JNSPG 75th Anniversary Invited Review Article
Zoher Ghogawala, Melissa R. Dunbar and Irfan Essa
There are a wide variety of comparative treatment options in neurosurgery that do not lend themselves to traditional randomized controlled trials. The object of this article was to examine how clinical registries might be used to generate new evidence to support a particular treatment option when comparable options exist. Lumbar spondylolisthesis is used as an example.
The authors reviewed the literature examining the comparative effectiveness of decompression alone versus decompression with fusion for lumbar stenosis with degenerative spondylolisthesis. Modern data acquisition for the creation of registries was also reviewed with an eye toward how artificial intelligence for the treatment of lumbar spondylolisthesis might be explored.
Current randomized controlled trials differ on the importance of adding fusion when performing decompression for lumbar spondylolisthesis. Standardized approaches to extracting data from the electronic medical record as well as the ability to capture radiographic imaging and incorporate patient-reported outcomes (PROs) will ultimately lead to the development of modern, structured, data-filled registries that will lay the foundation for machine learning.
There is a growing realization that patient experience, satisfaction, and outcomes are essential to improving the overall quality of spine care. There is a need to use practical, validated PRO tools in the quest to optimize outcomes within spine care. Registries will be designed to contain robust clinical data in which predictive analytics can be generated to develop and guide data-driven personalized spine care.
Zoher Ghogawala, Daniel K. Resnick, Steven D. Glassman, James Dziura, Christopher I. Shaffrey and Praveen V. Mummaneni
Paul M. Arnold, Zoher Ghogawala and Candan Tamerler
Khoi D. Than, Jill N. Curran, Daniel K. Resnick, Christopher I. Shaffrey, Zoher Ghogawala and Praveen V. Mummaneni
To date, the factors that predict whether a patient returns to work after lumbar discectomy are poorly understood. Information on postoperative work status is important in analyzing the cost-effectiveness of the procedure.
An observational prospective cohort study was completed at 13 academic and community sites (NeuroPoint–Spinal Disorders [NeuroPoint-SD] registry). Patients undergoing single-level lumbar discectomy were included. Variables assessed included age, sex, body mass index (BMI), SF-36 physical function score, Oswestry Disability Index (ODI) score, presence of diabetes, smoking status, systemic illness, workers' compensation status, and preoperative work status. The primary outcome was working status within 3 months after surgery. Stepwise logistic regression analysis was performed to determine which factors were predictive of return to work at 3 months following discectomy.
There were 127 patients (of 148 total) with data collected 3 months postoperatively. The patients' average age at the time of surgery was 46 ± 1 years, and 66.9% of patients were working 3 months postoperatively. Statistical analyses demonstrated that the patients more likely to return to work were those of younger age (44.5 years vs 50.5 years, p = 0.008), males (55.3% vs 28.6%, p = 0.005), those with higher preoperative SF-36 physical function scores (44.0 vs 30.3, p = 0.002), those with lower preoperative ODI scores (43.8 vs 52.6, p = 0.01), nonsmokers (83.5% vs 66.7%, p = 0.03), and those who were working preoperatively (91.8% vs 26.2%, p < 0.0001). When controlling for patients who were working preoperatively (105 patients), only age was a statistically significant predictor of postoperative return to work (44.1 years vs 51.1 years, p = 0.049).
In this cohort of lumbar discectomy patients, preoperative working status was the strongest predictor of postoperative working status 3 months after surgery. Younger age was also a predictor. Factors not influencing return to work in the logistic regression analysis included sex, BMI, SF-36 physical function score, ODI score, presence of diabetes, smoking status, and systemic illness.
Clinical trial registration no.: 01220921 (clinicaltrials.gov)
Leah Y. Carreon, Steven D. Glassman, Zoher Ghogawala, Praveen V. Mummaneni, Matthew J. McGirt and Anthony L. Asher
Transforaminal lumbar interbody fusion (TLIF) has become the most commonly used fusion technique for lumbar degenerative disorders. This suggests an expectation of better clinical outcomes with this technique, but this has not been validated consistently. How surgical variables and choice of health utility measures drive the cost-effectiveness of TLIF relative to posterolateral fusion (PSF) has not been established. The authors used health utility values derived from Short Form-6D (SF-6D) and EQ-5D and different cost-effectiveness thresholds to evaluate the relative cost-effectiveness of TLIF compared with PSF.
