scholarly journals Aducanumab: Appropriate Use Recommendations

2021 ◽  
pp. 1-13
Author(s):  
J. Cummings ◽  
P. Aisen ◽  
L.G. Apostolova ◽  
A. Atri ◽  
S. Salloway ◽  
...  
Keyword(s):  
Expert Panel ◽  
Informed Decision Making ◽  
Practice Setting ◽  
Efficacy And Safety ◽  
Appropriate Use ◽  
Patient Centered ◽  
The Us ◽  
Expected Outcome ◽  
Potential Risks ◽  
Prescribing Information

Aducanumab has been approved by the US Food and Drug Administration for treatment of Alzheimer’s disease (AD). Clinicians require guidance on the appropriate use of this new therapy. An Expert Panel was assembled to construct Appropriate Use Recommendations based on the participant populations, conduct of the pivotal trials of aducanumab, updated Prescribing Information, and expert consensus. Aducanumab is an amyloid-targeting monoclonal antibody delivered by monthly intravenous infusions. The pivotal trials included patients with early AD (mild cognitive impairment due to AD and mild AD dementia) who had confirmed brain amyloid using amyloid positron tomography. The Expert Panel recommends that use of aducanumab be restricted to this population in which efficacy and safety have been studied. Aducanumab is titrated to a dose of 10 mg/kg over a 6-month period. The Expert Panel recommends that the aducanumab be titrated to the highest dose to maximize the opportunity for efficacy. Aducanumab can substantially increase the incidence of amyloid-related imaging abnormalities (ARIA) with brain effusion or hemorrhage. Dose interruption or treatment discontinuation is recommended for symptomatic ARIA and for moderate-severe ARIA. The Expert Panel recommends MRIs prior to initiating therapy, during the titration of the drug, and at any time the patient has symptoms suggestive of ARIA. Recommendations are made for measures less cumbersome than those used in trials for the assessment of effectiveness in the practice setting. The Expert Panel emphasized the critical importance of engaging in a process of patient-centered informed decision-making that includes comprehensive discussions and clear communication with the patient and care partner regarding the requirements for therapy, the expected outcome of therapy, potential risks and side effects, and the required safety monitoring, as well as uncertainties regarding individual responses and benefits.

The US Expert Panel on the Appropriate Use Recommendations of Aducanumab in Clinical Practice

2021 ◽  
pp. 1-1
Author(s):  
S. Gauthier ◽  
P. Rosa-Neto
Keyword(s):  
Clinical Practice ◽  
Expert Panel ◽  
Amyloid Plaques ◽  
Public Domain ◽  
Phase Iii ◽  
Appropriate Use ◽  
The Public ◽  
New Class ◽  
The Us ◽  
The Brain

The authors of these recommendations must be congratulated on rapidly putting together a workable set of guidelines on the best use in clinical practice of the first drug approved (1) in a new class of medications acting on the excessive deposition of amyloid plaques in the brain of persons with early symptoms of Alzheimer’s disease (AD). These guidelines have been written despite the current lack of peer-reviewed publications about the Phase III pivotal studies so changes may be required once all the data is available in the public domain (2, 3, 4).

The Role of Shared Decision-Making in Audiologic Rehabilitation

2014 ◽  
Vol 21 (1) ◽  
pp. 15-23 ◽  
Author(s):  
Helen Pryce ◽  
Amanda Hall
Keyword(s):  
Decision Making ◽  
Shared Decision Making ◽  
Behavior Changes ◽  
Shared Decision ◽  
Patient Centered ◽  
Treatment Information ◽  
Centered Care ◽  
Potential Risks ◽  
Audiologic Rehabilitation

Shared decision-making (SDM), a component of patient-centered care, is the process in which the clinician and patient both participate in decision-making about treatment; information is shared between the parties and both agree with the decision. Shared decision-making is appropriate for health care conditions in which there is more than one evidence-based treatment or management option that have different benefits and risks. The patient's involvement ensures that the decisions regarding treatment are sensitive to the patient's values and preferences. Audiologic rehabilitation requires substantial behavior changes on the part of patients and includes benefits to their communication as well as compromises and potential risks. This article identifies the importance of shared decision-making in audiologic rehabilitation and the changes required to implement it effectively.

