Background
Methods
Inclusion/exclusion criteria for concept elicitation and cognitive interviews
Measures and methods
Data analysis
Results
Concept elicitation
Concept elicitation study sample
Characteristica
| CE (N = 35) | CI (N = 21) |
---|---|---|
Age (years) | ||
Mean, SD, (range) | 65.0, 7.5 (51–75) | 62.3, 8.3 (44–75) |
Gender n (%) | ||
Female | 17 (49) | 10 (48) |
Racial/Ethnic Background n (%) | ||
White | 28 (87) | 13 (62) |
Black or African American | 4 (11) | 4 (19) |
Hispanic or Latino | 4 (11) | 4 (19) |
Otherb
| 3 (9) | 4 (19) |
Employment Status n (%) | ||
Retired | 15 (43) | 9 (43) |
Disabled | 9 (26) | 8 (38) |
Full-time work | 6 (17) | 1 (5) |
Part-time work | 3 (9) | 2 (10) |
Otherc
| 2 (7) | 1 (5) |
Highest Level of Education Completed n (%) | ||
≤ Secondary/high school | 15 (43) | 7 (33) |
Associate degree | 2 (7) | 4 (19) |
Some college | 7 (20) | 6 (29) |
College degree | 9 (26) | 2 (10) |
Otherd
| 2 (7) | 2 (10) |
Current or Former Smoker n (%) | ||
Current smoker | 15 (43) | 3 (14) |
Former smoker | 20 (57) | 18 (86) |
Physician-reported GOLD Stage, n (%) | ||
GOLD I | 5 (14) | 2 (10) |
GOLD II | 11 (31) | 8 (38) |
GOLD III | 11 (31) | 7 (33) |
GOLD IV | 8 (23) | 4 (19) |
Physician-rated mMRC, n (%) | ||
0 | 0 (0.0) | 0 (0.0) |
1 | 12 (34.3) | 7 (33.3) |
2 | 18 (51.4) | 5 (23.8) |
3 | 5 (14.3) | 7 (33.3) |
4 | 0 (0.0) | 2 (9.5) |
Patient-reported CAT total score | ||
Mean, SD (range)e
| 22.0, 6.2 (11–32) | 20.1, 8.6 (5–36) |
Patient-reported SGRQ-C, mean, SD (range)f
| ||
Total score | 57.2, 19.9 (4–100) | -- |
Symptom | 71.8, 17.3 (25–100) | -- |
Activity | 66.9, 24.3 (0–100) | -- |
Impact | 46.6, 22.5 (0–99) | -- |
Concept elicitation findings
Core Symptom Concepts | Additional Symptom Conceptsa
| ||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
SOB | Cough | Phlegm | Chest Painb
| Wheeze | Trouble Sleeping | Headache | Fatiguec
| Back Pain | Dizzinessd
| Congestione
| Weak Legsf
| Nasal Drainage | Heart Palpitations | Foot/Ankle Swelling | Dry Mouth | Tight Throat | Numb Face, Lips | Inability to Think, Reason | |
Group 1 (n = 9) | |||||||||||||||||||
102-002 | S | P | S | S | P | ||||||||||||||
102-015 | S | S | S | S | S | ||||||||||||||
102-018 | S | S | S | S | P | S | S | ||||||||||||
102-028 | S | S | S | S | S | S | S | S | S | ||||||||||
102-033 | S | S | S | S | S | P | S | ||||||||||||
102-035 | S | S | S | S | S | P | |||||||||||||
104-001 | S | S | S | P | S | ||||||||||||||
104-004 | S | S | S | P | P | S | S | S | S | S | S | ||||||||
104-006 | S | S | S | P | |||||||||||||||
Group 2 (n = 9) | |||||||||||||||||||
103-003 | S | S | S | S | S | ||||||||||||||
103-011 | S | S | S | S | P | P | S | ||||||||||||
104-008 | S | S | S | S | S | S | P | S | S | ||||||||||
104-011 | S | S | S | P | S | S | |||||||||||||
105-001 | S | S | S | S | S | P | S | ||||||||||||
105-002 | S | S | P | S | |||||||||||||||
105-003 | S | S | S | S | S | ||||||||||||||
105-005 | S | S | S | P | P | ||||||||||||||
105-006 | S | S | S | S | P | P | |||||||||||||
Group 3 (n = 9) | |||||||||||||||||||
103-009 | S | S | S | P | P | S | S | S | S | S | |||||||||
103-012 | S | S | S | P | S | P | |||||||||||||
106-004 | S | P | P | S | P | P | |||||||||||||
106-006 | S | P | |||||||||||||||||
106-007 | S | S | P | P | P | P | S | ||||||||||||
106-010 | S | S | S | S | |||||||||||||||
106-015 | S | S | S | S | |||||||||||||||
106-016 | S | ||||||||||||||||||
106-017 | S | S | S | P | S | S | |||||||||||||
Group 4 (n = 8) | |||||||||||||||||||
102-036 | S | P | P | ||||||||||||||||
102-040 | S | S | S | P | |||||||||||||||
102-039 | S | S | S | S | P | S | P | S | |||||||||||
102-037 | S | S | P | S | S | S | |||||||||||||
108-002 | S | S | S | P | |||||||||||||||
108-003 | S | P | P | S | S | ||||||||||||||
108-006 | S | S | P | S | P | P | S | S | |||||||||||
108-007 | S | P | P | S | |||||||||||||||
Spontaneous | 35 | 27 | 24 | 16 | 10 | 7 | 4 | 8 | 4 | 3 | 5 | 3 | 2 | 1 | 1 | 1 | 1 | 1 | 1 |
Probed | 0 | 3 | 7 | 6 | 14 | 9 | 8 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
TOTAL (S + P) | 35 | 30 | 31 | 22 | 24 | 16 | 12 | 8 | 4 | 3 | 5 | 3 | 2 | 1 | 1 | 1 | 1 | 1 | 1 |
SOB | Phlegm | Cough | Wheeze | Chest Tightness/Discomfort | Nighttime Awakening/Sleep Disturbance | Headache | Exhaustion/Tiredness | |
---|---|---|---|---|---|---|---|---|
Group 1 (n = 9) | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
