| Literature DB >> 35819794 |
Lasse K Harris1, Anders Troelsen2, Berend Terluin3, Kirill Gromov2, Andrew Price4, Lina H Ingelsrud2.
Abstract
BACKGROUND ANDEntities:
Mesh:
Year: 2022 PMID: 35819794 PMCID: PMC9275498 DOI: 10.2340/17453674.2022.3909
Source DB: PubMed Journal: Acta Orthop ISSN: 1745-3674 Impact factor: 3.925
Anchor items used to determine minimal important change, patient acceptable symptom state, and treatment failure criteria
| Anchor questions Anchor response and classification of response options |
|---|
Figure 1Flowchart of patients enrolled. OKS, Oxford Knee Score.
Patient demographics and preoperative characteristics. Values are count (%) unless otherwise specified
| Factor | 3 months n = 331 | 12 months n = 340 | 24 months n = 235 |
|---|---|---|---|
| Age | 69 (61–74) | 68 (61–74) | 68 (60–74) |
| Female sex | 194 (59) | 196 (58) | 138 (59) |
| BMI | 29 (26–34) | 29 (25–33) | 28 (25–32) |
| ASA | |||
| 1 | 20 (6) | 26 (8) | 23 (10) |
| 2 | 257 (78) | 255 (75) | 176 (75) |
| 3 | 53 (16) | 58 (17) | 36 (15) |
| 4 | 1 (0) | 1 (0) | – |
| KL grade | |||
| 2 | 3 (1) | 10 (3) | 13 (5) |
| 3 | 79 (24) | 92 (27) | 68 (29) |
| 4 | 249 (75) | 238 (70) | 154 (66) |
| OKS | 23 (17–28) | 24 (19–28) | 24 (19–29) |
| EQ5D index | 0.66 (0.59–0.72) | 0.72 (0.62–0.72) | 0.72 (0.63–0.72) |
| EQ5D VAS | 70 (50–80) | 70 (50–80) | 70 (51–80) |
Values are median (0.025–0.975 quantile range).
Missing data, n = 1.
KL grade: Kellgren & Lawrence classification. OKS: Oxford Knee Score. EQ5D: EuroQol 5-Dimension. VAS: visual analog scale.
Patient demographics and preoperative characteristics. Values are count (%) unless otherwise specified
| Factor | Non-responders 3 months n = 92 | Responders 3 months n = 331 | p-value | Non-responders 12 months n = 139 | Responders 12 months n = 340 | p-value | Non-responders 24 months n = 103 | Responders 24 months n = 235 | p-value |
|---|---|---|---|---|---|---|---|---|---|
| Age | 67 (59–74) | 69 (61–74) | 0.3 | 67 (58–74) | 68 (61–74) | 0.2 | 68 (60–74) | 68 (60–74) | 0.9 |
| Female sex | 41 (45) | 194 (59) | 0.01 | 72 (52) | 196 (58) | 0.3 | 53 (52) | 138 (59) | 0.3 |
| BMI | 30 (26–34) | 29 (26–34) | 0.1 | 30 (26–35) | 29 (25–33) | 0.01 | 29 (26–34) | 28 (25–32) | 0.2 |
| ASA | |||||||||
| 1 | 3 (3) | 20 (6) | 0.03 | 12 (9) | 26 (8) | 0.4 | 7 (7) | 23 (10) | 0.1 |
| 2 | 62 (68) | 257 (78) | 95 (68) | 255 (75) | 71 (69) | 176 (75) | |||
| 3 | 27 (29) | 53 (16) | 32 (23) | 58 (17) | 25 (24) | 36 (15) | |||
| 4 | – | 1 (0) | – | 1 (0) | – | – | |||
| KL grade | |||||||||
| 2 | 2 (2) | 3 (1) | 0.03 | 10 (7) | 10 (3) | 0.4 | 7 (7) | 13 (5) | 0.4 |
| 3 | 24 (26) | 79 (24) | 40 (29) | 92 (27) | 23 (22) | 68 (29) | |||
| 4 | 66 (72) | 249 (75) | 89 (64) | 238 (70) | 73 (71) | 154 (66) | |||
| OKS | 21 (16–28) | 23 (17–28) | 0.3 | 19 (15–24) | 24 (19–28) | 0.01 | 20 (16–26) | 24 (19–29) | 0.01 |
| EQ5D index | 0.69 (0.57–0.77) | 0.66 (0.59–0.72) | 0.5 | 0.66 (0.50–0.72) | 0.72 (0.62–0.72) | 0.1 | 0.66 (0.34–0.72) | 0.72 (0.63–0.72) | 0.09 |
| EQ5D VAS | 70 (50–80) | 70 (50–80) | 1 | 60 (39–80) | 70 (50–80) | 0.05 | 50 (41–79) | 70 (51–80) | 0.01 |
Abbreviations: see Table 1.
