Background
Medicine has undergone rapid advancement in recent decades benefiting from the ongoing technological revolution and the dawn of personalised medicine, all made possible by a myriad of scientific discoveries [
1]. Medical applications of ionising radiation and associated radiation protection research are a cornerstone of this medical evolution [
2]. Exemplifying this flourishing progression in medical radiation research are the increasing number of novel imaging biomarkers [
3], continuous expansion of interventional radiology applications [
4], recent emergence of authorised theranostic radiopharmaceuticals [
5‐
9], development of nanomedicine [
10‐
12], establishment of new charged particle beam therapies [
13,
14], and increasing utilisation of AI-based systems for image enhancement, segmentation, interpretation and object detection [
15‐
17]. Moreover, our knowledge surrounding the adverse effects of human exposure to ionising radiation and the underlying biological pathways at play continue to expand and, in turn, radiation protection practices have become further enhanced [
18‐
23]. Nevertheless, a longstanding issue is that clinical implementation continues to severely lag innovation and knowledge generation [
1,
24]. Thus, a concerted effort is needed to develop robust translational roadmaps through which to overcome the hurdles encountered throughout the transition from research and development to wide-spread clinical implementation [
1,
3].
There have been several translational challenges acknowledged for medical applications of ionising radiation over the years. These have included accounts of financial barriers [
17,
24,
25], limited access and scarcity of resources [
24,
26‐
28], cumbersome and ill aligned regulatory requirements [
9,
28,
29], and insufficient data repositories [
15,
17,
30]. The need for greater standardisation, communication, and collaboration regarding the conduct of medical radiation-based research at all levels has also been widely noted [
24,
26,
28,
31‐
33]. Though, up to this point, reporting of translational challenges and proposed solutions to these challenges has been primarily ad hoc and project specific. To effectively translate ionising radiation research into wider clinical practice and ensure both the sustainability and competitiveness of medical radiation research at scale, a coordinated and integrated effort at the European level is needed. To this end, the objective of Work Package 5 within the larger EURAMED Rocc-n-Roll project was to analyse the research needs for innovation transfer in radiation based high-quality healthcare across Europe and develop an innovation transfer framework for medical ionising radiation research at scale. Specifically, Task 5.1 aimed to gain consensus on the key translational challenges causing this lack of innovation transfer and define a priority approach to addressing identified issues. The Delphi technique was employed to execute this task as it offers a validated means of gathering and synthesising expert opinion for the purposes of generating recommendations in medical research and has been used for similar studies addressing clinical research barriers, research priorities, and educational needs/core competencies across a range of healthcare disciplines, including emergency medicine, occupational therapy, and radiography [
34‐
39].
Methods
The study consisted of three Delphi rounds completed between March and September 2021. The first Delphi round began with a preliminary literature search to identify central aspects and commonly reported hurdles to clinical translation. Using prompts derived from the literature, an open-ended electronic survey was developed within SurveyMonkey® and distributed to all members of the Task 5.1 Working Group for their review and feedback prior to deployment. As a low-risk study, an exemption from full institutional review board approval was obtained from the UCD Human Research Ethics Committee – Life Sciences (Reference: LS-E-21–35-McNulty). Forty-six European leaders in medical radiation were then nominated by the Task 5.1 Working Group to participate in round one of the Delphi study for which respondents were given three weeks to generate a wide range of statements regarding key barriers to translation by way of the self-administered online survey. The survey link was distributed via email alongside a summary of the project’s aims and scope with participation being entirely voluntary and consent obtained within the survey form. Statements were submitted across four broad categories: Basic Research, Commercial Development, Clinical Implementation, and Education and Training. Submissions were subsequently consolidated, duplicates removed, and messaging refined by the core research team (authors SB, SF, and JM) through a series of online meetings to produce a final list of unique statements which were carried forward to the next round.
