Clinical Response to Questions Regarding Outcomes and Therapy Efficacy

2010 ◽  
Vol 20 (3) ◽  
pp. 76-83 ◽  
Author(s):  
Joseph Donaher ◽  
Tom Gurrister ◽  
Irving Wollman ◽  
Tim Mackesey ◽  
Michelle L. Burnett
Keyword(s):  
Risk Factors ◽  
Clinical Response ◽  
Speech Language Pathologists ◽  
Specific Therapy ◽  
Therapy Efficacy ◽  
Therapy Program ◽  
Adults Who Stutter ◽  
Cure Rates

Parents of children who stutter and adults who stutter frequently ask speech-language pathologists to predict whether or not therapy will work. Even though research has explored risk-factors related to persistent stuttering, there remains no way to determine how an individual will react to a specific therapy program. This paper presents various clinicians’answers to the question, “What do you tell parents or adults who stutter when they ask about cure rates, outcomes, and therapy efficacy?”

scholarly journals Telavancin for Acute Bacterial Skin and Skin Structure Infections, aPost HocAnalysis of the Phase 3 ATLAS Trials in Light of the 2013 FDA Guidance

2015 ◽  
Vol 59 (10) ◽  
pp. 6170-6174 ◽  
Author(s):  
Richard Pushkin ◽  
Steven L. Barriere ◽  
Whedy Wang ◽  
G. Ralph Corey ◽  
Martin E. Stryjewski
Keyword(s):  
Clinical Response ◽  
Lesion Size ◽  
Phase 3 ◽  
Two Phase ◽  
Skin Structure ◽  
Fda Guidance ◽  
Complicated Skin ◽  
Clinical Responses ◽  
Cure Rates ◽  
Post Hoc

ABSTRACTTwo phase 3 ATLAS trials demonstrated noninferiority of telavancin compared with vancomycin for complicated skin and skin structure infections. Data from these trials were retrospectively evaluated according to 2013 U.S. Food and Drug Administration (FDA) guidance on acute bacterial skin and skin structure infections. Thispost hocanalysis included patients with lesion sizes of ≥75 cm2and excluded patients with ulcers or burns (updated all-treated population;n= 1,127). Updated day 3 (early) clinical response was defined as a ≥20% reduction in lesion size from baseline and no rescue antibiotic. Updated test-of-cure (TOC) clinical response was defined as a ≥90% reduction in lesion size, no increase in lesion size since day 3, and no requirement for additional antibiotics or significant surgical procedures. Day 3 (early) clinical responses were achieved in 62.6% and 61.0% of patients receiving telavancin and vancomycin, respectively (difference, 1.7%, with a 95% confidence interval [CI] of −4.0% to 7.4%). Updated TOC visit cure rates were similar for telavancin (68.0%) and vancomycin (63.3%), with a difference of 4.8% (95% CI, −0.7% to 10.3%). Adopting current FDA guidance, this analysis corroborates previous noninferiority findings of the ATLAS trials of telavancin compared with vancomycin.

scholarly journals Association of polymorphic variants of xenobiotic biotransformation genes and glutation metabolizing genes with clinical course of cystic fibrosis, antimicrobial therapy efficacy and adverse reactions

2020 ◽  
pp. 64-65
Author(s):  
О.Г. Новоселова ◽  
Е.И. Кондратьева ◽  
Н.В. Петрова ◽  
В.Д. Шерман ◽  
А.Ю. Воронкова ◽  
...  
Keyword(s):  
Risk Factors ◽  
Cystic Fibrosis ◽  
Treatment Failure ◽  
Antimicrobial Therapy ◽  
Adverse Reactions ◽  
Clinical Course ◽  
Clinical Manifestations ◽  
Therapy Efficacy ◽  
Xenobiotic Biotransformation ◽  
Polymorphic Variants

