Abstract TP335: Comparative Impact of Timing From Ictus to Intracerebral Hemorrhage Evacuation on Outcome in MISTIE III, STICH I & II Trials

Stroke ◽  
2020 ◽  
Vol 51 (Suppl_1) ◽  
Author(s):  
Sean P Polster ◽  
Julian Carrion-Penagos ◽  
Barbara A Gregson ◽  
Ying Cao ◽  
Richard E Thompson ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Functional Outcome ◽  
Previous Analysis ◽  
Surgical Removal ◽  
Crossing Over ◽  
Affected Patient ◽  
Hematoma Volume ◽  
Probability Of Survival ◽  
End Of Treatment ◽  
Invasive Intervention

Introduction: Completion of the MISTIE procedure requires a period of hematoma stability before and during hematoma removal and, if necessary, dosing of rtPA which can take days to complete. Early surgery was intended in the STICH I and II trials, yet was performed after varying delays. No previous analysis has evaluated the timing for hematoma removal on outcomes in these trials. Objective: Determine if time from ictus to completion of hematoma removal may have affected patient outcome in three large surgical clinical trials of ICH evacuation. Methods: Patients randomized to surgery in the MISTIE III (n=242), STICH I (n=464) and STICH II (n=266) trials who received the procedure were analyzed, excluding cases crossing over to surgery. Time from ictus to end of treatment, defined as 24 hours after last dose in (MISTIE III) or time to craniotomy (STICH I and II), was analyzed in relation to likelihood of survival and functional outcome at 180 days. Cubic spline models with dichotomized outcomes were used. Results: The probability of achieving an mRS 0-3 increased significantly with longer time until completion of the procedure, up to 83 hours post-ictus, and worsened with longer delays thereafter (p=0.05). Better mRS was also achieved in STICH I patients with longer time until surgical removal, up to 60 hours post-ictus (p=0.0002), but not with longer delays (p=0.49). In STICH II (lobar cases), there was greater likelihood of mRS 0-3 with longer delay after 22 hours post-ictus (p=0.004), but not with earlier surgery (p=0.19). There was no significant benefit in survival, with earlier intervention across modalities and trials. Adjustment by initial hematoma volume further validated that early procedures do not favor survival or achieving a mRS 0-3. Conclusion: Early hematoma evacuation up to 60-80 hours post-ictus does not increase the probability of survival nor a good functional outcome in non-herniating ICH patients included in clinical trials, likely in view of bleeding instability. This was true in minimally invasive intervention as well as open surgeries.

Abstract WMP103: Comparative Impact of Extent of Lobar Intracerebral Hemorrhage Removal on Outcome in the MISTIE III and STICH II Trials

Stroke ◽  
2020 ◽  
Vol 51 (Suppl_1) ◽  
Author(s):  
Sean P Polster ◽  
Julian Carrion-Penagos ◽  
Barbara A Gregson ◽  
Ying Cao ◽  
Richard E Thompson ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Clinical Outcome ◽  
Minimally Invasive ◽  
Intracerebral Hemorrhage ◽  
Functional Outcome ◽  
Phase Iii ◽  
Surgical Interventions ◽  
Hematoma Evacuation ◽  
Functional Benefit ◽  
End Of Treatment

Introduction: The Minimally Invasive Surgery Plus Recombinant Tissue Plasminogen Activator for Intracerebral Hemorrhage Evacuation Phase III trial (MISTIE III) concluded that the extent of hematoma reduction confers a mortality and functional benefit. It is unclear if a minimum extent of evacuation is needed for mortality and functional outcome benefit in lobar cases with MISTIE and with open surgical interventions. Objective: We analyzed the effect of extent of lobar ICH evacuation on clinical outcome at 180 days after undergoing the MISTIE procedure and open craniotomy, in the context of the MISTIE III and STICH II clinical trials, respectively. Methods: Patients randomized to the surgical arm with lobar ICH, who underwent the procedure in the MISTIE III trial (n=84) and the STICH II trial (n=266) were analyzed, excluding cases crossing over to surgery. We assessed end of treatment ICH volume on post procedure CT scans and % hematoma evacuation, in relation to survival and likelihood of mRS 0-3. Cubic spline modeling with dichotomized outcome was used to compare the extent of hematoma evacuation on clinical outcome. Results: End of treatment volume of < 28 mL in lobar ICH MISTIE III patients and < 30 mL in STICH II trial patients showed a significantly increased probability of achieving an mRS of 0-3 at 180 days (p<0.03, p<0.006, respectively). This threshold was achieved in 83.1% of lobar cases undergoing MISTIE and in 92.1% of surgical cases in STICH II. Achieving survival benefit at 180 days trended towards improved probability with further hematoma volume reduction without a threshold value in MISTIE III, and was significant per mL reduction in STICH II (p<0.001). Analysis by percent of hematoma evacuation trended toward better probabilities of survival and improved functional outcome but were not significant. Conclusion: This analysis confirms that extent of hematoma evacuation is important in attaining the benefits of both minimally invasive and open surgical interventions in non-herniating lobar ICH patients randomized in clinical trials. Extent of ICH evacuation must be considered in the analysis of comparative effectiveness of various techniques and in the design of future trials.

