Surgical versus nonsurgical treatment for lumbar degenerative spondylolisthesis.

BACKGROUND: Management of degenerative spondylolisthesis with spinal stenosis is controversial. Surgery is widely used, but its effectiveness in comparison with that of nonsurgical treatment has not been demonstrated in controlled trials. METHODS: Surgical candidates from 13 centers in 11 U.S. states who had at least 12 weeks of symptoms and image-confirmed degenerative spondylolisthesis were offered enrollment in a randomized cohort or an observational cohort. Treatment was standard decompressive laminectomy (with or without fusion) or usual nonsurgical care. The primary outcome measures were the Medical Outcomes Study 36-Item Short-Form General Health Survey (SF-36) bodily pain and physical function scores (100-point scales, with higher scores indicating less severe symptoms) and the modified Oswestry Disability Index (100-point scale, with lower scores indicating less severe symptoms) at 6 weeks, 3 months, 6 months, 1 year, and 2 years. RESULTS: We enrolled 304 patients in the randomized cohort and 303 in the observational cohort. The baseline characteristics of the two cohorts were similar. The one-year crossover rates were high in the randomized cohort (approximately 40% in each direction) but moderate in the observational cohort (17% crossover to surgery and 3% crossover to nonsurgical care). The intention-to-treat analysis for the randomized cohort showed no statistically significant effects for the primary outcomes. The as-treated analysis for both cohorts combined showed a significant advantage for surgery at 3 months that increased at 1 year and diminished only slightly at 2 years. The treatment effects at 2 years were 18.1 for bodily pain (95% confidence interval [CI], 14.5 to 21.7), 18.3 for physical function (95% CI, 14.6 to 21.9), and -16.7 for the Oswestry Disability Index (95% CI, -19.5 to -13.9). There was little evidence of harm from either treatment. CONCLUSIONS: In nonrandomized as-treated comparisons with careful control for potentially confounding baseline factors, patients with degenerative spondylolisthesis and spinal stenosis treated surgically showed substantially greater improvement in pain and function during a period of 2 years than patients treated nonsurgically. (ClinicalTrials.gov number, NCT00000409 [ClinicalTrials.gov].)

Volume and process of care in high-risk cancer surgery The views expressed herein do not necessarily represent the views of Center for Medicare and Medicaid Services or the US Government.

BACKGROUND Although relations between procedure volume and operative mortality are well established for high-risk cancer operations, differences in clinical practice between high-volume and low-volume centers are not well understood. The current study was conducted to examine relations between hospital volume, process of care, and operative mortality in cancer surgery. METHODS Using the Medicare claims database (2000-2002), we identified all patients undergoing major resections for lung, esophageal, gastric, liver, or pancreatic cancer ( n = 71,558). Preoperative, intraoperative, and postoperative processes of care potentially related to operative mortality were identified from inpatient, outpatient, and physician claims files using appropriate International Classification of Diseases – Clinical Modification (ICD-9) and Current Procedural Terminology (CPT) codes. We then assessed variation in the use of each process according to hospital volume, adjusting for patient characteristics and procedure type. Study Participants were US Medicare patients. The main outcome measure was specific processes of care. RESULTS Relative to those at low-volume centers (lowest 20th by volume), patients at high-volume hospitals (highest 20th) were significantly more likely to undergo stress tests (odds ratio [OR]: 1.51, 95% confidence interval [CI]: 1.21-1.87), but not other preoperative imaging tests. They were more likely to see medical or radiation oncologists (OR: 1.37, 95% CI: 1.16-1.62), but not other specialists, preoperatively. Although blood transfusions and use of epidural pain management did not vary significantly by volume, patients at high-volume hospitals had significantly longer operations and were more likely to receive perioperative invasive monitoring (OR: 2.56, 95% CI: 1.82-3.60). Differences in measurable processes of care did not explain volume-related differences in operative mortality to any significant degree. CONCLUSIONS Although high-volume and low-volume hospitals differ with regard to many aspects of perioperative care, mechanisms underlying volume–outcome relations in high-risk cancer surgery remain to be identified. Cancer 2006. © 2006 American Cancer Society.Peer Reviewedhttp://deepblue.lib.umich.edu/bitstream/2027.42/55221/1/21888_ftp.pd