Varna Medical University Press: Journals
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Quality of life in malignant haematological diseases – physicians' and patients’ perspectives. A pilot study
Get PDFIntroduction: Malignant haematological diseases (MHDs) are increasingly the focus of research interest due to their rising global disease burden and the continuous need for improved management strategies. The dynamic evolution of therapeutic protocols has significantly enhanced survival rates for patients with MHDs. However, many of these patients often experience deteriorated overall health, emphasizing the importance of addressing health-related quality of life (HrQoL).Aim: This study aims to conduct a comparative analysis of the perspectives of MHD patients and hematologists regarding the nature and role of subjective assessment or HrQoL in routine clinical practice.Materials and Methods: The study, designed as a pilot initiative, explores the need and feasibility of larger-scale research within patient and haematologist communities. The research protocol targeted two groups of participants: a maximum of 100 MHD patients treated at the Clinical Haematology Clinic of St. Marina University Hospital in Varna between March and April 2024, and all 12 haematologists in the clinic. Inclusion criteria for patients were a confirmed MHD diagnosis, signed informed consent, and age of at least 18 years.The research was preceded by a literature review in PubMed and Google Scholar (as of April 2024) using key terms in Bulgarian and English: "health-related quality of life" and "malignant haematological diseases." Based on the literature, the team's experience, and the study’s objectives, two survey instruments were developed – one for MHD patients and one for medical professionals. A descriptive statistical approach was employed to analyse the collected data. Ethical approval for the protocol was obtained.Results: The study found that medical professionals prioritize therapeutic outcomes over HrQoL, though they acknowledge the need for routine HrQoL assessments. Patients, however, value not only clinical improvement but also the preservation or enhancement of HRQoL. Both groups agreed on the need for psychological support to improve HrQoL, including in clinical settings.Conclusion: Assessing HrQoL in MHD patients holds substantial social and personal importance, warranting its dedicated place in chronic disease management. Despite significant clinical and administrative workloads, medical professionals exhibit positive attitudes toward subjective health evaluations. Addressing these critical areas in routine care for MHD patients points to future research directions that could foster the development of effective practices and updated recommendations to support patients
Impact of glaucoma as a socially significant disease on the quality of life
Get PDFIntroduction: Glaucoma is a socially significant, progressive disease that affects the optic nerve and leads in its final stages to impaired visual function, potentially affecting the quality of life of patients.Aim:The purpose of the study is to determine the relationship between the presence of glaucoma and the quality of life, as well as the potential effects related to the progression of the disease.Materials and Methods:The study included 70 patients, all with established glaucoma at different stages. After obtaining an informed consent from all participants, a complete eye examination was performed. A survey method including questions about the participant’s daily activities was used to assess the quality of life, including the subjective feeling of the patients.Results: The results of the study established a direct relationship between the quality of life and the rate of glaucoma progression. The results of the survey showed an increased difficulty in carrying out routine daily activities as the disease progressed. A large number of the participants reported some degree of difficulty in seeing peripherally approaching objects, leading to a decline in their quality of life.Conclusion: The results of the present study show that, as the disease progresses, the patients’ quality of life and daily routine activities deteriorate. That is why early diagnosis, timely treatment, and frequent follow-up of these patients could slow down the progression of the disease and increase their quality of life
Oral leukoplakia and cervical lymphadenopathy—literature review and present data
