European Consensus Research Articles

Международные судебные органы как субъекты наднациональной специализированной контрольной деятельности

Introduction. In the context of the rapidly changing geopolitical situation in the world, the issue of increasing efficiency of interstate interaction within the framework of the functioning of international universal and regional organizations seems to be very relevant. Theoretical analysis. The authors prove the legitimacy of highlighting the control function as one of the main functions in the activities of international judicial subjects, the purpose of which is to protect natural law, law and preserve the principles and norms of international legal relations, including when considering disputes about the compliance of the domestic legislation of the participating countries with international agreements, which they have undertaken to comply with. Empirical analysis. The study provides a critical analysis of international jurisprudence, primarily containing the construction of the “European consensus”, which is a powerful lever of judicial activism and implies the exclusion of the possibility of applying the doctrine of freedom of appreciation of states that are parties to international agreements. Results. Consideration of international judicial subjects through the prism of the proposed scientific approach led to the conclusion about their leading role in the mechanism of protection of international treaties as an independent subject of specialized control activities, as well as their significant impact on the processes of state sovereignization and international globalization.

International Delphi-based consensus on the appropriate use and effect of Benzydamine hydrochloride in the treatment of sore throat

BackgroundBenzydamine hydrochloride is a locally-acting Non-Steroidal Anti-Inflammatory Drug (NSAID) with combined local anesthetic and analgesic properties, indicated for the symptomatic relief of pain in acute sore throat. The aim of this study was to obtain an European Consensus among pharmacists, general practitioners and pediatricians on the appropriate use of benzydamine hydrochloride in the treatment of sore throat.MethodsThe authors developed a Delphi questionnaire organized into 15 statements focused on 4 topics: the mechanism of action of benzydamine, the benzydamine treatment in an adult patient and in a pediatric patient, and the advantages of benzydamine over other topical treatments. The survey was administered to a panel of to 320 participants including general practitioners, pediatricians, and pharmacists from 6 European countries (Italy, Germany, Portugal, Romania, Russia, and Spain), who rated their level of agreement or disagreement with each statement on a 6-point Likert scale. Consensus was predefined as more than 66% of the panel agreeing/disagreeing with each statement.ResultsPanelists’ agreement on statements was very high. Consensus was reached for all 15 statements in the Delphi survey, with more than 98% positive agreement on topic 4, suggesting a shared view among European healthcare professionals (HCPs) about the advantages of benzydamine over other topical treatments. A strong consensus (> 99%) was reached for all the statements of topic 1 regarding the mechanism of action of benzydamine, except for its anesthetic properties (79%). Strong agreement was reached for all statements in topics 2 and 3 regarding the treatment of acute sore throat symptoms in the adult and pediatric patient, except for one on the efficacy of benzydamine in preventing post-operative sore throat, for which it was 67%.ConclusionBecause all relevant publications on benzydamine are dated and there are no recommendations on its use for the symptomatic treatment of sore throat in European guidelines, this Delphi-based international consensus may be important in reinforcing the appropriate use and effect of benzydamine in the treatment of sore throat among health care professionals.

Developing Core Outcome Sets for Vascular Conditions Across Europe, Not as Easy as It Sounds

Most of the outcomes reported in the literature have been chosen by doctors, constituting "traditional" outcome measures such as mortality and re-intervention. Some of the key outcome measures important to patients, families, health providers and other stakeholders may have been overlooked. Core outcome sets, consisting of 6-15 outcomes, can improve representation of all key stakeholders, standardise outcome reporting, and improve future ability to pool results. The aim of this study was to outline the methods and challenges of conducting European core outcome sets. As an overview, development of core outcome sets follows a multistep iterative process: (1) Systematic review of the literature summarising existing outcome measures, (2) Focus Group meeting with patients and other stakeholders to establish missing outcome measures, (3) Development and piloting of Delphi survey, (4) Delphi consensus study for prioritisation of outcomes and establishing consensus, and (5) European consensus meeting to produce a core outcome set. The challenges include the varying ethical requirements for survey work across Europe and translation for surveys and consensus meetings. There is an increasing need for core outcome sets to complement clinical practice guidelines. As a European vascular community we need to produce these through collaborative efforts. Unfortunately, there are considerable barriers to doing so - the time and energy required to set up a core outcome study is not dissimilar to that of a multicentre randomised trial. Currently only one core outcome set exists for vascular surgery, for critical limb ischaemia, but this was developed in a single country.

