Operational indications and self-assessment checklist for internal audits in cyclotron facilities – an Italian experience

In this work the authors intend to provide useful operational indications to approach, with the best practice, the design of a cyclotron facility for the production of PET radioisotopes. Special attention is devoted to organizational and safety aspects. In order to prompt toward a systematic application of the proposed indications, the article presents them in form of a specific self-assessment checklist, consisting in a list of items which address the design process in all the different phases. This checklist represents a useful toolbox both in the design stage and subsequently for the development of internal audits

Indicazioni operative utili alla progettazione di ambienti dedicati alla manipolazione di sorgenti non sigillate e alla produzione di radiofarmaci: medicina nucleare, PET, ciclotrone

Con il presente lavoro, l’Inail - organo tecnico consultivo del Ministero della Salute anche per la concessione delle autorizzazioni connesse ai nulla osta di categoria A in ambito nucleare - intende proporre indicazioni operative utili ad approcciare nel modo migliore la problematica relativa alla progettazione di un servizio di medicina nucleare ‘complesso’. Nel fare ciò, ha inteso stabilire una collaborazione con l’Enea, al fine di condividere il frutto delle reciproche competenze e delle specifiche esperienze acquisite, e di strutturare un gruppo di lavoro che potesse mettere a disposizione dell’utenza le più idonee sensibilità professionali. Il lavoro che ne è scaturito non intende porsi come uno ‘standard’ elettivo di riferimento, ma piuttosto come semplice modello di confronto per condurre il lettore a riflettere su determinate questioni invitandolo a una più ampia e sistematica valutazione. Ovviamente, il prodromo a questo tentativo è stato la presa d’atto del quadro normativo vigente, e quindi il documento necessiterà di una pronta rivalutazione allorquando anche nel nostro Paese risulterà recepita la direttiva Euratom 2013/59. L’emanazione dell’atto di recepimento comporterà infatti l’esigenza di allineare la trattazione alle nuove disposizioni, e l’occasione sarà anche utile per integrare il testo con indicazioni più propriamente dedicate agli aspetti di radioprotezione del lavoratore, che in questa fase - stante il momento di transizione normativo - sono stati volontariamente tralasciati

Cardiopulmonary Exercise Testing in Repaired Tetralogy of Fallot: Multiparametric Overview and Correlation with Cardiac Magnetic Resonance and Physical Activity Level

Patients with repaired Tetralogy of Fallot (rToF) typically report having preserved subjective exercise tolerance. Chronic pulmonary regurgitation (PR) with varying degrees of right ventricular (RV) dilation as assessed by cardiac magnetic resonance imaging (MRI) is prevalent in rToF and may contribute to clinical compromise. Cardiopulmonary exercise testing (CPET) provides an objective assessment of functional capacity, and the International Physical Activity Questionnaire (IPAQ) can provide additional data on physical activity (PA) achieved. Our aim was to assess the association between CPET values, IPAQ measures, and MRI parameters. All rToF patients who had both an MRI and CPET performed within one year between March 2019 and June 2021 were selected. Clinical data were extracted from electronic records (including demographic, surgical history, New York Heart Association (NYHA) functional class, QRS duration, arrhythmia, MRI parameters, and CPET data). PA level, based on the IPAQ, was assessed at the time of CPET. Eighty-four patients (22.8 ± 8.4 years) showed a reduction in exercise capacity (median peak VO2 30 mL/kg/min (range 25–33); median percent predicted peak VO2 68% (range 61–78)). Peak VO2, correlated with biventricular stroke volumes (RVSV: β = 6.11 (95%CI, 2.38 to 9.85), p = 0.002; LVSV: β = 15.69 (95% CI 10.16 to 21.21), p < 0.0001) and LVEDVi (β = 8.74 (95%CI, 0.66 to 16.83), p = 0.04) on multivariate analysis adjusted for age, gender, and PA level. Other parameters which correlated with stroke volumes included oxygen uptake efficiency slope (OUES) (RVSV: β = 6.88 (95% CI, 1.93 to 11.84), p = 0.008; LVSV: β = 17.86 (95% CI 10.31 to 25.42), p < 0.0001) and peak O2 pulse (RVSV: β = 0.03 (95%CI, 0.01 to 0.05), p = 0.007; LVSV: β = 0.08 (95% CI 0.05 to 0.11), p < 0.0001). On multivariate analysis adjusted for age and gender, PA level correlated significantly with peak VO2/kg (β = 0.02, 95% CI 0.003 to 0.04; p = 0.019). We observed a reduction in objective exercise tolerance in rToF patients. Biventricular stroke volumes and LVEDVi were associated with peak VO2 irrespective of RV size. OUES and peak O2 pulse were also associated with biventricular stroke volumes. While PA level was associated with peak VO2, the incremental value of this parameter should be the focus of future studies

