The Rest is Noise. The Promise of ecoa in Increasing Signal Detection
|
|
- Curtis Norman
- 5 years ago
- Views:
Transcription
1 Medavante Research White paper The Rest is Noise The Promise of ecoa in Increasing Signal Detection By Christopher Randolph, PhD, ABPP-CN Medical Director of Neuropsychology, Loyola University Medical Center VP of Neurocognition, MedAvante
2 3 The Rest is Noise: The Promise of ecoa in Increasing Signal Detection Inconclusive clinical trials keep treatments from patients who need them most: a problem that is especially prevalent in central nervous system (CNS) disorders. For all neurological conditions combined, researchers estimate the Phase 3 success rate to be approximately 5. 1 This is due, in part, to imprecise endpoint measurements that add noise and reduce signal detection, decreasing the chances of a successful trial. Alzheimer s disease (AD) provides a particularly striking example of the steep road to trial success: between 2002 and 2012, Phase 3 trials in AD had a failure rate estimated at 99.6%. 2 What s behind these daunting odds, and what can sponsors and contract research organizations (CROs) do to improve them? A recent study that I led with colleagues at MedAvante, a company dedicated to improving signal detection in clinical trials, suggests that the use of paper-based assessments could be an important factor in failed or inconclusive trials.3 Why? Paper increases the possibility of rater and administrative errors in an already difficult process. This effect is often compounded with the challenges posed by subjectively reported, subjectively scored assessments. Trial sponsors and CROs, then, should be aware of the limitations of paper in CNS trials and understand that digital alternatives offer significant benefits. The human and financial stakes are too high not to use all available means to achieve conclusive results. 1 Hay M, Thomas DW, Craighead JL, Economides C, Rosenthal J. Clinical development success rates for investigational drugs. Nat Biotechnol. 2014;1: doi: /nbt Cummings JL, Morstorf T, Zhong K. Alzheimer s disease drug-development pipeline: few candidates, frequent failures. Alzheimer s Research & Therapy. 2014;6(4):37. PMID: The study examined trials on Clinicaltrials.gov. The authors write, In the decade of 2002 through 2012, 244 compounds were assessed in 413 trials for AD. Of the agents advanced to Phase 3 (and excluding those currently in Phase 3), one was advanced to the FDA and approved for marketing (1.8%). Excluding the 14 compounds currently in Phase 3, the overall success rate for approval is 0.4% (99.6% attrition). This is among the lowest for any therapeutic area. 3 Negash S, Böhm P, Steele S, Sorantin P, Randolph C. Investigative Study Platform Minimizes Scoring Discrepancies to Improve Signal Detection. MedAvante Inc.; Loyola University Medical Center. Poster presentation, 14th Annual Athens/Springfield Symposium on Advances in Alzheimer Therapy, March Risks for imprecision in CNS trials A number of factors contribute to the high level of imprecision in CNS trials. First, traditional paper-based clinical outcome assessments are prone to high rates of error. For example, the total score of the Clinical Dementia Rating scale (CDR) requires calculation, either by the rater using the Sum of Boxes score, or by using an online tool in the case of the CDR Global Score. Then, in an additional step, score data must be transcribed manually into an electronic data capture (EDC) system and later be monitored for source data verification. Attempts to implement central oversight for data quality assurance typically involve scanning a large volume of paper, as well as uploading audio or video files. All these steps create the possibility of more errors being introduced as well as adding to the heavy administrative burden on trial sites, perpetuating significant obstacles in an already complex undertaking.4 Reviewing assessments based on source documents and recordings may reveal scoring discrepancies between raters and reviewers. Discrepancies take time to resolve and compromise data quality by calling ratings into question. A better option? Given the disadvantages of paper administration as well as the clinical challenges of neuropsychiatric assessments, an electronic clinical outcome assessment (ecoa) system that removes paper from the equation presents obvious advantages. That was the thinking that led to the development of the Investigative Study Platform, which reduces administrative burden and enables the real-time detection of calculation errors and discrepant scores. Such advantages point to a greater likelihood of a conclusive trial. ecoa can save time and increase accuracy for raters and study coordinators at the study sites, while also providing ready-to-analyze data to principal investigators, sponsors, and CROs far more quickly than paper collection. 4 Cummings JL, et al. Alzheimer's disease drug-development pipeline: few candidates, frequent failures. Alzheimers Res Ther Jul 3;6(4):37.