Phase 1/2a Study to Evaluate Safety, Pharmacokinetic and Pharmacodynamic Dose Escalation and Expansion Study of Pxs-5505 in Patients with Primary, Post-Polycythemia Vera or Post-Essential Thrombocythemia Myelofibrosis

Background: Janus kinase (JAK) inhibitors for myelofibrosis (MF) treatment have provided major clinical benefits, but do not improve cytopenias and demonstrate only modest effects on bone marrow fibrosis (BMF). High discontinuation rates are observed due to loss of therapeutic effect or drug induced toxicity. Reducing BMF may normalize the hematopoietic environment and improve symptoms of MF, particularly blood cell counts. Limited therapeutic options highlight the need for novel, effective therapies for primary MF (PMF). Lysyl oxidases (LOX) are a family of enzymes responsible for the critical post-translational modification essential for the biogenesis of cross-linked collagen and elastin, which form the basis of reticulin in bone marrow (BM). Importantly, several members of the lysyl oxidase family are upregulated in MF providing a rationale to therapeutically inhibit all lysyl oxidases. PXS-5505 is a pan-lysyl oxidase inhibitor that prevents the cross-linking of collagen and elastin and consequently exhibits anti-fibrotic effects in murine models of MF. PXS5505-MF-101 is an ongoing, multi-center, open-label phase 1/2a study evaluating the safety and tolerability of PXS-5505 in patients with primary, post-polycythemia vera (PV) or post-essential thrombocythemia (ET) myelofibrosis (NCT04676529). Herein, we present the study design and preliminary data from the dose escalation phase of this study. Methods: The primary objective is to determine the safety and tolerability of PXS-5505In patients with MF. Secondary objectives include determination of appropriate dose, pharmacokinetics (PK) and pharmacodynamics (PD), changes in BMF using European Consensus, spleen volume and MF symptoms (MFSAF). Efficacy endpoints are exploratory. Eligible patients must have PMF or post-ET/PV MF of intermediate/high risk, relapsed/refractory, intolerant or not eligible to available JAK inhibitors (ruxolitinib, febratinib), including those with severe thrombocytopenia, and requiring therapy for symptomatic disease. Patients participating in the DEP required BM biopsy within 6 months of the re-initiation of treatment with PXS-5505. For patients entering the CEP a BM biopsy must have been performed within 3 months prior to Day 1 treatment. The study consists of two phases: Dose Escalation Phase (DEP) and Cohort Expansion Phase (CEP). The DEP followed a 3+3 design with a starting dose of 100 mg PXS-5505 twice daily (BID) for 4 weeks (Level 1), escalating to 150 mg BID (Level 2) and to 200 mg BID (Level 3). The DEP was to determine the maximum tolerated dose (MTD) or if all doses were well tolerated, the dose which provided the highest target engagement PK and PD measures during dose escalation (Day 0, week 1 and week 4) included, maximum plasma concentration (C1hr=Cmax), minimum plasma concentration (Cmin) and LOX and LOXL2 inhibition in plasma which would subsequently be the dose selected for the CEP. Intra patient dose escalation was allowed and patients participating in the DEP phase were able to continue on the CEP up to 6 months of therapy. During the CEP, 24 patients will be treated at the dose determined from the DEP phase. At data cutoff (21 July 2022) the DEP was completed and enrollment for the CEP continues. Results: Five patients were enrolled in the DEP. This included three patients with post ET MF, one patient with post PV MF and one patient with post ET MF. The median age was 71 years (range, 60-77) and all were female. There were no suspected unexpected serious adverse reactions (SUSAR) or dose limiting toxicities during the dose escalation phase. One patient terminated early following transformation to AML (24 days post treatment initiation). Interim PK data from the DEP phase demonstrated that PK properties in patients were similar to PK in healthy volunteers as previously reported at all dose levels (ACTRN12619000332123). At the 200mg BID level the mean (trough) LOX inhibition was 94% and 91% (days 7 and 28), respectively (Figure 1). Similarly, the mean (trough) LOXL2 inhibition was 94% and 93% (days 7 and 28), respectively. Enrolment in the CEP continues and preliminary data will be presented. Conclusion: These findings indicate that excellent targeted LOX and LOXL2 inhibition is being achieved at the 200mg BID level which has been selected as the recommended dose for the currently ongoing expansion phase with no dose limiting toxicity seen. Figure 1View largeDownload PPTFigure 1View largeDownload PPT Close modal

