scholarly journals Patterns of use, effectiveness and safety of gadolinium contrast agents: a European prospective cross-sectional multicentre observational study

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Jarl Åsbjørn Jakobsen ◽  
Carlo Cosimo Quattrocchi ◽  
Frank H. H. Müller ◽  
Olivier Outteryck ◽  
Andrés Alcázar ◽  
...  

Abstract Background The EU gadolinium-based contrast agents (GBCA) market has changed in recent years due to the European Medicines Agency decision to suspend the marketing authorisation of linear GBCA and the marketing authorisation of new generic macrocyclic GBCA. The study aims to understand the patterns of (GBCA) use, and to study the effectiveness and safety of GBCA in routine practice across Europe. Methods Prospective, cross-sectional, multicentre, observational study in patients undergoing contrast-enhanced magnetic resonance. Reported usage patterns included indication, referral and examination details. Assessment of effectiveness included changes in radiological diagnosis, diagnostic confidence and image quality. Safety data were collected by spontaneous patient adverse event (AE) reporting. Results 2118 patients were included from 8 centres across 5 European countries between December 2018 and November 2019. Clariscan, Dotarem (gadoteric acid), Gadovist (gadobutrol) and ProHance (gadoteridol) were utilised in 1513 (71.4%), 356 (16.8%), 237 (11.2%) and 12 (0.6%) patients, respectively. Most were performed in CNS-related indications (46.2%). Mean GBCA doses were 0.10 mmol/kg body weight, except for Gadovist (mean 0.12 mmol/kg). GBCA use increased confidence in diagnosis in 96.2% of examinations and resulted in a change in radiological diagnosis in 73.9% of patients. Image quality was considered excellent or good in 96.1% of patients and across all GBCA. Four patients reported AEs (0.19%), with only 1 (0.05%) considered serious. Conclusions This European study confirmed that GBCAs are used appropriately in Europe for a wide range of indications. The study demonstrated a significant increase in diagnostic confidence after GBCA use and confirmed the good safety profile of GBCAs, with comparable results for all agents used.

BMJ Open ◽  
2019 ◽  
Vol 9 (7) ◽  
pp. e022777
Author(s):  
Niamh Allen ◽  
Collette Faherty ◽  
Andre Davies ◽  
Anne Lyons ◽  
Margarent Scarry ◽  
...  

ObjectiveRecent treatment developments for HIV, hepatitis C virus (HCV) and hepatitis B virus (HBV) have greatly improved prognoses. Current screening practices are mainly risk based and are suboptimal. Improved efforts are critically needed to identify persons with these viruses. The aims of this study were to assess the feasibility of an opt-out bloodborne virus (BBV) screening programme in an acute medical unit (AMU) and to describe the prevalence of HIV, HBV and HCV in this population.Design and settingThis was a cross-sectional observational study in the AMU of a tertiary referral hospital in Galway, a city in the west of Ireland.Participants1936 patients entered the study; 54% were male, mean age was 53.1 years (SD 19.6). During the study period, all patients attending the AMU aged ≧16 years who were having bloods drawn and who had the ability to verbally consent for an additional blood sample met the inclusion criteria for the study.ResultsOver 44 weeks, 1936/4793 (40.4%) patients consented to BBV panel testing. Diagnosed prevalence rates for HIV, HBV and HCV were 0.5/1000, 2/1000 and 1.5/1000, respectively. There was one HIV-positive result; the patient was already engaged in care. Four patients tested positive for HBV surface antigen; one new diagnosis, one previously lost to follow-up and two already engaged in care. Three patients had active HCV infection; two had been lost to follow-up and are now linked back into services.ConclusionBBV testing uptake of 40.4% is higher than previous studies in AMU settings that used opt-in strategies, but lower than expected, possibly due to not incorporating testing into routine practice. The diagnosed prevalence of HBV is notable as little data currently exist about its prevalence in Ireland. These data are valuable in order to inform further prevention strategies for these infections in low-prevalence settings.


2021 ◽  
Vol 2021 ◽  
pp. 1-8
Author(s):  
Won-Jin Moon ◽  
Young Ah Cho ◽  
Seok Hahn ◽  
Hye Min Son ◽  
Sung Koo Woo ◽  
...  