3 4 The Rest is Noise: The Promise of ecoa in Increasing Signal Detection For trial raters who administer multiple assessments throughout a day, the tablet-based platform can: eliminate calculation errors (by performing any calculations and auto-scoring) flag missing data capture all data input once and forever ease the process of central oversight by simultaneously audio- or video-recording the administration of assessments, facilitating review without creating extra steps for the site eliminate the EDC transfer step and associated SDV monitoring Equally important, ecoa addresses the problem of subjectivity. It provides raters with real-time clinical guidance developed by expert clinicians right on the screen of a tablet used to administer the assessment. Links to scoring anchors, item descriptions and study-specific guidelines help maintain consistency across the assessment s various domains. Imagine a rater administering the CDR who enters, say, a 0 or 0.5 (no or very mild impairment) in the memory domain after an informant had responded rarely to the question Can the patient recall recent events? A flag can then pop up on screen pointing out that this is a possible inconsistency and ask the rater if this was the intended scoring. Error rates in AD trials drop with the use of ecoa My colleagues at MedAvante and I examined data from our work in major clinical trials to evaluate the effectiveness of an ecoa solution to alleviate the root cause of inconclusive trials.5 We found that using MedAvante s tablet to administer neurocognitive assessments could significantly reduce error rates in AD trials. Our study compared error rates in the administration of clinical outcome assessments in AD trials between the traditional paper-and-pencil method and the tablet. 5 Negash S, et al. Investigative Study Platform Minimizes Scoring Discrepancies to Improve Signal Detection. Poster presentation, Athens/Springfield Symposium, March We compared paper-administered assessments from a recent clinical trial of mild cognitive impairment (MCI) due to AD with tablet administrations of the same assessments from two other, separate AD MCI trials. All trials were Phase II/III multinational trials. We examined the following four commonly used rating scales: the Alzheimer s Disease Assessment Scale-Cognition (ADAS-Cog) the Alzheimer s Disease Cooperative Study-Daily Life Inventory-Mild Cognitive Impairment (ADCS-ADL-MCI) the Mini Mental State Examination (MMSE) the Clinical Dementia Rating (CDR) A cohort of Central Reviewers examined the first 150 administrations of each assessment for the paper-and-pencil trial and then compared them with the first 150 administrations done with the tablet. This same cohort of reviewers then used audio recordings and worksheets to identify errors in both modes of administration. Comparing the paper-based and administrations, the study quantified the percentage of reviewed assessments with the following kinds of errors: one (different score found by rater and reviewer) two or more discrepancies The results? The study demonstrated that compared to paper-and-pencil administration, substantially reduced scoring- errors for all four AD rating scales. s reduction of errors shows just how effective its guidance is in leading raters to provide accurate scores. Figures 1a-1d show the magnitude of this reduction. The percentage of assessments with one declined by: 26% (CDR) 43% (ADAS-Cog) 78% (ADCS-ADL-MCI) 71% (MMSE)
4 5 The Rest is Noise: The Promise of ecoa in Increasing Signal Detection Fig 1a: CDR Fig 1b: ADAS-Cog 5 47% 35% 24% 5 44% 25% 27% 2 1 7% more discrepancies % more ANOVA: F(1,298) = 15.0 p<.001 ANOVA: F(1,298) = 8.6 p =.004 Fig. 1c: ADCS-ADL-MCI Fig. 1d: MMSE % 9% 16% 1% more discrepancies % 7% 8% 3% more discrepancies ANOVA: F(1,298) = 38.4 p<.0001 ANOVA: F(1,298) = 16.9 p<.0001
5 6 The Rest is Noise: The Promise of ecoa in Increasing Signal Detection At the same time, the percentage of assessments with two or more discrepancies declined by: Fig. 2b: ADAS-Cog 71% (CDR) 59% (ADAS-Cog) 94% (ADCS-ADL-MCI) 57% (MMSE) Such reductions are notable when considering that multi- assessments likely account for a greater amount of noise. 6 An item-by-item look at discrepancies provides further detail (Figures 2a-2d). Worth noting was s effectiveness in reducing discrepancies in the orientation domains of both the CDR and the ADAS-Cog, as well as in items that are particularly hard to score, such as the memory domain in the CDR.7 Here, paper-and-pencil administration resulted in a 19% rate compared to 9% with. Fig. 2a: CDR Orientation 23 % 10 % Memory 19 % 9 % Judgment and Problem Solving 18 % 9 % Community Affairs 13 % 8 % Home and Hobbies 11 % 7 % Personal Care 5 % 2 % Platform 6 Analysis of variance (ANOVA) showed that the rates of for the esource system were statistically significantly lower on all four types of assessments than for paperand-pencil assessment administration (all p values <.001). 7 Tractenberg RE, Schafer K, Morris JC. (2001). Interobserver disagreements on clinical dementia rating assessment: interpretation and implications for training. Alzheimer Dis Assoc Disord Jul-Sep;15(3): PMID: Platform Orientation Place 11 % 2 % Orientation Year 11 % 0 % Orientation Day of the Week 11 % 0 % Naming Total Number Correct 9 % 2 % Constructional Praxis Cube 9 % 3 % Delayed Word Recall Score 4 % 2 % Delayed Word Recall Number Recalled 4 % 2 % Spoken Language Score 3 % 0 % Word Recall 1 Total Not Recalled 3 % 1 % Word Recall 3 Total Not Recalled 3 % 5 % Constructional Praxis Rhombus 3 % 3 % Constructional Praxis Overlapping Rectangles 2 % 0 % Comprehension Score 2 % 0 % Word Finding Difficulties Score 1 % 0 % Constructional Praxis Circle 1 % 1 % Commands Score 0 % 0 % Word Recall 2 Total Not Recalled 0 % 3 % Ideational Praxis Score 0 % 0 % Orientation Date 0 % 0 % Orientation Time of Day 0 % 1 % Orientation Season 0 % 1 % Orientation Name 0 % 0 % Orientation Month 0 % 0 % Fig. 2c: ADCS- ADL- MCI Platform Appointments 2 % 0 % At home 1 % 0 % At home (< 1 hour) 1 % 5 % Balance banking 3 % 0 % Balance banking Performance 5 % 0 Cleaning Performance 1 % 0 Discuss (<1 hour) 5 % 0 % Discuss show 0 % 1 % Discuss show (24 hours) 2 % 0 % Family, Friends or Neighbors 1 % 0 % Finding Belongings Performance 3 % 0 Laundry Performance 5 % 0 Make meal/snack Performance 2 % 0 Pastime, Hobby or Game 2 % 0 % Regional, national or International 0 % 0 % Select clothes 1 % 0 % Select clothes Performance 2 % 0 Select or Ask for show 1 % 0 % Selection of items 1 % 0 % Shopping 1 % 0 % Travel Performance 1 % 0 Use of Telephone Performance 12 % 0 Watch television 1 % 0 %