Achondroplasia: Update on diagnosis, follow-up and treatment

Achondroplasia requieres multidisciplinary follow-up, with the aim of preventing and managing complications, improving the quality of life of people who suffer from it and favoring their independence and social inclusion. This review is justified by the multiple publications generated in recent years that have carried out a change in its management. Different guidelines and recommendations have been developed, among which the one made by the American Academy of Pediatrics in 2005 recently updated (2020), the Japanese guide (2020), the first European Consensus (2021) and the International Consensus on the diagnosis, approach multidisciplinary approach and management of individuals with achondroplasia throughout life (2021). However, and despite these recommendations, there is currently a great worldwide variability in the management of people with achondroplasia, with medical, functional and psychosocial consequences in patients and their families. Therefore, it is essential to integrate these recommendations into daily clinical practice, taking into account the particular situation of each health system.

The preanalytical phase - from an instrument-centred to a patient-centred laboratory medicine.

In order to guarantee patient safety, medical laboratories around the world strive to provide highest quality in the shortest amount of time. A major leap in quality improvement was achieved by aiming to avoid preanalytical errors within the total testing process. Although these errors were first described in the 1970s, it took additional years/decades for large-scale efforts, aiming to improve preanalytical quality by standardisation and/or harmonisation. Initially these initiatives were mostly on the local or national level. Aiming to fill this void, in 2011 the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) working group "Preanalytical Phase" (WG-PRE) was founded. In the 11 years of its existence this group was able to provide several recommendations on various preanalytical topics. One major achievement of the WG-PRE was the development of an European consensus guideline on venous blood collection. In recent years the definition of the preanalytical phase has been extended, including laboratory test selection, thereby opening a huge field for improvement, by implementing strategies to overcome misuse of laboratory testing, ideally with the support of artificial intelligence models. In this narrative review, we discuss important aspects and milestones in the endeavour of preanalytical process improvement, which would not have been possible without the support of the Clinical Chemistry and Laboratory Medicine (CCLM) journal, which was one of the first scientific journals recognising the importance of the preanalytical phase and its impact on laboratory testing quality and ultimately patient safety.

Real world experience of brodalumab treatment in patients with moderate-to-severe plaque psoriasis in the Greek population: Results from an interim analysis of the BrIDGE study.

