Introduction
Methods
Identification of key FCS symptoms and concerns
Mapping FCS symptoms and concerns to PROMIS
Item reduction
Cognitive interviews
Results
Identification of key FCS symptoms and concerns
Concepts identified from existing data and literature | Initial item pool (96 items) | After item reduction (32 items) | ||
---|---|---|---|---|
# of Items | Source(s) | # of Items | Source(s) | |
Symptoms | ||||
Abdominal pain | 5 | PROMIS | 5 | PROMIS |
Diarrhea | 6 | PROMIS | 6 | PROMIS |
Difficulty thinking | 6 | PROMIS, Neuro-QoL | 6 | PROMIS, Neuro-QoL |
Physical fatigue | 12 | PROMIS | 12 | PROMIS |
Bloating | 11 | PROMIS | 11 | PROMIS |
Nausea | 1 | PROMIS | 1 | PROMIS |
Vomiting | 1 | PROMIS | 1 | PROMIS |
Pain (not abdominal) | 5 | PROMIS | 5 | PROMIS |
Xanthomas | 2 | PROMIS, Neuro-QoL | 2 | PROMIS, Neuro-QoL |
Difficulty remembering words, names | 9 | PROMIS | 9 | PROMIS |
Impacts | ||||
Daily functioning | ||||
Dietary restrictions | – | – | – | – |
Physical activity | 3 | PROMIS | 3 | PROMIS |
Sleep disturbance | 4 | PROMIS | 1 | PROMIS |
Social functioning | ||||
Social activities and planning | 4 | PROMIS | 2 | PROMIS |
Ability to work/volunteer | ||||
Productivity | 2 | PROMIS | 2 | PROMIS |
Negative career impact | 5 | FACIT | 0 | – |
Financial | ||||
Financial strain | 1 | FACIT | 1 | FACIT |
Mental/emotional well-being | ||||
Worry about pancreatitis attack | 5 | PROMIS | 1 | Neuro-QoL |
Judged because of diagnosis | 4 | PROMIS, Neuro-QoL | 1 | Neuro-QoL |
Future health worries | 2 | Neuro-QoL | 1 | Neuro-QoL |
Burden to others | 3 | PROMIS, Neuro-QoL | 1 | Neuro-QoL |
Depressed because of diagnosis | 5 | PROMIS, ASCQ-Me | 1 | PROMIS |
Mapping FCS symptoms and concerns to PROMIS
Item reduction
Cognitive interviews
Patient characteristics | |
---|---|
Mean age in years (range) | 46.25 (25–64) |
% (n) | |
---|---|
Gender | |
Female | 75.0% (6) |
Male | 25.0% (2) |
Race/ethnicity | |
White | 100.0% (8) |
Education | |
High school graduate/GED | 12.5% (1) |
Some college/technical degree/AA | 37.5% (3) |
College degree (BA/BS) | 37.5% (3) |
Advanced degree (MA, MS, MBA, PhD, MD, JD) | 12.5% (1) |
Marital status | |
Currently married | 75.0% (6) |
Single (never married) | 25.0% (2) |
Employment status | |
Employed full time | 50.0% (4) |
Homemaker | 12.5% (1) |
Retired | 12.5% (1) |
Unemployed | 12.5% (1) |
On disability | 12.5% (1) |
Health insurance | |
Private insurance | 87.5% (7) |
Medicaid | 12.5% (1) |
Activity level | |
Normal activity without symptoms | 25.0% (2) |
Some symptoms but do not require rest | 50.0% (4) |
Require bed rest for < 50% of waking day | 25.0% (2) |
Require bed rest for > 50% of waking day | 0.0% (0) |
Follows an FCS diet… | |
All the time | 12.5% (1) |
Most of the time | 62.5% (5) |
Sometimes | 25.0% (2) |
Rarely | 0.0% (0) |
Never | 0.0% (0) |
Ever experienced acute pancreatitis | |
Yes | 100.0% (8) |
Experienced recurrent pancreatitisa | |
Yes | 75.0% (6) |
Diabetes diagnosis | |
Yes | 75.0% (6) |
No | 25.0% (2) |
Mean (range) | |
---|---|
Age when FCS symptoms began (years) | 17.6 (0–42) |
Age at time of FCS diagnosis (years) | 37.1 (0–60) |
Number of acute pancreatitis attacks in past 5 years | 10.0 (0–50) |
Typical daily fat intake (grams) (n = 6)b | 15.0 (10–30) |
Age when diagnosed with diabetes (years) (n = 6)c | 29.8 (13–45) |
Instructions, response options, and length of questionnaire
Face validity
Content validity
Respondent understanding of the items
Item preferences: difficulty thinking
Item | Participant ID | Total | |||||||