6 7 The Rest is Noise: The Promise of ecoa in Increasing Signal Detection Fig. 2d: MMSE Orientation to place Building type 7 % 5 % Repetition No ifs, ands, or buts 3 % 3 % Drawing Pentagons 4 % 1 % Orientation to place County 3 % 0 % Writing Sentence 3 % 0 % Orientation to time Date 3 % 0 % Attention 72 1 % 1 % Orientation to place City/town 3 % 0 % Orientation to place Floor 3 % 0 % Recall Penny Recall 1 % 1 % Recall Apple Recall 1 % 1 % Attention 65 1 % 1 % Orientation to time Season 2 % 0 % Attention 86 1 % 1 % Recall Table Recall 1 % 1 % Orientation to time Month 1 % 0 % Naming Watch 0 % 1 % Attention 93 1 % 0 % Orientation to time Day of week 1 % 0 % Orientation to place State 1 % 0 % Comprehension Put on floor 0 % 0 % Registration Apple 0 % 0 % Comprehension Fold in half 0 % 0 % Registration Penny 0 % 0 % Comprehension Right hand 0 % 0 % Registration Table 0 % 0 % Naming Pencil/pen 0 % 0 % Attention 79 0 % 0 % Orientation to time Year 0 % 0 % Reading Close your eyes 0 % 0 % Platform What do the results of this study suggest for raters, investigators, CROs, sponsors, regulatory agencies and, ultimately, patients? Conclusion Our study was the first to examine the actual error reduction outcomes that derive from using a tablet-based ecoa system such as. Directly comparable data sets from multinational clinical trials in MCI due to AD were available, and error rates were examined in a central review performed by the same cohort of calibrated raters. Error reduction was substantial, from approximately 5 to over 8 by scale, and highly statistically significant. This is a compelling demonstration of the clinical utility of the Investigative Study platform and its meaningful advantages over paper-and-pencil administration of assessments in clinical trials. The use of ecoa leads to fewer errors and discrepancies. This reduction in site-based scoring errors is likely due to the tablet s functions of displaying clinical guidance, performing auto-calculations, and offering consistency checks to raters in real-time. These advantages can increase signal detection and boost the chances of a successful trial. An ecoa system also has substantial benefits for sponsors and CROs, reducing administrative burden and costs and speeding trials. Such a system shows strong results with fewer errors and discrepancies, improved data quality, clearer signals, and standardized, accurate studies. The ultimate beneficiaries of clearer signals and reduced administrative burden are of course CNS patients and their families. Their quality of life depends on medical advances advances that improvements in the clinical trial process have vast potential to accelerate. They confirm the perception that traditional paper-and-pencil administration of COAs in AD trials is characterized by high error rates that contribute to error variance, which has the potential to degrade signal detection. Medavante 100 American Metro Boulevard #106 Hamilton, NJ 08619, USA medavante.com
NEUROPSYCHOMETRIC TESTS
NEUROPSYCHOMETRIC TESTS CAMCOG It is the Cognitive section of Cambridge Examination for Mental Disorders of the Elderly (CAMDEX) The measure assesses orientation, language, memory, praxis, attention, abstract
More informationMINI MENTAL STATE EXAM
MINI MENTAL STATE EXAM ID NUMBER: FORM CODE: M M E DATE: 06/01/2011 Version 2.0 ADMINISTRATIVE INFORMATION 0a. Completion Date: / / 0b. Staff ID: Month Day Year Materials: Black pen, pencil, wrist watch,
More informationMINI-MENTAL STATE EXA MINATION (M MSE)
MINI-MENTAL STATE EXA MINATION (M MSE) M axim u m Score Score 5 5 Orientation What is the (day of week) (day of month) (month) (year) (season)? Where are we: (state) (county) (town) (facility) (floor)?
More informationAD Prevention Trials: An Industry Perspective
AD Prevention Trials: An Industry Perspective Robert A. Lasser, MD, MBA Global Development Lead, Product Development Group Medical Director, Neurodegenerative Disorders F. Hoffmann - La Roche Ltd Regulatory
More informationCOGNITIVE ALTERATIONS IN CHRONIC KIDNEY DISEASE K K L E E
COGNITIVE ALTERATIONS IN CHRONIC KIDNEY DISEASE K K L E E Attention Problem Solving Language Cognitive Domains Decision Making Memory Reasoning The Cardiovascular Health Cognition Study shows higher S
More informationItem response theory analysis of cognitive tests in people with dementia: a systematic review
McGrory et al. BMC Psychiatry 2014, 14:47 RESEARCH ARTICLE Open Access Item response theory analysis of cognitive tests in people with dementia: a systematic review Sarah McGrory 1*, Jason M Doherty 2,
More informationName at birth. Address. MMSE: CASE: Cognigram. MMSE (Folstein and coll., 1975) Temporal Orientation Day: Date: Month: Season: Year: /5
CASE Cognitive Assessment Scale for the Elderly Daniel Geneau - Daniel Taillefer Institution Examiner Date of exam Age Education Date of birth Room File No y m d Name at birth Usual name or spouse name
More informationOverview. Case #1 4/20/2012. Neuropsychological assessment of older adults: what, when and why?
