodsA multistage approach was used for this quality improvement intervention. Semistructured interviews with individuals responsible for DDI screening were conducted to develop a prototype tool. The tool was used for screening DDI in subjects enrolling in National Clinical Trials Network trials of commercially available agents during a single-center 3-month pilot. Improvements were made, and a 3-month multicenter pilot was conducted at volunteer SWOG Cancer Research Network sites. Participants were surveyed to determine tool usability and efficiency.

resultsA tool was developed from semistructured interviews. A critical feature was reporting which medications had specific pharmacokinetic and pharmacodynamic characteristics including transporter and cytochrome P450 substrates, inhibitors, or inducers and QT prolongation. In the 12-site study, average (SD) DDI screening time for each patient decreased by 15.7 (10.2) minutes (range, 3-35 minutes; P < 0.001). Users reported the tool highly usable, with >90% agreeing with all positive usability characterizations and disagreeing with all negative complexity characterizations.

conclusionsA DDI screening tool for oncology clinical trial enrollment was created and its usability confirmed. Further testing with more diverse investigator sites and study drugs during eligibility screening is warranted to improve safety and data accuracy within clinical trials.

Indexed as

Clinical Trials as TopicDrug InteractionsEligibility DeterminationFemaleHumansMaleMass ScreeningNeoplasmsPharmaceutical PreparationsPilot ProjectsPharmaceutical Preparations

Identifiers

PMID33003175
PMCPMC7775319
OpenAlexW3090993078

What OpenQuestion holds

Textmetadata
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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.