---|---|---|---|---|---|---|---|---|---|
01 | 02 | 03 | 04 | 05a | 06 | 07 | 08 | ||
My thinking has been slow | X | X | X | X | 4 | ||||
I have been able to concentrate | X | X | X | 3 | |||||
I have trouble thinking clearly | X | X | 2 | ||||||
I have had trouble recalling the name of an object while talking to someone | X | X | 2 | ||||||
I have been able to remember to do things, like take medicine or buy something I need | X | 1 |
Item preferences: worry
Item | Participant ID | Total | |||||||
---|---|---|---|---|---|---|---|---|---|
01a | 02 | 03 | 04 | 05 | 06 | 07 | 08 | ||
I worry that my condition will get worse | X | X | X | X | X | X | X | 7 | |
I worried about my physical health | X | X | X | X | X | 5 |
Measure finalization
Draft item | Symptom/impact assessed | Reason for removal |
---|---|---|
I had trouble thinking clearly | Difficulty Thinking | Team and cognitive interview participants preferred “My thinking has been slow” and “I have been able to concentrate.” The latter item is on the PROMIS 29 + 2 |
I have had trouble recalling the name of an object while talking to someone | Difficulty remembering (words, names) | Team preferred “I have been able to remember to do things, like take medicine or buy something I need.” This item is on the PROMIS 29 + 2 |
I worried about my physical health | Worry about pancreatitis attack | Team and cognitive interview participants preferred “I worry that my condition will get worse” |
How much difficulty do you have doing your physical activities, because of your health? | Physical activity | Team preferred the following items to assess physical function and exercise: “To what extent are you able to carry out your everyday physical activities such as walking, climbing stairs, carrying groceries, or moving a chair?” and “Does your health now limit you in exercising regularly?” |
Final measure
Symptoms | Impacts |
---|---|
How often did you have belly pain? | Because of my illness, I worried about other people’s attitudes towards me |
At its worst, how would you rate your belly pain? | Because of my illness, I worried that I was a burden to others |
How much did belly pain interfere with your day-to-day activities? | I worry that my condition will get worse |
I feel fatigued | I felt depressed |
I have trouble starting things because I am tired | My sleep quality was… |
How many days did you have loose or watery stools? | I have trouble doing all of the activities with friends that I want to do |
How much did loose or watery stools interfere with your day-to-day activities? | I have trouble doing all of the family activities that I want to do |
My thinking has been slow | I have trouble doing all of my usual work (include work at home) |
I have been able to concentrate | I have trouble doing everything for work that I want to do (include work from home) |
I have been able to remember to do things, like take medicine or buy something I need | To what extent are you able to carry out your everyday physical activities such as walking, climbing stairs, carrying groceries, or moving a chair? |
I was unhappy about how my illness affected my appearance | Does your health now limit you in exercising regularly? |
How often did you feel bloated? | My illness has been a financial hardship to my family and me |
How often did you have nausea—that is, a feeling like you could vomit? | |
How often did you throw up or vomit? | |
How much did pain interfere with your day-to-day activities? | |
How would you rate your pain on average? |