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2022 ◽  
Vol 8 (1) ◽  
pp. 205521732110693
Author(s):  
Enrique Alvarez ◽  
Kavita V. Nair ◽  
Stefan Sillau ◽  
Ian Shelton ◽  
Rebecca Seale ◽  
...  

Background Ocrelizumab and rituximab are frequently used treatments for multiple sclerosis (MS). Data on switching from rituximab to ocrelizumab is limited. Objectives To assess the frequency, severity, and factors of infusion related reactions (IRRs) in patients with MS who switch from rituximab to ocrelizumab, compared to those who stay on rituximab. Methods Prospective study on MS patients aged 18–65, on rituximab for at least 2 cycles, who either switched to ocrelizumab (switch group) or stayed on rituximab (comparator group) (n = 100 each). Participants were followed for IRRs, safety, and tolerability over 12 months. Results The proportion of IRRs in patients who continue on rituximab (14%) were similar to those who switched to ocrelizumab on Day 1 (14%; p = 1.000) and Week 24 (12%; p = 0.647) but higher than at Day 15 (4%; 0.005). The risk of IRRs for the switch group was associated with the presence of B cells (CD19 and/or CD20 counts ≥1%) increasing by 5.01 (1.49, 16.82) times on Day 1 (p = 0.007). Antidrug antibodies to ocrelizumab were not associated with IRRs. No other safety concerns were identified in switching to ocrelizumab. Conclusion IRRs are similar between both groups, which suggests that it is safe to switch from rituximab to ocrelizumab.


2021 ◽  
pp. 026455052110656
Author(s):  
Susan Baines ◽  
Chris Fox ◽  
Jordan Harrison ◽  
Andrew Smith ◽  
Caroline Marsh

As part of a large pan-European project on co-creating public services we supported the design of a programme in England that attempted to operationalise research on desistance, through a model of co-created, strengths-based working. We then evaluated its implementation and impact. The programme was implemented in a Community Rehabilitation Company. It was delivered in the context of rapid organisational change, often in response to rapidly changing external events and a turbulent policy environment. These factors impeded implementation. An impact evaluation did not identify a statistically significant difference in re-offending rates between the intervention group and a comparator group. However, in-depth qualitative evaluation identified positive examples of co-production and co-creation, with individual case managers and service users supportive and noting positive change. Taken as a whole our findings suggest that a co-created, strengths-based model of probation case management is promising but needs to be accompanied by wider systems change if it is to be embedded successfully.


2021 ◽  
pp. 106-117
Author(s):  
S. K. Zyryanov ◽  
O. I. Butranova ◽  
A. V. Ershov ◽  
Z. Sh. Manasova

Introduction. The high incidence of community-acquired pneumonia and the high complication rates in the cases of severe pneumonia actualize the search for new pharmacotherapy tools to improve the effectiveness of standard patient management regimens. A high level of severe inflammatory response underlies the high risk for developing septic complications of pneumonia, along with impaired immune responses.The aim is to evaluate the efficacy of azoximer bromide introduction in the combination therapy regimen for hospitalized patients with moderate to severe community-acquired pneumonia.Materials and methods. A prospective, open label, parallel group, randomized study comparing the efficacy of azoximer bromide introduction in the combination therapy of hospitalized patients with moderate to severe community-acquired pneumonia was conducted at the premises of Federal Scientific and Clinical Center for Reanimatology and Rehabilitation. 30 patients were included in the study group and 37 patients in the comparator group. The baseline characteristics were comparable in both groups. Results. The azoximer bromide introduction in the combination therapy of patients with community-acquired pneumonia led to a statistically significant reduction in the duration of hospital stay (Me (LQ; HQ): 9 (8; 10) days for the study group and 13 (10; 14) days for the comparator group, (p = 0.000078), duration of ICU stay (Me (LQ; HQ) 2 days (1.5; 2.5) and 5 days (5.0; 6.0), respectively, (p = 0.00001), the duration of febrile fever 5 (± 0.6) days versus 10 (± 1.2) days (p = 0.0000), the incidence of acute respiratory failure (13.33% in group 1 versus 37.84% in group 2, p = 0.024) and septic shock (10% in group 1 versus 32.43% in group 2, p = 0.0285).Conclusions. The azoximer bromide introduction in the standard therapy regimen for patients with community-acquired pneumonia allowed to reduce the duration of hospital stay, the duration of ICU stay, the length of febrile fever, the incidence of septic shock and respiratory failure. The possible mechanisms of action may include a reduction of the severe inflammatory reactions and an optimization of the patient's immune response to the infectious process.


