Unravelling data for rapid evidence-based response to COVID-19: a summary of the unCoVer protocol

Introduction unCoVer - Unravelling data for rapid evidence-based response to COVID-19 - is a Horizon 2020-funded network of 29 partners from 18 countries capable of collecting and using real-world data (RWD) derived from the response and provision of care to patients with COVID-19 by health systems across Europe and elsewhere. unCoVer aims to exploit the full potential of this information to rapidly address clinical and epidemiological research questions arising from the evolving pandemic. Methods and analysis From the onset of the COVID-19 pandemic, partners are gathering RWD from electronic health records currently including information from over 22 000 hospitalised patients with COVID-19, and national surveillance and screening data, and registries with over 1 900 000 COVID-19 cases across Europe, with continuous updates. These heterogeneous datasets will be described, harmonised and integrated into a multi-user data repository operated through Opal-DataSHIELD, an interoperable open-source server application. Federated data analyses, without sharing or disclosing any individual-level data, will be performed with the objective to reveal patients' baseline characteristics, biomarkers, determinants of COVID-19 prognosis, safety and effectiveness of treatments, and potential strategies against COVID-19, as well as epidemiological patterns. These analyses will complement evidence from efficacy/safety clinical trials, where vulnerable, more complex/heterogeneous populations and those most at risk of severe COVID-19 are often excluded. Ethics and dissemination After strict ethical considerations, databases will be available through a federated data analysis platform that allows processing of available COVID-19 RWD without disclosing identification information to analysts and limiting output to data aggregates. Dissemination of unCoVer's activities will be related to the access and use of dissimilar RWD, as well as the results generated by the pooled analyses. Dissemination will include training and educational activities, scientific publications and conference communications.info:eu-repo/semantics/publishedVersio

Depression, anxiety and panic disorders in chronic obstructive pulmonary disease patients: correlations with tobacco use, disease severity and quality of life

Introduction The objective of this study is to assess anxiety, depression and panic disorders among patients diagnosed with COPD and to investigate their correlation with disease severity, quality of life as well as tobacco use. Material and Methods An observational study was performed between January and September 2014 among 60 patients diagnosed with COPD. COPD staging according to GOLD criteria, while anxiety and depression were assessed using Hospital Anxiety and Depression Scale and panic attacks were evaluated based on ICD 10 criteria. Results Almost 40% of the sample were smokers, the medium packs-years was 34.3 and the medium Fagerstrom score was 7.5. Overall, mean Modified Medical Research Council Dyspnea Scale (mMRC) was 2.86, mean COPD Assessment Test (CAT) score was 21.75 and study participants had 1.93 COPD exacerbations/year. Mean distribution of anxiety and depression symptoms scores among COPD subjects was 10.65 ± 3.5 and 9.93 ± 3.8, respectively. Smokers and ex-smokers had similar scores with regard to anxiety, depression or the presence of panic attacks. The results of the bivariate correlations indicated associations between anxiety, depression, panic attacks and disease severity, as well as poor quality of life of patients with COPD, regardless of their current tobacco use status. Conclusions In conclusion, the results of this study indicate that anxiety, depression and panic attacks were constant characteristics among COPD patients- regardless of their current tobacco use

Preparing the new generation of Romanian experts in tobacco control: PhD studies in the field

Scientific progresses and new regulatory global context about tobacco use and cessation have created attractive opportunities for young researchers seeking for a PhD in the field. As such, three most relevant ongoing PhD research topics at the University of Medicine and Pharmacy “Grigore T. Popa” Iasi were selected for presentation: 1. “Air pollution and tobacco smoke interactions in COPD” (to investigate cumulated effect of tobacco smoking and air pollution on clinical course and treatment benefits in COPD, in the actual upsetting increased local environmental pollution frame). 2. “Smoking and oxidative stress in mixed anxious and depressive disorder”( to reveal interactions between oxidative stress and tobacco smoking in mixed anxious an depressive disorders, to ascertain clinical practice benefits of tobacco exposure biomarkers in use and propose new such markers 1 to improve disease management). 3. “Personalized tobacco treatment" algorithms for smokers at high respiratory risk” (to develop and implement clinical practice personalized algorithms to treat tobacco dependence in smokers at high risk for respiratory disease and to test their feasibility in a real life respiratory disease clinical setting)

Smoking cessation in cardiovascular, diabetes and COPD patients - lessons from the pilot TOB G project in Romania

