Synthesis of the European ALARA network 20th workshop 'ALARA for interventional radiology and nuclear medicine'.

The European as low as reasonably achievable(ALARA) network regularly organises workshops on topical issues in radiation protection (RP). The topic of the 20th workshop was: 'ALARA for interventional radiology (IR) and nuclear medicine (NM)'. The objective was to examine the challenges faced when applying the optimisation principle (ALARA) in IR and NM and to consider how ALARA could be better implemented for patient and staff exposures. This memorandum provides a synthesis of the workshop sessions, and recommendations coming from the working groups discussion. Parallels are drawn with the recommendations arising from the 13th EAN workshop on 'ALARA and the medical sector (2011)' to consider how the optimisation challenges in IR and NM have evolved over the past decade. Current levels of exposure are presented along with operational practice and the challenges and opportunities for improvement, both in monitoring and practice. Whilst RP challenges remain, the application of ALARA appears more established in IR compared with experiences reported in 2011. The application of ALARA to emerging technologies in the NM setting is in need of further development to ensure that RP is considered at all stages in the development process of new radiopharmaceuticals. Besides the obvious technical and operational aspects, the importance of education and training, human factors and broadly the RP 'culture' were deemed fundamental to the success of the application of ALARA and where further emphasis is needed. All concerned parties, medical physics experts (MPEs), radiation protection experts, clinical staff, manufacturers and regulators have a role to play in the application of ALARA and this is discussed in the memorandum. Many of the recommendations from the 13th EAN workshop remain applicable today and overlap with the recommendations arising from the 20th workshop. This should prompt attention given that the use of IR and the development of novel radiopharmaceuticals for NM is only anticipated to increase with time.

Prescribing and using vitiligo treatments: lessons from a nested process evaluation within the HI-Light vitiligo randomized controlled trial.

BACKGROUND: The HI-Light Trial demonstrated that for active, limited vitiligo, combination treatment with potent topical corticosteroid (TCS) and handheld narrowband ultraviolet B offers a better treatment response than potent TCS alone. However, it is unclear how to implement these findings. AIM: We sought to answer three questions: (i) Can combination treatment be used safely and effectively by people with vitiligo?; (ii) Should combination treatment be made available as routine clinical care?; and (iii) Can combination treatment be integrated within current healthcare provision? METHODS: This was a mixed-methods process evaluation, including semi-structured interviews with a purposive sample of trial participants, structured interviews with commissioners, and an online survey and focus groups with trial staff. Transcripts were coded by framework analysis, with thematic development by multiple researchers. RESULTS: Participants found individual treatments easy to use, but the combination treatment was complicated and required nurse support. Both participants and site investigators felt that combination treatment should be made available, although commissioners were less certain. There was support for the development of services offering combination treatment, although this might not be prioritized above treatment for other conditions. A 'mixed economy' model was suggested, involving patients purchasing their own devices, although concerns regarding the safe use of treatments mean that training, monitoring and ongoing support are essential. The need for medical physics support may mean that a regional service is more practical. CONCLUSION: Combination treatment should be made available for people seeking treatment for vitiligo, but services require partnership with medical physics and ongoing training and support for patients.

National UK Survey of Radiation Doses During Endovascular Aortic Interventions.

PURPOSE: Endovascular aortic repair (EAR) interventions, endovascular abdominal aortic repair (EVAR) and thoracic endovascular aortic repair (TEVAR), are associated with significant radiation exposures. We aimed to investigate the radiation doses from real-world practice and propose diagnostic reference level (DRL) for the UK. MATERIALS AND METHODS: Radiation data and essential demographics were retrospectively collected from 24 vascular and interventional radiology centres in the UK for all patients undergoing EAR-standard EVAR or complex, branched/fenestrated (BEVAR/FEVAR), and TEVAR-between 2018 and 2021. The data set was further categorised according to X-ray unit type, either fixed or mobile. The proposed national DRL is the 75th percentile of the collective medians for procedure KAP (kerma area product), cumulative air kerma (CAK), fluoroscopy KAP and CAK. RESULTS: Data from 3712 endovascular aortic procedures were collected, including 2062 cases were standard EVAR, 906 cases of BEVAR/FEVAR and 509 cases of TEVAR. The majority of endovascular procedures (3477/3712) were performed on fixed X-ray units. The proposed DRL for KAP was 162 Gy cm2, 175 Gy cm2 and 266 Gy cm2 for standard EVAR, TEVAR and BEVAR/FEVAR, respectively. CONCLUSION: The development of DRLs is pertinent to EAR procedures as the first step to optimise the radiation risks to patients and staff while maintaining the highest patient care and paving the way for steps to reduce radiation exposures.

Combined approaches, including long-read sequencing, address the diagnostic challenge of HYDIN in primary ciliary dyskinesia.

