A method to study the effect of bronchodilators on smoke retention in COPD patients: study protocol for a randomized controlled trial

<p>Abstract</p> <p>Background</p> <p>Chronic obstructive pulmonary disease (COPD) is a common disease, associated with cardiovascular disease. Many patients use (long-acting) bronchodilators, whilst they continue smoking alongside. We hypothesised an interaction between bronchodilators and smoking that enhances smoke exposure, and hence cardiovascular disease. In this paper, we report our study protocol that explores the fundamental interaction, i.e. smoke retention.</p> <p>Method</p> <p>The design consists of a double-blinded, placebo-controlled, randomised crossover trial, in which 40 COPD patients smoke cigarettes during both undilated and maximal bronchodilated conditions. Our primary outcome is the retention of cigarette smoke, expressed as tar and nicotine weight. The inhaled tar weights are calculated from the correlated extracted nicotine weights in cigarette filters, whereas the exhaled weights are collected on Cambridge filters. We established the inhaled weight calculations by a pilot study, that included paired measurements from several smoking regimes. Our study protocol is approved by the local accredited medical review ethics committee.</p> <p>Discussion</p> <p>Our study is currently in progress. The pilot study revealed valid equations for inhaled tar and nicotine, with an R²of 0.82 and 0.74 (p < 0.01), respectively. We developed a method to study pulmonary smoke retentions in COPD patients under the influence of bronchodilation which may affect smoking-related disease. This trial will provide fundamental knowledge about the (cardiovascular) safety of bronchodilators in patients with COPD who persist in their habit of cigarette smoking.</p> <p>Trial registration</p> <p>ClinicalTrials.gov: <a href="http://www.clinicaltrials.gov/ct2/show/NCT00981851">NCT00981851</a></p

FAIR environmental and health registry (FAIREHR)- supporting the science to policy interface and life science research, development and innovation

The environmental impact on health is an inevitable by-product of human activity. Environmental health sciences is a multidisciplinary field addressing complex issues on how people are exposed to hazardous chemicals that can potentially affect adversely the health of present and future generations. Exposure sciences and environmental epidemiology are becoming increasingly data-driven and their efficiency and effectiveness can significantly improve by implementing the FAIR (findable, accessible, interoperable, reusable) principles for scientific data management and stewardship. This will enable data integration, interoperability and (re)use while also facilitating the use of new and powerful analytical tools such as artificial intelligence and machine learning in the benefit of public health policy, and research, development and innovation (RDI). Early research planning is critical to ensuring data is FAIR at the outset. This entails a well-informed and planned strategy concerning the identification of appropriate data and metadata to be gathered, along with established procedures for their collection, documentation, and management. Furthermore, suitable approaches must be implemented to evaluate and ensure the quality of the data. Therefore, the 'Europe Regional Chapter of the International Society of Exposure Science' (ISES Europe) human biomonitoring working group (ISES Europe HBM WG) proposes the development of a FAIR Environment and health registry (FAIREHR) (hereafter FAIREHR). FAIR Environment and health registry offers preregistration of studies on exposure sciences and environmental epidemiology using HBM (as a starting point) across all areas of environmental and occupational health globally. The registry is proposed to receive a dedicated web-based interface, to be electronically searchable and to be available to all relevant data providers, users and stakeholders. Planned Human biomonitoring studies would ideally be registered before formal recruitment of study participants. The resulting FAIREHR would contain public records of metadata such as study design, data management, an audit trail of major changes to planned methods, details of when the study will be completed, and links to resulting publications and data repositories when provided by the authors. The FAIREHR would function as an integrated platform designed to cater to the needs of scientists, companies, publishers, and policymakers by providing user-friendly features. The implementation of FAIREHR is expected to yield significant benefits in terms of enabling more effective utilization of human biomonitoring (HBM) data.Most co-authors were financialy supported with their respective inistitution. Some of the co-authors were financialy supportrd by the Safe and Efficient Chemistry by Design (SafeChem) project (grant no. DIA 2018/11) funded by the Swedish Foundation for Strategic Environmental Research, and by the PARC project (grant no. 101057014) funded under the European Union's Horizon Europe Research and Innovation program

Comparative performance testing of respirator versus surgical mask using a water droplet spray model

Background During the SARS-CoV-2 pandemic, there was shortage of the standard respiratory protective equipment (RPE). The aim of this study was to develop a procedure to test the performance of alternative RPEs used in the care of COVID-19 patients. Methods A laboratory-based test was developed to compare RPEs by total inward leakage (TIL). We used a crossflow nebulizer to produce a jet spray of 1–100 µm water droplets with a fluorescent marker. The RPEs were placed on a dummy head and sprayed at distances of 30 and 60 cm. The outcome was determined as the recovery of the fluorescent marker on a membrane filter placed on the mouth of the dummy head. Results At 30 cm, a type IIR surgical mask gave a 17.7% lower TIL compared with an FFP2 respirator. At 60 cm, this difference was similar, with a 21.7% lower TIL for the surgical mask compared to the respirator. When adding a face shield, the TIL at 30 cm was further reduced by 9.5% for the respirator and 16.6% in the case of the surgical mask. Conclusions A safe, fast and very sensitive test method was developed to assess the effectiveness of RPE by comparison under controlled conditions

