Governance of advanced materials: Shaping a safe and sustainable future.

The past few decades of managing the uncertain risks associated with nanomaterials have provided valuable insights (knowledge gaps, tools, methods, etc.) that are equally important to promote safe and sustainable development and use of advanced materials. Based on these insights, the current paper proposes several actions to optimize the risk and sustainability governance of advanced materials. We emphasise the importance of establishing a European approach for risk and sustainability governance of advanced materials as soon as possible to keep up with the pace of innovation and to manage uncertainty among regulators, industry, SMEs and the public, regarding potential risks and impacts of advanced materials. Coordination of safe and sustainable advanced material research efforts, and data management according to the Findable, Accessible, Interoperable and Reusable (FAIR) principles will enhance the generation of regulatory-relevant knowledge. This knowledge is crucial to identify whether current regulatory standardised and harmonised test methods are adequate to assess advanced materials. At the same time, there is urgent need for responsible innovation beyond regulatory compliance which can be promoted through the Safe and Sustainable Innovation Approach. that combines the Safe and Sustainable by Design concept with Regulatory Preparedness, supported by a trusted environment. We further recommend consolidating all efforts and networks related to the risk and sustainability governance of advanced materials in a single, easy-to-use digital portal. Given the anticipated complexity and tremendous efforts required, we identified the need of establishing an organisational structure dedicated to aligning the fast technological developments in advanced materials with proper risk and sustainability governance. Involvement of multiple stakeholders in a trusted environment ensures a coordinated effort towards the safe and sustainable development, production, and use of advanced materials. The existing infrastructures and network of experts involved in the governance of nanomaterials would form a solid foundation for such an organisational structure.

Deep pelvic infiltrating endometriosis: MRI consensus lexicon and compartment-based approach from the ENDOVALIRM group.

PURPOSE: The purpose of this consensus article was to develop guidelines by a focused panel of experts to elaborate a lexicon of image interpretation, and a standardized region-based reporting of deep infiltrating endometriosis (DIE) with magnetic resonance imaging (MRI). MATERIALS AND METHODS: Evidence-based data and expert opinion were combined using the RAND-UCLA Appropriateness Method to attain consensus guidelines. Experts scoring of pelvic compartment delineation and reporting template were collected; responses were analyzed and classified as "RECOMMENDED" versus "NOT RECOMMENDED" (when ≥ 80% consensus among experts) or uncertain (when < 80% consensus among experts). RESULTS: Consensus regarding pelvic compartment delineation and DIE reporting was attained using the RAND-UCLA Appropriateness Method. The pelvis was divided in nine compartments and extrapelvic lesions were assigned to an additional (tenth) compartment. A consensus was also reached for each structure attributed to a compartment and each reporting template item among the experts. No consensus was reached for a normal aspect of uterosacral ligament, but a consensus was reached for an unequivocal involvement leading to a positive diagnosis and an equivocal involvement leading to uncertain diagnosis. Tailored MRI lexicon and standardized region-based report were proposed. CONCLUSION: These consensus recommendations should be used as a guide for DIE reporting and staging with MRI. Standardized MRI compartment-based structured reporting is recommended to enable consistent accuracy and help select the best therapeutic approach.

Accuracy of combined physical examination, transvaginal ultrasonography, and magnetic resonance imaging to diagnose deep endometriosis.

OBJECTIVES: To assess the ability of physical examination (PE), transvaginal ultrasonography (TVUS), and magnetic resonance imaging (MRI) alone and combined to diagnose deep infiltrating endometriosis (DIE). DESIGN: We retrospectively queried our pelvic MRI database to identify women who underwent PE, TVUS, and pelvic MRI for DIE up to 12 months before surgery between January 1, 2016 and August 31, 2020. The presence of uterosacral ligaments (USL), vaginal, rectosigmoid (RS), parametrial, or sacrorectogenital septum (lateral) DIE shown by PE, TVUS, and MRI were correlated with surgical and histological findings. SETTING: Academic hospital. PATIENT(S): We included 178 patients. INTERVENTION(S): Clinical and imaging evaluation of women who were diagnosed at surgery with deep pelvic endometriosis. MAIN OUTCOME MEASURE(S): The sensitivity, specificity, positive and negative predictive values, and accuracy of each technique separately and combined were assessed for each location. When the 3 techniques were combined, 2 models were tested as follows: all 3 techniques positive and concordant; and ≥2 techniques positive and concordant. RESULT(S): The prevalence of USL, vaginal, RS, and lateral DIE were 94.4%, 20.2%, 34.3%, and 32.6%, respectively. In addition, MRI was more sensitive than PE, TVUS or any combination to detect DIE. Moreover, MRI and model B were the most accurate for detecting USL and RS locations with an accuracy of 90.4% and 82.6%, a sensitivity of 91.1% and 50%, and a specificity of 77.8% and 90.9%, respectively. Model B was the most accurate for the vaginal location with an accuracy, sensitivity, and specificity of 82.6%, 50%, and 90.9%, respectively. Finally, MRI was more accurate than any combination for identifying a lateral location with an accuracy, sensitivity, and specificity of 75.1%, 36%, and 93.8%, respectively. CONCLUSION(S): A combination of PE, TVUS, and MRI was more accurate than each technique separately to diagnose DIE because of the equally high sensitivity of each, as well as the high specificity of PE and TVUS.

