CRF Library

Established clinical practice guidelines for actigraphy from the American Academy of Sleep Medicine (AASM) International Classification of Sleep Disorders (ICSD) ? Third Edition. It is recommended that the participant wear the device while filling in a daily sleep diary.

The Apathy Motivation Index Caregiver Version (AMI-CG) is an 18 item caregiver reported index that assesses apathy in the behavioral activation (BA), emotional sensitivity (ES), and social motivation (SM) domains over the previous two weeks. It was adapted from the Lille Apathy Rating Scale (LARS).

The BDI-II was developed in 1996 and was derived from the BDI. The 21-item survey is self-administered and is scored on a scale of 0-3 in a list of four statements arranged in increasing severity about a particular symptom of depression, bringing the BDI-II into alignment with DSM-IV criteria.

Best practices for choice of connected sensor technology (digital technology) for digital health outcome measures for clinical research on Parkinson?s disease

One of the most widely used measurement tools for assessing clinical pain; shown to be an appropriate measure for pain caused by a wide range of clinical conditions

CANTAB contains a total of 25 cognitive tasks, each loading onto specific cognitive domains across memory, attention, executive function, social cognition, psychomotor and processing speed. Individual tests can be grouped together to create a battery relevant for particular research. Computer administered cognitive test battery which uses non-verbal visual stimuli and is culturally neutral. The constructs measured by this test are attention, executive functioning and memory.

The Cognitive Drug Research computerized cognitive assessment system (CDR System) is an integrated set of cognitive tasks, developed in the 1980s to provide a practical, sensitive, reliable and repeatable method of assessing core aspects of cognitive function in healthy volunteers and any patient population.

The Clinical Global Impression Scale-Severity (CGI-S) is a 7-point categorical scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis.

Cogstate Brief Battery contains four tests: One-Back (attention and working memory), One Card Learning (visual learning and memory), Identification (visual attention) and Detection (processing speed).

The screen version of the Columbia - Suicide Severity Rating Scale (C-SSRS) contains a total of 6 possible yes or no questions that assess suicidal ideation and behavior over the past month. Results triage respondents into low, moderate, and high risk categories.

The Compulsive Eating Scale (CES) is a 32-item self-report questionnaire that measures the degree of compulsive eating. Items in the CES include "emotional states related to food and eating as well as information with regard to weight, weight control, height, and eating binge.

Core Assessment Program for Surgical Interventional Therapies in PD (CAPSIT-PD) is a patient diary that assesses motor fluctuations in Parkinson's disease. It was developed for use in patients undergoing surgery but is also applicable to non-surgical programs and places special interest on the differentiation of OFF from partial-OFF periods.

Contains data elements that are collected to describe the demographics of the study population relevant to Parkinson's disease research. (Examples of CDEs included: General CDE demographic elements (sex assigned at birth, gender identity, race, ethnicity, etc.); date of birth)

Parkinson's Disease v2.0 Digital Technology Subgroup Summary

The Dimensional Apathy Scale (DAS) is a 24 item caregiver reported scale that measures apathy over the last month in three subscales: executive (lack of motivation for organization, planning, or attention), emotional (lack of emotional motivation, indifference or emotional neutrality), and initiation (lack of motivation for self-generation of thought and or/actions).

The Drooling Severity and Frequency Scale (DSFS) is a semi-quantitative assessment of the amount of drooling.

Parkinson's Disease v2.0 Epidemiology and Environment Subgroup Summary

Standardized measure of health status developed by the EuroQol Group in order to provide a simple, generic measure of health for clinical and economic appraisal

The Fatigue Severity Scale (FSS) is a nine-item questionnaire that assesses the effect of fatigue on daily living.

The Food Frequency Questionnaire (FFQ) consists of a list of foods with little descriptive detail, and the respondent answers questions about the frequency of each food on the list.

Contains data elements about pre-, intra-, and post-operative guidelines for DBS reports. (Examples of CDEs included: Head Position; Intraoperative Target Verification; L-dopa challenge responses; etc.)

Gastrointestinal Symptoms in Neurodegenerative Diseases Scale (GIND) assesses the severity of GI symptoms in Parkinson's disease. It covers all of the GI symptoms known to occur in PD (drooling, dysphagia, heartburn, reflux, nausea, vomiting, anorexia, early satiety, bloating, abdominal pain, gas, stool frequency, stool consistency, defecatory dysfunction, and weight loss) as well as the impact of these symptoms on mood and activities of daily living.