From the National Neurosurgery Quality and Outcomes Database (N2QOD), 101 patients with spondylolisthesis who underwent PSF were propensity matched to patients who underwent TLIF. Health-related quality of life measures and perioperative parameters were compared. Because health utility values derived from the SF-6D and EQ-5D questionnaires have been shown to vary in patients with low-back pain, quality-adjusted life years (QALYs) were derived from both measures. On the basis of these matched cases, a sensitivity analysis for the relative cost per QALY of TLIF versus PSF was performed in a series of cost-assumption models.
Operative time, blood loss, hospital stay, and 30-day and 90-day readmission rates were similar for the TLIF and PSF groups. Both TLIF and PSF significantly improved back and leg pain, Oswestry Disability Index (ODI) scores, and EQ-5D and SF-6D scores at 3 and 12 months postoperatively. At 12 months postoperatively, patients who had undergone TLIF had greater improvements in mean ODI scores (30.4 vs 21.1, p = 0.001) and mean SF-6D scores (0.16 vs 0.11, p = 0.001) but similar improvements in mean EQ-5D scores (0.25 vs 0.22, p = 0.415) as patients treated with PSF. At a cost per QALY threshold of $100,000 and using SF-6D–based QALYs, the authors found that TLIF would be cost-prohibitive compared with PSF at a surgical cost of $4830 above that of PSF. However, with EQ-5D–based QALYs, TLIF would become cost-prohibitive at an increased surgical cost of $2960 relative to that of PSF. With the 2014 US per capita gross domestic product of $53,042 as a more stringent cost-effectiveness threshold, TLIF would become cost-prohibitive at surgical costs $2562 above that of PSF with SF-6D–based QALYs or at a surgical cost exceeding that of PSF by $1570 with EQ-5D–derived QALYs.
As with all cost-effectiveness studies, cost per QALY depended on the measure of health utility selected, durability of the intervention, readmission rates, and the accuracy of the cost assumptions.
Anthony L. Asher, Matthew J. McGirt and Zoher Ghogawala
Robert G. Whitmore, Jill N. Curran, Zarina S. Ali, Praveen V. Mummaneni, Christopher I. Shaffrey, Robert F. Heary, Michael G. Kaiser, Anthony L. Asher, Neil R. Malhotra, Joseph S. Cheng, John Hurlbert, Justin S. Smith, Subu N. Magge, Michael P. Steinmetz, Daniel K. Resnick and Zoher Ghogawala
The authors have established a multicenter registry to assess the efficacy and costs of common lumbar spinal procedures using prospectively collected outcomes. Collection of these data requires an extensive commitment of resources from each site. The aim of this study was to determine whether outcomes data from shorter-interval follow-up could be used to accurately estimate long-term outcome following lumbar discectomy.
An observational prospective cohort study was completed at 13 academic and community sites. Patients undergoing single-level lumbar discectomy for treatment of disc herniation were included. SF-36 and Oswestry Disability Index (ODI) data were obtained preoperatively and at 1, 3, 6, and 12 months postoperatively. Quality-adjusted life year (QALY) data were calculated using SF-6D utility scores. Correlations among outcomes at each follow-up time point were tested using the Spearman rank correlation test.
One hundred forty-eight patients were enrolled over 1 year. Their mean age was 46 years (49% female). Eleven patients (7.4%) required a reoperation by 1 year postoperatively. The overall 1-year follow-up rate was 80.4%. Lumbar discectomy was associated with significant improvements in ODI and SF-36 scores (p < 0.0001) and with a gain of 0.246 QALYs over the 1-year study period. The greatest gain occurred between baseline and 3-month follow-up and was significantly greater than improvements obtained between 3 and 6 months or 6 months and 1 year(p < 0.001). Correlations between 3-month, 6-month, and 1-year outcomes were similar, suggesting that 3-month data may be used to accurately estimate 1-year outcomes for patients who do not require a reoperation. Patients who underwent reoperation had worse outcomes scores and nonsignificant correlations at all time points.
This national spine registry demonstrated successful collection of high-quality outcomes data for spinal procedures in actual practice. Three-month outcome data may be used to accurately estimate outcome at future time points and may lower costs associated with registry data collection. This registry effort provides a practical foundation for the acquisition of outcome data following lumbar discectomy.