Concomitant vesicovaginal fistula and rectovaginal fistula in a patient with a neglected pessary placed for pelvic organ prolapse.

INTRODUCTION: Pelvic organ prolapse is a very frequent affection especially in elderly women. Vaginal pessary is a common conservative treatment and recommended as first line therapy. Guidelines recommend to do a regular follow up every 6 to 12 months with a healthcare professional. We report the case of a patient with neglected vaginal pessary who had a vesicovaginal and a concomitant rectovaginal fistula. CASE REPORT: A 84-year-old woman was admitted for chronic pelvic pain and vaginal discharge. An entrapped cube pessary was removed and the diagnostic of a 3cm rectovaginal fistula with a vesicovaginal fistula was made. The patient had a two-stage surgery, vaginal way then open abdominal way, for closing the fistulas. CONCLUSION: Although vaginal pessary is a good conservative treatment for POP, it shall not be neglected or serious complications can be caused.

Endovascular Treatment of Pelvic Congestion Syndrome: Visual Analog Scale Follow-Up.

Purpose: To evaluate medium-term clinical outcomes of transcatheter embolization and stenting in women with several pelvic venous disorders responsible for chronic pelvic pain and varicose veins of the lower limbs. Materials and Methods: The study population included 327 consecutively recruited patients referred to the interventional radiology unit from January 2014 to December 2019 due to chronic pelvic congestion (91; 27.83%), lower limb varices (15; 4.59%), or a combination of both the symptoms (221; 67.58%). Preprocedural pelvic, transvaginal Doppler ultrasound (US), and MRI were conducted in all the patients and revealed anatomical varicosities and incompetent pelvic veins in 312 patients. In all the patients, selective catheterization demonstrated uterine venous engorgement, ovarian plexus congestion, or pelvic vein filling. Retrograde flow was detected on catheter venography in the left ovarian vein (250; 78%), the right ovarian vein (85; 26%), the left internal iliac vein (222; 68%), and the right internal iliac vein (185; 57%). Patients were followed-up at 1, 6, and 12 months, and years thereafter systematically by the referring angiologist and the interventional radiologist of center. They were contacted by telephone in November and December 2020 to assess pain perception and quality of life by using the visual analog scales from 0 to 10 with assessments made at the baseline and last follow-up. Of the 327 patients (mean age, 42 ± 12 years), 312 patients were suffering from pelvic congestion syndrome and 236 patients was suffering from lower limb varices. All underwent embolization by using ethylene vinyl alcohol copolymer (Onyx®). Eighty-five right ovarian veins, 249 left ovarian veins, 510 tributaries of the right internal iliac vein, and 624 tributaries of the left internal iliac vein were embolized. A cohort of patients also underwent nutcracker syndrome angioplasty (6.7%) and May-Thurner syndrome angioplasty (14%) with a stent placement. Results: The initial technical success rate was 80.9% for embolization of pathological veins and 100% for stenting of stenoses. Overall, 307 patients attended 12-month follow-up visits and 288 (82%) patients completed the telephone survey at mean 39 (±18)-month postintervention. Main pelvic pain significantly improved from 6.9 (±2.4) pre- to 2.0 (±2.4) postembolization (p < 0.001), as did specific symptoms in each category. Improvement or disappearance of pain was achieved in 266/288 (92.36%) patients with improved quality of life in 276/288 (95.8%) patients. There were 16 minor and 4 major adverse events reported on the follow-up. Conclusion: Pelvic vein embolization (Onyx®) is an effective and safe procedure with high clinical success and quality of life improvement rates.