Objective. Contrast-enhanced MR (CE-MR) imaging is often required to improve lesion detection and characterization and to increase diagnostic confidence. This study aimed to evaluate the safety and effectiveness, as well as the use pattern, of the macrocyclic gadolinium-based contrast agent Clariscan in real-world clinical practice in Korea. Materials and Methods. This was a prospective, multicenter, observational study of patients undergoing CE-MR as part of routine clinical care at 6 university hospitals in Korea. Effectiveness was evaluated by determining diagnostic confidence and image quality; safety evaluation included the adverse event (AE) expression rate. Subgroup analyses were conducted by body regions of diagnosis (musculoskeletal, nervous system, others) and in pediatric patients (aged ≤7 years). Results. From October 2019 to September 2020, 1,376 subjects were included in the study. The mean volume of Clariscan used was 0.26 mL/kg (0.13 mmol/kg). In the overall study population and in each subgroup, diagnostic confidence increased after contrast enhancement with Clariscan. Overall, image quality was excellent in 72.5% of subjects and good-to-adequate in 27.2%. Clariscan was well tolerated (14 AEs occurred in 10 subjects); all AEs were of mild severity. Subgroup analyses showed that the mean dose of Clariscan used was ≥0.1 mmol/kg for nervous system-related diagnoses (e.g., brain) and ≤0.1 mmol/kg for musculoskeletal and pediatric-related diagnoses. All musculoskeletal and pediatric examinations were provided with a smaller package of 5 mL Clariscan. By body region of MR examination, the most common region was the nervous system in 69.0%, musculoskeletal system in 13.6%, and reproductive system in 4.9%. Conclusions. This study confirmed the use pattern of Clariscan and its excellent effectiveness and safety in the real-world clinical environment in Korea. The small-dose package indicated the possibility of increasing the convenience and efficiency of drug use.


2021 ◽  
Vol 12 (4) ◽  
pp. 883-889
Author(s):  
Shabna P ◽  
Jigeesh P P ◽  
Subin V R

Introduction: Niruha Vasti plays a major role when compared to Anuvasana, because of its variety of drug combinations and utility in a wide range of clinical conditions. Many formulations of Vasti are, in practice which came from the clinical experiences of eminent physicians and from researches. There is a deficit of baseline data regarding the current practices of Niruha Vasti in LBP and the preparation of which may help to prioritize the topics for further research. Materials and Methods: The study design was prospective cross-sectional observational study and sample included all the patients admitted in VPSV Ayurveda College Hospital, Kottakkal during January-December 2018, presented with LBP and posted for Niruha Vasti. Study tool used was a Data collection form which was prepared from available literatures. Data was verified, analyzed and presented with the help of tables and charts. Statistical analysis was done by Microsoft office 2016 and IBM SPSS Statistics version 16. Observation and Results: Total 141 patients were observed and among them 474 Vasti done in 174 schedules and 16 different types of Vasti were used. Vaitarana Vasti, Madhutailika Vasti, Kshira Vasti, Ruksha Vasti, Erandamuladi Vasti and Grdhrasihara Vasti are the major Vasti prescribed in LBP patients. Conclusion: There are certain characteristic patterns in the practice of Niruha Vasti administered in cases of Low Back Pain.


2018 ◽  
Vol 9 (4) ◽  
pp. 46-50
Author(s):  
Manoj Bhattarai

Background: Presence of lumbosacral transitional vertebra may lead to number of clinical consequences because of failure to correctly number the problematic vertebra and also has been associated with low back pain. Different studies done at different part of the world have shown wide range of prevalence of lumbosacral transitional vertebra.Aims and Objective: This hospital based cross sectional observational study was undertaken to determine the prevalence of lumbosacral transitional vertebra among the Nepalese population.Materials and Methods: Plain radiographs (anteroposterior and lateral views of lumbosacral spine and KUB radiographs) of 947 patients (646 with lumbosacral spine and 301 with KUB radiographs) done from August 2015 to July 2016 and meeting inclusion criteria were retrospectively analyzed for the presence of lumbosacral transitional vertebra.Results: The overall prevalence of lumbosacral transitional vertebra was 14.7% with prevalence of 16.3% in patients with lumbosacral radiographs and 11.3% in patients with KUB radiographs and was statistically significant. Prevalence of sacralization was higher than lumbarization (11.9% Vs 2.7%). Lumbosacral transitional vertebra was more common in females than in males with Castellvi type I being most common and type IV least common.Conclusion: The overall prevalence of lumbosacral transitional vertebra in the studied Nepalese population was 14.7% with significantly higher prevalence in patients with lumbosacral radiographs than with KUB radiographs.Asian Journal of Medical Sciences Vol.9(4) 2018 46-50


