scholarly journals IDENTIFYING BETTER OUTCOME MEASURES TO IMPROVE TREATMENT OF AGITATION IN DEMENTIA: A REPORT FROM THE EU/US/CTAD TASK FORCE

2018 ◽  
pp. 1-5
Author(s):  
M. Sano ◽  
M. Soto ◽  
M. Carrillo ◽  
J. Cummings ◽  
S. Hendrix ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Outcome Measures ◽  
Primary Outcome ◽  
Task Force ◽  
Neuropsychiatric Symptoms ◽  
Training And Education ◽  
The Past ◽  
Global Ratings ◽  
Power Studies ◽  
The Eu

For the second time in the past 3 years, the EU-US CTAD Task Force addressed challenges related to designing clinical trials for agitation in dementia, which is one of the most disruptive aspects of the condition for both patients and caregivers. Six recommendations emerged from the Task Force meeting: 1 – Operationalizing agitation criteria established by the IPA; 2 – Combining clinician- and caregiver-derived outcomes as primary outcome measures; 3 – Using global ratings to define clinically meaningful effects and power studies; 4 – Improving the accuracy of caregiver reports by better training and education of caregivers; 5 – Employing emerging technologies to collect near real-time behavioral data; and 6 – Utilizing innovative trial designs and increasing the use of biomarkers to maximize the productivity of clinical trials for neuropsychiatric symptoms.

scholarly journals HFE in Diversity, Inclusion and Social Justice: A Practical Primer

2019 ◽  
Vol 63 (1) ◽  
pp. 636-639
Author(s):  
Abigail R. Wooldridge ◽  
Natalie Benda ◽  
Tonya L. Smith-Jackson ◽  
Theresa Nguyen ◽  
Kylie Gomes ◽  
...  
Keyword(s):  
Social Justice ◽  
Annual Meeting ◽  
Task Force ◽  
Education Session ◽  
Training And Education ◽  
The Past ◽  
Inclusive Excellence ◽  
Broadening Participation ◽  
Diversity Committee

The HFES Diversity Committee is entering its third year following many years existing as a task force. We have built a series of annual meeting content over the past years, with panels introducing the task force and then the committee; last year, we shifted focus to highlight examples of HFE research advancing diversity, inclusion and social justice. We continue to build off of previous years’ sessions – last year concluded with several questions seeking practical, concrete advice and suggestions to advance DISJ through HFE research and within the society. Therefore, this year we present an alternative format session that will function as a group of mini-workshops: two focused on research, one on broadening participation in HFE and one of inclusive excellence within HFE training and education. Session participants will develop “how to” knowledge and leave with a network of likeminded peers, colleagues and potential collaborators.

scholarly journals Comparison of Alternative Primary Outcome Measures for Use in Lupus Nephritis Clinical Trials

2013 ◽  
Vol 65 (6) ◽  
pp. 1586-1591 ◽  
Author(s):  
David Wofsy ◽  
Jan L. Hillson ◽  
Betty Diamond
Keyword(s):  
Clinical Trials ◽  
Lupus Nephritis ◽  
Outcome Measures ◽  
Primary Outcome

Misclassification and Treatment Effect on Primary Outcome Measures in Clinical Trials of Severe Neurotrauma

2002 ◽  
Vol 19 (1) ◽  
pp. 17-22 ◽  
Author(s):  
Sung C. Choi ◽  
Guy L. Clifton ◽  
Anthony Marmarou ◽  
Emmy R. Miller
Keyword(s):  
Clinical Trials ◽  
Outcome Measures ◽  
Treatment Effect ◽  
Primary Outcome

Statistical analysis, trial design and duration in Alzheimer's disease clinical trials: a review

2011 ◽  
Vol 24 (5) ◽  
pp. 689-697 ◽  
Author(s):  
P. A. Thompson ◽  
D. E. Wright ◽  
C. E. Counsell ◽  
J. Zajicek
Keyword(s):  
Alzheimer’S Disease ◽  
Alzheimer's Disease ◽  
Clinical Trials ◽  
Statistical Analysis ◽  
Statistical Methods ◽  
Outcome Measures ◽  
Primary Outcome ◽  
Outcome Measure ◽  
Primary Outcome Measure ◽  
Primary Analysis

ABSTRACTBackground: The social and economic burden of Alzheimer's disease (AD) and its increasing prevalence has led to much work on new treatment strategies and clinical trials. The search for surrogate markers of disease progression continues but traditional parallel group trial designs that use well-established, but often insensitive, clinical outcome measures predominate.Methods: We performed a systematic search across the Cochrane Library and PubMed abstracts published between January 2004 and August 2009. Information regarding the clinical trial methodology, outcome measures, intervention type and primary statistical analysis techniques was extracted and categorized, according to a standard protocol.Results: We identified 149 papers describing results from clinical trials in AD containing sufficient detail for our purposes. The largest proportion (38%) presented results of trials based on tests of cognition as the primary outcome measure. The primary analysis in most papers (85%) was a univariate significance test of a single primary outcome measure.Conclusions: The majority of trials reported a comparison of baseline and end-point assessment over relatively short patient follow-up periods, using univariate statistical methods to compare differences between intervention and control groups in the primary analysis. There is considerable scope to introduce newer statistical methods and trial designs in treatment evaluations in AD.

