Prolonged conservative treatment or 'early' surgery in sciatica caused by a lumbar disc herniation: rationale and design of a randomized trial [ISRCT 26872154]

BACKGROUND: The design of a randomized multicenter trial is presented on the effectiveness of a prolonged conservative treatment strategy compared with surgery in patients with persisting intense sciatica (lumbosacral radicular syndrome). METHODS/DESIGN: Patients presenting themselves to their general practitioner with disabling sciatica lasting less than twelve weeks are referred to the neurology outpatient department of one of the participating hospitals. After confirmation of the diagnosis and surgical indication MRI scanning is performed. If a distinct disc herniation is discerned which in addition covers the clinically expected site the patient is eligible for randomization. Depending on the outcome of the randomization scheme the patient will either be submitted to prolonged conservative care or surgery. Surgery will be carried out according to the guidelines and between six and twelve weeks after onset of complaints. The experimental therapy consists of a prolonged conservative treatment under supervision of the general practitioner, which may be followed by surgical intervention in case of persisting or progressive disability. The main primary outcome measure is the disease specific disability of daily functioning. Other primary outcome measures are perceived recovery and intensity of legpain. Secondary outcome measures encompass severity of complaints, quality of life, medical consumption, absenteeism, costs and preference. The main research question will be answered at 12 months after randomization. The total follow-up period covers two years. DISCUSSION: Evidence is lacking concerning the optimal treatment of lumbar disc induced sciatica. This pragmatic randomized trial, focusses on the 'timing' of intervention, and will contribute to the decision of the general practictioner and neurologist, regarding referral of patients for surgery

How do validated measures of functional outcome compare with commonly used outcomes in administrative database research for lumbar spinal surgery?

Clinical interpretation of health services research based on administrative databases is limited by the lack of patient-reported functional outcome measures. Reoperation, as a surrogate measure for poor outcome, may be biased by preferences of patients and surgeons and may even be planned a priori. Other available administrative data outcomes, such as postoperative cross sectional imaging (PCSI), may better reflect changes in functional outcome. The purpose was to determine if postoperative events captured from administrative databases, namely reoperation and PCSI, reflect outcomes as derived by validated functional outcome measures (short form 36 scores, Oswestry disability index) for patients who underwent discretionary surgery for specific degenerative conditions of the lumbar spine such as disc herniation, spinal stenosis, degenerative spondylolisthesis, and isthmic spondylolisthesis. After reviewing the records of all patients surgically treated for disc herniation, spinal stenosis, degenerative spondylolisthesis, and isthmic spondylolisthesis at our institution, we recorded the occurrence of PCSI (MRI or CT-myelograms) and reoperations, as well as demographic, surgical, and functional outcome data. We determined how early (within 6 months) and intermediate (within 18 months) term events (PCSI and reoperations) were associated with changes in intermediate (minimum 1 year) and late (minimum 2 years) term functional outcome, respectively. We further evaluated how early (6–12 months) and intermediate (12–24 months) term changes in functional outcome were associated with the subsequent occurrence of intermediate (12–24 months) and late (beyond 24 months) term adverse events, respectively. From 148 surgically treated patients, we found no significant relationship between the occurrence of PCSI or reoperation and subsequent changes in functional outcome at intermediate or late term. Similarly, earlier changes in functional outcome did not have any significant relationship with subsequent occurrences of adverse events at intermediate or late term. Although it may be tempting to consider administrative database outcome measures as proxies for poor functional outcome, we cannot conclude that a significant relationship exists between the occurrence of PCSI or reoperation and changes in functional outcome

U.S. Physicians’ Views on Financing Options to Expand Health Insurance Coverage: A National Survey

Background: Physician opinion can influence the prospects for health care reform, yet there are few recent data on physician views on reform proposals or access to medical care in the United States. Objective: To assess physician views on financing options for expanding health care coverage and on access to health care. Design and Participants: Nationally representative mail survey conducted between March 2007 and October 2007 of U.S. physicians engaged in direct patient care. Measurements: Rated support for reform options including financial incentives to induce individuals to purchase health insurance and single-payer national health insurance; rated views of several dimensions of access to care. Main results: 1,675 of 3,300 physicians responded (50.8%). Only 9% of physicians preferred the current employer-based financing system. Forty-nine percent favored either tax incentives or penalties to encourage the purchase of medical insurance, and 42% preferred a government-run, taxpayer-financed single-payer national health insurance program. The majority of respondents believed that all Americans should receive needed medical care regardless of ability to pay (89%); 33% believed that the uninsured currently have access to needed care. Nearly one fifth of respondents (19.3%) believed that even the insured lack access to needed care. Views about access were independently associated with support for single-payer national health insurance. Conclusions: The vast majority of physicians surveyed supported a change in the health care financing system. While a plurality support the use of financial incentives, a substantial proportion support single payer national health insurance. These findings challenge the perception that fundamental restructuring of the U.S. health care financing system receives little acceptance by physicians