Brodalumab's clinical efficacy and favorable safety profile have been demonstrated during controlled clinical trials, but real-world data remain scarce. BrIDGE, an ongoing 104 week, observational, prospective, multicenter study conducted in Greece, enrolled moderate-to-severe plaque psoriasis patients, with body surface area (BSA) > 10 or psoriasis area severity index score (PASI) > 10 and dermatology life quality index (DLQI) > 10, based on European consensus, initiating brodalumab treatment as per routine clinical practice. This interim analysis includes evaluations 12-16 weeks following treatment initiation. Key efficacy endpoints included proportion of patients achieving static Physician's Global Assessment (sPGA) score of "clear/almost clear" (0/1) and a reduction ≥75%, 90%, 100% from baseline in PASI (PASI75, PASI90, and PASI100) at weeks 12-16. Other endpoints included time to achieve PASI100, changes in self-reported DLQI and psoriasis symptom inventory (PSI) at weeks 12-16. From 200 patients (mean age 51.4 years, 70% male, mean disease duration 13.8 years) enrolled, 72.8% achieved sPGA of 0/1, whereas 70.2%, 47.5%, and 32.0% achieved corresponding PASI75, PASI90, and PASI100 responses following 12-16 weeks of brodalumab treatment, according to the "as-observed" analysis. The mean time to achieve PASI100 was 13.7 ± 1.2 weeks for the 32% who achieved PASI100. Concurrent decreases in mean DLQI and PSI were observed. Furthermore, 90% adherence to brodalumab was noted and nine adverse events were reported. Brodalumab confers substantial clinical improvements short-term as reflected by high levels of skin clearance in moderate-to-severe plaque psoriasis patients within 12-16 weeks of treatment under everyday clinical conditions, followed by improvements in symptoms and quality of life and a favorable safety profile.

Preventive treatment of refractory chronic cluster headache: systematic review and meta-analysis.

Preventive treatment for refractory chronic cluster headache (rCCH) is challenging and many therapies have been tried. To study what could be considered the therapy of choice in rCCH through a systematic review and meta-analysis. This review was conducted following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. The protocol was registered in PROSPERO (ID CRD42021290983). A systematic search was performed in MEDLINE, Embase, Cochrane, clinicaltrials.gov, and the WHO's-International-Clinical-Trials-Registry-Platform. Studies on the preventive treatment for rCCH as defined by the European Headache Federation consensus statement were included. A meta-analysis of the pooled response rate was conducted for the different therapies. Of 336 results, 45 were eligible for inclusion. Most articles studied the effect of neuromodulation as a preventive treatment for rCCH. The most studied neuromodulation technique was occipital nerve stimulation (ONS), with a pooled response rate in the meta-analysis of 57.3% (95% CI 0.481-0.665). Deep brain stimulation (DBS) was the second most studied treatment with a pooled response rate of 77.0% (95% CI 0.594-0.957). DBS results were more heterogeneous than ONS, which could be related to the different stimulation targets in DBS studies, and reported more serious adverse events than in ONS studies. The remaining therapies (anti-CGRP pathway drugs,warfarin, ketamine-magnesium infusions, serial occipital nerve blocks, clomiphene, onabotulinum toxin A, ketogenic diet, sphenopalatine ganglion radiofrequency or stimulation, vagus nerve stimulation, percutaneous bioelectric current stimulation, upper cervical cord stimulation, and vidian neurectomy) present weaker results or have less quality of evidence. The results of this systematic review and meta-analysis suggest that ONS could be the first therapeutic strategy for patients with rCCH based on the current evidence.

Anna-Maria Hoffmann-Vold: building bridges in systemic sclerosis.

“A lot of my focus is on building the bridge between basic science and clinical science,” says Anna-Maria Hoffmann-Vold, rheumatologist at Oslo University Hospital in Norway. Hoffmann-Vold leads research in inflammatory and fibrotic diseases and also runs a clinic for patients with systemic sclerosis and connective tissue disease-associated interstitial lung disease, noting the integral connection between the two. “Without basic evidence, what we do in the clinic is not really evidence-based. And on the other hand, if you develop anything in the lab, it doesn't help if it's not implemented into the clinics,” she says. Collaborative working is also a priority, uniting people who are “often in totally different worlds” but are travelling down the same road. With experience and persistence, Hoffmann-Vold builds the bridge piece by piece. The identification and management of interstitial lung disease in systemic sclerosis: evidence-based European consensus statementsThrough a robust modified Delphi process developed by a diverse panel of experts, the first evidence-based consensus statements were established on guidance for the identification and medical management of systemic sclerosis-associated ILD. Full-Text PDF

Subarachnoidal haemorrhage related cardiomyopathy: an overview of Tako-Tsubo cardiomyopathy and related cardiac syndromes

