Evidence map›Paper›PMID 37035034›Full record

ArticleAdvances in radiation oncology

Mitigation of Intensity Modulated Radiation Therapy and Stereotactic Body Radiation Therapy Treatment Planning Errors on the Novel RefleXion X1 System Using Failure Mode and Effect Analysis Within Six Sigma Framework.

Eric Simiele, Bin Han, Lawrie Skinner, Daniel Pham, Jonathan Lewis, Michael Gensheimer, Lucas Vitzthum, Daniel Chang, Murat Surucu, Nataliya Kovalchuk

Abstract read
In one paragraph

Article in Advances in radiation oncology. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 1 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

8 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. A Prospective First-In-Human Pilot StudyAdvances in radiation oncology · 2025
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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

10 authors.

Eric SimieleDepartment of Radiation Oncology, Rutgers Cancer Institute of New Jersey, Robert Wood Johnson Medical School, New Brunswick, New Jersey.
Bin HanDepartment of Radiation Oncology, Stanford University, Stanford, California.
Lawrie SkinnerDepartment of Radiation Oncology, Stanford University, Stanford, California.
Daniel PhamDepartment of Radiation Oncology, Stanford University, Stanford, California.
Jonathan LewisDepartment of Radiation Oncology, Stanford University, Stanford, California.
Michael GensheimerDepartment of Radiation Oncology, Stanford University, Stanford, California.
Lucas VitzthumDepartment of Radiation Oncology, Stanford University, Stanford, California.
Daniel ChangDepartment of Radiation Oncology, Stanford University, Stanford, California.
Murat SurucuDepartment of Radiation Oncology, Stanford University, Stanford, California.
Nataliya KovalchukDepartment of Radiation Oncology, Stanford University, Stanford, California.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Purpose: The aim of this study was to apply the Six Sigma methodology and failure mode and effect analysis (FMEA) to mitigate errors in intensity modulated radiation therapy (IMRT) and stereotactic body radiation therapy (SBRT) treatment planning with the first clinical installation of RefleXion X1. Methods and Materials: The Six Sigma approach consisted of 5 phases: define, measure, analyze, improve, and control Results: Overall, 100 plan check items were identified in which the RPN values ranged from 10.2 to 429.0. Fifty of these items (50%) were suitable for automation within ESAPI. Of the 10 highest-risk items, 8 were suitable for automation. Based on the results of the FMEA, 2 scripts were developed: Planning Assistant, used by the planner during preparation for planning, and Automated Plan Check, used by the planner and the plan checker during plan preparation for treatment. After 12 months of clinical use of the X1 and developed scripts, only 3 errors were reported. The average prescript RPN was 138.0, compared with the average postscript RPN of 47.8 ( Conclusions: Implementing new technology in the clinic can be an error-prone process in which the likelihood of errors increases with increasing pressure to implement the technology quickly. To limit errors in clinical implementation of the novel RefleXion X1 system, the Six Sigma method was used to identify failure modes, establish quality control checks, and re-evaluate these checks 1 year after clinical implementation.

Identifiers

PMID37035034
PMCPMC10073615

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.