Academic literature on the topic 'Commonwealth Advisory Committee on Advanced Education'

This report of NATO's Advanced Educational Technology (AET) advisory committee is written to provide a summary as well as a vision of the role of technology in education. Over fifty ARW's (Advanced Research Workshops) and ASI's (Advanced Study Institutes) have provided a forum for hundreds of AET professionals to interact and collaborate. The published books and reports have had an impact on thousands of educational designers and planners. The summary of position and thematic papers that were presented at the final capstone workshop provide a framework for future research, development, and effective implementation of AET systems.

Introduction: Advanced systemic mastocytosis (AdvSM) comprises a heterogeneous group of clonal mast cell neoplasms, primarily driven by KIT D816V. Measures of AdvSM response, including the International Working-Group for Myeloproliferative Neoplasms Research and Treatment and European Competence Network on Mastocytosis (IWG-MRT-ECNM) criteria, are based on improvements in mast cell-related organ damage (C-findings), and further sub-classified by the extent of reduction in measures of mast cell disease (e.g. serum tryptase level, bone marrow mast cell burden). However, assessment of some C-findings lacks precision (such as splenomegaly and its resolution). Normalization of C-findings may not be an adequate surrogate for important clinical outcomes such as overall survival (OS). We evaluated whether pure pathologic response (PPR) criteria based on changes in bone marrow mast cells, serum tryptase, and complete blood count was more closely correlated with OS compared to the modified IWG-MRT-ECNM (mIWG-MRT-ECNM) criteria. Methods: As an exploratory post-hoc analysis of the phase 1 EXPLORER study of avapritinib in AdvSM, we evaluated responses lasting ≥12 weeks by both mIWG-MRT-ECNM and PPR criteria. At baseline, evaluability for mIWG-MRT-ECNM response required ≥1 evaluable C-findings; PPR required presence of bone marrow mast cell aggregates and/or serum tryptase ≥20 ng/mL. Per PPR, morphologic complete remission (mCR) is absence of bone marrow mast cell aggregates, serum tryptase <20 ng/mL and full (or partial [mCRh]) hematologic recovery; morphologic partial remission (mPR) is ≥50% reduction in bone marrow mast cells and serum tryptase level. OS was analyzed by Kaplan-Meier method and was time from first dose to death. OS comparisons were by log-rank test, performed for best response and landmark analyses at various cycles. Results: As of the data cut-off of August 30, 2019, 80 patients enrolled including 62 with AdvSM (7 with aggressive SM [ASM], 44 SM with an associated hematologic neoplasm [SM-AHN] and 11 with mast cell leukemia [MCL]). Ten (16%) AdvSM patients (7 ASM, 3 SM-AHN) were not response evaluable (RE) per mIWG-MRT-ECNM criteria, due to a lack of an evaluable C-finding at baseline, and 4 additional AdvSM patients were recently enrolled and were not yet response evaluable. Of the 48 RE patients (3 ASM, 35 SM-AHN and 10 MCL) the best overall response rate (ORR) per mIWG-MRT-ECNM was 77% (8% CR, 19% CRh, 42% partial response [PR], and 8% clinical improvement [CI]). Non-responders had stable disease (SD; 21%) or were not evaluable (NE) due to insufficient (<13 weeks) follow-up (2%). Responders (CR/CRh/PR/CI) had 18-month OS of 85% (CR/CRh, 100%; PR, 77%; CI, 75%; Figure 1A); non-responders had 18-month OS of 48% (SD, 53%; NE, 0%) (P=0.042). Per PPR criteria, the best ORR was similar at 79%; however, a greater proportion of patients were assessed as being in a complete remission (15% mCR, 27% mCRh and 38% mPR). Non-responders by PPR all had SD (21%). This demonstrates that elimination of measurable mast cell burden can be discordant with complete C-finding resolution. Responders (mCR/mCRh/mPR) by PPR had 18-month OS of 88% (mCR/mCRh: 100%; mPR: 72%; Figure 1B); non-responders (all SD) had 18-month OS of 21% (P=0.0001). Eventually, all 62 AdvSM patients will be evaluable by PPR criteria, including those 10 patients without mIWG evaluable C-findings at baseline; however, 5 patients had insufficient follow-up at the time of analysis. For the 57 AdvSM patients with sufficient follow up, the best ORR per PPR criteria was similar at 77% (14% mCR, 26% mCRh and 37% mPR). Overall, no patients had a best response of progressive disease based on mIWG or PPR criteria. Landmark analyses of PPR at the end of 6 cycles showed a trend in 18-month OS of mCR/mCRh>mPR>SD in patients with similar starting avapritinib doses of ≥200 mg daily (n=48 of 57 PPR-evaluable patients). Conclusions : In the phase I EXPLORER study, response assessment in AdvSM using PPR criteria increases the evaluable population, significantly correlates with OS, and should be explored as a potential primary endpoint for future trials. Disclosures Gotlib: Blueprint Medicines Corporation: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: Chair of the Response Adjudication Committee and Research Funding, Research Funding; Deciphera: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: co-chair of the Study Steering Committee and Research Funding. Radia:Blueprint Medicines Corporation: Membership on an entity's Board of Directors or advisory committees; Novartis: Membership on an entity's Board of Directors or advisory committees, Other: Education events. George:Blueprint Medicines Corporation: Consultancy, Other: I have received no funding for this research. ARUP Laboratories, owned by the University of Utah, has received funding; Allakos: Consultancy; Deciphera: Other: consultancy, but has received no financial compensation for the past 12 months; Celgene: Consultancy. Robinson:Blueprint Medicines Corporation: Research Funding. Drummond:Jazz: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Pfizer: Consultancy, Membership on an entity's Board of Directors or advisory committees; Novartis: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau; Gilead: Membership on an entity's Board of Directors or advisory committees; Bristol Myers Squibb: Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Takeda: Membership on an entity's