P–values calculated with Wilcoxon signed rank test for continuous variables and chi–square test for dichotomous variables.
Numbers are median (0.025–0.975 quantile range).
Missing data, b n = 58, c n = 59, d n = 79, e n = 78, f n = 1, g n = 58, h n = 57.
Proportion of patient responses to minimal important change anchor question at 3, 12, and 24 months after surgery. Values are count (%)
| Factor | 3 months n = 331 | 12 months n = 340 | 24 months n = 235 |
|---|---|---|---|
| Importantly improved | |||
| Better, an important improvement | 224 (68) | 257 (76) | 183 (78) |
| Somewhat better, but enough to be an important improvement | 64 (19) | 44 (13) | 25 (11) |
| Unchanged | |||
| Very small change, not enough to be an important improvement | 21 (6) | 14 (4) | 8 (3) |
| About the same | 7 (2) | 7 (2) | 4 (2) |
| Very small change, not enough to be an important deterioration | 2 (1) | 2 (1) | 2 (1) |
| Importantly deteriorated | |||
| Somewhat worse, but enough to be an important deterioration | 9 (3) | 9 (2) | 12 (5) |
| Worse, an important deterioration | 4 (1) | 7 (2) | 1 (0) |
Figure 2Oxford Knee Change scores at 3, 12, and 24 months postoperatively by minimal important change anchor question response categories ranging from “better, an important improvement” to “worse, an important deterioration.” Horizontal bars present the median, the box the interquartile range (IQR), the whiskers the maximum and minimum scores within 1.5 * IQR from the box, and • represents outliers.
Proportions of patients achieving a satisfactory symptom level, considering treatment failure, or neither at 3, 12, and 24 months after surgery. Values are count (%)
| Factor | 3 months n = 331 | 12 months n = 340 | 24 months n = 235 |
|---|---|---|---|
| Satisfactory symptom level | 271 (82) | 282 (83) | 199 (85) |
| Neither satisfactory symptoms nor treatment failure | 47 (4) | 32 (9) | 14 (6) |
| Treatment failure | 13 (4) | 26 (8) | 22 (9) |
Figure 3Oxford Knee Score distribution at 3, 12, and 24 months postoperatively for patients with satisfactory symptoms, considering the treatment to have failed, or neither. See Figure 2 for boxplot interpretation.
Polyserial correlation coefficient for minimal important change (MIC) and point-biserial correlation coefficient for patient acceptable symptom state (PASS) and treatment failure (TF) anchor questions and OKS
| OKS follow-up | Anchor question and OKS correlation coefficient | ||||||
|---|---|---|---|---|---|---|---|
| MIC | PASS | TF | |||||
| Preop | Change | Postop | Preop | Postop | Preop | Postop | |
| 3-month | 0.05 | 0.51 | 0.58 | 0.12 | 0.55 | 0.08 | 0.33 |
| 12-month | 0.07 | 0.55 | 0.68 | 0.13 | 0.67 | 0.08 | 0.53 |
| 24-month | 0.07 | 0.61 | 0.76 | 0.09 | 0.67 | 0.04 | 0.59 |
Abbreviations: OKS: Oxford Knee Score; Preop: before operation; Postop: after operation.
Minimal important change (MIC), patient acceptable symptom state (PASS), and treatment failure (TF) cut-off values calculated with the adjusted predictive modeling method for the Oxford Knee Score at 3, 12, and 24 months after unicompartmental knee arthroplasty
| Follow-up | n | MIC value (CI) | PASS value (CI) | TF value (CI) |
|---|---|---|---|---|
| 3 months | 331 | 4.7 (3.3–6.0) | 28.9 (27.6–30.3) | 24.4 (20.7–27.4) |
| 12 months | 340 | 7.1 (5.2–8.6) | 32.7 (31.5–33.9) | 29.3 (27.3–31.1) |
| 24 months | 235 | 5.4 (3.4–7.3) | 31.3 (29.1–33.3) | 28.5 (26.0–30.5) |
95% confidence intervals (CI) are the 0.025–0.975 quantiles of the 1,000 bootstrap threshold values.