Тяжесть клинических проявлений муковисцидоза может быть обусловлена действием генов-модификаторов. Выяснение причин неэффективности терапии и нежелательных побочных реакций, определение факторов риска позволит улучшить прогноз для данной категории больных. Исследованы ассоциации 18 полиморфных вариантов 10 генов ферментов первой и второй фазы биотрансформации ксенобиотиков: CYP2C9 (c.430C>T, c.1075A> C), CYP2C19 (c.681G>A), CYP2D6 (1846G>A), CYP3A4 (c-392C>T), GSTT1 (del), GSTM1 (del), GSTP1 (c.313A>C), GCLC (TVR GAG, c.-129C>T), GCLM (c.-588C>T), NAT2 (c.282C>T, c.341T>C, c.434A>C, c.481C>T, c.590G>A, c.845A>C, c.857G>A) с тяжестью клинических проявлений муковисцидоза. CF clinical variability could be associated with interaction of modifier genes. Сlarification of the causes of treatment failure and adverse reactions, prediction of risk factors could improve the outcome of therapy. Association of 18 polymorphic variants of 10 genes of xenobiotic biotransformation: CYP2C9 (c.430C>T, c.1075A> C), CYP2C19 (c.681G>A), CYP2D6 (1846G>A), CYP3A4 (c-392C>T), GSTT1 (del), GSTM1 (del), GSTP1 (c.313A>C), GCLC (TVR GAG, c.-129C>T), GCLM (c.-588C>T), NAT2 (c.282C>T, c.341T>C, c.434A>C, c.481C>T, c.590G>A, c.845A>C, c.857G>A) with severity of clinical manifestations were analyzed in 333 CF patients.

Late-Onset Hemorrhagic Cystitis in Children After Hematopoietic Stem Cell Transplantation (HSCT) for Thalassemia and Sickle Cell Anemia: A Prospective Evaluation of Polyoma (BK) Virus Infection and Treatment with Cidofovir (CDV).

Blood ◽  
2009 ◽  
Vol 114 (22) ◽  
pp. 1133-1133
Author(s):  
Javid Gaziev ◽  
Guido Lucarelli ◽  
Stefano Germani ◽  
Pierpaolo Paba ◽  
Carlo Federico Perno ◽  
...  
Keyword(s):  
Risk Factors ◽  
Multivariate Analysis ◽  
Clinical Response ◽  
Median Duration ◽  
Cumulative Incidence ◽  
Late Onset ◽  
Hemorrhagic Cystitis ◽  
Bk Virus ◽  
Spontaneous Resolution ◽  
Grade 3