Contains data elements for all of the general core CDEs and has been duplicated across all of the disorders on the NINDS CDE website. (Examples of CDEs included: Date of birth; Sex assigned at birth; Gender identity; Race; Ethnicity; Education; SNOMED CT code)

Guidance for digital data sharing for clinical trials on Parkinson's disease summarizing the type of metadata, technology and environment information that should be included when uploading Digital Health Data to a database

Contains data elements which cumulatively rate the participant/subject's level of depression. (Examples of CDEs included: Insomnia; Feelings of Guilt; Agitation; etc.)

Contains data elements about the history of being breast fed, sibship/birth order, and preschool attendance. (Examples of CDEs included: Did you attend preschool; Numbers of brothers and sisters; Did your mother breastfeed you; etc.)

The Hospital Anxiety and Depression Scale (HADS) is a 14-item self-report scale that consists of a depression and an anxiety scale, each with 7 items. The scale was designed to screen for mood disorders in general (non-psychiatric) medical outpatients. It focuses on subjective disturbances of mood rather than physical signs, and aims at distinguishing depression from anxiety. Compared to other instruments scales, it focuses on emotional aspects of anxiety disturbances, as opposed to somatic and cognitive symptoms.

Guidance for Parkinson's disease imaging studies using an imaging tool specific approach; includes suggested analysis methods for some modalities

Contains data elements about the participant/subject's history of influenza, pneumonia, and meningitis. (Examples of CDEs included: Age at time of pneumonia; First influenza vaccination; Age at time of meningitis; etc.)

Contains data elements that assess the participant/subject's insomnia severity. (Examples of CDEs included: Falling asleep; Staying asleep; Sleep pattern; etc.)

The International Consultation on Incontinence Questionnaire (ICIQ) bladder diary records a patient?s urinary frequency, volume voided, fluid intake (amount, time, type), bladder sensation and pad use over a 3-day period. This validated diary can be used in clinical practice for the assessment of lower urinary tract symptoms (LUTS).

The King?s Parkinson?s Disease Pain Scale (KPPS) was developed to evaluate the multiple pain modalities present in Parkinson's disease, administered by health professionals. It assesses the severity and frequency of pain across seven domains: musculoskeletal, chronic, fluctuating, nocturnal, orofacial, edematous, radicular.

The Lumos Labs NeuroCognitive Performance Tests (NCPT) is a brief, repeatable, web-based platform of cognitive assessments. It measures functioning across cognitive domains including working memory, visuospatial memory, psychomotor speed, fluid and logical reasoning, response inhibition, numerical calculation, and selective and divided attention.

Mayo Sleep Questionnaire (MSQ) consists of 16 items designed to screen for the presence of a wide range of sleep disorders (e.g., REM sleep behavior disorder (RBD), periodic limb movements of sleep (PLMS), restless legs syndrome (RLS)). MSQ is designed to be completed by caregivers/bed partners.

Contains data elements related to the study participant's/ subject's health history when Parkinson's disease was first diagnosed. Particular attention is paid to motor symptoms. (Examples of CDEs included: Diagnostic features/criteria; Initial Motor Symptoms; etc.)

The Mini-Mental State Examination (MMSE) is a brief, global cognitive rating scale that was developed to identify cognitive status in adults. It covers orientation, repetition, verbal recall, attention and calculation, language, and visual construction.

The Montreal Cognitive Assessment MoCA was designed to efficiently screen for mild to moderate cognitive impairment, including patients with normal mini-mental state examination (MMSE). It screens eight domains: Visuospatial/executive, Naming, Memory, Attention, Language, Abstraction, Delayed recall, and Orientation. Alternate forms are available to mitigate practice effects across serial assessments.

The Movement Disorder Society Clinical Diagnostic Criteria for Parkinson's Disease (PD) instrument includes criteria for clinically established PD and
clinically probable PD. Exclusion criteria are defined that would suggest an alternate cause of parkinsonism. Red flags are proposed that must be factored in to determine level of certainty in the diagnosis.

Contains recommendations used in the assessment and diagnosis of excessive somnolence and evaluation of excessive daytime sleepiness.

The National Alzheimer's Coordinating Center (NACC) Neuropathology Data Form is used to collect a selected set of pathological features at autopsy.

The Neurogenic Bladder Symptom Score (NBSS) (24-item) and the Neurogenic Bladder Symptom Score short form (NBSS-SF) (10-item) are both freely available, self-administered, questionnaires that assesses urinary symptoms and bladder-related consequences in patients with acquired or congenital neurogenic bladder dysfunction as a result of spinal cord injury, multiple sclerosis, and spinal bifida.

