scholarly journals Centralised RECIST Assessment and Clinical Outcomes with Lenvatinib Monotherapy in Recurrent and Metastatic Adenoid Cystic Carcinoma

Cancers ◽  
2021 ◽  
Vol 13 (17) ◽  
pp. 4336
Author(s):  
Laura Feeney ◽  
Yatin Jain ◽  
Matthew Beasley ◽  
Oliver Donnelly ◽  
Anthony Kong ◽  
...  
Keyword(s):  
Decision Making ◽  
Adenoid Cystic Carcinoma ◽  
Clinical Outcomes ◽  
Clinical Decision Making ◽  
Kinase Inhibitor ◽  
Objective Response ◽  
Response Rates ◽  
Clinical Decision ◽  
Adenoid Cystic ◽  
Phase Ii Studies

Adenoid cystic carcinoma (ACC) is a rare cancer of secretory glands. Recurrent or metastatic (R/M) ACC is generally considered resistant to cytotoxic chemotherapy. Recent phase II studies have reported improved objective response rates (ORR) with the use of the multi-kinase inhibitor lenvatinib. We sought to evaluate real-world experience of R/M ACC patients treated with lenvatinib monotherapy within the UK National Health Service (NHS) to determine the response rates by Response Evaluation Criteria of Solid Tumour (RECIST) and clinical outcomes. Twenty-three R/M ACC patients from eleven cancer centres were included. All treatment assessments for clinical decision making related to drug therapy were undertaken at the local oncology centre. Central radiology review was performed by an independent clinical trial radiologist and blinded to the clinical decision making. In contrast to previously reported ORR of 12–15%, complete or partial response was not observed in any patients. Eleven patients (52.4%) had stable disease and 5 patients (23.8%) had progression of disease as the best overall response. The median time on treatment was 4 months and the median survival from discontinuation was 1 month. The median PFS and OS from treatment initiation were 4.5 months and 12 months respectively. Multicentre collaborative studies such as this are required to evaluate rare cancers with no recommended standard of care therapy and variable disease courses.

Debates in Dysphagia Management: How Do You Use Evidence-Based Practice in Your Dysphagia Patient Care?

2011 ◽  
Vol 20 (4) ◽  
pp. 121-123
Author(s):  
Jeri A. Logemann
Keyword(s):  
Decision Making ◽  
Patient Care ◽  
Clinical Outcomes ◽  
Clinical Judgment ◽  
Clinical Decision Making ◽  
Evidence Based Practice ◽  
Clinical Decision ◽  
Evidence Based ◽  
Clinical Method ◽  
Do So

Evidence-based practice requires astute clinicians to blend our best clinical judgment with the best available external evidence and the patient's own values and expectations. Sometimes, we value one more than another during clinical decision-making, though it is never wise to do so, and sometimes other factors that we are unaware of produce unanticipated clinical outcomes. Sometimes, we feel very strongly about one clinical method or another, and hopefully that belief is founded in evidence. Some beliefs, however, are not founded in evidence. The sound use of evidence is the best way to navigate the debates within our field of practice.

Decision-making under pressure: medical errors in uncertain and dynamic environments

2018 ◽  
Vol 42 (4) ◽  
pp. 395 ◽  
Author(s):  
Alicia M. Zavala ◽  
Gary E. Day ◽  
David Plummer ◽  
Anita Bamford-Wade
Keyword(s):  
Decision Making ◽  
Human Factors ◽  
Clinical Outcomes ◽  
Medical Errors ◽  
Thematic Analysis ◽  
Clinical Decision Making ◽  
Clinical Decision ◽  
Dynamic Environments ◽  
Emergency Situations ◽  
Case Complexity

