UDS version 3 Summary of major changes to UDS form packets
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1 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 and clarifications. Updated question on living situation to add additional options and clarifications. Added question on how referral source learned of ADC. Form A2: Co-participant demographics New question on how long co-participant has known the subject. Form A3: Subject family history Still collecting information on all biological parents, full siblings, and biological children (as in version 2), but with new questions on age at death, neurological problem, primary diagnosis, method of evaluation, and age of onset. The allowable options for primary diagnosis are adapted from Version 2 of the FTLD Module Family History Form A3F, adding neuropathology diagnoses by autopsy. New questions on family history of AD, FTLD, and other mutations. Form A4: Subject medications The list of medications has been updated to reflect the top 100 list reported by UDS subjects from 2011 to Form A5: Subject health history A5 will be submitted at the initial visit only. This form is now focused on capturing information from the subject/co-participant interview; all available information including laboratory tests and medical records to assess the presence of medical conditions will now be reviewed on Form D2. Changed the heart attack, transient ischemic attack (TIA), and stroke questions to assess whether the subject had more than one in the past and the year of the most recent heart attack, TIA, or stroke.
2 Changed the question assessing pacemaker history to Pacemaker and/or defibrillator. Changed traumatic brain injury (TBI) questions to allow assessment of single or multiple TBIs with brief and/or extended loss of consciousness. New questions about current alcohol consumption and frequency of consumption. New cardiovascular disease questions: angina and heart valve replacement or repair. New TBI questions: single or repeated TBI without loss of consciousness, year of most recent TBI. New question to assess diabetes type. New questions about sleep disorders: sleep apnea, REM sleep behavior disorder, hyposomnia/ insomnia, and other sleep disorder. New questions about arthritis: type and region affected. New questions about psychiatric disorders: PTSD, bipolar disorder, schizophrenia, anxiety, OCD, and other developmental neuropsychiatric disorders. Form B1: Evaluation form Physical No major changes Form B2: Evaluation form HIS/CVD This form has been eliminated. Questions on CVD signs, CVD imaging, and the temporal relationship between stroke and cognitive impairment have been moved to Forms B8 and D1. Form B3: Evaluation form UPDRS This form has been eliminated. A shortened assessment of parkinsonian signs is now included on Form B8. Form B4: Global staging CDR No major changes Form B5: Behavioral assessment NPI-Q The instructions have been edited to be consistent with the way the NPI-Q was originally intended to be completed (assessing symptoms that are new i.e., represent changes within the past month), as communicated by Jeff Cummings. Instead, Form B9 will be the place to assess symptoms that occur over more than one visit. Added checkbox option for Unknown for each question. UDS3 FORM CHANGES DECEMBER 2014 SUMMARY PAGE 2
3 Form B6: Behavioral assessment GDS Added checkbox option for Did not answer for each question. Form B7: Behavioral assessment FAQ Added checkbox option for Unknown for each question. Form B8: Evaluation Form Neurological examination findings This form is now required. It collects more detail about the neurological exam findings and assigns the presumed cause to the findings (e.g., parkinsonism, CVD). Only symptoms that are present need be checked as Present; all others will default to Absent in the NACC database (i.e., blank = Absent). This decision was made based on feedback and preferences of the ADC Clinical Task Force. New gateway question about abnormal findings; if no abnormal findings are present, the form is ended at the first question. New questions on parkinsonian signs. New questions on CVD findings. New question on PCA. New questions on PSP/CBS/other related disorder. New question on ALS. New question on normal-pressure hydrocephalus. New question on other findings, specify. Form B9: Clinician judgment of symptoms Age of onset can no longer be unknown; if exact age is unknown, the clinician must estimate it. If age of onset was provided at a previous visit, it need not be provided at subsequent visit(s). If first predominant symptom or domain was provided at a previous visit, it need not be provided at subsequent visit(s). New gateway questions for the cognitive, behavioral, and motor symptoms sections that allow the section to be skipped if there are no cognitive, behavioral, or motor symptoms. New question on orientation. New question on age of onset of fluctuating cognition. New question on age of onset of visual hallucinations. New question on anxiety. New question on age of onset of REM sleep behavior disorder. New question on age of onset of behavioral symptoms. New question on age of onset of motor changes consistent with parkinsonism. New question on whether changes in motor function is suggestive of ALS. UDS3 FORM CHANGES DECEMBER 2014 SUMMARY PAGE 3
