Medical use and combination drug therapy among US adult users of central nervous system stimulants: a cross-sectional analysis.

OBJECTIVE: Examine patterns of adult medical use of amphetamine and methylphenidate stimulant drugs, classified in the USA as Schedule II controlled substances with a high potential for psychological or physical dependence. DESIGN: Cross-sectional study. SETTING AND PARTICIPANTS: Prescription drug claims for US adults, age 19-64 years, included in a commercial insurance claims database with 9.1 million continuously enrolled adults from 1 October 2019, through 31 December 2020. Stimulant use was defined as adults filling one or more stimulant prescriptions during calendar 2020. OUTCOME MEASURES: The primary outcome was an outpatient prescription claim, service date and days' supply for central nervous system (CNS)-active drugs. Combination-2 was defined as 60 days or more of combination treatment with a Schedule II stimulant and one or more additional CNS-active drugs. Combination-3 therapy was defined as the addition of 2 or more additional CNS-active drugs. Using service date and days' supply, we examined the number of stimulant and other CNS-active drugs for each of the 366 days of 2020. RESULTS: Among 9 141 877 continuously enrolled adults, the study identified 276 223 individuals (3.0%) using Schedule II stimulants during 2020. They filled a median of 8 (IQR, 4-11) prescriptions for these stimulant drugs that provided 227 (IQR, 110-322) treatment days of exposure. Among this group, 125 781 (45.5%) combined use of one or more additional CNS active drugs for a median of 213 (IQR, 126-301) treatment days. Also, 66 996 (24.3%) stimulant users used two or more additional CNS-active drugs for a median of 182 (IQR, 108-276) days. Among stimulants users, 131 485 (47.6%) were exposed to an antidepressant, 85 166 (30.8%) filled prescriptions for anxiety/sedative/hypnotic medications and 54 035 (19.6%) received opioid prescriptions. CONCLUSION: A large proportion of adults using Schedule II stimulants are simultaneously exposed to one or more other CNS-active drugs, many with tolerance, withdrawal effects or potential for non-medical use. There are no approved indications and limited clinical trial testing of these multi-drug combinations, and discontinuation may be challenging.

How to predict return to work after lumbar discectomy: answers from the NeuroPoint-SD registry.

OBJECTIVE 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. METHODS 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. RESULTS 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). CONCLUSIONS 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 ).

Predictive value of 3-month lumbar discectomy outcomes in the NeuroPoint-SD Registry.

OBJECT: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.

Postoperative cervical sagittal imbalance negatively affects outcomes after surgery for cervical spondylotic myelopathy.

STUDY DESIGN: Prospective observational cohort study. OBJECTIVE: To determine if postoperative cervical sagittal balance is an independent predictor of health-related quality of life outcome after surgery for cervical spondylotic myelopathy. SUMMARY OF BACKGROUND DATA: Both ventral and dorsal fusion procedures for CSM are effective at reducing the symptoms of myelopathy. The importance of cervical sagittal balance in predicting overall health-related quality of life outcome after ventral versus dorsal surgery for CSM has not been previously explored. METHODS: A prospective, nonrandomized cohort of 49 patients undergoing dorsal and ventral fusion surgery for CSM was examined. Preoperative and postoperative C2-C7 sagittal vertical axis was measured on standing lateral cervical spine radiographs. Outcome was assessed with 2 disease-specific measures-the modified Japanese Orthopedic Association scale and the Oswestry Neck Disability Index and 2 generalized outcome measures-the Short-Form 36 physical component summary (SF-36 PCS) and Euro-QOL-5D. Assessments were performed preoperatively, and at 3 months, 6 months, and 1 year postoperatively. Statistical analyses were performed using SAS version 9.3 (SAS Institute). RESULTS: Most patients experienced improvement in all outcome measures regardless of approach. Both preoperative and postoperative C2-C7 sagittal vertical axis measurements were independent predictors of clinically significant improvement in SF-36 PCS scores (P = 0.03 and P = 0.02). The majority of patients with C2-C7 sagittal vertical axis values greater than 40 mm did not improve from an overall health-related quality of life perspective (SF-36 PCS) despite improvement in myelopathy. The postoperative sagittal balance value was inversely correlated with a clinically significant improvement of SF-36 PCS scores in patients undergoing dorsal surgery but not ventral surgery (P = 0.03 vs. P = 0.93). CONCLUSION: Preoperative and postoperative sagittal balance measurements independently predict clinical outcomes after surgery for CSM. LEVEL OF EVIDENCE: 2.