Objective This paper provides a narrative overview of the literature concerning clinical decision-making processes when staff come under pressure, particularly in uncertain, dynamic and emergency situations. Methods Studies between 1980 and 2015 were analysed using a six-phase thematic analysis framework to achieve an in-depth understanding of the complex origins of medical errors that occur when people and systems are under pressure and how work pressure affects clinical performance and patient outcomes. Literature searches were conducted using a Summons Search Service platform; search criteria included a variety of methodologies, resulting in the identification of 95 papers relevant to the present review. Results Six themes emerged in the present narrative review using thematic analysis: organisational systems, workload, time pressure, teamwork, individual human factors and case complexity. This analysis highlights that clinical outcomes in emergency situations are the result of a variety of interconnecting factors. These factors may affect the ability of clinical staff in emergency situations to provide quality, safe care in a timely manner. Conclusions The challenge for researchers is to build the body of knowledge concerning the safe management of patients, particularly where clinicians are working under pressure. This understanding is important for developing pathways that optimise clinical decision making in uncertain and dynamic environments. What is known about the topic? Emergency departments (EDs) are characterised by high complexity, high throughput and greater uncertainty compared with routine hospital wards or out-patient situations, and the ED is therefore prone to unpredictable workflows and non-replicable conditions when presented with unique and complex cases. What does this paper add? Clinical decision making can be affected by pressures with complex origins, including organisational systems, workload, time constraints, teamwork, human factors and case complexity. Interactions between these factors at different levels of the decision-making process can increase the complexity of problems and the resulting decisions to be made. What are the implications for practitioners? The findings of the present study provide further evidence that consideration of medical errors should be seen primarily from a ‘whole-of-system’ perspective rather than as being primarily the responsibility of individuals. Although there are strategies in place in healthcare organisations to eliminate errors, they still occur. In order to achieve a better understanding of medical errors in clinical practice in times of uncertainty, it is necessary to identify how diverse pressures can affect clinical decisions, and how these interact to influence clinical outcomes.

Clinical Assessment of Upper Extremity Injury Outcomes

2011 ◽  
Vol 20 (1) ◽  
pp. 61-73 ◽  
Author(s):  
Charles Thigpen ◽  
Ellen Shanley
Keyword(s):  
Decision Making ◽  
Clinical Outcome ◽  
Outcome Assessment ◽  
Clinical Outcomes ◽  
Clinical Decision Making ◽  
Clinical Decision ◽  
Assessment Tools ◽  
Bottom Line ◽  
Patient Scenario ◽  
Clinical Outcomes Assessment

Patient Scenario:The patient presented is a high school baseball pitcher who was unable to throw because of shoulder pain. He subsequently failed nonoperative management but was able to return to pitching after surgery and successful rehabilitation.Clinical Outcomes Assessment:The Disabilities of Arm, Shoulder and Hand (DASH) and the Pennsylvania Shoulder Score (PENN) were selected as clinical outcome assessment tools to quantify the patient’s perceived ability to perform common daily tasks and sport tasks and current symptoms such as pain and patient satisfaction.Clinical Decision Making:The DASH and PENN provide important information that can be used to target specific interventions, set appropriate patient goals, assess between-sessions changes in patient status, and quantify patients’ functional loss.Clinical Bottom Line:Best clinical practice involves the use of clinical outcome assessment tools to garner an objective measure of the impact of a patient’s disease process on functional expectations. This process should facilitate a patient-centered approach by clinicians while they select the optimal intervention strategies and establish prognostic timelines.

scholarly journals Medical Simulation in Relapsed Follicular Lymphoma Improves Clinical Decision Making of Hematologists/Oncologists

Blood ◽  
2020 ◽  
Vol 136 (Supplement 1) ◽  
pp. 33-34
Author(s):  
Lauren Willis ◽  
Donna Topping ◽  
Sarah Atwood ◽  
Jonathon B. Cohen
Keyword(s):  
Decision Making ◽  
Follicular Lymphoma ◽  
Treatment Option ◽  
Clinical Decision Making ◽  
Response Rates ◽  
Clinical Decision ◽  
Evidence Based ◽  
Cell Transplant ◽  
Clinical Decisions ◽  
Appropriate Treatment