2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Jinsup Kim ◽  
Min-Sun Kim ◽  
Byung-Kyu Suh ◽  
Cheol Woo Ko ◽  
Kee-Hyoung Lee ◽  
...  

Abstract Background Short stature is the most consistent characteristic feature of Turner syndrome (TS). To improve final heights of children with TS effectively, it is important to provide them with early and appropriate treatment using growth hormone (GH). The objective of this study was to assess the efficacy and safety of a new recombinant human GH, Growtropin®-II (DA-3002, Dong-A ST Co., Ltd) versus a comparator (Genotropin®, Pfizer Inc.) for Korean children with TS. Methods This open-label, active-controlled, parallel-group, randomized controlled phase III trial was conducted at 11 hospitals in Korea. Eligible patients (n = 58) were randomized to two groups: 1) DA-3002 group (administrated with DA-3002 at 0.14 IU [0.0450–0.050 mg] /kg/day); and 2) comparator group (administrated with the comparator at 0.14 IU [0.0450–0.050 mg] /kg/day). Results The change from baseline in annualized height velocity (HV) after a 52-week treatment period was 4.15 ± 0.30 cm/year in the DA-3002 group and 4.34 ± 0.29 cm/year in the comparator group. The lower bound of 95% two-sided confidence interval for group difference in the change of annualized HV (− 1.02) satisfied the non-inferiority margin (− 1.5). The change in height standard deviation score (HtSDS) at 52-week was 0.70 ± 0.23 for the DA-3002 group and 0.66 ± 0.39 for the comparator group, showing no significant (p = 0.685) difference between the two groups. The change of skeletal maturity defined as change in bone age/change in chronological age between the two groups was not significantly different (1.25 ± 0.58 for the DA-3002 group and 1.47 ± 0.45 for the comparator group, p = 0.134). Changes from baseline in serum insulin-like growth factor-1 (IGF-1) and insulin-like growth factor binding protein-3 (IGFBP-3) after 52 weeks of treatment did not differ significantly between the two groups (p = 0.565 and p = 0.388, respectively) either. The occurrence of adverse events was not statistically different between groups. Conclusions This study demonstrates that the efficacy and safety of GH treatment with DA-3002 in children with TS are comparable with those of the comparator. It is expected to analysis the long-term effect of DA-3002 on the increase of final adult height in children with TS and possible late-onset complications in the future. Trial registration The study was registered at ClinicalTrials.gov. ClinicalTrials.gov identifier: NCT01813630 (19/03/2013).


Blood ◽  
2021 ◽  
Vol 138 (Supplement 1) ◽  
pp. 3772-3772
Author(s):  
Itai Zamir ◽  
Tamir Shragai ◽  
Svetlana Trestman ◽  
Tomer Ziv Baran ◽  
Efrat Luttwak ◽  
...  