Primary ciliary dyskinesia (PCD), a disorder of the motile cilia, is now recognised as an underdiagnosed cause of bronchiectasis. Accurate PCD diagnosis comprises clinical assessment, analysis of cilia and the identification of biallelic variants in one of 50 known PCD-related genes, including HYDIN. HYDIN-related PCD is underdiagnosed due to the presence of a pseudogene, HYDIN2, with 98% sequence homology to HYDIN. This presents a significant challenge for Short-Read Next Generation Sequencing (SR-NGS) and analysis, and many diagnostic PCD gene panels do not include HYDIN. We have used a combined approach of SR-NGS with bioinformatic masking of HYDIN2, and state-of-the-art long-read Nanopore sequencing (LR_NGS), together with analysis of respiratory cilia including transmission electron microscopy and immunofluorescence to address the underdiagnosis of HYDIN as a cause of PCD. Bioinformatic masking of HYDIN2 after SR-NGS facilitated the detection of biallelic HYDIN variants in 15 of 437 families, but compromised the detection of copy number variants. Supplementing testing with LR-NGS detected HYDIN deletions in 2 families, where SR-NGS had detected a single heterozygous HYDIN variant. LR-NGS was also able to confirm true homozygosity in 2 families when parental testing was not possible. Utilising a combined genomic diagnostic approach, biallelic HYDIN variants were detected in 17 families from 242 genetically confirmed PCD cases, comprising 7% of our PCD cohort. This represents the largest reported HYDIN cohort to date and highlights previous underdiagnosis of HYDIN-associated PCD. Moreover this provides further evidence for the utility of LR-NGS in diagnostic testing, particularly for regions of high genomic complexity.

The Value of Sport: Wellbeing Benefits of Sport Participation during Adolescence.

Insight into the unique benefits of sport participation above and beyond those associated with participation in other physical activities among adolescents is limited in Aotearoa New Zealand (NZ). The purpose of this study was to examine the association between wellbeing and organised sport participation among adolescents whilst accounting for demographic characteristics and other recreational physical activity. Demographic characteristics (age, gender, ethnicity, deprivation, (dis)ability status), organized sport, recreational physical activity, and wellbeing were assessed in cohorts of NZ adolescents (11-17 years) between 2017 and 2019. After adjusting for demographics, better wellbeing was associated with participation in any recreational physical activity (OR = 2.49, 95%CI = 1.97-3.13), meeting physical activity recommendations (OR = 1.63, 95%CI = 1.47-1.81), and each additional hour of recreational physical activity (OR = 1.03, 95%CI = 1.02-1.04). After adjusting for demographics and overall recreational physical activity participation, better wellbeing was also associated with participation in any organized sport (OR = 1.66, 95%CI = 1.49-1.86), and each additional hour of organized sport (OR = 1.09, 95%CI = 1.07-1.11). Although participation in recreational physical activity appears to be beneficial for wellbeing, organized sport appears to offer unique additional wellbeing benefits. Positive experiences of organized sport participation may offer additional wellbeing value above and beyond other recreational physical activity types in young people who are active.

A comparison of two peak skin dose metrics calculated by patient dose management systems: implications for clinical management.

OBJECTIVE: The patient dose monitoring systems DoseWatch and DoseWise were compared to evaluate their reported patient Peak Skin Dose. METHODS: 20 patients with the highest Peak Skin Dose on DoseWise were obtained; the values were converted to a Reference Point Air Kerma (RPAK) value and used for comparison. These patients were accessed in DoseWatch to obtain the recorded Worst Case RPAK. The co-ordinates for the position were obtained for each patient to find a primary and secondary angular position for the peak skin dose. The two positions produced by the two softwares were compared. RESULTS: There is a mean deviation of over 0.5 Gy between the two software packages when comparing the calculated maximum skin air kerma Peak skin dose from DoseWise and the Worst Case RPAK from DoseWatch. CONCLUSION: We have shown mean deviations between these two systems. This difference is enough, for higher peak skin absorbed dose patients, to change the management of patients, so local services must understand their models to properly implement patient management. ADVANCES IN KNOWLEDGE: Neither system is incorrect, but these differences show that a deeper understanding of the analysis limitations is required to properly inform post-procedural high-skin dose follow-up procedures.

Home interventions and light therapy for the treatment of vitiligo (HI-Light Vitiligo Trial): study protocol for a randomised controlled trial.

