scholarly journals Olfactory training and visual stimulation assisted by web-application in patients with persistent olfactory dysfunction after SARS-CoV-2 infection: observational study. (Preprint)

2021 ◽  
Author(s):  
Fabrice Denis ◽  
Anne-Lise Septans ◽  
Lea Periers ◽  
Jean-Michel Maillard ◽  
Florian Legoff ◽  
...  
Keyword(s):  
Web Application ◽  
Primary Outcome ◽  
Visual Stimulation ◽  
Real Life ◽  
Olfactory Dysfunction ◽  
High Concentration ◽  
Real Life Data ◽  
The Mean ◽  
Mean Time ◽  
Olfactory Training

BACKGROUND Persistent olfactory dysfunction (OD) is a significant complication of SARS-CoV-2 infection. Olfactory training (OT) using aromatic oils are recommended to improve olfactory recovery, but quantitative data are missing. OBJECTIVE We aimed to quantify the benefit of OT associated with visual stimulation assisted by a dedicated web-application on patients with 1-month or more OD. METHODS We performed an observational real-life data-based study on a cohort of patients with at least 1-month persistent OD included between 1/30/21 and 3/26/2021. Analysis was performed after a 4-weeks mean time of OT and at least 500 patients assessable for primary outcome. Participants exposed themselves twice daily to odors from four high concentration oils and visual stimulation assisted by a dedicated web-application. Improvement was defined as a 2/10 points increase on self-assessed olfactory visual analogue scale. RESULTS 548 were assessable for primary outcome assessment. The mean baseline self-assessed olfactory score was 1.9/10 (SD 1.7) and increase to 4.6 (SD 2.8) beyond a mean time of olfactory training of 27.7 days (SD 17.2). Olfactory training was associated with at least 2-points increase in 64.2% (n=352). The rate of patients with improvement was higher in patients having trained for more than 28 days versus patients having trained for less than 28 days (72.2% vs 59.0% respectively, p=.002). The benefit was observed regardless of the duration of the OD. CONCLUSIONS OT associated with visual stimulation assisted by a dedicated web-application was associated with significant improvement in olfaction, especially if OT duration was superior to 28 days. CLINICALTRIAL NCT04806880

scholarly journals Olfactory training and visual stimulation assisted by web-application in patients with persistent olfactory dysfunction after SARS-CoV-2 infection: observational study.

2021 ◽  
Author(s):  
Fabrice Denis ◽  
Anne-Lise Septans ◽  
Lea Periers ◽  
Jean-Michel Maillard ◽  
Florian Legoff ◽  
...  
Keyword(s):  
Web Application ◽  
Primary Outcome ◽  
Visual Stimulation ◽  
Real Life ◽  
Olfactory Dysfunction ◽  
High Concentration ◽  
Real Life Data ◽  
The Mean ◽  
Mean Time ◽  
Olfactory Training

Background: Persistent olfactory dysfunction (OD) is a significant complication of SARS-CoV-2 infection. Olfactory training (OT) using aromatic oils are recommended to improve olfactory recovery, but quantitative data are missing. Objective: We aimed to quantify the benefit of OT associated with visual stimulation assisted by a dedicated web-application on patients with 1-month or more OD. Methods: We performed an observational real-life data-based study on a cohort of patients with at least 1-month persistent OD included between 1/30/21 and 3/26/2021. Analysis was performed after a 4-weeks mean time of OT and at least 500 patients assessable for primary outcome. Participants exposed themselves twice daily to odors from four high concentration oils and visual stimulation assisted by a dedicated web-application. Improvement was defined as a 2/10 points increase on self-assessed olfactory visual analogue scale. Results: 548 were assessable for primary outcome assessment. The mean baseline self-assessed olfactory score was 1.9/10 (SD 1.7) and increase to 4.6 (SD 2.8) beyond a mean time of olfactory training of 27.7 days (SD 17.2). Olfactory training was associated with at least 2-points increase in 64.2% (n=352). The rate of patients with improvement was higher in patients having trained for more than 28 days versus patients having trained for less than 28 days (72.2% vs 59.0% respectively, p=.002). The kinetic of improvement was 8 days faster in hyposmic than in anosmic patients (p<.001). The benefit was observed regardless of the duration of the OD. Conclusions: OT associated with visual stimulation assisted by a dedicated web-application was associated with significant improvement in olfaction, especially if OT duration was superior to 28 days.

