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1.
Folia Med (Plovdiv) ; 66(1): 59-65, 2024 Feb 29.
Article En | MEDLINE | ID: mdl-38426466

INTRODUCTION: Severe and critical forms of SARS-CoV-2 pneumonia are associated with high morbidity and mortality. Numerous research studies have been conducted around the world to investigate various variables (demographic, clinical, laboratory, etc.) in an attempt to understand the relationships between them and the course and outcome of patients with COVID-19 infection and pneumonia.


COVID-19 , Humans , COVID-19/complications , SARS-CoV-2 , Retrospective Studies
2.
Rheumatol Int ; 44(1): 157-164, 2024 Jan.
Article En | MEDLINE | ID: mdl-37776498

The COVID-19 hurt various lifestyle aspects, especially the treatment and follow-up of patients with chronic diseases such as autoimmune inflammatory rheumatic diseases (RD). The new circumstances changed the frequency of medical examinations and the way patients with rheumatic diseases are followed up. The objective is to study the impact of COVID-19 on RD patients' satisfaction with access to medical services. A national multicenter observational cross-sectional anonymous online survey was conducted on patients with RD using a specially developed web-based platform and structured questionnaire https://rheumatologycovid19.bg/ . The study was carried out with the support of intra-university project №6/2022 MU-Plovdiv. 1288 patients participated, with an average age of 47.03 (SD ± 12.80 years), of whom 992 (81.6%) were women. The questionnaire contained 41 questions grouped into 5 panels. Descriptive statistics were used-mean, alternative analysis, logistic regression and Decision Tree using the CRT (classification and regression trees) method. The study found that RD patients' satisfaction with access to medical services was influenced by communication type and the frequency of visits to the rheumatologist, difficulties in prescribing and finding medicines and the presence of comorbidities. The likelihood of patients' satisfaction with their rheumatologist was 5.5 and 3 times higher for in-person and other means of communication, respectively, compared to those without any communication. The relative share of patients who communicated by phone was larger (59%) compared to pre-pandemic (41%), where direct contact with the physician prevailed (80%). The results of the study confirmed the need to optimize remote access to medical care for patients with RD during the pandemic.


COVID-19 , Rheumatic Diseases , Female , Humans , Male , Middle Aged , COVID-19/epidemiology , Cross-Sectional Studies , Pandemics , Patient Satisfaction , Rheumatic Diseases/epidemiology , Rheumatic Diseases/therapy , Adult
3.
Vaccine ; 41(30): 4422-4430, 2023 07 05.
Article En | MEDLINE | ID: mdl-37321898

BACKGROUND: On 2/27/2021, FDA authorized Janssen COVID-19 Vaccine (Ad.26.COV2.S) for use in individuals 18 years of age and older. Vaccine safety was monitored using the Vaccine Adverse Event Reporting System (VAERS), a national passive surveillance system, and v-safe, a smartphone-based surveillance system. METHODS: VAERS and v-safe data from 2/27/2021 to 2/28/2022 were analyzed. Descriptive analyses included sex, age, race/ethnicity, seriousness, AEs of special interest (AESIs), and cause of death. For prespecified AESIs, reporting rates were calculated using the total number of doses of Ad26.COV2.S administered. For myopericarditis, observed-to-expected (O/E) analysis was performed based on the number verified cases, vaccine administration data, and published background rates. Proportions of v-safe participants reporting local and systemic reactions, as well as health impacts, were calculated. RESULTS: During the analytic period, 17,018,042 doses of Ad26.COV2.S were administered in the United States, and VAERS received 67,995 reports of AEs after Ad26.COV2.S vaccination. Most AEs (59,750; 87.9 %) were non-serious and were similar to those observed during clinical trials. Serious AEs included COVID-19 disease, coagulopathy (including thrombosis with thrombocytopenia syndrome; TTS), myocardial infarction, Bell's Palsy, and Guillain-Barré syndrome (GBS). Among AESIs, reporting rates per million doses of Ad26.COV2.S administered ranged from 0.06 for multisystem inflammatory syndrome in children to 263.43 for COVID-19 disease. O/E analysis revealed elevated reporting rate ratios (RRs) for myopericarditis; among adults ages 18-64 years, the RR was 3.19 (95 % CI 2.00, 4.83) within 7 days and 1.79 (95 % CI 1.26, 2.46) within 21 days of vaccination. Of 416,384 Ad26.COV2.S recipients enrolled into v-safe, 60.9 % reported local symptoms (e.g. injection site pain) and 75.9 % reported systemic symptoms (e.g., fatigue, headache). One-third of participants (141,334; 33.9 %) reported a health impact, but only 1.4 % sought medical care. CONCLUSION: Our review confirmed previously established safety risks for TTS and GBS and identified a potential safety concern for myocarditis.