INTRODUCTION: Vitiligo is a condition resulting in white patches on the skin. People with vitiligo can suffer from low self-esteem, psychological disturbance and diminished quality of life. Vitiligo is often poorly managed, partly due to lack of high-quality evidence to inform clinical care. We describe here a large, independent, randomised controlled trial (RCT) assessing the comparative effectiveness of potent topical corticosteroid, home-based hand-held narrowband ultraviolet B-light (NB-UVB) or combination of the two, for the management of vitiligo. METHODS AND ANALYSIS: The HI-Light Vitiligo Trial is a multicentre, three-arm, parallel group, pragmatic, placebo-controlled RCT. 516 adults and children with actively spreading, but limited, vitiligo are randomised (1:1:1) to one of three groups: mometasone furoate 0.1% ointment plus dummy NB-UVB light, vehicle ointment plus NB-UVB light or mometasone furoate 0.1% ointment plus NB-UVB light. Treatment of up to three patches of vitiligo is continued for up to 9 months with clinic visits at baseline, 3, 6 and 9 months and four post-treatment questionnaires.The HI-Light Vitiligo Trial assesses outcomes included in the vitiligo core outcome set and places emphasis on participants' views of treatment success. The primary outcome is proportion of participants achieving treatment success (patient-rated Vitiligo Noticeability Scale) for a target patch of vitiligo at 9 months with further independent blinded assessment using digital images of the target lesion before and after treatment. Secondary outcomes include time to onset of treatment response, treatment success by body region, percentage repigmentation, quality of life, time-burden of treatment, maintenance of response, safety and within-trial cost-effectiveness. ETHICS AND DISSEMINATION: Approvals were granted by East Midlands-Derby Research Ethics Committee (14/EM/1173) and the MHRA (EudraCT 2014-003473-42). The trial was registered 8 January 2015 ISRCTN (17160087). Results will be published in full as open access in the NIHR Journal library and elsewhere. TRIAL REGISTRATION NUMBER: ISRCTN17160087.

Co-operation of employers in the area of personal monitoring: a commentary on BIR guidance on the UK regulatory situation.

The requirement for organizations to co-operate regarding doses to staff who work across organizational boundaries is well established. However, in the field of personal dosimetry there is little guidance as to how to actually achieve legal compliance. Following improvement action in the UK by the regulator, The Health & Safety Executive, a guidance document was developed by the leading professional bodies in this area. This guidance was also commented on by the Health & Safety Executive Specialist Inspectorate (Radiation) enabling the published guidance to represent a compliant standard. This commentary describes the guidance and discusses the issues involved with developing systems for compliance in this area.

UK guidance on the management of personal dosimetry systems for healthcare staff working at multiple organizations.

There has been concern expressed by the UK regulator, the Health & Safety Executive, regarding the management of occupation dose for healthcare radiation workers who work across multiple organizations. In response to this concern, the British Institute of Radiology led a working group of relevant professional bodies to develop guidance in this area. The guidance addresses issues of general system management that would apply to all personal dosimetry systems, regardless of whether or not the workers within that system work across organizational boundaries, along with exploring efficient strategies to comply with legislation where those workers do indeed work across organizational boundaries. For those specific instances, the guidance discusses both system requirements to enable organizations to co-operate (Ionising Radiation Regulations 1999 Regulation 15), as well as specific instances of staff exposure. This is broken down into three categories-low, medium and high risk. A suggested approach to each is given to guide employers and their radiation advisers in adopting sensible strategies for the monitoring of their staff and the subsequent sharing of dosimetry data to ensure overall compliance with both dose limits and optimization requirements.

Radiation Safety Culture in the UK Medical Sector: A Top to Bottom Strategy.

UK professional bodies have established a number of sectorial working parties to provide guidance on the improvement of radiation safety (RS) culture in the workplace. The medical sector provides unique challenges in this regard, and the remit of the medical group was to review the current state of RS culture and to develop a framework for improvement. The review of current RS culture was based on measurable indicators, including data from regulatory inspections, personal monitoring data and incident data. An online survey to capture the RS-related views and experience of hospital staff at all levels was carried out, and the responses provided a wealth of information on RS awareness and implementation across the country. The framework for improving RS culture includes both 'top-down' initiatives to engage management and regulators, and 'bottom-up' initiatives relating to engagement and training of different staff groups. A 'Ten-point Assessment' on what constitutes a good approach to medical RS culture has been proposed, which provides a tool for management to assess RS culture in the workplace and has potential use in regulatory inspections in the UK.

Calibration of Kodak EDR2 film for patient skin dose assessment in cardiac catheterization procedures.

Kodak EDR2 film has been calibrated across the range of exposure conditions encountered in our cardiac catheterization laboratory. Its dose-response function has been successfully modelled, up to the saturation point of 1 Gy. The most important factor affecting film sensitivity is the use of beam filtration. Spectral filtration and kVp together account for a variation in dose per optical density of -10% to +25%, at 160 mGy. The use of a dynamic wedge filter may cause doses to be underestimated by up to 6%. The film is relatively insensitive to variations in batch, field size, exposure rate, time to processing and day-to-day fluctuations in processor performance. Overall uncertainty in the calibration is estimated to be -20% to +40%, at 160 mGy. However, the uncertainty increases at higher doses, as the curve saturates. Artefacts were seen on a number of films, due to faults in the light-proofing of the film packets.

COREC and IRMER--is co-existence achievable?

The competitive pressures within clinical research are severe, and the need for a streamlined process to enable first-class research is self-evident. Conflict between ethical approval processes and legal requirements for the use of radiation within research has hindered such streamlining and has led to a call for action. This Commentary explores the background to this conflict and describes recent initiatives to generate a smoother process and unblock bottlenecks in relevant approval systems. It concludes by suggesting ways to improve the integration of these systems.