scholarly journals Variation in Outcome Measures in Hip and Knee Arthroplasty Clinical Trials: A Proposed Approach to Achieving Consensus

2009 ◽  
Vol 36 (9) ◽  
pp. 2050-2056 ◽  
Author(s):  
DANIEL L. RIDDLE ◽  
PAUL W. STRATFORD ◽  
JASVINDER A. SINGH ◽  
C. VIBEKE STRAND
Keyword(s):  
Clinical Trials ◽  
Outcome Measures ◽  
Knee Arthroplasty ◽  
Randomized Trials ◽  
Survey Design ◽  
Hip Osteoarthritis ◽  
Optimal Outcome ◽  
The Past ◽  
Hip And Knee Arthroplasty ◽  
Knee And Hip Arthroplasty

OMERACT began work over a decade ago on a consensus effort to identify optimal outcome measures for knee and hip osteoarthritis clinical trials. Recent evidence indicates extensive variation in outcome measures used in clinical trials of knee and hip arthroplasty published since 2000. This heterogeneity leads to confusion, not only for conducting systematic reviews but also for applying evidence to clinical practice. Given the extensive psychometric research conducted in the past 2 decades, the timing seems ideal to design and implement a study to develop consensus on optimal outcome measures for hip and knee arthroplasty trials. We describe a Delphi survey design and an approach for synthesizing the extensive psychometric literature on the outcome measures used in hip and knee arthroplasty trials. Plans for dissemination of the findings are also discussed. This proposed study could have an important influence on the design and reporting of future randomized trials of knee arthroplasty.

COMMENTARY: COMBINATION THERAPY FOR ALZHEIMER’S DISEASE: PERSPECTIVES OF THE EU/US CTAD TASK FORCE

2019 ◽  
pp. 1-2
Author(s):  
E. Siemers
Keyword(s):  
Alzheimer’S Disease ◽  
Alzheimer's Disease ◽  
European Union ◽  
Clinical Trials ◽  
Task Force ◽  
Pharmaceutical Companies ◽  
The European Union ◽  
Combination Therapies ◽  
Regulatory Pathways ◽  
The Eu

In October 2018, the European Union-North American Clinical Trials in Alzheimer’s Disease Task Force (EU/US CTAD Task Force) met to discuss an increasingly important topic, the scientific, regulatory, and logistical challenges to the development of combination therapies for AD. Challenges related to ever-changing scientific knowledge, challenges related to complex regulatory pathways and challenges related to the necessity for pharmaceutical companies to collaborate must all be addressed. These challenges must be met since task Force members unanimously agreed that successful treatment of AD will likely require combination therapies targeting multiple mechanisms and pathways.

EULAR points to consider for conducting clinical trials in systemic lupus erythematosus: literature based evidence for the selection of endpoints: Table 1

2008 ◽  
Vol 68 (4) ◽  
pp. 477-483 ◽  
Author(s):  
G K Bertsias ◽  
J P A Ioannidis ◽  
J Boletis ◽  
S Bombardieri ◽  
R Cervera ◽  
...  
Keyword(s):  
Systemic Lupus Erythematosus ◽  
Clinical Trials ◽  
Literature Review ◽  
Outcome Measures ◽  
Lupus Erythematosus ◽  
Task Force ◽  
Evidence Base ◽  
Cochrane Library ◽  
Systemic Lupus ◽  
End Points

Objective:To assess available evidence on the use of end-points (outcome measures) in clinical trials in systemic lupus erythematosus (SLE), as a part of the development of evidence-based recommendations for points to consider in clinical trials in SLE.Methods:The European League Against Rheumatism (EULAR) Task Force on SLE comprised 19 specialists, a clinical epidemiologist and a research fellow. Key questions addressing the evidence for clinical trial end-points in SLE were compiled using the Delphi technique. A systematic search of the PubMed and Cochrane Library databases was performed using McMaster/Hedges clinical query strategies and an array of relevant terms. Evidence was categorised based on sample size and type of design, and the categories of available evidence were identified for each recommendation. The strength of recommendation was assessed based on the category of available evidence and agreement on the statements was measured across the 19 specialists.Results:Eight questions were generated regarding end-points for clinical trials. The evidence to support each proposition was evaluated. The literature review revealed that most outcome measures used in phase 2/3 trials in SLE have not been formally validated in clinical trials, although some indirect validation has been undertaken.Conclusion:This systematic literature review forms the evidence base considered in the development of the EULAR recommendations for end-points in clinical trials in SLE.

scholarly journals Measuring Disease Activity in Psoriatic Arthritis

2012 ◽  
Vol 2012 ◽  
pp. 1-10 ◽  
Author(s):  
Priscilla C. H. Wong ◽  
Ying-Ying Leung ◽  
Edmund K. Li ◽  
Lai-Shan Tam
Keyword(s):  
Clinical Trials ◽  
Clinical Practice ◽  
Psoriatic Arthritis ◽  
Disease Activity ◽  
Disease Control ◽  
Outcome Measures ◽  
The Past ◽  
Composite Measures

