Evidence map›Paper›PMID 26071401›Full record

ArticleRadiation oncology (London, England)2015

Multi-institutional application of Failure Mode and Effects Analysis (FMEA) to CyberKnife Stereotactic Body Radiation Therapy (SBRT).

Ivan Veronese, Elena De Martin, Anna Stefania Martinotti, Maria Luisa Fumagalli, Cristina Vite, Irene Redaelli, Tiziana Malatesta, Pietro Mancosu, Giancarlo Beltramo, Laura Fariselli and 1 more

Abstract readMulticenter Study
In one paragraph

Article in Radiation oncology (London, England), 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 26 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
26citing 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

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

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  7. Clinical effects of re-evaluating a lung SBRT failure mode and effects analysis in a radiotherapy department.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2024
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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

11 authors.

Ivan VeroneseDipartimento di Fisica, Università degli Studi di Milano, Via Celoria 16, Milan, 20133, Italy. ivan.veronese@unimi.it.
Elena De MartinFondazione IRCCS Istituto Neurologico Carlo Besta Milano, UO Direzione Sanitaria, Milan, Italy. Elena.DeMartin@istituto-besta.it.
Anna Stefania MartinottiCentro Diagnostico Italiano, Reparto Cyberknife, Milan, Italy. AnnaStefania.Martinotti@cdi.it.
Maria Luisa FumagalliFondazione IRCCS Istituto Neurologico Carlo Besta Milano, UO Direzione Sanitaria, Milan, Italy. MariaLuisa.Fumagalli@istituto-besta.it.
Cristina ViteCentro Diagnostico Italiano, Reparto Cyberknife, Milan, Italy. Cristina.Vite@gmail.com.
Irene RedaelliCentro Diagnostico Italiano, Reparto Cyberknife, Milan, Italy. irene.redaelli@gmail.com.
Tiziana MalatestaOspedale San Giovanni Calibita Fatebenefratelli, UOC Fisica Sanitaria AFAR, Rome, Italy. tiziana.malatesta@tin.it.
Pietro MancosuReparto di Radioterapia Oncologica, Istituto Clinico Humanitas, Milan, Italy. pietro.mancosu@humanitas.it.
Giancarlo BeltramoCentro Diagnostico Italiano, Reparto Cyberknife, Milan, Italy. giancarlo.beltramo@cdi.it.
Laura FariselliFondazione IRCCS Istituto Neurologico Carlo Besta Milano, Unità di Radioterapia, Milan, Italy. laura.fariselli@istituto-besta.it.
Marie Claire CantoneDipartimento di Fisica, Università degli Studi di Milano, Via Celoria 16, Milan, 20133, Italy. marie.cantone@unimi.it.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundA multidisciplinary and multi-institutional working group applied the Failure Mode and Effects Analysis (FMEA) approach to assess the risks for patients undergoing Stereotactic Body Radiation Therapy (SBRT) treatments for lesions located in spine and liver in two CyberKnife® Centres.

methodsThe various sub-processes characterizing the SBRT treatment were identified to generate the process trees of both the treatment planning and delivery phases. This analysis drove to the identification and subsequent scoring of the potential failure modes, together with their causes and effects, using the risk probability number (RPN) scoring system. Novel solutions aimed to increase patient safety were accordingly considered.

resultsThe process-tree characterising the SBRT treatment planning stage was composed with a total of 48 sub-processes. Similarly, 42 sub-processes were identified in the stage of delivery to liver tumours and 30 in the stage of delivery to spine lesions. All the sub-processes were judged to be potentially prone to one or more failure modes. Nineteen failures (i.e. 5 in treatment planning stage, 5 in the delivery to liver lesions and 9 in the delivery to spine lesions) were considered of high concern in view of the high RPN and/or severity index value.

conclusionsThe analysis of the potential failures, their causes and effects allowed to improve the safety strategies already adopted in the clinical practice with additional measures for optimizing quality management workflow and increasing patient safety.

Indexed as

Healthcare Failure Mode and Effect AnalysisRadiosurgeryHumansItalyLiver NeoplasmsMedical ErrorsPatient SafetyPostoperative ComplicationsRiskSpinal NeoplasmsTreatment Failure

Identifiers

PMID26071401
PMCPMC4469574

What OpenQuestion holds

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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.