Board of Directors or advisory committees; Astellas: Membership on an entity's Board of Directors or advisory committees; Blueprint Medicine Corporation: Research Funding. Bose:Incyte Corporation: Consultancy, Honoraria, Research Funding, Speakers Bureau; Kartos Therapeutics: Honoraria, Research Funding; Astellas Pharmaceuticals: Research Funding; NS Pharma: Research Funding; Pfizer, Inc.: Research Funding; Promedior, Inc.: Research Funding; Constellation Pharmaceuticals: Research Funding; Celgene Corporation: Honoraria, Research Funding; CTI BioPharma: Honoraria, Research Funding; Blueprint Medicines Corporation: Honoraria, Research Funding. Hexner:Samus Therapeutics: Research Funding; Novartis: Research Funding; American Board of Internal Medicine: Other: member of the hematology exam committee; Blueprint Medicines Corporation: Other: serves on a data safety monitoring committee, Research Funding. Winton:Blueprint Medicines Corporation: Research Funding; Samus Therapeutics: Research Funding; Incyte Corporation: Research Funding. Horny:Novartis: Consultancy; Blueprint Medicines Corporation: Consultancy. Tugnait:Blueprint Medicines Corporation: Current equity holder in publicly-traded company, Ended employment in the past 24 months. Schmidt-Kittler:Blueprint Medicines Corporation: Current equity holder in publicly-traded company, Ended employment in the past 24 months. Evans:Blueprint Medicines Corporation: Current equity holder in publicly-traded company, Ended employment in the past 24 months. Lin:Blueprint Medicines Corporation: Current Employment, Current equity holder in publicly-traded company. Mar:Blueprint Medicines Corporation: Current Employment, Current equity holder in publicly-traded company. Deininger:Leukemia & Lymphoma Society: Research Funding; Bristol-Myers Squibb: Consultancy, Honoraria, Other, Research Funding; Ariad: Consultancy, Honoraria, Other; Incyte: Consultancy, Honoraria, Other, Research Funding; Novartis: Consultancy, Other, Research Funding; Medscape: Consultancy; Takeda: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding; Fusion Pharma: Consultancy; Blueprint Medicines Corporation: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: part of a study management committee, Research Funding; DisperSol: Consultancy; Galena: Consultancy, Honoraria, Other; Celgene: Research Funding; Gilead Sciences: Research Funding; SPARC: Research Funding; Sangamo: Consultancy, Membership on an entity's Board of Directors or advisory committees; Pfizer: Honoraria, Other, Research Funding. DeAngelo:Incyte Corporation: Consultancy; Glycomimetics: Research Funding; Forty-Seven: Consultancy; Amgen: Consultancy; Novartis: Consultancy, Research Funding; Pfizer: Consultancy; Abbvie: Research Funding; Jazz: Consultancy; Autolos: Consultancy; Shire: Consultancy; Takeda: Consultancy; Blueprint Medicines Corporation: Consultancy, Research Funding; Agios: Consultancy.

V ancomycin-resistant enterococci (VRE) are increasingly recognised nosocomial pathogens in clinical areas with high antibiotic usage. Patients with chronic renal failure, including those requiring haemodialysis, are at particular risk. Investigation and control of an outbreak of VRE in two renal wards, highlighting mattresses as reservoirs and environmental measures to control VRE are reported in this paper. Outbreak control measures included standard isolation in accordance with the Recommendations of the Hospital Infection Control Practices Advisory Committee (HICPAC). Patients were screened on admission and weekly using a rectal swab. The inanimate environment including mattresses was also screened. Enhanced environmental decontamination was performed on a daily basis. The outbreak continued over a 20-week period with most cases occurring in the first 6 weeks. The results of screening indicated that 59 (13%) of 451 patients and 54 (8.3%) of 647 environmental samples were positive for VRE. VRE was isolated from 35 (8%) of 433 mattresses, 12 (8.1%) of 148 environmental ledges, 4 (8%) of 50 toilets, and 3 (18.8%) of 16 items of cleaning equipment. Molecular typing indicated that a predominant strain was also implicated in mattress contamination, thus highlighting a potential and important reservoir for transmission of VRE. Difficulty with eradication of VRE from the environment was encountered despite enhanced cleaning regimens and a doubling of use of disinfectant was necessary. Restriction of antibiotics, hand hygiene, hygiene and education are the cornerstone of VRE prevention and control. Lessons from this outbreak highlight the role of the environment in VRE transmission and the need for attention to the environment, especially mattress decontamination.

Scientific advances in genetics and genomics are rapidly redefining our understanding of health and illness and creating a significant shift in practice for all health care disciplines. Nurses educated at the graduate level are well-prepared to assume clinical and leadership roles in health care systems and must also be prepared to assume similar roles related to genetic/genomic health care. This chapter describes the processes used to create a consensus document identifying the genetic/genomic competencies essential for nurses prepared at the graduate level. Three groups were involved in the competency development; a steering committee provided leadership and used qualitative methods to review and analyze pertinent source documents and create an initial competency draft; an advisory board evaluated and revised the draft, and a consensus panel refined and validated the final set of competencies. The concensus process resulted in 38 competencies organized under the following categories: Risk Assessment and Interpretation; Genetic Education, Counseling, Testing and Results Interpretation; Clinical Management; Ethical, Legal, and Social Implications; Professional Role; Leadership, and Research. These competencies apply to all individuals functioning at the graduate level in nursing, including but not limited to advanced practice registered nurses, clinical nurse leaders, nurse educators, nurse administrators, and nurse scientists and are intended to inform and guide their practice.