Background: Frontline treatment of follicular lymphoma (FL) yields high response rates, but most patients relapse. In addition, response rates and duration of response have historically declined with subsequent treatments. These factors make management of this disease challenging. Therefore, this study was conducted to determine if an online, simulation-based continuing medical education (CME) intervention could improve clinical decision making of hematologists/oncologists (hem/oncs) regarding treatment selection for relapsed/refractory (R/R) FL. Description of Intervention: A CME certified virtual patient simulation (VPS) was made available via a website dedicated to continuous professional development. The VPS consisted of 2 cases of R/R FL presented in a platform that allows hem/oncs to assess the patients and make diagnostic and therapeutic decisions supported by an extensive database of diagnostic and treatment possibilities, matching the scope and depth of actual practice. Case 1: Patient with FL who failed 2 prior lines of therapy (R-CHOP, bendamustine/obinutuzumab), past medical history (PMH) well controlled hypertension and poorly controlled type 2 diabetes, presenting with constitutional symptoms and needs 3rd line treatment. Case 2: Patient with FL who failed 2 prior lines of therapy (bendamustine/rituximab, lenalidomide/rituximab), PMH well controlled atrial fibrillation and ulcerative colitis, patient requests intravenous therapy because he has trouble remembering to take oral medications. Methods: Clinical decisions were analyzed using a sophisticated decision engine, and tailored clinical guidance (CG) employing up-to-date evidence-base and faculty recommendations was provided after each decision. Decisions were collected post-CG and compared with each user's baseline (pre-CG) decisions using McNemar's test to determine p-values (P < .05 indicates significance). Data were collected between 11/20/19 and 2/19/20. Results: At the time of assessment, 154 hem/oncs who made clinical decisions were included in the analysis. From pre- to post-CG in the VPS, hem/oncs were more likely to make evidence-based practice decisions in: -Diagnosing patients with relapsed FL: 55% pre-CG and 73% post-CG (P < 0.001) -Starting an appropriate treatment for a patient with R/R FL ----Case 1: Ordering idelalisib: 7% pre-CG and 33% post-CG (P < 0.001) ----Case 1: Ordering lenalidomide + rituximab: 6% pre-CG and 28% post-CG (P < 0.001) ----Case 1: Ordering duvelisib: 2% pre-CG and 9% post-CG (P < 0.001) ----Case 2: Ordering copanlisib: 32% pre-CG and 73% post-CG (P < 0.001) The top rationales for selecting an appropriate treatment option were: recommended by guidelines, convenience of administration route, better efficacy compared to other agents, and best option based on patient comorbidities. Other relevant concomitant therapies ordered were consult for chimeric antigen receptor (CAR) T-cell therapy, consult for stem cell transplant, radiation therapy, refer to a clinical trial, and Pneumocystis jirovecii pneumonia (PJP) prophylaxis (Figure 1). Conclusion: This study demonstrates that VPS that immerses and engages hem/oncs in an authentic and practical learning experience improved evidence-based clinical decisions related to the management of R/R FL. This VPS increased the percentage of heme/oncs who correctly diagnosed R/R FL and selected an appropriate treatment option. This study indicates that unique educational methodologies and platforms, which are available on-demand, can be effective tools for promoting guideline-based therapy selection and clinical decision making. Acknowledgement: This CME activity was supported by an independent educational grant from Bayer, Celgene Corporation, and Verastem Oncology. Jake Cohen contributed to data analysis for this research. Reference: https://www.medscape.org/viewarticle/915986 Figure Disclosures Cohen: Janssen, Adicet, Astra Zeneca, Genentech, Aptitude Health, Cellectar, Kite/Gilead, Loxo: Consultancy; Genentech, BMS, Novartis, LAM, BioInvent, LRF, ASH, Astra Zeneca, Seattle Genetics: Research Funding.

