Independent of efficacy, information on safety of surgical procedures is essential for informed choices. We seek to develop standardized methodology for describing the safety of spinal operations and apply these methods to study lumbar surgery. We present a conceptual model for evaluating the safety of spine surgery and describe development of tools to measure principal components of this model: (1) specifying outcome by explicit criteria for adverse event definition, mode of ascertainment, cause, severity, or preventability, and (2) quantitatively measuring predictors such as patient factors, comorbidity, severity of degenerative spine disease, and invasiveness of spine surgery.We created operational definitions for 176 adverse occurrences and established multiple mechanisms for reporting them. We developed new methods to quantify the severity of adverse occurrences, degeneration of lumbar spine, and invasiveness of spinal procedures. Using kappa statistics and intra-class correlation coefficients, we assessed agreement for the following: four reviewers independently coding etiology, preventability, and severity for 141 adverse occurrences, two observers coding lumbar spine degenerative changes in 10 selected cases, and two researchers coding invasiveness of surgery for 50 initial cases.During the first six months of prospective surveillance, rigorous daily medical record reviews identified 92.6% of the adverse occurrences we recorded, and voluntary reports by providers identified 38.5% (surgeons reported 18.3%, inpatient rounding team reported 23.1%, and conferences discussed 6.1%). Trained observers had fair agreement in classifying etiology of 141 adverse occurrences into 18 categories (kappa = 0.35), but agreement was substantial (kappa > or = 0.61) for 4 specific categories: technical error, failure in communication, systems failure, and no error. Preventability assessment had moderate agreement (mean weighted kappa = 0.44). Adverse occurrence severity rating had fair agreement (mean weighted kappa = 0.33) when using a scale based on the JCAHO Sentinel Event Policy, but agreement was substantial for severity ratings on a new 11-point numerical severity scale (ICC = 0.74). There was excellent inter-rater agreement for a lumbar degenerative disease severity score (ICC = 0.98) and an index of surgery invasiveness (ICC = 0.99).Composite measures of disease severity and surgery invasiveness may allow development of risk-adjusted predictive models for adverse events in spine surgery. Standard measures of adverse events and risk adjustment may also facilitate post-marketing surveillance of spinal devices, effectiveness research, and quality improvement.
Epidural glucocorticoid injections are widely used to treat symptoms of lumbar spinal stenosis, a common cause of pain and disability in older adults. However, rigorous data are lacking regarding the effectiveness and safety of these injections.In a double-blind, multisite trial, we randomly assigned 400 patients who had lumbar central spinal stenosis and moderate-to-severe leg pain and disability to receive epidural injections of glucocorticoids plus lidocaine or lidocaine alone. The patients received one or two injections before the primary outcome evaluation, performed 6 weeks after randomization and the first injection. The primary outcomes were the score on the Roland-Morris Disability Questionnaire (RMDQ, in which scores range from 0 to 24, with higher scores indicating greater physical disability) and the rating of the intensity of leg pain (on a scale from 0 to 10, with 0 indicating no pain and 10 indicating "pain as bad as you can imagine").At 6 weeks, there were no significant between-group differences in the RMDQ score (adjusted difference in the average treatment effect between the glucocorticoid-lidocaine group and the lidocaine-alone group, -1.0 points; 95% confidence interval [CI], -2.1 to 0.1; P=0.07) or the intensity of leg pain (adjusted difference in the average treatment effect, -0.2 points; 95% CI, -0.8 to 0.4; P=0.48). A prespecified secondary subgroup analysis with stratification according to type of injection (interlaminar vs. transforaminal) likewise showed no significant differences at 6 weeks.In the treatment of lumbar spinal stenosis, epidural injection of glucocorticoids plus lidocaine offered minimal or no short-term benefit as compared with epidural injection of lidocaine alone. (Funded by the Agency for Healthcare Research and Quality; ClinicalTrials.gov number, NCT01238536.).
There are contradictory findings about whether there are differences in personality and/or amount of emotional disturbance between patients with functional versus organic low back pain. The MMPI scores of 42 back pain patients diagnosed as "organic" were compared with the scores of 37 patients classified as "functional". The functional patients scored significantly higher than the organics on the Hs, Hy, Pd, Sc, Ma, and Si scales. The organics scored significantly higher than the functional on the K scale. The results confirm the view that certain symptoms of emotional disturbance are more characteristic of patients who have relatively little evidence of physical findings. However, the degree of overlap between groups was high enough to suggest caution in making predictions and diagnoses about functional versus organic pain on individual patients solely on the basis of personality data.
Multidisciplinary Pain Center, Departments of Psychiatry and Behavioral Sciences, and Rehabilitation Medicine, University of Washington, Seattle, WA 98195 U.S.A.
Objective: To assess the frequency of use of different treatments and pain management strategies and their perceived helpfulness in male patients with pelvic pain. Methods: Approximately 1 month after a health maintenance oganization visit for pelvic pain, 286 men (mean age 46.7 years) completed telephone interviews about their symptoms and treatments and pain management strategies used in the past year. Participants rated the helpfulness of each treatment and strategy used on 0 to 10 scales. Results: Even though men with identified bacterial etiology were excluded from the study, antibiotic medication was the most commonly reported treatment (67% of patients) and rated as the second most helpful treatment [mean (SD) = 6.3 (3.6)]. Opiates were rated as the most helpful treatment on average [mean (SD) = 7.9 (2.1)], but were used by only 12% of patients. Substantial minorities of patients reported several behaviors as helpful, including urinating (reported as helpful by 26%), taking warm baths (23%), and drinking water (23%), although patterns of effects differed for men with versus without urinary symptoms. Activities most commonly reported as worsening symptoms were sitting (42%), walking/jogging (27%), and sexual activity (25%). Discussion: Patients with male pelvic pain syndrome are commonly prescribed antibiotics, which they perceive as moderately helpful, despite the lack of scientific evidence of efficacy. Clinicians may find it useful to support patient use of safe, inexpensive, self-management approaches, especially warm baths, increased water intake, and avoidance of prolonged sitting.
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