scholarly journals A prospective, observational study on conversion of Clinically Isolated Syndrome to Multiple Sclerosis during 4-year period (MS NEO study) in Taiwan

2018 ◽  
Author(s):  
Long-Sun Ro ◽  
Chih-Chao Yang ◽  
Rong-Kuo Lyu ◽  
Kon-Ping Lin ◽  
Tzung-Chang Tsai ◽  
...  
Keyword(s):  
Observational Study ◽  
Conversion Rate ◽  
Prognostic Significance ◽  
Risk Indicators ◽  
Clinical Event ◽  
First Episode ◽  
Conversion Rates ◽  
Demyelinating Lesions ◽  
Baseline Characteristics

AbstractImportanceCIS to MS conversion rates vary depending on population cohorts, initial manifestations, and durations of follow-up.ObjectiveTo investigate conversion rate of patients from CIS to MS and the prognostic significance of demographic and clinical variables in Taiwanese population.DesignNationwide, prospective, multi-centric, observational study from November 2008 to November 2014 with 4 years follow-up.SettingMulti-centre setting at 5 institutions in Taiwan.Participants152 patients having single clinical event potentially suggestive of MS in last 2 years were enrolled as consecutive sample. 33 patients were lost to follow-up and 16 patients did not complete the study.103 patients completed the study.Intervention(s) (for clinical trials) or Exposure(s) (for observational studies)Natural progression from first episode of CIS to MS or NMO was observed.Main Outcome(s) and Measure(s)Variables analysed were ‘proportion of patients converting to MS or NMO after first episode of CIS’, ‘duration between first episode of neurological event and diagnosis of MS’, ‘status of anti-AQP4 IgG’ and ‘length of longest contiguous spinal cord lesion in MS patients’. Association between baseline characteristics and progression to MS from CIS was analyzed using multiple logistic regression. Multivariate time dependent effect of baseline characteristics on progression to MS was plotted.Results14.5% patients with CIS converted to MS after 1.1 ± 1.0 years with greater predisposition (18.8%) in those having syndromes referable to the cerebral hemispheres. Conversion rate from ON to MS was 9.7%. 90.9% patients had benign disease course. 46.7% patients had abnormal MRIs at baseline, with 0.6±0.5 contrast enhanced lesions. ‘Below normal BMI’ and ‘MRI lesion load (≥ 4 lesions)’ were identified as risk indicators for the development of MS. Only 4.5% were positive for anti-AQP4 antibody in MS patients and amongst them, 80% were NMO patients as diagnosed by modern criteria.Conclusions and Relevance‘Below normal BMI’ and ‘number of demyelinating lesions (≥4)’ are significant predictors of conversion from CIS to MS. A low conversion rate to MS in Taiwanese CIS patients and majority of them having a benign course and minimal disability suggest the roles of geographic, genetic and ethnic factors.Trial RegistrationNon-trial observational study.

Serial T-SPOT.TB in household contacts of tuberculosis patients: a 6-year observational study in China

2019 ◽  
Vol 23 (9) ◽  
pp. 989-995 ◽  
Author(s):  
H-C. Zhang ◽  
Q-L. Ruan ◽  
J. Wu ◽  
S. Zhang ◽  
S-L. Yu ◽  
...  
Keyword(s):  
Observational Study ◽  
Preventive Treatment ◽  
Preventive Therapy ◽  
Interferon Gamma Release Assay ◽  
Household Contacts ◽  
Conversion Rates ◽  
Ltbi Prevalence ◽  
Release Assay ◽  
Latent Tb Infection

BACKGROUND: Screening tuberculosis (TB) contacts is a priority for TB control; however, it remains inadequate in most regions of China.OBJECTIVE: To investigate the progression of latent TB infection (LTBI) using the interferon-gamma release assay (IGRA) in contacts of active TB patients.DESIGN: This longitudinal prospective observational study included 159 household contacts aged ≥14 years without preventive treatment who were followed up for 6 years to compare their conversion and reversion rates using the T-SPOT®.TB IGRA to diagnose LTBI.RESULTS: Among the 159 household contacts, LTBI positivity was 47.5%. Age was independently associated with LTBI (OR 3.6, 95%CI 1.81–7.14; P = 0.00). T-SPOT.TB conversion rates were respectively 29.4% and 18.8% at 3- and 6-year follow-up. The reversion rates were 9.4% of contacts during the 3-year follow-up period, which increased to 38.2% at the 6-year follow-up. A decreasing trend in spot-forming cells on T-SPOT.TB was observed in most patients at the 6-year follow-up.CONCLUSION: LTBI prevalence among household contacts was relatively high, particularly in elderly patients. Furthermore, serial IGRA testing was highly dynamic; however, this overall trend gradually decreased over time, even if preventive therapy was not prescribed.

