ISO/TR 24290:2023

TECHNICAL ISO/TR
REPORT 24290
First edition
2023-05
Health informatics — Datasets
and data structure for clinical and
biological evaluation metrics in
radiotherapy
Informatique de santé — Jeux de données et structure de
données pour les métriques d'évaluation clinique et biologique en
radiothérapie
Reference number
© ISO 2023
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Abbreviated terms . 3
5 CBEMs in EBRT .4
5.1 General . 4
5.2 CBEMs . 4
5.3 Use case of CBEMs . 5
5.3.1 Selection of the EBRT modality . 5
5.3.2 Clinical trials . 5
5.4 Existing data format for CBEMs . 6
6 Datasets and data structure for a CBEM . 6
6.1 General . 6
6.2 Datasets and data structure . 6
6.2.1 Structure of the CBEM report . 6
6.2.2 Structure of the body part . 6
6.2.3 Patient condition information . 6
6.2.4 Treatment plan information. 7
6.2.5 CBEM information . 7
6.2.6 Comments on CBEM report . 9
Annex A (informative) Example of a CBEM model and related data elements .10
Bibliography .12
iii
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the
different types of ISO document should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).
ISO draws attention to the possibility that the implementation of this document may involve the use
of (a) patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed
patent rights in respect thereof. As of the date of publication of this document, ISO had not received
notice of (a) patent(s) which may be required to implement this document. However, implementers are
cautioned that this may not represent the latest information, which may be obtained from the patent
database available at www.iso.org/patents. ISO shall not be held responsible for identifying any or all
such patent rights.
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO’s adherence to
the World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see
www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 215, Health informatics.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www.iso.org/members.html.
iv
Introduction
Radiotherapy or radiation therapy is a treatment method used mostly in cancer care. Due to rapid
technical advances of the radiotherapy treatment modalities, it is becoming increasingly important to
select an appropriate radiotherapy treatment modality for individual patients by considering patient
conditions and the resources that are required.
In the case of external-beam radiation therapy (EBRT), where the therapeutic radiation beams are
emitted from a machine outside the body of the patient, treatment planning is performed prior to
treatment. When selecting a treatment modality from among possible candidates, treatment plans are
made for the candidates, if necessary, and then the dosimetric indices and/or radiobiological metrics
corresponding to the treatment plans are compared.
Tumour control probability (TCP) and normal tissue complication probability (NTCP) are among
the metrics used in the comparisons. They are simple phenomenological models based on clinical
[12]
observations which are described in ICRU 83 as clinical and biological evaluation metrics (CBEMs),
along with other metrics such as equivalent uniform dose, conformity and homogeneity indices.
Recently, more sophisticated models incorporating non-dosimetric patient factors, spatial dose metrics
and -omics elements (e.g. radiomics and proteomics) have also received attention and some of them are
starting to be referred to in clinical trials in some countries.
For wider and safer use of CBEMs in clinical practice and clinical trials, it is important to provide
an effective framework for ensuring the traceability of calculated metrics. Standardization of data
formats for reporting calculated CBEMs is one possible way. However, no attention has been paid to
such standardization to date, while there is active research on new metrics or new models as well as
increasing attention to transparent reporting of developed models.
This document describes datasets and data structure for the reporting of CBEMs, especially of simple
model types of TCP and NTCP. Scientific aspects of reliability of CBEMs are not in the scope of this
document. Because of the variety of CBEM models, when an evaluated CBEM is to be reported and/
or referred to, it is important to report and/or refer to the value of the calculated CBEM along with
information about the CBEM model itself as well as with dose information and non-dosimetric factors
of the patient that are used in the calculation. It is also important to include descriptions about
uncertainties, underlying assumptions, limitations and situations for application of the CBEM model.
In general, the dose information of the treatment plan used in the calculations (dose-volume histogram
(DVH) in most cases) is converted to match the model definition; for instance, adjusting the differences
in fraction size between the plan of the patient and the reference fraction size of the CBEM model. This
means that the apparent values of the doses (e.g. maximum dose and mean dose) used in the calculation
are CBEM-model-specific. To ensure traceability, inclusion of the description about the process of
such dose conversions along with the value of the representative dose values would be a great help.
This document provides datasets and data structure for CBEM reporting by considering the above
mentioned aspects.
While this document is not intended to cover the reporting of CBEMs by contemporary sophisticated
models, the data structures described in this document can apply to the reporting of them as well.
v
TECHNICAL REPORT ISO/TR 24290:2023(E)
Health informatics — Datasets and data structure for
clinical and biological evaluation metrics in radiotherapy
1 Scope
This document reports on the datasets and a data structure for reporting clinical and biological
evaluation metrics (CBEMs). The reporting of radiation dose estimates is outside the scope of this
document.
This document is applicable to CBEMs for external-beam radiation therapy (EBRT) modalities, but not
CBEMs for brachytherapy or molecular radiotherapy.
Various types of radiotherapy treatment modalities are available for cancer care. Consequently, there
is a growing awareness of the need for objective schemes that will contribute to enable the selection of
an appropriate radiotherapy treatment modality for individual patients. The use of CBEMs, the metrics
associated with a certain radiotherapy treatment plan for a patient, is attracting attention for clinical
purposes in the field of EBRT. In anticipation of the clinical use of CBEMs, the importance of research on
clinical and scientific aspects of CBEMs is increasing, in concert with the importance of establishing a
standardized data format for reporting of specifics of a CBEM.
2 Normative references
There are no normative references in this document.
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at https:// www .electropedia .org/
3.1
data element
unit of data that is considered in context to be indivisible
Note 1 to entry: The definition states that a data element is “indivisible” in some context. This means it is possible
that a data element considered indivisible in one context (e.g. telephone number) can be divisible in another
context (e.g. country code, area code, local number).
[SOURCE: ISO/IEC 11179-1:2023, 3.3.4, modified — Example deleted.]
3.2
Digital Imaging and Communications in Medicine
DICOM
standard for the communication and management of medical imaging information and related data
Note 1 to entry: The DICOM Standard facilitates interoperability of medical imaging equipment.
Note 2 to entry: DICOM is defined in ISO 12052.
[SOURCE: ISO/IEC 39794-16:2021, 3.16]
3.3
dose fractionation
method of administration of radiation in which the absorbed dose is divided into two or more fractions
separated in time
[SOURCE: IEV ref 881-11-18]
3.4
dose-volume histogram
DVH
dose as a distribution-function or frequency-function over a spec
...