Group 2 (n = 9) | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
Group 3 (n = 9) | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
Group 4 (n = 8) | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
Spontaneous (S) | 35 | 24 | 27 | 10 | 16 | 7 | 4 | 8 |
Probed (P) | 0 | 7 | 3 | 14 | 6 | 9 | 8 | 0 |
Total (S + P) | 35 | 31 | 30 | 24 | 22 | 16 | 12 | 8 |
Routine Indoor Physical Activitya
| Routine Outdoor Physical Activityb
| Getting Oneself Readyc
| General Houseworkd
| Miscellaneous Strenuous Activitye
| |
---|---|---|---|---|---|
Group 1 (n = 9) | ✓ | ✓ | ✓ | ✓ | ✓ |
Group 2 (n = 9) | ✓ | ✓ | ✓ | ✓ | ✓ |
Group 3 (n = 9) | ✓ | ✓ | ✓ | ✓ | ✓ |
Group 4 (n = 8) | ✓ | ✓ | ✓ | ✓ | |
Spontaneous | 33 | 18 | 11 | 12 | 20 |
Probed | 2 | 7 | 13 | 11 | 0 |
Total (S + P) | 35 | 25 | 24 | 23 | 20 |
Item generation
Notes/Group Decisions |
---|
• It is difficult for subjects to link nighttime awakenings to symptoms, thus do not ask subjects to report number of awakenings related to symptoms; one advisor suggested adding a proxy item to capture nighttime awakenings (“How rested did you feel this morning?”) – this item would be in addition to a question regarding how tired or fatigued the subject felt |
• All symptom concepts, including those with relatively low subject endorsement (e.g., headaches, exhaustion/tiredness), should be included; advisors agreed to err on side of inclusivity in the early stages of instrument development. It was noted items that perform poorly would drop out in the future based on psychometric assessments |
• Wheeze was debated at length among advisors with some noting it was a difficult symptom to measure, however advisors agreed to include wheeze for now with potential for deleting later |
• Although unclear if “chest congestion” was viewed by subjects as a distinct symptom from phlegm or other chest symptoms (i.e., tightness, discomfort), include as separate item for now |
• For those miscellaneous symptoms that were mentioned infrequently (n < 5) and were not clearly related to COPD (e.g., back pain), advisors agreed to exclude from COPD-MSD |
• Shortness of breath (but not other symptoms) should be measured in the context of performing activities, however need to select activities that are relatively universal; advisors recommended reviewing literature and exploring this with subjects in cognitive interviews |
• Advisors concluded a Likert scale would be best suited for the COPD-MSD items |
• Key questions or themes to explore during cognitive interview phase: |
o Explore subject language used around the “tiredness/exhaustion” concept as well as how subjects describe and define “chest congestion” (i.e., is chest congestion different from chest tightness and chest discomfort?) |
o Explore what morning activities are universal or common to all subjects |
• For recall period, ask about morning timeframe in general, do not limit or narrow to a specific hour within the morning period |
Cognitive interview
COPD Item | Response Rangea
| |
---|---|---|
Items asking about “this morning” | ||
AM 1 | SOB upon getting out of bed | No SOB → Unable to because of SOB |
AM 2 | SOB while washing self | No SOB → Unable to because of SOB |
AM 3 | SOB while using arms to do things | No SOB → Unable to because of SOB |
AM 4 | SOB while getting dressed | No SOB → Unable to because of SOB |
AM 5 | SOB while bending over | No SOB → Unable to because of SOB |
AM 6 | SOB upon moving around the home | No SOB → Unable to because of SOB |
AM 7 | Coughing attacks | 0 → More than 5 |
AM 8 | Frequency of cough | Not at all → Almost constantly |
AM 9 | Severity of cough | Did not cough → Very severe |
AM 10 | Amount of phlegm | None → Very large amount |
AM 11 | Difficulty bringing up phlegm | Did not have phlegm → Very difficult |
AM 12 | Severity of chest tightness | No chest tightness → Very severe |
AM 13 | Severity of chest discomfort | No chest discomfort → Very severe |
AM 14 | Severity of chest congestion | No chest congestion → Very severe |
AM 15 | Severity/amount of wheezing | Not at all → Very much |
AM 16 | Feeling tired | Not at all → Extremely |
AM 17 | Feeling rested | Not at all → Extremely |
Items asking about “last night, after going to bed” | ||
PM 1 | Severity/amount of wheezing | Not at all → Very much |
PM 2 | Sleep disturbance | Not at all → Very much |