scholarly journals Temporal trend of clinical events in patients with atrial fibrillation on edoxaban therapy: results from the non-interventional global ETNA-AF program

2021 ◽  
Vol 42 (Supplement_1) ◽  
Author(s):  
L Dinshaw ◽  
C Chen ◽  
R De Caterina ◽  
W Jiang ◽  
Y.-H Kim ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Clinical Practice ◽  
Ischaemic Stroke ◽  
Major Bleeding ◽  
Temporal Trend ◽  
Routine Clinical Practice ◽  
Clinical Event ◽  
Clinical Events ◽  
Baseline Characteristics

Abstract Background Patients with atrial fibrillation (AF) who initiated vitamin K antagonist (VKA) were at highest risk of stroke and bleeding in the first few months of therapy. Understanding of the temporal trend of clinical events in AF patients on non-VKA oral anticoagulant (NOAC) therapy should aid therapeutic decisions. Purpose To evaluate the temporal trend of clinical events in AF patients receiving edoxaban in routine clinical practice in the Global ETNA-AF program. Methods Global ETNA-AF is a multicentre, prospective, noninterventional program evaluating the safety and effectiveness of edoxaban in patients from European and Asian countries. Thromboembolic, bleeding and death events were analysed separately for the 1st and 2nd year of the follow-up period, using a time-to-first-event estimation of cumulative incidence and annual rate via Kaplan-Meier method. Results A total of 27,617 patients were included in this analysis, 48.6% from Europe and 51.4% from Japan, Korea, and Taiwan. Baseline characteristics were consistent with typical AF population in real world studies (Table 1). Approximately 83% of patients received the recommended edoxaban dose. Annualized rates of ischaemic stroke and major bleeding (ISTH) were lower in the 2nd year than in the 1st year: ischaemic stroke 0.59% (95% CI, 0.50–0.70) vs 0.86% (95% CI, 0.75–0.98), p=0.015; major bleeding 0.87% (95% CI, 0.75–1.00) vs 1.15% (95% CI, 1.02–1.29), p=0.036. The trend toward lower rates of ischaemic stroke and major bleeding in the 2nd year was consistent across regions. All-cause mortality increased slightly from the 1st year to the 2nd year, which was not statistically significant and was not driven by cardiovascular (CV) mortality (Table 2). Conclusion In routine clinical practice in the Global ETNA-AF program, major bleeding and ischaemic stroke rates in >27,000 patients on edoxaban therapy declined from 1st year to 2nd year. Further analyses will investigate whether such trend is influenced by selection for healthier patients over time. Longer follow-up is needed to better understand long-term trends. FUNDunding Acknowledgement Type of funding sources: Private company. Main funding source(s): Daiichi Sankyo Table 1. Baseline characteristics Table 2. Annualised clinical event rates

scholarly journals Safety and effectiveness of the Low Profile Visualized Intraluminal Support (LVIS and LVIS Jr) devices in the endovascular treatment of intracranial aneurysms: results of the TRAIL multicenter observational study

2017 ◽  
Vol 10 (7) ◽  
pp. 675-681 ◽  
Author(s):  
Christina Iosif ◽  
Michel Piotin ◽  
Suzana Saleme ◽  
Xavier Barreau ◽  
Jacques Sedat ◽  
...  
Keyword(s):  
Observational Study ◽  
Intracranial Aneurysms ◽  
Clinical Event ◽  
Morbidity Rate ◽  
Complication Rates ◽  
Clinical Safety ◽  
Multicenter Observational Study ◽  
Low Profile ◽  
Unruptured Intracranial Aneurysms

