Intravenous immunoglobulins in the treatment of relapsing remitting multiple sclerosis - results of a retrospective multicenter observational study over five years

2005 ◽  
Vol 11 (5) ◽  
pp. 562-567 ◽  
Author(s):  
J Haas ◽  
M Maas-Enriquez ◽  
H P Hartung
Keyword(s):  
Observational Study ◽  
Intravenous Immunoglobulins ◽  
Ivig Treatment ◽  
Routine Practice ◽  
Consensus Recommendation ◽  
Multicenter Observational Study ◽  
First Line Therapy ◽  
Retrospective Data Analysis ◽  
Study Results ◽  
The Impact

Use of intravenous immunoglobulins (IVIG) has been recommended for treatment of RRMS if first line therapy with beta-interferon or glatiramer acetate is not tolerated, or if contraindications exist. This consensus recommendation is based on the demonstration of efficacy and tolerability of IVIG in four randomized controlled trials (RCTs). The impact of non-randomized observational trials on evidence-based recommendations for treatment is still under discussion. In order to evaluate the transferability of study results derived from RCTs into a routine practice setting, we carried out a retrospective data analysis on patients with RRMS who had been treated with IVIG during the last five years. Data sets from 308 out of 1122 screened patients were available for analysis. Treatment with IVIG resulted in a 69% reduction of the mean annual relapse rate (ARR) (calculated over two years) from 1.749±1.15 before IVIG treatment to 0.539±0.61 after start of IVIG treatment. Mean expanded disability status scale (EDSS) values remained stable throughout the observation period. The results of this observational study were similar to the results of previous RCTs with IVIG.

scholarly journals Evaluating the Impact of Database Heterogeneity on Observational Study Results

2013 ◽  
Vol 178 (4) ◽  
pp. 645-651 ◽  
Author(s):  
David Madigan ◽  
Patrick B. Ryan ◽  
Martijn Schuemie ◽  
Paul E. Stang ◽  
J. Marc Overhage ◽  
...  
Keyword(s):  
Observational Study ◽  
Study Results ◽  
The Impact

scholarly journals Clinical Application of Radioembolization in Hepatic Malignancies: Protocol for a Prospective Multicenter Observational Study (Preprint)

2019 ◽  
Author(s):  
Thomas Helmberger ◽  
Dirk Arnold ◽  
José I Bilbao ◽  
Niels de Jong ◽  
Geert Maleux ◽  
...  
Keyword(s):  
Observational Study ◽  
Clinical Application ◽  
Treatment Modality ◽  
Large Scale ◽  
Liver Tumors ◽  
Real Life ◽  
Routine Practice ◽  
Resin Microspheres ◽  
The Impact

BACKGROUND Radioembolization, also known as transarterial radioembolization or selective internal radiation therapy with yttrium-90 (90Y) resin microspheres, is an established treatment modality for patients with primary and secondary liver tumors. However, large-scale prospective observational data on the application of this treatment in a real-life clinical setting is lacking. OBJECTIVE The main objective is to collect data on the clinical application of radioembolization with 90Y resin microspheres to improve the understanding of the impact of this treatment modality in its routine practice setting. METHODS Eligible patients are 18 years or older and receiving radioembolization for primary and secondary liver tumors as part of routine practice, as well as have signed informed consent. Data is collected at baseline, directly after treatment, and at every 3-month follow-up until 24 months or study exit. The primary objective of the Cardiovascular and Interventional Radiological Society of Europe Registry for SIR-Spheres Therapy (CIRT) is to observe the clinical application of radioembolization. Secondary objectives include safety, effectiveness in terms of overall survival, progression-free survival (PFS), liver-specific PFS, imaging response, and change in quality of life. RESULTS Between January 2015 and December 2017, 1047 patients were included in the study. The 24-month follow-up period ended in December 2019. The first results are expected in the third quarter of 2020. CONCLUSIONS The CIRT is the largest observational study on radioembolization to date and will provide valuable insights to the clinical application of this treatment modality and its real-life outcomes. CLINICALTRIAL ClinicalTrials.gov NCT02305459; https://clinicaltrials.gov/ct2/show/NCT02305459 INTERNATIONAL REGISTERED REPORT DERR1-10.2196/16296

scholarly journals Impact of the day of the week on the discontinuation of broad-spectrum antibiotic prescriptions; a multi-centered observational study

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Hiroyuki Honda ◽  
Hideharu Hagiya ◽  
Tsukasa Higashionna ◽  
Yuto Haruki ◽  
Mai Haruki ◽  
...  
Keyword(s):  
Observational Study ◽  
Antimicrobial Stewardship ◽  
Broad Spectrum ◽  
Antibiotic Use ◽  
Antibiotic Administration ◽  
Multicenter Observational Study ◽  
Broad Spectrum Antibiotics ◽  
Admission Ward ◽  
Day Of The Week ◽  
The Impact