Abstract Abstract 1133 Poster Board I-155 Background Hemorrhagic cystitis (HC) is a significant cause of morbidity after allogeneic HSCT. BK virus infection has been associated with development of HC after HSCT, however most studies detected the virus at the time of cystitis, therefore not allowing estimation of the relationship between BK reactivation and HC. Furthermore little is known about development of late-onset HC in children following HSCT, its association with BK virus and treatment with Cidofovir. Therefore we prospectively investigated BK virus reactivation in pts receiving HSCT from HLA-identical related donors, risk factors for development of HC and treatment efficacy with CDV. Patients and Methods 117 pts with thalassemia (n=107) and sickle cell anemia (n=10) with median age of 9 years (range, 1.7-17) were enrolled in this study. All pts received BUCY ± Thiotepa containing conditioning regimens. GVHD prophylaxis was cyclosporine and short MTX ± Thymoglobulin-ATG (in 26 pts). Before August 2006 qualitative BK-PCR was performed on urine samples in pts with HC. Since then we prospectively performed qualitative and quantitative PCR on blood and urine samples collected before conditioning regimen and weekly thereafter until at least 100 days post transplant in 64 pts. The quantitative BK virus assay was performed with Real Time Alert Q-PCR-Nanogen kit. Risk factors for the development of HC were evaluated on univariate and multivariate analysis using cumulative incidence curves and Competing risk regression analysis respectively. The cumulative incidence of HC was estimated considering death without HC as competing event. Nineteen pts with HC were given CDV at 1.5 mg/kg/day 3 times/week (n= 10) or 5 mg/kg/week (n=9). Results 60 out of 64 pts (94%) had at least 1 positive and 52 of them (81%) 2 or more positive samples for BK viruria. 34 pts (53%) showed al least 1 and 18 of them (28%) 2 or more positive samples for BK viremia. The number of viral copies varied from <556 to >55 million copies. Median time to platelet engraftment was 23 days (range,8-163) and median number of platelets at onset of HC was 81×109/l (range, 2-274 ×109/l). Thirty pts (26%) developed clinically significant (grade 2 to 4) HC within 1 year after HSCT at a median of 38 days (range, 13- 114). All pts with HC had BK viruria. Coexisting viral infections were found in 3 pts: CMV in 2 and adenovirus in 1. The severity of HC was grade 2 in 24 pts, grade 3 in 2 and grade 4 in 4. The 4 pts with grade 4 HC had moderate or severe hydronephrosis along with partial ureteral obstruction which necessitated ureteral stent placement. The cumulative incidence of grade 2 or 3-4 HC was 21%(95% CI 13%-28%) and 5%(95%CI 2%-10%) respectively. In univariate analysis the use of ATG, peak BK viruria, GVHD and age >8 years were associated with HC. Multivariate analysis confirmed the prognostic importance of ATG (HR=10.5; p=0.001), peak BK viruria >100,000 copies (HR=6.2; p=0.004), and acute GVHD (HR=5.3; p=0.007), but not age for HC development. The cumulative incidence of HC in pts who had 2 adverse factors was 64%, compared with 31% (or 53%) and 10 % who had either one (GVHD or ATG) or none of these factors (p<0.0001). However, there were 10 pts who had at 2 or more time points BK viruria >6 millions copies without developing HC. With a median follow-up among survivors of 35 months (range, 5-61) HC did not have a significant impact on survival. Both dosing schedules of CDV were well tolerated and no cases of dose-limiting nephrotoxicity were observed. The median duration of HC was 17 days (range 9-53). The median duration of therapy was 27 days (range,21-180) with a median of 9 doses given (range,6-22). All pts had clinical response but only 6 pts (32%) had microbiological response at 2 weeks after therapy. None of these patients cleared BK viruria when a complete clinical response was achieved. The median time from clinical response to BK viruria clearance was 74 days (range, 14-176). Ten pts with grade 2 and one with grade 3 HC occurred before prospective trial of CDV had spontaneous resolution of HC. The median duration of HC in these pts was similar to those treated with CDV. Conclusion BK viruria is common after HSCT and high viral load is a risk factor for HC. However, even higher-level BK replication alone is not sufficient to cause HC. Coexisting factors such as the use of ATG and GVHD significantly contribute to the development of HC. Cidofovir may have some activity against BK virus-related HC, although our data showed that spontaneous resolution of HC could also occur. Disclosure No relevant conflicts of interest to declare Disclosures Off Label Use: Cidofovir as antiviral drug for treatment of BK virus-related hemorrhagic cystitis.

Efficacy of trastuzumab and potential risk factors on survival in patients with HER2-positive metastatic gastric cancer

2021 ◽  
Author(s):  
Atakan Topcu ◽  
Muhammed Mustafa Atci ◽  
Saban Secmeler ◽  
Mehmet Besiroglu ◽  
Murat Ayhan ◽  
...  
Keyword(s):  
Risk Factors ◽  
Gastric Cancer ◽  
Overall Survival ◽  
Clinical Response ◽  
Potential Risk ◽  
Group Performance ◽  
Eastern Cooperative Oncology Group ◽  
Metastatic Gastric Cancer ◽  
Her2 Positive ◽  
Potential Risk Factors

Aim: To evaluate the efficacy of trastuzumab and potential risk factors on survival in patients with HER2-positive metastatic gastric cancer. Methods: We retrospectively included 138 patients who were given trastuzumab-based chemotherapy as first-line treatment and analyzed the relationship between clinical response rates and maintenance treatment status and survival outcomes. Results: In the whole group, the median progression-free survival and overall survival were 10.2 and 16 months, respectively. Clinical response was obtained in 79% of patients. The median overall survival was 16.9 months in follow-up group and 19.0 months in the maintenance group in patients with clinical response. Continuation of maintenance trastuzumab created a significant survival advantage (p = 0.021). Eastern Cooperative Oncology Group performance status 2 (hazard ratio [HR]: 2.02), grade 3 (HR: 1.78) and more than four metastatic lesions (HR: 1.67) were determined as risk factors for death. Conclusion: We recommend the continuation of maintenance trastuzumab in patients with clinical response, but those with identified risk factors may not benefit from treatment because life expectancy may be low.

