Evidence map›Paper›PMID 39101683›Full record

ArticleJournal of applied clinical medical physics2024

Improving the safety of radiotherapy treatment processes via incident-driven FMEA feedback loops.

Dominik Kornek, Michael Lotter, Juliane Szkitsak, Christopher Dürrbeck, Andre Karius, Oliver J Ott, Carolin Brandl, Christoph Bert

Abstract read
In one paragraph

Article in Journal of applied clinical medical physics, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing 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

6 citing papers in PubMed.

  1. Article
  2. Radiation incident learning in multi-site centers.Journal of applied clinical medical physics · 2025
    Article
  3. Article
  4. Article
  5. Article
  6. 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

8 authors.

Dominik KornekDepartment of Radiation Oncology, Universitätsklinikum Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU), Erlangen, Germany.ORCID https://orcid.org/0000-0002-1665-1014
Michael LotterDepartment of Radiation Oncology, Universitätsklinikum Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU), Erlangen, Germany.
Juliane SzkitsakDepartment of Radiation Oncology, Universitätsklinikum Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU), Erlangen, Germany.
Christopher DürrbeckDepartment of Radiation Oncology, Universitätsklinikum Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU), Erlangen, Germany.ORCID https://orcid.org/0000-0002-6809-8580
Andre KariusDepartment of Radiation Oncology, Universitätsklinikum Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU), Erlangen, Germany.ORCID https://orcid.org/0000-0002-3842-1375
Oliver J OttDepartment of Radiation Oncology, Universitätsklinikum Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU), Erlangen, Germany.
Carolin BrandlDepartment of Radiation Oncology, Universitätsklinikum Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU), Erlangen, Germany.
Christoph BertDepartment of Radiation Oncology, Universitätsklinikum Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU), Erlangen, Germany.ORCID https://orcid.org/0000-0002-8539-6600

Funding

Bavarian Ministry of Economic Affairs, Regional Development, and Energy 07 03/686 68/287/21/4/22/5/23/6/24Bavarian Ministry of Economic Affairs, Regional Development, and Energy 07 03/686 68/288/21/7/22/8/23/9/24
6 · The paper itself

Abstract

backgroundFailure mode and effects analysis (FMEA) is a valuable tool for radiotherapy risk assessment, yet its outputs might be unreliable due to failures not being identified or due to a lack of accurate error rates. PURPOSE: A novel incident reporting system (IRS) linked to an FMEA database was tested and evaluated. The study investigated whether the system was suitable for validating a previously performed analysis and whether it could provide accurate error rates to support the expert occurrence ratings of previously identified failure modes.

methodsTwenty-three pre-identified failure modes of our external beam radiotherapy process, covering the process steps from patient admission to treatment delivery, were proffered on dedicated FMEA feedback and incident reporting terminals generated by the IRS. The clinical setting involved a computed tomography scanner, dosimetry, and five linacs. Incoming reports were used as basis to identify additional failure modes or confirm initial ones. The Kruskal-Wallis H test was applied to compare the risk priorities of the retrospective and prospective failure modes. Wald's sequential probability ratio test was used to investigate the correctness of the experts' occurrence ratings by means of the number of incoming reports.

resultsOver a 15-month period, 304 reports were submitted. There were 0.005 (confidence interval [CI], 0.0014-0.0082) reported incidents per imaging study and 0.0006 (CI, 0.0003-0.0009) reported incidents per treatment fraction. Sixteen additional failure modes could be identified, and their risk priorities did not differ from those of the initial failure modes (p = 0.954). One failure mode occurrence rating could be increased, whereas the other 22 occurrence ratings could not be disproved.

conclusionsOur approach is suitable for validating FMEAs and deducing additional failure modes on a continual basis. Accurate error rates can only be provided if a sufficient number of reports is available.

Indexed as

Healthcare Failure Mode and Effect AnalysisRadiotherapy DosageRadiotherapy Planning, Computer-AssistedFeedbackHumansMedical ErrorsNeoplasmsPatient SafetyProspective StudiesQuality Assurance, Health CareRadiotherapy, Intensity-ModulatedRetrospective StudiesRisk AssessmentRisk ManagementTomography, X-Ray Computederror ratesfailure mode and effects analysis (FMEA)incident reporting system (IRS)radiotherapyrisk assessment

Identifiers

PMID39101683
PMCPMC11492396

What OpenQuestion holds

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LicenceCC BY
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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.