COVID-19 Vaccines , COVID-19 , Guillain-Barre Syndrome , Adolescent , Adult , Child , Humans , Ad26COVS1 , Adverse Drug Reaction Reporting Systems , COVID-19/prevention & control , COVID-19 Vaccines/adverse effects , United States/epidemiology , Vaccines
4.
Medicina (Kaunas) ; 59(2)2023 Jan 27.
Article En | MEDLINE | ID: mdl-36837441

Background and Objectives: To answer the research question: "Is prophylactic central neck lymph node dissection (pCNLD) beneficial among differentiated thyroid carcinoma (DTC) patients?" Materials and Methods: This was a retrospective cohort study enrolling DTC patients treated at the University Hospital Kaspela, Bulgaria, from 30 January 2019 to October 2021. The predictor variable was presence of pCNLD (total thyroidectomy with vs. without pCNLD). The main outcome variables were postoperative complications (i.e., vocal cord paralysis, hypoparathyroidism, postoperative bleeding, and adjacent organ injury) and recurrence parameters. Appropriate statistics were computed with the significant level at p ≤ 0.05. Results: During the study period, 300 DTC patients (59.7% with pCNLD; 79.3% females) with an average age of 52 ± 2.8 years were treated. The mean follow-up period of the entire cohort was 45.8 ± 19.1 months. On bivariate analyses, TT with pCNLD, when compared to TT alone, required longer surgical time (mean difference: 9.4 min), caused nearly similar complications (except transient hypothyroidism: p = 0.04; relative risk, 1.32; 95% confidence interval, 1.0 to 1.73), and no significantly different recurrence events, time to recurrence, and recurrent sites. The benefit-risk analyses using the number needed to treat and to harm (NNT; NNH) also confirmed that TT plus pCNLD was not very beneficial in DTC management. Conclusion: The results of this study refute the benefit of pCNLD in DTC patient care with TT. Further well-designed studies in a larger cohort with a longer follow-up period are required to confirm this conclusion.


Adenocarcinoma , Thyroid Neoplasms , Female , Humans , Middle Aged , Male , Thyroidectomy/methods , Retrospective Studies , Neck Dissection/methods , Adenocarcinoma/pathology , Neoplasm Recurrence, Local/pathology , Lymph Node Excision , Lymph Nodes/pathology
5.
Pharmacoepidemiol Drug Saf ; 32(7): 763-772, 2023 Jul.
Article En | MEDLINE | ID: mdl-36813704

PURPOSE: Despite widely available safety information for the COVID-19 vaccines, vaccine hesitancy remains a challenge. In some cases, vaccine hesitancy may be related to concerns about the number of reports of death to the Vaccine Adverse Event Reporting System (VAERS). We aimed to provide information and context about reports of death to VAERS following COVID-19 vaccination. METHODS: This is a descriptive study evaluating reporting rates for VAERS death reports for COVID-19 vaccine recipients in the United States between December 14, 2020, and November 17, 2021. Reporting rates were calculated as death events per million persons vaccinated and compared to expected all-cause (background) death rates. RESULTS: 9201 death events were reported for COVID-19 vaccine recipients aged 5 years and older (or age unknown). Reporting rates for death events increased with increasing age, and males generally had higher reporting rates than females. For death events within 7 days and 42 days of vaccination, respectively, observed reporting rates were lower than the expected all-cause death rates. Reporting rates for Ad26.COV2.S vaccine were generally higher than for mRNA COVID-19 vaccines, but still lower than the expected all-cause death rates. Limitations of VAERS data include potential reporting bias, missing or inaccurate information, lack of a control group, and reported diagnoses, including deaths, are not causally verified diagnoses. CONCLUSIONS: Reporting rates for death events were lower than the all-cause death rates expected in the general population. Trends in reporting rates reflected known trends in background death rates. These findings do not suggest an association between vaccination and overall increased mortality.