scholarly journals Olfactory Training and Visual Stimulation Assisted by a Web-Application for Patients With Persistent Olfactory Dysfunction After SARS-CoV-2 Infection

2021 ◽  
Author(s):  
Fabrice Denis ◽  
Anne-Lise Septans ◽  
Léa Périers ◽  
Jean-Michel Maillard ◽  
Florian Legoff ◽  
...  
Keyword(s):  
Web Application ◽  
Visual Stimulation ◽  
Olfactory Dysfunction ◽  
Severe Toxicity ◽  
High Concentration ◽  
Point Increase ◽  
Spontaneous Improvement ◽  
Study Participants ◽  
Mild Toxicity ◽  
Olfactory Training

Abstract IntroductionWe aimed to quantify the benefit of olfactory training and visual stimulation assisted by a dedicated web application for patients who experienced olfactory dysfunction for ≥1 month after Sars-Cov-2 infection and compared it with published cohorts of spontaneous recoveries.Materials and MethodsWe performed a prospective observational study. Participants performed olfactory training and visual stimulation assisted by a dedicated web-application. Improvement was defined as a 2-point increase on a 10-point, self-assessed olfactory visual analogue scale.ResultsIn total, 1155 patients were assessable. Improvement was observed in patients who trained 4 weeks and 4 to 8 weeks with high concentration oils in 63.0% (58/92) and 72.9% (137/188) respectively, whereas in historical cohorts, a spontaneous improvement was observed in 7% to 27% without training respectively (p<.001). The benefit was observed regardless of the duration of the olfactory dysfunction. No or mild toxicity was reported by 86.6% (662/764) of patients. Severe toxicity leading to stop training was reported in 0.5% of patients.ConclusionsOlfactory training and visual stimulation assisted by a dedicated web application seems to accelerate olfactive improvement in persistent olfactory dysfunction following SARS-CoV-2 infection, especially after 30 days of olfactory training. Maximal duration of training appeared to be 8 weeks.

PP126 MEA In Italy: Correlation Between Time To Payment By Result And Time To Off Treatment Curve

2017 ◽  
Vol 33 (S1) ◽  
pp. 131-132
Author(s):  
Gabriele Vittoria ◽  
Antonio Fascì ◽  
Matteo Ferrario ◽  
Giovanni Giuliani
Keyword(s):  
Clinical Trials ◽  
Treatment Failure ◽  
Median Time ◽  
Real Life ◽  
Standard Of Care ◽  
Phase Iii ◽  
Experimental Drug ◽  
The Mean ◽  
Line Of Therapy ◽  
Mean Time

INTRODUCTION:Payment by result agreements have been quite widely used in Italy to provide access for high costs oncologic drugs and minimize uncertainties of real life benefits (1). The aim of this analysis was to overview the Roche experience in terms of Payment by Result (Pbr) in oncology and investigate the relation between timing for the evaluation of treatment failures and observed Time to Off Treatment (TTOT) from Phase III clinical trials (2).METHODS:A retrospective analysis of the Roche payment by results schemes in place in Italy was conducted. For each drug included in the analysis it was collected: (i) the negotiated timing to assess the treatment failure for payment by result, (ii) the median time to off treatment curve observed in clinical trials for the experimental drug, (iii) the median time to off treatment observed in clinical trials for the control arm. The mean ratios between timing to assess the treatment failure for payment by result and the time to off treatment observed for the experimental drug or the median time to off treatment observed in the control arm were calculated to identify potential correlations. High level of correlation was expected if ratio was close to 1 (±.2).RESULTS:Roche products or different indications of the same product were identified as candidates for the analysis from 2008 to 2016. The timing for the evaluation of treatment failures for Pbr varies between 2 and 9 months, depending on the type of tumor and line of therapy. The mean Time to Payment By Result (TTPbr) / Control arm Time To Off Treatment (cTTOT) ratio was 1.16 (±.37) while the mean Time to Payment By Result (TTPbr) / Experimental arm Time To Off Treatment (eTTOT) ratio was .71 (±.13). Data analysis according to different time periods shows that the mean TTPbr/cTTOT and TTPbr/eTTOT for drugs negotiated from 2008 to 2015 were respectively 1.07 and 1.39 whereas for drugs negotiated in 2016 were respectively and .63 and 1.CONCLUSIONS:Good level of correlation between TTPbr and cTTOT was found. This finding is in line with the methodology used by Italian Medicines Agency so far, leveraging the cTTOT as the most appropriate proxy to assess any incremental effect of a new drug compared to the previous Standard of Care. The analysis over time of TTPbr shows that in the first years of payment by result negotiation TTPbr is more correlated to the cTTOT whereas in the last years is moving closer to the experimental one.