Introduction: The utility of amyloidosis staging systems has been validated for newly diagnosed patients, but their role in restaging after starting treatment has not been explored. Given the high early mortality in this disease, restaging remote from the diagnosis may have clinical value. We designed this study to evaluate whether the currently used staging systems are prognostic when applied at 3 and 6 months from starting first-line treatment, and whether stage migration impacts survival. Methods: This is a retrospective study including patients with systemic light chain amyloidosis diagnosed between January, 1st 2006 and June, 30th 2019 and were seen in Mayo Clinic, Rochester, MN within 90 days of diagnosis; the analysis included 535 and 301 patients who had restaging data available for at least one of the staging systems at 3 and 6 months, respectively. Patients were grouped into 4 stages using the 2015 European modification of the Mayo 2004 staging system based on values of cardiac biomarkers (cardiac troponin T and NTproBNP), and using the Mayo 2012 staging system based on cardiac biomarkers and the difference in serum free light chain concentration (dFLC). Overall survival (OS) was calculated from the time of re-staging until death or last follow up. Results: Using the modified Mayo 2004 staging system at 3 months from starting first-line treatment, median OS was 11.8 [95%CI: 11.4-not reached (NR)], 10.8 (95%CI: 9.4-NR), 4.6 (95%CI: 2.8-6.7), and 1.1 (95%CI: 0.7-2.6) years in patients with stage I, II, IIIa, and IIIb, respectively. Using Mayo 2012 staging at 3 months, OS was 11.8 (95%CI: 10.9-NR), 9.0 (95%CI: 6.2-NR), 5.2 (95%CI: 3.3-6.1), and 0.8 (95%CI: 0.7-1.1) years in patients with stage I, II, III, and IV, respectively (Figure 1a &b). Using the modified Mayo 2004 staging system at 6 months from starting first-line treatment, median OS was NR (95%CI: NR-NR), 9.8 (95%CI: 6.2-NR), 5.4 (95%CI: 3.2-9.0) and 0.9 (95%CI: 0.6-3.7) years in patients with stage I, II, IIIa, and IIIb, respectively. Using Mayo 2012 staging at 6 months, OS was NR (95%CI: 8.4-NR), NR (95%CI: 7.9-NR), 4.6 (95%CI: 3.0-6.5), and 0.9 (95%CI: 0.2-1.8) years in patients with stage I, II, III, and IV, respectively (Figure 1c &d). On multivariate analysis, advanced (stage > 2) modified Mayo 2004 stage (HR: 1.6, P=0.004) and advanced (stage > 2) Mayo 2012 stage (HR: 2.4, P<0.001) at 3 months were associated with decreased survival independent of cardiac response, hematologic response, and transplantation status. Although advanced Mayo 2004 stage at 6 months was associated with decreased survival, it was not statistically significant (HR: 1.5, P=0.09). In contrast, advanced Mayo 2012 stage at 6 months was independently associated with decreased survival (HR: 2.1, P=0.02). For both systems, worsening stage at 3 months or at 6 months was associated with a worse survival than retaining the original stage. In contrast, improving stage as compared to remaining in same stage was not associated with better survival at 3 or 6 months (Table 1). When the analysis was restricted to patients who had an advanced stage at diagnosis, improving stage at 3 months was associated with longer survival compared to retaining the original stage, with both modified Mayo 2004 (10.8 vs. 3.3 years, P<0.001) and Mayo 2012 (8.1 vs. 2.6 years, P<0.001) staging systems. At 6 months, stage improvement was associated with longer survival than retaining the original stage when the modified Mayo 2004 staging system was used (NR vs. 5.0 years, P=0.02), but it was not statistically significant when the Mayo 2012 staging system was used (5.9 vs. 3.7 years, P=0.12). Conclusion: The modified Mayo 2004 and the Mayo 2012 staging systems have independent prognostic value when used for restaging after 3 and 6 months from initiation of first-line treatment. Migration to a higher stage from diagnosis predicts decreased survival, compared to retaining the same stage. Stage improvement is associated with a better OS in patients with advanced stage at diagnosis. Disclosures Dispenzieri: Alnylam, Intellia, Janssen, Takeda, Pfizer, Prothena, Celgene: Membership on an entity's Board of Directors or advisory committees, Research Funding. Kapoor:GlaxoSmithKline: Research Funding; Sanofi: Consultancy, Research Funding; Janssen: Research Funding; Celgene: Honoraria; Amgen: Research Funding; Takeda: Honoraria, Research Funding; Cellectar: Consultancy. Dingli:Rigel: Consultancy; Millenium: Consultancy; Sanofi-Genzyme: Consultancy; Bristol Myers Squibb: Research Funding; Karyopharm Therapeutics: Research Funding; Janssen: Consultancy; Alexion: Consultancy; Apellis: Consultancy. Lin:Novartis: Consultancy; Celgene: Consultancy, Research Funding; Bluebird Bio: Consultancy, Research Funding; Sorrento: Consultancy, Membership on an entity's Board of Directors or advisory committees; Gamida Cells: Consultancy; Takeda: Research Funding; Merck: Research Funding; Legend BioTech: Consultancy; Juno: Consultancy; Janssen: Consultancy, Research Funding; Vineti: Consultancy; Kite, a Gilead Company: Consultancy, Research Funding. Gertz:Alnylam: Consultancy; NCI SPORE MM: Research Funding; Ionis/Akcea: Consultancy; Amyloidosis Foundation: Research Funding; Celgene: Consultancy; Johnson and Johnson: Speakers Bureau; DAVA oncology: Speakers Bureau; Advisory Board for Pharmacyclics: Membership on an entity's Board of Directors or advisory committees; Advisory Board for Proclara: Membership on an entity's Board of Directors or advisory committees; i3Health: Consultancy; Springer Publishing: Patents & Royalties; Prothena: Consultancy; Sanofi: Consultancy; Janssen: Consultancy; Spectrum: Consultancy, Research Funding; Annexon: Consultancy; Appellis: Consultancy; Amgen: Consultancy; Medscape: Consultancy, Speakers Bureau; Physicians Education Resource: Consultancy; Data Safety Monitoring board from Abbvie: Membership on an entity's Board of Directors or advisory committees; International Waldenstrom Foundation: Research Funding. Kumar:Oncopeptides: Consultancy, Other: Independent Review Committee; IRC member; Genecentrix: Consultancy; Cellectar: Other; Genentech/Roche: Other: Research funding for clinical trials to the institution, Consulting/Advisory Board participation with no personal payments; Celgene/BMS: Other: Research funding for clinical trials to the institution, Consulting/Advisory Board participation with no personal payments; Kite Pharma: Consultancy, Research Funding; MedImmune: Research Funding; Carsgen: Other, Research Funding; Amgen: Consultancy, Other: Research funding for clinical trials to the institution, Consulting/Advisory Board participation with no personal payments, Research Funding; Merck: Consultancy, Research Funding; Janssen Oncology: Other: Research funding for clinical trials to the institution, Consulting/Advisory Board participation with no personal payments; Takeda: Other: Research funding for clinical trials to the institution, Consulting/Advisory Board participation with no personal payments; Karyopharm: Consultancy; AbbVie: Other: Research funding for clinical trials to the institution, Consulting/Advisory Board participation with no personal payments; BMS: Consultancy, Research Funding; Novartis: Research Funding; Adaptive Biotechnologies: Consultancy; Tenebio: Other, Research Funding; Dr. Reddy's Laboratories: Honoraria; Sanofi: Research Funding.

Although there are a number of quality frameworks available for evaluating palliative services, it is necessary to adapt these frameworks to models of care designed for the rural context. The purpose of this paper was to describe the development of a program assessment framework for evaluating a rural palliative supportive service as part of a community-based research project designed to enhance the quality of care for patients and families living with life-limiting chronic illness. A review of key documents from electronic databases and grey literature resulted in the identification of general principles for high-quality palliative care in rural contexts. These principles were then adapted to provide an assessment framework for the evaluation of the rural palliative supportive service. This framework was evaluated and refined using a community-based advisory committee guiding the development of the service. The resulting program assessment framework includes 48 criteria organized under seven themes: embedded within community; palliative care is timely, comprehensive, and continuous; access to palliative care education and experts; effective teamwork and communication; family partnerships; policies and services that support rural capacity and values; and systematic approach for measuring and improving outcomes of care. It is important to identify essential elements for assessing the quality of services designed to improve rural palliative care, taking into account the strengths of rural communities and addressing common challenges. The program assessment framework has potential to increase the likelihood of desired outcomes in palliative care provisions in rural settings and requires further validation.

Objective: A needs assessment was undertaken for faculty development needs of nurse educators teaching in baccalaureate nursing education programs across Pakistan.Methodology: The survey instrument was developed by the researcher in consultation with an advisory committee. It contained 25 items that reflected the demographic profile of the participants and another 98 statements on a 5 point Likert type scale to assess faculty development. Data collection was done across twenty schools of nursing.Results: The major findings of the study indicated a critical shortage of academically prepared nursing faculty with advanced degrees and teaching experience to perform their role effectively. Female faculty outnumbered male faculty. Five factors were identified that could both promote or obstruct faculty development and included awareness and convenience, institutional support, prevailing leadership, politics and personal factors. Additionally, four factors were extracted for challenges for undertaking faculty development; technology and curriculum, students and resources, academic leadership and professional role. Lastly, four factors were identified as areas of interests for faculty development; learning and instruction, support for scholars, support for teaching and national curriculum.Conclusion: This is the first national needs assessment that has been undertaken for faculty development for baccalaureate nursing programs in Pakistan. Although, the data may not hold international significance it would add to the existing international data base on needs assessment for faculty development.

CME/CNE Information Activity Available Online: To access the article, post-test, and evaluation online, go to http://www.cmscscholar.org. Target Audience: The target audience for this activity is physicians, physician assistants, nursing professionals, and other health-care providers involved in the management of patients with multiple sclerosis (MS). Learning Objectives: Apply new information about MS to a comprehensive individualized treatment plan for patients with MS Integrate the team approach into long-term planning in order to optimize rehabilitation care of patients with MS Accreditation Statement: This activity has been planned and implemented in accordance with the accreditation requirements and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint providership of the Consortium of Multiple Sclerosis Centers (CMSC), Nurse Practitioner Alternatives (NPA), and Delaware Media Group. The CMSC is accredited by the ACCME to provide continuing medical education for physicians. The CMSC designates this journal-based CME activity for a maximum of 1.0 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity. Nurse Practitioner Alternatives (NPA) is accredited as a provider of continuing nursing education by the American Nurses Credentialing Center's Commission on Accreditation. NPA designates this enduring material for 1.0 Continuing Nursing Education credit. Laurie Scudder, DNP, NP, has served as Nurse Planner for this activity. She has disclosed no relevant financial relationships. Disclosures: Francois Bethoux, MD, Editor in Chief of the International Journal of MS Care (IJMSC), has served as Physician Planner for this activity. He has received royalties from Springer Publishing and has received intellectual property rights from Biogen. Laurie Scudder, DNP, NP, has served as Nurse Planner for this activity. She has disclosed