scholarly journals Estimation of risk of neuropsychiatric adverse events from varenicline, bupropion and nicotine patch versus placebo: secondary analysis of results from the EAGLES trial using Bayes factors

Addiction ◽  
2021 ◽  
Author(s):  
Emma Beard ◽  
Sarah E. Jackson ◽  
Robert M. Anthenelli ◽  
Neal L. Benowitz ◽  
Lisa St. Aubin ◽  
...  
Keyword(s):  
Adverse Events ◽  
Nicotine Patch ◽  
Secondary Analysis ◽  
Bayes Factors ◽  
Analysis Of Results ◽  
Estimation Of Risk

scholarly journals Older Blood Is Associated With Increased Mortality and Adverse Events in Massively Transfused Trauma Patients: Secondary Analysis of the PROPPR Trial

2019 ◽  
Vol 73 (6) ◽  
pp. 650-661 ◽  
Author(s):  
Allison R. Jones ◽  
Rakesh P. Patel ◽  
Marisa B. Marques ◽  
John P. Donnelly ◽  
Russell L. Griffin ◽  
...  
Keyword(s):  
Adverse Events ◽  
Secondary Analysis ◽  
Trauma Patients

Methotrexate and Adverse Events in CIRT Secondary Analysis

JAMA ◽  
2020 ◽  
Vol 323 (16) ◽  
pp. 1543
Author(s):  
Anita Slomski
Keyword(s):  
Adverse Events ◽  
Secondary Analysis

scholarly journals Development and Testing of a Lymphoma Clinical Trials Specific Frailty Index: A Secondary Analysis of the LY.12 Clinical Trial

Blood ◽  
2021 ◽  
Vol 138 (Supplement 1) ◽  
pp. 4076-4076
Author(s):  
Abi Vijenthira ◽  
Xinzhi Li ◽  
Michael Crump ◽  
Annette E. Hay ◽  
Lois E. Shepherd ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Adverse Events ◽  
Board Of Directors ◽  
Research Funding ◽  
Frailty Index ◽  
Secondary Analysis ◽  
Advisory Committees ◽  
Frail Patients ◽  
The Impact