The Neuropsychiatric Inventory (NPI) is a clinician administered, caregiver reported interview assessing patient behavioral disturbances occurring in dementia. Ten domains are measured; delusions, hallucinations, dysphoria, anxiety, agitation/aggression, euphoria, disinhibition, irritability/lability, apathy, and aberrant motor activity. The 12-item version also includes sleep/night time behavior changes and appetite/eating changes.

Contains data elements about the participant/subject's non-PD medication history during study enrollment. (Examples of CDEs included: Macroscopic aspects; Alzheimer's type pathology; Lewy body pathology; etc.)

Ohio State University TBI Identification Method-Short Form (OSU TBI-ID-SF) is a shortened version of a structured interview developed using recommendations from the CDC for the detection of history of exposure to traumatic brain injury. It elicits self- or proxy-reports of TBI occurring over a person's lifetime according to selected summary indices.

The Orthostatic Symptom Grading Scale is a self-report orthostatic rating scale that assesses frequency of orthostatic symptoms, severity, conditions under which symptoms occur, interference with activities of daily living, and ability for stand for periods of time.

Parkinson's Disease v2.0 Other Non-Motor Subgroup Summary

The Parkinson's Disease - Cognitive Functional Rating Scale (PD-CFRS) assesses the functional aspects of cognitive impairment in Parkinson's disease. It includes 12 questions about activities of daily living (e.g., handling money, controlling medication regimen, using public transportation).

Contains data elements collecting information on the genetic etiology of participants with Parkinson?s disease/parkinsonism. The focus is on variables related to sample processing and genetic testing results while also capturing some information on variables related to phenotype in both the clinical and research setting.

The Parkinson?s Disease-Cognitive Rating Scale (PD-CRS) was developed to ?capture the whole spectrum of cognitive functions impaired over the course of PD.?

The Parkinson's Psychosis Questionnaire (PPQ) is a screening tool for early detection of psychosis in PD. It measures the frequency and severity of four domains: sleep disturbances, hallucinations/illusions, delusions, and orientation. It was developed to screen early drug-induced psychosis in PD.

The Pathological Gambling version of the Yale-Brown Obsessive Compulsive Scale (PG-YBOCS) is a 10-item clinician-administered scale that measures the severity of pathological gambling within a set period of time (i.e., the past one / two week(s)).

PHQ-9 provides a reliable and valid measure of depression severity and also yields a DSM-IV criteria based diagnosis of a depressive disorder. This 9 item measure asks subjects whether and how often they have been bothered by depression related symptoms over the last two weeks, ranging from not at all (0) to nearly every day (3). Based on total score, depression severity ranges from minimal symptoms (5-9) to greater than 20 indicating severe major depression.

Measures contrast sensitivity using a single large letter size (20/60 optotype), with contrast varying across groups of letters

Contains data elements used to measure cellular/tissue change in a participant/subject. (Examples of CDEs included: Radioligand; Quantitative Imaging Outcome; etc.)

The Pittsburgh Sleep Quality Index is a self-rated questionnaire that primarily assesses nighttime sleep problems. It focuses on sleep experiences over the past month. It has 19 self-rated questions and 5 additional questions for a bed partner or roommate.

The PROMIS Scale v1.2 - Global Health (also referred to as PROMIS-10) is a ten-item patient reported measure of physical, mental and social health.

Parkinson's Disease v2.0 Psychiatry Subgroup Summary

Quality of Life in Neurological Disorders (Neuro-QOL) is a measurement system designed for neurologically impaired populations that includes patient reported outcomes of functioning, such as social, psychological, and mental well-being. Item banks cover the following domains: Lower Extremity Function-Mobility, Upper Extremity Function-Fine Motor, ADL, Depression, Anxiety, Positive Affect and Well-Being, Stigma, Cognitive Function, Social Role Performance, Satisfaction with Social Roles and Activities, Fatigue, Emotional and Behavioral Dyscontrol, and Sleep Disturbance.

Contains data elements for the Quality of Life in Swallowing Disorders (SWAL-QOL) [Examples of CDEs included: Dealing with my swallowing problem is very difficult; My swallowing problem is a major distraction in my life]

The Buying Questionnaire is a 19-item self-rated questionnaire that measures severity of buying behaviors.