2020 ◽  
Vol 2 (2) ◽  
pp. 08-15
Author(s):  
Rahma Triyana ◽  
Salmi Salmi

Malaria is one of the health problems in Indonesia, especially West Sumatra. Determination of the description of Malaria disease in an area is needed to determine the spread and severity of the disease. This study aims to determine the frequency distribution according to age, sex and place of residence, description of the types of Plasmodium causes of Malaria and hematological features in Malaria patients at Siti Rahmah Padang Hospital in 2018. This type of research is a descriptive observational study with an approach or design cross section (cross sectional). The frequency distribution of Malaria sufferers in Siti Rahmah Padang Hospital in 2018 according to the highest age was in the age group 21-30 years as many as 28 cases (36.8%), the highest sex among men was 46 (60.5%) and the highest number of residences was found in Koto Tangah sub-district there were 31 cases (40.8%). The type of Plasmodium found in Malaria cases in Siti Rahmah Padang Hospital in 2018 was P. vivax (73 cases (96.05%)) and P. falciparum (3 cases (3.95%)). The results of laboratory tests on Hb, hematocrit, platelet and leukocyte levels in Malaria positive patients in Siti Rahmah Padang Hospital in 2018 were in the normal range.


2020 ◽  
Vol 2 (2) ◽  
pp. 08-15
Author(s):  
Rahma Triyana Y ◽  
Salmi Salmi

Malaria is one of the health problems in Indonesia, especially West Sumatra. Determination of the description of Malaria disease in an area is needed to determine the spread and severity of the disease. This study aims to determine the frequency distribution according to age, sex and place of residence, description of the types of Plasmodium causes of Malaria and hematological features in Malaria patients at Siti Rahmah Padang Hospital in 2018. This type of research is a descriptive observational study with an approach or design cross section (cross sectional). The frequency distribution of Malaria sufferers in Siti Rahmah Padang Hospital in 2018 according to the highest age was in the age group 21-30 years as many as 28 cases (36.8%), the highest sex among men was 46 (60.5%) and the highest number of residences was found in Koto Tangah sub-district there were 31 cases (40.8%). The type of Plasmodium found in Malaria cases in Siti Rahmah Padang Hospital in 2018 was P. vivax (73 cases (96.05%)) and P. falciparum (3 cases (3.95%)). The results of laboratory tests on Hb, hematocrit, platelet and leukocyte levels in Malaria positive patients in Siti Rahmah Padang Hospital in 2018 were in the normal range.


2020 ◽  
Vol 43 (1) ◽  
pp. 75-80
Author(s):  
Md Zulfekar Ali ◽  
Mohammad Moktader Moula ◽  
Zafar Ahmed Bhuiyan ◽  
Muhammad Tariq Javed

AbstractChicken astroviruses (CAstV) are enteric viruses of poultry causing gastroenteritis, malabsorption, gout and white chick disease commonly known as runting-stunting syndrome (RSS). It can affect the wide range of poultry birds, especially chicken, turkey and duck worldwide. To our best knowledge there is no published report on presence of antibodies against CAstV in Bangladesh. Therefore, the study aimed to detect the presence of CAstV antibodies in broilers and sonali chickens (a cross-bread) in Bangladesh through a cross-sectional survey. A total of 454 blood samples from 66 flocks of broiler (n=343) and sonali chickens (n=111) of different ages were obtained during 2017 from four districts. The birds were healthy but were not vaccinated against CAstV. The samples were tested for specific antibodies against CAstV Group B by using commercially available ELISA kit. Overall, 16.74% (76/454) samples and 34.84% (23/66) flocks were positive for CAstV antibodies. The seroprevalence of CAstV was significantly (p=0.001) higher in sonali chickens (36.96%) than broiler (10.20%), while it was significantly higher (p=0.001) in birds of Bogura district (36.94%) than the other three districts. Regarding the age groups, seroprevalence was insignificantly (p=0.192) higher in sonali chicken before laying age (45%) than during laying age (27.45%). Regarding the seasons, CAstV infection was prevalent significantly (p=0.001) higher in winter season. Thus, the present study indicated the presence of CAstV in poultry in Bangladesh, so further studies are required to find out the magnitude of the problem in the country.


Sign in / Sign up

Export Citation Format

Share Document