COVID-19 Vaccines , COVID-19 , Vaccines , Female , Humans , Male , Ad26COVS1 , Adverse Drug Reaction Reporting Systems , COVID-19/epidemiology , COVID-19/prevention & control , COVID-19 Vaccines/adverse effects , United States/epidemiology , Vaccination/adverse effects , Vaccines/adverse effects
6.
Vaccine ; 41(2): 532-539, 2023 01 09.
Article En | MEDLINE | ID: mdl-36496287

BACKGROUND: Monitoring safety outcomes following COVID-19 vaccination is critical for understanding vaccine safety especially when used in key populations such as elderly persons age 65 years and older who can benefit greatly from vaccination. We present new findings from a nationally representative early warning system that may expand the safety knowledge base to further public trust and inform decision making on vaccine safety by government agencies, healthcare providers, interested stakeholders, and the public. METHODS: We evaluated 14 outcomes of interest following COVID-19 vaccination using the US Centers for Medicare & Medicaid Services (CMS) data covering 30,712,101 elderly persons. The CMS data from December 11, 2020 through Jan 15, 2022 included 17,411,342 COVID-19 vaccinees who received a total of 34,639,937 doses. We conducted weekly sequential testing and generated rate ratios (RR) of observed outcome rates compared to historical (or expected) rates prior to COVID-19 vaccination. FINDINGS: Four outcomes met the threshold for a statistical signal following BNT162b2 vaccination including pulmonary embolism (PE; RR = 1.54), acute myocardial infarction (AMI; RR = 1.42), disseminated intravascular coagulation (DIC; RR = 1.91), and immune thrombocytopenia (ITP; RR = 1.44). After further evaluation, only the RR for PE still met the statistical threshold for a signal; however, the RRs for AMI, DIC, and ITP no longer did. No statistical signals were identified following vaccination with either the mRNA-1273 or Ad26 COV2.S vaccines. INTERPRETATION: This early warning system is the first to identify temporal associations for PE, AMI, DIC, and ITP following BNT162b2 vaccination in the elderly. Because an early warning system does not prove that the vaccines cause these outcomes, more robust epidemiologic studies with adjustment for confounding, including age and nursing home residency, are underway to further evaluate these signals. FDA strongly believes the potential benefits of COVID-19 vaccination outweigh the potential risks of COVID-19 infection.


COVID-19 Vaccines , COVID-19 , Purpura, Thrombocytopenic, Idiopathic , Aged , Humans , 2019-nCoV Vaccine mRNA-1273 , Ad26COVS1 , BNT162 Vaccine , COVID-19/prevention & control , COVID-19 Vaccines/adverse effects , Medicare , United States/epidemiology , Vaccination/adverse effects
7.
Vaccine ; 41(2): 333-353, 2023 01 09.
Article En | MEDLINE | ID: mdl-36404170

BACKGROUND: The U.S. Food and Drug Administration (FDA) Biologics Effectiveness and Safety (BEST) Initiative conducts active surveillance of adverse events of special interest (AESI) after COVID-19 vaccination. Historical incidence rates (IRs) of AESI are comparators to evaluate safety. METHODS: We estimated IRs of 17 AESI in six administrative claims databases from January 1, 2019, to December 11, 2020: Medicare claims for adults ≥ 65 years and commercial claims (Blue Health Intelligence®, CVS Health, HealthCore Integrated Research Database, IBM® MarketScan® Commercial Database, Optum pre-adjudicated claims) for adults < 65 years. IRs were estimated by sex, age, race/ethnicity (Medicare), and nursing home residency (Medicare) in 2019 and for specific periods in 2020. RESULTS: The study included >100 million enrollees annually. In 2019, rates of most AESI increased with age. However, compared with commercially insured adults, Medicare enrollees had lower IRs of anaphylaxis (11 vs 12-19 per 100,000 person-years), appendicitis (80 vs 117-155), and narcolepsy (38 vs 41-53). Rates were higher in males than females for most AESI across databases and varied by race/ethnicity and nursing home status (Medicare). Acute myocardial infarction (Medicare) and anaphylaxis (all databases) IRs varied by season. IRs of most AESI were lower during March-May 2020 compared with March-May 2019 but returned to pre-pandemic levels after May 2020. However, rates of Bell's palsy, Guillain-Barré syndrome, narcolepsy, and hemorrhagic/non-hemorrhagic stroke remained lower in multiple databases after May 2020, whereas some AESI (e.g., disseminated intravascular coagulation) exhibited higher rates after May 2020 compared with 2019. CONCLUSION: AESI background rates varied by database and demographics and fluctuated in March-December 2020, but most returned to pre-pandemic levels after May 2020. It is critical to standardize demographics and consider seasonal and other trends when comparing historical rates with post-vaccination AESI rates in the same database to evaluate COVID-19 vaccine safety.


