Table 4.
Known groups validity at baseline: Associations between PRO measures and validity indicators
| PRO measure | Validity indicator |
P value | |
|---|---|---|---|
| Surgical procedure | |||
| Lumpectomy | Mastectomy | ||
| Satisfaction With Breast Cosmetic Outcomes | 3.7 (0.9) (n = 224) |
3.1 (1.0) (n = 523) |
<.001 |
| Zubrod Performance Status |
|||
| Normal activity | Symptomatic and ambulatory | ||
| FACT-B trial outcome index | 66.9 (14.0) (n = 508) |
63.5 (15.3) (n = 252) |
.002 |
| PROMIS fatigue | 49.7 (9.8) (n = 503) |
51.6 (10.2) (n = 249) |
.018 |
| PROMIS anxiety | 51.9 (9.4) (n = 511) |
52.5 (8.7) (n = 249) |
.400 |
| PROMIS ability to participate in social roles and activities | 50.8 (8.5) (n = 510) |
48.1 (9.5) (n = 246) |
<.001 |
| PRO-CTCAE | |||
| What was the severity of your shortness of breath at its worst? | |||
| None | 313 (62%) | 173 (69%) | |
| Mild | 141 (28%) | 46 (18%) | .002 |
| Moderate | 44 (9%) | 20 (8%) | |
| Severe, very severe | 5 (1%) | 10 (4%) | |
| How much does your shortness of breath interfere with your usual or daily activities? | |||
| Not at all | 371 (77%) | 180 (73%) | |
| A little bit | 76 (16%) | 39 (16%) | .026 |
| Somewhat | 26 (5%) | 12 (5%) | |
| Quite a bit, very much | 9 (2%) | 15 (6%) | |
| How often did you feel chest pain, chest tightness, or angina? | |||
| Never | 373 (74%) | 175 (71%) | |
| Rarely | 70 (14%) | 30 (12%) | .264 |
| Occasionally | 43 (9%) | 30 (12%) | |
| Frequently, almost constantly | 18 (4%) | 13 (5%) | |
| What was the severity of your chest pain, chest tightness, or angina at its worst? | |||
| None | 353 (74%) | 175 (71%) | |
| Mild | 86 (18%) | 43 (18%) | .539 |
| Moderate | 33 (7%) | 19 (8%) | |
| Severe, very severe | 8 (2%) | 8 (3%) | |
| How much does your chest pain, chest tightness, or angina interfere with your usual daily activities? | |||
| Not at all | 405 (84%) | 202 (83%) | |
| A little bit | 45 (9%) | 25 (10%) | .638 |
| Somewhat | 19 (4%) | 7 (3%) | |
| Quite a bit, very much | 13 (3%) | 10 (4%) | |
Entries in table denote mean (SD) or n (%). For Satisfaction With Breast Cosmetic Outcomes, higher scores (range, 1–5) represent more satisfaction. For FACT-B, higher scores represent better health-related quality of life. For PROMIS, higher scores represent more of the outcome, eg, more fatigue, more anxiety, better ability.
Abbreviations: FACT-B = Functional Assessment of Cancer Therapy-Breast; PRO = patient-reported outcome; PRO-CTCAE = Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events; PROMIS = Patient-Reported Outcomes Measurement Information System.