The cost–utility of lumbar disc herniation surgery

The cost and utility of surgery for a herniated lumbar disc has not been determined simultaneously in a single cohort. The aim of this study is to perform a cost–utility analysis of surgical and nonsurgical treatment of patients with lumbar disc herniation. Ninety-two individuals in a cohort of 1,146 Swedish subjects underwent lumbar disc herniation surgery during a 2-year study. Each person operated on was individually matched with one treated conservatively. The effects and costs of the treatments were determined individually. By estimating quality of life before and after the treatment, the number of quality adjusted life years (QALY) gained with and without surgery was calculated. The medical costs were much higher for surgical treatment; however, the total costs, including disability costs, were lower among those treated surgically. Surgery meant fewer recurrences and less permanent disability benefits. The gain in QALY was ten times higher among those operated. Lower total costs and better utility resulted in a better cost utility for surgical treatment. Surgery for lumbar disc herniation was cost-effective. The total costs for surgery were lower due to lower recurrence rates and fewer disability benefits, and surgery improved quality of life much more than nonsurgical treatments

A decade's experience in lumbar spine surgery in Belgium: sickness fund beneficiaries, 2000-2009.

PURPOSE: The purpose is to study rates, trends, geographic variations and outcome of lumbar spine surgery in the Belgian population during the last decade. METHODS: This is a retrospective cohort study using administrative data of the largest Belgian sickness fund from January 1, 2000 through December 31, 2009. Cases included lumbar laminectomy, combined discectomy and fusion, posterior interarticular fusion, anterior lumbar interbody fusion (ALIF), posterior lumbar interbody fusion (PLIF) and standard discectomy. The main outcome measures were age- and sex-adjusted rates of lumbar spine surgery, 1-year mortality, 1-year iterative surgery, no return to work (RTW) rate 1 year after surgery and length of hospital stay. Multivariate logistic regression analysis was used to determine the association between age, sex, geographic region, type of surgery, year of intervention and duration of pre-operative sick leave on outcome. RESULTS: Spine surgery rates rose 44 % from 2001 through 2009 and data for 2009 showed twofold variations in spine surgery rates among 10 Belgian provinces. Reported 1-year mortality varied from 0.6 to 2.5 % among surgical procedures performed in 2008. The overall 5-year reoperation rate was 12 %. RTW rates 1 year after standard discectomy, ALIF, PLIF and combined discectomy and fusion for the follow-up sample of 2008 were 14.4, 22.7, 26.1 and 30.6 %, respectively. The median length of hospital stay significantly decreased throughout the decade. Type of surgery and geographic region were significantly related to patient outcomes. CONCLUSIONS: Regional variations highlight professional uncertainty and controversy. The study results point to the need for peer comparisons and surgeon feedback.JOURNAL ARTICLEinfo:eu-repo/semantics/publishe

Health economic evaluation in lumbar spinal fusion: a systematic literature review anno 2005

The goal of this systematic literature review was to assess the evidence for cost-effectiveness of various surgical techniques in lumbar spinal fusion in conformity with the guidelines provided by the Cochrane Back Review Group. As new technology continuously emerges and divergent directions in clinical practice are present, economic evaluation is needed in order to facilitate the decision-makers’ budget allocations. NHS Economic Evaluation Database, MEDLINE, EMBASE and Cochrane Library were searched. Two independent reviewers (one clinical content expert and one economic content expert) applied the eligibility criteria. A list of criteria for methodological quality assessment was established by merging the criteria recommended by leading health economists with the criteria recommended by the Cochrane Back Review Group. The two reviewers independently scored the selected literature and the disagreement was resolved by means of consensus following discussion. Key data were extracted and the level of evidence concluded. Seven studies were eligible; these studies reflected the diversified choices of economic methodology, study populations (diagnosis), outcome measures and comparators. At the conclusion of quality assessment, the methodological quality of three studies was judged credible. Two studies investigated posteolateral fusion (PLF) ± instrumentation in different populations: one investigated non-specific low back pain and one investigated degenerative stenosis + spondylolisthesis. Both studies reflected that cost-effectiveness of instrumentation in PLF is not convincing. The third study concerned the question of circumferential vs anterior lumbar interbody fusion and found a non-significant difference between the techniques. In conclusion, the literature is limited and, in view of the fact that the clinical effects are statistically synonymous, it does not support the use of high-cost techniques. There is a great potential for improvement of methodological quality in economic evaluations of lumbar spinal fusion and further research is imperative