1. New FOTO Measure Development
Stroke and Lymphedema

2. Steps to a New FOTO Measure
Develop the item pool
Expert panel
programming  PI Web
CAT
Calibration >>
Item Bank
Data Collection

3. Functional Status
The patient’s perception of his or her ability to perform the functional tasks as described in the measure and which represent the Activities and Participation dimension of the World Health Organization’s International Classification of Functioning, Disability and Health.

4. The ICF and Functional Status
Pain, Sleep, Joint Mobility/ROM, muscle power/strength
Functional Status

5. ICF d4 Mobility d410-d429 Changing and maintaining body position
d430-d449 Carrying, moving and handling objects
d450-d469 Walking and moving
d5 Self-Care
d510-d560 washing oneself, caring for body parts, toileting, dressing, eating, drinking

6. “Patient Reported Outcomes (PROs) provide the most direct method for gauging individuals’ symptoms, functional status, participation, health status, and quality of life. PROs play a particularly important role in the approval process for chronic conditions where the goal of treatment is not curative but rather to alleviate symptoms, and improve functional ability and quality of life.”
International Society for Quality of Life Research

7. What Does a CAT Need?

8. Low
High

9. Goal: Provide estimate of FS that is precise and efficient
What Does a CAT Need?
Items represent a single construct (FS)
Items mean the same thing to different people
Range from low to high function

10. Existing Guidelines (PROMIS)
Why
Clinician Experts
Stroke
Discovery Phase
Previous Work
Scientific Advisor
Existing Measures
Existing Guidelines (PROMIS)

11. Stroke Identified Needs High level questions for low level patients
UE vs. LE
High level questions for low level patients
Stroke
Identified Needs
Low function items
Assistance, Mobility Aids
Question Phrasing & Reading Level
Hand Dominance, Chronicity

12. Stroke Module Classification

13. Examples of Low Function Questions
Wash your face
Use a knife and fork to cut food
Turning over in bed
Moving about one floor of your home using a wheelchair
Comb or brush your hair
Getting in and out of a car with help from a person or assistive device

14. Examples - Reading Level
If you do not do or have not done this activity, please make your best guess as to which response is most accurate. (8.4) 
If you have not done this activity, choose the answer that you think fits the best. (5.4)
Using the hand that was affected by your stroke, do you have any difficulty washing your face? (8.3)
Using the hand that was affected by your stroke, are you able to wash your face? (5.4)
Are you able to position your affected hand so the fingernails can be trimmed? (7.5)
Are you able to open your affected hand so the fingernails can be trimmed? (6.7)

15. Skip Patterns Skip Pattern A Skip Pattern B No Skip Pattern
Patient unable to stand (with or without support)
Patient able to stand but unable to walk 25 feet, with or without support.
Patient is able to walk at least 25 feet, with or without support.
PROMIS ®

16. Skip Patterns

17. Lymphedema Discovery Phase
Why
Clinician Experts
Lymphedema Discovery Phase
Previous Work
Scientific Advisor
Existing Measures
ICF

18. Lymphedema Identified Needs
Body Region Specific
Self Care
Lymphedema Identified Needs
Condition-specific content
Common Understanding of CAT
Question phrasing and reading level

19. Lymphedema Body Regions Lower Body Regions Upper Body Regions Head/
Leg
Lower Body Regions
Trunk
Lymphedema
Body Regions
Genital
Arm/hand
Upper Body Regions
Head/
Neck
Breast/
Chest

20. Examples of Condition-Specific and Self-Care Items
Getting dressed (including compression garment, if that applies to you)
Cleaning yourself after toileting?
Squatting and Bending/Stooping (separate questions)
Buttons (fine motor and self-care)
Walking and putting on shoes/socks (separate)
Reach across front of body

21. Lymphedema Current StatusLE LE LE
Lower Body LE LE LE LE LE LE UE
Lymphedema Current Status UE UE UE
Upper Body UE UE UE UE UE UE
Head & Neck

22. Current Status Lymphedema Stroke Step1 Step2 Step3 Step4 Step5 Step6
Develop the item pool
Stroke
Lymphedema
Expert panel
programming  PI Web
Pilot testing
CAT
Calibration>>>
Item Bank
Data Collection

23. Next Step: Data Collection
Develop the item pool
Expert panel
programming  PI Web
CAT version for live FOTO use
Data analysis >> Calibrated Item Bank
Data Collection

24. Next, Next Steps
Vestibular
Pelvic Floor

25. Gratuitous Slide
Functional Change is Greater for Patients With Greater Impairment
Functional Change is Less for Patients
With Lower Initial Severity
(based on 87,717 Medicare B patients with Lumbar, Knee, Shoulder and Neck conditions during 2014)

26. Coordinator of Internal Research, Design and Development
Thank you!
Deanna Hayes, PT, DPT, MS
Coordinator of Internal Research, Design and Development