scholarly journals Influence of EPs 7630 on Antipyretic Comedication and Recovery from Acute Tonsillopharyngitis in Children: A Meta-analysis of Randomized, Placebo-Controlled, Clinical Trials

2021 ◽  
Author(s):  
Georg Seifert ◽  
Petra Funk ◽  
Thorsten Reineke ◽  
Walter Lehmacher
Keyword(s):  
Clinical Trials ◽  
Medical Literature ◽  
Meta Analysis ◽  
Controlled Clinical Trials ◽  
Viral Origin ◽  
Treatment Risk ◽  
Pelargonium Sidoides ◽  
Clinical Trial Registries ◽  
End Of Treatment ◽  
Seasonal Infection

Abstract Objective Acute tonsillopharyngitis (ATP) is a common, seasonal infection of predominantly viral origin. Management is aimed at shortening the course of the disease and restoring the comfort of the patient. We performed a meta-analysis to investigate whether treatment with the Pelargonium sidoides extract EPs 7630 reduces the use of antipyretic comedication (i.e., acetaminophen) in children suffering from ATP. Methods Studies were identified from clinical trial registries and medical literature. Randomized, placebo-controlled, clinical trials investigating EPs 7630 in children with ATP and reporting the coadministration of paracetamol were eligible. Based on the raw data of eligible trials, we analyzed cumulative paracetamol use, as well as the ability to attend school at the end of treatment. Three trials including a total of 345 children aged 6 to 10 years and suffering from non-β-hemolytic streptococcal ATP were identified and eligible. Children were administered EPs 7630 or placebo for 6 days. Results Compared with placebo, EPs 7630 reduced the cumulative paracetamol dose by an average of 449 mg (95% confidence interval [CI]: 252–646 mg; p < 0.001). A total of 19.1% (EPs 7630) and 71.5% (placebo) of children were still unable to attend school at the end of the treatment (risk ratio = 0.28; 95% CI: 0.16–0.48; p < 0.001). Conclusion Our meta-analysis demonstrates that EPs 7630 reduced the use of antipyretic comedication and accelerated recovery.

scholarly journals Efficacy and Safety of Oritavancin Relative to Vancomycin for Patients with Acute Bacterial Skin and Skin Structure Infections (ABSSSI) in the Outpatient Setting: Results From the SOLO Clinical Trials

2017 ◽  
Vol 4 (1) ◽  
Author(s):  
Thomas P. Lodise ◽  
Mark Redell ◽  
Shannon O. Armstrong ◽  
Katherine A. Sulham ◽  
G. Ralph Corey
Keyword(s):  
Clinical Trials ◽  
Composite Endpoint ◽  
Outpatient Setting ◽  
Efficacy And Safety ◽  
Phase 3 ◽  
Double Blind ◽  
Skin Structure ◽  
Efficacy Outcome ◽  
End Of Treatment ◽  
Secondary Endpoints