scholarly journals Predicting Clinical Outcomes Using Molecular Biomarkers

2016 ◽  
Vol 8 ◽  
pp. BIC.S33380 ◽  
Author(s):  
Harry B. Burke
Keyword(s):  
Decision Making ◽  
Clinical Outcomes ◽  
Clinical Decision Making ◽  
Clinical Care ◽  
Clinical Decision ◽  
Molecular Biomarkers ◽  
The Past ◽  
Diagnosis And Prognosis ◽  
Molecular Therapies ◽  
Physician Patient

Over the past 20 years, there has been an exponential increase in the number of biomarkers. At the last count, there were 768,259 papers indexed in PubMed.gov directly related to biomarkers. Although many of these papers claim to report clinically useful molecular biomarkers, embarrassingly few are currently in clinical use. It is suggested that a failure to properly understand, clinically assess, and utilize molecular biomarkers has prevented their widespread adoption in treatment, in comparative benefit analyses, and their integration into individualized patient outcome predictions for clinical decision-making and therapy. A straightforward, general approach to understanding how to predict clinical outcomes using risk, diagnostic, and prognostic molecular biomarkers is presented. In the future, molecular biomarkers will drive advances in risk, diagnosis, and prognosis, they will be the targets of powerful molecular therapies, and they will individualize and optimize therapy. Furthermore, clinical predictions based on molecular biomarkers will be displayed on the clinician's screen during the physician–patient interaction, they will be an integral part of physician–patient-shared decision-making, and they will improve clinical care and patient outcomes.

Choice of Intra-arterial Therapy for Hepatocellular Carcinoma: Evidence and Future Horizons

2017 ◽  
Vol 01 (02) ◽  
pp. 105-114 ◽  
Author(s):  
Mansur Ghani ◽  
Vinayak Thakur ◽  
Jean-François Geschwind
Keyword(s):  
Hepatocellular Carcinoma ◽  
Decision Making ◽  
Clinical Decision Making ◽  
Kinase Inhibitor ◽  
Transarterial Embolization ◽  
Clinical Decision ◽  
The United States ◽  
Surrounding Tissue ◽  
Western World ◽  
Antiangiogenic Agents

AbstractHepatocellular carcinoma is the second most common cause of cancer-related deaths worldwide. Along with viral and alcoholic hepatitis, obesity is the leading cause for increasing incidence in the western world, specifically in the United States. As most patients initially present with intermediate to advanced stage disease, curative therapies such as ablation, surgical resection, or liver transplantation cannot usually be applied. Thus, intra-arterial therapies (IATs), such as transarterial chemoembolization (TACE), have become a mainstay of treatment. Several variations of transarterial embolotherapy, such as bland transarterial embolization or drug-eluting bead TACE, are currently available and used in clinical practice. Yttrium-90 radioembolization is a distinct IAT that relies on delivery of radiation to surrounding tissue for tumor death. However, no clear guidelines or evidence exist that would favor one of these options over the other, leaving the decision-making process open to influence by local expertise and experience. In addition, combining TACE with systemic antiangiogenic agents, such as the multityrosine kinase inhibitor sorafenib, has been investigated in several prospective clinical trials without clearly demonstrating substantial survival benefits of the combination over TACE alone. This review will summarize and discuss the available clinical evidence and indications for each treatment modality with the goal of facilitating clinical decision-making processes, and provide an overview of the ongoing efforts to compare different IAT modalities.