Environmental health guideline for Municipal Health Services : Biomonitoring for small scale chemical incidents

Er is een richtlijn ontwikkeld om te beoordelen of het zinvol is te onderzoeken of mensen als gevolg van een incident inwendig aan chemische stoffen zijn blootgesteld (biomonitoring). Het RIVM heeft de richtlijn met de GGD'en opgesteld; de GGD wordt standaard bij incidenten met chemische stoffen ingeschakeld. Na een dergelijk incident ontstaat vaak de vraag hoeveel personen daadwerkelijk aan specifieke stoffen zijn blootgesteld en in welke mate. Een meting in bloed, urine of uitgeademde lucht kan dit bevestigen. Voordelen biomonitoring: Deze metingen leveren een aantal voordelen op ten opzichte van metingen van stoffen in de lucht. Zo wordt beter inzicht verkregen in welke stoffen, en in welke mate, door het lichaam zijn opgenomen. Een ander voordeel is dat hiermee, indien relevant, het totaal aan stoffen die tijdens een incident uit verschillende bronnen zijn vrijgekomen, in het lichaam kan worden gemeten. Ook zijn inwendige blootstellingen beter in verband te brengen met eventuele gezondheidsklachten. Benodigdheden voor biomonitoring: De richtlijn maakt duidelijk bij welk type stoffen biomonitoring kan worden uitgevoerd. Afhankelijk van de stofeigenschappen zijn namelijk niet alle stoffen terug te vinden in het lichaam. Daarnaast is aangegeven welke informatie nodig is om het onderzoek technisch en logistiek uit te kunnen voeren. De richtlijn kan de GGD ook ondersteunen bij de (crisis)communicatie. Dit omvat adviezen aan het bevoegd gezag over de gezondheidsrisico's en benodigde maatregelen en onderzoek, evenals advies over de informatievoorziening naar betrokkenen. De richtlijn is vooral gericht op kleinschalige chemische incidenten.A guideline has been drawn up to assess whether people have been exposed to chemicals following a small scale incident involving chemicals. The guideline was made by the National Institute for Public Health and the Environment (RIVM) in collaboration with the Municipal Health Services (GGD). The GGD is consulted as part of standard procedure when incidents with chemicals occur. Following a chemical accident, it is important to determine the following: how many people have been affected, which substances are involved, and the extent of the exposure. This can be achieved through testing samples of blood, urine or exhaled air. Advantage of biomonitoring: The testing of clinical samples has some advantages compared with environmental measurements. For example, more information can be gained on the exact nature and the quantity of the chemicals absorbed, especially where different sources are concerned. Biomonitoring also helps to relate internal exposure to clinical symptoms. Tools necessary for biomonitoring: The guideline outlines which chemicals can be investigated with biomonitoring. This depends on the toxicokinetic properties of the chemicals. Information is also provided on the technical and logistic details necessary for testing. The guideline also acts as a support to the GGD with regard to risk-communication. This involves advising the authorities about the following: the health risks, the necessary measurements, surveillance and providing information to the general public. This guideline has been drawn up for use with small-scale chemical accidents in particular. Biomonitoring in small scale (chemical) incidents.VW

GGD-richtlijn medische milieukunde : Biomonitoring bij kleinschalige (chemische) incidenten

Er is een richtlijn ontwikkeld om te beoordelen of het zinvol is te onderzoeken of mensen als gevolg van een incident inwendig aan chemische stoffen zijn blootgesteld (biomonitoring). Het RIVM heeft de richtlijn met de GGD'en opgesteld; de GGD wordt standaard bij incidenten met chemische stoffen ingeschakeld. Na een dergelijk incident ontstaat vaak de vraag hoeveel personen daadwerkelijk aan specifieke stoffen zijn blootgesteld en in welke mate. Een meting in bloed, urine of uitgeademde lucht kan dit bevestigen. Voordelen biomonitoring: Deze metingen leveren een aantal voordelen op ten opzichte van metingen van stoffen in de lucht. Zo wordt beter inzicht verkregen in welke stoffen, en in welke mate, door het lichaam zijn opgenomen. Een ander voordeel is dat hiermee, indien relevant, het totaal aan stoffen die tijdens een incident uit verschillende bronnen zijn vrijgekomen, in het lichaam kan worden gemeten. Ook zijn inwendige blootstellingen beter in verband te brengen met eventuele gezondheidsklachten. Benodigdheden voor biomonitoring: De richtlijn maakt duidelijk bij welk type stoffen biomonitoring kan worden uitgevoerd. Afhankelijk van de stofeigenschappen zijn namelijk niet alle stoffen terug te vinden in het lichaam. Daarnaast is aangegeven welke informatie nodig is om het onderzoek technisch en logistiek uit te kunnen voeren. De richtlijn kan de GGD ook ondersteunen bij de (crisis)communicatie. Dit omvat adviezen aan het bevoegd gezag over de gezondheidsrisico's en benodigde maatregelen en onderzoek, evenals advies over de informatievoorziening naar betrokkenen. De richtlijn is vooral gericht op kleinschalige chemische incidenten