Abstract Background The objective of this analysis was to evaluate the efficacy and safety of oritavancin compared with vancomycin for patients with acute bacterial skin and skin structure infections (ABSSSIs) who received treatment in the outpatient setting in the Phase 3 SOLO clinical trials. Methods SOLO I and SOLO II were 2 identically designed comparative, multicenter, double-blind, randomized studies to evaluate the efficacy and safety of a single 1200-mg dose of intravenous (IV) oritavancin versus 7–10 days of twice-daily IV vancomycin for the treatment of ABSSSI. Protocols were amended to allow enrolled patients to complete their entire course of antimicrobial therapy in an outpatient setting. The primary efficacy outcome was a composite endpoint (cessation of spread or reduction in size of the baseline lesion, absence of fever, and no rescue antibiotic at early clinical evaluation [ECE]) (48 to 72 hours). Key secondary endpoints included investigator-assessed clinical cure 7 to 14 days after end of treatment (posttherapy evaluation [PTE]) and 20% or greater reduction in lesion area at ECE. Safety was assessed until day 60. Results Seven hundred ninety-two patients (oritavancin, 392; vancomycin, 400) received entire course of treatment in the outpatient setting. Efficacy response rates at ECE and PTE were similar (primary composite endpoint at ECE: 80.4% vs 77.5% for oritavancin and vancomycin, respectively) as was incidence of adverse events. Five patients (1.3%) who received oritavancin and 9 (2.3%) vancomycin patients were subsequently admitted to a hospital. Conclusions Oritavancin provides a single-dose alternative to multidose vancomycin for treatment of ABSSSI in the outpatient setting.

Defining and Measuring Abstinence in Clinical Trials of Smoking Cessation Interventions: An Updated Review

2019 ◽  
Vol 22 (7) ◽  
pp. 1098-1106 ◽  
Author(s):  
Megan E Piper ◽  
Christopher Bullen ◽  
Suchitra Krishnan-Sarin ◽  
Nancy A Rigotti ◽  
Marc L Steinberg ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Smoking Cessation ◽  
Smokeless Tobacco ◽  
Research Question ◽  
Point Prevalence ◽  
Research Network ◽  
Tobacco Products ◽  
End Of Treatment ◽  
Smokeless Tobacco Products ◽  
Treatment Research

AbstractBackgroundChanges in tobacco products, use patterns, and assessment technology in the last 15 years led the Society for Research on Nicotine and Tobacco (SRNT) Treatment Research Network to call for an update to the 2003 SRNT recommendations for assessing abstinence in clinical trials of smoking cessation interventions.MethodsThe SRNT Treatment Research Network convened a group of investigators with decades of experience in conducting tobacco treatment clinical trials. To arrive at the updated recommendations, the authors reviewed the recommendations of the prior SRNT Workgroup as well as current literature. Ten additional experts in the field provided feedback on this paper and these recommendations.ResultsWith respect to defining abstinence, the authors recommend: (1) continuing to use the definition of no use of combustible tobacco products (regardless of use of noncombustible tobacco products [e.g., snus] and alternative products [e.g., e-cigarettes]) and collecting additional data to permit alternate abstinence definitions; (2) no use of combustible or smokeless tobacco products; and (3) no use of combustible or smokeless tobacco products or alternative products, as appropriate for the research question being addressed. The authors also recommend reporting point prevalence and prolonged abstinence at multiple timepoints (end of treatment, ≥3 months after the end of treatment, and ≥6 months postquit or posttreatment initiation).ConclusionsDefining abstinence requires specification of which products a user must abstain from using, the type of abstinence (i.e., point prevalence or continuous), and the duration of abstinence. These recommendations are intended to serve as guidelines for investigators as they collect the necessary data to accurately describe participants’ abstinence during smoking cessation clinical trials.ImplicationsThis paper provides updated recommendations for defining abstinence in the context of smoking cessation treatment clinical trials.

scholarly journals Empirically defining treatment response and remission in body dysmorphic disorder

2019 ◽  
pp. 1-7 ◽  
Author(s):  
Lorena Fernández de la Cruz ◽  
Jesper Enander ◽  
Christian Rück ◽  
Sabine Wilhelm ◽  
Katharine A. Phillips ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Treatment Response ◽  
Body Dysmorphic Disorder ◽  
Detection Methods ◽  
Obsessive Compulsive ◽  
Pooled Data ◽  
Randomized Controlled ◽  
Full Remission ◽  
End Of Treatment ◽  
The Usa