Introduction Subarachnoid haemorrhage (SAH) is caused by a ruptured intracranial aneurysm leading to acute extravasation of blood into the subarachnoid space. SAH has an incidence of 6.3 per 100000 persons per year in Europe and accounts for 5% of all strokes. SAH occurs at relatively young age and has poor clinical outcomes and high mortality rates. Cardiac syndromes are regularly seen in patients with acute neurologic disease including SAH. These cardiac complications of SAH are associated with increased morbidity and mortality, and present in a large variety and severity. Areas covered The main goal of this review is to describe the subarachnoid haemorrhage related cardiac syndromes. Secondly, we will provide an overview of the underlying pathophysiology regarding the development of cardiac syndromes. Thirdly, we will describe the impact of cardiac syndromes on patient outcome. Expert opinion Of all neurology patients SAH patients have the highest risk of developing Takotsubo syndrome (TTS) in SAH patients occurs in about 0.8% to 30% of patients. Both TTS and Neurogenic stunned myocardium (NSM) have many similarities on echocardiographic evaluation. In European Cardiology consensus SAH is recognized as primary cause of TTS.

Advancing our understanding of skeletal muscle across the lifecourse: Protocol for the MASS_Lifecourse study and characteristics of the first 80 participants.

Sarcopenia, the age-related loss of skeletal muscle strength and mass, carries a significant burden for affected individuals. There has been little investigation of sarcopenia using experimental medicine techniques to study human muscle tissue in detail. The aim of the Muscle Ageing Sarcopenia Studies Lifecourse (MASS_Lifecourse) study is to recruit up to 160 participants, equally divided between females and males between ages 45 and 85years for detailed phenotyping of skeletal muscle health. Here we describe the protocol for the study and the characteristics of the first 80 participants. We are recruiting participants from three sources in the north-east of England. Study fieldwork comprises a home visit (or videocall) for consent and assessment of health, cognition, lifestyle, and wellbeing. This is followed by a visit to a clinical research facility for assessment of sarcopenia status and collection of samples including a vastus lateralis muscle biopsy. We produced descriptive statistics for the first 80 participants, including expressing their grip strength relative to normative data in the form of Z-scores. The first 80 participants (53.8% female) covered the target ages, ranging from 48 to 84years. They were regularly physically active, reported good physical function and had a prevalence of sarcopenia (including probable sarcopenia) of 11.3% based on the revised European consensus. Their grip strength was similar to that in the general population, with a mean Z-score of 0.09 standard deviations (95% CI: -1.64, 1.83) above that expected. The MASS_Lifecourse study combines comprehensive health and lifestyle data with a range of biological samples including skeletal muscle. The findings from planned analyses should contribute to improvements in the diagnosis, treatment, and prevention of sarcopenia.

Lipoprotein(a) in atherosclerotic cardiovascular disease and aortic stenosis: a European Atherosclerosis Society consensus statement.

This 2022 European Atherosclerosis Society lipoprotein(a) [Lp(a)] consensus statement updates evidence for the role of Lp(a) in atherosclerotic cardiovascular disease (ASCVD) and aortic valve stenosis, provides clinical guidance for testing and treating elevated Lp(a) levels, and considers its inclusion in global risk estimation. Epidemiologic and genetic studies involving hundreds of thousands of individuals strongly support a causal and continuous association between Lp(a) concentration and cardiovascular outcomes in different ethnicities; elevated Lp(a) is a risk factor even at very low levels of low-density lipoprotein cholesterol. High Lp(a) is associated with both microcalcification and macrocalcification of the aortic valve. Current findings do not support Lp(a) as a risk factor for venous thrombotic events and impaired fibrinolysis. Very low Lp(a) levels may associate with increased risk of diabetes mellitus meriting further study. Lp(a) has pro-inflammatory and pro-atherosclerotic properties, which may partly relate to the oxidized phospholipids carried by Lp(a). This panel recommends testing Lp(a) concentration at least once in adults; cascade testing has potential value in familial hypercholesterolaemia, or with family or personal history of (very) high Lp(a) or premature ASCVD. Without specific Lp(a)-lowering therapies, early intensive risk factor management is recommended, targeted according to global cardiovascular risk and Lp(a) level. Lipoprotein apheresis is an option for very high Lp(a) with progressive cardiovascular disease despite optimal management of risk factors. In conclusion, this statement reinforces evidence for Lp(a) as a causal risk factor for cardiovascular outcomes. Trials of specific Lp(a)-lowering treatments are critical to confirm clinical benefit for cardiovascular disease and aortic valve stenosis.