Abstract Background: Frailty is common in older patients with lymphoma. However, it remains unknown whether frailty is prevalent in patients included in clinical trials of lymphoma, as those with frailty may meet inclusion criteria of a trial which do not include functional information beyond performance status (PS). Understanding the prevalence and impact of frailty in clinical trials is important to direct future stratification criteria, as well as to have robust data to counsel frail patients on their potential outcomes. Methods: We conducted a secondary analysis using data from the phase III LY.12 clinical trial in which patients with relapsed aggressive non-Hodgkin lymphoma were randomized to gemcitabine-dexamethasone-cisplatin or dexamethasone-high dose cytarabine-cisplatin chemotherapy prior to autologous stem cell transplant. The primary objective of our study was to construct a lymphoma clinical trials specific frailty index (FI) using previously described methods (Searle. BMC Geriatr. 2008;8:24). Secondary objectives were to describe the association of frailty (binary variable) with overall survival (OS), event-free survival (EFS), hospitalization, adverse events (AE), serious adverse events (SAE), and proceeding to transplant, and to describe the association of frailty with these outcomes, controlling for important covariates (age, sex, immunophenotype, revised international prognostic index score (rIPI), Eastern Cooperative Oncology Group (ECOG) PS, stage, and response to previous chemotherapy). Results: 619 patients in the LY12 trial were used to construct the frailty index (Table 1). Using a binary cut-off for frailty (<0.2), 15% (N=93) of patients were classified as frail. There were no differences in age or sex between frail and non-frail patients; however they differed in terms of other lymphoma-related characteristics (Table 2). Frailty was strongly associated with OS (HR 2.012, 95% CI 1.57-2.58), EFS (HR 1.94, 95% CI 1.53-2.46), frequency of the worst overall Grade >3 AE (OR 2.65 (15% vs. 6%), p=0.003), and likelihood of proceeding to ASCT (OR 0.26, 95% CI 0.15-0.43), but not hospitalization (OR 1.52, 95% CI 0.97-2.40) or SAE (6% vs. 4%, p=0.3). In multivariable analysis, frailty was not significantly associated with OS, EFS, likelihood of proceeding to ASCT, nor hospitalization (Table 3), though there was a trend to significance for ASCT. However, rIPI remained significantly associated with OS and EFS, ECOG remained significantly associated with OS (Table 3) Conclusion: A potentially broadly applicable lymphoma clinical trials specific FI was constructed through secondary analysis of LY12 data. 15% of patients were classified as frail. Frailty was significantly associated with OS, EFS, frequency of grade >3 AE and likelihood of proceeding to transplant. However, this relationship no longer was significant when controlling for lymphoma-related prognostic variables, suggesting that the impact of poor prognostic features of lymphoma supersede the impact of frailty alone in this younger clinical trial population. Interestingly, rIPI and ECOG demonstrated their value as simple predictors that are highly associated with OS and/or EFS even when controlling for other important covariates including frailty. These findings require further testing in an external data set, and would be particularly valuable to test in an older population. Calibration of the FI against clinical frailty assessment (e.g. Clinical Frailty Scale, Comprehensive Geriatric Assessment) would also be meaningful to confirm its ability to classify frail versus non-frail patients. Figure 1 Figure 1. Disclosures Crump: Epizyme: Research Funding; Roche: Research Funding; Kyte/Gilead: Membership on an entity's Board of Directors or advisory committees; Novartis: Membership on an entity's Board of Directors or advisory committees. Hay: Merck: Research Funding; Roche: Research Funding; Abbvie: Research Funding; Amgen: Research Funding; Karyopharm: Research Funding; Seattle Genetics: Research Funding. Prica: Astra-Zeneca: Honoraria; Kite Gilead: Honoraria.

scholarly journals Preliminary Estimates of Change in Physical Function After Targeted Kyphosis Exercise Intervention in Older Adults With Low Function: A Secondary Analysis of The SCOR Trial

2020 ◽  
Author(s):  
Amy Gladin ◽  
Wendy Katzman ◽  
Yoshimi Fukuoka ◽  
Neeta Parimi ◽  
Shirley Wong ◽  
...  
Keyword(s):  
Older Adults ◽  
Adverse Events ◽  
Physical Function ◽  
High Intensity ◽  
Exercise Intervention ◽  
Secondary Analysis ◽  
Community Dwelling ◽  
Spinal Curvature ◽  
Targeted Interventions ◽  
Function Group

Abstract Background: Hyperkyphosis is common in older adults and associated with low physical function and reduced health related quality of life (HrQol). Improved kyphosis has been previously established in kyphosis-targeted interventions in randomized controlled trials in older adults with hyperkyphosis however evidence for improved physical function is conflicting. Few studies have investigated change in physical function after a targeted kyphosis intervention in older adults with low physical function. The primary aim in this descriptive study was to explore change in physical function after a progressive high intensity 3-month targeted kyphosis exercise and posture training intervention in older adults with low physical function and hyperkyphosis. Secondary aims were to explore change in HrQol, spinal strength and spinal curvature, and adherence and safety of the intervention in older adults with low physical function and hyperkyphosis.Methods: In this secondary analysis of the Specialized Center of Research (SCOR) Kyphosis randomized trial, 101 community dwelling older men and women with hyperkyphosis who completed the intervention were divided into a low function group (LFG) and high function group (HFG). Baseline characteristics were compared between LFG and HFG. Physical function, HrQol, spinal strength and spinal curvature (kyphosis and lordosis) pre/post intervention change scores were explored within and between groups. Adherence and adverse events were examined in the LFG and HFG. Results:Twenty-six (26%) older adults were LFG, mean SPPB 9.62 (SD=1.17) points. At baseline, the LFG was older than HFG (p=0.005), endorsed more pain, (p=0.060), had worse physical function and HrQol (p≤0.001), and comparable kyphosis (p=0.640). SPPB increased 0.62 (95% CI: -0.20 to 1.44) points in the LFG and decreased 0.04 (95%CI: -0.28 to 0.19) points in the HFG, p=0.020. Gait speed improved 0.04 (95%CI: -0.02 to 0.10) m/s in the LFG. Kyphosis improved equally in both groups. Adherence was similar and there were no adverse events in the LFG or HFG. Conclusions:Older adults with low physical function and hyperkyphosis may improve physical function after a kyphosis targeted intervention. Older adults with low physical function may safely participate in targeted high-intensity kyphosis exercise and posture training. This observation needs to be confirmed in larger adequately powered studies. Clinicaltrials.gov dentifier: NCT01766674