Abstract Introduction: Multiple myeloma (MM) is malignancy of plasma cells, which secrete monoclonal antibodies that are detectable in the patient's (pt) serum and/or urine. Infrequently, MM may present as an oligosecretory disease, where monoclonal protein (M-protein) and involved free light chain (iFLC) are either not detected (=non-secretory) or are both below the threshold for measurable disease (=oligosecretory) as defined by International Myeloma Working Group (IMWG). The incidence of non-secretory MM at presentation has been estimated at 1-2% [Chawla, Eur J Haematol 2015], yet data regarding the frequency and clinical phenotype of oligosecretory relapse is lacking. These pts are typically excluded from most clinical trials. Methods: Pt's MM was classified as oligo-secretory, in the absence of measurable disease according to the IMWG criteria (M-protein≥1 gr/dL, or U-PEP > 200 mg/24 hrs or involved free light chain≥ 100 mg/L). Relapse was defined according to IMWG criteria, based on changes in monoclonal protein in the serum or urine, bone or extramedullary lesions on imaging, bone-marrow plasmacytosis, serum hemoglobin, creatinine and calcium levels. Pts treated at our center for MM, who had secretory (i.e., measurable disease) MM at diagnosis, and relapsed (secretory or non-secretory relapse) between January 2016 to July 2020, were included. MM baseline pt and disease characteristics, disease characteristics at relapse, treatment regimens and outcomes were documented. The first oligosecretory relapse (OSR) that any given pt experienced was defined as the index OSR for that pt. For each pt with an OSR, we identified the first 4 pts with a secretory relapse (SR) in the dataset, who matched the pt by the relapse index number and calendar year of relapse, to form a SR comparator group. We compared pt and disease characteristics, therapy patterns and outcomes between the OSR and SR groups. Results: One hundred and seventy-seven pts with relapse were identified; 8 (4.5%) had oligo-secretory disease at MM diagnosis and were excluded; 152 of the 169 pts who were secretory at presentation (89.9%) had secretory MM at all relapses; 17 (10.0%) had an OSR (4 non-secretory and 13 oligosecretory), the SR comparator group included 67 pts. Pts with OSR had similar characteristics compared to SR pts at MM presentation, in terms of demographics, FISH cytogenetics, ISS, levels of M-protein and involved FLC, frequency of extramedullary disease, target organ involvement; Treatment pattern and response to upfront therapy were comparable (Fig1 A). Oligosecretory disease was more frequent at relapse compared to newly diagnosed MM (10% vs 4.5%), proportion of OSR among pts with previously secretory MM increased in later relapses. The proportion of OSR from total 3 rd or 4 th relapses, was high as 20% and 17.6%, respectively (Fig 1B). OSR pts had a higher rate of new plasmacytoma (53% vs 9%, p<0.001) as the criteria for relapse, and a trended towards increase in LDH, and higher rate of extramedullary disease (17% vs 4.4%, p=0.09) whereas increase in monoclonal protein was more frequent in the SR group as a criterion for relapse. Overall response rate to therapy of the index relapse was similar between groups among evaluable pts (58% vs 64%), however, in 5/17 (29%) of the OSR, response was non evaluable from available documentation. Median follow up was 10.2 months [Q1 4.1- Q3 16.7]. Twelve-months progression free survival was 82.4% vs 73.8% (p=0.76), and 12-months overall survival was 60.2% vs 64.75% (p=0.60) in RS and OSR, respectively. Conclusions: Oligosecretory disease was more frequent in relapsed MM, compared to its rate at MM presentation, reaching 10% of the pts with relapsed MM and increasing in more advanced relapses. Pts with OSR and those with SR had similar clinical characteristics of their MM at presentation as well as comparable outcomes, but pts with OSR had higher rates of new skeletal and extramedullary lesions. As identification of the OSR may be challenging in the absence of serum and urine biomarkers, awareness and clinical alertness are warranted to avoid end organ damage. We suggest inclusion of OSR pts in clinical trials should be considered, despite some challenges in following their therapy response, as they comprise a non-negligible proportion of pts, in particular in the advanced relapse setting. Figure 1 Figure 1. Disclosures Avivi: Kite, a Gilead Company: Speakers Bureau; Novartis: Speakers Bureau. Cohen: Neopharm / promedico: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding; Karophram: Membership on an entity's Board of Directors or advisory committees, Research Funding; Takeda: Membership on an entity's Board of Directors or advisory committees, Research Funding; GSK: Consultancy, Membership on an entity's Board of Directors or advisory committees; Amgen: Membership on an entity's Board of Directors or advisory committees, Research Funding; Janssen: Membership on an entity's Board of Directors or advisory committees.


2021 ◽  
Vol 6 ◽  
pp. 256
Author(s):  
Vilas Navapurkar ◽  
Josefin Bartholdson Scott ◽  
Mailis Maes ◽  
Thomas P Hellyer ◽  
Ellen Higginson ◽  
...  