Prostate MRI Qualification: AJR Expert Panel Narrative Review.

Prostate MRI is now established as a first-line investigation for individuals presenting with suspected localized or locally advanced prostate cancer. Successful delivery of the MRI-directed pathway for prostate cancer diagnosis relies on high-quality imaging as well as the interpreting radiologist's experience and expertise. Radiologist certification in prostate MRI may help limit interreader variability, optimize outcomes, and provide individual radiologists with documentation of meeting predefined standards. This AJR Expert Panel Narrative Review summarizes existing certification proposals, recognizing variable progress across regions in establishing prostate MRI certification programs. To our knowledge, Germany is the only country with a prostate MRI certification process that is currently available for radiologists. However, prostate MRI certification programs have also recently been proposed in the United States and United Kingdom and by European professional society consensus panels. Recommended qualification processes entail a multifaceted approach, incorporating components such as minimum case numbers, peer learning, course participation, continuing medical education credits, and feedback from pathology results. Given the diversity in health care systems, including in the provision and availability of MRI services, national organizations will likely need to take independent approaches to certification and accreditation. The relevant professional organizations should begin developing these programs or continue existing plans for implementation.

Primary ciliary dyskinesia: review of the draft clinical guidelines, 2022

Primary ciliary dyskinesia (PCD) is a rare hereditary disease from the group of ciliopathies, which is based on a defect in the cilia ultrastructure of the respiratory epithelium and similar structures (sperm flagella, villi of the fallopian tubes, ventricular ependyma, etc.), leading to motor function impairment. The prevalence of the disease varies significantly around the world and is not known reliably in the Russian Federation.The aim of the review was to analyze literature data on modern approaches to the diagnosis and treatment of PCD.Methodology. The data of 90 articles and the opinions of experts providing care to patients with PCD were used.Results. The classic manifestations of PCD depend on age. The leading manifestations of the disease in patients with PCD are recurrent inflammatory diseases of the upper and lower respiratory tract (bronchitis, pneumonia), with the formation of bronchiectasis, damage to the ENT organs (chronic rhinitis, rhinosinusitis, nasal polyposis, repeated otitis media, progressive hearing loss). Currently, there is no single method which could serve as a “gold” standard for diagnosing PCD. The diagnosis of PCD is based on the characteristic clinical picture in combination with the results of special tests (nitric oxide in exhaled air, DNA diagnostics, high-speed video microscopy, transmission electron microscopy). The genetic diagnostics has not been developed sufficiently in the global practice yet and is unavailable in our country. The approach to the treatment of a patient with PCD should be multidisciplinary due to multiple organ lesions. According to the European consensus, the goal of PCD therapy is to restore or maintain normal lung function. There have been no randomized trials of treatment for PCD, and therefore all treatment recommendations are based on very low-level evidence or extrapolated from cystic fibrosis guidelines. Recommendations on mucolytic, antibacterial and anti-inflammatory therapy of PCD are given with consideration for the international and domestic experience.Conclusion. The development of a new version of clinical guidelines containing up-to-date relevant information will improve the diagnosis and treatment of PCD in the Russian Federation.

The frequency and characteristics of ultrasonographic ankle joint involvement in systemic lupus erythematosus: A prospective cross-sectional single-center study.

