| Literature DB >> 34766096 |
Dustin J Randall1,2, Yue Zhang3, Andrew P Harris4, Yuqing Qiu5, Haojia Li3, Andrew R Stephens1, Nikolas H Kazmers1.
Abstract
BACKGROUND: Minimal clinically important difference (MCID) estimates are useful for gauging clinical relevance when interpreting changes or differences in patient-reported outcomes scores. These values are lacking in the setting of elbow trauma. Our primary purpose was to estimate the MCID of the Patient-Reported Outcomes Measurement Information System (PROMIS) physical function (PF) computer adaptive test (CAT), the PROMIS upper extremity (UE) CAT, and the QuickDASH using an anchor-based approach for patients recovering from elbow trauma and related surgeries. Secondarily, we aimed to estimate the MCID using the 1/2 standard deviation method. MATERIALS &Entities:
Keywords: Elbow; Minimal clinically important difference (MCID); Orthopaedic/orthopedic trauma; PROMIS physical function (PF) computer adaptive test (CAT); PROMIS upper extremity (UE) computer adaptive test; QuickDash
Year: 2021 PMID: 34766096 PMCID: PMC8568814 DOI: 10.1016/j.jseint.2021.06.005
Source DB: PubMed Journal: JSES Int ISSN: 2666-6383
Figure 1Attrition of patients included in analysis based on study selection criteria.
Baseline patient characteristics.
| Variable | Stats/Subgroups | All included patients (N = 146) | PROMIS PF CAT v1.2/2.0 (N = 131) | PROMIS UE CAT v1.2 (N = 87) | QuickDASH (N = 110) |
|---|---|---|---|---|---|
| Age | Mean (SD) | 45.5 (18) | 44.5 (18) | 45.7 (17.7) | 46.4 (17.5) |
| Median (IQR) | 47 (30.2, 60) | 46 (29.2, 58) | 46 (30.5, 58) | 48 (31.5, 59) | |
| Range | (11, 86) | (11, 86) | (11, 86) | (11, 86) | |
| Sex | F | 67 (46%) | 58 (44%) | 41 (47%) | 52 (47%) |
| M | 79 (54%) | 73 (56%) | 46 (53%) | 58 (53%) | |
| BMI | Mean (SD) | 28.6 (7.4) | 28.8 (7.4) | 29.5 (8.2) | 29.2 (7.8) |
| Median (IQR) | 27.1 (23.4, 32) | 27.1 (23.6, 32.4) | 28.1 (23.3, 33.3) | 27.6 (23.5, 33.2) | |
| Range | (17.4, 56) | (17.9, 56) | (18.3, 56) | (17.4, 56) | |
| Race | White or Caucasian | 103 (87%) | 96 (87%) | 57 (85%) | 71 (86%) |
| Asian | 3 (3%) | 3 (3%) | 1 (1%) | 1 (1%) | |
| Choose not to disclose | 1 (1%) | 1 (1%) | 1 (1%) | 0 (0%) | |
| Native Hawaiian and Other Pacific Islander | 3 (3%) | 2 (2%) | 2 (3%) | 3 (4%) | |
| Other | 8 (7%) | 8 (7%) | 6 (9%) | 8 (10%) | |
| Insurance | Commercial | 66 (56%) | 63 (57%) | 39 (58%) | 49 (59%) |
| Government Other | 11 (9%) | 11 (10%) | 6 (9%) | 7 (8%) | |
| Medicaid | 8 (7%) | 8 (7%) | 5 (7%) | 5 (6%) | |
| Medicare | 18 (15%) | 15 (14%) | 9 (13%) | 11 (13%) | |
| Self-pay | 7 (6%) | 6 (5%) | 4 (6%) | 5 (6%) | |
| Worker’s compensation | 8 (7%) | 7 (6%) | 4 (6%) | 6 (7%) | |
| Smoking | Yes | 17 (12%) | 17 (13%) | 8 (9%) | 10 (9%) |
| Quit | 22 (15%) | 18 (14%) | 13 (15%) | 16 (15%) | |
| No | 95 (66%) | 86 (67%) | 59 (68%) | 73 (67%) | |
| Unknown | 10 (7%) | 8 (6%) | 7 (8%) | 10 (9%) | |
| Alcohol use | Yes | 58 (40%) | 54 (42%) | 36 (41%) | 43 (39%) |
| No | 72 (50%) | 64 (50%) | 42 (48%) | 53 (49%) | |
| Unknown | 14 (10%) | 11 (9%) | 9 (10%) | 13 (12%) | |
| ASA class | 0 | 17 (12%) | 14 (11%) | 12 (14%) | 16 (15%) |
| 1 | 52 (36%) | 48 (37%) | 30 (34%) | 39 (35%) | |
| 2 | 50 (34%) | 45 (34%) | 29 (33%) | 36 (33%) | |
| 3 | 26 (18%) | 23 (18%) | 15 (17%) | 18 (16%) | |
| 4 | 1 (1%) | 1 (1%) | 1 (1%) | 1 (1%) | |
| Hand dominance | Left | 7 (5%) | 6 (5%) | 5 (6%) | 7 (6%) |
| Right | 65 (45%) | 62 (47%) | 44 (51%) | 50 (45%) | |
| Unknown | 74 (51%) | 63 (48%) | 38 (44%) | 53 (48%) | |
| Injury to dominant hand | Yes | 26 (18%) | 24 (18%) | 17 (20%) | 22 (20%) |
| No | 35 (24%) | 34 (26%) | 26 (30%) | 25 (23%) | |
| Left | 15 (10%) | 12 (9%) | 8 (9%) | 13 (12%) | |
| Right | 17 (12%) | 13 (10%) | 12 (14%) | 16 (15%) | |
| Unknown | 53 (36%) | 48 (37%) | 24 (28%) | 34 (31%) |
BMI, body mass index; IQR, interquartile range; SD, standard deviation.