Introduction Smoking cessation is the most effective intervention to stop disease progression in high risk categories of smokers like cardiovascular (CVD), diabetes and COPD patients. The “TOB G” project has implemented a set of specialized guidelines in a pilot program for such patients, developed in the Clinical Hospital of Pulmonary Diseases of Iasi, Romania. Aim and objective: To determine the real world effectiveness and barriers of the TOB-G guideline recommendations among 150 smokers enrolled in the pilot TOB G running in Romania. Material and Methods Smokers with CVD, diabetes and COPD willing to quit smoking were recruited from the hospital’database and enrolled in the pilot TOB G. They were delivered a smoking cessation counselling intervention consisting of 4 sessions either in-person or by telephone. Abstinence rate was assessed at 1, 2 and 6 months, with careful observation of the barriers and inconvenients arising from pilot implementation in a real life clinical setting. Results 150 patients were enrolled. Smoking abstinence was documented at the 6-month follow-up with 36.0% abstinent in the CVD group (biochemically validated in 22%), 63.3% (40.8% validated) in the diabetes group and 64% ( 51.6% validated ) in COPD group, respectively. The major pilot implementation barriers were observed in the severe COPD smokers, in smokers with mild CVD and in smokers uncompliant to diabetes care. Conclusions The TOBG Guidelines for CVD, diabetes and COPD patients proved feasible to implement and produced significant increases in patient smoking abstinence and in disease outcomes. Future research is needed to improve the guidelines applicability in real life clinical settings. Funding The research describes activity performed in the TOB-G EU project Grant Agreement Number 66429

Promoting smoking cessation among health professionals - the educational role of the Tobacco Control Section of The Romanian Society of Pulmonologists

The tabacology section was set up in 2007 at the second National Conference on Tobacco, entitled "Health or Tobacco", held in Cluj, between May 10-12 2007, with the wish to help smokers, and not just only them. The objectives of this department were to attract as many pneumologists as possible to the smoking cessation cabinet, but also to develop educational materials for smokers (brochures, flyers, video clips, DVDs, etc.) to be distributed in specialized smoking cessation services. Another challenge was the continuation of the work that started with the introduction of the concept of smoking cessation in both the university and postgraduate medical curricula. Also, the activity of the section was devoted mainly to the elaboration of the first Romanian guide for granting specialized smoking cessation assistance - the GREFA guide, published in 2008, updated in 2010. Another objective was the continuation of already initiated partnerships with other professional societies (Romanian Society of Cardiology, Romanian Society of Internal Medicine, etc.) and the development of new collaborations in the field of assistance to smokers with still unaddressed professional categories such as psychologists, psychiatrists, oncologists, nurses, obstetricians, occupational medicine specialists, etc., as well as the organization of scientific and continuing medical education in the field of local and national conferences of the Romanian Society of Pulmonologists (RSP) or other medical societies of various specialties

E-cigarettes as a smoking cessation tool: efficacy versus addiction

Introduction Currently, there are conflicting data regarding the use e-cigarettes as a tool for smoking cessation. This study aims to evaluate the efficacy of e-cigarettes as a smoking tool among Romanian consumers. Methods A questionnaire was applied online on 22 profile groups (Rovapers, Carpathian Vapers, Romanian Vapers ets.) between May- November 2016.Were included all subjects that smoked or were currently smoking e-cigarettes and subjects that tried e-cigarettes. The statistical analysis was made using MedCalc Statistical Software version 17.5.5. Results 810 out of 13 616 subjects that viewed the questionnaire filled it in. 13 questionnaire were not completed, so 797 subjects were left in the end. Median age was 24 years old, mostly men (63.5%), former smokers of classic cigars (46.8%). The main reason of starting smoking e-cigarettes was the need to reduce or cessation of classic cigarettes, especially in heavy smokers. Fewer negative health effects, the fact that it can be used without nicotine and has lower prices than classic tobacco were among the factors that contribute in switching to electronic device. 60.7 % of heavy smokers quit and 15% significantly reduced the cigars, after starting e-cigarettes. Conclusions The results of this study, alongside other data from the literature 1,2 are optimistic in recommending e-cigarettes as a safe smoking cessations tool, especially in heavy smokers 3 . However the lack of data regarding long term side effects and the fact that smoking E-cigarettes stimulated the need for classic cigars, or even increased the desire to smoke more impose some cautions preventing solid recommendation. 1. Trofor A, Man MA, Marginean C et al. Smoking cessation for free: outcomes of a study of three Romanian clinics. Open Medicine. 2016 11( 1): 605-10 2. Lotrean LM, Varga B. Popa M et al. Opinions and practices regarding electronic cigarette use among Romanian high school students. Gaceta Sanitaria. 2016. 30 (5): 366-69. 3. Trofor A., Petris O., Trofor L., Man M.A., Filipeanu D., Miron R. Biochemistry in assessing tobacco exposure - smokers versus non-smokers -correlations with clinical practice. Revista de Chimie. 2017. 68(5):1002-1006

Impact of the Tobacco Treatment Guidelines for High Risk Groups (TOB.g): A pilot study among physicians specializing in CVD, Diabetes and COPD