Get PDFInrtoduction: Current epidemiological data clearly indicate a steady rise in the incidence of malignant diseases. Although advances in surgical techniques, radiotherapy, and chemotherapy have improved treatment outcomes, overall cancer-related mortality continues to show an upward trend. For this reason, research in oncology must emphasize not only early detection and therapeutic interventions but also preventive strategies. One effective preventive approach is the management of oral preneoplastic conditions. Among these, leukoplakia is recognized as the most frequent precancerous lesion of the oral cavity and is frequently associated with enlargement of cervical lymph nodes.Materials and Methods: This review synthesizes information obtained from an in-depth analysis of 56 peer-reviewed, full-text publications in English.Discussion: Oral leukoplakia is clinically identified as a white mucosal lesion resulting from abnormal keratinization. It carries malignant potential and is defined by the World Health Organization as “a white plaque of questionable risk, excluding other conditions that are not associated with an elevated risk of cancer.” The etiology is complex, often multifactorial, and in many instances remains idiopathic. Clinically, leukoplakia is classified into homogeneous and non-homogeneous forms, which differ in their presentation and malignant potential. Given its prevalence and potential severity, optimal management requires collaboration within an interdisciplinary medical team. Monitoring for cervical lymphadenopathy should always include detailed clinical examination supported by imaging modalities. In cases where malignancy is suspected, fine-needle aspiration cytology should be performed, supplemented by incisional or excisional biopsy of suspicious nodes to confirm the diagnosis.Conclusion: Recognizing the early manifestations of oral preneoplastic lesions, particularly leukoplakia, the most common entity, is of paramount importance. Early intervention not only reduces the likelihood of malignant transformation but also represents a vital step in minimizing the long-term impact of cancer
Research of the impact of chronic dialysis treatment in patients with CKD-BMD on physical activity and individual quality of life
Get PDFIntroduction: Chronic kidney disease–mineral and bone disorder (CKD-BMD) significantly impacts the health-related quality of life (HRQoL) of patients undergoing chronic hemodialysis.Materials and Methods: This study analyzes the relationship between physical activity, biochemical parameters (serum calcium, phosphorus, and intact parathyroid hormone levels), and HRQoL in patients with CKD-BMD receiving hemodialysis treatment. A cross-sectional study was conducted at the “St. Marina” University Hospital in Varna, Bulgaria, involving 81 patients assessed via the KDQoL-SF-36 questionnaire. Participants were grouped based on serum biochemical markers to evaluate the influence of these parameters on physical activity and perceived health.Results and Discussion: Results indicated that abnormal levels of calcium, phosphorus, and iPTH were significantly associated with reduced physical endurance and negative perceptions of general health. The highest HRQoL scores were observed in patients with calcium levels of 2.2–2.55 mmol/l, phosphorus below 1.2 mmol/l, and iPTH between 150–300 pg/ml.Conclusion: The findings underscore the importance of managing CKD-BMD through monitoring and correcting mineral imbalances to improve both physical function and overall quality of life in dialysis patients
Laryngeal mask ventilation during flexible bronchoscopy
Get PDFIntroduction: For many years flexible bronchoscopy has been a mainstay for airway inspection, the diagnosis of airway lesions, therapeutic aspiration of airway secretions, and transbronchial biopsy to diagnose parenchymal lung disorders. Anesthesia for bronchoscopy poses unique challenges for the anesthesiologist. There is a general tendency towards using supraglottic devices in ENT surgeries.The Aim of the study is to determine and characterize the specifics and complications of LMA use during flexible bronchoscopy. Materials and methods: A 2-years prospective cohort study of 20 patients who underwent flexible bronchoscopy in the Department of ENT Surgery; University Hospital „Queen Giovanna”– ISUL; Medical University-Sofia. Results and discussion: Mean age of the patients included in the study is 5.4 years. A predominance of male sex is observed: women – 35%, men – 65%. Most patients have low preoperative ASA grades. None of the patients suffered desaturation during the operation. LMA displacement and need for repositioning by the anesthesiologist was observed in 5% of the patients. In all patients ETCO2 values are in the normal range. Ten percent (10%) of the patients experienced postoperative nausea and vomiting. In none of the cases we observed aspiration under the LMA and laryngospasm.Conclusion: The results from the study showed that LMA can be successfully and safely used in patients during flexible bronchoscopy
Modern approach in the treatment of choanal atresia
Get PDFIntroduction: Choanal atresia is a well-recognized condition characterized by an anatomical closure of the posterior choanae in the nasal cavity.Case presentation: We report the case of a term female infant from first normal pregnancy. During routine delivery room aspiration an obstruction of the upper airways was suspected due to failure of passing a suction catheter through the nasal passages. The infant was transferred to neonatal intensive care unit where after initial sedation with phenobarbital and midazolam was intubated and assisted ventilation was initiated. A nasogastric tube was inserted for feeding. The diagnosis of bilateral bony choanal atresia was confirmed by a CT scan. On the 7th day of life, the infant was transported from the NICU of ACC University Hospital Tokuda to the Department of ENT Surgery in University Hospital “Queen Giovanna” – ISUL for surgical treatment. Under general anesthesia