by Maarten Paulides, Gerard van Rhoon, Sergio Curto, Marta Cavagnaro, Lourdes Farrugia.
Following the discussions during the previous meeting organized by Working group 2 on establishing the needs of Standardisation for EM hyperthermic technologies here, it emerged that different organisations have already ongoing efforts, partly addressing Standardisation in EM hyperthermia technologies. In particular, the ESHO Technical Committee has already published guidelines in the area and the ASME Lexicon and tissue properties group has been doing extensive work to address this. Additionally, the Swiss Hyperthermia Network has been working in this area as well. All these efforts and initiatives create a great opportunity for COST MyWAVE since these are all in line with our objectives. Therefore, in an attempt to harmonise these efforts, for this meeting we invited speakers from ESHO, ASME and SHN to talk about ongoing efforts and also to highlight persistent needs in this field of research.
The program of the meeting and key points addressed by the speakers:
| Lourdes Farrugia | Welcome and Introduction to COST Action MYWave |
| Marta Cavagnaro | Introduction to WG2 |
| Sergio Curto | Introduction to the meeting |
| Luis Pulgarin | ASME: Standards definitions & how are established. Presentation of ASME: structure, activities, tools. How standards are developedDifference between standards (public discussion) and guidelines (proposal by a few experts) |
| Dario Rodrigues | ASME: Lexicon & tissue properties, Translation to Hyperthermia and analysing current gaps. Presentation of Thermal Medicine Committee of ASME. Importance of standardization for clinical progress. At present 2 projects are carried on: lexicon, development of measurement standard. |
| Hana Trefna | ESHO tech committee: Current and future actions. Reviewed the standardsMove from SAR-based to temperature-based standards in view of clinical evidence on thermal dose-effect relations |
| Stephan Bodis | Standardization from the physician perspective. Mentioned 7 clear needs for progress:Evidence based data, Multi-centric prospective trials, ISO certification for clinical HT thermotherapy (maybe also training should be included), Clinical research Network for better exchange of information (Hyperboost, others), Need for reimbursement, Standardization of software and hardware, Standardization patient workflow and QA |
| Gerard van Rhoon | Panel discussion along provocative propositions. Setting worldwide standards will fail due to the different culture between the dominant health authorities governing regulation Setting standards means only obtaining agreement on values for critical parameters. That is why it will work.Current guidelines are recommendations: is there a need to require certification for the institution applying HT aiming at guarantee that they comply the guidelines? |
| Maarten Paulides | Summarizing and closing. Standardisation is the way forward!To be continued at ICHO2021 |
Each of the speakers discussed aspects of standardization related to the overall spectrum of quality, but each addressed from his/her own area of expertise. Altogether the presentations covered the fundamental idea of setting standards and the long and public road to arrive at a worldwide standard, as well as how quality assurance guidelines which are implemented in the current state of art to guarantee safe and reliable application of the hyperthermia treatment from a technological and clinical field of view. The presentations and recording of the meeting can be accessed on the MyWAVE website intranet here (LINK).
Hereafter, an interactive panel discussion started whereby provocative propositions were first addressed by the speakers to encourage participants to also share their opinion on the topic. In this way the gap between the various disciplines (medical, biological, physics and engineering) was bridged, however a stronger participation of clinicians and physicians should be further enhanced. This was noted for all organizations involved.
Answers to these provocative propositions provided a leveled playing field and fostered general consent on how to move forward to widespread acceptance of standards in thermal therapy. Broad agreement exists and that improvement goes step by step and with each step knowledge about the overall technology and clinical procedure to apply thermal therapy grows. Eventually, this will result in the formulation of standards and protocols. Furthermore, research on technology or clinical efficacy should then be initiated with the earlier defined standards and protocols as the reference/control arm in the study design.
In conclusion, two critical points were highlighted: mainly to better communicate the technology to the medical community. Such communication should be supported with evidence-based data and it is critical to harmonize efforts in different organisations and collectively work towards standardisation.
Standardisation is the way forward!
(To access the recording of the meeting please log in the webpage intranet.)