Abstract Background The number of clinical trials in body dysmorphic disorder (BDD) has steadily increased in recent years. As the number of studies grows, it is important to define the most empirically useful definitions for response and remission in order to enhance field-wide consistency and comparisons of treatment outcomes across studies. In this study, we aim to operationally define treatment response and remission in BDD. Method We pooled data from three randomized controlled trials of cognitive-behavior therapy (CBT) for BDD (combined n = 153) conducted at four academic sites in Sweden, the USA, and England. Using signal detection methods, we examined the Yale-Brown Obsessive Compulsive Scale modified for BDD (BDD–YBOCS) score that most reliably identified patients who responded to CBT and those who achieved remission from BDD symptoms at the end of treatment. Results A BDD–YBOCS reduction ⩾30% was most predictive of treatment response as defined by the Clinical Global Impression (CGI) – Improvement scale (sensitivity 0.89, specificity 0.91, 91% correctly classified). At post-treatment, a BDD–YBOCS score ⩽16 was the best predictor of full or partial symptom remission (sensitivity 0.85, specificity 0.99, 97% correctly classified), defined by the CGI – Severity scale. Conclusion Based on these results, we propose conceptual and operational definitions of response and full or partial remission in BDD. A consensus regarding these constructs will improve the interpretation and comparison of future clinical trials, as well as improve communication among researchers, clinicians, and patients. Further research is needed, especially regarding definitions of full remission, recovery, and relapse.

scholarly journals Non-invasive interventions in idiopathic scoliosis: a systematic review

2017 ◽  
Vol 30 (suppl 1) ◽  
pp. 325-333
Author(s):  
André Ivaniski Mello ◽  
Ana Carolina Kanitz ◽  
Flávia Gomes Martinez
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Literature Review ◽  
Idiopathic Scoliosis ◽  
Scientific Basis ◽  
Evidence Based ◽  
Therapeutic Exercise ◽  
Non Invasive ◽  
Noninvasive Therapy ◽  
Invasive Intervention

Abstract Introduction: Idiopathic Scoliosis (IS) is an idiopathic curvature of the spine in all three plans, been treated conservatively (non-invasive) or surgicaly (invasive). The effectiveness of noninvasive therapy still remains lacking in a scientific basis to support their evidence-based applicability. Objective: Evaluate the effects of non-invasive interventions in spine lateral inclination in IS through a systematic literature review. Methods: The search of studies in MEDLINE, SCOPUS and COCHRANE databases was performed on 24th March, 2014. The terms used were: Scoliosis, therapeutic exercise, physical therapy. Clinical trials with scoliotic patients undergoing some type of non-invasive intervention were included. The outcome was spine lateral inclination. Results: The research found 941 studies, seven of these were included after a screening performed by two independent reviewers. Six studies (85.7%) have adopted some sort of kinesiotherapeutic technic, and three studies (42.8%) used corrective orthosis. The average intervention time in kinesiotherapeutic technique studies was of 37.6 weeks and 91.6 weeks in the studies of corrective brace. The progression improvement of the spine lateral inclination was reported by 83.3% (5 of 6) of the kinesiotherapeutic technique studies and in 66.6% (2 of 3) of studies with corrective brace. Conclusion: An improvement was found, in general, in the progression of spine lateral inclination in IS subjects of both sexes from 11 to 25 years of age undergoing non-invasive interventions.

scholarly journals Assessment and identification of some factors affecting the results of treatment by orthotic bracing for pectus carinatum

2018 ◽  
Vol 2 (5) ◽  
Author(s):  
Trinh Quang Dung ◽  
Nguyen Huu Chut ◽  
Tran Vinh Son
Keyword(s):  
Intervention Study ◽  
Objective Assessment ◽  
Time Of Day ◽  
Pectus Carinatum ◽  
Factors Affecting ◽  
Non Invasive ◽  
Haller Index ◽  
Results Of Treatment ◽  
End Of Treatment ◽  
Invasive Intervention

Objective: Assessment and identification of some factors affecting the outcome of treatment of children withPectus carinatum by orthotic bracing (Non - Invasive Intervention).Subjectives: 86 children with Pectus carinatum end of treatment and re-examination at the RehabilitationDepartment of Viet Nam National Children’s Hospital from January 2015 to January 2017.Methods: The intervention study no control group.Result: 100% of children improved on deformity. The Haller Index increased from 1.81 before interventionto 2.23 after 36 months of intervention (p <0.001). Some factors related to progression: The Haller Index beforetreatment (B = 0.383, p <0.001). Time of day Wearing the brace (B = 0.017; p <0.001).

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