Neuropsychological assessment of older adults: what, when and why? Benjamin Mast, Ph.D. Associate Professor & Vice Chair, Psychological & Brain Sciences Associate Clinical Professor, Family & Geriatric
More informationCLINICAL DEMENTIA RATING SUMMARY
CLINICAL DEMENTIA RATING SUMMARY ID NUMBER: FORM CODE: C D S DATE: 4//6 Version. ADMINISTRATIVE INFORMATION a. Completion Date: / / b. Staff ID: Month Day Year Instructions: This form is to be completed
More informationSeptember 30, Eric BASTINGS, MD. Acting Director Division of Neurology Products (DNP) Center for Drug Evaluation and Research (CDER)
ISCTM Autumn Conference Options and methods to improve cognitive assessment in clinical trials of AD and its precursors September 30, 2013 Eric BASTINGS, MD Acting Director Division of Neurology Products
More informationSpeech perception in individuals with dementia of the Alzheimer s type (DAT) Mitchell S. Sommers Department of Psychology Washington University
Speech perception in individuals with dementia of the Alzheimer s type (DAT) Mitchell S. Sommers Department of Psychology Washington University Overview Goals of studying speech perception in individuals
More informationCognitive Assessment 4/29/2015. Learning Objectives To be able to:
Supporting the Desire to Age in Place: Important Considerations for the Aging Population AGENDA 8:45 9:00 AM Geriatric Principles Robert L. Kane, MD *9:00 9:55 AM Cognitive Assessments Ed Ratner, MD 10:00
More informationCritical Path Institute Coalition Against Major Diseases (CAMD) Alzheimer s Clinical Trial Database
Critical Path Institute Coalition Against Major Diseases (CAMD) Alzheimer s Clinical Trial Database Dr. Carolyn Compton, M.D., Ph.D. Chief Executive Officer Critical Path Institute 1 What We Do DEVELOP
More informationTHE ROLE OF ACTIVITIES OF DAILY LIVING IN THE MCI SYNDROME
PERNECZKY 15/06/06 14:35 Page 1 THE ROLE OF ACTIVITIES OF DAILY LIVING IN THE MCI SYNDROME R. PERNECZKY, A. KURZ Department of Psychiatry and Psychotherapy, Technical University of Munich, Germany. Correspondence
More informationDementia of the Alzheimer Type: the Drug Treatment Debate
Dementia of the Alzheimer Type: the Drug Treatment Debate I have no financial conflict of interest. Many years ago I was given a trip to San Fran and taught to use a slide set from the drug company. I
More informationApplication of Item Response Theory to ADAS-cog Scores Modeling in Alzheimer s Disease
Application of Item Response Theory to ADAS-cog Scores Modeling in Alzheimer s Disease Sebastian Ueckert 1, Elodie L. Plan 2, Kaori Ito 3, Mats O. Karlsson 1, Brian W. Corrigan 3, Andrew C. Hooker 1 1.
More informationOutcome measures in neuroscience clinical trials
Neuroscience TM Outcome measures in neuroscience clinical trials Jang-Ho Cha, Head, Translational Medicine Neuroscience Novartis Institute for BioMedical Research February 2017 Outline What is our problem?
More informationClinician-reported Outcomes (ClinROs), Concepts and Development
Clinician-reported Outcomes (ClinROs), Concepts and Development William Lenderking, PhD, Senior Research Leader; Dennis Revicki, PhD, Senior Vice President, Outcomes Research In heathcare, there are many
More informationCognitive Screening in Risk Assessment. Geoffrey Tremont, Ph.D. Rhode Island Hospital & Alpert Medical School of Brown University.
Cognitive Screening in Risk Assessment Geoffrey Tremont, Ph.D. Rhode Island Hospital & Alpert Medical School of Brown University Outline of Talk Definition of Dementia and MCI Incidence and Prevalence
More informationImproving. Bracket. with. Alzheimer s Disease Clinical Research
Improving Alzheimer s Disease Clinical Research with Bracket An ebook on the State of Alzheimer s Disease Clinical Trials and How Bracket is Improving Outcomes with Technology B RACKETG LOBA L.COM CONTENTS
More informationOverview of neurological changes in Alzheimer s disease. Eric Karran
Overview of neurological changes in Alzheimer s disease Eric Karran Alzheimer s disease Alois Alzheimer 1864-1915 Auguste D. 1850-1906 Case presented November 26 th 1906 Guildford Talk.ppt 20 th March,
More informationAging: Tools for Assessment
Aging: Tools for Assessment Eugenia L. Siegler, MD Mason Adams Professor of Geriatric Medicine Weill Cornell Medicine New York, New York San Antonio, Texas: August 21 to 23, 2017 Learning Objectives After
More informationFACTORS AFFECTING CAPACITY
FACTORS AFFECTING CAPACITY Psychosocial Factors Affecting Capacity Psychosocial factors include one s surroundings, way of life & things that affect relationships between the adult and their environment.
More informationSupplementary Online Content
Supplementary Online Content Atri A, Frölich L, Ballard C, et al. Effect of idalopirdine as adjunct to cholinesterase inhibitors on in cognition in patients with Alzheimer disease: three randomized clinical
More information(5) Severe Alzheimer s Disease (SEV):
CST MEAN : () Severe Alzheimer s Disease (SEV): The severe AD group shows extreme deficits in all cognitive domains. This group in our database did not show symptoms of anosognosia. Numerous difficulties
More informationGary Wieczorek, Associate Director, Regulatory Affairs Eisai Medical Research Inc. 300 Tice Blvd Woodcliff Lake, NJ 07677
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration Silver Spring, MD 20993 TRANSMITTED BY FACSIMILE Gary Wieczorek, Associate Director, Regulatory Affairs 300 Tice
More informationCognitive Assessment. Part Two: Assessing Capacity, Beyond The Basics. Using Information To Make Decisions (Appreciating) What s s The Correct Method?