AbstractTo encourage and guide antimicrobial stewardship team (AST) activity and promote appropriate antibiotic use, we studied the impact of day of the week on the initiation and discontinuation of antibiotic administration. This was a multicenter observational study conducted at 8 Japanese hospitals from April 1 to September 30, 2019, targeting patients who underwent treatment with broad-spectrum antibiotics, such as anti-methicillin-resistant Staphylococcus aureus agents and anti-pseudomonal agents. We compared the weekly numbers of initiations and discontinuations of antibiotic prescription on each day of the week or on the days after a holiday. There was no statistical difference in the number of antibiotic initiations on both weekdays and the day after a holiday. However, antibiotic discontinuation was significantly higher from Tuesday onward than Monday and from the second day than the first day after a holiday. Similar trends were observed regardless of the categories of antibiotics, hospital and admission ward, and AST activity. This study suggests that broad-spectrum antibiotics tend to be continued during weekends and holidays and are most likely to be discontinued on Tuesday or the second day after a holiday. This was probably due to behavioral factors beyond medical indications, requiring further antimicrobial stewardship efforts in the future.

scholarly journals The impact of blood type on the mortality of patients with severe abdominal trauma: a multicenter observational study

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Wataru Takayama ◽  
Akira Endo ◽  
Kiyoshi Murata ◽  
Kota Hoshino ◽  
Shiei Kim ◽  
...  
Keyword(s):  
Observational Study ◽  
Abdominal Trauma ◽  
Blood Type ◽  
Abbreviated Injury Scale ◽  
Trauma Outcomes ◽  
Multicenter Observational Study ◽  
Transfusion Volume ◽  
Type Of Injury ◽  
The Impact ◽  
The Relationship

AbstractFew studies have investigated the relationship between blood type and trauma outcomes according to the type of injury. We conducted a retrospective multicenter observational study in twelve emergency hospitals in Japan. Patients with isolated severe abdominal injury (abbreviated injury scale for the abdomen ≥ 3 and that for other organs < 3) that occurred between 2008 and 2018 were divided into four groups according to blood type. The association between blood type and mortality, ventilator-free days (VFD), and total transfusion volume were evaluated using univariate and multivariate regression models. A total of 920 patients were included, and were divided based on their blood type: O, 288 (31%); A, 345 (38%); B, 186 (20%); and AB, 101 (11%). Patients with type O had a higher in-hospital mortality rate than those of other blood types (22% vs. 13%, p < 0.001). This association was observed in multivariate analysis (adjusted odds ratio [95% confidence interval] = 1.48 [1.25–2.26], p = 0.012). Furthermore, type O was associated with significantly higher cause-specific mortalities, fewer VFD, and larger transfusion volumes. Blood type O was associated with significantly higher mortality and larger transfusion volumes in patients with isolated severe abdominal trauma.

Multicenter observational study evaluating the impact of platelet transport bags on product wastage

Transfusion ◽  
2021 ◽  
Author(s):  
Amie Kron ◽  
Shangari Vijenthira ◽  
Jacob Pendergrast ◽  
Dimpy Modi ◽  
Alyson McLaren ◽  
...  
Keyword(s):  
Observational Study ◽  
Multicenter Observational Study ◽  
The Impact ◽  
Platelet Transport

scholarly journals Clinical Application of Radioembolization in Hepatic Malignancies: Protocol for a Prospective Multicenter Observational Study

10.2196/16296 ◽  
2020 ◽  
Vol 9 (4) ◽  
pp. e16296 ◽  
Author(s):  
Thomas Helmberger ◽  
Dirk Arnold ◽  
José I Bilbao ◽  
Niels de Jong ◽  
Geert Maleux ◽  
...  
Keyword(s):  
Observational Study ◽  
Clinical Application ◽  
Treatment Modality ◽  
Large Scale ◽  
Liver Tumors ◽  
Real Life ◽  
Routine Practice ◽  
Resin Microspheres ◽  
The Impact

Background Radioembolization, also known as transarterial radioembolization or selective internal radiation therapy with yttrium-90 (90Y) resin microspheres, is an established treatment modality for patients with primary and secondary liver tumors. However, large-scale prospective observational data on the application of this treatment in a real-life clinical setting is lacking. Objective The main objective is to collect data on the clinical application of radioembolization with 90Y resin microspheres to improve the understanding of the impact of this treatment modality in its routine practice setting. Methods Eligible patients are 18 years or older and receiving radioembolization for primary and secondary liver tumors as part of routine practice, as well as have signed informed consent. Data is collected at baseline, directly after treatment, and at every 3-month follow-up until 24 months or study exit. The primary objective of the Cardiovascular and Interventional Radiological Society of Europe Registry for SIR-Spheres Therapy (CIRT) is to observe the clinical application of radioembolization. Secondary objectives include safety, effectiveness in terms of overall survival, progression-free survival (PFS), liver-specific PFS, imaging response, and change in quality of life. Results Between January 2015 and December 2017, 1047 patients were included in the study. The 24-month follow-up period ended in December 2019. The first results are expected in the third quarter of 2020. Conclusions The CIRT is the largest observational study on radioembolization to date and will provide valuable insights to the clinical application of this treatment modality and its real-life outcomes. Trial Registration ClinicalTrials.gov NCT02305459; https://clinicaltrials.gov/ct2/show/NCT02305459 International Registered Report Identifier (IRRID) DERR1-10.2196/16296

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