Background: The diagnosis of pneumonia has been hampered by a reliance on bacterial cultures which take several days to return a result, and are frequently negative. In critically ill patients this leads to the use of empiric, broad-spectrum antimicrobials and compromises good antimicrobial stewardship. The objective of this study was to establish the performance of a syndromic molecular diagnostic approach, using a custom TaqMan array card (TAC) covering 52 respiratory pathogens, and assess its impact on antimicrobial prescribing. Methods: The TAC was validated against a retrospective multi-centre cohort of broncho-alveolar lavage samples. The TAC was assessed prospectively in patients undergoing investigation for suspected pneumonia, with a comparator cohort formed of patients investigated when the TAC laboratory team were unavailable. Co-primary outcomes were sensitivity compared to conventional microbiology and, for the prospective study, time to result. Metagenomic sequencing was performed to validate findings in prospective samples. Antibiotic free days (AFD) were compared between the study cohort and comparator group. Results: 128 stored samples were tested, with sensitivity of 97% (95% confidence interval (CI) 88-100%). Prospectively, 95 patients were tested by TAC, with 71 forming the comparator group. TAC returned results 51 hours (interquartile range 41-69 hours) faster than culture and with sensitivity of 92% (95% CI 83-98%) compared to conventional microbiology. 94% of organisms identified by sequencing were detected by TAC. There was a significant difference in the distribution of AFDs with more AFDs in the TAC group (p=0.02). TAC group were more likely to experience antimicrobial de-escalation (odds ratio 2.9 (95%1.5-5.5)). Conclusions: Implementation of a syndromic molecular diagnostic approach to pneumonia led to faster results, with high sensitivity and impact on antibiotic prescribing.


2021 ◽  
Vol 42 (Supplement_1) ◽  
Author(s):  
M Terenicheva ◽  
R M Shakhnovich ◽  
O V Stukalova ◽  
E A Butorova ◽  
S K Ternovoy

Abstract Purpose To investigate the impact of coronary anatomy and pPCI parameters on the most prognostically significant MRI measures of acute MI with ST segment elevation (MVO, infarct size). Methods The study included 52 patients with STEMI and primary percutaneous coronary intervention (pPCI) of infarct-related arteries (IRA). On Days 3–7 contrast-enhanced cardiac MRI was done. Tissue analysis of scans was performed evaluating infarct size, presence and size of MVO. Results The study included 52 patients with first STEMI within <48 hours of onset. All patients urgently underwent pPCI for reperfusion. Patients were divided into 2 groups separated by the median time to reperfusion treatment (3 hours). There were no significant differences between groups in MRI-measured EF (In the group with later pPCI (>3 hours of symptom onset EF was 49.0±11.0%, and in the comparator group – 45.7±10.5%, p=0,2). MRI-measured infarct size was significantly higher in the group where pPCI was done >3 hours of symptom onset: 18.1±1.7% of the LV mass, compared to the early reperfusion group – 10.9±1.9% (p=0.009). MVO magnitude was also higher in the later pPCI group (2.6±0.64% vs 0.03±0.3% in the comparator group), (p<0,027). Correlation analysis also revealed a reliable relationship between IS and time to reperfusion (R 0.381, p=0.006). LAD lesions were associated with higher infarct size values (p=0.02) and higher risk of MVO (odds ratio 2.9, CI 0.83–10.0, p=0.03). Complete occlusion of IRA was associated with higher IS (16,97±3.3 vs 12.05±1.4, p=0.02). There was no reliable correlations between IRA patientcy and MVO magnitude (p=0.7). Conclusions In this study pPCI timing, in groups of below and more than 3 hours after symptom onset, had no significant impact on EF, as determined by MRI. However, pPCI timing exceeding 3 hours significantly influenced infarct size, the occurrence and magnitude of microvascular obstruction. LAD being the IRA was associated with larger IS, higher risks of MVO development. Patient IRA was associated with smaller IS as determined by MRI. FUNDunding Acknowledgement Type of funding sources: Public grant(s) – National budget only. Main funding source(s): Ministry of Healthcare Russian Federation


2021 ◽  
Author(s):  
Jinsup Kim ◽  
Min-Sun Kim ◽  
Byung-Kyu Suh ◽  
Cheol Woo Ko ◽  
Kee-Hyoung Lee ◽  
...  