Anaphylaxis , COVID-19 , Narcolepsy , Adult , Male , Female , Humans , Aged , United States/epidemiology , COVID-19 Vaccines/adverse effects , Medicare , COVID-19/epidemiology , COVID-19/prevention & control
8.
Healthcare (Basel) ; 10(8)2022 Aug 14.
Article En | MEDLINE | ID: mdl-36011192

Until now, the COVID-19 pandemic has resulted in at least 27 million cases and over 900,000 deaths worldwide. Bulgaria is one of the countries that is the most severely affected by the COVID-19 pandemic, and the mortality rate is among the highest registered in the world. The aim of this study is to investigate and analyze mortality rates due to the fact of COVID-19 in addition to the most common related underlying medical conditions in those hospitalized to outline the factors that have an impact on the mortality rate due to the fact of COVID-19. A descriptive cross-sectional research design with a retrospective analysis was used to collect data from a total of 128,269 hospitalized patients during the period from April 2020 to November 2021. During the study period, the number of hospital admissions due to the fact of COVID-19 was 5200. The patients' mean age was 67.34 (SD ± 19.65), and 51.7% (2689) of the patients were men. Only 10% of out of a total of 5200 patients did not test positive for COVID-19 upon admission based on the antigen or PCR test. Out of all patients, 41.5% had no underlying medical conditions upon presentation, and the remaining 58.5% had diagnosed comorbidities, varying from one to five. One-third (1470) had a lethal outcome, and the remaining 71.7% recovered from the infection and were discharged from the hospital. Based on the analysis of our results, there is definite evidence that the CFR and susceptibility to symptomatic COVID-19 were higher in the elderly, men, and patients with more comorbidities, especially chronic cardiovascular, metabolic, and respiratory disorders, as well as in those admitted to hospital within 6 h after an emergency ward visit and who had a shorter mean hospital stay.

9.
Healthcare (Basel) ; 10(7)2022 Jul 03.
Article En | MEDLINE | ID: mdl-35885767

Patient safety culture is a key component of the organizational culture and a critical measure of the quality of healthcare. The aim of this study was to gain an insight into the problems concerning patient safety culture, based on the analysis of data, collected after interviewing healthcare specialists working in surgical and nonsurgical units in selected Bulgarian hospitals. This was a cross-sectional online study using a web-platform and the Bulgarian Version of Hospital Survey on Patient Safety Culture. It was conducted among healthcare workers (n = 620) in 2021. The B-HSOPSC incudes 42 scales grouped in 12 different domains. We compared the percentage of positive ratings and outcome dimensions between surgical and other hospital departments with the nonparametric Mann-Whitney U test, χ2 tests, Fisher's Exact Test, and OR. The results showed that there are no statistically significant differences between the ratings on Patient Safety Culture given by the surgical and the nonsurgical staff except for the dimension "Hospital management support for patient safety". Results from the study highlighted that the most important aspect of hospital patient safety is the shortage of medical staff in both surgical and nonsurgical hospital units. Communication, work shift organization, handoffs and transitions between shifts and among different hospital units, as well as communication with line managers were rated as satisfactory in Bulgarian hospitals.