Over the past decade, the assessment of the disease activity in psoriatic arthritis (PsA) has rapidly evolved in view of the need for valid, feasible, and reliable outcome measures that can be ideally employed in longitudinal cohorts, clinical trials, and clinical practice as well as the growing paradigm of tight disease control and treating to target in the management of PsA. This paper reviews the currently available measures used in the assessment of the disease activity in PsA. The composite measures for PsA that are under development are also discussed.

scholarly journals Changes in Estonian Defense Policy Following Episodes of Russian Aggression

2018 ◽  
Vol 12 (1) ◽  
Author(s):  
Benjamin Cooper
Keyword(s):  
North Atlantic ◽  
Task Force ◽  
Policy Changes ◽  
Government Officials ◽  
The Past ◽  
The North ◽  
Effective Deterrent ◽  
The Subject ◽  
Overall Effectiveness ◽  
The Eu

After successive episodes of Russian aggression, both Estonia and the North Atlantic Treaty Organization (NATO) remain on edge about the future of their relationship with Moscow. To understand how Estonia has deterred Russia from further hostile acts, this paper analyzes the Estonian government’s response to them and how the establishment of defense programs have made Estonia a pillar of anti-Russian policy in Europe. Such programs and policy changes which continue to deter Russia from these aggressive tactics include but are not limited to NATO’s Cooperative Cyber Defense Center of Excellence, the EU’s East StratCom Task Force, and the development of dependable relationships between NATO, the EU, and the Estonian private defense sector. The paper also analyzes the overall successes and deficiencies of these policy changes, makes future recommendations for the Estonian government, and evaluates the implications of these changes in the broad realm of international security. Analyzing these successes and deficiencies is important for determining the overall effectiveness of the changes in Estonian policy over the past decade. Through in-person interviews with both American and Estonian government officials, online research, and interactions with academic experts on the subject, the paper argues these new programs and evolving relationships are an adequate and effective deterrent to prevent further Russian cyber and conventional military attacks.

#3080 A systematic review of extra-motor symptom evaluation in clinical trials for amyotrophic lateral sclerosis

2021 ◽  
Vol 92 (8) ◽  
pp. A5.1-A5
Author(s):  
Emily Beswick ◽  
Deborah Forbes ◽  
Zachary Hassan ◽  
Charis Wong ◽  
Siddharthan Chandran ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Amyotrophic Lateral Sclerosis ◽  
Outcome Measures ◽  
Sleep Disturbances ◽  
Neuropsychiatric Symptoms ◽  
Behavioural Change ◽  
Assessment Tools ◽  
Motor Symptom ◽  
Motor Symptoms ◽  
Lateral Sclerosis

BackgroundAmyotrophic lateral sclerosis (ALS) is increasingly recognised as a multi-system disorder, presenting with extra-motor symptoms which arise secondary to motor degeneration or are indicative of wider pathophysiology. Extra-motor symptoms such as cognitive impairment, behavioural change, neuropsychiatric symptoms, sleep disturbances, fatigue, sialorrhea, and pain are common in, and impactful upon, people with ALS.Aim/HypothesisWe aimed to systematically review historical clinical trials in ALS to identify if extra-motor features of ALS were explored as outcome measures and if so describe the tools used. We hypothesise that assessment of extra-motor symptoms has been largely neglected in trial design and that where evaluated, it has been with assessment tools which are not designed to evaluate these symptoms in people with ALS.MethodsWe reviewed clinical trials of investigative medicinal products in ALS, since the licensing of riluzole. Trial registry databases including WHO International Trials Registry, European Clinical Trials Register, clinicaltrials.gov, and PubMed were systematically searched for Phase II, III or IV trials registered, completed or published between 01/01/1994 and 16/09/2020. No language restrictions were applied. We evaluated the use of assessment tools to investigate extra-motor symptom as outcome measures.Results237 clinical trials were included in this review for use of outcome measures. These trials evaluated cognitive impairment (16 trials, 6.8%), behavioural change (38, 16%), neuropsychiatric symptoms (75, 32%), sleep disturbances (12, 5%), fatigue (18), 8%, saliva (182, 77%) and pain (55, 23%). 29 trials (12%) did not include any assessment of extra-motor symptoms. 51 versions or combinations of assessment tools were utilised in these trials. The most commonly used primary outcome measure in ALS trials, the ALS-FRS(R), is a physical functioning assessment with one sub-domain item assessing saliva. The ALS-FRS accounted for the full number of trials assessing saliva in this review. 6 instruments used were ALS-specific (designed and validated specifically for people with ALS), 14 were symptom-specific, 4 were both, and 9 were generic (evaluated the symptom within a general measure, eg QoL).ConclusionsExtra-motor symptoms have been under-evaluated in trials for people with ALS. Where evaluated, this has been primarily using assessment tools which are not specific to ALS or the extra-motor symptom, which may affect the validity of conclusions drawn regarding the impact of candidate drugs.

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