no relevant financial relationships. Scott D. Newsome, DO, MSCS (author), has served on scientific advisory boards for Biogen, Genentech, Novartis, and Genzyme, and has performed contracted research (institution received funds) for Biogen, Genentech, and Novartis. Philip J. Aliotta, MD, MSHA, CHCQM, FACS (author), has served on speakers' bureaus for Astellas Pharma, Actavis, Augmenix, and Allergan and has performed contracted research for Allergan. Jacquelyn Bainbridge, PharmD (author), has disclosed no relevant financial relationships. Susan E. Bennett, PT, DPT, EdD, NCS, MSCS (author), has served on speakers' bureaus for Acorda Therapeutics, Biogen, and Medtronic; has received consulting fees from and performed contracted research for Acorda Therapeutics; and is chair of the Clinical Events Committee at Innovative Technologies. Gary Cutter, PhD (author), has participated on Data and Safety Monitoring Committees for AMO Pharma, Apotek, Gilead Pharmaceuticals, Horizon Pharmaceuticals, Modigenetech/Prolor, Merck, Merck/Pfizer, Opko Biologics, Neuren, Sanofi-Aventis, Reata Pharmaceuticals, Receptos/Celgene, Teva Pharmaceuticals, NHLBI (Protocol Review Committee), and NICHD (OPRU Oversight Committee); has received consulting fees from and/or served on speakers' bureaus and scientific advisory boards for Cerespir, Genzyme, Genentech, Innate Therapeutics, Janssen Pharmaceuticals, Klein-Buendel Incorporated, MedImmune, Medday, Nivalis, Novartis, Opexa Therapeutics, Roche, Savara, Somahlution, Teva Pharmaceuticals, Transparency Life Sciences, and TG Therapeutics; and is President of Pythagoras, Inc., a private consulting company located in Birmingham, AL. Kaylan Fenton, CRNP, APNP, MSCN (author), has disclosed no relevant financial relationships. Fred Lublin, MD (author), has received consulting fees/fees for non-CME/CE activities from Bayer HealthCare Pharmaceuticals, Biogen, EMD Serono, Novartis, Teva Neuroscience, Actelion, Sanofi/Genzyme, Acorda, Questcor/Mallinckrodt, Roche/Genentech, MedImmune, Osmotica, Xenoport, Receptos/Celgene, Forward Pharma, Akros, TG Therapeutics, AbbVie, Toyama, Amgen, Medday, Atara Biotherapeutics, Polypharma, Pfizer, Johnson & Johnson, Revalesio, Coronado Bioscience, and Bristol-Myers Squibb; has served on speakers' bureaus for Genentech/Roche and Genzyme/Sanofi; has performed contracted research for Acorda, Biogen, Novartis, Teva Neuroscience, Genzyme, Xenoport, and Receptos; is the co–chief editor of Multiple Sclerosis and Related Disorders; and has an ownership interest in Cognition Pharmaceuticals. Dorothy Northrop, MSW, ACSW (author), has disclosed no relevant financial relationships. David Rintell, EdD (author), has received consulting fees from Novartis and has served as a patient education speaker for Teva Neuroscience. He started as a salaried employee of Sanofi Genzyme in November 2015. Dr. Rintell's work on this project was completed before he became a salaried employee of Sanofi Genzyme. Bryan D. Walker, MHS, PA-C (author), has served on scientific advisory boards for EMD Serono and Sanofi Genzyme and owns stock in Biogen. Megan Weigel, DNP, ARNP-C, MSCN (author), has received consulting fees from Mallinckrodt, Genzyme, and Genentech, and has served on speakers' bureaus for Bayer Corp, Acorda Therapeutics, Teva Neuroscience, Biogen, Mallinckrodt, Genzyme, Novartis, and Pfizer. Kathleen Zackowski, PhD, OTR, MSCS (author), has performed contracted research for Acorda Therapeutics. David E. Jones, MD (author), has received consulting fees from Biogen and Novartis, and has performed contracted research for Biogen. One anonymous peer reviewer for the IJMSC has performed contracted research (institution received funds) for Novartis, Chugai, and Biogen. Another reviewer has received consulting fees and served on speakers' bureaus for Biogen, Sanofi Genzyme, Genentech, EMD Serono, and Novartis. The third reviewer has disclosed no relevant financial relationships. Lori Saslow, MS (medical writer), has disclosed no relevant financial relationships. The staff at the IJMSC, CMSC, NPA, and Delaware Media Group who are in a position to influence content have disclosed no relevant financial relationships. Note: Disclosures listed for authors are those applicable at the time of their work on this project and within 12 months previously. Financial relationships for some authors may have changed in the interval between the time of their work on this project and publication of the article. Funding/Support: Funding for the Framework of Care consensus conference was provided by the Consortium of Multiple Sclerosis Centers, Mallinckrodt Pharmaceuticals, and Mylan Pharmaceuticals. Method of Participation: Release Date: December 1, 2016 Valid for Credit Through: December 1, 2017 In order to receive CME/CNE credit, participants must:Review the CME/CNE information, including learning objectives and author disclosures.Study the educational content.Complete the post-test and evaluation, which are available at http://www.cmscscholar.org. Statements of Credit are awarded upon successful completion of the post-test with a passing score of >70% and the evaluation. There is no fee to participate in this activity. Disclosure of Unlabeled Use: This CME/CNE activity may contain discussion of published and/or investigational uses of agents that are not approved by the FDA. CMSC, NPA, and Delaware Media Group do not recommend the use of any agent outside of the labeled indications. The opinions expressed in the educational activity are those of the faculty and do not necessarily represent the views of CMSC, NPA, or Delaware Media Group. Disclaimer: Participants have an implied responsibility to use the newly acquired information to enhance patient outcomes and their own professional development. The information presented in this activity is not meant to serve as a guideline for patient management. Any medications, diagnostic procedures, or treatments discussed in this publication should not be used by clinicians or other health-care professionals without first evaluating their patients' conditions, considering possible contraindications or risks, reviewing any applicable manufacturer's product information, and comparing any therapeutic approach with the recommendations of other authorities.

