Clinical and General Population Testing
Wave I
Conducted entirely online, Wave I was comprised of a clinical testing sample (Wave IA) and a general population testing sample (Wave IB). Using online panels, this type of data collection enabled diversification of the sample by disease, geography, gender, economic status and race/ethnicity. The items to be tested were transferred to the survey layout team at YouGovPolimetrix (Wave 1A) and Greenfield Online (Wave 1B), and subsequently entered into their online administration systems. The panel companies then began using stratified random sampling (to meet diversification requirements) of their pre-registered panels.
Wave IA: Online Clinical Testing. The purpose of Wave IA was to field test the stigma bank and disease targeted scales which would not be appropriate for the Wave IB General Population Testing (see below). Study participants included 553 adults (diagnosed with epilepsy, stroke, ALS, Multiple Sclerosis or Parkinson’s disease) and 59 children (diagnosed with epilepsy or muscular dystrophy).
Wave IB: Online General Population Testing. 3000 adults (2000 English-speaking and 1000 Spanish speaking) and 1500 children (1000 English-speaking and 500 Spanish-speaking) have been recruited for Wave IB, with each participant taking approximately 80 items.
Development of Short Forms and Wave II Testing. Following psychometric analysis of Wave I data, short forms were constructed from the item banks, with content and item location based upon the specific assessment goals and characteristics of the patient population. The number of short forms and the specific focus of each were determined by the investigators in consultation with the Project Officer, Neuro-QOL scientific team and outside expert advisors in neurology. The multiple short forms were combined into a single instrument (one each for adults and children) with the combined instruments used to assess test-retest reliability, responsiveness to change, and the usefulness of proxy data. One form each for adult and pediatric patients are being tested with English speaking patients and their proxies. See the table below for the Neuro-QOL short forms and disease specific scales.
|
|
|
Banks |
Adult |
Peds |
Short Form (SF) or Disease Specific Scale (DSS) |
|
Depression |
X |
|
SF |
|
Anxiety/Fear |
X |
|
SF |
|
Stigma |
X |
X |
SF |
|
Positive Psychological Function |
X |
|
SF |
|
Emotional Health |
-- |
X |
SF |
|
Perceived Cognitive Function |
X |
|
SF |
|
Applied Cognitive Function |
X |
|
SF |
|
Mobility and Ambulation |
X |
X |
SF |
|
Fine Motor/Upper Extremity Function |
X |
X |
SF |
|
Role Performance |
X |
|
SF |
|
Role Satisfaction |
X |
|
SF |
|
Social Function |
-- |
X |
SF |
|
Cognition |
-- |
X |
DSS |
|
Fatigue/Weakness |
X |
X |
DSS |
|
Sleep Disturbance |
X |
|
DSS |
|
Personality and Behavior Changes |
X |
|
DSS |
Patient recruitment for Wave II utilizes multiple methods, including direct in-clinic approaches. Clinic patients are enrolled at collaborating clinics. Disease specific scales are administered to each appropriate sample. Medical professional ratings, administration of concurrent measures and/or chart review are conducted at baseline and as part of the 180-day follow up sample. This wave will enroll approximately 500 adults across five clinical conditions with 100 proxies matched to the Stroke sample, and 100 children across two clinical conditions, with another 100 proxies matched to the pediatric sample.
|
|
|
|
Assessment I (Baseline) |
Assessment II (7 days) |
Assessment III
(180days) |
|
Stroke |
100 |
100 |
100 |
|
Multiple Sclerosis |
100 |
100 |
100 |
|
Parkinson’s Disease |
100 |
100 |
100 |
|
Adult Epilepsy |
100 |
100 |
100 |
|
ALS |
100 |
100 |
100 |
|
Proxies matched to Stroke |
100 |
100 |
100 |
|
Pediatric Epilepsy |
50 |
50 |
50 |
|
Proxies matched to above Epilepsy |
50 |
50 |
50 |
|
Pediatric Muscular Dystrophy |
50 |
50 |
50 |
|
Proxies matched to above MD |
50 |
50 |
50 |
|
Maximum Subtotal |
800 |
|
|