Small talk as work talk: Enacting the patient-centered approach in nurse-practitioner-patient visits

2018 ◽  
Vol 14 (2) ◽  
pp. 97-107 ◽  
Author(s):  
Staci Defibaugh
Keyword(s):  
Nurse Practitioners ◽  
Nurse Practitioner ◽  
Medical Visit ◽  
Patient Centered ◽  
Small Talk ◽  
Medical Visits ◽  
Relational Work ◽  
The Us ◽  
The Individual ◽  
Patient Relationships

Small talk in medical visits has received ample attention; however, small talk that occurs at the close of a medical visit has not been explored. Small talk, with its focus on relational work, is an important aspect of medical care, particularly so considering the current focus in the US on the patient-centered approach and the desire to construct positive provider– patient relationships, which have been shown to contribute to higher patient satisfaction and better health outcomes. Therefore, even small talk that is unrelated to the transactional aspect of the medical visit in fact serves an important function. In this article, I analyze small talk exchanges between nurse practitioners (NPs) and their patients which occur after the transactional work of the visit is completed. I focus on two exchanges which highlight different interactional goals. I argue that these examples illustrate a willingness on the part of all participants to extend the visit solely for the purpose of constructing positive provider–patient relationships. Furthermore, because exchanges occur after the ‘work’ of the visit has been completed, they have the potential to construct positive relationships that extend beyond the individual visit.

scholarly journals Ultrasound-guided implantation of radioactive 125I seed in radioiodine refractory differentiated thyroid carcinoma

BMC Cancer ◽  
2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Wei Chen ◽  
Yu kun Luo ◽  
Ying Zhang ◽  
Qing Song ◽  
Jie Tang
Keyword(s):  
Thyroid Carcinoma ◽  
Reduction Rate ◽  
Differentiated Thyroid Carcinoma ◽  
Comprehensive Treatment ◽  
Efficacy And Safety ◽  
Ultrasound Guided ◽  
Contrast Enhanced ◽  
The Us ◽  
Median Volume

Abstract Background Treatment for radioiodine refractory differentiated thyroid carcinoma (RR-DTC) is challenging. The purpose of this study was to assess the efficacy and safety of ultrasound-guided implantation of radioactive 125I-seed in radioiodine refractory differentiated thyroid carcinoma. Methods Thirty-six cervical metastatic lymph nodes (CMLNs) diagnosed with RR-DTC from 18 patients were enrolled in this retrospective study. US and contrast-enhanced ultrasound (CEUS) examinations were performed before implantation. Follow-up comprised US, CEUS, thyroglobulin (Tg) level and routine hematology at 1–3, 6, 9 and 12 months and every 6 months thereafter. The volumes of the nodules were compared before implantation and at each follow-up point. The volume reduction rate (VRR) of nodules was also recorded. Results The median volume of the nodules was 523 mm3 (148, 2010mm3) initially, which decreased significantly to 53mm3 (0, 286mm3) (P < 0.01) at the follow-up point of 24 months with a median VRR as 95% (86,100%). During the follow-up period (the range was 24–50 months), 25 (69%) nodules had VRR greater than 90%, of which 12 (33%) nodules had VVR ≈ 100% with unclear structures and only 125I seed images were visible in the US. At the last follow-up visit, the serum Tg level decreased from 57.0 (8.6, 114.8) ng/ml to 4.9 (0.7, 50.3) ng/ml, (P < 0.01). Conclusion US-guided 125I seed implantation is safety and efficacy in treating RR- DTC. It could be an effective supplement for the comprehensive treatment of thyroid cancer.

Cetuximab Plus Irinotecan in Heavily Pretreated Metastatic Colorectal Cancer Progressing on Irinotecan: MABEL Study

2008 ◽  
Vol 26 (33) ◽  
pp. 5335-5343 ◽  
Author(s):  
Hansjochen Wilke ◽  
Robert Glynne-Jones ◽  
Josef Thaler ◽  
Antoine Adenis ◽  
Peter Preusser ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Metastatic Colorectal Cancer ◽  
Progression Free Survival ◽  
Primary Objective ◽  
Practice Setting ◽  
Community Practice ◽  
Efficacy And Safety ◽  
Intention To Treat ◽  
Heavily Pretreated ◽  
N 93