Complete pathological response to olaparib and bevacizumab in advanced cervical cancer following chemoradiation in a BRCA1 mutation carrier: a case report.

BACKGROUND: Homologous recombination deficiency is a marker of response to poly(ADP-ribose) polymerase inhibitors in different cancer types including ovary, prostate, and pancreatic cancer. To date, no report about poly(ADP-ribose) polymerase inhibitors has been published on cervical cancer. CASE PRESENTATION: Here we present the case of a patient with cervical cancer treated in this setting. A 49-year-old woman diagnosed with International Federation of Obstetricians and Gynecologists stage 2018 IIIC2 locally advanced undifferentiated cervical cancer received first-line chemoradiotherapy followed by carboplatin, paclitaxel, and bevacizumab with partial response. Because of a family history of cancers, the patient was tested and found positive for a pathogenic BRCA1 germline and somatic mutation, which motivated bevacizumab plus olaparib maintenance treatment. A simple hysterectomy was performed after 2 years stable disease; pathological report showed complete pathological response, and 12 months follow-up showed no recurrence. CONCLUSION: Poly(ADP-ribose) polymerase inhibitors could be an alternative maintenance treatment for patients with persistent advanced cervical cancer previously treated with platinum, especially when familial history of cancers is reported. Clinical trials using poly(ADP-ribose) polymerase inhibitors for advanced cervical cancer are warranted.

Evaluation of Iterative Denoising 3-Dimensional T2-Weighted Turbo Spin Echo for the Diagnosis of Deep Infiltrating Endometriosis.

OBJECTIVES: The primary end point of this study was to evaluate the image quality and reliability of a highly accelerated 3-dimensional T2 turbo spin echo (3D-T2-TSE) sequence with prototype iterative denoising (ID) reconstruction compared with conventional 2D T2 sequences for the diagnosis of deep infiltrating endometriosis (DIE). The secondary end point was to demonstrate the 3D-T2-TSE sequence image quality improvement using ID reconstruction. MATERIAL AND METHODS: Patients were prospectively enrolled to our institution for pelvis magnetic resonance imaging because of a suspicion of endometriosis over a 4-month period. Both conventional 2D-T2 (sagittal, axial, coronal T2 oblique to the cervix) and 3D-T2-TSE sequences were performed with a scan time of 7 minutes 43 seconds and 4 minutes 58 seconds, respectively. Reconstructions with prototype ID (3D-T2-denoised) and without prototype ID (3D-T2) were generated inline at the end of the acquisition. Two radiologists independently evaluated the image quality of 3D-T2, 3D-T2-denoised, and 2D-T2 sequences. Diagnosis confidence of DIE was evaluated for both 3D-T2-denoised and 2D-T2 sequences. Intraobserver and interobserver agreements were calculated using Cohen κ coefficient. RESULTS: Ninety female patients were included. Both readers found that the ID algorithm significantly improved the image quality and decreased the artifacts of 3D-T2-denoised compared with 3D-T2 sequences (P < 0.001). A significant image quality improvement was found by 1 radiologist for 3D-T2-denoised compared with 2D-T2 sequences (P = 0.002), whereas the other reader evidenced no significant difference. The interobserver agreement of 3D-T2-denoised and 2D-T2 sequences was 0.84 (0.73-0.95) and 0.78 (0.65-0.9), respectively, for the diagnosis of DIE. Intraobserver agreement for readers 1 and 2 was 0.86 (0.79-1) and 0.83 (0.76-1), respectively. For all localization of DIE, interobserver and intraobserver agreements were either almost perfect or substantial for both 3D-T2-denoised and 2D-T2 sequences. CONCLUSIONS: Three-dimensional T2-denoised imaging is a promising tool to replace conventional 2D-T2 sequences, offering a significant scan time reduction without compromising image quality or diagnosis information for the assessment of DIE.

Socio-economic and psychological impact of the COVID-19 outbreak on private practice and public hospital radiologists.