Background and purposeTo evaluate the safety and effectiveness of the low-profile braided intracranial stents called the Low Profile Visualized Intraluminal Support (LVIS) devices for stent-assisted coil embolization of wide-necked intracranial aneurysms.Materials and methodsThis was a prospective, multicenter, observational study of unruptured and ruptured intracranial aneurysms treated with the LVIS devices. Imaging and clinical data were independently analyzed respectively by CoreLab and Clinical Event Committee. Primary endpoints were clinical safety, effectiveness, and angiographic stability of the results at 6 and 18 months.ResultsTen centers participated in the study; 102 patients were included and 90 patients (42.2% men, 57.8% women) were eventually analyzed, among which 27 (30.0%) had multiple aneurysms. Twenty-three (25.6%) were ruptured aneurysms, four of which (4.4%) were treated in the acute phase. One aneurysm was treated per patient; 92 LVIS and LVIS Jr devices were placed overall. The total aneurysm occlusion rate was 91.0% on immediate post-procedure angiograms, which remained unchanged at 6-month follow-up and was 92.4% at 18-month follow-up. One patient (1.1%) underwent retreatment between 6 and 18 months of follow-up. A modified Rankin score of 0 was documented for most cases immediately after the procedure (86.7%) and at 6-month (86.8%) and 18-month (83.3%) follow-up. The overall permanent morbidity rate at 18 months was 5.6% and the overall rate of events with sequelae related to the stent was 2.2%. The 18-month procedure-related mortality rate was 3.3%. No patient was deemed to require retreatment at 18-month follow-up.ConclusionThe LVIS/LVIS Jr endovascular devices are safe and effective in the treatment of ruptured and unruptured intracranial aneurysms, with acceptable complication rates, very high immediate total occlusion rates, and stable angiographic results.

HANNA: Real-world outcomes from an observational study with nivolumab in patients with recurrent or metastatic squamous cell carcinoma of the head and neck in Germany.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 6532-6532
Author(s):  
Andreas Dietz ◽  
Manfred Welslau ◽  
Dennis Hahn ◽  
Christine Langer ◽  
Ulrike Bockmühl ◽  
...  
Keyword(s):  
Squamous Cell Carcinoma ◽  
Adverse Events ◽  
Observational Study ◽  
Cell Carcinoma ◽  
Real World ◽  
Platinum Sensitive ◽  
Metastatic Squamous Cell Carcinoma ◽  
Baseline Characteristics ◽  
Ecog Ps

6532 Background: Nivolumab has demonstrated efficacy in clinical trials of recurrent or metastatic squamous cell carcinoma of the head and neck (R/M SCCHN). As only limited real-world data are available, we describe the use of nivolumab and its outcomes in routine clinical practice. Methods: HANNA is a prospective, observational study of patients with R/M SCCHN treated with nivolumab in 56 hospitals and practices in Germany. In total, 385 patients will be followed for ≤ 5 years from treatment initiation until death, withdrawal of consent, loss of follow-up/record, or end of study. The primary objective is overall survival (OS). Secondary objectives include baseline characteristics, safety profiles, and quality of life (QOL) assessment. Results: By November 2019, data from 311 patients were available. Median follow-up was 3.5 months. Baseline characteristics were male, 81.7%; median age, 63 years; history of smoking, 73.3%; Eastern Cooperative Oncology Group performance status (ECOG PS) 0/1, 60.8%; ECOG PS 2/3, 29.6%. Location of primary tumor was oropharynx, 38.3%; hypopharynx, 20.9%; oral cavity, 22.8%; larynx, 11.6%; others, 6.4%. 55.6% of R/M SCCHN patients progressed ≤ 6 months after platinum-based therapy, whereas 43.4% were platinum-sensitive (progressed > 6 months after platinum-based therapy). Nivolumab was received by 25.1% of patients as first therapy after platinum-based chemo- or radiochemotherapy, by 62.1% as second therapy, and by 12.9% as later line therapy. Median treatment duration was 4.6 months. OS at 1 year was 43.3%. 1-year OS for patients with ECOG PS 0 was 75.9%; ECOG PS 1, 41.2%; and ECOG PS 2, 27.3%. Platinum-sensitive patients had higher 1-year OS probability (51.6%). Drug-related adverse events (grade 1/2) and serious adverse events (grade 3/4) were observed in 28.9% and 10.0% of patients, respectively. Interim QOL data (per FACT-H&N and EQ-5D questionnaire) indicated a tendency toward stabilization or slight improvement. We will present an update of the data with longer follow-up (data cut March 2020). Conclusions: HANNA represents one of the largest real-world datasets for nivolumab in R/M SCCHN and comprises a more diverse set of patients than the phase 3 CheckMate 141 trial, including patients with higher ECOG PS, age, and platinum sensitivity. Outcomes from HANNA show that the improved OS, safety, and QOL seen with nivolumab in the real-world setting are consistent with the outcomes from CheckMate 141. Clinical trial information: NCT03114163 .