CME/CNE Information Activity Available Online: To access the article, post-test, and evaluation online, go to http://www.cmscscholar.org. Target Audience: The target audience for this activity is physicians, physician assistants, nursing professionals, and other health-care providers involved in the management of patients with multiple sclerosis (MS). Learning Objectives: Apply new information about MS to a comprehensive individualized treatment plan for patients with MS Adjust rehabilitative interventions to accommodate for fluctuating or ongoing MS symptoms Accreditation Statement: This activity has been planned and implemented in accordance with the accreditation requirements and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint providership of the Consortium of Multiple Sclerosis Centers (CMSC), Nurse Practitioner Alternatives (NPA), and Delaware Media Group. The CMSC is accredited by the ACCME to provide continuing medical education for physicians. The CMSC designates this journal-based CME activity for a maximum of 1.0 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity. Nurse Practitioner Alternatives (NPA) is accredited as a provider of continuing nursing education by the American Nurses Credentialing Center's Commission on Accreditation. NPA designates this enduring material for 1.0 Continuing Nursing Education credit. Laurie Scudder, DNP, NP, has served as Nurse Planner for this activity. She has disclosed no relevant financial relationships. Disclosures: Francois Bethoux, MD, Editor in Chief of the International Journal of MS Care (IJMSC), has served as Physician Planner for this activity. He has received royalties from Springer Publishing; has received intellectual property rights from Biogen; has received consulting fees from Acorda Therapeutics, Ipsen, and Merz Pharma; and has performed contracted research for Acorda Therapeutics. Laurie Scudder, DNP, NP, has served as Nurse Planner for this activity. She has disclosed no relevant financial relationships. Scott D. Newsome, DO, MSCS (author), has served on scientific advisory boards for Biogen, Genentech, Novartis, and Genzyme and has performed contracted research (institution received funds) for Biogen, Genentech, and Novartis. Philip J. Aliotta, MD, MSHA, CHCQM, FACS (author), has served on speakers' bureaus for Astellas Pharma, Actavis, Augmenix, and Allergan and has performed contracted research for Allergan. Jacquelyn Bainbridge, PharmD (author), has disclosed no relevant financial relationships. Susan E. Bennett, PT, DPT, EdD, NCS, MSCS (author), has served on speakers' bureaus for Acorda Therapeutics, Biogen, and Medtronic; has received consulting fees from and performed contracted research for Acorda Therapeutics; and is chair of the Clinical Events Committee at Innovative Technologies. Gary Cutter, PhD (author), has participated on Data and Safety Monitoring Committees for AMO Pharma, Apotek, Gilead Pharmaceuticals, Horizon Pharmaceuticals, Modigenetech/Prolor, Merck, Merck/Pfizer, Opko Biologics, Neuren, Sanofi-Aventis, Reata Pharmaceuticals, Receptos/Celgene, Teva Pharmaceuticals, NHLBI (Protocol Review Committee), and NICHD (OPRU Oversight Committee); has received consulting fees from and/or served on speakers' bureaus and scientific advisory boards for Cerespir, Genzyme, Genentech, Innate Therapeutics, Janssen Pharmaceuticals, Klein-Buendel Incorporated, MedImmune, Medday, Nivalis, Novartis, Opexa Therapeutics, Roche, Savara, Somahlution, Teva Pharmaceuticals, Transparency Life Sciences, and TG Therapeutics; and is President of Pythagoras, Inc., a private consulting company located in Birmingham, AL. Kaylan Fenton, CRNP, APNP, MSCN (author), has disclosed no relevant financial relationships. Fred Lublin, MD (author), has received consulting fees/fees for non-CME/CE activities from Bayer HealthCare Pharmaceuticals, Biogen, EMD Serono, Novartis, Teva Neuroscience, Actelion, Sanofi/Genzyme, Acorda, Questcor/Mallinckrodt, Roche/Genentech, MedImmune, Osmotica, Xenoport, Receptos/Celgene, Forward Pharma, Akros, TG Therapeutics, AbbVie, Toyama, Amgen, Medday, Atara Biotherapeutics, Polypharma, Pfizer, Johnson & Johnson, Revalesio, Coronado Bioscience, and Bristol-Myers Squibb; has served on speakers' bureaus for Genentech/Roche and Genzyme/Sanofi; has performed contracted research for Acorda, Biogen, Novartis, Teva Neuroscience, Genzyme, Xenoport, and Receptos; is the co–chief editor of Multiple Sclerosis and Related Disorders; and has an ownership interest in Cognition Pharmaceuticals. Dorothy Northrop, MSW, ACSW (author), has disclosed no relevant financial relationships. David Rintell, EdD (author), has received consulting fees from Novartis and has served as a patient education speaker for Teva Neuroscience. He started as a salaried employee of Sanofi Genzyme in November 2015. Dr. Rintell's work on this project was completed before he became a salaried employee of Sanofi Genzyme. Bryan D. Walker, MHS, PA-C (author), has served on scientific advisory boards for EMD Serono and Sanofi Genzyme and owns stock in Biogen. Megan Weigel, DNP, ARNP-C, MSCN (author), has received consulting fees from Mallinckrodt, Genzyme, and Genentech, and has served on speakers' bureaus for Bayer Corp, Acorda Therapeutics, Teva Neuroscience, Biogen, Mallinckrodt, Genzyme, Novartis, and Pfizer. Kathleen Zackowski, PhD, OTR, MSCS (author), has performed contracted research for Acorda Therapeutics. David E. Jones, MD (author), has received consulting fees from Biogen, Novartis, and Genzyme and has performed contracted research for Biogen (institution received funds). One anonymous peer reviewer for the IJMSC has performed contracted research (institution received funds) for Novartis, Chugai, and Biogen. Another reviewer has received consulting fees and served on speakers' bureaus for Biogen, Sanofi Genzyme, Genentech, EMD Serono, and Novartis. The third reviewer has disclosed no relevant financial relationships. Lori Saslow, MS (medical writer), has disclosed no relevant financial relationships. The staff at the IJMSC, CMSC, NPA, and Delaware Media Group who are in a position to influence content have disclosed no relevant financial