4 afew addition New question on age of onset of motor changes consistent with ALS. New question on age of onset of motor symptoms. Two new questions on whether subject is a candidate for further evaluation of LBD or FTLD. Form C1: Neuropsychological battery scores (UDS 2 BATTERY) Centers will have the option of administering the battery used for UDS 2 (i.e., submitting Form C1) on previously enrolled ADC subjects who are being seen for follow-up visits. Any newly enrolled subjects that will be receiving an initial visit packet must be administered the new battery instead (i.e., for newly enrolled subjects, the Center must submit Form C2). For each subject visit, NACC expects to receive either Form C1 or Form C2; the form submitted will indicate which battery was used for the subject. Added skip patterns so that, for example, multiple questions about the MMSE need not have a code if the MMSE was not completed. Added two questions on whether subject was unable to complete some or all of the MMSE because of a visual or hearing impairment. Added Benson Complex Figure Copy and Recall. Added Verbal Fluency Phonemic Test (F&L). Deleted WAIS-R Digit Symbol. Form C2: Neuropsychological battery scores (new battery) This new form is for use with the new neuropsychological battery. Centers are required to use the new battery for all newly enrolled subjects receiving an initial visit packet. At the Center s discretion, however, returning subjects may instead be given the UDS 2 battery Form C1. For each subject visit, NACC expects to receive either Form C1 or Form C2. The form submitted will indicate which battery was used for the subject. Added MoCA. Added two questions on whether subject was unable to complete some or all of MoCA due to a visual or hearing impairment. Added Number Span Forward. Added Number Span Backward. Added MINT. Added Craft Story 21 Immediate and Delayed Recall. Added Benson Complex Figure Copy and Recall. Added Verbal Fluency Phonemic Test (F&L). Form D1: Clinician diagnosis Question on diagnosis method (single clinician, formal consensus panel) now has option for Two or more clinicians or other informal group. UDS3 FORM CHANGES DECEMBER 2014 SUMMARY PAGE 4
5 The form has been divided into three sections: cognitive status; biomarkers, imaging, and genetics; and etiological diagnoses. Dementia criteria have been updated to indicate that the subject has to be affected in at least one domain, and that for subjects who are only affected in one domain, they must not meet the criteria for MCI (with the result that this will capture demented subjects with single-domain PPA, bvftd, or PCA). Only syndromes and etiologic diagnoses that are present need to be checked as present; all others will default to absent in the NACC database (i.e., blank = Absent). This change was made based on feedback and preferences of the CTF. Question on hydrocephalus changed to specify normal-pressure hydrocephalus. New section for dementia syndromes: Amnestic multidomain dementia syndrome PCA syndrome PPA syndrome and PPA types bvftd syndrome Lewy body disease syndrome Non-amnestic multidomain dementia, not PCA, PPA, bvftd, or DLB syndrome New section on biomarker findings based on local standards for positivity New section on CVD imaging findings (previously collected on B2) New questions under etiologic diagnosis section: Multiple system atrophy FLTD (specifically PSP, CBD, FTLD with motor neuron, FTLD NOS, and FTLD subtype) Vascular brain injury (replaced vascular dementia questions) Essential tremor Chronic traumatic encephalopathy Epilepsy Benign or malignant designation for CNS neoplasm HIV Bipolar disorder Schizophrenia Anxiety Delirium PTSD Deleted assessment of possible and probable AD. Deleted assessment of possible and probable vascular dementia/cognitive impairment. Form D2: Clinician-assessed medical conditions On this new form, the clinician will indicate the presence or absence of medical conditions after a review of all available information (medical records, laboratory tests, etc.). UDS3 FORM CHANGES DECEMBER 2014 SUMMARY PAGE 5
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