Cost-effectiveness of lumbar discectomy and single-level fusion for spondylolisthesis: experience with the NeuroPoint-SD registry.

OBJECT: There is significant practice variation and uncertainty as to the value of surgical treatments for lumbar spine disorders. The authors' aim was to establish a multicenter registry to assess the efficacy and costs of common lumbar spinal procedures by using prospectively collected outcomes. METHODS: An observational prospective cohort study was completed at 13 academic and community sites. Patients undergoing single-level fusion for spondylolisthesis or single-level lumbar discectomy were included. The 36-Item Short Form Health Survey (SF-36) and Oswestry Disability Index (ODI) data were obtained preoperatively and at 1, 3, 6, and 12 months postoperatively. Power analysis estimated a sample size of 160 patients: lumbar disc (125 patients) and lumbar listhesis (35 patients). The quality-adjusted life year (QALY) data were calculated using 6-dimension utility index scores. Direct costs and complication costs were estimated using Medicare reimbursement values from 2011, and indirect costs were estimated using the human capital approach with the 2011 US national wage index. Total costs equaled $14,980 for lumbar discectomy and $43,852 for surgery for lumbar spondylolisthesis. RESULTS: There were 198 patients enrolled over 1 year. The mean age was 46 years (49% female) for lumbar discectomy (n = 148) and 58.1 years (60% female) for lumbar spondylolisthesis (n = 50). Ten patients with disc herniation (6.8%) and 1 with listhesis (2%) required repeat operation at 1 year. The overall 1-year follow-up rate was 88%. At 30 days, both lumbar discectomy and single-level fusion procedures were associated with significant improvements in ODI, visual analog scale, and SF-36 scores (p = 0.0002), which persisted at the 1-year evaluation (p < 0.0001). By 1 year, more than 80% of patients in each cohort who were working preoperatively had returned to work. Lumbar discectomy was associated with a gain of 0.225 QALYs over the 1-year study period ($66,578/QALY gained). Lumbar spinal fusion for Grade I listhesis was associated with a gain of 0.195 QALYs over the 1-year study period ($224,420/QALY gained). CONCLUSIONS: This national spine registry demonstrated successful collection of high-quality outcomes data for spinal procedures in actual practice. These data are useful for demonstrating return to work and cost-effectiveness following surgical treatment of single-level lumbar disc herniation or spondylolisthesis. One-year cost per QALY was obtained, and this cost per QALY is expected to improve further by 2 years. This work sets the stage for real-world analysis of the value of health interventions.

Cigarette smoking and the risk of dying from tobacco-related malignancies by race.

BACKGROUND: The aim was to investigate whether differential risks from cigarette smoking contribute to the disproportionate burden of tobacco-related malignancies other than lung cancer (TRM-nonLC) suffered by African Americans (AAs) compared to Caucasians. MATERIALS AND METHODS: Data from two prospective cohort studies (39% AAs) established in 1960 and followed through 1990 and 2000 in the southeastern U.S. were pooled (N=5,363). Each cohort had 30 years minimum follow-up. RESULTS: Compared to Caucasians, the association between cigarette smoking and TRM-nonLC was significantly weaker in the AA men (hazards ratio (HR) 1.0 in AA men versus 3.6 in Caucasian men) and non-significantly weaker in the AA women (HR 1.1 in AA women versus 2.7 in Caucasian women). CONCLUSION: In these study cohorts, differential susceptibility to tobacco-caused carcinogenesis was, by itself, an unlikely contributing factor to the racial disparity in tobacco-related malignancies.