PURPOSE: The COVID-19 pandemic has led to an urgent reorganisation of the healthcare system to prevent hospitals from overflowing and the virus from spreading. Our objective was to evaluate the socioeconomic and psychological impact of the COVID-19 outbreak on radiologists. MATERIAL AND METHODS: French radiologists were invited to answer an online survey during the pandemic through mailing lists. The questionnaire was accessible for nine days. It covered socio-demographic information, exposure to COVID-19 at work and impact on work organisation, and included the Insomnia Severity Index and Hospital Anxiety and Depression Scale. Outcomes were moderate to severe insomnia, definite symptoms of depression or anxiety. Risk and protective factors were identified through multivariate binary logistic regression. RESULTS: 1515 radiologists answered the survey. Overall, 674 (44.5 %) worked in a highCOVID-19 density area, 671 (44.3 %) were women, and 809 (53.4 %) worked in private practice. Among responders, 186 (12.3 %) expressed insomnia, 222 (14.6 %) anxiety, and 189 (12.5 %) depression symptoms. Lack of protective equipment, increased teleradiology activity and negative impact on education were risk factors for insomnia (respectively OR [95 %CI]:1.7[1.1-2.7], 1.5[1.1-2.2], and 2.5[1.8-3.6]). Female gender, respiratory history, working in COVID-19 high density area, increase of COVID-19 related activity, and impacted education were risk factors for anxiety (OR[95 %CI]:1.7[1.2-2.3], 2[1.1-3.4], 1.5[1.1-2], 1.2[1-1.4], and 2.1[1.5-3]). Conversely, working in a public hospital was a protective factor against insomnia, anxiety, and depression (OR[95 %CI]:0.4[0.2-0.7], 0.6[0.4-0.9], and 0.5[0.3-0.8]). CONCLUSIONS: During COVID-19 pandemic, many radiologists expressed depression, anxiety and insomnia symptoms. Working in a public hospital was a protective factor against every psychological symptom. Socio-economic impact was also major especially in private practice.

Building biosecurity for synthetic biology.

The fast-paced field of synthetic biology is fundamentally changing the global biosecurity framework. Current biosecurity regulations and strategies are based on previous governance paradigms for pathogen-oriented security, recombinant DNA research, and broader concerns related to genetically modified organisms (GMOs). Many scholarly discussions and biosecurity practitioners are therefore concerned that synthetic biology outpaces established biosafety and biosecurity measures to prevent deliberate and malicious or inadvertent and accidental misuse of synthetic biology's processes or products. This commentary proposes three strategies to improve biosecurity: Security must be treated as an investment in the future applicability of the technology; social scientists and policy makers should be engaged early in technology development and forecasting; and coordination among global stakeholders is necessary to ensure acceptable levels of risk.

Tiered Approach to Resilience Assessment.

Regulatory agencies have long adopted a three-tier framework for risk assessment. We build on this structure to propose a tiered approach for resilience assessment that can be integrated into the existing regulatory processes. Comprehensive approaches to assessing resilience at appropriate and operational scales, reconciling analytical complexity as needed with stakeholder needs and resources available, and ultimately creating actionable recommendations to enhance resilience are still lacking. Our proposed framework consists of tiers by which analysts can select resilience assessment and decision support tools to inform associated management actions relative to the scope and urgency of the risk and the capacity of resource managers to improve system resilience. The resilience management framework proposed is not intended to supplant either risk management or the many existing efforts of resilience quantification method development, but instead provide a guide to selecting tools that are appropriate for the given analytic need. The goal of this tiered approach is to intentionally parallel the tiered approach used in regulatory contexts so that resilience assessment might be more easily and quickly integrated into existing structures and with existing policies.

Comparative, collaborative, and integrative risk governance for emerging technologies.

Various emerging technologies challenge existing governance processes to identify, assess, and manage risk. Though the existing risk-based paradigm has been essential for assessment of many chemical, biological, radiological, and nuclear technologies, a complementary approach may be warranted for the early-stage assessment and management challenges of high uncertainty technologies ranging from nanotechnology to synthetic biology to artificial intelligence, among many others. This paper argues for a risk governance approach that integrates quantitative experimental information alongside qualitative expert insight to characterize and balance the risks, benefits, costs, and societal implications of emerging technologies. Various articles in scholarly literature have highlighted differing points of how to address technological uncertainty, and this article builds upon such knowledge to explain how an emerging technology risk governance process should be driven by a multi-stakeholder effort, incorporate various disparate sources of information, review various endpoints and outcomes, and comparatively assess emerging technology performance against existing conventional products in a given application area. At least in the early stages of development when quantitative data for risk assessment remain incomplete or limited, such an approach can be valuable for policymakers and decision makers to evaluate the impact that such technologies may have upon human and environmental health.