10.
Vaccine ; 40(31): 4116-4120, 2022 07 29.
Article En | MEDLINE | ID: mdl-35667915

BACKGROUND: On February 27, 2021, the Food and Drug Administration (FDA) issued an Emergency Use Authorization for Ad.26.COV2.S COVID-19 vaccine. As part of post-authorization safety surveillance, the FDA has identified a potential safety concern for thrombocytopenia following receipt of Ad.26.COV2.S COVID-19 vaccine. METHODS: Reports of thrombocytopenia were identified in a passive reporting system (Vaccine Adverse Event Reporting System; VAERS) February-December 2021. Demographics, clinical characteristics, laboratory values, and relevant medical history were reviewed. The reporting rate was analyzed, including calculation of the observed-to-expected ratio based on vaccine administration data and the background rate of thrombocytopenia in the general (unvaccinated) population. RESULTS: As of December 31, 2021, 100 reports of thrombocytopenia were identified in VAERS following vaccination with Ad.26.COV2.S. The median platelet count was 33,000 per µL (interquartile range 8,000-86,000). Fifteen reports (15%) documented a platelet count of 5,000 per µL or lower. The median time to onset of thrombocytopenia was 9 days (interquartile range 3-18.5), with most cases (69; 69%) beginning within 14 days after vaccination. A large majority of cases (84; 84%) were serious, including six deaths. With approximately 16,292,911 doses of Ad.26.COV2.S administered to adults in the US, the crude reporting rate was 0.61 cases of thrombocytopenia per 100,000 doses administered. The overall estimated observed-to-expected rate ratio was 2.43 (95% CI 1.97, 2.95). CONCLUSIONS: These findings suggest an increased risk of thrombocytopenia following receipt of Ad.26.COV2.S.


Anemia , COVID-19 , Thrombocytopenia , Vaccines , Adult , Adverse Drug Reaction Reporting Systems , COVID-19/prevention & control , COVID-19 Vaccines/adverse effects , Humans , Thrombocytopenia/chemically induced , Thrombocytopenia/epidemiology , United States/epidemiology , Vaccines/adverse effects
12.
JAMA ; 326(16): 1606-1613, 2021 10 26.
Article En | MEDLINE | ID: mdl-34617967

Importance: As part of postauthorization safety surveillance, the US Food and Drug Administration (FDA) has identified a potential safety concern for Guillain-Barré syndrome (GBS) following receipt of the Ad26.COV2.S (Janssen/Johnson & Johnson) COVID-19 vaccine. Objective: To assess reports of GBS received in the Vaccine Adverse Event Reporting System (VAERS) following Ad26.COV2.S vaccination. Design, Setting, and Participants: Reports of presumptive GBS were identified in a US passive reporting system (VAERS) February-July 2021 and characterized, including demographics, clinical characteristics, and relevant medical history. Exposures: Receipt of the Ad26.COV2.S vaccine; the comparator was the background rate of GBS in the general (unvaccinated) population that had been estimated and published based on a standardized case definition. Main Outcomes and Measures: Presumptive GBS; the reporting rate was analyzed, including calculation of the observed to expected ratio based on background rates and vaccine administration data. Because of limited availability of medical records, cases were not assessed according to the Brighton Collaboration criteria for GBS. Results: As of July 24, 2021, 130 reports of presumptive GBS were identified in VAERS following Ad26.COV2.S vaccination (median age, 56 years; IQR, 45-62 years; 111 individuals [86.0%] were < 65 years; 77 men [59.7%]). The median time to onset of GBS following vaccination was 13 days (IQR, 10-18 days), with 105 cases (81.4%) beginning within 21 days and 123 (95.3%) within 42 days. One hundred twenty-one reports (93.1%) were serious, including 1 death. With approximately 13 209 858 doses of vaccine administered to adults in the US, the estimated crude reporting rate was 1 case of GBS per 100 000 doses administered. The overall estimated observed to expected rate ratio was 4.18 (95% CI, 3.47-4.98) for the 42-day window, and in the worst-case scenario analysis for adults 18 years or older, corresponded to an estimated absolute rate increase of 6.36 per 100 000 person-years (based on a rate of approximately 8.36 cases per 100 000 person-years [123 cases per 1 472 162 person-years] compared with a background rate of approximately 2 cases per 100 000 person-years). For both risk windows, the observed to expected rate ratio was elevated in all age groups except individuals aged 18 through 29 years. Conclusions and Relevance: These findings suggest a potential small but statistically significant safety concern for Guillain-Barré syndrome following receipt of the Ad26.COV2.S vaccine. However, the findings are subject to the limitations of passive reporting systems and presumptive case definition, and they must be considered preliminary pending analysis of medical records to establish a definitive diagnosis.