Introduction The 2017 Tobacco Cessation Guidelines for High-risk Groups (TOB-G) is a comprehensive document on best practices for smoking cessation in clinical practice. The purpose of this pilot study was to assess physician satisfaction and changes in tobacco-related knowledge, selfefficacy and attitudes following exposure to training in the TOB-G guidelines for patients with cardiovascular disease (CVD), chronic obstructive pulmonary disease (COPD), or diabetes. Methods A pre-post pilot study was conducted. All participating physicians received an electronic or printed copy of the TOB-G guidelines for patients with CVD, COPD or diabetes. Physicians were also exposed to a one-day training focused on the key clinical practice recommendations from the TOB.g guidelines. Outcome measurement occurred via survey before, immediately following and 6 months after exposure to the training. Results Fifty physicians participated in the TOB.g training session. High rates of participant satisfaction were documented (exceeded expectations 47.7%; met expectations to a great extent 52.3%). Significant increases in physician knowledge and self-efficacy were documented immediately following and 6 months after exposure to the guideline training session. Exposure to the training was associated with positive changes in some but not all tobacco-related treatment attitudes, however these were no longer significant at the 6-month follow-up. Lower knowledge, confidence and unfavourable attitudes were documented for aspects of treatment related to pharmacotherapy. Conclusions Positive changes in previously reported barriers to the delivery of tobacco treatment among physicians were documented following exposure to the TOB.g guidelines and training for patients with CVD, COPD or diabetes

The Risk of Sarcoidosis Misdiagnosis and the Harmful Effect of Corticosteroids When the Disease Picture Is Incomplete

Sarcoidosis is a complex granulomatous disease of unknown etiology. Due to the heterogeneity of the disease, the diagnosis remains challenging in many cases, often at the physician’s discretion, requiring a thorough and complex investigation. Many other granulomatous diseases have the potential to mimic sarcoidosis, whether infectious, occupational, or autoimmune diseases and starting an unnecessary corticosteroid treatment can worsen the patient’s prognosis, leading to side effects that can be harder to treat than the actual disease

A Debate on Surgical and Nonsurgical Approaches for Obstructive Sleep Apnea: A Comprehensive Review

Regular and unobstructed breathing during the night is the prerequisite for an undisturbed and restful sleep. The most prevalent nocturnal breathing disturbance with morbid consequences is obstructive sleep apnea syndrome. The prevalence of obstructive sleep apnea (OSA) is increasing, and a significant number of patients with OSA are undiagnosed. On the other hand, the “obesity epidemic” is a growing concern globally. A sleep test is required to diagnose sleep apnea and to individualize therapy. A multidisciplinary approach is the key to success. This narrative review presents a debate on whether surgery is a friend or a foe in the treatment of sleep apnea. Depending on the type and severity of the apnea, the causal factor, and the presence of obesity and hypercapnia as well as the associated pathologies, the optimal therapeutic method is determined for each individual case. The article concludes that each case is unique, and there is no ideal method. Positive pressure ventilation, although a therapeutic gold standard, has its disadvantages extensively discussed in this paper. Nevertheless, it is necessary prior to any surgical intervention, either for the curative treatment of the causal factor of apnea or for elective surgery for another condition. The anesthetic risks associated with the presence of apnea and obesity should not be neglected and should form the basis for decision making regarding surgical interventions for the treatment of sleep apnea

Polycyclic Aromatic Hydrocarbons Induced by Smoking and Air Pollution: Correlation with Oxidative Stress in Chronic Obstructive Pulmonary Disease Patients

Oxidative stress is induced by tobacco smoking and is also associated with exposure to air pollution, which are two of the most important risk factors for chronic obstructive pulmonary disease (COPD). The aim of this study was to correlate tobacco use and exposure to air pollution with oxidative stress markers useful in clinical practice in patients with COPD. A total of 102 patients were included and the levels of polycyclic aromatic hydrocarbons (PAHs), malondialdehyde, uric acid and number of packs-years (PY) were determined. Also, six different ratios were used to assess the source of exposure. The results obtained in this study show an admission of pollutants according to smoking status (former smokers/smoker/non-smokers) quantified in average total concentrations for the group of patients with COPD of 4.12 ng/mL, 6.76 ng/mL, 6.04 ng/mL. The six ratios used show that in COPD, the content of PAHs in the blood could be a result of diesel emissions and fuel combustion. Uric acid levels were lower in the smoker group of COPD patients (mean = 5.21 mg/dL), which indicates that oxidative stress is intensified with each cigarette smoked. Additionally, high concentrations of malondialdehyde were quantified for smoking patients diagnosed with COPD (mean = 2.72 µmol/L) compared to former smokers (mean = 2.43 µmol/L) and non-smoking (mean = 2.32 µmol/L) patients, which is another indicator of the implication of smoking in oxidative stress in COPD patients