AUTONOMY, CAPACITY AND UNDUE INFLUENCE: KEMP Page 1 of 9 Part Two: Assessing Capacity, Beyond The Basics Cognitive Assessment Bryan Kemp, Ph. D. Center of Excellence in Elder Abuse and Neglect UC Irvine
More informationCHAPTER 5 NEUROPSYCHOLOGICAL PROFILE OF ALZHEIMER S DISEASE
CHAPTER 5 NEUROPSYCHOLOGICAL PROFILE OF ALZHEIMER S DISEASE 5.1 GENERAL BACKGROUND Neuropsychological assessment plays a crucial role in the assessment of cognitive decline in older age. In India, there
More informationInstitute of Medicine Workshop: DIGITAL DATA PRIORITIES FOR CONTINUOUS LEARNING IN HEALTH AND HEALTH CARE
Institute of Medicine Workshop: DIGITAL DATA PRIORITIES FOR CONTINUOUS LEARNING IN HEALTH AND HEALTH CARE Data Quality in Clinical Research 23 March 2012 Rebecca D. Kush, PhD President and CEO, CDISC CDISC
More information21/05/2018. Today s webinar will answer. Presented by: Valorie O Keefe Consultant Psychologist
Today s webinar will answer. 1. What is the RBANS, and how is the updated version different than the original version? 2. What are the neurocognitive areas assessed by the RBANS and what scores are available?
More informationAward Number: W81XWH TITLE: "Longitudinal Study of a Novel Performance-based Measure of Daily Function."
Award Number: W81XWH-12-1-0084 TITLE: "Longitudinal Study of a Novel Performance-based Measure of Daily Function." PRINCIPAL INVESTIGATOR: Terry Goldberg, PhD CONTRACTING ORGANIZATION: The Feinstein Institute
More informationRecognizing Dementia can be Tricky
Dementia Abstract Recognizing Dementia can be Tricky Dementia is characterized by multiple cognitive impairments that cause significant functional decline. Based on this brief definition, the initial expectation
More informationBioArctic announces detailed results of the BAN2401 Phase 2b study in early Alzheimer s disease presented at AAIC 2018
Press release BioArctic announces detailed results of the BAN2401 Phase 2b study in early Alzheimer s disease presented at AAIC 2018 Stockholm, Sweden, July 25, 2018 BioArctic AB (publ) (Nasdaq Stockholm:
More informationAmerican Society for Experimental Neurotherapeutics - ASENT 2019 Annual Meeting. Walter E Kaufmann, MD CMO Nasdaq: AVXL March 2019
LONGITUDINAL 148-WEEK EXTENSION STUDY OF ANAVEX 2-73 FOR THE TREATMENT OF ALZHEIMER S DISEASE DEMONSTRATES MAINTAINED ACTIVITIES OF DAILY LIVING SCORE (ADCS-ADL) AND REDUCED COGNITIVE DECLINE (MMSE) FOR
More informationdakim Frequently Asked Questions
Product dakim Frequently Asked Questions Q. Why was Dakim BrainFitness invented? A. Dakim BrainFitness is the product of inventor, founder, and CEO Dan Michel s experience with his father s 13-year struggle
More informationMeasuring health-related quality of life in persons with dementia DOMS results & recommendations
Measuring health-related quality of life in persons with dementia DOMS results & recommendations Madeleine King, Siggi Zapart, Jan Sansoni, Nick Marosszeky On behalf of the Dementia Outcomes Measurement
More informationMedicare Part C Medical Coverage Policy
Medicare Part C Medical Coverage Policy Neuropsychological Testing Origination: September 19, 2001 Review Date: February 21, 2018 Next Review: February, 2020 DESCRIPTION OF PROCEDURE SERVICE Neuropsychological
More informationSession 2, Document A: The Big Ideas and Properties in Multiplication
Session 2, Document A: The Big Ideas and Properties in Multiplication In groups, respond to one of the prompts below. Your group should: 1) Read the prompt you are assigned. 2) Read the sections of the
More informationAlzheimer s disease dementia: a neuropsychological approach
Alzheimer s disease dementia: a neuropsychological approach Dr. Roberta Biundo, PhD Neuropsychology Coordinator at Parkinson s disease and movement disorders unit of San Camillo rehabilitation hospital
More informationOutline. Minority Issues in Aging Research. The Role of Research in the Clinical Setting. Why Participate in Research
Outline Minority Issues in Aging Research Mary Sano, Ph.D Mount Sinai School of Medicine Bronx Veterans Medical Research Center 130 West Kingsbridge Rd Bronx NY, 10468 Phone: 718 741-4228; Fax: 718 562-9120
More informationThe Reliability and Validity of the Korean Instrumental Activities of Daily Living (K-IADL)
The Reliability and Validity of the Korean Instrumental Activities of Daily Living (K-IADL Sue J. Kang, M.S., Seong Hye Choi, M.D.*, Byung H. Lee, M.A., Jay C. Kwon, M.D., Duk L. Na, M.D., Seol-Heui Han
More informationPDF hosted at the Radboud Repository of the Radboud University Nijmegen
PDF hosted at the Radboud Repository of the Radboud University Nijmegen The following full text is a preprint version which may differ from the publisher's version. For additional information about this
More informationCan aspirin slow cognitive decline and the onset of dementia? The ASPREE study. Mark Nelson on behalf of ASPREE Investigators
Can aspirin slow cognitive decline and the onset of dementia? The ASPREE study. Mark Nelson on behalf of ASPREE Investigators ASPREE Randomized, double-blind, placebo-controlled trial for extending healthy
More informationMeasuring health related quality of life in persons with dementia
University of Wollongong Research Online Australian Health Services Research Institute Faculty of Business 2008 Measuring health related quality of life in persons with dementia Madeleine King University
More informationAAIC 2018, Chicago, Illinois, US. July 22, 2018
