TABLE 5. Subgroup Results from Adjusted* As-Treated Outcome Analysis by Diabetes for the Randomized and Observational Cohorts Combined Patients with Lumbar Lumbar.
| Outcome | 1-Yr | 2-Yr | 3-Yr | 4-Yr | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| IDH (RCT & OBS) | Diabetes | Surgical | Nonoperative | Treatment Effect,† OR (95% CI) |
Surgical | Nonoperative | Treatment Effect,† OR (95% CI) |
Surgical | Nonoperative | Treatment Effect,† OR (95% CI) |
Surgical | Nonoperative | Treatment Effect,† OR (95% CI) |
| Primary outcomes | |||||||||||||
| SF-36 bodily pain (0–100), mean (SE) |
Not diabetic | 33 (1.3) | 14 (1.5) | 19 (15.4 to 22.7) | 33.3 (1.3) | 13.2 (1.6) | 20.1 (16.2 to 24.1) | 33.9 (1.4) | 15.3 (1.8) | 18.6 (14.5 to 22.8) | 32.2 (1.5) | 15.5 (1.9) | 16.7 (12.2 to 21.2) |
| Diabetic‡ | 29.9 (3.9) | 12.5 (4.2) | 17.3 (6.7 to 28) | 21.9 (3.6) | 11.6 (4.5) | 10.3 (−0.3 to 20.9) | 22.7 (3.7) | 13.5 (4.9) | 9.2 (−2.3 to 20.7) | 27.3 (4.2) | 16.7 (5.3) | 10.6 (−2.1 to 23.3) | |
| P § | 0.44 | 0.74 | 0.77 | 0.003 | 0.74 | 0.085 | 0.004 | 0.74 | 0.13 | 0.27 | 0.83 | 0.37 | |
| SF-36 physical function (0–100), mean (SE) |
Not diaetic | 28.5 (1.3) | 10.9 (1.4) | 17.6 (14.2 to 21.1) | 27.3 (1.3) | 9.8 (1.6) | 17.4 (13.7 to 21.2) | 26.3 (1.3) | 8.7 (1.7) | 17.6 (13.7 to 21.6) | 27.7 (1.4) | 7.8 (1.8) | 19.9 (15.6 to 24.2) |
| Diabetic | 27.8 (3.8) | 8.6 (4.1) | 19.2 (9.1 to 29.4) | 16.1 (3.5) | 5.5 (4.3) | 10.6 (0.5 to 20.7) | 14.8 (3.6) | 9.9 (4.8) | 4.9 (−6.3 to 16) | 18.9 (4) | 8.7 (5.2) | 10.2 (−2.1 to 22.5) | |
| P | 0.86 | 0.59 | 0.77 | 0.003 | 0.34 | 0.21 | 0.002 | 0.81 | 0.032 | 0.037 | 0.87 | 0.14 | |
| Mental component summary (0–100), mean (SE) |
Not diabetic | 2.8 (0.5) | 1.5 (0.6) | 1.3 (−0.2 to 2.9) | 2.9 (0.5) | 1.2 (0.7) | 1.6 (0 to 3.3) | 2.7 (0.6) | 0.5 (0.7) | 2.2 (0.4 to 4) | 2.7 (0.6) | 0.4 (0.8) | 2.4 (0.4 to 4.3) |
| Diabetic | 4.9 (1.6) | 1.5 (1.7) | 3.4 (−1.1 to 7.8) | 0.7 (1.5) | −1.8 (1.9) | 2.5 (−2 to 7) | 0.6 (1.5) | −2.1 (2.1) | 2.7 (−2.2 to 7.6) | 0.1 (1.8) | −2.9 (2.4) | 3 (−2.7 to 8.7) | |
| P | 0.20 | 0.96 | 0.39 | 0.15 | 0.12 | 0.72 | 0.19 | 0.24 | 0.86 | 0.17 | 0.19 | 0.83 | |
| Oswestry Disability Index (0–100), mean (SE) |
Not diabetic | −24.8 (1) | −7.9 (1.1) | −16.9 (−19.5 to −14.2) | −24.7 (1) | −7.7 (1.2) | −17 (_19.9 to −14.1) | −22.6 (1) | −8.8 (1.3) | −13.8 (−16.9 to −10.8) | −23.5 (1.1) | −8 (1.4) | −15.6 (−18.9 to −12.3) |
| Diabetic | −27.5 (3) | −7.8 (3.2) | −19.7 (−27.6 to −11.9) | −18.5 (2.8) | −9.3 (3.4) | −9.2 (−17.2 to −1.3) | −16.9 (2.9) | −11.4 (3.6) | −5.5 (−13.9 to 3) | −20.3 (3.1) | −12.7 (4) | −7.6 (−17 to 1.9) | |