Summary of surgeries performed.
| Surgery/Injury type | Count (% of all included patients) | |
|---|---|---|
| Distal biceps repair | 24 | 16.4 |
| Nonoperative | 17 | 11.6 |
| Olecranon ORIF | 15 | 10.3 |
| Distal humerus ORIF | 11 | 7.5 |
| Radial head ORIF | 6 | 4.1 |
| Total elbow arthroplasty | 6 | 4.1 |
| Radial head excision | 5 | 3.4 |
| Terrible triad ORIF | 5 | 3.4 |
| Elbow manipulation under anesthesia | 3 | 2.1 |
| Olecranon ORIF with open fracture debridement | 3 | 2.1 |
| Radial head arthroplasty | 3 | 2.1 |
| Contracture release with hardware removal | 2 | 1.4 |
| Ligament reconstruction | 2 | 1.4 |
| Monteggia ORIF | 2 | 1.4 |
| Radial head arthroplasty with ligamentous repair | 2 | 1.4 |
| Removal of loose body | 2 | 1.4 |
| Total elbow arthroplasty with cubital tunnel decompression | 2 | 1.4 |
| Brachial artery and median/ulnar nerve repair with distal biceps repair | 1 | 0.7 |
| Capitellum ORIF | 1 | 0.7 |
| Chronic dislocation ORIF with capsulectomy and cubital tunnel release | 1 | 0.7 |
| Closed reduction of elbow dislocation | 1 | 0.7 |
| Contracture release with cubital tunnel release and radial head excision | 1 | 0.7 |
| Contracture release with exostectomy | 1 | 0.7 |
| Cotracture release with ligament reconstruction | 1 | 0.7 |
| Contracture release with loose body removal | 1 | 0.7 |
| Contracture release with radial head excision | 1 | 0.7 |
| Contracture release with synovectomy | 1 | 0.7 |
| Contracture release with ulnar nerve decompression and synovectomy | 1 | 0.7 |
| Coronoid ORIF with external fixator removal and ligamentous repair | 1 | 0.7 |
| Coronoid ORIF with ligamentous repair | 1 | 0.7 |
| Distal humerus ORIF with ligament repair | 1 | 0.7 |
| Distal humerus ORIF with open fracture debridement | 1 | 0.7 |
| Distal triceps tendon repair | 1 | 0.7 |
| Elbow arthrodesis | 1 | 0.7 |
| Hardware removal | 1 | 0.7 |
| Heterotopic ossification excision with ligamentous repair and radial nerve neurolysis | 1 | 0.7 |
| Heterotopic ossification excision with revision cubital tunnel release | 1 | 0.7 |
| Ligament reconstruction with coronoid ORIF | 1 | 0.7 |
| Ligament repair | 1 | 0.7 |
| Olecranon and radial head ORIF with ligamentous repair | 1 | 0.7 |
| Olecranon ORIF revision with hardware removal | 1 | 0.7 |
| Radial head arthroplasty with ligament repair | 1 | 0.7 |
| Radial head arthroplasty, ulnar shortening osteotomy, interosseous membrane reconstruction | 1 | 0.7 |
| Radial head excision with hardware removal | 1 | 0.7 |
| Radial head excision with ulna nonunion repair and removal of hardware | 1 | 0.7 |
| Radial head excision with ulnar shortening osteotomy | 1 | 0.7 |
| Radial head nonunion repair with ligamentous repair | 1 | 0.7 |
| Radial head ORIF with ligament repair | 1 | 0.7 |
| Removal of loose body with ligament repair | 1 | 0.7 |
| Ulna malunion correction with open reduction of the radiocapitellar joint | 1 | 0.7 |
| Uln malunion repair with radial head excision | 1 | 0.7 |
| Ulnar nerve decompression | 1 | 0.7 |
| Ulnar nerve decompression with elbow manipulation | 1 | 0.7 |
ORIF, open reduction internal fixation.
