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

E Hwang; N G Burnet; A M Crellin; V Ahern; D I Thwaites; S Gaito; Y-C Chang; E Smith

doi:10.1016/j.clon.2021.09.010

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

Clin Oncol (R Coll Radiol). 2022 Jan;34(1):11-18. doi: 10.1016/j.clon.2021.09.010. Epub 2021 Sep 30.

Authors

E Hwang¹, N G Burnet², A M Crellin³, V Ahern⁴, D I Thwaites⁵, S Gaito⁶, Y-C Chang⁷, E Smith⁸

Affiliations

¹ The Christie Proton Beam Therapy Centre, The Christie NHS Foundation Trust, Manchester, UK; Institute of Medical Physics, School of Physics, University of Sydney, New South Wales, Australia. Electronic address: ehwa9372@uni.sydney.edu.au.
² The Christie Proton Beam Therapy Centre, The Christie NHS Foundation Trust, Manchester, UK.
³ NHS England National Clinical Lead Proton Beam Therapy, UK.
⁴ Department of Radiation Oncology, Sydney West Radiation Oncology Network, Crown Princess Mary Cancer Centre, Sydney, New South Wales, Australia; Medical Physics, Leeds Institute of Cancer and Pathology, School of Medicine, Leeds University, Leeds, UK.
⁵ Institute of Medical Physics, School of Physics, University of Sydney, New South Wales, Australia; Westmead Clinical School, Faculty of Medicine and Health, University of Sydney, New South Wales, Australia.
⁶ Proton Clinical Outcomes Unit, The Christie NHS Foundation Trust, Manchester, UK.
⁷ University College London Hospital NHS Foundation Trust (UCLH), London, UK.
⁸ The Christie Proton Beam Therapy Centre, The Christie NHS Foundation Trust, Manchester, UK; Proton Clinical Outcomes Unit, The Christie NHS Foundation Trust, Manchester, UK; University of Manchester, Manchester Cancer Research Centre, Manchester Academic Health Science Centre, Manchester, UK.

PMID: 34602320
DOI: 10.1016/j.clon.2021.09.010

Abstract

Aims: To establish an infrastructure for sustainable, comprehensive data collection and systematic outcomes evaluation for UK patients receiving proton beam therapy (PBT).

Materials and methods: A Proton Outcomes Working Group was formed in 2014 to develop a national minimum dataset for PBT patients and to define a clinically integrated informatics solution for data collection. The Christie Proton Beam Therapy Centre formed its Proton Clinical Outcomes Unit in 2018 to collect, curate and analyse outcomes data prospectively for UK-treated patients and retrospectively for UK patients referred abroad for PBT since 2008 via the Proton Overseas Programme (POP).

Results: A single electronic form (eForm) was developed to capture the agreed data, using a data tree approach including conditional logic: data items are requested once, further questions depend on previous answers and are sensitive to tumour site and patient pathway time point. Relevant data automatically populate other forms, saving time, prompting completeness of clinical assessments and ensuring data consistency. Completed eForm data populate the electronic patient record and generate individualised outputs, including consultation letters, treatment summary and surveillance plans, based on organs at risk irradiated, age and sex. All data regarding POP-treated patients are verified and migrated into the system, ensuring that patient data, whether overseas or UK treated, are consistently recorded. The eForm utilises a 'user friendly' web portal interface, the Clinical Web Portal, including clickable tables and infographics. Data items are coded to a universally recognised standard comparable with other data systems. Patient-reported outcomes are also integrated, highlighting significant toxicities and prompting a response. Outcomes data can be correlated with dosimetric DICOM data to support radiation dose modelling.

Conclusion: Outcomes data from both POP-treated and The Christie-treated patients support long-term care, allow evaluation of PBT efficacy and safety, assist future selection of PBT patients and support hypothesis generation for future clinical trials.

Keywords: Clinical trials; data collection; outcomes data; patient-reported outcomes; proton beam therapy.

MeSH terms

Data Collection
Humans
Proton Therapy*
Radiometry
Retrospective Studies
United Kingdom