Evidence map›Paper›PMID 34838891›Full record

Trial reportRadiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology2022

The radiotherapy quality assurance gap among phase III cancer clinical trials.

Kelsey L Corrigan, Stephen Kry, Rebecca M Howell, Ramez Kouzy, Joseph Abi Jaoude, Roshal R Patel, Anuja Jhingran, Cullen Taniguchi, Albert C Koong, Mary Fran McAleer and 7 more

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing 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

7 citing papers in PubMed.

  1. Review
  2. Review
  3. Article
  4. Article
  5. Review
  6. Article
  7. Lung SBRT credentialing in the Canadian OCOG-LUSTRE randomized trial.Clinical and translational radiation oncology · 2022
    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

17 authors.

Kelsey L CorriganThe University of Texas MD Anderson Cancer Center, Houston, USA. Electronic address: KLCorrigan@mdanderson.org.
Stephen KryThe University of Texas MD Anderson Cancer Center, Houston, USA. Electronic address: SFKry@mdanderson.org.
Rebecca M HowellThe University of Texas MD Anderson Cancer Center, Houston, USA. Electronic address: RHowell@mdanderson.org.
Ramez KouzyThe University of Texas MD Anderson Cancer Center, Houston, USA. Electronic address: RKouzy@mdanderson.org.
Joseph Abi JaoudeThe University of Texas MD Anderson Cancer Center, Houston, USA. Electronic address: JBabi@mdanderson.org.
Roshal R PatelThe University of Texas MD Anderson Cancer Center, Houston, USA. Electronic address: roshal.r.patel@kp.org.
Anuja JhingranThe University of Texas MD Anderson Cancer Center, Houston, USA. Electronic address: AJhingra@mdanderson.org.
Cullen TaniguchiThe University of Texas MD Anderson Cancer Center, Houston, USA. Electronic address: CTaniguchi@mdanderson.org.
Albert C KoongThe University of Texas MD Anderson Cancer Center, Houston, USA. Electronic address: AKoong@mdanderson.org.
Mary Fran McAleerThe University of Texas MD Anderson Cancer Center, Houston, USA. Electronic address: MFMcalee@mdanderson.org.
Paige NitschThe University of Texas MD Anderson Cancer Center, Houston, USA. Electronic address: PLNitsch@mdanderson.org.
Claus RödelUniversity of Frankfurt, Frankfurt, Germany; German Cancer Research Center, Heidelberg, Germany; German Cancer Consortium, Frankfurt, Germany; Frankfurt Cancer Institute, Frankfurt, Germany. Electronic address: ClausMichael.Roedel@kgu.de.
Emmanouil FokasUniversity of Frankfurt, Frankfurt, Germany; German Cancer Research Center, Heidelberg, Germany; German Cancer Consortium, Frankfurt, Germany; Frankfurt Cancer Institute, Frankfurt, Germany. Electronic address: Emmanouil.Fokas@kgu.de.
Bruce D MinskyThe University of Texas MD Anderson Cancer Center, Houston, USA. Electronic address: BMinsky@mdanderson.org.
Prajnan DasThe University of Texas MD Anderson Cancer Center, Houston, USA. Electronic address: PrajDas@mdanderson.org.
C David FullerThe University of Texas MD Anderson Cancer Center, Houston, USA. Electronic address: CDFuller@mdanderson.org.
Ethan B LudmirThe University of Texas MD Anderson Cancer Center, Houston, USA. Electronic address: EBLudmir@mdanderson.org.

Funding

Tumor Evolution and Metastasis ProgramP30CA016672 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI Scott Kopetz · 1985 to 2026
$290.8M
NCI NIH HHS P30 CA016672
6 · The paper itself

Abstract

purposeQuality assurance (QA) practices improve the quality level of oncology trials by ensuring that the protocol is followed and the results are valid and reproducible. This study investigated the utilization of QA among randomized controlled trials that involve radiotherapy (RT). METHODS AND MATERIALS: We searched ClinicalTrials.gov in February 2020 for all phase III oncology randomized clinical trials (RCTs). These trials were screened for RT-specific RCTs that had published primary trial results. Information regarding QA in each trial was collected from the study publications and trial protocol if available. Two individuals independently performed trial screening and data collection. Pearson's Chi-square tests analyses were used to assess factors that were associated with QA inclusion in RT trials.

resultsForty-two RCTs with RT as the primary intervention or as a mandatory component of the protocol were analyzed; the earliest was started in 1994 and one trial was still active though not recruiting. Twenty-nine (69%) trials mandated RT quality assurance (RTQA) practices as part of the trial protocol, with 19 (45%) trials requiring institutional credentialing. Twenty-one (50%) trials published protocol deviation outcomes. Clinical trials involving advanced radiation techniques (IMRT, VMAT, SRS, SBRT) did not include more RTQA than trials without these advanced techniques (73% vs. 65%, p = 0.55). Trials that reported protocol deviation outcomes were associated with mandating RTQA in their protocols as compared to trials that did not report these outcomes (100% vs. 38%, p < 0.001).

conclusionsThere is a lack of RTQA utilization and transparency in RT clinical trials. It is imperative for RT trials to include increased QA for safe, consistent, and high-quality RT planning and delivery.

Indexed as

NeoplasmsRadiation OncologyCredentialingHumansQuality Assurance, Health CareQuality assuranceRadiotherapyRandomized controlled trials

Identifiers

PMID34838891
PMCPMC8900671

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.