scholarly journals Retrospective analysis of complications associated with dorsal root ganglion stimulation for pain relief in the FDA MAUDE database

2019 ◽  
Vol 44 (1) ◽  
pp. 100-106 ◽  
Author(s):  
Eellan Sivanesan ◽  
Mark C Bicket ◽  
Steven P Cohen
Keyword(s):  
Pain Relief ◽  
Dorsal Root Ganglion ◽  
Adverse Events ◽  
Dorsal Root ◽  
New Technology ◽  
Safety Data ◽  
Secondary Analysis ◽  
Freedom Of Information ◽  
Serious Adverse Events ◽  
Innovative Therapy

Background and objectivesDorsal root ganglion stimulation is an emerging therapy in the treatment of chronic pain. Compared with traditional spinal cord stimulation, it allows a discretely targeted stimulation profile and may act via differing mechanisms of action. Despite these advantages, little is known about the complications associated with this new modality.MethodsWe queried the MAUDE (Manufacturer and User Facility Device Experience) database for all entries named ‘Dorsal root ganglion stimulator for pain relief’ reported between May 1, 2016 and December 31, 2017. We verified these data through the Office of the Freedom of Information Act at the US Food and Drug Administration. We then eliminated duplicate entries and categorized each complication based on the event description. A secondary analysis was performed to characterize the serious adverse events and the severity of new neurologic symptoms and infections.ResultsWe identified 979 unique episodes following our process of deduplication. Almost half (47%) of entries were categorized as device-related complications, a quarter (28%) as procedural complications, with the remainder as patient complaints (12%), serious adverse events (2.4%), and ‘other’ complications (4.6%). The majority of complications were managed surgically with revision (n = 488; 49.8%) rather than explant (n = 161; 16.4%) events, respectively.ConclusionsThe ‘Dorsal root ganglion stimulator for pain relief’ device has been publicized as a breakthrough in neuromodulation technologies. As with any new technology, we must proceed with caution and re-evaluate effectiveness as information becomes available. The MAUDE database has provided safety data unique for this device that will aid in informed consent and further refinement of this innovative therapy.

scholarly journals Impact of strategic planning, organizational culture imprint and care bundles to reduce adverse events in the ICU

2018 ◽  
Vol 31 (6) ◽  
pp. 480-484
Author(s):  
Pablo Álvarez-Maldonado ◽  
Arturo Reding-Bernal ◽  
Alejandro Hernández-Solís ◽  
Raúl Cicero-Sabido
Keyword(s):  
Organizational Culture ◽  
Strategic Planning ◽  
Adverse Events ◽  
Usual Care ◽  
Care Center ◽  
Tertiary Care ◽  
Secondary Analysis ◽  
Healthcare Personnel ◽  
Cross Sectional ◽  
Care Bundles