24-Month Analysis of Change From Baseline In Clinical Dementia Rating Scale Cognitive and Functional Domains in PRIME, A Randomized Phase b Study of the Anti-Amyloid Beta Monoclonal Antibody Aducanumab
More informationNeuropsychiatric Syndromes
Neuropsychiatric Syndromes Susan Czapiewski,MD VAHCS December 10, 2015 Dr. Czapiewski has indicated no potential conflict of interest to this presentation. She does intend to discuss the off-label use
More informationSupplementary online data
THELANCETNEUROLOGY-D-07-00083 Supplementary online data MRI assessments MRI at each site included a volumetric spoiled gradient echo (T1-weighted) sequence with slice partition thickness of 1 5 mm or less
More informationDementia and Primary Care. A Structured Team Approach UNE/MGEC Conference June 2014
Dementia and Primary Care A Structured Team Approach UNE/MGEC Conference June 2014 First Proviso I have no actual or potential conflict of interest in relation to this program or presentation. Second Proviso
More informationBioArctic announces positive topline results of BAN2401 Phase 2b at 18 months in early Alzheimer s Disease
Press release BioArctic announces positive topline results of BAN2401 Phase 2b at 18 months in early Alzheimer s Disease The full 18 month analysis of the 856 patient BAN2401 Phase 2b clinical study in
More informationCOLLECTING ecoa IN DERMATOLOGY TRIALS
Best Practice Guide ERT develops gold standard for training raters on the psoriasis area severity index (PASI) CUSTOMIZED RATER TRAINING FOR DERMATOLOGY ASSESSMENTS Clinician rater training has been shown
More informationEnhancing mental capacity. Dr Sarah JL Edwards Senior Lecturer in Research Governance
Enhancing mental capacity Dr Sarah JL Edwards Senior Lecturer in Research Governance Contents Patients understanding medical information Assessing mental capacity Treating those without capacity Informational
More informationUDS version 3 Summary of major changes to UDS form packets
UDS version 3 Summary of major changes to UDS form packets from version 2 to VERSION 3 february 18 final Form A1: Subject demographics Updated question on principal referral source to add additional options
More informationALZHEIMER'S DISEASE PREVENTION TRIALS
ALZHEIMER'S DISEASE PREVENTION TRIALS Laurie Ryan, PhD Chief, Dementias of Aging Branch & Program Director, Alzheimer s Disease Clinical Trials Division of Neuroscience National Institute on Aging/National
More information2015 Exam Committees Report for the National Physical Therapy Examination Program
2015 Exam Committees Report for the National Physical Therapy Examination Program Executive Summary This report provides a summary of the National Physical Therapy Examination (NPTE) related activities
More informationLanguage Access Plan Basics
Language Access Plan Basics What you need to know to build a compliant and effective program InDemand Interpreting 01 Compliance HOW TO COMPLY WITH UPDATED LANGUAGE ACCESS STANDARDS Federal mandates require
More informationDriving and Dementia. By Alison Morris OT.
Driving and Dementia. By Alison Morris OT. Introduction. Early memory assessment has meant that more people are being diagnosed sooner with MCI or early dementia. This means that professionals are having
More informationAssessing cognitive function after stroke. Glyn Humphreys
Assessing cognitive function after stroke Glyn Humphreys (glyn.humphreys@psy.ox.ac.uk) Write down 3 important cognitive problems after stroke What things are important to detect? OCS Impairment incidences
More informationAssessing and Managing the Patient with Cognitive Decline
Assessing and Managing the Patient with Cognitive Decline Center of Excellence For Alzheimer s Disease for State of NY Capital Region Alzheimer s Center of Albany Medical Center Earl A. Zimmerman, MD Professor
More informationRegulatory Challenges across Dementia Subtypes European View
Regulatory Challenges across Dementia Subtypes European View Population definition including Early disease at risk Endpoints in POC studies Endpoints in pivotal trials 1 Disclaimer No CoI The opinions
More informationExploring Outcomes and Value across the Spectrum of Alzheimer s Disease Pennsylvania Avenue NW, Washington, DC June 20, 2017
Exploring Outcomes and Value across the Spectrum of Alzheimer s Disease 1201 Pennsylvania Avenue NW, Washington, DC 20004 June 20, 2017 Meeting Summary Meeting Objectives Alzheimer s disease (AD) has a
More informationThese questions are about the physical problems which may have occurred as a result of your stroke. Quite a bit of strength
PhenX Measure: Functionality after Stroke (#820700) PhenX Protocol: Stroke Impact Scale (SIS) - Adults (#820701) Date of Interview/Examination (MM/DD/YYYY): _ Stroke Impact Scale VERSION 3.0 The purpose
More informationThe experiential impact of cognitive function tests upon men with dementia and their carers
The experiential impact of cognitive function tests upon men with dementia and their carers Dr Edward Tolhurst Lecturer in Health Research 5 th November 2015 Research overview Qualitative study into the
More informationAdvancing Use of Patient Preference Information as Scientific Evidence in Medical Product Evaluation Day 2
Advancing Use of Patient Preference Information as Scientific Evidence in Medical Product Evaluation Day 2 Theresa Mullin, PhD Director, Office of Strategic Programs FDA Center for Drug Evaluation and
More informationhomeinstead.com Each Home Instead Senior Care franchise office is independently owned and operated Home Instead, Inc.