N = 129 for surgical patients. N = 17 for nonoperative patients.
Nonoperative patients had injuries including radial head fracture (N = 17), elbow dislocation closed reduction (N = 2), coronoid fracture (N = 1), non-displaced distal humerus extra-articular fracture (N = 1), and closed reduction of a recurrent elbow dislocation (N = 1).
Summary of scores.
| Statistic | Baseline score | Follow-up score | ||
|---|---|---|---|---|
| All included patients | ||||
| PROMIS PF CAT v1.2/2.0 (N = 131) | Mean (SD) | 38.4 (9.8) | 42.5 (9.4) | <.001 |
| Median (IQR) | 36.6 (15.3) | 42.9 (13.7) | - | |
| Range | (19.3, 67.3) | (22.2, 66.8) | - | |
| PROMIS UE CAT v1.2 (N = 87) | Mean (SD) | 28.3 (8.5) | 32.1 (9.2) | <.001 |
| Median (IQR) | 28.2 (11.4) | 32.3 (13.1) | - | |
| Range | (14.7, 56.4) | (14.7, 56.4) | - | |
| QuickDASH (N = 110) | Mean (SD) | 54.0 (22.8) | 41.1 (24.2) | <.001 |
| Median (IQR) | 56.8 (31.3) | 40.9 (41.8) | - | |
| Range | (0, 95.5) | (0, 95.5) | - | |
| Patients included in anchor-based calculations | ||||
| PROMIS PF CAT v1.2/2.0 (N = 61) | Mean (SD) | 37.7 (10.4) | 40.8 (9.7) | <.001 |
| Median (IQR) | 35.1 (15.1) | 41.0 (14.8) | - | |
| Range | (23.2, 67.3) | (23.5, 61.1) | - | |
| PROMIS UE CAT v1.2 (N = 42) | Mean (SD) | 27.9 (9.1) | 29.9 (8.1) | .13 |
| Median (IQR) | 27.1 (14.0) | 29.3 (10.9) | - | |
| Range | (14.7, 47.6) | (14.7, 49.0) | - | |
| QuickDASH (N = 56) | Mean (SD) | 55.0 (22.9) | 44.8 (22.3) | <.001 |
| Median (IQR) | 59.1 (31.8) | 43.2 (36.4) | - | |
| Range | (0, 95.5) | (0, 81.8) | - |
CAT, computer adaptive test; IQR, interquartile range; PF, physical function; PROMIS, Patient-Reported Outcomes Measurement Information System; SD, standard deviation; UE, upper extremity.
Statistical significance was based on the Wilcoxon rank-sum test.
Statistical significance was based on the Student’s t-test.
Summary of score change by anchor group.
| Instrument | Score change by anchor question group mean ± SD (N) | ||
|---|---|---|---|
| No change | Slightly improved /Improved | ||
| PROMIS PF CAT v1.2/2.0 | −1.9 ± 6.7 (10) | 3.9 ± 8.4 (52) | .014 |
| PROMIS UE CAT v1.2 | −1.5 ± 6.74 (10) | 3.1 ± 9.1 (33) | .061 |
| QuickDASH | −6.6 ± 9.4 (12) | −11.9 ± 22.5 (45) | .225 |
CAT, computer adaptive test; PF, physical function; PROMIS, Patient-Reported Outcomes Measurement Information System; UE, upper extremity.
Data represent mean ± SD (N).
Statistical significance was based upon the Wilcoxon Rank-Sum test.
Statistical significance was based upon the student’s t-test.
MCID estimates.
| 1/2 SD method | Anchor-based | |
|---|---|---|
| PROMIS PF CAT v1.2/2.0 | 4.3 (N = 136) | 5.7 (N = 62) |
| PROMIS UE CAT v1.2 | 4.8 (N = 91) | 4.6 (N = 43) |
| QuickDASH | 11.7 (N = 114) | 5.3 (N = 57) |
CAT, computer adaptive test; PF, physical function; PROMIS, Patient-Reported Outcomes Measurement Information System; UE, upper extremity.