relationships. Note: Disclosures listed for authors are those applicable at the time of their work on this project and within 12 months previously. Financial relationships for some authors may have changed in the interval between the time of their work on this project and publication of the article. Funding/Support: Funding for the Framework of Care consensus conference was provided by the Consortium of Multiple Sclerosis Centers, Mallinckrodt Pharmaceuticals, and Mylan Pharmaceuticals. Method of Participation: Release Date: February 1, 2017 Valid for Credit Through: February 1, 2018 In order to receive CME/CNE credit, participants must:Review the CME/CNE information, including learning objectives and author disclosures.Study the educational content.Complete the post-test and evaluation, which are available at http://www.cmscscholar.org. Statements of Credit are awarded upon successful completion of the post-test with a passing score of >70% and the evaluation. There is no fee to participate in this activity. Disclosure of Unlabeled Use: This CME/CNE activity may contain discussion of published and/or investigational uses of agents that are not approved by the FDA. CMSC, NPA, and Delaware Media Group do not recommend the use of any agent outside of the labeled indications. The opinions expressed in the educational activity are those of the faculty and do not necessarily represent the views of CMSC, NPA, or Delaware Media Group. Disclaimer: Participants have an implied responsibility to use the newly acquired information to enhance patient outcomes and their own professional development. The information presented in this activity is not meant to serve as a guideline for patient management. Any medications, diagnostic procedures, or treatments discussed in this publication should not be used by clinicians or other health-care professionals without first evaluating their patients' conditions, considering possible contraindications or risks, reviewing any applicable manufacturer's product information, and comparing any therapeutic approach with the recommendations of other authorities.

Background: Newly diagnosed patients with AL Amyloidosis are a heterogeneous population, ranging from incidentally found nephrotic syndrome to delayed advanced cardiac disease. For the purposes of trials, patients with the highest-risk disease are often excluded from trial participation. An NT-proBNP of 8500 or higher is the criterion most often used for exclusion from clinical trials due to high rates of early death. It is well documented that overall survival is improving over time, in part due to earlier diagnosis and in part due to more effective therapies. It is our aim to describe outcomes of patients with very high (NT-proBNP >=8500) and advanced stage amyloidosis excluding very high (VH) NT-proBNP. Methods: To address this need, we examined the outcomes of AL patients diagnosed between 1/2012 and 7/2020 and seen at our institution within 90 days of diagnosis. Of the 1290 patients, 291 were seen beyond the 90 day threshold and were thus excluded. Another 170 patients were excluded due to missing biomarkers to calculate stage, leaving 829 patients for our analysis. Thresholds for troponins and BNPs were used according to Muchtar Blood 133(7):2019 to correct for assay used. The vast majority of patients had troponin T measured, and for them the 0.025 mcg/L and the 0.035 mcg/L cut-points were used for the 2012 and 2004 staging systems. A minority of patients did not have troponin T, but rather high sensitivity troponin T (n=129) or troponin I (n=23). For patients with high sensitivity troponin T, cut-points of 41 and 50 ng/L were used, respectively, for the 2012 and 2004 systems, and for patients with troponin I only, a cut-point of 0.1 mcg/L was used for both systems. In the 3 patients with no NT-proBNP but with BNP, 400 and 81 ng/L were used respectively for the 2012 and 2004 systems; otherwise, the 1800 ng/L and 332 ng/L cut-offs were used. A BNP of > 700 ng/L was considered equivalent to NT-proBNP greater than or equal to 8500 ng/L. For the 2012 system, the dFLC of 18 mg/dL was used as a cut-off. Survival estimates were done using the method of Kaplan-Meier, and differences in survival were by determined by Log-Rank. Results: The median age of patients was 65 (range 29, 89), and 65% were male. 148 (17%) of these newly diagnosed patients had a VH (>=8500) NT-proBNP. Patients with VH NT-proBNP were older (67 versus 64 years, p=0.004). Only 4% of the VH NT-proBNP patients received an ASCT in contrast to 34% without VH NT-proBNP. With a median follow-up of 30 months for surviving patients, median OS for VH NT-proBNP patients was 3.3 months in contrast to patients without VH NT-proBNP at 68.4 months (Figure). Breakdown of early death for patients with VH NT-proBNP by stage is shown in Table. Of Mayo 2012 patients staged I, II, III, and IV, the percent of patients with VH NT-proBNP was 0, 3, 20, and 45%. In contrast, for the European modification of the Mayo 2004 system, the percent with VH NT-proBNP by stage was 0, 6, 0, 100 for stages I, II, IIIa, and IIIb, respectively. Among the VH NT-proBNP patients, there was stage discrimination using the Mayo 2012 system (6-month death rates were 17, 45, and 66% for patients with stages II, III, and IV, respectively, p=0.02). In contrast, using the Mayo 2004 system in the patients with VH NT-proBNP, 6-month death rates were 45 and 60% for stage II and IIIb patients, respectively (p= 0.12). Among patients without VH NT-proBNP, rates of death in the first year were 21% including stage I patients whose death rates were well under 10%. Patients without VH NT-proBNP but Mayo 2012 Stage III and IV had 1-year mortalities of 28 and 43% respectively. Using the modified Mayo 2004 system, excluding the VH NT-proBNP 1-year mortality was 19 and 37% for patients with stage II and IIIa, respectively. Discussion: Establishing expected outcomes for the sickest AL amyloidosis patients is a means by which trials can be designed for these patients with an unmet need. Patients with VH NT-proBNP should be considered for specially designed trials, and patients without VH NT-proBNP and advanced stage should