The Objective Vocal Quality, Vocal Risk Factors, Vocal Complaints, and Corporal Pain in Dutch Female Students Training to be Speech-Language Pathologists During the 4 Years of Study

2010 ◽  
Vol 24 (5) ◽  
pp. 592-598 ◽  
Author(s):  
Kristiane M. Van Lierde ◽  
Evelien D'haeseleer ◽  
Floris L. Wuyts ◽  
Sophia De Ley ◽  
Ruben Geldof ◽  
...  
Keyword(s):  
Risk Factors ◽  
Female Students ◽  
Speech Language Pathologists ◽  
Vocal Quality

scholarly journals Me, My Stuttering, and Them! Effect of Self-Disclosure of Stuttering on Listener Perception

2017 ◽  
Vol 6 ◽  
pp. 117957271773299 ◽  
Author(s):  
Gagan Bajaj ◽  
Malavika Anakkathil Anil ◽  
Aiswarya Varghese ◽  
Jayashree S Bhat ◽  
Pooja Sheth ◽  
...  
Keyword(s):  
College Students ◽  
Speech Language Pathologists ◽  
Self Disclosure ◽  
Adults Who Stutter ◽  
Age Range ◽  
The Impact

Purpose: A common question encountered by speech-language pathologists while dealing with adults who stutter (AWS) is whether their disclosure of stuttering to listeners would change their perception. The purpose of this study was to assess the impact of self-disclosure and speaker sex on adult listeners’ perceptions of simulated stuttering. Method: The study involved a group of 100 college students between the age range of 18 and 25 years, who judged the videotaped speech samples of 1 male and 1 female person, who simulated stuttering in disclosed and undisclosed state. The listener perception was evaluated through a questionnaire developed for the purpose. Results: The trends suggested that a female AWS possessed overall better listener perception as compared with male AWS in undisclosed condition and received better perception by listeners in more domains than male AWS in disclosed state. Conclusions: Listener perception seems to be a sex-specific phenomenon which gets affected by one’s disclosure about stuttering and the culture of the listeners.

Safety Behaviors and Stuttering

2017 ◽  
Vol 60 (5) ◽  
pp. 1246-1253 ◽  
Author(s):  
Robyn Lowe ◽  
Fjola Helgadottir ◽  
Ross Menzies ◽  
Rob Heard ◽  
Sue O'Brian ◽  
...  
Keyword(s):  
Negative Evaluation ◽  
Fear Of Negative Evaluation ◽  
Safety Behaviors ◽  
Negative Effects ◽  
Negative Cognitions ◽  
Socially Anxious ◽  
Therapy Program ◽  
Potential Safety ◽  
Social Encounters ◽  
Adults Who Stutter

Purpose Those who are socially anxious may use safety behaviors during feared social interactions to prevent negative outcomes. Safety behaviors are associated with anxiety maintenance and poorer treatment outcomes because they prevent fear extinction. Social anxiety disorder is often comorbid with stuttering. Speech pathologists reported in a recent publication (Helgadottir, Menzies, Onslow, Packman, & O'Brian, 2014a) that they often recommended procedures for clients that could be safety behaviors. This study investigated the self-reported use of safety behaviors by adults who stutter. Method Participants were 133 adults who stutter enrolled in an online cognitive-behavior therapy program. Participants completed a questionnaire about their use of potential safety behaviors when anxious during social encounters. Correlations were computed between safety behaviors and pretreatment scores on measures of fear of negative evaluation and negative cognitions. Results Of 133 participants, 132 reported that they used safety behaviors. Many of the safety behaviors correlated with higher scores for fear of negative evaluation and negative cognitions. Conclusions Adults who stutter report using safety behaviors, and their use is associated with pretreatment fear of negative evaluation and unhelpful thoughts about stuttering. These results suggest that the negative effects of safety behaviors may extend to those who stutter, and further research is needed.

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