Abstract Objective To evaluate the occurrence of adverse events during a multifaceted program implementation. Design Cross-sectional secondary analysis. Setting The respiratory-ICU of a large tertiary care center. Participants Retrospectively collected data of patients admitted from 1 March 2010 to 28 February 2014 (usual care period) and from 1 March 2014 to 1 March 2017 (multifaceted program period) were used. Interventions The program integrated three components: (1) strategic planning and organizational culture imprint; (2) training and practice and (3) implementation of care bundles. Strategic planning redefined the respiratory-ICU Mission and Vision, its SWOT matrix (strengths, weaknesses, opportunities, threats) as well as its medium to long-term aims and planned actions. A ‘Wear the Institution's T-shirt’ monthly conference was given in order to foster organizational culture in healthcare personnel. Training was conducted on hand hygiene and projects ‘Pneumonia Zero’ and ‘Bacteremia Zero’. Finally, actions of both projects were implemented. Main outcome measures Rates of adverse events (episodes per 1000 patient/days). Results Out of 1662 patients (usual care, n = 981; multifaceted program, n = 681) there was a statistically significant reduction during the multifaceted program in episodes of accidental extubation ([Rate ratio, 95% CI] 0.31, 0.17–0.55), pneumothorax (0.48, 0.26–0.87), change of endotracheal tube (0.17, 0.07–0.44), atelectasis (0.37, 0.20–0.68) and death in the ICU (0.82, 0.69–0.97). Conclusions A multifaceted program including strategic planning, organizational culture imprint and care protocols was associated with a significant reduction of adverse events in the respiratory-ICU.

scholarly journals Quitting Failure and Success With and Without Using Medication: Latent Classes of Abstinence and Adherence to Nicotine Monotherapy, Combination Therapy, and Varenicline

2018 ◽  
Vol 21 (11) ◽  
pp. 1488-1495 ◽  
Author(s):  
Danielle E McCarthy ◽  
Mark V Versella
Keyword(s):  
Combination Therapy ◽  
Repeated Measures ◽  
Latent Class ◽  
Interactive Voice Response ◽  
Nicotine Patch ◽  
Secondary Analysis ◽  
Comparative Trial ◽  
Smoking History ◽  
Latent Classes ◽  
Increased Risk

Abstract Introduction Nonadherence to pharmacotherapies complicates studies of comparative pharmacotherapy effectiveness. Modeling adherence and abstinence simultaneously may facilitate analysis of both treatment acceptability and effectiveness. Methods Secondary analyses of a three-arm randomized comparative trial of nicotine patch, varenicline, and combination nicotine patch and lozenge among adult daily smokers (N = 1086) were conducted. Adherence rates collected via interactive voice response systems during the first 27 days of quitting were compared across treatment conditions. Repeated measures latent class analyses of adherence and abstinence in 3-day parcels through 27 days of a quit attempt were conducted with treatment, demographic, and smoking history covariates. Results Adherence varied across treatments and was lowest for nicotine lozenge use in combination nicotine replacement therapy (NRT). Five latent classes that differed significantly in 6-month abstinence rates were retained, including three subgroups of adherent participants varying in treatment response and two nonadherent groups varying in abstinence probabilities. Nonadherence was more likely among those receiving varenicline and combination NRT, relative to patch monotherapy. Varenicline and combination NRT did not promote abstinence among adherent latent classes but did promote abstinence among those partially adherent, relative to patch alone. Combination therapy attenuated increased risk of treatment disengagement with more years smoking. Minority smokers, those high in dependence, and those with shorter past abstinence were at increased risk for low-adherence and low-abstinence latent classes. Conclusions Varenicline and combination nicotine patch and lozenge are less likely to be used as directed and may not increase first-month abstinence better than patch alone when taken adherently. Implications This secondary analysis of adherence and abstinence in a comparative effectiveness trial shows that adherence is highest for the nicotine patch, next highest for varenicline, and lowest for combination nicotine patch and lozenge therapy due to low lozenge use. Distinct latent classes were found that varied in both first-month abstinence and adherence. Varenicline and combination NRT may not enhance abstinence over patch alone among smokers who take medication adherently. Adherent use of medication especially benefits those who are low in dependence and have positive quitting histories; it is less beneficial to at-risk smokers and members of racial minorities.

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