scholarly journals Comparison of bipolar plasmakinetic resection of prostate versus photoselective vaporization of prostate by a three year retrospective observational study

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Xu Cheng ◽  
Chuying Qin ◽  
Peng Xu ◽  
Yijian Li ◽  
Mou Peng ◽  
...  
Keyword(s):  
Observational Study ◽  
Sexual Function ◽  
Comprehensive Evaluation ◽  
Operation Time ◽  
Retrospective Observational Study ◽  
Urinary Tract Symptoms ◽  
Photoselective Vaporization ◽  
Photoselective Vaporization Of Prostate ◽  
Baseline Characteristics

AbstractComprehensive evaluation of photoselective vaporization of the prostate (PVP) versus plasmakinetic resection of the prostate (PKRP) in treating benign prostatic hyperplasia (BPH) is inadequate. This single-centre, retrospective observational study was designed to compare their efficacy, complications and sexual function. A total of 215 patients under PVP or PKRP were included in the study, propensity score matching (PSM) was performed to match the baseline characteristics of the two groups, and perioperative and three-year follow-up data were compared between them. Finally, 120 patients (60 for PVP and 60 for PKRP) were matched after PSM. Compared with the PKRP group, the intraoperative haemoglobin loss was lower (9.08 vs 13.75 g/L, P < 0.001) and the duration of catheterization and postoperative hospital stay were shorter (2.97 vs 4.10 day, P < 0.001; 3.95 vs 5.13 day, P < 0.001, respectively), but the operation time was longer (56.72 vs 49, 90 min, P < 0.001) in the PVP group. Urination measurements were improved for both groups after surgery, although no significant differences were found between them during follow-up. Sexual function after surgery was partly increased; however, frequent retrograde and discomfortable ejaculation occurred in both groups. In addition, dysuria incidence and retreatment were higher in the PVP group at 12 months. In conclusion, PVP is safe and effective in relieving BPH-related lower urinary tract symptoms with less perioperative blood loss and earlier recovery without inferior sexual function effects. However, the study is potentially affected by residual unmeasured confounding.

Efficiency of the Neonatal Screening Program for Sickle Cell Disease. the Belgian Experience

Blood ◽  
2010 ◽  
Vol 116 (21) ◽  
pp. 4816-4816
Author(s):  
Phu-Quoc Le ◽  
Alina Ferster ◽  
Françoise Vertongen ◽  
Christiane Vermylen ◽  
Anna Vanderfaeillie ◽  
...  
Keyword(s):  
Neonatal Screening ◽  
Screening Program ◽  
Comprehensive Care ◽  
Clinical Event ◽  
First Episode ◽  
Severe Anemia ◽  
Cerebral Lesions ◽  
Significant Difference ◽  
Neonatal Screening Program