| P | 0.39 | 0.96 | 0.50 | 0.033 | 0.66 | 0.068 | 0.056 | 0.49 | 0.065 | 0.33 | 0.26 | 0.11 | |
| Very/somewhat satisfied with symptoms (%) |
Not diabetic | 71.9 | 26.8 | 45 (37.3 to 52.8) | 70.6 | 32.4 | 38.3 (29.6 to 47) | 66.9 | 37 | 30 (20.3 to 39.6) | 64.2 | 28.9 | 35.3 (25.3 to 45.4) |
| Diabetic | 81.4 | 30.8 | 50.6 (29.3 to 72) | 61.4 | 30.4 | 31 (7 to 55) | 62.4 | 28.9 | 33.5 (7.7 to 59.2) | 68.6 | 39.7 | 28.9 (−1 to 58.9) | |
| P | 0.28 | 0.67 | 0.59 | 0.29 | 0.86 | 0.60 | 0.63 | 0.51 | 0.81 | 0.67 | 0.44 | 0.71 | |
| Very/somewhat satisfied with care (%) |
Not diabetic | 89.8 | 67.6 | 22.2 (14.7 to 29.7) | 88.4 | 68.3 | 20.1 (11.7 to 28.4) | 88 | 65.4 | 22.6 (13.4 to 31.8) | 86.1 | 66.9 | 19.2 (9 to 29.4) |
| Diabetic | 90.3 | 75.2 | 15.1 (−4.2 to 34.4) | 93.3 | 57.8 | 35.5 (13.7 to 57.4) | 86.7 | 86.9 | −0.2 (−18 to 17.6) | 91.7 | 63.6 | 28.1 (1.8 to 54.5) | |
| P | 0.92 | 0.44 | 0.67 | 0.36 | 0.36 | 0.19 | 0.83 | 0.024 | 0.08 | 0.38 | 0.80 | 0.41 | |
| Self-rated progress major improvement (%) |
Not diabetic | 74.8 | 24.7 | 50.1 (42.6 to 57.6) | 74.7 | 23.6 | 51.1 (43.1 to 59.1) | 72.1 | 23.8 | 48.3 (39.8 to 56.8) | 66.9 | 19.1 | 47.8 (38.7 to 56.9) |
| Diabetic | 84.1 | 26.5 | 57.5 (37.2 to 77.9) | 63.2 | 19.5 | 43.8 (22.3 to 65.3) | 65.5 | 30.7 | 34.8 (9 to 60.5) | 76 | 32.5 | 43.5 (15.3 to 71.7) | |
| P | 0.23 | 0.86 | 0.50 | 0.18 | 0.68 | 0.68 | 0.44 | 0.55 | 0.35 | 0.34 | 0.28 | 0.75 | |
Adjusted for age, sex, body mass index, work status, income, smoking status, self-assessed health trend at baseline, treatment preference, baseline score (for SF-36, ODI), baseline stenosis bothersomeness, and center.
Treatment effect is the difference between the surgical and nonoperative mean change from baseline. Analysis is done by using a mixed model with a random subject intercept term. Treatment is a time-varying covariate where a patients’ experience before surgery is attributed to the nonoperative arm, and time is measured from enrollment; his/her postsurgery outcomes are attributed to the surgical arm, and time is measured from the time of surgery.
Patients who report being told by their doctors that they have diabetes and also report that they are currently receiving treatment for diabetes.
P values at each time-point are from multiple degree-of-freedom Wald tests.
CI indicates confidence interval; OBS, …; OR, odds ratio; RCT, …; SF-36, 36-Item Short Form Health Survey; SpS, spinal stenosis.