COVID-19 Vaccines/adverse effects , Guillain-Barre Syndrome/epidemiology , Ad26COVS1 , Adult , Age Distribution , Aged , COVID-19 Vaccines/administration & dosage , Female , Guillain-Barre Syndrome/etiology , Humans , Male , Middle Aged , Preliminary Data , Product Surveillance, Postmarketing , United States/epidemiology , Vaccination/statistics & numerical data , Young Adult
13.
Zdr Varst ; 60(2): 97-104, 2021 Jun.
Article En | MEDLINE | ID: mdl-33822831

INTRODUCTION: A patient safety culture (PSC) is a complex phenomenon, representing an essential part of the organizational culture and refers to the shared values, conceptions and beliefs which contribute to the formation and encouragement of safe behavioural models in a health organization. With this study, the authors wanted to delineate the attitude of hospital staff in Bulgaria regarding PSC and to document to whether attitudes differ between physicians and other healthcare professionals (HCPs). METHODS: A national cross-sectional survey among 384 HCPs was conducted using an online version of the Bulgarian version of Hospital Survey on Patient Safety Culture (B-HSOPSC). The data was analysed with descriptive statistics, non-parametric Mann-Whitney U and x 2 tests. RESULTS: The physicians represented 37.50% (144) of the sample and other HCPs 62.50% (240). Respondents from governmental/municipal hospitals prevailed (53.6%). The dimensions "Staffing" and "Non-punitive response to error" were most problematic, as their percentage of positive response rates (PRRs) were lowest. However, "Handoffs and transitions" and "Supervisor/manager expectations and actions promoting safety" showed the highest mean values in both physicians and other HCPs. From all participants, 76.0% have never reported an adverse event or error. CONCLUSION: The results of the study show that all respondents demonstrate a positive attitude regarding PSC. A comparison of the mean values and that of PRRs in the dimensions did not show any group differences, according to the type of staff position, i.e. physicians or other HCPs.

14.
J Viral Hepat ; 27(12): 1369-1387, 2020 12.
Article En | MEDLINE | ID: mdl-32615009

Hepatitis C virus (HCV) screening among individuals born between 1945 and 1965 (ie birth cohort) may augment risk factor-based screening. We assessed HCV seropositivity among injection drug users (IDUs) and birth cohort members from New York City. We assessed HCV risk factors and seropositivity in 7722 participants from community health, HIV prevention, syringe exchange and drug treatment programmes. A total of 26.6% were HCV seropositive, 55.8% were born between 1945 and 1965, and 82.2% had ever injected drugs. Among all participants, HCV seropositivity was higher among IDUs compared to non-IDUs (60.5% versus 7.7%, odds ratio (OR) = 18.5, 95% confidence interval (CI) [16.2, 21.1], P < .0001) and among birth cohort members compared to non-birth cohort members (31.3% versus 22.3%, OR = 1.6, 95%CI [1.4, 1.8], P < .0001). Within the birth cohort, HCV seroprevalence among IDUs was 68.5% versus 11.8%, OR = 16.2, 95%CI [13.7, 19.3]. After adjustment, HCV seroprevalence was higher in IDUs, previously incarcerated, whites (<42 years) and 'other races' (versus blacks), HIV-infected, those who snorted heroin, those with liver disease history, and those who had sex with an HCV-seropositive partner. HCV seroprevalence among IDU, birth cohort members, was considerably higher than among the general population. In this high-risk, urban population, the association between IDU and HCV seropositivity was approximately ten times that between birth cohort membership and HCV seropositivity.


HIV Infections , Hepatitis C , Substance Abuse, Intravenous , HIV Infections/complications , HIV Infections/epidemiology , Hepacivirus , Hepatitis C/epidemiology , Humans , Risk Factors , Seroepidemiologic Studies , Substance Abuse, Intravenous/complications , Substance Abuse, Intravenous/epidemiology , Urban Population
15.
Int J Qual Health Care ; 32(6): 396-404, 2020 Jul 20.
Article En | MEDLINE | ID: mdl-32472119