The involvement of ankles in systemic lupus erythematosus (SLE) has not been widely studied. The aim of our prospective study was to determine the characteristics of the ankle joint and tendon involvement in SLE using ultrasound (US) as an imaging modality. Sixty consecutive patients with SLE underwent a detailed clinical evaluation and US examination. Gray-scale and power Doppler US of the bilateral tibiotalar (TT) joints, subtalar (ST) joints, and ankle tendons were performed using a multiplanar scanning technique. Joint effusion, synovitis, tenosynovitis, enthesitis, and vascularization were assessed according to the OMERACT recommendations. The Total Ankle Ultrasound Score (TAUSS) was calculated as the sum of the grades of joint effusion and synovial hypertrophy for both TT and ST joints bilaterally (ranging from 0–24) and power Doppler activity was assessed separately. Finally, US findings were correlated with physical evaluation, laboratory parameters, and SLE activity scores. US ankle joint involvement was present in 32/60 (53.3%) patients. TT joints were affected in 26 (43.3%) and ST joints in 16 (26.7%) patients. Thirteen (21.7%) patients had US tendons and/or enthesal involvement. TT joint effusion was the most frequent finding, present in 55/240 (22.9%) examined joints, followed by synovial hypertrophy detected in 18/240 (7.5%) joints. The median (interquartile range; range) TAUSS of the US-affected joints was 1 (0–2; range 1–10). There were no significant correlations between US findings and inflammatory parameters or serological parameters of disease activity, but we found a weak positive correlation between TAUSS and the European Consensus Lupus Activity Measurement (r = 0.281, P = .029). This study revealed a high prevalence of pathological US ankle changes in patients with SLE and a positive correlation between ankle US involvement and disease activity score (European Consensus Lupus Activity Measurement).

Treatment of coronary bifurcation lesions, part I: implanting the first stent in the provisional pathway. The 16th expert consensus document of the European Bifurcation Club.

Stepwise layered provisional stenting (PS) is the most commonly used strategy to treat coronary bifurcation lesions (CBL). The term 'stepwise layered' emphasises the versatility of this approach that allows the adjustment of the procedure plan according to the CBL complexity, starting with stent implantation in one branch and implantation of a second stent in the other branch only when required. A series of refinements have been implemented over the years to facilitate the achievement of predictable procedural results using this approach. However, despite its simplicity and versatility, operators using this technique require full knowledge of the pitfalls of each procedural step. Part I of this 16th European Bifurcation Club consensus paper provides a detailed step-by-step overview of the pitfalls and technical troubleshooting during the implantation of the first stent using the PS strategy for the treatment of CBL.

Systemic Treatment of Breast Cancer. 1st Central-Eastern European Professional Consensus Statement on Breast Cancer

Systemic Treatment of Breast Cancer. 1st Central-Eastern European Professional Consensus Statement on Breast Cancer

Randomised Controlled Trial of Fish Oil Supplementation on Responsiveness to Resistance Exercise Training in Sarcopenic Older Women.

This study aims to investigate the effects of fish oil supplementation on the muscle adaptive response to resistance exercise training, physical performance and serum levels of inflammatory cytokines in sarcopenic older women. A randomised, double-blind, placebo-controlled trial is performed with thirty-four sarcopenic women (2010 European Consensus of Sarcopenia), aged ≥ 65 years. The participants are allocated into the following two groups: Exercise and Fish Oil (EFO) and Exercise and Placebo (EP). Both groups undertook a resistance exercise programme over 14 weeks. All participants are instructed to ingest 4 g/day of food supplements; the EP group received sunflower oil capsules, and the EFO group, fish oil capsules. The cross-sectional area (CSA) of the quadriceps muscle is calculated using magnetic resonance imaging (MRI). The strength of the lower limbs is measured using isokinetic dynamometry. Both groups show improvements in CSA and strength after the intervention. Changes in EFO are significantly greater compared with EP for muscle strength (peak torque, 19.46 Nm and 5.74 Nm, respectively, p < 0.001). CSA increased after the intervention in both groups (EFO; 6.11% and EP; 2.91%), although there is no significant difference between the groups (p = 0.23). There are no significant intra-group, inter-group or time differences in any of the cytokines measured. The use of fish oil supplementation potentiates the neuromuscular response to the anabolic stimulus from training, increasing muscle strength and physical performance in sarcopenic older women.