Meta-analysis: The Placebo Rate of Abdominal Pain Remission in Clinical Trials of Chronic Pancreatitis.

OBJECTIVES: Treatment of the pain caused by chronic pancreatitis (CP) is not standardized. Knowledge of the response to placebo in this setting may aid the design of future trials. We aimed at investigating the placebo effect on abdominal pain remission rates in patients with CP. METHODS: MEDLINE, EMBASE, and Scopus were searched, and randomized placebo-controlled trials in CP providing data on abdominal pain remission rates in placebo arms were included. Pooled estimates of the placebo rate were calculated using random-effects logistic regression analysis. Stratum-specific rates for different patients and study-level covariates were calculated to account for heterogeneity. RESULTS: Seven randomized controlled trials (202 placebo-treated patients) met the predefined criteria. The pooled estimate of the placebo rate for pain remission was 19.9\% (95\% confidence interval, 9\%-36\%). There was a statistically significant heterogeneity among the studies (I = 76\%; P < 0.001). A multicenter design, a run-in period of less than 2 weeks, and absence of a washout in crossover trials were all significant sources of heterogeneity associated with higher placebo responses. CONCLUSIONS: This meta-analysis identifies for the first time the efficacy of placebo for pain in CP and variables determining it. These data provide a sound basis for designing future placebo-controlled randomized clinical trials for the treatment of pain in CP

Review of operational indications on the design of facilities for radiopharmaceutical manufacturing in italy

Purpose. In this article, the authors propose useful operational indications to approach in the best possible way the issues concerning the design of a facility for manufacturing radiopharmaceuticals, with focus on organizational and safety aspects. Methods. Several documents produced by authoritative bodies, national and international scientific institutions and associations were examined and referenced, to the purpose of reviewing all available information in the field. Results. Indications are gathered for the design stage, including the organization of accesses and routes and characteristics and requirements of premises and systems. Conclusions. Main goal is to guide the reader in evaluating and choosing the most suitable features and equipment to limit the risks due to ionizing radiation and to prevent contamination of the workers and the environment

Review of operational indications on the design of facilities for radiopharmaceutical manufacturing in Italy

In this article, the authors propose useful operational indications to approach in the best possible way the issues concerning the design of a facility for manufacturing radiopharmaceuticals, with focus on organizational and safety aspects. Methods. Several documents produced by authoritative bodies, national and international scientific institutions and associations were examined and referenced, to the purpose of reviewing all available information in the field. Results. Indications are gathered for the design stage, including the organization of accesses and routes and characteristics and requirements of premises and systems. Conclusions. Main goal is to guide the reader in evaluating and choosing the most suitable features and equipment to limit the risks due to ionizing radiation and to prevent contamination of the workers and the environment

Review of operational indications on the design of facilities for radiopharmaceutical manufacturing in italy

Purpose. In this article, the authors propose useful operational indications to approach in the best possible way the issues concerning the design of a facility for manufacturing radiopharmaceuticals, with focus on organizational and safety aspects. Methods. Several documents produced by authoritative bodies, national and international scientific institutions and associations were examined and referenced, to the purpose of reviewing all available information in the field. Results. Indications are gathered for the design stage, including the organization of accesses and routes and characteristics and requirements of premises and systems. Conclusions. Main goal is to guide the reader in evaluating and choosing the most suitable features and equipment to limit the risks due to ionizing radiation and to prevent contamination of the workers and the environment.</jats:p