The second Delphi round engaged a broader panel of subject matter experts across all areas of medical radiation and radiation protection research – radiology, nuclear medicine, radiotherapy, and social science. An email invitation was sent to all members of the EURAMED Rocc-n-Roll Consortium in addition to the same 20 panellists who participated in round one of the Delphi process. Furthermore, eleven well-known international organisations were contacted by email asking for their support in distributing the survey link. Within the electronic survey tool, nominated individuals were asked to rate the extent to which they agreed (or disagreed) with each generated statement as a key translational challenge for radiation research via a 6-point Likert Scale (1 = Strongly Disagree to 6 = Strongly Agree). Statements which achieved consensus, defined as a median rating of ≥ 4 with ≥ 60% of responses in the upper tertile of the 6-point Likert Scale (i.e., Agree/Strongly agree), were automatically progressed forward to a third Delphi round. Concurrently, statements on the verge of consensus underwent a supplementary review process by the core research team with regard for both the literature and under-represented research areas for inclusion in the final iteration of the Delphi process. Respondents were also provided the opportunity to submit original statements at the end of the survey form and novel submissions progressed forward for expert rating.
Four weeks following the close of the second-round survey the same cross-disciplinary panel of experts was asked to rate the prioritised round two statements through a third iteration of the Delphi process to produce a final set of core translational challenges. Central tendency and dispersion were used to descriptively analyse aggregated data following each of the latter two Delphi rounds. The proportion of question responses in the upper tertile of the Likert Scale was also determined to identify and prioritise consensus statements. Moreover, a Wilcoxon Matched Pairs Signed Rank Test was conducted on each statement to assess the stability of panel responses across Delphi rounds. Descriptive and statistical analyses were conducted by a single member of the research team using Excel version 16.56 (Microsoft Corp., Redmond, USA) and SPSS version 27 (IBM Corp., New York, USA) respectively; statistical findings were subsequently reviewed by two additional members of the research team to increase validity of results.
Discussion
The laborious and often unsuccessful transfer of medical innovations into clinical practice has been an issue at the forefront of medical research for decades and the focus of much infrastructural and strategic reform at the national and international levels since the turn of the century [
1,
25,
40‐
42]. The clinical and translational research continuum is intensively promoted as the gold standard through which to actualise the untapped potential of scientific discoveries [
1,
43]; however, the core roadmap must be further adapted to best meet product and application specific needs with no one size fits all formula for innovation transfer [
19,
40]. The extensive list of translational challenges identified through the presented Delphi work solidifies the need for an adapted innovation transfer framework specific to clinical applications of ionising radiation.
Through the Delphi process a distinct set of sixty translational challenges was identified from which ten high priority issues emerged which require immediate attention (Table
1). A prominent theme amongst the top ranked translational challenges was a lack of interoperability and information exchange. The statement which achieved the greatest level of combined agreement and stability across Delphi rounds being “robust and efficient database structures that facilitate research across different repositories/platforms through secure data storage and information exchange are needed.” This consensus statement is well aligned with the 2017 Common Strategic Research Agenda (SRA) for medical radiation protection, though not one of the agenda’s primary research topics, wherein a problematic degree of technological variability was acknowledged and an interdisciplinary collaboration for the development of harmonised procedures and standards of practice proposed as a potential solution to this problem [
31]. Structured reporting and standardised coding systems were also promoted within the SRA and have been reported throughout the broader literature as a necessary means to facilitate information transfer [
2,
31]. Similarly, limitations brought about by vendor-specific technology, heterogeneous data, and lack of data security are at the core of the NIH National Center for Data to Health’s (CD2H) research strategy [
44]. The European Society for Translational Medicine (EUSTM) has also emphasised the importance of a robust data management framework built upon the principles of data integration, regulatory compliance, security, and scalability for successful translation of medical research [
45]. The current Delphi work’s identification of “[complex clinical settings] with multiple technologies, and software systems working together” provides further support for the promotion of good data management systems and standardised coding, while the statement “Commercial software is often a black box” highlights the need for close collaboration between clinical research centres and industry when developing software and database structures. However, the latter two consensus statements lacked stability across Delphi rounds indicating these issues may not be as pressing as the need for robust and efficient database structures.