OBJECTIVE: To explore the psychometrics of the Bulgarian version of the Hospital Survey on Patient Safety Culture (B-HSOPSC) and its suitability for use in Bulgaria. DESIGN: A national web-based cross-sectional survey of the safety patient culture. SETTING: The hospitals' staffs from 28 administrative areas in the country. INTERVENTIONS: Web-based self-administered questionnaire. PARTICIPANTS: Physicians and non-physicians such as nurses, midwifes, etc., working at hospitals. MAIN OUTCOME MEASURES: Confirmatory factor analysis (CFA) was performed to assess the psychometric properties of the original US structure. Assessment of construct validity included convergent validity, discriminant validity, and nomological validity of constructs. RESULTS: A total of 525 valid cases were included in the analysis. The results of CFA revealed acceptable values for absolute indices and lower for the incremental index, comparative fit index. Due to the very low convergence validity, the dimension 'staffing' was removed from the model. Additionally, one item was removed from another dimension. The B-HSOPSC included 11 dimensions and 37 items. CONCLUSIONS: The B-HSOPSC had acceptable levels of global and local fits. Its safety culture dimensions were sufficiently distinguishable and correlated with outcome variables.


Patient Safety , Safety Management , Surveys and Questionnaires , Bulgaria , Cross-Sectional Studies , Factor Analysis, Statistical , Humans , Organizational Culture , Personnel, Hospital , Psychometrics
16.
Med Pharm Rep ; 92(4): 374-381, 2019 Oct.
Article En | MEDLINE | ID: mdl-31750438

BACKGROUND AND AIMS: Assessment of Health-related Quality of Life in chronic hemodialysis patients (CHD) is a predictive indicator of the outcome of the disease, including mortality and hospitalization. Regular surveys of the quality of life (QoL) in CHD patients have been conducted worldwide, using various, internationally validated and standardized tools, including the Missoula-VITAS Quality of Life Index scale (MVQOLI). The aim of this study was to examine the reliability and validity of the Bulgarian version of the Missoula-VITAS Quality of Life Index-15 (B-MVQOLI-15) and QoL in CHD patients using this instrument. METHODS: Our study was designed as multi-center cross-sectional. It incorporated 263 end-stage renal disease (ESRD) patients on CHD from across the country and applied the B-MVQOLI-15. Internal consistency and convergent validity of the index were assessed. Non-parametric methods were used to evaluate the impact of demographic factors on the different dimensions scores and on the total score. The relationship between the total QoL score, the total MVQOLI-15 score and dimensions scores were measured based on Spearman's rho Correlation Coefficient. RESULTS: The total MVQOLI-15 score in the study was 16.44, which is slightly above the middle of the index scale. The patients with higher education were less satisfied with the level of their symptom control compared to patients with lower education. However, high education patients seem to manage better with everyday life compared to those with low education. Men seem to feel more satisfied than women when fulfilling their daily activities (P=0.026). Retired patients and unemployed expressed more satisfaction, compared to the employed (P=0.021). Also, patients on dialysis for over 5 years had lower QoL scores (P=0.043). CONCLUSIONS: B-MVQOLI-15 is a reliable instrument to measure QoL in Bulgarian patients with CHD. The majority of CHD patients rate their QoL as "Fair". Four of all five dimensions positively affect the QoL of CHD patients. The most important dimensions positively affecting the QoL of CHD patients were: interpersonal relationships and transcendent factors. Future studies are necessary to assess the adequacy of the delivered dialysis, the level of medico-social care and the needs of ESRD patients treated with CHD in order to improve their QoL.

17.
Open Access Maced J Med Sci ; 7(14): 2384-2390, 2019 Jul 30.
Article En | MEDLINE | ID: mdl-31592284

BACKGROUND: Employees' work satisfaction, combined with democratic management, are important predictors of future productivity in any organisation. AIM: The aim of this study is to investigate job satisfaction in academic staff as well as the associated working environment factors, using an original self-administered questionnaire. METHODS: A cross-sectional survey was conducted using an original standardised questionnaire. It involved 370 academic staff members at one of the five medical universities in Bulgaria. The questionnaire consists of 17 items (including occupational hazards, management style, conflict solving and demographic characteristics) rated on a 5-point Likert scale. RESULTS: The results revealed that the majority of academic staff (71.7%) works in a risky environment. Employees indicate that "mental strain", "work with chemical agents and dust" and "work with biological hazards" are the most common risk factors. Democratic leadership and cooperation are most commonly applied management styles. CONCLUSION: The instrument for the measurement of job satisfaction revealed high values of psychometric characteristics for reliability and validity. The study found a high level of satisfaction of academics with their working conditions. It is necessary to conduct similar studies periodically to detect more precisely the decrease in academic staff work satisfaction and take timely and adequate measures to improve it.