The Radboud Oral Motor Inventory for Parkinson?s Disease (ROMP) is a self-reported questionnaire. It screens for abnormalities of speech, swallowing, saliva control and it measures the physical and psychosocial impact of each domain.

Contains data elements about occupation and employment status of the participant/subject during different phases of life. (Examples of CDEs included: Military history; Occupation history from birth-25 years, 26-35 years, 36-45 years, 46-55 years, 56-65 years, and 66 years and above; etc.)

Contains data elements about the participant/subject's current and past residences during different periods of life. (Examples of CDEs included: Residence from birth-17 years, 18-25 years, 26-35 years, 36-45 years, 46-55 years, 56-65 years, and 66 years and above; Pesticide spraying at residence; etc.)

Contains data elements about the participant's/subject's height, weight, and body type at 3 different age periods. (Examples of CDEs included: Height and weight at 25 years, 40 years, and 60 years; etc.)

Contains data elements about the participant/subject's lifetime pesticide exposure at work and home. (Examples of CDEs included: Exposure to pesticides in different work environments from birth-25 years, 26-35 years, 36-45 years, 46-55 years, 56-65 years, and 66 years and above; etc.)

This questionnaire was developed to assist physicians, health care professionals and researchers in identifying individuals who have one or more functional gastrointestinal disorders (FGIDs).

Contains data elements that assess the extent in the past month the participant/subject has had problems with bodily functions. (Examples of CDEs included: Difficulty swallowing; Difficulty passing urine; Excessive sweating; etc.)

Contains data elements which are used to assess positive symptoms such as hallucinations, delusions, bizarre behavior, and positive formal thought disorder that occur primarily in schizophrenia. (Examples of CDEs included: Hallucinations; Delusions; Bizarre Behavior; etc.) .

Contains data elements to assess specific aspects of cognitive function in Parkinson's disease. (Examples of CDEs included: Memory and Function; Attention; Executive Functions; etc.)

The Schwab and England Activities of Daily Living Scale estimates the abilities of individuals living with a disease relative to a range of life activities spanning from a bedridden, vegetative state (the lowest score of 0%) to complete independence of function (the highest score of 100%).

The Sexual Compulsivity Scale is a 10-item self-rated questionnaire that assesses tendencies toward sexual preoccupation.

The Sialorrhea Clinical Scale for PD (SCS-PD) assesses drooling severity and frequency as well as social and functional impairment from drooling.

The South Oaks Gambling Screen (SOGS) is a self-rated screening questionnaire and is the most commonly used instrument to screen for pathological or problem gambling in the general population.

The STOP-BANG Questionnaire is an 8-item self-administered questionnaire that assesses the risk of obstructive sleep apnea. It includes 8 questions related to snoring, daytime sleepiness, stopped breathing during sleep, and hypertension. The acronym represents the way the questions are presented: Snoring, Tired, Observed, Blood Pressure (STOP) and Body Mass Index, Age, Neck size, Gender (BANG).

The Gastrointestinal Dysfunction Scale for Parkinson?s Disease is a patient-reported, questionnaire-based assessment of GI symptoms. It includes questions about stool frequency (both increased and decreased), straining during defecation, stool consistency, incomplete evacuation, abdominal pain, bloating, weight loss, dysphagia, drooling, heartburn, and nausea.

The International Parkinson and Movement Disorder Society - Non-Motor Rating Scale (MDS-NMS) is a revised version of the Non-Motor Symptoms Scale (NMSS). It is a rater-completed assessment of non-motor symptoms in Parkinson?s disease (PD). Frequency and severity of PD and treatment related non-motor symptoms are measured across 13 non-motor domains.

The Swallowing Clinical Assessment in PD (SCAS-PD) aims to identify the occurrence of specific alterations of each phase of swallowing (oral, pharyngeal, and laryngotracheal) giving the patient 3 different consistencies of food: 20 ml liquid (water), 10 ml paste (liquid with pudding consistency), and one unit solid (salt cracker).

The Unified Dyskinesia Rating Scale (UDysRS) has four parts: I) Historical Disability (patient perceptions) of On-Dyskinesia impact; II) Historical Disability (patient perceptions) of Off-Dystonia impact; III) Objective Impairment (Dyskinesia severity, anatomical distribution over seven body regions, and type (choreic or dystonic) based on four activities observed or video-recorded; IV) Objective Disability based on Part III activities.

The Wearing Off Questionnaire (WOQ) is a screening tool to quantify the change of "wearing-off" (a predictable recurrence of motor and nonmotor symptoms preceding scheduled doses of antiparkinsonian medication).