Abstract Background Short stature is the most consistent characteristic feature of Turner syndrome (TS). To improve final heights of children with TS effectively, it is important to provide them with early and appropriate treatment using growth hormone (GH). The objective of this study was to assess the efficacy and safety of a new recombinant human GH, Growtropin®-II (DA-3002, Dong-A ST Co., Ltd) in comparison with a comparator (Genotropin®, Pfizer Inc.) for Korean children with TS. Methods This open-label, active-controlled, parallel-group, randomized controlled phase III trial was conducted at 11 hospitals in Korea. Eligible patients (n = 58) were randomized to two groups: 1) DA-3002 group (administrated with DA-3002 at 0.14 IU /kg/day); and 2) comparator group (administrated with the comparator at 0.14 IU /kg/day). Results The change from baseline in annualized height velocity (HV) after a 52-week treatment was 4.15 ± 0.30 cm/year in the DA-3002 group and 4.34 ± 0.29 cm/year in the comparator group. The lower bound of 95% two-sided confidence interval for group difference in the change of annualized HV (-1.02) satisfied the non-inferiority margin (-1.5). The change in height standard deviation score (HtSDS) at 52-week was 0.70 ± 0.23 for the DA-3002 group and 0.66 ± 0.39 for the comparator group, showing no significant (p = 0.685) difference between the two groups. Skeletal maturity defined as a change in bone age or a change in chronological age between the two groups was not significantly different (1.25 ± 0.58 for the DA-3002 group and 1.47 ± 0.45 for the comparator group, p = 0.134). Changes of serum insulin-like growth factor-1 (IGF-1) and insulin-like growth factor binding protein-3 (IGFBP-3) after 52 weeks of treatment did not differ significantly between the two groups (p = 0.565 and p = 0.388, respectively) either. Adverse events were not significant in either group. Conclusions This study demonstrates that the efficacy and safety of GH treatment with DA-3002 in children with TS are comparable with those of the comparator. Thus, treatment with DA-3002 can be used to improve their growth. DA-3002 is also well tolerated in children with TS. Trial registration: The study was registered at ClinicalTrials.gov. ClinicalTrials.gov identifier: NCT01813630 (19/03/2013)


2021 ◽  
Author(s):  
Haruhiko Yamazaki ◽  
Kiminori Sugino ◽  
Jaeduk Yoshimura Noh ◽  
Ryohei Katoh ◽  
Kenichi Matsuzu ◽  
...  

Abstract Purpose There is no sufficient data about the clinical course and outcome in thyroid cancer patients who become pregnant after diagnosis of distant metastasis (DM). The current study was conducted to collect information regarding the clinical and reproductive characteristics, and outcomes in thyroid cancer patients who became pregnant after being diagnosed with DM. Methods Records of 125 differentiated thyroid cancer (DTC) patients with age ≤ 45 years at DM diagnosis who had visited Ito Hospital from January 2005 to June 2021 were retrospectively reviewed. Among those 125 patients, 28 who became pregnant after DM diagnosis were classified as pregnant group, and the remained 97 patients were classified as comparator group. Results In pregnant group, the median age at malignancy diagnosis, DM diagnosis, and first pregnancy after DM diagnosis was 25 years (range, 4–41 years), 27 years (range, 11–41 years), and 32 years (range, 25–45 years), respectively. Fifty-five pregnancies and 40 live births were reported. Three patients had live births by embryo transfer. Other pregnancy outcomes were miscarriage (n = 14) and induced abortion (n = 1). No one died during the follow-up period in this study. The 10-year progression free survival (PFS) rates of pregnant and comparator group were 92.1% and 74.4%, respectively. Conclusion DTC patients who became pregnant after DM diagnosis had good survival. Our results add to the information required for counseling thyroid cancer patients who have concerns about their fertility in the future.


Pharmacy ◽  
2021 ◽  
Vol 9 (3) ◽  
pp. 140
Author(s):  
Srujitha Marupuru ◽  
Harman Dhatt ◽  
Jennifer M. Bingham ◽  
Terri Warholak

Nearly half of all patients prescribed a chronic medication do not adhere to their regimen. Conversion from a 30- to 90-day medication refill is associated with improved adherence. The objective of the study was to assess the change in proportion of days covered (PDC) in those who converted to a 90-day fill and those who did not after a telehealth pharmacist-delivered, medication adherence intervention. This retrospective review involved data collected between May and December 2018. Patients with ≤85% baseline PDC rates were targeted. One group included patients who converted to a 90-day fill after the pharmacist intervention. The comparator group did not convert to a 90-day fill. Differences in median end-of-year (EOY) PDC rates for each medication class were compared between groups. An alpha level of 0.05 was set a priori. Overall, 237 patients converted to a 90-day fill and 501 did not. There was no significant difference in age, sex, and total number of drugs per patient. A Mann–Whitney U test revealed statistically significant improvements in median EOY PDC in the group that converted to a 90-day fill (+9% vs. −3%, p < 0.001). Pharmacist-delivered telehealth interventions were associated with improved PDC rates in those who converted to a 90-day fill.


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