be included in trials for newly diagnosed patients regardless of stage as long as there is appropriate stratification. Disclosures Dispenzieri: Janssen: Research Funding; Pfizer: Research Funding; Intellia: Research Funding; Alnylam: Research Funding; Celgene: Research Funding; Takeda: Research Funding. Kumar:AbbVie: Other: Research funding for clinical trials to the institution, Consulting/Advisory Board participation with no personal payments; Tenebio: Other, Research Funding; BMS: Consultancy, Research Funding; Sanofi: Research Funding; Carsgen: Other, Research Funding; Amgen: Consultancy, Other: Research funding for clinical trials to the institution, Consulting/Advisory Board participation with no personal payments, Research Funding; Oncopeptides: Consultancy, Other: Independent Review Committee; IRC member; Celgene/BMS: Other: Research funding for clinical trials to the institution, Consulting/Advisory Board participation with no personal payments; Merck: Consultancy, Research Funding; Takeda: Other: Research funding for clinical trials to the institution, Consulting/Advisory Board participation with no personal payments; Janssen Oncology: Other: Research funding for clinical trials to the institution, Consulting/Advisory Board participation with no personal payments; Adaptive Biotechnologies: Consultancy; Dr. Reddy's Laboratories: Honoraria; Novartis: Research Funding; MedImmune: Research Funding; Genecentrix: Consultancy; Kite Pharma: Consultancy, Research Funding; Cellectar: Other; Karyopharm: Consultancy; Genentech/Roche: Other: Research funding for clinical trials to the institution, Consulting/Advisory Board participation with no personal payments. Dingli:Karyopharm Therapeutics: Research Funding; Bristol Myers Squibb: Research Funding; Millenium: Consultancy; Janssen: Consultancy; Alexion: Consultancy; Rigel: Consultancy; Apellis: Consultancy; Sanofi-Genzyme: Consultancy. Kapoor:Celgene: Honoraria; Cellectar: Consultancy; Janssen: Research Funding; Sanofi: Consultancy, Research Funding; Amgen: Research Funding; Takeda: Honoraria, Research Funding; GlaxoSmithKline: Research Funding. Lin:Janssen: Consultancy, Research Funding; Kite, a Gilead Company: Consultancy, Research Funding; Novartis: Consultancy; Celgene: Consultancy, Research Funding; Bluebird Bio: Consultancy, Research Funding; Juno: Consultancy; Legend BioTech: Consultancy; Merck: Research Funding; Takeda: Research Funding; Gamida Cells: Consultancy; Sorrento: Consultancy, Membership on an entity's Board of Directors or advisory committees; Vineti: Consultancy. Gertz:Springer Publishing: Patents & Royalties; Amyloidosis Foundation: Research Funding; International Waldenstrom Foundation: Research Funding; NCI SPORE MM: Research Funding; Ionis/Akcea: Consultancy; Alnylam: Consultancy; Prothena: Consultancy; Sanofi: Consultancy; Janssen: Consultancy; Spectrum: Consultancy, Research Funding; Annexon: Consultancy; Appellis: Consultancy; Amgen: Consultancy; Medscape: Consultancy, Speakers Bureau; Physicians Education Resource: Consultancy; Data Safety Monitoring board from Abbvie: Membership on an entity's Board of Directors or advisory committees; Celgene: Consultancy; Johnson and Johnson: Speakers Bureau; DAVA oncology: Speakers Bureau; Advisory Board for Pharmacyclics: Membership on an entity's Board of Directors or advisory committees; Advisory Board for Proclara: Membership on an entity's Board of Directors or advisory committees; i3Health: Consultancy.

This thesis examines the history of Commonwealth Government higher education policy in Australia between 1958 and 1997 and its impact on the development of two groups of academic librarians: the Association of Librarians in Colleges in Advanced Education (ALCAE) and the Committee of Australian University Librarians (CAUL). Although university librarians had met occasionally since the late 1920s, it was only in 1965 that a more formal organisation, known as CAUL, was established to facilitate the exchange of ideas and information. ALCAE was set up in 1969 and played an important role helping develop a special concept of library service peculiar to the newly formed College of Advanced Education (CAE) sector. As well as examining the impact of Commonwealth Government higher education policy on ALCAE and CAUL, the thesis also explores the influence of other factors on these two groups, including the range of personalities that comprised them, and their relationship with their parent institutions and with other professional groups and organisations. The study focuses on how higher education policy and these other external and internal factors shaped the functions, aspirations, and internal dynamics of these two groups and how this resulted in each group evolving differently. The author argues that, because of the greater attention given to the special educational role of libraries in the CAE curriculum, the group of college librarians had the opportunity to participate in, and have some influence on, Commonwealth Government statutory bodies responsible for the coordination of policy and the distribution of funding for the CAE sector. The link between ALCAE and formal policy-making processes resulted in a more dynamic group than CAUL, with the university librarians being discouraged by their Vice-Chancellors from having contact with university funding bodies because of the desire of the universities to maintain a greater level of control over their affairs and resist interference from government. The circumstances of each group underwent a reversal over time as ALCAE's effectiveness began to diminish as a result of changes to the CAE sector and as member interest was transferred to other groups and organisations. Conversely, CAUL gradually became a more active group during the 1980s and early 1990s as a result of changes to higher education, the efforts of some university librarians, and changes in membership. This study is based principally on primary source material, with the story of ALCAE and CAUL being told through the use of a combination of original documentation (including minutes of meetings and correspondence) and interviews with members of each group and other key figures.