Phase II study of dovitinib (TKI258) in patients with progressive metastatic adenoid cystic carcinoma.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 6021-6021 ◽  
Author(s):  
Patrick Michael Dillon ◽  
Chris Moskaluk ◽  
Paula M. Fracasso ◽  
Gina R. Petroni ◽  
Christopher Y. Thomas
Keyword(s):  
Adenoid Cystic Carcinoma ◽  
Kinase Inhibitor ◽  
Lung Metastases ◽  
Objective Response ◽  
Tumor Growth Rate ◽  
Type I ◽  
Duration Of Treatment ◽  
Open Label ◽  
Adenoid Cystic ◽  
Stomach Pain

6021 Background: Adenoid cystic carcinoma (ACC) is an uncommon malignancy of secretory glands for which there is no standard systemic therapy. At least 90% of ACC tumors carry a t(6;9)(q22–23;p23–24) chromosome translocation that results in overexpression of the MYB oncogene that in turn upregulates FGF2 and other growth factors. Dovitinib is a multiple receptor kinase inhibitor that could potentially block autocrine activation of the FGFR and VEGFR-mediated angiogenesis. In a mouse model, dovitinib suppressed the growth of low passage ACC xenografts. Methods: In this open-label, single-arm trial, patients (n=21) with metastatic ACC that progressed in the last 6 months were treated with dovitinib 500 mg/d, 5-days on/2-days off. The primary endpoint was objective response rate using a two-stage design to test a null and alternative rate of 1% and 18%, respectively, with 90% power and type I error <5%. Secondary endpoints were progression-free survival, safety, quality of life, biomarker studies, and change in tumor growth rate. Results: All 21 patients (median age 54.3, range 29-74) had previous treatment with chemotherapy, radiotherapy or targeted agents. Median duration of treatment to date is 5.7 months (range 2-10 months) and is ongoing in 11 patients. Nine of 21 patients required dose reductions. Grade 3/4 drug-related adverse events included thromboembolism (4), hematuria (1), dehydration (1), pneumonia (2), hypertriglyceridemia (3), diarrhea (2), stomach pain (2), anxiety (1), transaminitis (3) and cytopenias (4). One death occurred unrelated to study drug. Among 19 evaluable patients, 2 had partial responses by RECIST criteria (1 with lung metastases and 1 with tracheal recurrence and stable bone metastases). Both experienced improvements in pain ratings and are free of disease progression at 8+ and 5+ months. Stable disease >6 months was observed in 9 patients while 6 others with shorter follow-up have not progressed. Four patients progressed early (<4 months) and two are too early to assess. Conclusions: Dovitinib produces objective partial responses and prolonged tumor stabilization with acceptable toxicity in patients with progressive ACC. Clinical trial information: NCT01524692.

Evidence-based Guidelines for Anxiety Disorders: Can They Improve Clinical Outcomes?

CNS Spectrums ◽  
2006 ◽  
Vol 11 (S12) ◽  
pp. 34-39 ◽  
Author(s):  
David S. Baldwin
Keyword(s):  
Decision Making ◽  
Anxiety Disorders ◽  
Clinical Outcomes ◽  
Clinical Guidelines ◽  
Clinical Decision Making ◽  
Treatment Guidelines ◽  
Clinical Decision ◽  
Evidence Based ◽  
Mental Health Programs ◽  
Evidence Based Guidelines

AbstractEvidence-based medicine (EBM) enables clinicians to justify decision making, enhances the quality of medical practice, identifies unanswered research questions, and ensures the efficient practice of medicine. Implementation of evidence-based mental health programs requires education, time, and improved effort by administration, regulatory, and clinical professionals. Essential to these efforts are consistent incentives for change, effective training materials, and clear clinical guidelines. Guidelines exist within the framework of EBM. Good guidelines are simple, specific, and user friendly, focus on key clinical decisions, are based on research evidence, and present evidence and recommendations in a concise and accessible format. Potential limitations of guidelines to improve clinical outcomes in anxiety disorders are the widespread distribution of anxiety symptoms in primary care, health inequalities across patient groups, persistent misconceptions regarding psychotropic drugs, and low confidence in using simple psychological treatments. Clinical guidelines generally specify therapeutic areas covered and not covered, but often there is no mention of cost or cost effectiveness of treatment. Guidelines can inform clinical decision making, but administrators of drug formularies may regard themselves as being primarily responsible for limiting costs and access to certain medications, even if these decisions are at odds with guideline recommendations.

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