Financial constraints was another common theme that arose out of the Delphi work, with approximately 80% (n = 52 and n = 61, respectively) of statement raters having agreed or strongly agreed with the following two statements in round three: “access to modern technology/up-to-date equipment in radiology, nuclear medicine, or radiotherapy is limited by financial factors due to the high cost of resources, with end-users often lagging behind commercial development” and “there is a lack of funding, as well as a lack of funding opportunities, particularly for basic radiation protection research.” These findings are not entirely unexpected given insufficient funding has been a commonly cited barrier to translation for both the medical radiation and wider medical research community [
26‐
28,
43]. Though the continued prominence of this issue contradicts the influx of funding for translational research projects in recent decades, indicating a re-evaluation of current funding distribution may be needed [
25,
46]. Insufficient access to personnel and equipment was also identified as a key translational challenge. A finding that converges with a recent study out of the United Kingdom that identified a general lack of resources (funding, staffing, and infrastructure) as one of four primary contributors to the inefficient set-up of radiotherapy trials [
27]; though these findings may be due in part to the repercussions of the United Kingdom’s recent exit from the European Union [
47‐
49]. Looking further into the staffing shortage, a survey of radiotherapy research staff revealed that most clinical centres had ≤ 1 whole time equivalent physicist, research nurse, data manager, and radiographer working within their radiotherapy research centre [
33]. The existence of a severe staffing shortage further supported by the European Association of Nuclear Medicine (EANM) Internal Dosimetry Task Force’s 2015 survey which found that only 68% of radionuclide therapies involved a medical physicist [
50]. Taken together with the high priority challenges identified through the current Delphi study and the alarming radiology workforce shortages reported across Europe, these survey findings shed light on a severe drought in the current medical radiation workforce which must be addressed if the field of radiation research is to realise the tremendous potential of its scientific discoveries [
25,
51‐
54].
One proposed solution to the current workforce shortage is to increase the number of professionals trained in clinical and translational research. This solution echoes the prominence of education and training within the strategic agenda of medical societies and research funding bodies across North America and Europe [
25,
31,
40]. However, the findings from the current study demonstrate the need for a more standardised and multidisciplinary approach to education and training. Two of the top ten translational challenges identified stating: “Experience and background knowledge varies greatly” and “there is a need for multidisciplinary approaches to education and training that incorporate a team of educators with radiation protection expertise from a range of professions/disciplines.” It must also be stated that training programmes cannot solely be directed at young professionals. Consensus around “adequate training often [being] a challenge as clinical demands minimise the number of staff and average time spent on end user training (often working around clinical work/examinations/procedures)” signifies that greater emphasis must also be placed on continuing professional development. Protected clinician/researcher time should be dedicated for both teaching & learning, particularly if staff are to stay up to date with the rapid advancements to technology and techniques. “General awareness (by the public and other healthcare workers) of the benefits, risks, and applications of ionising radiation [also] needs improvement.” This consensus statement converges with the trend towards patient-centric approaches and shared decision medicine [
41]; though community access to both research data and scientific literature must be improved, and efforts directed at ensuring research outcomes are communicated in a manner easily understood by the general public. Most importantly, further work is needed to develop an innovation transfer framework that engages patients as key stakeholders [
41].
The systematic and structured Delphi technique has enabled consensus on which translational challenges are most affecting the radiation research community today. Nevertheless, there are several limitations to the current study that must be noted, not least of which include the study’s self-selection sampling method and self-administered survey design. Additionally, consolidation and refinement of developed statements was conducted via content analysis, hence a degree of interpretation was required. The imbalanced panel composition and minimal participation from radiation oncologists also represents a potential limitation of the current findings; the translational challenges identified via the study panels being potentially not as relevant to the field of radiotherapy compared to radiology and nuclear medicine applications. Nonetheless, the Delphi work presented herein provides valuable insight into the current roadblocks which prevent medical radiation applications and protection research from achieving wide-spread clinical use.
Conclusion
A lack of interoperability to facilitate information exchange, insufficient resources, unsatisfactory education and training, and the need for greater public awareness around the benefits, risks and applications of ionising radiation were identified as central issues in need of urgent attention. While these translational barriers are well-aligned with previous reports throughout the literature, the structured Delphi process provides added value to the existing body of knowledge. As a next step, presented consensus statements will be used to inform the development of a bespoke innovation transfer framework for medical applications of ionising radiation and corresponding radiation protection research. The resulting framework will provide a tool to help overcome key translational challenges currently facing the European radiation research community and help to inform future research and development work in medical applications of ionising radiation for maximum benefit to patients, professionals, and the wider European and global community.
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