Abstract Abstract 4816 The objective of this study was to determine the efficiency of the neonatal screening program for SCD which was implemented in 1994 in few maternities and extended in 2003 to all maternities in Brussels. It is a systematic screening performed on liquid cord blood. Affected children are referred to a specialized center. We reviewed 146 medical records of patients with SCD born in Belgium and prospectively followed from the time of their diagnosis in three Brussels' Academic Centers. The study was approved by each local ethical committee and informed consent of each patient was received. Data were collected from the time of diagnosis of SCD (either done by neonatal screening or when a clinical event led to the diagnosis) until December 31, 2007. We focused on the subgroup of patients older than 3 years of age at December 31, 2007 and those were divided into two groups: those diagnosed by the neonatal screening (NS) and those diagnosed later (no NS). The incidence of major events (first septicemia, first stroke, first episode of severe anemia, first hospitalization and its duration, and death) was compared. Among the total population studied, 89 patients were diagnosed through the NS and 57 were not (no NS). While among those older than 3 years of age at the time of evaluation, 55 (median age 6.7 year, range: 3–16) and 49 (median age 11.2 year, range: 4–27) patients were in the NS or no NS group, respectively. The median age at diagnosis for the no NS cohort is 1 year (range: 1–6). The follow-up of the NS and no NS cohort account for 301.5 and 473.8 patient-years, respectively. Most of the patients were homozygous for Hb S (Hb SS) (82% in NS group and 94% in no NS group). Incidence of a first episode of septicemia was similar in both groups (10.9% in NS group versus 12.3% in no NS group). The median age at the time of sepsis was 27.6 months and 10 months in the NS and no NS group, respectively (Table 1). All the patients from the NS group were on penicillin prophylaxis versus 40 % in the no NS group. The main pathogen remained Streptococcus pneumoniae and there were no resistant strain despite regular prophylaxis.Table 1:Data on first septicemia in the non neonatal screening groupPatientAge at diagnosisAge at septicemiaProphylaxisPathogen13 m12 mYesSt. pneumoniae226 m3 mNoSt. pneumoniae310 m16 mYesSalmonella42 m14 mNoSt. pneumoniae511 m1 dNoSt.β hemol gr A61 m26 mYesSt. pneumoniae Incidence of stroke was 1.8% (1/55; 3.2 y.o.) in the NS cohort compared to 8.2% (4/49; 2.8, 5.3, 8.0 and 18.8 y.o.) in the no NS cohort. All the patients were Hb SS. The unique patient from the NS group was previously treated with Hydroxyurea (HU) for repeated vaso-occlusive crisis. 2 were also under HU prior to stroke for the same reason. Ischemic cerebral lesions were observed on MRI for all, except for the NS group patient. There was no significant difference either in the incidence of the first episode of severe anemia or the first hospitalization defined in term of number of days of hospitalization for both groups. Two deaths occurred in the NS cohort in the very early childhood (septicemia in one and acute severe anemia for the other). These deaths are attributable to no compliance to antibio-prophylaxis in the first patient and poor follow-up in the second one. Furthermore these deaths happen in the very early period after neonatal screening has been initiated. No death occurred in the NS group since 12 years probably due to better parents' education and comprehensive care. One death was observed in the no NS group (sudden rupture of cerebral aneurysm). In conclusion, neonatal screening program is feasible, safe and appropriate to detect SCD. It enables early diagnosis and therefore early treatment, and could improve both morbidity and eventually mortality of SCD. Although the relative small size of our study and the bias due to unreported early deaths by infection or severe anemia in the no NS group before the diagnosis of SCD has been done, our results are very encouraging: neonatal screening delays the age of the first severe infection and might reduce the incidence of early neurological complications. It also underlines the better outcome with improvement of parental education and comprehensive care. These data emphasize the need to continue neonatal screening for SCD in Brussels and to extend it to all Belgian maternities. Disclosures: No relevant conflicts of interest to declare.

Tumefactive demyelinating lesions as a first clinical event: Clinical, imaging, and follow-up observations

2015 ◽  
Vol 358 (1-2) ◽  
pp. 118-124 ◽  
Author(s):  
In Hye Jeong ◽  
Su-Hyun Kim ◽  
Jae-Won Hyun ◽  
AeRan Joung ◽  
Hyo-Jin Cho ◽  
...  
Keyword(s):  
Clinical Event ◽  
Clinical Imaging ◽  
Demyelinating Lesions

scholarly journals Parkinson's disease mild cognitive impairment classifications and neurobehavioral symptoms clarification letter

2018 ◽  
Vol 30 (9) ◽  
pp. 1417-1417
Author(s):  
Richard Camicioli ◽  
Kirstie Mcdermott
Keyword(s):  
Parkinson’S Disease ◽  
Parkinson's Disease ◽  
Cognitive Impairment ◽  
Mild Cognitive Impairment ◽  
Conversion Rate ◽  
Cognitive Domain ◽  
Targeted Interventions ◽  
Conversion Rates ◽  
Incident Cases

We thank Ms. Horne et al. for the clarification of our misquoting of their paper (Wood et al., 2016). They clarify that 21% of their overall sample of patients with Parkinson's disease (PD-MCI) converted to dementia in over four years, which we erroneously attributed to the mild cognitive impairment (MCI) group in our discussion (McDermott et al., 2017). This was virtually identical to our overall conversion rate of 20%. Their conversion rate of patients with PD-MCI, as defined by two cognitive tests impaired (1.5 SD) within a single cognitive domain, was 51%, whereas the conversion rate was 38% when the PD-MCI group included patients with impairment within and between cognitive domains. Their conversion rates are similar to our rate of 42% (as defined with 1.5 SD impairment within or across domains) and the rate of 39% in a study with five-years of follow-up of incident cases (Pedersen et al., 2017). Our overall conversion occurred over a slightly shorter time span. In addition to conversion rates, all the studies acknowledge that some patients can revert to normal cognitive status, which varies based on classification criteria and length of follow-up. Comparable conversion across studies using similar criteria is reassuring and can encourage planning of targeted interventions (Hoogland et al., 2017).

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