Mean difference in minimal important change (MIC), patient acceptable symptom state (PASS), and treatment failure (TF) across follow-up time-points after unicompartmental knee arthroplasty for the OKS. Values are mean difference obtained from adjusted predictive modeling. Values in parentheses are 95% confidence interval, calculated using 1,000-replication bootstrapping and reported as 0.025–0.975 quantiles
| OKS follow-up between months | MIC | PASS | TF |
|---|---|---|---|
| 3 and 12 | –2.3 (–4.3 to –0.2) | –3.8 (–5.6 to –2.0) | –5.1 (–8.9 to –1.4) |
| 12 and 24 | 1.6 (–1.0 to 4.2) | 1.4 (–1.0 to 3.9) | 0.8 (–2.1 to 3.8) |
| 3 and 24 | –0.7 (–3.1 to 1.9) | –2.4 (–4.6 to 0.1) | –4.3 (–8.4 to –0.3) |
OKS: Oxford Knee Score.
Baseline dependency of minimal important change (MIC), patient acceptable symptom state (PASS), and treatment failure (TF) cut-off OKS values calculated with adjusted predictive modeling using a baseline dependency method. Values are adjusted predictive value with 95% confidence interval in parentheses calculated using 1,000-replication bootstrapping and reported as 0.025–0.975 quantiles
| OKS follow-up | Low baseline | High baseline | Difference |
|---|---|---|---|
| MIC | |||
| 3-month | 7.2 (5.6–8.8) | 2.5 (0.3–4.1) | 4.7 (2.7–7.3) |
| 12-month | 9.1 (7.0–11.2) | 5.1 (2.6–6.8) | 4.0 (1.6–7.2) |
| 24-month | 8.0 (5.3–10.7) | 2.7 (-0.5–4.4) | 5.3 (2.8–9.6) |
| PASS | |||
| 3-month | 26.6 (24.8–28.5) | 31.4 (29.5–33.0) | 4.7 (2.0–7.2) |
| 12-month | 30.0 (28.1–31.9) | 35.3 (33.4–36.7) | 5.4 (2.5–7.7) |
| 24-month | 29.0 (24.9–32.0) | 33.9 (31.2–35.6) | 5.0 (0.6–9.2) |
| TF | |||
| 3-month | 21.5 (16.0–25.8) | 27.9 (21.5–31.9) | 6.4 (–0.9–13.5) |
| 12-month | 26.4 (23.1–29.1) | 31.8 (28.9–33.8) | 5.4 (1.3–9.1) |
| 24-month | 26.0 (21.7–28.8) | 31.8 (28.1–33.8) | 5.8 (1.0–10.2) |
OKS: Oxford Knee Score.
Minimal important change (MIC), patient acceptable symptom state (PASS), and treatment failure (TF) OKS thresholds obtained from adjusted predictive modeling, unadjusted predictive modeling, and ROC statistics. Values in parentheses are 95% confidence interval, calculated using 1,000-replication bootstrapping and reported as 0.025–0.975 quantiles
| OKS follow-up | Modeling approach | ||
|---|---|---|---|
| Adjusted Adjusted | Unadjusted predictive | ROC statistics | |
| MIC | |||
| 3-month | 4.7 (3.3–6.0) | 7.0 (5.7–8.1) | 11.5 (3.5–13.5) |
| 12-month | 7.1 (5.2–8.6) | 9.6 (8.0–11.0) | 10.5 (5.5–10.5) |
| 24-month | 5.4 (3.4–7.3) | 8.3 (6.4–9.9) | 7.5 (5.5–7.5) |
| PASS | |||
| 3-month | 28.9 (27.6–30.3) | 30.8 (29.7–32.0) | 30.5 (27.5–36.5) |
| 12-month | 32.7 (31.5–33.9) | 34.8 (33.7–35.8) | 35.5 (34.5–36.5) |
| 24-month | 31.3 (29.1–33.3) | 33.7 (31.7–35.4) | 34.5 (29.0–34.5) |
| TF | |||
| 3-month | 24.4 (20.7–27.4) | 27.8 (24.5–30.5) | 28.5 (18.5–35.5) |
| 12-month | 29.3 (27.3–31.1) | 32.3 (30.6–33.9) | 35.5 (29.5–35.5) |
| 24-month | 28.5 (26.0–30.5) | 31.5 (29.3–33.3) | 33.5 (27.5–33.5) |
OKS: Oxford Knee Score; ROC: receiver operating characteristic.