Purpose This large, multinational study aimed to confirm in a community practice setting the efficacy and safety of cetuximab plus irinotecan in patients with epidermal growth factor–expressing metastatic colorectal cancer (mCRC) who had recently failed an irinotecan-containing regimen. Patients and Methods The primary objective was to determine the progression-free survival (PFS) rate at 12 weeks. The initial cetuximab dose was 400 mg/m2 and was followed weekly by 250 mg/m2; irinotecan (according to prestudy regimen) was given weekly (125 mg/m2 weekly for 4 of 6 weeks), every 2 weeks (180 mg/m2 each), or every 3 weeks (350 mg/m2 each). Results The intention-to-treat/safety population comprised 1,147 treated patients who received irinotecan weekly (n = 93); every 2 weeks (n = 670); every 3 weeks (n = 356); or another dose (n = 28). The PFS rate at 12 weeks was 61%, and the median survival was 9.2 months. Treatment was generally well tolerated. The most common treatment-related grades 3 to 4 adverse events were diarrhea (19%), neutropenia (10%), rash (7%), and asthenia (6%). The rate of grades 3 to 4 infusion-related reactions (IRRs; composite adverse event category) was 1% for patients who received both antihistamine and corticosteroid premedication. Conclusion Tolerability (except IRR incidence), PFS rate, and overall survival rate were in line with previous results. At 1%, the rate of IRRs in patients who received prophylactic premedication with both antihistamine and corticosteroid is lower than previously reported. MABEL clearly confirms in a community practice setting the efficacy and safety of cetuximab plus irinotecan in the treatment of mCRC.

scholarly journals A Randomized Controlled Trial to Evaluate and Assess the Effect of Comprehensive Pre-End Stage Kidney Disease Education on Home Dialysis Use in Veterans, Rationale and Design

2021 ◽  
Author(s):  
Ashutosh M. Shukla ◽  
Jennifer Hale-Gallardo ◽  
Tatiana Orozco ◽  
Ivette Freytes ◽  
Sergio Romero ◽  
...  
Keyword(s):  
Kidney Disease ◽  
Controlled Trial ◽  
End Stage Kidney Disease ◽  
Patient Centered ◽  
Advanced Chronic Kidney Disease ◽  
Home Dialysis ◽  
Clinical Patient ◽  
Randomized Controlled ◽  
The Us ◽  
End Stage

Abstract Background Informed dialysis selection and greater home dialysis use are the two long-desired, underachieved targets of advanced chronic kidney disease care in the US healthcare system. Observational institutional studies have shown that comprehensive pre-end stage kidney disease (ESKD) disease education (CPE) can improve both these outcomes. However, lack of validated protocols, well-controlled studies, and systemic models have limited wide-spread adoption of CPE in the US. We hypothesized that a universal CPE and patient-centered initiation of renal replacement therapy can improve multiple clinical, patient-centered and health service outcomes in advanced chronic kidney disease (CKD) and ESKD.Methods Trial to Evaluate and Assess the effects of CPE on Home dialysis in Veterans (TEACH-VET) is a mixed method randomized controlled trial aimed to evaluate the effects of a system-based approach for providing CPE to all Veterans with advanced CKD across a regional healthcare System. The study will randomize 544 Veterans with non-dialysis stage 4 and 5 CKD in a 1:1 allocation stratified by their annual family income and the stage of CKD to an intervention (CPE) arm or control arm. Intervention arm will receive a two-phase CPE in an intent-to-teach manner. Control arm will receive usual clinical care supplemented by resources for the freely-available kidney disease information. Participants will be followed after intervention/control for the duration of the study or until 90-days post-ESKD, whichever occurs earlier.Results The primary outcome will assess the proportion of Veterans using home dialysis at 90-days post-ESKD, and secondary outcomes will include post-intervention/control CKD knowledge, confidence in dialysis decision and home dialysis selection. Qualitative arm of the study will use semi-structured interviews to in-depth assess Veterans’ satisfaction with the intervention, preference for delivery, and barriers and facilitators to home dialysis selection and use. Several post-ESKD clinical, patient-centered and health services outcomes will be assessed 90-days post-ESKD as additional secondary outcomes.Conclusion The results will provide evidence regarding the need and efficacy of a system-based, patient-centered approach towards universal CPE for all patients with advanced CKD. If successful, this may provide a blueprint for developing such programs across the similar healthcare infrastructures throughout the country.Trial registration: NCT04064086

FRESCO-2: A global phase III study of the efficacy and safety of fruquintinib in patients (pts) with metastatic colorectal cancer (mCRC).