Effectiveness and tolerability of oral versus subcutaneous methotrexate in patients with rheumatoid arthritis

Rheumatology ◽  
2021 ◽  
Author(s):  
Janne Heuvelmans ◽  
Nathan den Broeder ◽  
Geke A H van den Elsen ◽  
Alfons A den Broeder ◽  
Bart J F van den Bemt
Keyword(s):  
Rheumatoid Arthritis ◽  
Retrospective Cohort ◽  
Primary Outcome ◽  
Real Life ◽  
Treat To Target ◽  
Oral Methotrexate ◽  
Real Life Setting ◽  
Significant Difference ◽  
The Mean ◽  
Secondary Outcomes

Abstract Objectives The aim of this study was to compare the effectiveness and tolerability between oral methotrexate (MTX) and subcutaneous MTX in a large group of rheumatoid arthritis (RA) patients in a real-life setting. Methods In this retrospective cohort study, adult patients with clinical diagnosis of RA who started MTX treatment (monotherapy or combined with hydroxychloroquine), either started with oral or subcutaneous MTX. The primary outcome was superiority testing of between group difference in change in DAS28CRP between baseline and 3–6 months, and subsequent non inferiority testing (NI margin 0.6) analyses in case of non-superiority. Secondary outcomes included MTX dose, side effects, laboratory abnormalities, and use of comedication. Results 640 RA patients were included: 259 started with oral MTX and 381 with subcutaneous. There was no significant difference in ΔDAS28CRP, after adjusting for confounding, 0.13 (95%-CI: -0.14, 0.40), and oral MTX strategy was non inferior to subcutaneous. The mean MTX dose was slightly lower for the oral strategy (18.0 SD6.9 vs 19.9 SD8.2, p= 0.002), which was accompanied by a lower cumulative incidence of adverse events (41% vs 52%, p= 0.005). No differences were seen in use of other comedication. Conclusions Starting with oral MTX in RA in a real-life setting is non inferior to a subcutaneous MTX treatment with regard to disease activity control, at least when used in dosages up to 25 mg and on a background of HCQ cotreatment and a treat-to-target approach. In addition, tolerability was better. This supports the strategy of starting with oral MTX.

The rate of successful four-corner arthrodesis with a locking, dorsal circular polyether-ether-ketone (PEEK-Optima) plate

2013 ◽  
Vol 38 (7) ◽  
pp. 767-773 ◽  
Author(s):  
P. C. Rhee ◽  
A. Y. Shin
Keyword(s):  
Circular Plate ◽  
Primary Outcome ◽  
Outcome Measure ◽  
Primary Outcome Measure ◽  
Accurate Assessment ◽  
Polyether Ether Ketone ◽  
The Mean ◽  
Ether Ketone ◽  
Mean Time

The purpose of this study is to evaluate the rate of union after four-corner arthrodesis with a locking, dorsal circular plate comprised of polyether-ether-ketone. A retrospective review was conducted of all patients who underwent four-corner arthrodesis with a locking, dorsal circular plate at our institution from January 2005 to May 2009. The primary outcome measure was radiographic and clinical union. During the study period, 26 consecutive wrists underwent four-corner arthrodesis with a locking, dorsal circular plate. Twenty-three wrists were included. The mean clinical follow-up was 16 months (range 3–37). Union was achieved in 22 of 23 wrists at a mean time of 3 months (range 1–12). There was one partial union that underwent successful revision arthrodesis. In summary, four-corner fusion with a polyether-ether-ketone locking, dorsal circular plate results in high union rates. The use of a radiolucent plate allows for more accurate assessment of union with the biomechanical advantages of a fixed angle construct.

scholarly journals Routine follow-up of native valve disease: real life data from a physiologist-led valve clinic