18.
Med Pharm Rep ; 92(3): 265-270, 2019 Jul.
Article En | MEDLINE | ID: mdl-31460508

BACKGROUND AND AIMS: Patient safety culture (PSC) is an essential component of the quality of healthcare. Improving PSC is considered a priority in many developed countries. A specialized software platform for registration and evaluation of hospital patient safety culture has been developed with the support of the Medical University Plovdiv Project №11/2017.The aim of the study is to assess the status of PSC in Bulgarian hospitals and to compare it to that in USA and Croatian hospitals. METHODS: The study was conducted from June 01 to July 31, 2018 using the web-based Bulgarian Version of the Hospital Survey on Patient Safety Culture Questionnaire (B-HSOPSC). Two hundred and forty-eight medical professionals from different hospitals in Bulgaria participated in the study. In order to quantify the differences of positive scores distributions for each of the 42 HSOPSC items between Bulgarian, Croatian and USA samples, the χ2-test was applied. The research hypothesis assumed that there were no significant differences between the Bulgarian, Croatian and US PSCs. RESULTS: The results revealed 14 significant differences in the positive scores between the Bulgarian and Croatian PSCs and 15 between the Bulgarian and the USA PSC, respectively. Bulgarian medical professionals provided less positive responses to 12 items compared with Croatian and USA respondents. The Bulgarian respondents were more positive compared to Croatians on the feedback and communication of medical errors (Items - C1, C4, C5) as well as on the employment of locum staff (A7) and the frequency of reported mistakes (D1). Bulgarian medical professionals were more positive compared with their USA colleagues on the communication of information at shift handover and across hospital units (F5, F7). The distribution of positive scores on items: "Staff worry that their mistakes are kept in their personnel file" (RA16), "Things 'fall between the cracks' when transferring patients from one unit to another" (RF3) and "Shift handovers are problematic for patients in this hospital" (RF11) were significantly higher among Bulgarian respondents compared with Croatian and US respondents. CONCLUSIONS: Significant differences of positive scores distribution were found between Bulgarian and USA PSC on one hand and between Bulgarian and Croatian on the other. The study reveals that distribution of positive responses could be explained by the cultural, organizational and healthcare system differences.

20.
J BUON ; 23(4): 941-949, 2018.
Article En | MEDLINE | ID: mdl-30358197

PURPOSE: To investigate the attitudes and willingness of the general practitioners (GPs) as well as their actual participation in the voluntary colorectal cancer (CRC) screening campaign without additional financial incentives for them, combining quantitative and qualitative approaches. METHODS: A multiple-case practice based study was designed using a mixed method, triangulation techniques and a sequential explanatory design strategy. The study included all 41 GPs practices in the Municipality of Asenovgrad. A questionnaire, face-to-face semi-structured interviews, nonparticipant direct structured observations and documentation review were used to collect data. Variation analysis, alternative analysis for percentage calculation and Mann-Whitney U test to compare two independent groups and Fisher's Exact Test were used. Statistical significance of the null hypothesis was assumed at p<0.05. RESULTS: Older GPs (p=0.015) and those working with a practice nurse (p=0.000) were more inclined to participate in the CRC screening campaign. GPs more knowledgeable of the importance of CRC screening with iFOBT (immunochemical faecal occult blood test), (p=0.002) and those trusting its quality (p=0.007) were more willing and ready to take part in the screening campaign. Among barriers that GPs encountered in the present screening campaign were lack of knowledge and experience about iFOBT, lack of materials and insufficient incentives. CONCLUSION: Some limitations influence the voluntary participation of GPs in CRC screening campaign that have to be considered before decisions can be made on the implementation of population-based CRC screening programme in Bulgaria in accordance with European guidelines on best practice.


Colorectal Neoplasms/diagnosis , General Practitioners/psychology , Early Detection of Cancer/psychology , Female , Humans , Male , Middle Aged
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