a transnasal endoscopic choanoplasty was performed and bilateral stents were inserted. After the surgery the patient was transported back to the NICU of ACC University Hospital Tokuda in a stable condition for additional intensive care and treatment.Discussion: Complex pathologies must be managed in a coordinated way by the ‘multidisciplinary team’ approach. Bilateral choanal atresia in the infant may present as a life-threatening respiratory distress immediately after birth or later at the first feeding. When diagnosed the main priority is to ensure free airway. This can be achieved by the use of different oropharyngeal devices or by endotracheal intubation. The perioperative anesthetic management of neonates is challenging even for the experienced anesthesiologist. Neonatal anesthesia demands profound understanding of the rapidly changing physiology of the neonate and both the pharmacokinetics and pharmacodynamics of the medications used to provide anesthesia.Conclusion: Successful management of complicated medical cases with complex pathologies require modern approach and close coordination between different specialties. Our therapeutic success is a result of the close collaboration between the anesthesia, surgery and neonatology teams
Reimbursement of biomarkers in oncology: advantages and economic analysis of their application for diagnostics as part of the personalized medicine аpproach
Get PDFBiomarkers are essential tools for determining the optimal therapeutic strategy for each cancer patient, maximizing therapeutic response, and minimizing treatment-related toxicities. Cancer cells exhibit a variety of genetic and protein variations, even within the same cancer type, impacting treatment response. Incorporating biomarker testing into the diagnostic process allows for a more accurate understanding of a tumor’s molecular profile, enabling oncologists to tailor and personalize treatment plans based on each patient's specific biomarkers. This personalized medicine approach not only increases treatment efficacy but also minimizes unnecessary exposure to therapies that may not be effective for the individual patient. The purpose of this analysis is to provide an economic assessment of the costs and benefits of biomarker testing in cancer patient care in Bulgaria, as well as the expected budgetary impact of incorporating reimbursement of biomarker diagnostics by the NHIF. If the estimated number of tests is paid for at the estimated cost of biomarker diagnostics, the total cost to the NHIF is estimated at BGN 10,885,100.00. The benefits linked to this increased cost are presented in two groups: health and economic benefits. Within the analysis, the health benefits are presented in terms of life years gained (LY) and quality-adjusted life years gained (QALY) when using biomarker-based targeted therapies. The data for LY and QALY are based on results from published studies and represent average increases in LY and QALY for each type of cancer and each biomarker. According to the analysis, the use of biomarker assays would result in an average increase in LY of 1.18 LY and 0.93 QALY per patient (average values for all cancer types in the analysis). Calculating the total health benefits for all patients included (and all diagnoses) in the analysis yields a total health benefit of +21,035.35 LY and +16,617.33 QALY (cumulative values for all patients considered in the analysis). In addition to the added health benefits, biomarker testing and the application of targeted cancer therapy, respectively, would result in added benefits to the GDP of Bulgaria, which amount to BGN 151,046,275.62 (cumulative value for all patients considered in the analysis). In conclusion, incorporating biomarker diagnostics into cancer patient care would add cost but also provide significant health and economic benefits. The health benefits to the patients are in the form of added life years and added quality-adjusted life years, and the economic benefits to society are in the form of added contribution to GDP in Bulgaria due to increased labor force participation
Extension of therapeutic indication and marketing authorization refusal – key aspects in EMA procedures during the period 2022-2024
Get PDFEuropean pharmaceutical legislation includes the assessment of key quality, efficacy, and safety parameters during CHMP meetings. Marketing authorization refusals are an important element of the Committee's work, and an analysis of these refusals for the period 2022-2024 clearly shows deficiencies in the design and conduct of clinical trials as a major cause. The low proportion of refusals (4%) compared to positive opinions testifies to the good communication between the Agency and the applicants, as well as to the effective implementation of various initiatives such as scientific advice and others. The extension of therapeutic indications, as an approach of the CHMP for timely patient access to treatment, supports the process of drug repositioning. The study on extension recommendations for the same period reports a dominant number versus positive opinions for new drug molecules not yet authorized in the EU. This overall leads to several advantages, with the main ones being the reduction of drug development time and costs