2021 ◽  
Vol 22 (Supplement_1) ◽  
Author(s):  
K Hyams ◽  
K Balkhausen ◽  
C Townsend
Keyword(s):  
Real Life ◽  
Heart Association ◽  
Native Valve ◽  
Conservative Strategy ◽  
Funding Sources ◽  
Real Life Data ◽  
Number Of Patients ◽  
The Mean ◽  
Funding Acknowledgements

Abstract Funding Acknowledgements Type of funding sources: None. Purpose The 2014 American Heart Association (AHA) guidelines for the management of Valvular Heart Disease (VHD) suggest that patients with mild and moderate native VHD should be followed up with echocardiography at regular intervals. Following audits at our hospital in 2016, dedicated Physiologist Led Valve Clinics (PLVC) were initiated to improve guideline adherence. A conservative strategy for follow-up frequency based on AHA guidelines was chosen (3 years for mild VHD, and 1 year for moderate VHD). This audit aimed to ascertain adherence to this conservative follow-up strategy, and to assess the progression of VHD between echocardiographic assessments to inform a strategy for safe follow-up in our PLVC. Methods Our echocardiography database Cognos was searched for patients with isolated mild and moderate native VHD, seen in our PLVC between 2016-2018 and followed up between 2017-2019. Patients with severe, prosthetic, combined or significant mixed VHD were excluded. Echocardiography reports on McKesson were reviewed and the follow-up interval recorded for each patient. The severity of VHD at the index visit, and then at follow-up, was recorded to determine whether there had been a progression in VHD severity. For patients with progression, it was recorded whether they were symptomatic at follow-up or subsequently underwent valvular intervention. Results 466 index echocardiograms were reviewed; 134 patients were included (mean age 73.4) after removing those with exclusion criteria. The mean follow-up interval in mild VHD ranged between 587.6 ± 188.3 days, and 667.3 ± 174.6 days, well above the recommended 3 years (or 1095 days). The majority of patients with moderate VHD received follow-up well before the upper limit of AHA guidance (2 years, or 730 days). Mean follow-up ranged between 408.3 ± 80.8 days (in moderate aortic stenosis (AS)) and 504.0 ± 29.0 days (in moderate mitral stenosis (MS)). The number of patients followed up with mild VHD was very low. 1 patient in each group progressed to moderate VHD (out of 2, 3 and 5 respectively); none became symptomatic, and none progressed from mild to severe VHD. In moderate VHD, progression rates were highest in AS (34.8%). Patients with progressive disease were more frequently symptomatic (43%) or underwent valve intervention (25%). Fewer with mitral regurgitation (MR) (22%) progressed, 44.5% of whom were symptomatic, 11% undergoing intervention. Patients with moderate aortic regurgitation (AR) saw the lowest progression rates (11.4%), 50% of whom were symptomatic. There was no progression in moderate MS. Conclusions Patients with mild VHD can safely be followed up less conservatively in the PLVC setting, adhering to AHA guidance (3-5 years). Patients with moderate AS should be considered to remain under conservative follow-up (12-18 months). Follow-up for moderate AR, MR and MS can safely be adjusted towards the less conservative end of the AHA guidance (2 years). Abstract Figure.

On designing a robust double exponentially weighted moving average control chart for process monitoring

2018 ◽  
Vol 40 (15) ◽  
pp. 4253-4265 ◽  
Author(s):  
Ishaq Adeyanju Raji ◽  
Nasir Abbas ◽  
Muhammad Riaz
Keyword(s):  
Moving Average ◽  
Real Life ◽  
Exponentially Weighted Moving Average ◽  
Data Set ◽  
Parameter Estimations ◽  
Real Life Data ◽  
Monitoring Process ◽  
The Mean ◽  
Weighted Moving Average ◽  
Exponentially Weighted

A double exponentially weighted moving average chart has been proven more efficient for monitoring process mean in comparison to the classical exponentially weighted moving average chart. We, in this article, made a careful investigation on how well this scheme performs with the presence of disturbances in the process under consideration. This investigation was motivated in exploring the scheme with some robust statistic, as the mean estimator performs woefully. We also evaluated the effects of parameter estimation on the phase II assuming the parameters are unknown. Adopting a 20% trimmed mean of trimeans (robust) reveals the effect of parameter estimations. We substantiated these claims by applying the scheme on a real-life data set. The findings of the study pronounced the trimean estimator to be the best of all the five estimators used, including the mean.

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