Each Home Instead Senior Care franchise office is independently owned and operated. 2010 Home Instead, Inc. homeinstead.com Many of us may joke about having old timers disease, but when cognitive impairment
More informationTranslating the Mini-Mental State Exam into American Sign Language:
Western University Scholarship@Western Undergraduate Honors Theses Psychology 4-30-2017 Translating the Mini-Mental State Exam into American Sign Language: Jesslyn Taylor King's University College Follow
More informationNeuropsychological Evaluation of
Neuropsychological Evaluation of Alzheimer s Disease Joanne M. Hamilton, Ph.D. Shiley-Marcos Alzheimer s Disease Research Center Department of Neurosciences University of California, San Diego Establish
More informationGENERAL SELF-EFFICACY AND SELF-EFFICACY FOR MANAGING CHRONIC CONDITIONS
GENERAL SELF-EFFICACY AND SELF-EFFICACY FOR MANAGING CHRONIC CONDITIONS A brief guide to the PROMIS Self-Efficacy Instruments ADULT PROMIS Item Bank v1.0 General Self-Efficacy PROMIS Short Form v1.0 General
More informationPSYCHIATRY. THE POWER OFx. Experts. Experience. Execution. A Deeper Dive into Psychiatry. Scientifically-Driven Clinical Development
THE POWER OFx Experts. Experience. Execution. A Deeper Dive into Psychiatry Incidences of mental disorders such as depression, bipolar, anxiety disorders, and schizophrenia continue to grow around the
More informationRecommendations on Screening for Cognitive Impairment in Older Adults 2015
Recommendations on Screening for Cognitive Impairment in Older Adults 2015 Canadian Task Force on Preventive Health Care (CTFPHC) Putting Prevention into Practice Canadian Task Force on Preventive Health
More informationPatients Driving Progress
Patients Driving Progress Ellen V Sigal, PhD WIN Symposium 2018 June 25, 2018 Paris, France Nothing to disclose The Evolution of Patient Advocacy The Agnew Clinic, Thomas Eakins (1899) Partial mastectomy
More informationScreening for Normal Cognition, Mild Cognitive Impairment, and Dementia with the Korean Dementia Screening Questionnaire
ORIGINAL ARTICLE https://doi.org/10.30773/pi.2017.08.24 Print ISSN 1738-3684 / On-line ISSN 1976-36 OPEN ACCESS Screening for Normal Cognition, Mild Cognitive Impairment, and Dementia with the Korean Dementia
More informationEstimating the Validity of the Korean Version of Expanded Clinical Dementia Rating (CDR) Scale
Estimating the Validity of the Korean Version of Expanded Clinical Dementia Rating (CDR) Scale Seong Hye Choi, M.D.*, Duk L. Na, M.D., Byung Hwa Lee, M.A., Dong-Seog Hahm, M.D., Jee Hyang Jeong, M.D.,
More informationMENTAL STATE EXAMINATION FAHAD ALOSAIMI MBBS, SSC- PSYCH CONSULTATION LIAISON PSYCHIATRIST KING SAUD UNIVERSITY
MENTAL STATE EXAMINATION FAHAD ALOSAIMI MBBS, SSC- PSYCH CONSULTATION LIAISON PSYCHIATRIST KING SAUD UNIVERSITY The mental status examination( MSE) MSE is a cross-sectional, systemic documentation of the
More informationDEMENTIA? 45 Million. What is. WHAT IS DEMENTIA Dementia is a disturbance in a group of mental processes including: 70% Dementia is not a disease
What is PRESENTS DEMENTIA? WHAT IS DEMENTIA Dementia is a disturbance in a group of mental processes including: Memory Reasoning Planning Learning Attention Language Perception Behavior AS OF 2013 There
More informationINFORMATION PAPER: INTRODUCING THE NEW DSM-5 DIAGNOSTIC CRITERIA FOR AUTISM SPECTRUM DISORDER
INFORMATION PAPER: INTRODUCING THE NEW DSM-5 DIAGNOSTIC CRITERIA FOR AUTISM SPECTRUM DISORDER What is the DSM-5? The Diagnostic and Statistical Manual of Mental Disorders (the DSM) is developed by the
More informationBaseline Characteristics of Patients Attending the Memory Clinic Serving the South Shore of Boston
Article ID: ISSN 2046-1690 Baseline Characteristics of Patients Attending the www.thealzcenter.org Memory Clinic Serving the South Shore of Boston Corresponding Author: Dr. Anil K Nair, Chief of Neurology,
More informationInvestor Presentation September Cogstate Ltd. All rights reserved.
