A Novel Model and Infrastructure for Clinical Outcomes Data Collection and Their Systematic Evaluation for UK Patients Receiving Proton Beam Therapy

Hwang, Eun Ji; Burnet, N.G.; Crellin, A.; Ahern, Verity; Thwaites, David; Gaito, S.; Chang, Yu Shan; Smith, Ed

doi:10.1016/j.clon.2021.09.010

Cited by 20 publications

(14 citation statements)

References 37 publications

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“…In countries like the UK, the critical importance of data collection for PT was recognised early, as evidenced by their dedication to embed data collection into the daily clinical practice of their proton beam therapy (PBT) centre. Their novel model and underlying infrastructure has been described, 10 utilising electronic forms and data tree approaches including conditional logic, to minimise the time needed for data entry and optimise a user‐friendly experience through its integration into clinical workflows.…”

Section: Discussionmentioning

confidence: 99%

“…The evidence base for PT is accumulating, 2–4 but due to limitations and barriers unique to PT, and the tumours thought to most benefit from PT, 5–7 further data are required to understand its role and value in the treatment of cancer. As more and more level I evidence is awaited, the value of other forms of evidence such as registry‐based and database‐derived studies based on real‐world data is increasingly recognised 8–10 . The proposed registry in Australia, The Australian Particle Therapy Clinical Quality Registry (ASPIRE) seeks to provide a uniform approach to data collection, recording patient, tumour and treatment outcomes.…”

Section: Introductionmentioning

confidence: 99%

“…As more and more level I evidence is awaited, the value of other forms of evidence such as registrybased and database-derived studies based on real-world data is increasingly recognised. [8][9][10] The proposed registry in Australia, The Australian Particle Therapy Clinical Quality Registry (ASPIRE) seeks to provide a uniform approach to data collection, recording patient, tumour and treatment outcomes. The objective is to validate the health economic modelling as outlined in the MBS application for PT, as well as provide a source of evidence for future MBS applications to expand the clinical indications for PT in Australia.…”

Section: Introductionmentioning

confidence: 99%

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Minimum data elements for the Australian Particle Therapy Clinical Quality Registry

et al. 2023

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IntroductionConstruction of the first Australian particle therapy (PT) centre is underway. Establishment of a national registry, to be known as the Australian Particle Therapy Clinical Quality Registry (ASPIRE), has been identified as a mandatory requirement for PT treatment to be reimbursed by the Australian Medicare Benefits Schedule. This study aimed to determine a consensus set of Minimum Data Elements (MDEs) for ASPIRE.MethodsA modified Delphi and expert consensus process was completed. Stage 1 compiled currently operational English‐language international PT registries. Stage 2 listed the MDEs included in each of these four registries. Those included in three or four registries were automatically included as a potential MDE for ASPIRE. Stage 3 interrogated the remaining data items, and involved three rounds – an online survey to a panel of experts, followed by a live poll session of PT‐interested participants, and finally a virtual discussion forum of the original expert panel.ResultsOne hundred and twenty‐three different MDEs were identified across the four international registries. The multi‐staged Delphi and expert consensus process resulted in a total of 27 essential MDEs for ASPIRE; 14 patient factors, four tumour factors and nine treatment factors.ConclusionsThe MDEs provide the core mandatory data items for the national PT registry. Registry data collection for PT is paramount in the ongoing global effort to accumulate more robust clinical evidence regarding PT patient and tumour outcomes, quantifying the magnitude of clinical benefit and justifying the relatively higher costs of PT investment.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Minimum data elements for the Australian Particle Therapy Clinical Quality Registry

et al. 2023

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“…After treatment, patients received follow-up care at their referring UK center. Clinical follow-up data and detailed information about “baseline toxicities” have been prospectively collected on patients treated with PBT since the POP's inception and are now stored centrally in a national database managed by the Proton Clinical Outcomes Unit at The Christie NHS PBT center [ 11 ].…”

Section: Methods and Patient Outcome Datamentioning

confidence: 99%

Late Dental Toxicities After Proton Chemoradiation for Rhabdomyosarcoma: A Pediatric Case Report

Foster-Thomas

Aznar

Indelicato

et al. 2023

International Journal of Particle Therapy

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Purpose Radiation therapy is an independent risk factor for adverse sequelae to the oral cavity and dentition in childhood cancer survivors. However, dental toxicities after radiation therapy often are underreported and there are minimal published data on disturbances in tooth development after proton beam therapy (PBT). We present the long-term clinical and radiographic dental findings 8 years after treatment completion for a patient treated with PBT and chemotherapy for rhabdomyosarcoma. Materials and Methods Clinical follow-up data of patients treated with PBT within the Proton Overseas Programme (POP) is stored in a National Database and curated by a dedicated outcomes unit at the Christie NHS PBT center. This case report was identified from the extraction and analysis of data for pediatric head and neck cancer patients in this database for a service evaluation project. Results The permanent dentition in this patient aged 3.5 years at the time of treatment was severely affected with abnormal dental development first observed 3.5 years after treatment completion. PBT delivered mean doses of 30 Gy(RBE = 1.1) to the maxilla and 25.9 Gy(RBE = 1.1) to the mandible. Conclusion Significant dental development abnormalities occurred in this pediatric patient, despite doses in areas being lower than the proposed thresholds in the literature. Improved descriptions of dental toxicities and routine contouring of the maxilla and mandible are needed to correlate dosimetric data. The dose to teeth should be kept as low as reasonably possible in younger patients until the dose thresholds for dental toxicities are known.

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“…133 Registry-based studies can provide additional approaches to evidence generation for PT. 98,129,130,133,134 Costs and Cost Effectiveness? Facility factors affecting costs PT facilities and operational costs are greater than for an XRT facility; and CIRT costs are greater than for an equivalent PBT facility.…”

Section: Clinical Trialsmentioning

confidence: 99%

The rationale for a carbon ion radiation therapy facility in Australia

Thwaites,

Prokopovich,

Garrett

et al. 2023

J of Medical Radiation Sci

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Australia has taken a collaborative nationally networked approach to achieve particle therapy capability. This supports the under‐construction proton therapy facility in Adelaide, other potential proton centres and an under‐evaluation proposal for a hybrid carbon ion and proton centre in western Sydney. A wide‐ranging overview is presented of the rationale for carbon ion radiation therapy, applying observations to the case for an Australian facility and to the clinical and research potential from such a national centre.

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A Novel Model and Infrastructure for Clinical Outcomes Data Collection and Their Systematic Evaluation for UK Patients Receiving Proton Beam Therapy

Cited by 20 publications

References 37 publications

Minimum data elements for the Australian Particle Therapy Clinical Quality Registry

Minimum data elements for the Australian Particle Therapy Clinical Quality Registry

Late Dental Toxicities After Proton Chemoradiation for Rhabdomyosarcoma: A Pediatric Case Report

The rationale for a carbon ion radiation therapy facility in Australia

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