| Literature DB >> 23531640 |
Paul Licina1, Michelle Johnston, Laura Ewing, Mark Pearcy.
Abstract
STUDYEntities:
Year: 2012 PMID: 23531640 PMCID: PMC3592768 DOI: 10.1055/s-0032-1328138
Source DB: PubMed Journal: Evid Based Spine Care J ISSN: 1663-7976
Fig. 1Patient sampling and selection.
Patient characteristics and surgical procedures.*
| N = 145 | |
|---|---|
| Patient characteristics, No. (%) | |
| Age, y (mean ± SD) | 54 ± 15 |
| Male | 91 (63) |
| Privately insured | 117 (81) |
| Workers compensation | 22 (15) |
| Uninsured | 6 (4) |
| Surgical procedures, No. (%) | |
| Discectomy | 58 (40) |
| Laminectomy | 20 (14) |
| Laminectomy and posterolateral fusion | 27 (19) |
| TLIF | 27 (19) |
| ALIF | 13 (9) |
TLIF indicates transforaminal lumbar interbody fusion; ALIF, anterior lumbar interbody fusion.
Change in ODI and VAS at 6 weeks and 6 months after surgery.*
| Improved from baseline, No. (%) | Achieved clinical benefit, No. (%) | No improvement from baseline, No. (%) | Worse compared with baseline, No. (%) | |||||
|---|---|---|---|---|---|---|---|---|
| ODI | 138 (95) | 138 (95) | 95 (66) | 111 (77) | 2 (1) | 4 (3) | 5 (3) | 3 (2) |
| Back VAS | 130 (90) | 133 (92) | 105 (72) | 110 (76) | 7 (5) | 6 (4) | 8 (6) | 6 (4) |
| Leg VAS | 131 (90) | 130 (90) | 119 (82) | 124 (86) | 8 (6) | 9 (6) | 6 (4) | 6 (4) |
ODI indicates Oswestry Disability Index; VAS, Visual Analog Scale.
Average outcome and expectation scores of patients.*
| Preop | 6 wk | 6 mo | Expectation | |
|---|---|---|---|---|
| ODI | 51% | 22% | 17% | 14% |
| Back VAS | 5.8 | 2.1 | 1.7 | 1.5 |
| Leg VAS | 6.2 | 1.4 | 1.2 | 1.1 |
Preop indicates preoperative; ODI, Oswestry Disability Index; and VAS, Visual Analog Scale.
Fig. 2Patients' expected outcome scores recorded preoperatively. Numbers of patients in bands of expected values are shown to indicate the nature of the expectations. ODI indicates Oswestry Disability Index; VAS, Visual Analog Scale.
Percentage of patients who achieved actual (ΔAB) and clinically relevant expectations (ΔRB).*
| 6 wk, % | 6 mo, % | |||
|---|---|---|---|---|
| ΔAB | ΔRB | ΔAB | ΔRB | |
| ODI | 37 | 66 | 50 | 77 |
| Back VAS | 51 | 72 | 59 | 76 |
| Leg VAS | 62 | 82 | 63 | 86 |
ODI indicates Oswestry Disability Index; VAS, Visual Analog Scale.
Fig. 3Patients meeting or exceeding expectations (Oswestry Disability Index [ODI] and Visual Analog Scale [VAS] scores) at 6 months.
Outcome and expectations of “somewhat satisfied” patients compared with “very satisfied” and “satisfied” patients (P < .05 shaded).*
| Preoperative | 6 wk | 6 mo | Expectation | |
|---|---|---|---|---|
| Somewhat (n = 10) | 63% | 50% | 38% | 17% |
| Very satisfied and satisfied (n = 135) | 50% | 20% | 16% | 14% |
| Somewhat (n = 10) | 6.5 | 5.9 | 4.3 | 2.6 |
| Very satisfied and satisfied (n = 135) | 5.8 | 1.8 | 1.5 | 1.4 |
| Somewhat (n = 10) | 6.1 | 2.9 | 3 | 2 |
| Very satisfied and satisfied (n = 135) | 6.2 | 1.3 | 1.1 | 1.1 |
ODI indicates Oswestry Disability Index; VAS, Visual Analog Scale.
Comparison of “very satisfied” patient expectations (preoperative ODI or VAS score – expected ODI or VAS score) and satisfaction rates (> .05 for all groups).*
| Preoperative to expected change | Expected change | |||||
|---|---|---|---|---|---|---|
| Very high | Very low | Very high | Very low | Very high | Very low | |
| Very satisfied | 15/21 (71%) | 11/16 (69%) | 3/4 (75%) | 20/24 (83%) | 13/14 (93%) | 14/21 (67%) |
ODI indicates Oswestry Disability Index; VAS, Visual Analog Scale.
“Very satisfied” patients and the degree expectation exceeded or not reached (total number of patients, and percentages).*
| ODI | ODI | Back VAS | Back VAS | Leg VAS | Leg VAS | |
| “Very satisfied” | 12/18 (67%) | 9/15 (60%) | 5/9 (56%) | 10/19 (53%) | 5/10 (50%) | 11/18 (61%) |
ODI indicates Oswestry Disability Index; VAS, Visual Analog Scale.
| Final class of evidence-treatment | |
|---|---|
| Study design | |
| RCT | |
| Cohort | |
| Case control | |
| Case series | • |
| Methods | |
| Concealed allocation (RCT) | |
| Intention to treat (RCT) | |
| Blinded/independent evaluation of primary outcome | |
| F/U ≥ 85% | • |
| Adequate sample size | • |
| Control for confounding | |
| The definiton of the different classes of evidence is available on page 67. | |