Investor Presentation September 2017 2017 Cogstate Ltd. All rights reserved. We believe that brain health is profoundly important to quality of life and should be easier to measure. That s why we so passionately
More informationCASE HISTORY (ADULT) Date form completed:
Mailing Address: TCU Box 297450 Fort Worth, TX 76129 MILLER SPEECH AND HEARING CLINIC TEXAS CHRISTIAN UNIVERSITY Street Address: 3305 W. Cantey Fort Worth, TX 76129 CASE HISTORY (ADULT) Date form completed:
More informationPatient Reported Outcomes (PROs) Tools for Measurement of Health Related Quality of Life
Patient Reported Outcomes (PROs) Tools for Measurement of Health Related Quality of Life David Victorson, Ph.D. Assistant Professor Department of Medical Social Sciences Northwestern University Feinberg
More informationStudy Endpoint Considerations: Final PRO Guidance and Beyond
Study Endpoint Considerations: Final PRO Guidance and Beyond Laurie Burke Associate Director for Study Endpoints and Labeling OND/CDER/FDA Presented at: FIRST ANNUAL PATIENT REPORTED OUTCOMES (PRO) CONSORTIUM
More informationAddressing Content Validity of PRO Measures: The Unique Case of Rare Diseases
Disclaimer: Presentation slides from the Rare Disease Workshop Series are posted by the Kakkis EveryLife Foundation, for educational purposes only. They are for use by drug development professionals and
More informationNational Quali cations SPECIMEN ONLY
N5 S868/75/11 National Quali cations SPECIMEN ONLY Sociology Date Not applicable Duration 2 Hours Total s 70 Attempt ALL questions Write your answers clearly in the answer booklet provided. In the answer
More informationPerformance Outcome Measures: A Regulatory Perspective
Performance Outcome Measures: A Regulatory Perspective International Society for Pharmacoeconomics and Outcomes Research (ISPOR) May 18, 2015 Ashley F. Slagle, MS, PhD Study Endpoints and Labeling Development
More information(Visual) Attention. October 3, PSY Visual Attention 1
(Visual) Attention Perception and awareness of a visual object seems to involve attending to the object. Do we have to attend to an object to perceive it? Some tasks seem to proceed with little or no attention
More informationContent Scope & Sequence
Content Scope & Sequence GRADE 2 scottforesman.com (800) 552-2259 Copyright Pearson Education, Inc. 0606443 1 Counting, Coins, and Combinations Counting, Coins, and Combinations (Addition, Subtraction,
More informationDavid A Scott Lis Evered. Department of Anaesthesia and Acute Pain Medicine St Vincent s Hospital, Melbourne University of Melbourne
David A Scott Lis Evered Department of Anaesthesia and Acute Pain Medicine St Vincent s Hospital, Melbourne University of Melbourne This talk will include live polling so please be sure to have the meeting
More informationPatient-Centered Endpoints in Oncology
Patient-Centered Endpoints in Oncology SIXTH ANNUAL PATIENT-REPORTED OUTCOME CONSORTIUM WORKSHOP April 29-30, 2015 Silver Spring, MD Disclaimer The views and opinions expressed in the following slides
More informationRunning head: CPPS REVIEW 1
Running head: CPPS REVIEW 1 Please use the following citation when referencing this work: McGill, R. J. (2013). Test review: Children s Psychological Processing Scale (CPPS). Journal of Psychoeducational
More informationEuropean Prevention of Alzheimer s Dementia (EPAD)
European Prevention of Alzheimer s Dementia (EPAD) Ron Marcus, MD ISCTM Adaptive Design Workshop February 20, 2018 1 EPAD Goal The European Prevention of Alzheimer's Dementia (EPAD) project aims to develop
More informationAnswers to end of chapter questions
Answers to end of chapter questions Chapter 1 What are the three most important characteristics of QCA as a method of data analysis? QCA is (1) systematic, (2) flexible, and (3) it reduces data. What are
More informationWHI Memory Study (WHIMS) Investigator Data Release Data Preparation Guide December 2012
WHI Memory Study (WHIMS) Investigator Data Release Data Preparation Guide December 2012 1. Introduction Changes in the current update (December 2012): New data sets Post Trial - Form A, Phase 2: Administration
More informationCOGNITIVE FUNCTION. PROMIS Pediatric Item Bank v1.0 Cognitive Function PROMIS Pediatric Short Form v1.0 Cognitive Function 7a
COGNITIVE FUNCTION A brief guide to the PROMIS Cognitive Function instruments: ADULT PEDIATRIC PARENT PROXY PROMIS Item Bank v1.0 Applied Cognition - Abilities* PROMIS Item Bank v1.0 Applied Cognition
More informationINSTRUCTIONS FOR THE AD8 DEMENTIA SCREENING INTERVIEW (10/22/2015) (ADS, VERSION 1, 4/29/2015)
INSTRUCTIONS FOR THE AD8 DEMENTIA SCREENING INTERVIEW (10/22/2015) (ADS, VERSION 1, 4/29/2015) I. General Instructions The AD8 Dementia Screening Interview (ADS) is a measure used to detect dementia. The
More informationEstablishing Interrater Agreement for Scoring Criterion-based Assessments: Application for the MEES
Establishing Interrater Agreement for Scoring Criterion-based Assessments: Application for the MEES Mark C. Hogrebe Washington University in St. Louis MACTE Fall 2018 Conference October 23, 2018 Camden
More informationProcess of a neuropsychological assessment
Test selection Process of a neuropsychological assessment Gather information Review of information provided by referrer and if possible review of medical records Interview with client and his/her relative
More informationPHYSICAL STRESS EXPERIENCES
PHYSICAL STRESS EXPERIENCES A brief guide to the PROMIS Physical Stress Experiences instruments: PEDIATRIC PROMIS Pediatric Bank v1.0 - Physical Stress Experiences PROMIS Pediatric Short Form v1.0 - Physical
More informationCognitive Training Interventions for Delaying Cognitive Decline
Cognitive Training Interventions for Delaying Cognitive Decline Jessica B. Langbaum, Ph.D. Principal Scientist, Banner Alzheimer s Institute Associate Director, Alzheimer s Prevention Initiative Disclosures
More informationCNADC NIA ADC Clinical Task Force UDS Neuropsychology Work Group April 2011
NIA ADC Clinical Task Force UDS Neuropsychology Work Group April 2011 Members: Hiroko Dodge (OHSU) Steven Ferris (NYU) Joel Kramer (UCSF) Ex Officio David Loewenstein (Miami) Po Lu (UCLA) Bruno Giordani
More informationPMDA Considerations for Outcome Assessments
PMDA Considerations for Outcome Assessments Keiju Motohashi Office of New Drug II Pharmaceuticals and Medical Devices Agency/ The University of Tokyo Hospital Disclaimer The views and opinions expressed
More information