Relationship between serum uric acid and hypertension in patients with primary Sjögren's syndrome: A retrospective cohort study

Primary Sjögren's syndrome (pSS) patients with hypertension (pSS‐HT) have a significantly increased risk of cardio‐cerebrovascular events. Serum uric acid (SUA), a potential inflammatory substance, is considered to be closely related to hypertension in the general population. Our aim is to assess the association between SUA and pSS‐HT. This is a retrospective cohort study. The diagnosis of pSS is based on the American European Consensus Classification criteria. Primary outcome was incident hypertension in pSS patients. Cox regression model was used to estimate the hazard ratios (HR) and 95% CI of SUA in pSS‐HT. The authors also plotted Kaplan–Meier plots to assess the cumulative risk of first hypertension in patients with hyperuricemia and normal uric acid. In addition, the dose‐response curve was also used to discuss the relationship between SUA and pSS‐HT. Finally, three hundred and fifty‐one pSS patients were enrolled from May 2011 to May 2020, of which 166 cases developed hypertension within a mean follow‐up of 3.91 years. Univariate Cox regression demonstrated that SUA was associated with the onset of hypertension in pSS (HR: 1.005 95%Cl: 1.002–1.009). After adjusting for the potential risk factors, the relationship remained unchanged (HR: 1.003, 95%Cl: 1.001–1.005). Kaplan‐Meier survival analysis showed a statistically significant difference of hypertension risk between hyperuricemia patients and normal uric acid patients (P = .026). There was also a significant dose‐effect relationship between SUA and hypertension in pSS in dose‐response model. In this study, the authors find that SUA may be closely associated with the development of hypertension in pSS, which is also confirmed by our dose‐response model. Therefore, SUA could be considered in the management of pSS‐HT.

Association between food insecurity and probable sarcopenia: Data from the 2011–2014 National Health and nutrition examination survey

Aging alters biological processes resulting in body fat redistribution, loss of lean muscle mass, and reduced muscle strength, termed sarcopenia. Nutrition is an important modifiable risk factor in the development of sarcopenia. Food insecurity refers to limited or uncertain access to enough food for an active, healthy life, and is prevalent among older adults. The objective of this study was to examine the relationship between food insecurity and probable sarcopenia in older adults. We examined 3632 adults ≥60 years old from the 2011-2014 National Health and Nutrition Examination Surveys (NHANES). For our analysis food insecurity was identified using the Food Security Survey Module (FSSM). The primary outcome was based on the Sarcopenia Definitions and Outcomes consortium (SDOC) definition. Secondary outcomes were based on three other different grip strength cut-offs as there is debate within the field as to the optimal definition of sarcopenia. Consistent with the revised European consensus on the definition and diagnosis of Sarcopenia (EWGSOP2) recommendations, we used the term probable sarcopenia throughout this text as definitions were based on muscle strength alone and did not include an evaluation of muscle quality. Sensitivity analyses were performed using the standard four category definition of food security. We used logistic regression to examine the association between food insecurity and sarcopenia. Using the Sarcopenia Definitions and Outcomes Consortium definition, 24.7% were classified as having probable sarcopenia (low grip strength); 5.5% had food insecurity and food insecurity was associated with probable sarcopenia (OR 1.51, 95%CI 1.03-2.22). Using three other definitions of probable sarcopenia, food insecurity was significantly associated with probable sarcopenia using the Foundation for the National Institute of Health definition using grip strength alone (OR 1.71, 95%CI 1.08-2.71), but food insecurity was not associated with food insecurity using definitions related to grip strength/BMI (OR 1.16, 95%CI 0.76-1.78) or grip strength/weight (OR 1.14, 95%CI 0.85-1.54). In this nationally representative cohort study, individuals classified as having food insecurity were more likely to have probable sarcopenia (low grip strength) compared to those with full food security. Future studies should examine whether food insecurity interventions may reduce probable sarcopenia and associated adverse outcomes.