2021 ◽  
Vol 39 (3_suppl) ◽  
pp. TPS154-TPS154
Author(s):  
Arvind Dasari ◽  
James C. Yao ◽  
Alberto F. Sobrero ◽  
Takayuki Yoshino ◽  
William R. Schelman ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Growth Factor ◽  
Phase Iii ◽  
Controlled Study ◽  
Efficacy And Safety ◽  
Wild Type ◽  
Phase 3 ◽  
Prior Therapy ◽  
Anti Vegf ◽  
The Us

TPS154 Background: Pts with mCRC have limited treatment options following progression on standard therapies. Current standard of care (SOC) after pts progress on trifluridine/tipiracil (TAS-102) or regorafenib is re-challenge with previous systemic treatments, enrollment in a clinical trial, or best supportive care (BSC). Fruquintinib (Elunate) is a novel, highly selective, vascular endothelial growth factor (VEGF) receptor (VEGFR)-1, -2, and -3 tyrosine kinase inhibitor (TKI) ( Cancer Biol Ther 2014;15:1635-1645). Fruquintinib is approved in China to treat pts with mCRC who received or are intolerant to fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, anti-VEGF therapy, and, if RAS wild type, anti-epidermal growth factor receptor (EGFR) therapy. Approval was based on results of the phase 3 FRESCO study (2013-013-00CH1; NCT02314819; JAMA 2018;319:2486-2496), in which fruquintinib 5 mg daily (QD), 3 weeks on, 1 week off (3 on/1 off), significantly improved overall survival (OS) in pts with mCRC in the 3rd-line+ setting when compared to placebo (median OS 9.3 months [mo] versus 6.6 mo; hazard ratio [HR] 0.65; p < .001). Progression-free survival (PFS) was also superior (median PFS 3.7 mo versus 1.8 mo; HR 0.26; p < .001). The toxicities of fruquintinib were consistent with those of other VEGF TKIs and were manageable. At the time FRESCO was conducted in China, SOC for pts with mCRC differed from that in the US, EU, and Japan. We describe here a global phase 3 study (FRESCO-2; 2019-013-GLOB1; NCT04322539) being conducted to investigate fruquintinib’s efficacy and safety in pts with refractory mCRC and a treatment profile representative of the global SOC. Methods: FRESCO-2 is a randomized, double-blind, placebo-controlled study to compare fruquintinib + BSC to placebo + BSC. Key inclusion criteria are progression on or intolerance to treatment with TAS-102 and/or regorafenib; previous treatment with standard approved therapies including chemotherapy, anti-VEGF therapy, and, if RAS wild type, anti-EGFR therapy. Prior therapy with immune checkpoint or BRAF inhibitors is required for pts with corresponding tumor alterations. Pts (~522) will be randomized 2:1 to receive either fruquintinib 5 mg orally (PO) QD + BSC or placebo 5 mg PO QD + BSC, with a 3 on/1 off schedule. Randomization will be stratified by prior therapy, RAS status, and duration of metastatic disease. The primary endpoint is OS; secondary endpoints include PFS, disease control rate, objective response rate, duration of response, and safety. Final OS analyses will be performed when 364 OS events are observed; futility analysis will be conducted with 1/3 (121) OS events. If enrichment of post-regorafenib pts occurs, enrollment to that strata will be capped at approximately 262. FRESCO-2 will be activated in the US, EU, and Japan; global enrollment is anticipated over 13 mo. Clinical trial information: NCT04322539.

scholarly journals Fidaxomicin for the treatment of Clostridioides difficile in children

2020 ◽  
Vol 15 (11) ◽  
pp. 967-979
Author(s):  
Andrew M Skinner ◽  
Tonya Scardina ◽  
Larry K Kociolek
Keyword(s):  
Clinical Trial ◽  
Efficacy And Safety ◽  
Narrow Spectrum ◽  
Clostridioides Difficile ◽  
Macrocyclic Antibiotic ◽  
The Us ◽  
Us Fda ◽  
Multinational Clinical Trial

Fidaxomicin is an oral narrow-spectrum novel 18-membered macrocyclic antibiotic that was initially approved in 2011 by the US FDA for the treatment of Clostridioides difficile infections (CDI) in adults. In February 2020, the FDA approved fidaxomicin for the treatment of CDI in children age >6 months. In adults, fidaxomicin is as efficacious as vancomycin in treating CDI and reduces the risk of recurrent CDI. An investigator-blinded, randomized, multicenter, multinational clinical trial comparing the efficacy and safety of fidaxomicin with vancomycin in children was recently published confirming similar findings as previously reported in adults. Fidaxomicin is the first FDA-approved treatment for CDI in children and offers a promising option for reducing recurrent CDI in this population.

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